Sleep

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Questions about sleep – from newborns to teenagers – are among the most common in pediatric practice. A good night’s sleep is in everyone’s best interest for daily functioning and healthy development. Asking about sleep also provides a window into the family’s perspectives on discipline, parental cooperation, family stresses, and views on a child’s developing autonomy.

During their first year, infants may need as many as 18 hours of sleep daily, and the duration of sleep gradually declines thereafter to 8-10 hours nightly in adolescence. Sleep plays an essential role in consolidating memories, attention, and other cognitive functions; the immune system; and metabolism. Additionally, developing healthy sleep habits is one of the first and most profound ways that children learn to expect consistency from their parents, to soothe themselves, and to manage limits. As a child grows, her ability to plan, manage anxiety, and exercise discipline is cultivated through managing her sleep with increasing independence.

Dr. Susan D. Swick

Preschoolers who are not getting adequate sleep may have behavioral problems, particularly in new settings (like school) or at transitional times (like bedtime). When a preschooler presents with hyperactivity, irritability, and tantrums, or failure to keep up with developmental expectations, asking about sleep patterns is a good early step. Although sleep disruption may be symptomatic of psychiatric disorders related to mood, anxiety, or attention, before you consider a disorder and treatment make sure that tensions at bedtime and poor sleeping habits are not a major factor.

How do you help tired, stressed parents encourage or enforce healthy sleep habits? Does the family have a routine after dinner that allows a child to settle down (such as taking a bath and then a quiet activity like reading a book with a parent)? Are the parents able to enforce this routine consistently, or does bedtime get dragged out for hours? And if so, why? In addition to ensuring that a child gets enough exercise during the day (but not in the hour before bed), parents will need to turn off the lights at a reasonably early hour so that a child may get adequate sleep before they will awaken with daylight.

Many parents will delay sleep until later as children push to stay awake and play. Sometimes, if both parents work and feel their only time with their children is after they return from work well into the evening, they may want more time with their children or feel guilty about having a strict, early bedtime routine. Reassure parents that even a short stretch of quality time with their children (reading to them, snuggling, asking about their day) is enough to nurture a profound connection.

"Screen time" merits special mention, especially in younger children. Letting children watch television or play on computers in order to "unwind" at the end of a long day is common, but in the time before bed, screen content can be very disruptive to restful sleep. Parents should assess if "screen time" is helping or hurting their child’s ability to fall asleep. Some families have found it helpful to have no screen time (any screen: television, computer, tablet, or cell phone) within 1 hour of lights going out: back-lit screens suppress endogenous melatonin release and can delay sleep. With school-age children, reading at bedtime is certainly preferable to an additional hour of computer time.

It is also worth asking where a child is sleeping. Do they have their own bed? Are they alone in their room? Is their room on the same level of the house as their parents’ room? Children who are anxious may sleep better if they share a room with a sibling or are close to their parents’ room. On the other hand, if they sleep with a sibling who is waking often during the night, they may have disrupted sleep.

Dr. Michael Jellinek

It is worth finding out if a child is able to sleep through the night in their own bed. Many children have their own bed and room, but have a routine of sleeping in their parents’ bed. This usually results in inadequate sleep for both child and parents, and a child who does not learn how to appropriately soothe himself. Is it permissible for a child to climb into their parents’ bed in the middle of the night once in a while, if they have a bad dream, do not feel well, or have faced a stressful day? Yes. Is a child arguing to go to sleep in their parents’ bed, refusing to sleep in their own bed, with their parents "giving in"? Then it is a habit worth undoing.

 

 

School-age children who are not getting adequate sleep also may appear more irritable, forgetful, and inattentive, and they may have problems with academic, athletic, and social performance. These are years in which children start to have more independence and responsibility for their bedtime routines. They may have greater access to screens in the evening, and may be in charge of setting an alarm or turning their light out. These are also years in which children are more likely to experience anxiety, as they face and manage a host of new challenges. Anxiety can be very disruptive of restful sleep, and will in turn cause more problems about which these children get anxious. Alongside their greater responsibility, school-age children still need basic and consistently enforced ground rules about sleep in order to build independence. Clearly at this age, reading before bedtime is a good option.

Parents should help their school-age children to start their homework early, and to enjoy screen time, but not within an hour of bedtime, and to follow a consistent (and more independent) routine before bed. Do they have a consistent bedtime? Do they take a shower or bath each night? (A hot shower or bath naturally cues the body that it is time for sleep as the body’s core temperature rises and then drops.) Do they read before lights out? Is the house quiet at their bedtime? Parents should also find out if their children have worries that are making it difficult to go to sleep. Are they worried about a test or big game? Or about bigger issues of safety? Parents can help a child to discuss their worries and address those that are addressable; usually, this is enough to help children learn to master their worries. When a school-age child’s anxiety does not improve with open discussion, then it may be helpful to have a more formal evaluation for anxiety with a mental health clinician.

Adolescence is a time in which sleep patterns naturally shift, while the need for sleep remains robust. Teenagers become tired later and need to sleep in until later in the morning, just at the same time that school demands impinge on sleep with an earlier start to the day and more extensive homework at night. Older adolescents may go out with friends on weekends and shift their bedtime routine by 4 or more hours for two nights out of every seven, which is as profoundly disruptive to restful sleep as traveling across four time zones and back every week. These are years in which more independence can again lead to more screen use in the evening, whether for writing a paper on a computer or texting a friend late into the night.

An adolescent who is sleep deprived may have low energy, be forgetful and distractible, and see their academic and athletic performance suffer. They may appear more withdrawn or moody. This is an age in which serious mood problems, such as depression, are more likely to emerge, and are associated with sleep problems. But these problems will not improve with simple sleep hygiene interventions; thus, the teens who do not get better after these interventions may need a psychiatric evaluation.

The strategies that might help adolescents are not much different from those for younger children. It is important with adolescents, however, to explain why they should exercise regularly, have a consistent bedtime routine, and not bring their cell phone to bed. While parents should still be able to set and enforce ground rules, they also need to be equipping their adolescents to understand and manage their sleep independently, which they will need to do soon enough. Encouraging self-regulation between ages 13 and 17 is essential as college or independence approaches, and efforts at control are hard to enforce and send the wrong message.

Inconsistent, inadequate sleep often reflects what has been a frustrating struggle for parents. Asking questions about sleep gives parents the supportive message that sleep is challenging and important, and may empower them to approach it with renewed firmness and clarity. When you help parents to set routines and limits that support consistent, adequate sleep, their children will be on a path to healthy development.

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor of psychiatry and of pediatrics at Harvard Medical School, Boston. E-mail them at [email protected].

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Questions about sleep – from newborns to teenagers – are among the most common in pediatric practice. A good night’s sleep is in everyone’s best interest for daily functioning and healthy development. Asking about sleep also provides a window into the family’s perspectives on discipline, parental cooperation, family stresses, and views on a child’s developing autonomy.

During their first year, infants may need as many as 18 hours of sleep daily, and the duration of sleep gradually declines thereafter to 8-10 hours nightly in adolescence. Sleep plays an essential role in consolidating memories, attention, and other cognitive functions; the immune system; and metabolism. Additionally, developing healthy sleep habits is one of the first and most profound ways that children learn to expect consistency from their parents, to soothe themselves, and to manage limits. As a child grows, her ability to plan, manage anxiety, and exercise discipline is cultivated through managing her sleep with increasing independence.

Dr. Susan D. Swick

Preschoolers who are not getting adequate sleep may have behavioral problems, particularly in new settings (like school) or at transitional times (like bedtime). When a preschooler presents with hyperactivity, irritability, and tantrums, or failure to keep up with developmental expectations, asking about sleep patterns is a good early step. Although sleep disruption may be symptomatic of psychiatric disorders related to mood, anxiety, or attention, before you consider a disorder and treatment make sure that tensions at bedtime and poor sleeping habits are not a major factor.

How do you help tired, stressed parents encourage or enforce healthy sleep habits? Does the family have a routine after dinner that allows a child to settle down (such as taking a bath and then a quiet activity like reading a book with a parent)? Are the parents able to enforce this routine consistently, or does bedtime get dragged out for hours? And if so, why? In addition to ensuring that a child gets enough exercise during the day (but not in the hour before bed), parents will need to turn off the lights at a reasonably early hour so that a child may get adequate sleep before they will awaken with daylight.

Many parents will delay sleep until later as children push to stay awake and play. Sometimes, if both parents work and feel their only time with their children is after they return from work well into the evening, they may want more time with their children or feel guilty about having a strict, early bedtime routine. Reassure parents that even a short stretch of quality time with their children (reading to them, snuggling, asking about their day) is enough to nurture a profound connection.

"Screen time" merits special mention, especially in younger children. Letting children watch television or play on computers in order to "unwind" at the end of a long day is common, but in the time before bed, screen content can be very disruptive to restful sleep. Parents should assess if "screen time" is helping or hurting their child’s ability to fall asleep. Some families have found it helpful to have no screen time (any screen: television, computer, tablet, or cell phone) within 1 hour of lights going out: back-lit screens suppress endogenous melatonin release and can delay sleep. With school-age children, reading at bedtime is certainly preferable to an additional hour of computer time.

It is also worth asking where a child is sleeping. Do they have their own bed? Are they alone in their room? Is their room on the same level of the house as their parents’ room? Children who are anxious may sleep better if they share a room with a sibling or are close to their parents’ room. On the other hand, if they sleep with a sibling who is waking often during the night, they may have disrupted sleep.

Dr. Michael Jellinek

It is worth finding out if a child is able to sleep through the night in their own bed. Many children have their own bed and room, but have a routine of sleeping in their parents’ bed. This usually results in inadequate sleep for both child and parents, and a child who does not learn how to appropriately soothe himself. Is it permissible for a child to climb into their parents’ bed in the middle of the night once in a while, if they have a bad dream, do not feel well, or have faced a stressful day? Yes. Is a child arguing to go to sleep in their parents’ bed, refusing to sleep in their own bed, with their parents "giving in"? Then it is a habit worth undoing.

 

 

School-age children who are not getting adequate sleep also may appear more irritable, forgetful, and inattentive, and they may have problems with academic, athletic, and social performance. These are years in which children start to have more independence and responsibility for their bedtime routines. They may have greater access to screens in the evening, and may be in charge of setting an alarm or turning their light out. These are also years in which children are more likely to experience anxiety, as they face and manage a host of new challenges. Anxiety can be very disruptive of restful sleep, and will in turn cause more problems about which these children get anxious. Alongside their greater responsibility, school-age children still need basic and consistently enforced ground rules about sleep in order to build independence. Clearly at this age, reading before bedtime is a good option.

Parents should help their school-age children to start their homework early, and to enjoy screen time, but not within an hour of bedtime, and to follow a consistent (and more independent) routine before bed. Do they have a consistent bedtime? Do they take a shower or bath each night? (A hot shower or bath naturally cues the body that it is time for sleep as the body’s core temperature rises and then drops.) Do they read before lights out? Is the house quiet at their bedtime? Parents should also find out if their children have worries that are making it difficult to go to sleep. Are they worried about a test or big game? Or about bigger issues of safety? Parents can help a child to discuss their worries and address those that are addressable; usually, this is enough to help children learn to master their worries. When a school-age child’s anxiety does not improve with open discussion, then it may be helpful to have a more formal evaluation for anxiety with a mental health clinician.

Adolescence is a time in which sleep patterns naturally shift, while the need for sleep remains robust. Teenagers become tired later and need to sleep in until later in the morning, just at the same time that school demands impinge on sleep with an earlier start to the day and more extensive homework at night. Older adolescents may go out with friends on weekends and shift their bedtime routine by 4 or more hours for two nights out of every seven, which is as profoundly disruptive to restful sleep as traveling across four time zones and back every week. These are years in which more independence can again lead to more screen use in the evening, whether for writing a paper on a computer or texting a friend late into the night.

An adolescent who is sleep deprived may have low energy, be forgetful and distractible, and see their academic and athletic performance suffer. They may appear more withdrawn or moody. This is an age in which serious mood problems, such as depression, are more likely to emerge, and are associated with sleep problems. But these problems will not improve with simple sleep hygiene interventions; thus, the teens who do not get better after these interventions may need a psychiatric evaluation.

The strategies that might help adolescents are not much different from those for younger children. It is important with adolescents, however, to explain why they should exercise regularly, have a consistent bedtime routine, and not bring their cell phone to bed. While parents should still be able to set and enforce ground rules, they also need to be equipping their adolescents to understand and manage their sleep independently, which they will need to do soon enough. Encouraging self-regulation between ages 13 and 17 is essential as college or independence approaches, and efforts at control are hard to enforce and send the wrong message.

Inconsistent, inadequate sleep often reflects what has been a frustrating struggle for parents. Asking questions about sleep gives parents the supportive message that sleep is challenging and important, and may empower them to approach it with renewed firmness and clarity. When you help parents to set routines and limits that support consistent, adequate sleep, their children will be on a path to healthy development.

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor of psychiatry and of pediatrics at Harvard Medical School, Boston. E-mail them at [email protected].

Questions about sleep – from newborns to teenagers – are among the most common in pediatric practice. A good night’s sleep is in everyone’s best interest for daily functioning and healthy development. Asking about sleep also provides a window into the family’s perspectives on discipline, parental cooperation, family stresses, and views on a child’s developing autonomy.

During their first year, infants may need as many as 18 hours of sleep daily, and the duration of sleep gradually declines thereafter to 8-10 hours nightly in adolescence. Sleep plays an essential role in consolidating memories, attention, and other cognitive functions; the immune system; and metabolism. Additionally, developing healthy sleep habits is one of the first and most profound ways that children learn to expect consistency from their parents, to soothe themselves, and to manage limits. As a child grows, her ability to plan, manage anxiety, and exercise discipline is cultivated through managing her sleep with increasing independence.

Dr. Susan D. Swick

Preschoolers who are not getting adequate sleep may have behavioral problems, particularly in new settings (like school) or at transitional times (like bedtime). When a preschooler presents with hyperactivity, irritability, and tantrums, or failure to keep up with developmental expectations, asking about sleep patterns is a good early step. Although sleep disruption may be symptomatic of psychiatric disorders related to mood, anxiety, or attention, before you consider a disorder and treatment make sure that tensions at bedtime and poor sleeping habits are not a major factor.

How do you help tired, stressed parents encourage or enforce healthy sleep habits? Does the family have a routine after dinner that allows a child to settle down (such as taking a bath and then a quiet activity like reading a book with a parent)? Are the parents able to enforce this routine consistently, or does bedtime get dragged out for hours? And if so, why? In addition to ensuring that a child gets enough exercise during the day (but not in the hour before bed), parents will need to turn off the lights at a reasonably early hour so that a child may get adequate sleep before they will awaken with daylight.

Many parents will delay sleep until later as children push to stay awake and play. Sometimes, if both parents work and feel their only time with their children is after they return from work well into the evening, they may want more time with their children or feel guilty about having a strict, early bedtime routine. Reassure parents that even a short stretch of quality time with their children (reading to them, snuggling, asking about their day) is enough to nurture a profound connection.

"Screen time" merits special mention, especially in younger children. Letting children watch television or play on computers in order to "unwind" at the end of a long day is common, but in the time before bed, screen content can be very disruptive to restful sleep. Parents should assess if "screen time" is helping or hurting their child’s ability to fall asleep. Some families have found it helpful to have no screen time (any screen: television, computer, tablet, or cell phone) within 1 hour of lights going out: back-lit screens suppress endogenous melatonin release and can delay sleep. With school-age children, reading at bedtime is certainly preferable to an additional hour of computer time.

It is also worth asking where a child is sleeping. Do they have their own bed? Are they alone in their room? Is their room on the same level of the house as their parents’ room? Children who are anxious may sleep better if they share a room with a sibling or are close to their parents’ room. On the other hand, if they sleep with a sibling who is waking often during the night, they may have disrupted sleep.

Dr. Michael Jellinek

It is worth finding out if a child is able to sleep through the night in their own bed. Many children have their own bed and room, but have a routine of sleeping in their parents’ bed. This usually results in inadequate sleep for both child and parents, and a child who does not learn how to appropriately soothe himself. Is it permissible for a child to climb into their parents’ bed in the middle of the night once in a while, if they have a bad dream, do not feel well, or have faced a stressful day? Yes. Is a child arguing to go to sleep in their parents’ bed, refusing to sleep in their own bed, with their parents "giving in"? Then it is a habit worth undoing.

 

 

School-age children who are not getting adequate sleep also may appear more irritable, forgetful, and inattentive, and they may have problems with academic, athletic, and social performance. These are years in which children start to have more independence and responsibility for their bedtime routines. They may have greater access to screens in the evening, and may be in charge of setting an alarm or turning their light out. These are also years in which children are more likely to experience anxiety, as they face and manage a host of new challenges. Anxiety can be very disruptive of restful sleep, and will in turn cause more problems about which these children get anxious. Alongside their greater responsibility, school-age children still need basic and consistently enforced ground rules about sleep in order to build independence. Clearly at this age, reading before bedtime is a good option.

Parents should help their school-age children to start their homework early, and to enjoy screen time, but not within an hour of bedtime, and to follow a consistent (and more independent) routine before bed. Do they have a consistent bedtime? Do they take a shower or bath each night? (A hot shower or bath naturally cues the body that it is time for sleep as the body’s core temperature rises and then drops.) Do they read before lights out? Is the house quiet at their bedtime? Parents should also find out if their children have worries that are making it difficult to go to sleep. Are they worried about a test or big game? Or about bigger issues of safety? Parents can help a child to discuss their worries and address those that are addressable; usually, this is enough to help children learn to master their worries. When a school-age child’s anxiety does not improve with open discussion, then it may be helpful to have a more formal evaluation for anxiety with a mental health clinician.

Adolescence is a time in which sleep patterns naturally shift, while the need for sleep remains robust. Teenagers become tired later and need to sleep in until later in the morning, just at the same time that school demands impinge on sleep with an earlier start to the day and more extensive homework at night. Older adolescents may go out with friends on weekends and shift their bedtime routine by 4 or more hours for two nights out of every seven, which is as profoundly disruptive to restful sleep as traveling across four time zones and back every week. These are years in which more independence can again lead to more screen use in the evening, whether for writing a paper on a computer or texting a friend late into the night.

An adolescent who is sleep deprived may have low energy, be forgetful and distractible, and see their academic and athletic performance suffer. They may appear more withdrawn or moody. This is an age in which serious mood problems, such as depression, are more likely to emerge, and are associated with sleep problems. But these problems will not improve with simple sleep hygiene interventions; thus, the teens who do not get better after these interventions may need a psychiatric evaluation.

The strategies that might help adolescents are not much different from those for younger children. It is important with adolescents, however, to explain why they should exercise regularly, have a consistent bedtime routine, and not bring their cell phone to bed. While parents should still be able to set and enforce ground rules, they also need to be equipping their adolescents to understand and manage their sleep independently, which they will need to do soon enough. Encouraging self-regulation between ages 13 and 17 is essential as college or independence approaches, and efforts at control are hard to enforce and send the wrong message.

Inconsistent, inadequate sleep often reflects what has been a frustrating struggle for parents. Asking questions about sleep gives parents the supportive message that sleep is challenging and important, and may empower them to approach it with renewed firmness and clarity. When you help parents to set routines and limits that support consistent, adequate sleep, their children will be on a path to healthy development.

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor of psychiatry and of pediatrics at Harvard Medical School, Boston. E-mail them at [email protected].

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Shame

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Shame

At 16, Eddie is tall and athletic. He’s been treating closed comedones on his forehead and chest off and on for a couple of years.

"I hope you can help him," his mother says. "There are days when he won’t go to school, he’s so embarrassed."

Really?

If you sat people down and asked them to list what people hate about their bodies, they wouldn’t come close to guessing what we dermatologists run into every day. Here are some cases I’ve seen lately. I’m sure you can easily come up with your own examples.

• A 50-year-old attorney with a wart on the dorsum of his right hand wanted me to take it off. "I sign a lot of documents," he said," and I’d prefer that clients remember me for my legal skills, not the wart on my hand."

• A 36-year-old waiter with a picker’s nodule over the proximal interphalangeal joint of his left fifth finger said I just had to get rid of it. "I’m a waiter," he said. "This is killing my tips."

• A 36-year-old woman gave up yoga a year ago, because she was sure the woman on the adjacent mat was disgusted by her plantar warts.

• A sprightly retiree, age 88(!), insisted on paying out of pocket to remove dermatosis papulosa nigra lesions from her face. Her explanation? "My children want me to stay at home, but I want to get out and be social!"

Self-consciousness doesn’t require lesions. For instance, I saw an 11-year-old last month with widespread atopic dermatitis, the kind that’s lifelong, miserably itchy, and hard to control. Yet she wasn’t even being treated. Why had she come now?

"What bothers you most about this?" I asked her.

"This brown patch on my neck," she said.

That’s right – not the itch, not the scratching, not the staying awake at night. What bothered her was the postinflammatory pigmentation on her neck that other kids would see and comment on.

She’s not alone. Another mother brought her 8-year-old daughter to see me. The girl’s eczema was being treated with nothing but moisturizer (which was "working, sort of").

"The reason we’re here," said Mom, "is that now she is starting to get self-conscious about the dark staining on her hand."

As doctors, we’re trained to think functionally so we can measure the ways disease impairs functionality: length of life, duration of fever, days out of work, oxygen saturation, percentage of involved body surface.

But you can’t measure shame. Nor can you predict what will produce it. Even after all these years, people surprise me all the time.

The secondary codes some insurers demand to cover wart treatment include pain, rapid growth, or bleeding. They do not include, "Clients are staring at my hand at real estate closings." Or, "This bump is reducing my tips." We could, of course, tell people not to mind being stared at, but they will not agree. They know how people look at them, and what parts of them they look at.

If any of us had a big welt over one eye, we might think twice before going to work, knowing that every patient and staff member are going to ask, "What bar were you in, and what does the other guy look like?" The teenager with the stain on her neck and the boy with the papules on his forehead and chest feel that way every morning.

Basically, nobody wants to stand out. If we do, we’d like it to be for some admirable quality. The truth is, we shouldn’t really take credit for being called handsome, smart, or healthy, but we do anyway. By the same token, it’s not our fault if we’re ill or different, but being singled out for either makes things worse – not functionally, just humanly.

Many years ago, a 15-year-old girl asked me to take off a mole from the top of her foot.

"The mole’s fine," I said. "Why do you want it off?"

"It’s embarrassing," she said.

"How?" I asked her. "Don’t you go to pools in the summer?"

"I stand with the one foot covering the spot on the other foot. Nobody has ever seen it."

Not everything people are embarrassed about can be removed with a cream or a hyfrecator. But shame is powerful, and we need to recognize it for what it is so we can address it if we can.

Dr. Rockoff practices dermatology in Brookline, Mass. He is on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years.

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At 16, Eddie is tall and athletic. He’s been treating closed comedones on his forehead and chest off and on for a couple of years.

"I hope you can help him," his mother says. "There are days when he won’t go to school, he’s so embarrassed."

Really?

If you sat people down and asked them to list what people hate about their bodies, they wouldn’t come close to guessing what we dermatologists run into every day. Here are some cases I’ve seen lately. I’m sure you can easily come up with your own examples.

• A 50-year-old attorney with a wart on the dorsum of his right hand wanted me to take it off. "I sign a lot of documents," he said," and I’d prefer that clients remember me for my legal skills, not the wart on my hand."

• A 36-year-old waiter with a picker’s nodule over the proximal interphalangeal joint of his left fifth finger said I just had to get rid of it. "I’m a waiter," he said. "This is killing my tips."

• A 36-year-old woman gave up yoga a year ago, because she was sure the woman on the adjacent mat was disgusted by her plantar warts.

• A sprightly retiree, age 88(!), insisted on paying out of pocket to remove dermatosis papulosa nigra lesions from her face. Her explanation? "My children want me to stay at home, but I want to get out and be social!"

Self-consciousness doesn’t require lesions. For instance, I saw an 11-year-old last month with widespread atopic dermatitis, the kind that’s lifelong, miserably itchy, and hard to control. Yet she wasn’t even being treated. Why had she come now?

"What bothers you most about this?" I asked her.

"This brown patch on my neck," she said.

That’s right – not the itch, not the scratching, not the staying awake at night. What bothered her was the postinflammatory pigmentation on her neck that other kids would see and comment on.

She’s not alone. Another mother brought her 8-year-old daughter to see me. The girl’s eczema was being treated with nothing but moisturizer (which was "working, sort of").

"The reason we’re here," said Mom, "is that now she is starting to get self-conscious about the dark staining on her hand."

As doctors, we’re trained to think functionally so we can measure the ways disease impairs functionality: length of life, duration of fever, days out of work, oxygen saturation, percentage of involved body surface.

But you can’t measure shame. Nor can you predict what will produce it. Even after all these years, people surprise me all the time.

The secondary codes some insurers demand to cover wart treatment include pain, rapid growth, or bleeding. They do not include, "Clients are staring at my hand at real estate closings." Or, "This bump is reducing my tips." We could, of course, tell people not to mind being stared at, but they will not agree. They know how people look at them, and what parts of them they look at.

If any of us had a big welt over one eye, we might think twice before going to work, knowing that every patient and staff member are going to ask, "What bar were you in, and what does the other guy look like?" The teenager with the stain on her neck and the boy with the papules on his forehead and chest feel that way every morning.

Basically, nobody wants to stand out. If we do, we’d like it to be for some admirable quality. The truth is, we shouldn’t really take credit for being called handsome, smart, or healthy, but we do anyway. By the same token, it’s not our fault if we’re ill or different, but being singled out for either makes things worse – not functionally, just humanly.

Many years ago, a 15-year-old girl asked me to take off a mole from the top of her foot.

"The mole’s fine," I said. "Why do you want it off?"

"It’s embarrassing," she said.

"How?" I asked her. "Don’t you go to pools in the summer?"

"I stand with the one foot covering the spot on the other foot. Nobody has ever seen it."

Not everything people are embarrassed about can be removed with a cream or a hyfrecator. But shame is powerful, and we need to recognize it for what it is so we can address it if we can.

Dr. Rockoff practices dermatology in Brookline, Mass. He is on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years.

At 16, Eddie is tall and athletic. He’s been treating closed comedones on his forehead and chest off and on for a couple of years.

"I hope you can help him," his mother says. "There are days when he won’t go to school, he’s so embarrassed."

Really?

If you sat people down and asked them to list what people hate about their bodies, they wouldn’t come close to guessing what we dermatologists run into every day. Here are some cases I’ve seen lately. I’m sure you can easily come up with your own examples.

• A 50-year-old attorney with a wart on the dorsum of his right hand wanted me to take it off. "I sign a lot of documents," he said," and I’d prefer that clients remember me for my legal skills, not the wart on my hand."

• A 36-year-old waiter with a picker’s nodule over the proximal interphalangeal joint of his left fifth finger said I just had to get rid of it. "I’m a waiter," he said. "This is killing my tips."

• A 36-year-old woman gave up yoga a year ago, because she was sure the woman on the adjacent mat was disgusted by her plantar warts.

• A sprightly retiree, age 88(!), insisted on paying out of pocket to remove dermatosis papulosa nigra lesions from her face. Her explanation? "My children want me to stay at home, but I want to get out and be social!"

Self-consciousness doesn’t require lesions. For instance, I saw an 11-year-old last month with widespread atopic dermatitis, the kind that’s lifelong, miserably itchy, and hard to control. Yet she wasn’t even being treated. Why had she come now?

"What bothers you most about this?" I asked her.

"This brown patch on my neck," she said.

That’s right – not the itch, not the scratching, not the staying awake at night. What bothered her was the postinflammatory pigmentation on her neck that other kids would see and comment on.

She’s not alone. Another mother brought her 8-year-old daughter to see me. The girl’s eczema was being treated with nothing but moisturizer (which was "working, sort of").

"The reason we’re here," said Mom, "is that now she is starting to get self-conscious about the dark staining on her hand."

As doctors, we’re trained to think functionally so we can measure the ways disease impairs functionality: length of life, duration of fever, days out of work, oxygen saturation, percentage of involved body surface.

But you can’t measure shame. Nor can you predict what will produce it. Even after all these years, people surprise me all the time.

The secondary codes some insurers demand to cover wart treatment include pain, rapid growth, or bleeding. They do not include, "Clients are staring at my hand at real estate closings." Or, "This bump is reducing my tips." We could, of course, tell people not to mind being stared at, but they will not agree. They know how people look at them, and what parts of them they look at.

If any of us had a big welt over one eye, we might think twice before going to work, knowing that every patient and staff member are going to ask, "What bar were you in, and what does the other guy look like?" The teenager with the stain on her neck and the boy with the papules on his forehead and chest feel that way every morning.

Basically, nobody wants to stand out. If we do, we’d like it to be for some admirable quality. The truth is, we shouldn’t really take credit for being called handsome, smart, or healthy, but we do anyway. By the same token, it’s not our fault if we’re ill or different, but being singled out for either makes things worse – not functionally, just humanly.

Many years ago, a 15-year-old girl asked me to take off a mole from the top of her foot.

"The mole’s fine," I said. "Why do you want it off?"

"It’s embarrassing," she said.

"How?" I asked her. "Don’t you go to pools in the summer?"

"I stand with the one foot covering the spot on the other foot. Nobody has ever seen it."

Not everything people are embarrassed about can be removed with a cream or a hyfrecator. But shame is powerful, and we need to recognize it for what it is so we can address it if we can.

Dr. Rockoff practices dermatology in Brookline, Mass. He is on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years.

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The world is not only getting older and warmer, but it’s getting heavier and more unfit each year. According to the World Health Organization’s most recent data, more than 1.4 billion adults were overweight in 2008, and 500 million of these adults were obese. In 2012, more than 40 million young children were overweight or obese. Diabetes, a disorder closely linked with obesity, affects about 347 million people worldwide – approximately ten times more people than those with HIV/AIDS. Although the number of AIDS-related deaths has steadily decreased over the last decade, even in developing countries, the number of diabetes-related deaths has steadily increased. The WHO projects that diabetes-related deaths will double by 2030, making it the seventh leading cause of death worldwide. In the United States, diabetes already is the seventh leading cause of death.

According to the Centers for Disease Control and Prevention, obesity-related diseases cost $147 billion annually, a number which dwarfs the health care costs associated with smoking ($96 billion). In addition to the link with type 2 diabetes, there are strong links between obesity and heart disease, kidney disease, depression, and hypertension. From 1987 to 2007, obesity was estimated to have caused more than a 20% increase in total health care spending.

The American Diabetes Association estimates that people diagnosed with diabetes have average yearly medical expenditures of over $13,000, which is over two times higher than the expenditures of a person without diagnosed diabetes. The 2012 estimated annual cost of care for diagnosed diabetes was $245 billion, which includes $176 billion in direct medical costs and $69 billion in reduced productivity (Diabetes Care 2013 [doi:10.2337/dc12-2625]). These figures, while staggering, do not include projected expenditures for people who have yet to receive a diabetes diagnosis.

The federal government has chosen to take dramatic steps to help Americans lose weight. Since 2011, the Centers for Medicare & Medicaid Services has covered screening and intensive behavioral therapy for obesity by primary care physicians during office visits or outpatient hospital care. Additionally, the Affordable Care Act (ACA) now requires insurance companies to help overweight and obese patients try to lose weight and be healthier. The 2012 Institute of Medicine (IOM) report, Accelerating Progress in Obesity Prevention: Solving the Weight of the Nation also has made major recommendations for health care practitioners, schools, and the food and beverage industry to take a more active part in improving our overall health.

Simple steps make a big impact on health

Despite the daunting – and perhaps somewhat disheartening – statistics on obesity and diabetes in the United States and around the world, research has shown that small steps to achieving a healthy weight and maintaining an active lifestyle can make a dramatic difference on the course of a person’s life. According to the Department of Agriculture, healthier diets could prevent about $71 billion in yearly health care costs, lost productivity, and premature deaths. This number is staggering, when you consider that the change could be as small as choosing a salad instead of fries for a side dish.

Medical research backs up the well-worn adage that "an apple a day keeps the doctor away." The Diabetes Prevention Program study, conducted in the early 2000s, found that lifestyle changes, such as getting more exercise and eating a balanced diet, had a major impact on whether a patient who is overweight with prediabetes developed type 2 diabetes (N. Engl. J. Med. 2002;346:393-403).

Lifestyle changes can also reduce the onset of diabetes in high-risk groups such as Asian Indians, where the incidence of diabetes is the highest in the world. The Indian Diabetes Prevention Programme showed that weight loss and healthy eating reduced the incidence of type 2 diabetes in this population at a rate similar to the use of metformin, one of the most common oral antidiabetic drugs (Diabetologia 2006;49:289-97).

The 16th U.S. Surgeon General, David Satcher, M.D., Ph.D., is famous for giving his "Prescription for Great Health" when he addresses colleges and universities, which includes not smoking, staying away from illicit drug use, and abstaining from unsafe sex. Importantly, the first two key points of his "prescription" are exercising at least five times a week for 30 minutes and eating at least five servings of fruits and vegetables daily. Again, very simple recommendations, but his advice has lasting and profound ramifications.

Do obstetrician/gynecologists have a role?

As ob.gyns., we always have played an incredibly critical role in maintaining the health and well-being of our patients. Now, more than ever, we have a significant opportunity to set our patients on a path to better eating, incorporating exercise into their daily routines and passing down these good habits to their children.

 

 

In the "old days," the ob.gyn. focused on a limited period in a patient’s life. Perhaps we only saw a patient for annual exams and then for a more intense time prior to and during pregnancy, and then for a checkup post partum where we may have examined our patients only for complications of the pregnancy and delivery and not much more. Although we may have included some counseling on maintaining a healthy pregnancy, many of us relied on a patient’s primary care physician to provide ongoing support.

Today, however, we must take a more active role in helping our patients establish and maintain a healthy lifestyle. Despite the increased insurance coverage under the ACA and the expansion of Medicaid, a woman’s ob.gyn. may be the only health care practitioner she will see on a routine basis. Many women do not visit a general practitioner for routine physical examinations, but women will see their ob.gyn. for regular exams. We can use these annual or biannual office visits to help women set goals to live a healthy life, approaching each patient as a whole person who needs comprehensive care throughout her reproductive life and beyond.

For patients who are overweight or obese, we may focus on helping them reduce their body mass index and blood pressure and encourage them to stay fit. We also should do everything we can to ensure that if a woman has had gestational diabetes, she’s doing what she can to reduce her risk of developing type 2 diabetes after pregnancy. For these patients, we should consider testing their blood glucose every 1-2 years during the annual checkup.

Healthy weight in pregnancy: to gain or to lose?

Whether or not an ob.gyn. practice implements a screening program and more intensive obesity and diabetes counseling, we all will face the same question: How much weight should my patient gain to have a healthy baby? Interestingly, in the first half of the 20th century, ob.gyns. were discouraged from recommending that their pregnant patients gain very much weight. Indeed, the 13th edition of "Williams Obstetrics" (New York: Appleton-Century-Crofts, 1966, p. 326) stated that obstetricians should limit their patients from gaining more than 25 pounds during gestation, and that the ideal weight gain was 15 pounds.

This guidance was called into question by a 1970 National Academy of Sciences report, "Maternal Nutrition and the Course of Pregnancy," which indicated a strong link between infant mortality and low maternal pregnancy weight. Further evidence suggested a need for new standards and, in 1990, the IOM issued recommendations on women’s nutrition during pregnancy (Nutrition During Pregnancy, Weight Gain and Nutrient Supplements. Washington, D.C.: National Academy Press, 1990). (See table.)

Americans consume 31% more calories today than they did 40 years ago. Because of this, a woman’s need to gain weight to improve the outcome of her pregnancy is significantly reduced. The calories that many people include in their diets often come from high-fat, sodium-loaded, processed foods. We also have become a more sedentary society, spending our days at a computer, browsing the internet, watching TV, and opting to drive rather than to walk. Taking these factors into account, revising the recommendations for weight gain seemed crucial. In 2009, the IOM revised its guidance on healthy weight gain in pregnancy, and these ranges are currently widely accepted by obstetricians today (iom.edu/Reports/2009/Weight-Gain-During-Pregnancy-Reexamining-the-Guidelines.aspx). (See table.)

With the obesity and diabetes epidemics on the rise, we may need to update the 2009 IOM guidelines again – and very soon. Isolated studies have indicated that, for women who are severely obese, moderate weight loss during pregnancy may improve pregnancy outcomes. These findings remain controversial, but the "heavy" burden of diabetes and obesity on the U.S. health care system in general, and the need to reduce obstetrical complications that accompany deliveries in patients who are overweight or obese and diabetic, means that we as a community may need to reexamine our practices and approaches much more closely.

"Food" for thought

We all know of patients who, once they become pregnant, begin justifying a greater intake of food as "eating for two." Many women may use their pregnancy as an excuse to overindulge in unhealthy foods or to forgo the gym and other regular exercise regimens. Recommending basic steps to change a patient’s lifestyle can make an incredible difference in improving maternal and fetal health outcomes.

Summary recommendations for healthy pregnancy

• A low-glycemic diet, combined with moderate exercise, can reduce or eliminate many of the negative consequences of obesity on pregnant women and their babies.

 

 

• Proper weight management during pregnancy can improve birth outcomes.

• Weight loss during pregnancy is not recommended, except, potentially, for morbidly obese women (BMI greater than 40).

• For women who are normal weight, overweight or obese, leading healthy lifestyles can greatly improve maternal and fetal health outcomes. These include physical exercise, balanced diet, and weight loss, in combination with medication in some cases.

• It is never too late to begin healthy habits!

If we microfocus only on a woman’s predelivery and postdelivery health, then we’re losing a big opportunity to improve her whole self and prevent future health complications during and outside of pregnancy. The good news for ob.gyns. is that this complex problem has a simple, well-documented, and proven solution.

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].

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The world is not only getting older and warmer, but it’s getting heavier and more unfit each year. According to the World Health Organization’s most recent data, more than 1.4 billion adults were overweight in 2008, and 500 million of these adults were obese. In 2012, more than 40 million young children were overweight or obese. Diabetes, a disorder closely linked with obesity, affects about 347 million people worldwide – approximately ten times more people than those with HIV/AIDS. Although the number of AIDS-related deaths has steadily decreased over the last decade, even in developing countries, the number of diabetes-related deaths has steadily increased. The WHO projects that diabetes-related deaths will double by 2030, making it the seventh leading cause of death worldwide. In the United States, diabetes already is the seventh leading cause of death.

According to the Centers for Disease Control and Prevention, obesity-related diseases cost $147 billion annually, a number which dwarfs the health care costs associated with smoking ($96 billion). In addition to the link with type 2 diabetes, there are strong links between obesity and heart disease, kidney disease, depression, and hypertension. From 1987 to 2007, obesity was estimated to have caused more than a 20% increase in total health care spending.

The American Diabetes Association estimates that people diagnosed with diabetes have average yearly medical expenditures of over $13,000, which is over two times higher than the expenditures of a person without diagnosed diabetes. The 2012 estimated annual cost of care for diagnosed diabetes was $245 billion, which includes $176 billion in direct medical costs and $69 billion in reduced productivity (Diabetes Care 2013 [doi:10.2337/dc12-2625]). These figures, while staggering, do not include projected expenditures for people who have yet to receive a diabetes diagnosis.

The federal government has chosen to take dramatic steps to help Americans lose weight. Since 2011, the Centers for Medicare & Medicaid Services has covered screening and intensive behavioral therapy for obesity by primary care physicians during office visits or outpatient hospital care. Additionally, the Affordable Care Act (ACA) now requires insurance companies to help overweight and obese patients try to lose weight and be healthier. The 2012 Institute of Medicine (IOM) report, Accelerating Progress in Obesity Prevention: Solving the Weight of the Nation also has made major recommendations for health care practitioners, schools, and the food and beverage industry to take a more active part in improving our overall health.

Simple steps make a big impact on health

Despite the daunting – and perhaps somewhat disheartening – statistics on obesity and diabetes in the United States and around the world, research has shown that small steps to achieving a healthy weight and maintaining an active lifestyle can make a dramatic difference on the course of a person’s life. According to the Department of Agriculture, healthier diets could prevent about $71 billion in yearly health care costs, lost productivity, and premature deaths. This number is staggering, when you consider that the change could be as small as choosing a salad instead of fries for a side dish.

Medical research backs up the well-worn adage that "an apple a day keeps the doctor away." The Diabetes Prevention Program study, conducted in the early 2000s, found that lifestyle changes, such as getting more exercise and eating a balanced diet, had a major impact on whether a patient who is overweight with prediabetes developed type 2 diabetes (N. Engl. J. Med. 2002;346:393-403).

Lifestyle changes can also reduce the onset of diabetes in high-risk groups such as Asian Indians, where the incidence of diabetes is the highest in the world. The Indian Diabetes Prevention Programme showed that weight loss and healthy eating reduced the incidence of type 2 diabetes in this population at a rate similar to the use of metformin, one of the most common oral antidiabetic drugs (Diabetologia 2006;49:289-97).

The 16th U.S. Surgeon General, David Satcher, M.D., Ph.D., is famous for giving his "Prescription for Great Health" when he addresses colleges and universities, which includes not smoking, staying away from illicit drug use, and abstaining from unsafe sex. Importantly, the first two key points of his "prescription" are exercising at least five times a week for 30 minutes and eating at least five servings of fruits and vegetables daily. Again, very simple recommendations, but his advice has lasting and profound ramifications.

Do obstetrician/gynecologists have a role?

As ob.gyns., we always have played an incredibly critical role in maintaining the health and well-being of our patients. Now, more than ever, we have a significant opportunity to set our patients on a path to better eating, incorporating exercise into their daily routines and passing down these good habits to their children.

 

 

In the "old days," the ob.gyn. focused on a limited period in a patient’s life. Perhaps we only saw a patient for annual exams and then for a more intense time prior to and during pregnancy, and then for a checkup post partum where we may have examined our patients only for complications of the pregnancy and delivery and not much more. Although we may have included some counseling on maintaining a healthy pregnancy, many of us relied on a patient’s primary care physician to provide ongoing support.

Today, however, we must take a more active role in helping our patients establish and maintain a healthy lifestyle. Despite the increased insurance coverage under the ACA and the expansion of Medicaid, a woman’s ob.gyn. may be the only health care practitioner she will see on a routine basis. Many women do not visit a general practitioner for routine physical examinations, but women will see their ob.gyn. for regular exams. We can use these annual or biannual office visits to help women set goals to live a healthy life, approaching each patient as a whole person who needs comprehensive care throughout her reproductive life and beyond.

For patients who are overweight or obese, we may focus on helping them reduce their body mass index and blood pressure and encourage them to stay fit. We also should do everything we can to ensure that if a woman has had gestational diabetes, she’s doing what she can to reduce her risk of developing type 2 diabetes after pregnancy. For these patients, we should consider testing their blood glucose every 1-2 years during the annual checkup.

Healthy weight in pregnancy: to gain or to lose?

Whether or not an ob.gyn. practice implements a screening program and more intensive obesity and diabetes counseling, we all will face the same question: How much weight should my patient gain to have a healthy baby? Interestingly, in the first half of the 20th century, ob.gyns. were discouraged from recommending that their pregnant patients gain very much weight. Indeed, the 13th edition of "Williams Obstetrics" (New York: Appleton-Century-Crofts, 1966, p. 326) stated that obstetricians should limit their patients from gaining more than 25 pounds during gestation, and that the ideal weight gain was 15 pounds.

This guidance was called into question by a 1970 National Academy of Sciences report, "Maternal Nutrition and the Course of Pregnancy," which indicated a strong link between infant mortality and low maternal pregnancy weight. Further evidence suggested a need for new standards and, in 1990, the IOM issued recommendations on women’s nutrition during pregnancy (Nutrition During Pregnancy, Weight Gain and Nutrient Supplements. Washington, D.C.: National Academy Press, 1990). (See table.)

Americans consume 31% more calories today than they did 40 years ago. Because of this, a woman’s need to gain weight to improve the outcome of her pregnancy is significantly reduced. The calories that many people include in their diets often come from high-fat, sodium-loaded, processed foods. We also have become a more sedentary society, spending our days at a computer, browsing the internet, watching TV, and opting to drive rather than to walk. Taking these factors into account, revising the recommendations for weight gain seemed crucial. In 2009, the IOM revised its guidance on healthy weight gain in pregnancy, and these ranges are currently widely accepted by obstetricians today (iom.edu/Reports/2009/Weight-Gain-During-Pregnancy-Reexamining-the-Guidelines.aspx). (See table.)

With the obesity and diabetes epidemics on the rise, we may need to update the 2009 IOM guidelines again – and very soon. Isolated studies have indicated that, for women who are severely obese, moderate weight loss during pregnancy may improve pregnancy outcomes. These findings remain controversial, but the "heavy" burden of diabetes and obesity on the U.S. health care system in general, and the need to reduce obstetrical complications that accompany deliveries in patients who are overweight or obese and diabetic, means that we as a community may need to reexamine our practices and approaches much more closely.

"Food" for thought

We all know of patients who, once they become pregnant, begin justifying a greater intake of food as "eating for two." Many women may use their pregnancy as an excuse to overindulge in unhealthy foods or to forgo the gym and other regular exercise regimens. Recommending basic steps to change a patient’s lifestyle can make an incredible difference in improving maternal and fetal health outcomes.

Summary recommendations for healthy pregnancy

• A low-glycemic diet, combined with moderate exercise, can reduce or eliminate many of the negative consequences of obesity on pregnant women and their babies.

 

 

• Proper weight management during pregnancy can improve birth outcomes.

• Weight loss during pregnancy is not recommended, except, potentially, for morbidly obese women (BMI greater than 40).

• For women who are normal weight, overweight or obese, leading healthy lifestyles can greatly improve maternal and fetal health outcomes. These include physical exercise, balanced diet, and weight loss, in combination with medication in some cases.

• It is never too late to begin healthy habits!

If we microfocus only on a woman’s predelivery and postdelivery health, then we’re losing a big opportunity to improve her whole self and prevent future health complications during and outside of pregnancy. The good news for ob.gyns. is that this complex problem has a simple, well-documented, and proven solution.

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].

The world is not only getting older and warmer, but it’s getting heavier and more unfit each year. According to the World Health Organization’s most recent data, more than 1.4 billion adults were overweight in 2008, and 500 million of these adults were obese. In 2012, more than 40 million young children were overweight or obese. Diabetes, a disorder closely linked with obesity, affects about 347 million people worldwide – approximately ten times more people than those with HIV/AIDS. Although the number of AIDS-related deaths has steadily decreased over the last decade, even in developing countries, the number of diabetes-related deaths has steadily increased. The WHO projects that diabetes-related deaths will double by 2030, making it the seventh leading cause of death worldwide. In the United States, diabetes already is the seventh leading cause of death.

According to the Centers for Disease Control and Prevention, obesity-related diseases cost $147 billion annually, a number which dwarfs the health care costs associated with smoking ($96 billion). In addition to the link with type 2 diabetes, there are strong links between obesity and heart disease, kidney disease, depression, and hypertension. From 1987 to 2007, obesity was estimated to have caused more than a 20% increase in total health care spending.

The American Diabetes Association estimates that people diagnosed with diabetes have average yearly medical expenditures of over $13,000, which is over two times higher than the expenditures of a person without diagnosed diabetes. The 2012 estimated annual cost of care for diagnosed diabetes was $245 billion, which includes $176 billion in direct medical costs and $69 billion in reduced productivity (Diabetes Care 2013 [doi:10.2337/dc12-2625]). These figures, while staggering, do not include projected expenditures for people who have yet to receive a diabetes diagnosis.

The federal government has chosen to take dramatic steps to help Americans lose weight. Since 2011, the Centers for Medicare & Medicaid Services has covered screening and intensive behavioral therapy for obesity by primary care physicians during office visits or outpatient hospital care. Additionally, the Affordable Care Act (ACA) now requires insurance companies to help overweight and obese patients try to lose weight and be healthier. The 2012 Institute of Medicine (IOM) report, Accelerating Progress in Obesity Prevention: Solving the Weight of the Nation also has made major recommendations for health care practitioners, schools, and the food and beverage industry to take a more active part in improving our overall health.

Simple steps make a big impact on health

Despite the daunting – and perhaps somewhat disheartening – statistics on obesity and diabetes in the United States and around the world, research has shown that small steps to achieving a healthy weight and maintaining an active lifestyle can make a dramatic difference on the course of a person’s life. According to the Department of Agriculture, healthier diets could prevent about $71 billion in yearly health care costs, lost productivity, and premature deaths. This number is staggering, when you consider that the change could be as small as choosing a salad instead of fries for a side dish.

Medical research backs up the well-worn adage that "an apple a day keeps the doctor away." The Diabetes Prevention Program study, conducted in the early 2000s, found that lifestyle changes, such as getting more exercise and eating a balanced diet, had a major impact on whether a patient who is overweight with prediabetes developed type 2 diabetes (N. Engl. J. Med. 2002;346:393-403).

Lifestyle changes can also reduce the onset of diabetes in high-risk groups such as Asian Indians, where the incidence of diabetes is the highest in the world. The Indian Diabetes Prevention Programme showed that weight loss and healthy eating reduced the incidence of type 2 diabetes in this population at a rate similar to the use of metformin, one of the most common oral antidiabetic drugs (Diabetologia 2006;49:289-97).

The 16th U.S. Surgeon General, David Satcher, M.D., Ph.D., is famous for giving his "Prescription for Great Health" when he addresses colleges and universities, which includes not smoking, staying away from illicit drug use, and abstaining from unsafe sex. Importantly, the first two key points of his "prescription" are exercising at least five times a week for 30 minutes and eating at least five servings of fruits and vegetables daily. Again, very simple recommendations, but his advice has lasting and profound ramifications.

Do obstetrician/gynecologists have a role?

As ob.gyns., we always have played an incredibly critical role in maintaining the health and well-being of our patients. Now, more than ever, we have a significant opportunity to set our patients on a path to better eating, incorporating exercise into their daily routines and passing down these good habits to their children.

 

 

In the "old days," the ob.gyn. focused on a limited period in a patient’s life. Perhaps we only saw a patient for annual exams and then for a more intense time prior to and during pregnancy, and then for a checkup post partum where we may have examined our patients only for complications of the pregnancy and delivery and not much more. Although we may have included some counseling on maintaining a healthy pregnancy, many of us relied on a patient’s primary care physician to provide ongoing support.

Today, however, we must take a more active role in helping our patients establish and maintain a healthy lifestyle. Despite the increased insurance coverage under the ACA and the expansion of Medicaid, a woman’s ob.gyn. may be the only health care practitioner she will see on a routine basis. Many women do not visit a general practitioner for routine physical examinations, but women will see their ob.gyn. for regular exams. We can use these annual or biannual office visits to help women set goals to live a healthy life, approaching each patient as a whole person who needs comprehensive care throughout her reproductive life and beyond.

For patients who are overweight or obese, we may focus on helping them reduce their body mass index and blood pressure and encourage them to stay fit. We also should do everything we can to ensure that if a woman has had gestational diabetes, she’s doing what she can to reduce her risk of developing type 2 diabetes after pregnancy. For these patients, we should consider testing their blood glucose every 1-2 years during the annual checkup.

Healthy weight in pregnancy: to gain or to lose?

Whether or not an ob.gyn. practice implements a screening program and more intensive obesity and diabetes counseling, we all will face the same question: How much weight should my patient gain to have a healthy baby? Interestingly, in the first half of the 20th century, ob.gyns. were discouraged from recommending that their pregnant patients gain very much weight. Indeed, the 13th edition of "Williams Obstetrics" (New York: Appleton-Century-Crofts, 1966, p. 326) stated that obstetricians should limit their patients from gaining more than 25 pounds during gestation, and that the ideal weight gain was 15 pounds.

This guidance was called into question by a 1970 National Academy of Sciences report, "Maternal Nutrition and the Course of Pregnancy," which indicated a strong link between infant mortality and low maternal pregnancy weight. Further evidence suggested a need for new standards and, in 1990, the IOM issued recommendations on women’s nutrition during pregnancy (Nutrition During Pregnancy, Weight Gain and Nutrient Supplements. Washington, D.C.: National Academy Press, 1990). (See table.)

Americans consume 31% more calories today than they did 40 years ago. Because of this, a woman’s need to gain weight to improve the outcome of her pregnancy is significantly reduced. The calories that many people include in their diets often come from high-fat, sodium-loaded, processed foods. We also have become a more sedentary society, spending our days at a computer, browsing the internet, watching TV, and opting to drive rather than to walk. Taking these factors into account, revising the recommendations for weight gain seemed crucial. In 2009, the IOM revised its guidance on healthy weight gain in pregnancy, and these ranges are currently widely accepted by obstetricians today (iom.edu/Reports/2009/Weight-Gain-During-Pregnancy-Reexamining-the-Guidelines.aspx). (See table.)

With the obesity and diabetes epidemics on the rise, we may need to update the 2009 IOM guidelines again – and very soon. Isolated studies have indicated that, for women who are severely obese, moderate weight loss during pregnancy may improve pregnancy outcomes. These findings remain controversial, but the "heavy" burden of diabetes and obesity on the U.S. health care system in general, and the need to reduce obstetrical complications that accompany deliveries in patients who are overweight or obese and diabetic, means that we as a community may need to reexamine our practices and approaches much more closely.

"Food" for thought

We all know of patients who, once they become pregnant, begin justifying a greater intake of food as "eating for two." Many women may use their pregnancy as an excuse to overindulge in unhealthy foods or to forgo the gym and other regular exercise regimens. Recommending basic steps to change a patient’s lifestyle can make an incredible difference in improving maternal and fetal health outcomes.

Summary recommendations for healthy pregnancy

• A low-glycemic diet, combined with moderate exercise, can reduce or eliminate many of the negative consequences of obesity on pregnant women and their babies.

 

 

• Proper weight management during pregnancy can improve birth outcomes.

• Weight loss during pregnancy is not recommended, except, potentially, for morbidly obese women (BMI greater than 40).

• For women who are normal weight, overweight or obese, leading healthy lifestyles can greatly improve maternal and fetal health outcomes. These include physical exercise, balanced diet, and weight loss, in combination with medication in some cases.

• It is never too late to begin healthy habits!

If we microfocus only on a woman’s predelivery and postdelivery health, then we’re losing a big opportunity to improve her whole self and prevent future health complications during and outside of pregnancy. The good news for ob.gyns. is that this complex problem has a simple, well-documented, and proven solution.

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].

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Diabesity – Fattening the U.S. health care budget

The world is not only getting older and warmer, but it’s getting heavier and more unfit each year. According to the World Health Organization’s most recent data, more than 1.4 billion adults were overweight in 2008, and 500 million of these adults were obese. In 2012, more than 40 million young children were overweight or obese. Diabetes, a disorder closely linked with obesity, affects about 347 million people worldwide – approximately ten times more people than those with HIV/AIDS. Although the number of AIDS-related deaths has steadily decreased over the last decade, even in developing countries, the number of diabetes-related deaths has steadily increased. The WHO projects that diabetes-related deaths will double by 2030, making it the seventh leading cause of death worldwide. In the United States, diabetes already is the seventh leading cause of death.

According to the Centers for Disease Control and Prevention, obesity-related diseases cost $147 billion annually, a number which dwarfs the health care costs associated with smoking ($96 billion). In addition to the link with type 2 diabetes, there are strong links between obesity and heart disease, kidney disease, depression, and hypertension. From 1987 to 2007, obesity was estimated to have caused more than a 20% increase in total health care spending.

The American Diabetes Association estimates that people diagnosed with diabetes have average yearly medical expenditures of over $13,000, which is over two times higher than the expenditures of a person without diagnosed diabetes. The 2012 estimated annual cost of care for diagnosed diabetes was $245 billion, which includes $176 billion in direct medical costs and $69 billion in reduced productivity (Diabetes Care 2013 [doi:10.2337/dc12-2625]). These figures, while staggering, do not include projected expenditures for people who have yet to receive a diabetes diagnosis.

The federal government has chosen to take dramatic steps to help Americans lose weight. Since 2011, the Centers for Medicare & Medicaid Services has covered screening and intensive behavioral therapy for obesity by primary care physicians during office visits or outpatient hospital care. Additionally, the Affordable Care Act (ACA) now requires insurance companies to help overweight and obese patients try to lose weight and be healthier. The 2012 Institute of Medicine (IOM) report, Accelerating Progress in Obesity Prevention: Solving the Weight of the Nation also has made major recommendations for health care practitioners, schools, and the food and beverage industry to take a more active part in improving our overall health.

Simple steps make a big impact on health

Despite the daunting – and perhaps somewhat disheartening – statistics on obesity and diabetes in the United States and around the world, research has shown that small steps to achieving a healthy weight and maintaining an active lifestyle can make a dramatic difference on the course of a person’s life. According to the Department of Agriculture, healthier diets could prevent about $71 billion in yearly health care costs, lost productivity, and premature deaths. This number is staggering, when you consider that the change could be as small as choosing a salad instead of fries for a side dish.

Medical research backs up the well-worn adage that "an apple a day keeps the doctor away." The Diabetes Prevention Program study, conducted in the early 2000s, found that lifestyle changes, such as getting more exercise and eating a balanced diet, had a major impact on whether a patient who is overweight with prediabetes developed type 2 diabetes (N. Engl. J. Med. 2002;346:393-403).

Lifestyle changes can also reduce the onset of diabetes in high-risk groups such as Asian Indians, where the incidence of diabetes is the highest in the world. The Indian Diabetes Prevention Programme showed that weight loss and healthy eating reduced the incidence of type 2 diabetes in this population at a rate similar to the use of metformin, one of the most common oral antidiabetic drugs (Diabetologia 2006;49:289-97).

The 16th U.S. Surgeon General, David Satcher, M.D., Ph.D., is famous for giving his "Prescription for Great Health" when he addresses colleges and universities, which includes not smoking, staying away from illicit drug use, and abstaining from unsafe sex. Importantly, the first two key points of his "prescription" are exercising at least five times a week for 30 minutes and eating at least five servings of fruits and vegetables daily. Again, very simple recommendations, but his advice has lasting and profound ramifications.

Do obstetrician/gynecologists have a role?

As ob.gyns., we always have played an incredibly critical role in maintaining the health and well-being of our patients. Now, more than ever, we have a significant opportunity to set our patients on a path to better eating, incorporating exercise into their daily routines and passing down these good habits to their children.

 

 

In the "old days," the ob.gyn. focused on a limited period in a patient’s life. Perhaps we only saw a patient for annual exams and then for a more intense time prior to and during pregnancy, and then for a checkup post partum where we may have examined our patients only for complications of the pregnancy and delivery and not much more. Although we may have included some counseling on maintaining a healthy pregnancy, many of us relied on a patient’s primary care physician to provide ongoing support.

Today, however, we must take a more active role in helping our patients establish and maintain a healthy lifestyle. Despite the increased insurance coverage under the ACA and the expansion of Medicaid, a woman’s ob.gyn. may be the only health care practitioner she will see on a routine basis. Many women do not visit a general practitioner for routine physical examinations, but women will see their ob.gyn. for regular exams. We can use these annual or biannual office visits to help women set goals to live a healthy life, approaching each patient as a whole person who needs comprehensive care throughout her reproductive life and beyond.

For patients who are overweight or obese, we may focus on helping them reduce their body mass index and blood pressure and encourage them to stay fit. We also should do everything we can to ensure that if a woman has had gestational diabetes, she’s doing what she can to reduce her risk of developing type 2 diabetes after pregnancy. For these patients, we should consider testing their blood glucose every 1-2 years during the annual checkup.

Healthy weight in pregnancy: to gain or to lose?

Whether or not an ob.gyn. practice implements a screening program and more intensive obesity and diabetes counseling, we all will face the same question: How much weight should my patient gain to have a healthy baby? Interestingly, in the first half of the 20th century, ob.gyns. were discouraged from recommending that their pregnant patients gain very much weight. Indeed, the 13th edition of "Williams Obstetrics" (New York: Appleton-Century-Crofts, 1966, p. 326) stated that obstetricians should limit their patients from gaining more than 25 pounds during gestation, and that the ideal weight gain was 15 pounds.

This guidance was called into question by a 1970 National Academy of Sciences report, "Maternal Nutrition and the Course of Pregnancy," which indicated a strong link between infant mortality and low maternal pregnancy weight. Further evidence suggested a need for new standards and, in 1990, the IOM issued recommendations on women’s nutrition during pregnancy (Nutrition During Pregnancy, Weight Gain and Nutrient Supplements. Washington, D.C.: National Academy Press, 1990). (See table.)

Americans consume 31% more calories today than they did 40 years ago. Because of this, a woman’s need to gain weight to improve the outcome of her pregnancy is significantly reduced. The calories that many people include in their diets often come from high-fat, sodium-loaded, processed foods. We also have become a more sedentary society, spending our days at a computer, browsing the internet, watching TV, and opting to drive rather than to walk. Taking these factors into account, revising the recommendations for weight gain seemed crucial. In 2009, the IOM revised its guidance on healthy weight gain in pregnancy, and these ranges are currently widely accepted by obstetricians today (iom.edu/Reports/2009/Weight-Gain-During-Pregnancy-Reexamining-the-Guidelines.aspx). (See table.)

With the obesity and diabetes epidemics on the rise, we may need to update the 2009 IOM guidelines again – and very soon. Isolated studies have indicated that, for women who are severely obese, moderate weight loss during pregnancy may improve pregnancy outcomes. These findings remain controversial, but the "heavy" burden of diabetes and obesity on the U.S. health care system in general, and the need to reduce obstetrical complications that accompany deliveries in patients who are overweight or obese and diabetic, means that we as a community may need to reexamine our practices and approaches much more closely.

"Food" for thought

We all know of patients who, once they become pregnant, begin justifying a greater intake of food as "eating for two." Many women may use their pregnancy as an excuse to overindulge in unhealthy foods or to forgo the gym and other regular exercise regimens. Recommending basic steps to change a patient’s lifestyle can make an incredible difference in improving maternal and fetal health outcomes.

Summary recommendations for healthy pregnancy

• A low-glycemic diet, combined with moderate exercise, can reduce or eliminate many of the negative consequences of obesity on pregnant women and their babies.

 

 

• Proper weight management during pregnancy can improve birth outcomes.

• Weight loss during pregnancy is not recommended, except, potentially, for morbidly obese women (BMI greater than 40).

• For women who are normal weight, overweight or obese, leading healthy lifestyles can greatly improve maternal and fetal health outcomes. These include physical exercise, balanced diet, and weight loss, in combination with medication in some cases.

• It is never too late to begin healthy habits!

If we microfocus only on a woman’s predelivery and postdelivery health, then we’re losing a big opportunity to improve her whole self and prevent future health complications during and outside of pregnancy. The good news for ob.gyns. is that this complex problem has a simple, well-documented, and proven solution.

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].

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The world is not only getting older and warmer, but it’s getting heavier and more unfit each year. According to the World Health Organization’s most recent data, more than 1.4 billion adults were overweight in 2008, and 500 million of these adults were obese. In 2012, more than 40 million young children were overweight or obese. Diabetes, a disorder closely linked with obesity, affects about 347 million people worldwide – approximately ten times more people than those with HIV/AIDS. Although the number of AIDS-related deaths has steadily decreased over the last decade, even in developing countries, the number of diabetes-related deaths has steadily increased. The WHO projects that diabetes-related deaths will double by 2030, making it the seventh leading cause of death worldwide. In the United States, diabetes already is the seventh leading cause of death.

According to the Centers for Disease Control and Prevention, obesity-related diseases cost $147 billion annually, a number which dwarfs the health care costs associated with smoking ($96 billion). In addition to the link with type 2 diabetes, there are strong links between obesity and heart disease, kidney disease, depression, and hypertension. From 1987 to 2007, obesity was estimated to have caused more than a 20% increase in total health care spending.

The American Diabetes Association estimates that people diagnosed with diabetes have average yearly medical expenditures of over $13,000, which is over two times higher than the expenditures of a person without diagnosed diabetes. The 2012 estimated annual cost of care for diagnosed diabetes was $245 billion, which includes $176 billion in direct medical costs and $69 billion in reduced productivity (Diabetes Care 2013 [doi:10.2337/dc12-2625]). These figures, while staggering, do not include projected expenditures for people who have yet to receive a diabetes diagnosis.

The federal government has chosen to take dramatic steps to help Americans lose weight. Since 2011, the Centers for Medicare & Medicaid Services has covered screening and intensive behavioral therapy for obesity by primary care physicians during office visits or outpatient hospital care. Additionally, the Affordable Care Act (ACA) now requires insurance companies to help overweight and obese patients try to lose weight and be healthier. The 2012 Institute of Medicine (IOM) report, Accelerating Progress in Obesity Prevention: Solving the Weight of the Nation also has made major recommendations for health care practitioners, schools, and the food and beverage industry to take a more active part in improving our overall health.

Simple steps make a big impact on health

Despite the daunting – and perhaps somewhat disheartening – statistics on obesity and diabetes in the United States and around the world, research has shown that small steps to achieving a healthy weight and maintaining an active lifestyle can make a dramatic difference on the course of a person’s life. According to the Department of Agriculture, healthier diets could prevent about $71 billion in yearly health care costs, lost productivity, and premature deaths. This number is staggering, when you consider that the change could be as small as choosing a salad instead of fries for a side dish.

Medical research backs up the well-worn adage that "an apple a day keeps the doctor away." The Diabetes Prevention Program study, conducted in the early 2000s, found that lifestyle changes, such as getting more exercise and eating a balanced diet, had a major impact on whether a patient who is overweight with prediabetes developed type 2 diabetes (N. Engl. J. Med. 2002;346:393-403).

Lifestyle changes can also reduce the onset of diabetes in high-risk groups such as Asian Indians, where the incidence of diabetes is the highest in the world. The Indian Diabetes Prevention Programme showed that weight loss and healthy eating reduced the incidence of type 2 diabetes in this population at a rate similar to the use of metformin, one of the most common oral antidiabetic drugs (Diabetologia 2006;49:289-97).

The 16th U.S. Surgeon General, David Satcher, M.D., Ph.D., is famous for giving his "Prescription for Great Health" when he addresses colleges and universities, which includes not smoking, staying away from illicit drug use, and abstaining from unsafe sex. Importantly, the first two key points of his "prescription" are exercising at least five times a week for 30 minutes and eating at least five servings of fruits and vegetables daily. Again, very simple recommendations, but his advice has lasting and profound ramifications.

Do obstetrician/gynecologists have a role?

As ob.gyns., we always have played an incredibly critical role in maintaining the health and well-being of our patients. Now, more than ever, we have a significant opportunity to set our patients on a path to better eating, incorporating exercise into their daily routines and passing down these good habits to their children.

 

 

In the "old days," the ob.gyn. focused on a limited period in a patient’s life. Perhaps we only saw a patient for annual exams and then for a more intense time prior to and during pregnancy, and then for a checkup post partum where we may have examined our patients only for complications of the pregnancy and delivery and not much more. Although we may have included some counseling on maintaining a healthy pregnancy, many of us relied on a patient’s primary care physician to provide ongoing support.

Today, however, we must take a more active role in helping our patients establish and maintain a healthy lifestyle. Despite the increased insurance coverage under the ACA and the expansion of Medicaid, a woman’s ob.gyn. may be the only health care practitioner she will see on a routine basis. Many women do not visit a general practitioner for routine physical examinations, but women will see their ob.gyn. for regular exams. We can use these annual or biannual office visits to help women set goals to live a healthy life, approaching each patient as a whole person who needs comprehensive care throughout her reproductive life and beyond.

For patients who are overweight or obese, we may focus on helping them reduce their body mass index and blood pressure and encourage them to stay fit. We also should do everything we can to ensure that if a woman has had gestational diabetes, she’s doing what she can to reduce her risk of developing type 2 diabetes after pregnancy. For these patients, we should consider testing their blood glucose every 1-2 years during the annual checkup.

Healthy weight in pregnancy: to gain or to lose?

Whether or not an ob.gyn. practice implements a screening program and more intensive obesity and diabetes counseling, we all will face the same question: How much weight should my patient gain to have a healthy baby? Interestingly, in the first half of the 20th century, ob.gyns. were discouraged from recommending that their pregnant patients gain very much weight. Indeed, the 13th edition of "Williams Obstetrics" (New York: Appleton-Century-Crofts, 1966, p. 326) stated that obstetricians should limit their patients from gaining more than 25 pounds during gestation, and that the ideal weight gain was 15 pounds.

This guidance was called into question by a 1970 National Academy of Sciences report, "Maternal Nutrition and the Course of Pregnancy," which indicated a strong link between infant mortality and low maternal pregnancy weight. Further evidence suggested a need for new standards and, in 1990, the IOM issued recommendations on women’s nutrition during pregnancy (Nutrition During Pregnancy, Weight Gain and Nutrient Supplements. Washington, D.C.: National Academy Press, 1990). (See table.)

Americans consume 31% more calories today than they did 40 years ago. Because of this, a woman’s need to gain weight to improve the outcome of her pregnancy is significantly reduced. The calories that many people include in their diets often come from high-fat, sodium-loaded, processed foods. We also have become a more sedentary society, spending our days at a computer, browsing the internet, watching TV, and opting to drive rather than to walk. Taking these factors into account, revising the recommendations for weight gain seemed crucial. In 2009, the IOM revised its guidance on healthy weight gain in pregnancy, and these ranges are currently widely accepted by obstetricians today (iom.edu/Reports/2009/Weight-Gain-During-Pregnancy-Reexamining-the-Guidelines.aspx). (See table.)

With the obesity and diabetes epidemics on the rise, we may need to update the 2009 IOM guidelines again – and very soon. Isolated studies have indicated that, for women who are severely obese, moderate weight loss during pregnancy may improve pregnancy outcomes. These findings remain controversial, but the "heavy" burden of diabetes and obesity on the U.S. health care system in general, and the need to reduce obstetrical complications that accompany deliveries in patients who are overweight or obese and diabetic, means that we as a community may need to reexamine our practices and approaches much more closely.

"Food" for thought

We all know of patients who, once they become pregnant, begin justifying a greater intake of food as "eating for two." Many women may use their pregnancy as an excuse to overindulge in unhealthy foods or to forgo the gym and other regular exercise regimens. Recommending basic steps to change a patient’s lifestyle can make an incredible difference in improving maternal and fetal health outcomes.

Summary recommendations for healthy pregnancy

• A low-glycemic diet, combined with moderate exercise, can reduce or eliminate many of the negative consequences of obesity on pregnant women and their babies.

 

 

• Proper weight management during pregnancy can improve birth outcomes.

• Weight loss during pregnancy is not recommended, except, potentially, for morbidly obese women (BMI greater than 40).

• For women who are normal weight, overweight or obese, leading healthy lifestyles can greatly improve maternal and fetal health outcomes. These include physical exercise, balanced diet, and weight loss, in combination with medication in some cases.

• It is never too late to begin healthy habits!

If we microfocus only on a woman’s predelivery and postdelivery health, then we’re losing a big opportunity to improve her whole self and prevent future health complications during and outside of pregnancy. The good news for ob.gyns. is that this complex problem has a simple, well-documented, and proven solution.

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].

The world is not only getting older and warmer, but it’s getting heavier and more unfit each year. According to the World Health Organization’s most recent data, more than 1.4 billion adults were overweight in 2008, and 500 million of these adults were obese. In 2012, more than 40 million young children were overweight or obese. Diabetes, a disorder closely linked with obesity, affects about 347 million people worldwide – approximately ten times more people than those with HIV/AIDS. Although the number of AIDS-related deaths has steadily decreased over the last decade, even in developing countries, the number of diabetes-related deaths has steadily increased. The WHO projects that diabetes-related deaths will double by 2030, making it the seventh leading cause of death worldwide. In the United States, diabetes already is the seventh leading cause of death.

According to the Centers for Disease Control and Prevention, obesity-related diseases cost $147 billion annually, a number which dwarfs the health care costs associated with smoking ($96 billion). In addition to the link with type 2 diabetes, there are strong links between obesity and heart disease, kidney disease, depression, and hypertension. From 1987 to 2007, obesity was estimated to have caused more than a 20% increase in total health care spending.

The American Diabetes Association estimates that people diagnosed with diabetes have average yearly medical expenditures of over $13,000, which is over two times higher than the expenditures of a person without diagnosed diabetes. The 2012 estimated annual cost of care for diagnosed diabetes was $245 billion, which includes $176 billion in direct medical costs and $69 billion in reduced productivity (Diabetes Care 2013 [doi:10.2337/dc12-2625]). These figures, while staggering, do not include projected expenditures for people who have yet to receive a diabetes diagnosis.

The federal government has chosen to take dramatic steps to help Americans lose weight. Since 2011, the Centers for Medicare & Medicaid Services has covered screening and intensive behavioral therapy for obesity by primary care physicians during office visits or outpatient hospital care. Additionally, the Affordable Care Act (ACA) now requires insurance companies to help overweight and obese patients try to lose weight and be healthier. The 2012 Institute of Medicine (IOM) report, Accelerating Progress in Obesity Prevention: Solving the Weight of the Nation also has made major recommendations for health care practitioners, schools, and the food and beverage industry to take a more active part in improving our overall health.

Simple steps make a big impact on health

Despite the daunting – and perhaps somewhat disheartening – statistics on obesity and diabetes in the United States and around the world, research has shown that small steps to achieving a healthy weight and maintaining an active lifestyle can make a dramatic difference on the course of a person’s life. According to the Department of Agriculture, healthier diets could prevent about $71 billion in yearly health care costs, lost productivity, and premature deaths. This number is staggering, when you consider that the change could be as small as choosing a salad instead of fries for a side dish.

Medical research backs up the well-worn adage that "an apple a day keeps the doctor away." The Diabetes Prevention Program study, conducted in the early 2000s, found that lifestyle changes, such as getting more exercise and eating a balanced diet, had a major impact on whether a patient who is overweight with prediabetes developed type 2 diabetes (N. Engl. J. Med. 2002;346:393-403).

Lifestyle changes can also reduce the onset of diabetes in high-risk groups such as Asian Indians, where the incidence of diabetes is the highest in the world. The Indian Diabetes Prevention Programme showed that weight loss and healthy eating reduced the incidence of type 2 diabetes in this population at a rate similar to the use of metformin, one of the most common oral antidiabetic drugs (Diabetologia 2006;49:289-97).

The 16th U.S. Surgeon General, David Satcher, M.D., Ph.D., is famous for giving his "Prescription for Great Health" when he addresses colleges and universities, which includes not smoking, staying away from illicit drug use, and abstaining from unsafe sex. Importantly, the first two key points of his "prescription" are exercising at least five times a week for 30 minutes and eating at least five servings of fruits and vegetables daily. Again, very simple recommendations, but his advice has lasting and profound ramifications.

Do obstetrician/gynecologists have a role?

As ob.gyns., we always have played an incredibly critical role in maintaining the health and well-being of our patients. Now, more than ever, we have a significant opportunity to set our patients on a path to better eating, incorporating exercise into their daily routines and passing down these good habits to their children.

 

 

In the "old days," the ob.gyn. focused on a limited period in a patient’s life. Perhaps we only saw a patient for annual exams and then for a more intense time prior to and during pregnancy, and then for a checkup post partum where we may have examined our patients only for complications of the pregnancy and delivery and not much more. Although we may have included some counseling on maintaining a healthy pregnancy, many of us relied on a patient’s primary care physician to provide ongoing support.

Today, however, we must take a more active role in helping our patients establish and maintain a healthy lifestyle. Despite the increased insurance coverage under the ACA and the expansion of Medicaid, a woman’s ob.gyn. may be the only health care practitioner she will see on a routine basis. Many women do not visit a general practitioner for routine physical examinations, but women will see their ob.gyn. for regular exams. We can use these annual or biannual office visits to help women set goals to live a healthy life, approaching each patient as a whole person who needs comprehensive care throughout her reproductive life and beyond.

For patients who are overweight or obese, we may focus on helping them reduce their body mass index and blood pressure and encourage them to stay fit. We also should do everything we can to ensure that if a woman has had gestational diabetes, she’s doing what she can to reduce her risk of developing type 2 diabetes after pregnancy. For these patients, we should consider testing their blood glucose every 1-2 years during the annual checkup.

Healthy weight in pregnancy: to gain or to lose?

Whether or not an ob.gyn. practice implements a screening program and more intensive obesity and diabetes counseling, we all will face the same question: How much weight should my patient gain to have a healthy baby? Interestingly, in the first half of the 20th century, ob.gyns. were discouraged from recommending that their pregnant patients gain very much weight. Indeed, the 13th edition of "Williams Obstetrics" (New York: Appleton-Century-Crofts, 1966, p. 326) stated that obstetricians should limit their patients from gaining more than 25 pounds during gestation, and that the ideal weight gain was 15 pounds.

This guidance was called into question by a 1970 National Academy of Sciences report, "Maternal Nutrition and the Course of Pregnancy," which indicated a strong link between infant mortality and low maternal pregnancy weight. Further evidence suggested a need for new standards and, in 1990, the IOM issued recommendations on women’s nutrition during pregnancy (Nutrition During Pregnancy, Weight Gain and Nutrient Supplements. Washington, D.C.: National Academy Press, 1990). (See table.)

Americans consume 31% more calories today than they did 40 years ago. Because of this, a woman’s need to gain weight to improve the outcome of her pregnancy is significantly reduced. The calories that many people include in their diets often come from high-fat, sodium-loaded, processed foods. We also have become a more sedentary society, spending our days at a computer, browsing the internet, watching TV, and opting to drive rather than to walk. Taking these factors into account, revising the recommendations for weight gain seemed crucial. In 2009, the IOM revised its guidance on healthy weight gain in pregnancy, and these ranges are currently widely accepted by obstetricians today (iom.edu/Reports/2009/Weight-Gain-During-Pregnancy-Reexamining-the-Guidelines.aspx). (See table.)

With the obesity and diabetes epidemics on the rise, we may need to update the 2009 IOM guidelines again – and very soon. Isolated studies have indicated that, for women who are severely obese, moderate weight loss during pregnancy may improve pregnancy outcomes. These findings remain controversial, but the "heavy" burden of diabetes and obesity on the U.S. health care system in general, and the need to reduce obstetrical complications that accompany deliveries in patients who are overweight or obese and diabetic, means that we as a community may need to reexamine our practices and approaches much more closely.

"Food" for thought

We all know of patients who, once they become pregnant, begin justifying a greater intake of food as "eating for two." Many women may use their pregnancy as an excuse to overindulge in unhealthy foods or to forgo the gym and other regular exercise regimens. Recommending basic steps to change a patient’s lifestyle can make an incredible difference in improving maternal and fetal health outcomes.

Summary recommendations for healthy pregnancy

• A low-glycemic diet, combined with moderate exercise, can reduce or eliminate many of the negative consequences of obesity on pregnant women and their babies.

 

 

• Proper weight management during pregnancy can improve birth outcomes.

• Weight loss during pregnancy is not recommended, except, potentially, for morbidly obese women (BMI greater than 40).

• For women who are normal weight, overweight or obese, leading healthy lifestyles can greatly improve maternal and fetal health outcomes. These include physical exercise, balanced diet, and weight loss, in combination with medication in some cases.

• It is never too late to begin healthy habits!

If we microfocus only on a woman’s predelivery and postdelivery health, then we’re losing a big opportunity to improve her whole self and prevent future health complications during and outside of pregnancy. The good news for ob.gyns. is that this complex problem has a simple, well-documented, and proven solution.

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].

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Getting past bad drug outcomes

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In my first year of fellowship, I met a delightful old man who had temporal arteritis. We naturally treated him with steroids, but he consequently suffered a vertebral fracture. He passed away soon after that from pneumonia that was probably aggravated by his inability to breathe deeply and cough appropriately.

An elderly patient with rheumatoid arthritis was diagnosed with lymphoma. For want of something to blame, his children blamed it on the methotrexate.

A woman with lupus nephritis got pregnant while on mycophenolate despite being on contraception. Her baby was born with malformed ears and eyes, and by all accounts will probably be deaf and blind.

We have been gifted with this mind-blowing ability to make our patients’ lives much better. That sense of accomplishment can be intoxicating. After all, how many of your polymyalgia rheumatica patients worship you because you made the diagnosis and made them 100% better by putting them on prednisone? Yet we forget that although bad things rarely happen, that does not mean that they won’t happen.

In a beautiful book called "Where’d You Go, Bernadette?" the husband of the title character says that the brain is a discounting mechanism: "Let’s say you get a crack in your windshield and you’re really upset. Oh no, my windshield, it’s ruined, I can hardly see out of it, this is a tragedy! But you don’t have enough money to fix it, so you drive with it. In a month, someone asks you what happened to your windshield, and you say, What do you mean? Because your brain has discounted it. ... It’s for survival. You need to be prepared for novel experiences because often they signal danger."

The book is about an artist who we are led to believe has completed her downward spiral, going from genius to wacko. In the above passage, the artist’s husband is explaining to their daughter why they loved their family home so much, despite its state of extreme disrepair. They loved the house so much that they couldn’t see that it was a safety hazard.

As a fresh graduate I insisted on weaning everyone off prednisone, terrified of the potential side effects. Five years later and with the benefit of the collected wisdom of hundreds of rheumatologists before me, I have accepted that some people need a low dose of steroid to keep their disease quiet. I have used this and other, more toxic drugs to such great effects – taking for granted their ability to make people better – that I forget sometimes that they can cause serious problems.

Bad outcomes can and do happen in spite of our best intentions. In my case, my default is to blame myself. In my more melodramatic moments, I wonder if I deserve to be a doctor. But when I am done feeling angry or sad, or, frankly, feeling sorry for myself, then I need that discounting mechanism to kick in, to remind myself that this is one bad outcome out of many good outcomes. There are things beyond my control, and I cannot let a bad outcome keep me from doing the good work that I am still able to do.

There is a scene from the TV series "The West Wing" where the president asks one of his staffers if he thought the president was being kept from doing a great job because his demons were "shouting down the better angels" in his brain. Thankfully, my brain’s discounting mechanism helps keep the demons at bay.

Dr. Chan practices rheumatology in Pawtucket, R.I.

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In my first year of fellowship, I met a delightful old man who had temporal arteritis. We naturally treated him with steroids, but he consequently suffered a vertebral fracture. He passed away soon after that from pneumonia that was probably aggravated by his inability to breathe deeply and cough appropriately.

An elderly patient with rheumatoid arthritis was diagnosed with lymphoma. For want of something to blame, his children blamed it on the methotrexate.

A woman with lupus nephritis got pregnant while on mycophenolate despite being on contraception. Her baby was born with malformed ears and eyes, and by all accounts will probably be deaf and blind.

We have been gifted with this mind-blowing ability to make our patients’ lives much better. That sense of accomplishment can be intoxicating. After all, how many of your polymyalgia rheumatica patients worship you because you made the diagnosis and made them 100% better by putting them on prednisone? Yet we forget that although bad things rarely happen, that does not mean that they won’t happen.

In a beautiful book called "Where’d You Go, Bernadette?" the husband of the title character says that the brain is a discounting mechanism: "Let’s say you get a crack in your windshield and you’re really upset. Oh no, my windshield, it’s ruined, I can hardly see out of it, this is a tragedy! But you don’t have enough money to fix it, so you drive with it. In a month, someone asks you what happened to your windshield, and you say, What do you mean? Because your brain has discounted it. ... It’s for survival. You need to be prepared for novel experiences because often they signal danger."

The book is about an artist who we are led to believe has completed her downward spiral, going from genius to wacko. In the above passage, the artist’s husband is explaining to their daughter why they loved their family home so much, despite its state of extreme disrepair. They loved the house so much that they couldn’t see that it was a safety hazard.

As a fresh graduate I insisted on weaning everyone off prednisone, terrified of the potential side effects. Five years later and with the benefit of the collected wisdom of hundreds of rheumatologists before me, I have accepted that some people need a low dose of steroid to keep their disease quiet. I have used this and other, more toxic drugs to such great effects – taking for granted their ability to make people better – that I forget sometimes that they can cause serious problems.

Bad outcomes can and do happen in spite of our best intentions. In my case, my default is to blame myself. In my more melodramatic moments, I wonder if I deserve to be a doctor. But when I am done feeling angry or sad, or, frankly, feeling sorry for myself, then I need that discounting mechanism to kick in, to remind myself that this is one bad outcome out of many good outcomes. There are things beyond my control, and I cannot let a bad outcome keep me from doing the good work that I am still able to do.

There is a scene from the TV series "The West Wing" where the president asks one of his staffers if he thought the president was being kept from doing a great job because his demons were "shouting down the better angels" in his brain. Thankfully, my brain’s discounting mechanism helps keep the demons at bay.

Dr. Chan practices rheumatology in Pawtucket, R.I.

In my first year of fellowship, I met a delightful old man who had temporal arteritis. We naturally treated him with steroids, but he consequently suffered a vertebral fracture. He passed away soon after that from pneumonia that was probably aggravated by his inability to breathe deeply and cough appropriately.

An elderly patient with rheumatoid arthritis was diagnosed with lymphoma. For want of something to blame, his children blamed it on the methotrexate.

A woman with lupus nephritis got pregnant while on mycophenolate despite being on contraception. Her baby was born with malformed ears and eyes, and by all accounts will probably be deaf and blind.

We have been gifted with this mind-blowing ability to make our patients’ lives much better. That sense of accomplishment can be intoxicating. After all, how many of your polymyalgia rheumatica patients worship you because you made the diagnosis and made them 100% better by putting them on prednisone? Yet we forget that although bad things rarely happen, that does not mean that they won’t happen.

In a beautiful book called "Where’d You Go, Bernadette?" the husband of the title character says that the brain is a discounting mechanism: "Let’s say you get a crack in your windshield and you’re really upset. Oh no, my windshield, it’s ruined, I can hardly see out of it, this is a tragedy! But you don’t have enough money to fix it, so you drive with it. In a month, someone asks you what happened to your windshield, and you say, What do you mean? Because your brain has discounted it. ... It’s for survival. You need to be prepared for novel experiences because often they signal danger."

The book is about an artist who we are led to believe has completed her downward spiral, going from genius to wacko. In the above passage, the artist’s husband is explaining to their daughter why they loved their family home so much, despite its state of extreme disrepair. They loved the house so much that they couldn’t see that it was a safety hazard.

As a fresh graduate I insisted on weaning everyone off prednisone, terrified of the potential side effects. Five years later and with the benefit of the collected wisdom of hundreds of rheumatologists before me, I have accepted that some people need a low dose of steroid to keep their disease quiet. I have used this and other, more toxic drugs to such great effects – taking for granted their ability to make people better – that I forget sometimes that they can cause serious problems.

Bad outcomes can and do happen in spite of our best intentions. In my case, my default is to blame myself. In my more melodramatic moments, I wonder if I deserve to be a doctor. But when I am done feeling angry or sad, or, frankly, feeling sorry for myself, then I need that discounting mechanism to kick in, to remind myself that this is one bad outcome out of many good outcomes. There are things beyond my control, and I cannot let a bad outcome keep me from doing the good work that I am still able to do.

There is a scene from the TV series "The West Wing" where the president asks one of his staffers if he thought the president was being kept from doing a great job because his demons were "shouting down the better angels" in his brain. Thankfully, my brain’s discounting mechanism helps keep the demons at bay.

Dr. Chan practices rheumatology in Pawtucket, R.I.

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Firing your patient

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How often do you fire patients? I do it here and there, maybe a few times a year, but certainly not as often as patients fire me.

Contrary to popular belief, I don’t get some sort of perverse thrill out of it. I am maybe relieved, knowing that I’m (hopefully) done with a difficult relationship. But it’s a pain, always requiring a trip to the post office to send the registered letter. There’s also the fear that they’ll report me to the board for it, and I’ll have to defend my actions. And I certainly can’t guard against the one-sided Yelp reviews.

What tips you over the edge? I consider myself pretty tolerant. In long-standing patients, I’ll generally let the occasional no-show slide. For drug abusers, I’m actually willing to continue with many of them, but will let them know that I’m not going to give them controlled substances anymore. Most of them leave at that point anyway.

I have zero tolerance for malicious behavior. Abuse my staff, and you’re out of here. I’m more willing to put up with someone who’s nasty to me than one who treats my staff the same way.

What other things do I fire them for? Occasionally noncompliance, especially if it’s putting their own safety in danger. Only once have I fired someone for refusing to have tests done. That was after, literally, 5 years of him repeatedly showing up annually to ask me to order them for his symptoms, then never following through and showing up a year later to start over again. At some point, my patience for that type of thing runs out, and I consider myself fairly patient.

Like most doctors, I’ve had more patients fire me than I’ve fired patients. For most, you don’t realize they’re gone. They just never come back. Occasionally, you get a release from another doctor, but more often you don’t.

Rarely, someone sends a nasty letter telling me why they went elsewhere and what they think of my medical skills/fashion sense/office décor ... whatever. The first time I got one of those, it hurt. Nowadays, I just don’t care.

Part of growing up as a doctor is realizing you’ll never make everyone happy or be able to help them all. Trying to do so will only lessen your sanity, so it’s a message best learned early.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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How often do you fire patients? I do it here and there, maybe a few times a year, but certainly not as often as patients fire me.

Contrary to popular belief, I don’t get some sort of perverse thrill out of it. I am maybe relieved, knowing that I’m (hopefully) done with a difficult relationship. But it’s a pain, always requiring a trip to the post office to send the registered letter. There’s also the fear that they’ll report me to the board for it, and I’ll have to defend my actions. And I certainly can’t guard against the one-sided Yelp reviews.

What tips you over the edge? I consider myself pretty tolerant. In long-standing patients, I’ll generally let the occasional no-show slide. For drug abusers, I’m actually willing to continue with many of them, but will let them know that I’m not going to give them controlled substances anymore. Most of them leave at that point anyway.

I have zero tolerance for malicious behavior. Abuse my staff, and you’re out of here. I’m more willing to put up with someone who’s nasty to me than one who treats my staff the same way.

What other things do I fire them for? Occasionally noncompliance, especially if it’s putting their own safety in danger. Only once have I fired someone for refusing to have tests done. That was after, literally, 5 years of him repeatedly showing up annually to ask me to order them for his symptoms, then never following through and showing up a year later to start over again. At some point, my patience for that type of thing runs out, and I consider myself fairly patient.

Like most doctors, I’ve had more patients fire me than I’ve fired patients. For most, you don’t realize they’re gone. They just never come back. Occasionally, you get a release from another doctor, but more often you don’t.

Rarely, someone sends a nasty letter telling me why they went elsewhere and what they think of my medical skills/fashion sense/office décor ... whatever. The first time I got one of those, it hurt. Nowadays, I just don’t care.

Part of growing up as a doctor is realizing you’ll never make everyone happy or be able to help them all. Trying to do so will only lessen your sanity, so it’s a message best learned early.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

How often do you fire patients? I do it here and there, maybe a few times a year, but certainly not as often as patients fire me.

Contrary to popular belief, I don’t get some sort of perverse thrill out of it. I am maybe relieved, knowing that I’m (hopefully) done with a difficult relationship. But it’s a pain, always requiring a trip to the post office to send the registered letter. There’s also the fear that they’ll report me to the board for it, and I’ll have to defend my actions. And I certainly can’t guard against the one-sided Yelp reviews.

What tips you over the edge? I consider myself pretty tolerant. In long-standing patients, I’ll generally let the occasional no-show slide. For drug abusers, I’m actually willing to continue with many of them, but will let them know that I’m not going to give them controlled substances anymore. Most of them leave at that point anyway.

I have zero tolerance for malicious behavior. Abuse my staff, and you’re out of here. I’m more willing to put up with someone who’s nasty to me than one who treats my staff the same way.

What other things do I fire them for? Occasionally noncompliance, especially if it’s putting their own safety in danger. Only once have I fired someone for refusing to have tests done. That was after, literally, 5 years of him repeatedly showing up annually to ask me to order them for his symptoms, then never following through and showing up a year later to start over again. At some point, my patience for that type of thing runs out, and I consider myself fairly patient.

Like most doctors, I’ve had more patients fire me than I’ve fired patients. For most, you don’t realize they’re gone. They just never come back. Occasionally, you get a release from another doctor, but more often you don’t.

Rarely, someone sends a nasty letter telling me why they went elsewhere and what they think of my medical skills/fashion sense/office décor ... whatever. The first time I got one of those, it hurt. Nowadays, I just don’t care.

Part of growing up as a doctor is realizing you’ll never make everyone happy or be able to help them all. Trying to do so will only lessen your sanity, so it’s a message best learned early.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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Polyunsaturated fatty acid supplementation

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Supplementation with polyunsaturated fatty acids – or omega-3 fatty acids – during pregnancy is an important topic because of unproven claims that polyunsaturated fatty acids (PUFAs) improve fetal brain and eye development if taken during pregnancy, resulting in unnecessary expense for many women who buy these products. In Canada, there are prenatal vitamins available that contain omega-3 fatty acids with a statement that the product "helps support cognitive health and/or brain function" or that omega-3 fatty acids "support "healthy fetal brain and eye development." These are misleading, inappropriate statements, considering that there is no compelling evidence to support these claims.

Claims about the benefits of PUFA supplementation during pregnancy, which have circulated for about a decade, originate from studies that show that when PUFAs are restricted during pregnancy, fetal brain development can be adversely affected, particularly in animals. Other data include several human studies that have linked high cognitive scores to a high seafood content of the maternal diet. The highest levels of PUFAs are measured in the retina, which is part of the visual acuity claim.

My colleagues and I addressed the uncertainties about the benefits of PUFA supplementation in a systematic review of nine randomized controlled trials comparing visual and neurobehavioral outcomes in infants whose mothers received PUFA supplements during gestation with control women who received placebos. Three studies evaluated retinal development and six evaluated neurodevelopment; most ended the supplement at delivery, and evaluations were conducted during the first year, or up to age 2.5, 4, and 7 years in different studies.

Overall, there was no evidence of a beneficial effect of PUFA supplementation during pregnancy on neurodevelopment (IQ, language behaviors) or on visual acuity. As we concluded, there were "very limited, if any" benefits identified, and in the studies with statistically significant differences between the two groups, "the differences were small and of little potential clinical importance" (Obstet. Gynecol. Int. 2012 [doi:10.1155/2012/591531]).

A study published in May 2014 also found no beneficial effect of prenatal supplementation with 800 mg/day of omega-3 fatty acid docosahexaenoic acid (DHA) on neurodevelopmental outcomes in children followed to age 4 years, and the authors concluded that the data "do not support prenatal DHA supplementation to enhance early childhood development." The randomized placebo-controlled study evaluated about 650 children at age 4 years, whose mothers had received the supplement or 333 who received placebo. The mean cognitive scores were not different between the two groups, and the proportion of children with delayed or advanced scores also did not differ between the two groups, nor did other objective assessments of cognition, language, and executive functioning (JAMA 2014;311:1802-4).

Based on the lack of evidence to date, there is no reason to add PUFAs to prenatal vitamins or recommend that women take a PUFA supplement during pregnancy.

The bottom line for clinicians/health care providers is that although the available evidence today has found no detrimental effects of even high doses of omega-3 fatty acid supplementation (up to 3.7 g/day), with the present state of knowledge, there is no evidence that prenatal supplementation with PUFAs improves brain development or acuity of vision in children. Instead of supplementation with PUFA during pregnancy, women should consume a diet with adequate PUFAs, with food that includes eggs and fish, with caution about the mercury content of fish.

Dr. Koren is professor of pediatrics, pharmacology, pharmacy, medicine, and medical genetics at the University of Toronto. He heads the Research Leadership for Better Pharmacotherapy During Pregnancy and Lactation at the Hospital for Sick Children, Toronto, where he is director of the Motherisk Program. He also holds the Ivey Chair in Molecular Toxicology at the department of medicine, University of Western Ontario, London. He had no disclosures relevant to this topic. E-mail him at [email protected].

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Supplementation with polyunsaturated fatty acids – or omega-3 fatty acids – during pregnancy is an important topic because of unproven claims that polyunsaturated fatty acids (PUFAs) improve fetal brain and eye development if taken during pregnancy, resulting in unnecessary expense for many women who buy these products. In Canada, there are prenatal vitamins available that contain omega-3 fatty acids with a statement that the product "helps support cognitive health and/or brain function" or that omega-3 fatty acids "support "healthy fetal brain and eye development." These are misleading, inappropriate statements, considering that there is no compelling evidence to support these claims.

Claims about the benefits of PUFA supplementation during pregnancy, which have circulated for about a decade, originate from studies that show that when PUFAs are restricted during pregnancy, fetal brain development can be adversely affected, particularly in animals. Other data include several human studies that have linked high cognitive scores to a high seafood content of the maternal diet. The highest levels of PUFAs are measured in the retina, which is part of the visual acuity claim.

My colleagues and I addressed the uncertainties about the benefits of PUFA supplementation in a systematic review of nine randomized controlled trials comparing visual and neurobehavioral outcomes in infants whose mothers received PUFA supplements during gestation with control women who received placebos. Three studies evaluated retinal development and six evaluated neurodevelopment; most ended the supplement at delivery, and evaluations were conducted during the first year, or up to age 2.5, 4, and 7 years in different studies.

Overall, there was no evidence of a beneficial effect of PUFA supplementation during pregnancy on neurodevelopment (IQ, language behaviors) or on visual acuity. As we concluded, there were "very limited, if any" benefits identified, and in the studies with statistically significant differences between the two groups, "the differences were small and of little potential clinical importance" (Obstet. Gynecol. Int. 2012 [doi:10.1155/2012/591531]).

A study published in May 2014 also found no beneficial effect of prenatal supplementation with 800 mg/day of omega-3 fatty acid docosahexaenoic acid (DHA) on neurodevelopmental outcomes in children followed to age 4 years, and the authors concluded that the data "do not support prenatal DHA supplementation to enhance early childhood development." The randomized placebo-controlled study evaluated about 650 children at age 4 years, whose mothers had received the supplement or 333 who received placebo. The mean cognitive scores were not different between the two groups, and the proportion of children with delayed or advanced scores also did not differ between the two groups, nor did other objective assessments of cognition, language, and executive functioning (JAMA 2014;311:1802-4).

Based on the lack of evidence to date, there is no reason to add PUFAs to prenatal vitamins or recommend that women take a PUFA supplement during pregnancy.

The bottom line for clinicians/health care providers is that although the available evidence today has found no detrimental effects of even high doses of omega-3 fatty acid supplementation (up to 3.7 g/day), with the present state of knowledge, there is no evidence that prenatal supplementation with PUFAs improves brain development or acuity of vision in children. Instead of supplementation with PUFA during pregnancy, women should consume a diet with adequate PUFAs, with food that includes eggs and fish, with caution about the mercury content of fish.

Dr. Koren is professor of pediatrics, pharmacology, pharmacy, medicine, and medical genetics at the University of Toronto. He heads the Research Leadership for Better Pharmacotherapy During Pregnancy and Lactation at the Hospital for Sick Children, Toronto, where he is director of the Motherisk Program. He also holds the Ivey Chair in Molecular Toxicology at the department of medicine, University of Western Ontario, London. He had no disclosures relevant to this topic. E-mail him at [email protected].

Supplementation with polyunsaturated fatty acids – or omega-3 fatty acids – during pregnancy is an important topic because of unproven claims that polyunsaturated fatty acids (PUFAs) improve fetal brain and eye development if taken during pregnancy, resulting in unnecessary expense for many women who buy these products. In Canada, there are prenatal vitamins available that contain omega-3 fatty acids with a statement that the product "helps support cognitive health and/or brain function" or that omega-3 fatty acids "support "healthy fetal brain and eye development." These are misleading, inappropriate statements, considering that there is no compelling evidence to support these claims.

Claims about the benefits of PUFA supplementation during pregnancy, which have circulated for about a decade, originate from studies that show that when PUFAs are restricted during pregnancy, fetal brain development can be adversely affected, particularly in animals. Other data include several human studies that have linked high cognitive scores to a high seafood content of the maternal diet. The highest levels of PUFAs are measured in the retina, which is part of the visual acuity claim.

My colleagues and I addressed the uncertainties about the benefits of PUFA supplementation in a systematic review of nine randomized controlled trials comparing visual and neurobehavioral outcomes in infants whose mothers received PUFA supplements during gestation with control women who received placebos. Three studies evaluated retinal development and six evaluated neurodevelopment; most ended the supplement at delivery, and evaluations were conducted during the first year, or up to age 2.5, 4, and 7 years in different studies.

Overall, there was no evidence of a beneficial effect of PUFA supplementation during pregnancy on neurodevelopment (IQ, language behaviors) or on visual acuity. As we concluded, there were "very limited, if any" benefits identified, and in the studies with statistically significant differences between the two groups, "the differences were small and of little potential clinical importance" (Obstet. Gynecol. Int. 2012 [doi:10.1155/2012/591531]).

A study published in May 2014 also found no beneficial effect of prenatal supplementation with 800 mg/day of omega-3 fatty acid docosahexaenoic acid (DHA) on neurodevelopmental outcomes in children followed to age 4 years, and the authors concluded that the data "do not support prenatal DHA supplementation to enhance early childhood development." The randomized placebo-controlled study evaluated about 650 children at age 4 years, whose mothers had received the supplement or 333 who received placebo. The mean cognitive scores were not different between the two groups, and the proportion of children with delayed or advanced scores also did not differ between the two groups, nor did other objective assessments of cognition, language, and executive functioning (JAMA 2014;311:1802-4).

Based on the lack of evidence to date, there is no reason to add PUFAs to prenatal vitamins or recommend that women take a PUFA supplement during pregnancy.

The bottom line for clinicians/health care providers is that although the available evidence today has found no detrimental effects of even high doses of omega-3 fatty acid supplementation (up to 3.7 g/day), with the present state of knowledge, there is no evidence that prenatal supplementation with PUFAs improves brain development or acuity of vision in children. Instead of supplementation with PUFA during pregnancy, women should consume a diet with adequate PUFAs, with food that includes eggs and fish, with caution about the mercury content of fish.

Dr. Koren is professor of pediatrics, pharmacology, pharmacy, medicine, and medical genetics at the University of Toronto. He heads the Research Leadership for Better Pharmacotherapy During Pregnancy and Lactation at the Hospital for Sick Children, Toronto, where he is director of the Motherisk Program. He also holds the Ivey Chair in Molecular Toxicology at the department of medicine, University of Western Ontario, London. He had no disclosures relevant to this topic. E-mail him at [email protected].

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Hormone therapy for menopausal vasomotor symptoms

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Estrogen therapy is highly effective in the treatment of hot flashes among postmenopausal women. For postmenopausal women with a uterus, estrogen treatment for hot flashes is almost always combined with a progestin to reduce the risk of endometrial polyps, hyperplasia, and cancer. For instance, in the Postmenopausal Estrogen/Progestin Interventions Trial, 62% of the women with a uterus treated with conjugated equine estrogen (CEE) 0.625 mg daily without a progestin developed endometrial hyperplasia.1

In the United States, the most commonly prescribed progestin for hormone therapy has been medroxyprogesterone acetate (MPA; Provera). However, data from the Women’s Health Initiative (WHI) trials indicate that MPA, when combined with CEE, may have adverse health effects among postmenopausal women.

Let’s examine the WHI data
Among women 50 to 59 years of age with a uterus, the combination of CEE plus MPA was associated with a trend toward an increased risk of breast cancer, coronary heart disease, and myocardial infarction.2 In contrast, among women 50 to 59 years of age without a uterus, CEE monotherapy was associated with a trend toward a decreased risk of invasive breast cancer, coronary heart disease, and myocardial infarction (TABLE 1).

Among women 50 to 79 years of age with a uterus, the combination of CEE plus MPA was associated with a significantly increased risk of breast cancer (hazard ratio [HR], 1.24; 95% confidence interval [CI], 1.01–1.53; P = .04).2 In contrast, among women 50 to 79 years of age without a uterus, CEE monotherapy was associated with a trend toward a decreased risk of breast cancer (HR, 0.79; 95% CI, 0.61–1.02, P = .07).2

Related article: In the latest report from the WHI, the data contradict the conclusions. Holly Thacker, MD (Commentary; March 2014)

When the analysis was limited to women consistently adherent to their CEE monotherapy, the estrogen treatment significantly decreased the risk of invasive breast cancer (HR, 0.67; 95% CI, 0.47–0.97; P = .03).3

The addition of MPA to CEE appears to reverse some of the health benefits of CEE monotherapy, although the biological mechanisms are unclear. This observation should prompt us to explore alternative and novel treatments of vasomotor symptoms that do not utilize MPA. Some options for MPA-free hormone therapy include:

  • transdermal estradiol plus micronized progesterone
  • CEE plus a levonorgestrel-releasing intrauterine system
  • bazedoxifene plus CEE.

In addition, nonhormonal treatment of hot flashes is an option, with selective serotonin reuptake inhibitors (SSRIs).

Related article: Is one oral estrogen formulation safer than another for menopausal women? Andrew M. Kaunitz, MD (Examining the Evidence; January 2014)

MPA-free hormone therapy for hot flashes
Estrogen plus micronized progesterone

When using an estrogen plus progestin regimen to treat hot flashes, many experts favor a combination of low-dose transdermal estradiol and oral micronized progesterone (Prometrium). This combination is believed by some experts to result in a lower risk of venous thromboembolism, stroke, cardiovascular disease, and breast cancer than an estrogen-MPA combination.4–7

When prescribing transdermal estradiol plus oral micronized progesterone for a woman within 1 to 2 years of her last menses, a cyclic regimen can help reduce episodes of irregular, unscheduled uterine bleeding. I often use this cyclic regimen: transdermal estradiol 0.0375 mg plus cyclic oral micronized progesterone 200 mg prior to bedtime for calendar days 1 to 12.

When using transdermal estradiol plus oral micronized progesterone in a woman more than 2 years from her last menses, a continuous regimen is often prescribed. I often use this continuous regimen: transdermal estradiol 0.0375 mg plus continuous oral micronized progesterone 100 mg daily prior to bedtime.

Related article: When should a menopausal woman discontinue hormone therapy? Andrew M. Kaunitz, MD (Cases in Menopause; February 2014)

Estrogen plus a levonorgestrel-releasing intrauterine systemThe levonorgestrel intrauterine system (LNG-IUS; 20 µg daily; Mirena) is frequently used in Europe to protect the endometrium against the adverse effects of estrogen therapy in postmenopausal women. In a meta-analysis of five clinical trials involving postmenopausal women, the LNG-IUS provided excellent protection against endometrial hyperplasia, compared with MPA.8

One caution about using the LNG-IUS system with estrogen in postmenopausal women is that an observational study of all women with breast cancer in Finland from 1995 through 2007 reported a significantly increased risk of breast cancer among postmenopausal women using an LNG-IUS compared with women who did not use hormones or used only estrogen because they had a hysterectomy (TABLE 2).9 This study was not a randomized clinical trial and patients at higher baseline risk for breast cancer, including women with a high body mass index, may have been preferentially treated with an LNG-IUS. More information is needed to better understand the relationship between the LNG-IUS and breast cancer in postmenopausal women.



Related article:
What we’ve learned from 2 decades’ experience with the LNG-IUS. Q&A with Oskari Heikinheimo, MD, PhD (February 2011)

Progestin-free hormone treatment, bazedoxifene plus CEE

The main reason for adding a progestin to estrogen therapy for vasomotor symptoms in postmenopausal women with a uterus is to prevent estrogen-induced development of endometrial polyps, hyperplasia, and cancer. A major innovation in hormone therapy is the discovery that third-generation selective estrogen receptor modulators (SERMs), such as bazedoxifene (BZA), can prevent estrogen-induced development of endometrial polyps, hyperplasia, and cancer but do not interfere with the efficacy of estrogen in the treatment of vasomotor symptoms.

BZA is an estrogen agonist in bone and an estrogen antagonist in the endometrium.10–12 The combination of BZA (20 mg daily) plus CEE (0.45 mg daily) (Duavee) is approved for the treatment of moderate to severe vasomotor symptoms and prevention of osteoporosis.13–15 Over 24 months of therapy, various doses of BZA plus CEE reduced reported daily hot flashes by 52% to 86%.16 In the same study, placebo treatment was associated with a 17% reduction in hot flashes.16

The main adverse effect of BZA/CEE is an increased risk of deep venous thrombosis. Therefore, BZA/CEE is contraindicated in women with a known thrombophilia or a personal history of hormone-induced deep venous thrombosis. The effect of BZA/CEE on the risk of developing invasive breast cancer is not known; over 52 weeks of therapy it did not increase breast density on mammogram.17,18

BZA/CEE is a remarkable advance in hormone therapy. It is progestin-free, uses estrogen to treat vasomotor symptoms, and uses BZA to protect the endometrium against estrogen-induced hyperplasia.

Related article:
New option for treating menopausal vasomotor symptoms receives FDA approval. (News for your Practice; October 2013)

Nonhormone treatment of vasomotor symptoms Paroxetine mesylateFor postmenopausal women with vasomotor symptoms who cannot take estrogen, SSRIs are modestly effective in reducing moderate to severe hot flashes. The US Food and Drug Administration recently approved paroxetine mesylate (Brisdelle) for the treatment of postmenopausal vasomotor symptoms. The approved dose is 7.5 mg daily taken at bedtime.

Data supporting the efficacy of paroxetine mesylate are available from two studies involving 1,184 menopausal women with vasomotor symptoms randomly assigned to receive paroxetine 7.5 mg daily or placebo for 12 weeks of treatment.19-22 In one of the two clinical trials, women treated with paroxetine mesylate 7.5 mg daily had 5.6 fewer moderate to severe hot flashes daily after 12 weeks of treatment compared with 3.9 fewer hot flashes with placebo (median treatment difference, 1.7; P<.001).21

 

 

Paroxetine can block the metabolism of tamoxifen to its highly potent metabolite, endoxifen. Consequently, paroxetine may reduce the effectiveness of tamoxifen treatment for breast cancer and should be used with caution in postmenopausal women with breast cancer being treated with tamoxifen.

Related article:
Paroxetine mesylate 7.5 mg found to be a safe alternative to hormone therapy for menopausal women with hot flashes. (News for your Practice; June 2014)

Escitalopram
Gynecologists are familiar with the use of venlafaxine, desvenlafaxine, clonidine, citalopram, sertraline, and fluoxetine for the treatment of postmenopausal hot flashes. Recently, escitalopram (Lexapro) at doses of 10 to 20 mg daily has been shown to be more effective than placebo in the treatment of hot flashes and sleep disturbances in postmenopausal women.23,24 In one trial of escitalopram 10 to 20 mg daily versus placebo in 205 postmenopausal women averaging 9.8 hot flashes daily at baseline, escitalopram and placebo reduced mean daily hot flashes by 4.6 and 3.2, respectively (P<.001), after 8 weeks of treatment.

In a meta-analysis of SSRIs for the treatment of hot flashes, data from a mixed-treatment comparison analysis indicated that the rank order from most to least effective therapy for hot flashes was: escitalopram > paroxetine > sertraline > citalopram > fluoxetine.25 Venlafaxine and desvenlafaxine, two serotonin and  norepinephrine reuptake inhibitors that are effective in the treatment of hot flashes, were not included in the mixed-treatment comparison.

Use of alternatives to MPA could mean fewer health risks for women on a wide scale

Substantial data indicate that MPA is not an optimal progestin to combine with estrogen for hormone therapy. Currently, many health insurance plans and Medicare use pharmacy management formularies that prioritize dispensing MPA for postmenopausal hormone therapy. Dispensing an alternative to MPA, such as micronized progesterone, often requires the patient to make a significant copayment.

Hopefully, health insurance companies, Medicare, and their affiliated pharmacy management administrators will soon stop their current policy of using financial incentives to favor dispensing MPA when hormone therapy is prescribed because alternatives to MPA appear to be associated with fewer health risks for postmenopausal women.

WE WANT TO HEAR FROM YOU! Share your thoughts on this article. Send your Letter to the Editor to: [email protected] 

References

1. The Writing Group for the PEPI Trial. Effects of hormone replacement therapy on endometrial histology in postmenopausal women. The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. JAMA. 1996;275(5):370–375.
2. Manson JE, Chlebowski RT, Stefnick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women’s Health Initiative randomized trials. JAMA. 2013;310(13):1353–1368.
3. Stefanick ML, Anderson GL, Margolis KL, et al; WHI Investigators. Effects of conjugated equine estrogens on breast cancer and mammography screening in postmenopausal women with hysterectomy. JAMA. 2006;295(14):1647–1657.
4. Simon JA. What if the Women’s Health Initiative had used transdermal estradiol and oral progesterone instead? [published online head of print January 6, 2014]. Menopause. PMID: 24398406.
5. Manson JE. Current recommendations: What is the clinician to do? Fertil Steril. 2014;101(4):916–921.
6. Fournier A, Berrino F, Clavel-Chapelon F. Unequal risks for breast cancer associated with different hormone replacement therapies: Results from the E3N cohort study [published correction appears in Breast Cancer Res Treat. 2008;107(2):307–308]. Breast Cancer Res Treat. 2008;107(1):103–111.
7. Renoux C, Dell’aniello S, Garbe E, Suissa S. Transdermal and oral hormone replacement therapy and the risk of stroke: A nested case-control study. BMJ. 2010;340:c2519.
8. Somboonpom W, Panna S, Temtanakitpaisan T, Kaewrudee S, Soontrapa S. Effects of the levonorgestrel-releasing intrauterine system plus estrogen therapy in perimenopausal and postmenopausal women: Systematic review and meta-analysis. Menopause. 2011;18(10):1060–1066.
9. Lyytinen HK, Dyba T, Ylikorkala O, Pukkala EI. A case-control study on hormone therapy as a risk factor for breast cancer in Finland: Intrauterine system carries a risk as well. Int J Cancer. 2010;126(2):483–489.
10. Komm BS, Mirkin S. An overview of current and emerging SERMs. J Steroid Biochem Mol Biol. 2014;143C:207–222.
11. Ethun KF, Wood CE, Cline JM, Register TC, Appt SE, Clarkson TB. Endometrial profile of bazedoxifene acetate alone and in combination with conjugated equine estrogens in a primate model. Menopause. 2013;20(7):777–784.
12. Pinkerton JV, Harvey JA, Lindsay R, et al; SMART-5 Investigators. Effects of bazedoxifene/conjugated estrogens on the endometrium and bone: A randomized trial. J Clin Endocrinol Metab. 2014;99(2):E189–E198.
13. Pinkerton JV, Pickar JH, Racketa J, Mirkin S. Bazedoxifene/conjugated estrogens for menopausal symptom treatment and osteoporosis prevention. Climacteric. 2012;15(5):411–418.
14. Pinkerton JV, Abraham L, Bushmakin AG, et al. Evaluation of the efficacy and safety of bazedoxifene/conjugated estrogens for secondary outcomes including vasomotor symptoms in postmenopausal women by years since menopause in the Selective estrogens, Menopause and Response to Therapy (SMART) trials. J Womens Health (Larchmt). 2014;23(1):18–28.
15. Pinkerton JV, Harvey JA, Pan K, et al. Breast effects of bazedoxifene-conjugated estrogens: A randomized controlled trial. Obstet Gynecol. 2013;121(5):959–968.
16. Lobo RA, Pinkerton JV, Gass ML, et al. Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile. Fertil Steril. 2009;92(3):1025–1038.
17. Harvey JA, Holm MK, Ranganath R, Guse PA, Trott EA, Helzner E. The effects of bazedoxifene on mammographic breast density in postmenopausal women with osteoporosis. Menopause. 2009;16(6):1193–1196.
18. Harvey JA, Pinkerton JV, Baracat EC, Shi H, Chines AA, Mirkin S. Breast density changes in a randomized controlled trial evaluating bazedoxifene/conjugated estrogens. Menopause. 2013;20(2):138–145.
19. Simon JA, Portman DJ, Kaunitz AM, et al. Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms: Two randomized controlled trials. Menopause. 2013;20(10):1027–1035.
20. Simon JA, Portman DJ, Kazempour K, Mekonnen H, Bhaskar S, Lippman J. Safety profile of paroxetine 7.5 mg in women with moderate-to-severe vasomotor symptoms. Obstet Gynecol. 2014;123(suppl 1):132S–133S.
21. Orleans RJ, Li L, Kim MJ, et al. FDA approval of paroxetine for menopausal hot flashes. N Engl J Med. 2014;370(19):1777–1779.
22. Paroxetine (Brisdelle) for hot flashes. Med Lett Drugs Ther. 2013;55(1428):85–86.
23. Freeman EW, Guthrie KA, Caan B, et al. Efficacy of escitalopram for hot flashes in health menopausal women. A randomized controlled trial. JAMA. 2011;305(3):267–274.
24. Ensrud KE, Joffe H, Guthrie KA, et al. Effect of escitalopram on insomnia symptoms and subjective sleep quality in healthy perimenopausal and postmenopausal women with hot flashes: A randomized controlled trial. Menopause. 2012;19(8):848–855.
25. Shams T, Firwana B, Habib F, et al. SSRIs for hot flashes: A systematic review and meta-analysis of randomized trials. J Gen Intern Med. 2014;29(1):204–213.

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Dr. Barbieri reports no financial relationships relevant to this article.

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Robert Barbieri,hormone therapy,menopause,vasomotor symptoms,hot flashes,medroxyprogesterone acetate,MPA,Provera,estrogen,postmenopausal women,uterus,progestin,endometrial polyps,hyperplasia,cancer,conjugated equine estrogen,CEE,Women’s Health Iniative,WHI,breast cancer,coronary heart disease,myocardial infarction,monotherapy,transdermal estradiol plus micronized progesterone,Prometrium,CEE plus a levonorgestrel-releasing intrauterine system,LNG-IUS,Mirena,bazedoxifene plus CEE, selective serotonin reuptake inhibitors,SSRIs,hysterectomy,selective estrogen receptor modulators,SERMs,bazedoxifene,BZA,BZA/CEE,paroxetine mesylate,Brisdelle,escitalopram,Lexapro
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Robert L. Barbieri, MD
Editor in Chief, OBG Management Chair, Obstetrics and Gynecology Brigham and Women’s Hospital, Boston, Massachusetts Kate Macy Ladd Professor of Obstetrics, Gynecology and Reproductive Biology Harvard Medical School, Boston.

Dr. Barbieri reports no financial relationships relevant to this article.

Author and Disclosure Information

Robert L. Barbieri, MD
Editor in Chief, OBG Management Chair, Obstetrics and Gynecology Brigham and Women’s Hospital, Boston, Massachusetts Kate Macy Ladd Professor of Obstetrics, Gynecology and Reproductive Biology Harvard Medical School, Boston.

Dr. Barbieri reports no financial relationships relevant to this article.

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Related Articles

Estrogen therapy is highly effective in the treatment of hot flashes among postmenopausal women. For postmenopausal women with a uterus, estrogen treatment for hot flashes is almost always combined with a progestin to reduce the risk of endometrial polyps, hyperplasia, and cancer. For instance, in the Postmenopausal Estrogen/Progestin Interventions Trial, 62% of the women with a uterus treated with conjugated equine estrogen (CEE) 0.625 mg daily without a progestin developed endometrial hyperplasia.1

In the United States, the most commonly prescribed progestin for hormone therapy has been medroxyprogesterone acetate (MPA; Provera). However, data from the Women’s Health Initiative (WHI) trials indicate that MPA, when combined with CEE, may have adverse health effects among postmenopausal women.

Let’s examine the WHI data
Among women 50 to 59 years of age with a uterus, the combination of CEE plus MPA was associated with a trend toward an increased risk of breast cancer, coronary heart disease, and myocardial infarction.2 In contrast, among women 50 to 59 years of age without a uterus, CEE monotherapy was associated with a trend toward a decreased risk of invasive breast cancer, coronary heart disease, and myocardial infarction (TABLE 1).

Among women 50 to 79 years of age with a uterus, the combination of CEE plus MPA was associated with a significantly increased risk of breast cancer (hazard ratio [HR], 1.24; 95% confidence interval [CI], 1.01–1.53; P = .04).2 In contrast, among women 50 to 79 years of age without a uterus, CEE monotherapy was associated with a trend toward a decreased risk of breast cancer (HR, 0.79; 95% CI, 0.61–1.02, P = .07).2

Related article: In the latest report from the WHI, the data contradict the conclusions. Holly Thacker, MD (Commentary; March 2014)

When the analysis was limited to women consistently adherent to their CEE monotherapy, the estrogen treatment significantly decreased the risk of invasive breast cancer (HR, 0.67; 95% CI, 0.47–0.97; P = .03).3

The addition of MPA to CEE appears to reverse some of the health benefits of CEE monotherapy, although the biological mechanisms are unclear. This observation should prompt us to explore alternative and novel treatments of vasomotor symptoms that do not utilize MPA. Some options for MPA-free hormone therapy include:

  • transdermal estradiol plus micronized progesterone
  • CEE plus a levonorgestrel-releasing intrauterine system
  • bazedoxifene plus CEE.

In addition, nonhormonal treatment of hot flashes is an option, with selective serotonin reuptake inhibitors (SSRIs).

Related article: Is one oral estrogen formulation safer than another for menopausal women? Andrew M. Kaunitz, MD (Examining the Evidence; January 2014)

MPA-free hormone therapy for hot flashes
Estrogen plus micronized progesterone

When using an estrogen plus progestin regimen to treat hot flashes, many experts favor a combination of low-dose transdermal estradiol and oral micronized progesterone (Prometrium). This combination is believed by some experts to result in a lower risk of venous thromboembolism, stroke, cardiovascular disease, and breast cancer than an estrogen-MPA combination.4–7

When prescribing transdermal estradiol plus oral micronized progesterone for a woman within 1 to 2 years of her last menses, a cyclic regimen can help reduce episodes of irregular, unscheduled uterine bleeding. I often use this cyclic regimen: transdermal estradiol 0.0375 mg plus cyclic oral micronized progesterone 200 mg prior to bedtime for calendar days 1 to 12.

When using transdermal estradiol plus oral micronized progesterone in a woman more than 2 years from her last menses, a continuous regimen is often prescribed. I often use this continuous regimen: transdermal estradiol 0.0375 mg plus continuous oral micronized progesterone 100 mg daily prior to bedtime.

Related article: When should a menopausal woman discontinue hormone therapy? Andrew M. Kaunitz, MD (Cases in Menopause; February 2014)

Estrogen plus a levonorgestrel-releasing intrauterine systemThe levonorgestrel intrauterine system (LNG-IUS; 20 µg daily; Mirena) is frequently used in Europe to protect the endometrium against the adverse effects of estrogen therapy in postmenopausal women. In a meta-analysis of five clinical trials involving postmenopausal women, the LNG-IUS provided excellent protection against endometrial hyperplasia, compared with MPA.8

One caution about using the LNG-IUS system with estrogen in postmenopausal women is that an observational study of all women with breast cancer in Finland from 1995 through 2007 reported a significantly increased risk of breast cancer among postmenopausal women using an LNG-IUS compared with women who did not use hormones or used only estrogen because they had a hysterectomy (TABLE 2).9 This study was not a randomized clinical trial and patients at higher baseline risk for breast cancer, including women with a high body mass index, may have been preferentially treated with an LNG-IUS. More information is needed to better understand the relationship between the LNG-IUS and breast cancer in postmenopausal women.



Related article:
What we’ve learned from 2 decades’ experience with the LNG-IUS. Q&A with Oskari Heikinheimo, MD, PhD (February 2011)

Progestin-free hormone treatment, bazedoxifene plus CEE

The main reason for adding a progestin to estrogen therapy for vasomotor symptoms in postmenopausal women with a uterus is to prevent estrogen-induced development of endometrial polyps, hyperplasia, and cancer. A major innovation in hormone therapy is the discovery that third-generation selective estrogen receptor modulators (SERMs), such as bazedoxifene (BZA), can prevent estrogen-induced development of endometrial polyps, hyperplasia, and cancer but do not interfere with the efficacy of estrogen in the treatment of vasomotor symptoms.

BZA is an estrogen agonist in bone and an estrogen antagonist in the endometrium.10–12 The combination of BZA (20 mg daily) plus CEE (0.45 mg daily) (Duavee) is approved for the treatment of moderate to severe vasomotor symptoms and prevention of osteoporosis.13–15 Over 24 months of therapy, various doses of BZA plus CEE reduced reported daily hot flashes by 52% to 86%.16 In the same study, placebo treatment was associated with a 17% reduction in hot flashes.16

The main adverse effect of BZA/CEE is an increased risk of deep venous thrombosis. Therefore, BZA/CEE is contraindicated in women with a known thrombophilia or a personal history of hormone-induced deep venous thrombosis. The effect of BZA/CEE on the risk of developing invasive breast cancer is not known; over 52 weeks of therapy it did not increase breast density on mammogram.17,18

BZA/CEE is a remarkable advance in hormone therapy. It is progestin-free, uses estrogen to treat vasomotor symptoms, and uses BZA to protect the endometrium against estrogen-induced hyperplasia.

Related article:
New option for treating menopausal vasomotor symptoms receives FDA approval. (News for your Practice; October 2013)

Nonhormone treatment of vasomotor symptoms Paroxetine mesylateFor postmenopausal women with vasomotor symptoms who cannot take estrogen, SSRIs are modestly effective in reducing moderate to severe hot flashes. The US Food and Drug Administration recently approved paroxetine mesylate (Brisdelle) for the treatment of postmenopausal vasomotor symptoms. The approved dose is 7.5 mg daily taken at bedtime.

Data supporting the efficacy of paroxetine mesylate are available from two studies involving 1,184 menopausal women with vasomotor symptoms randomly assigned to receive paroxetine 7.5 mg daily or placebo for 12 weeks of treatment.19-22 In one of the two clinical trials, women treated with paroxetine mesylate 7.5 mg daily had 5.6 fewer moderate to severe hot flashes daily after 12 weeks of treatment compared with 3.9 fewer hot flashes with placebo (median treatment difference, 1.7; P<.001).21

 

 

Paroxetine can block the metabolism of tamoxifen to its highly potent metabolite, endoxifen. Consequently, paroxetine may reduce the effectiveness of tamoxifen treatment for breast cancer and should be used with caution in postmenopausal women with breast cancer being treated with tamoxifen.

Related article:
Paroxetine mesylate 7.5 mg found to be a safe alternative to hormone therapy for menopausal women with hot flashes. (News for your Practice; June 2014)

Escitalopram
Gynecologists are familiar with the use of venlafaxine, desvenlafaxine, clonidine, citalopram, sertraline, and fluoxetine for the treatment of postmenopausal hot flashes. Recently, escitalopram (Lexapro) at doses of 10 to 20 mg daily has been shown to be more effective than placebo in the treatment of hot flashes and sleep disturbances in postmenopausal women.23,24 In one trial of escitalopram 10 to 20 mg daily versus placebo in 205 postmenopausal women averaging 9.8 hot flashes daily at baseline, escitalopram and placebo reduced mean daily hot flashes by 4.6 and 3.2, respectively (P<.001), after 8 weeks of treatment.

In a meta-analysis of SSRIs for the treatment of hot flashes, data from a mixed-treatment comparison analysis indicated that the rank order from most to least effective therapy for hot flashes was: escitalopram > paroxetine > sertraline > citalopram > fluoxetine.25 Venlafaxine and desvenlafaxine, two serotonin and  norepinephrine reuptake inhibitors that are effective in the treatment of hot flashes, were not included in the mixed-treatment comparison.

Use of alternatives to MPA could mean fewer health risks for women on a wide scale

Substantial data indicate that MPA is not an optimal progestin to combine with estrogen for hormone therapy. Currently, many health insurance plans and Medicare use pharmacy management formularies that prioritize dispensing MPA for postmenopausal hormone therapy. Dispensing an alternative to MPA, such as micronized progesterone, often requires the patient to make a significant copayment.

Hopefully, health insurance companies, Medicare, and their affiliated pharmacy management administrators will soon stop their current policy of using financial incentives to favor dispensing MPA when hormone therapy is prescribed because alternatives to MPA appear to be associated with fewer health risks for postmenopausal women.

WE WANT TO HEAR FROM YOU! Share your thoughts on this article. Send your Letter to the Editor to: [email protected] 

Estrogen therapy is highly effective in the treatment of hot flashes among postmenopausal women. For postmenopausal women with a uterus, estrogen treatment for hot flashes is almost always combined with a progestin to reduce the risk of endometrial polyps, hyperplasia, and cancer. For instance, in the Postmenopausal Estrogen/Progestin Interventions Trial, 62% of the women with a uterus treated with conjugated equine estrogen (CEE) 0.625 mg daily without a progestin developed endometrial hyperplasia.1

In the United States, the most commonly prescribed progestin for hormone therapy has been medroxyprogesterone acetate (MPA; Provera). However, data from the Women’s Health Initiative (WHI) trials indicate that MPA, when combined with CEE, may have adverse health effects among postmenopausal women.

Let’s examine the WHI data
Among women 50 to 59 years of age with a uterus, the combination of CEE plus MPA was associated with a trend toward an increased risk of breast cancer, coronary heart disease, and myocardial infarction.2 In contrast, among women 50 to 59 years of age without a uterus, CEE monotherapy was associated with a trend toward a decreased risk of invasive breast cancer, coronary heart disease, and myocardial infarction (TABLE 1).

Among women 50 to 79 years of age with a uterus, the combination of CEE plus MPA was associated with a significantly increased risk of breast cancer (hazard ratio [HR], 1.24; 95% confidence interval [CI], 1.01–1.53; P = .04).2 In contrast, among women 50 to 79 years of age without a uterus, CEE monotherapy was associated with a trend toward a decreased risk of breast cancer (HR, 0.79; 95% CI, 0.61–1.02, P = .07).2

Related article: In the latest report from the WHI, the data contradict the conclusions. Holly Thacker, MD (Commentary; March 2014)

When the analysis was limited to women consistently adherent to their CEE monotherapy, the estrogen treatment significantly decreased the risk of invasive breast cancer (HR, 0.67; 95% CI, 0.47–0.97; P = .03).3

The addition of MPA to CEE appears to reverse some of the health benefits of CEE monotherapy, although the biological mechanisms are unclear. This observation should prompt us to explore alternative and novel treatments of vasomotor symptoms that do not utilize MPA. Some options for MPA-free hormone therapy include:

  • transdermal estradiol plus micronized progesterone
  • CEE plus a levonorgestrel-releasing intrauterine system
  • bazedoxifene plus CEE.

In addition, nonhormonal treatment of hot flashes is an option, with selective serotonin reuptake inhibitors (SSRIs).

Related article: Is one oral estrogen formulation safer than another for menopausal women? Andrew M. Kaunitz, MD (Examining the Evidence; January 2014)

MPA-free hormone therapy for hot flashes
Estrogen plus micronized progesterone

When using an estrogen plus progestin regimen to treat hot flashes, many experts favor a combination of low-dose transdermal estradiol and oral micronized progesterone (Prometrium). This combination is believed by some experts to result in a lower risk of venous thromboembolism, stroke, cardiovascular disease, and breast cancer than an estrogen-MPA combination.4–7

When prescribing transdermal estradiol plus oral micronized progesterone for a woman within 1 to 2 years of her last menses, a cyclic regimen can help reduce episodes of irregular, unscheduled uterine bleeding. I often use this cyclic regimen: transdermal estradiol 0.0375 mg plus cyclic oral micronized progesterone 200 mg prior to bedtime for calendar days 1 to 12.

When using transdermal estradiol plus oral micronized progesterone in a woman more than 2 years from her last menses, a continuous regimen is often prescribed. I often use this continuous regimen: transdermal estradiol 0.0375 mg plus continuous oral micronized progesterone 100 mg daily prior to bedtime.

Related article: When should a menopausal woman discontinue hormone therapy? Andrew M. Kaunitz, MD (Cases in Menopause; February 2014)

Estrogen plus a levonorgestrel-releasing intrauterine systemThe levonorgestrel intrauterine system (LNG-IUS; 20 µg daily; Mirena) is frequently used in Europe to protect the endometrium against the adverse effects of estrogen therapy in postmenopausal women. In a meta-analysis of five clinical trials involving postmenopausal women, the LNG-IUS provided excellent protection against endometrial hyperplasia, compared with MPA.8

One caution about using the LNG-IUS system with estrogen in postmenopausal women is that an observational study of all women with breast cancer in Finland from 1995 through 2007 reported a significantly increased risk of breast cancer among postmenopausal women using an LNG-IUS compared with women who did not use hormones or used only estrogen because they had a hysterectomy (TABLE 2).9 This study was not a randomized clinical trial and patients at higher baseline risk for breast cancer, including women with a high body mass index, may have been preferentially treated with an LNG-IUS. More information is needed to better understand the relationship between the LNG-IUS and breast cancer in postmenopausal women.



Related article:
What we’ve learned from 2 decades’ experience with the LNG-IUS. Q&A with Oskari Heikinheimo, MD, PhD (February 2011)

Progestin-free hormone treatment, bazedoxifene plus CEE

The main reason for adding a progestin to estrogen therapy for vasomotor symptoms in postmenopausal women with a uterus is to prevent estrogen-induced development of endometrial polyps, hyperplasia, and cancer. A major innovation in hormone therapy is the discovery that third-generation selective estrogen receptor modulators (SERMs), such as bazedoxifene (BZA), can prevent estrogen-induced development of endometrial polyps, hyperplasia, and cancer but do not interfere with the efficacy of estrogen in the treatment of vasomotor symptoms.

BZA is an estrogen agonist in bone and an estrogen antagonist in the endometrium.10–12 The combination of BZA (20 mg daily) plus CEE (0.45 mg daily) (Duavee) is approved for the treatment of moderate to severe vasomotor symptoms and prevention of osteoporosis.13–15 Over 24 months of therapy, various doses of BZA plus CEE reduced reported daily hot flashes by 52% to 86%.16 In the same study, placebo treatment was associated with a 17% reduction in hot flashes.16

The main adverse effect of BZA/CEE is an increased risk of deep venous thrombosis. Therefore, BZA/CEE is contraindicated in women with a known thrombophilia or a personal history of hormone-induced deep venous thrombosis. The effect of BZA/CEE on the risk of developing invasive breast cancer is not known; over 52 weeks of therapy it did not increase breast density on mammogram.17,18

BZA/CEE is a remarkable advance in hormone therapy. It is progestin-free, uses estrogen to treat vasomotor symptoms, and uses BZA to protect the endometrium against estrogen-induced hyperplasia.

Related article:
New option for treating menopausal vasomotor symptoms receives FDA approval. (News for your Practice; October 2013)

Nonhormone treatment of vasomotor symptoms Paroxetine mesylateFor postmenopausal women with vasomotor symptoms who cannot take estrogen, SSRIs are modestly effective in reducing moderate to severe hot flashes. The US Food and Drug Administration recently approved paroxetine mesylate (Brisdelle) for the treatment of postmenopausal vasomotor symptoms. The approved dose is 7.5 mg daily taken at bedtime.

Data supporting the efficacy of paroxetine mesylate are available from two studies involving 1,184 menopausal women with vasomotor symptoms randomly assigned to receive paroxetine 7.5 mg daily or placebo for 12 weeks of treatment.19-22 In one of the two clinical trials, women treated with paroxetine mesylate 7.5 mg daily had 5.6 fewer moderate to severe hot flashes daily after 12 weeks of treatment compared with 3.9 fewer hot flashes with placebo (median treatment difference, 1.7; P<.001).21

 

 

Paroxetine can block the metabolism of tamoxifen to its highly potent metabolite, endoxifen. Consequently, paroxetine may reduce the effectiveness of tamoxifen treatment for breast cancer and should be used with caution in postmenopausal women with breast cancer being treated with tamoxifen.

Related article:
Paroxetine mesylate 7.5 mg found to be a safe alternative to hormone therapy for menopausal women with hot flashes. (News for your Practice; June 2014)

Escitalopram
Gynecologists are familiar with the use of venlafaxine, desvenlafaxine, clonidine, citalopram, sertraline, and fluoxetine for the treatment of postmenopausal hot flashes. Recently, escitalopram (Lexapro) at doses of 10 to 20 mg daily has been shown to be more effective than placebo in the treatment of hot flashes and sleep disturbances in postmenopausal women.23,24 In one trial of escitalopram 10 to 20 mg daily versus placebo in 205 postmenopausal women averaging 9.8 hot flashes daily at baseline, escitalopram and placebo reduced mean daily hot flashes by 4.6 and 3.2, respectively (P<.001), after 8 weeks of treatment.

In a meta-analysis of SSRIs for the treatment of hot flashes, data from a mixed-treatment comparison analysis indicated that the rank order from most to least effective therapy for hot flashes was: escitalopram > paroxetine > sertraline > citalopram > fluoxetine.25 Venlafaxine and desvenlafaxine, two serotonin and  norepinephrine reuptake inhibitors that are effective in the treatment of hot flashes, were not included in the mixed-treatment comparison.

Use of alternatives to MPA could mean fewer health risks for women on a wide scale

Substantial data indicate that MPA is not an optimal progestin to combine with estrogen for hormone therapy. Currently, many health insurance plans and Medicare use pharmacy management formularies that prioritize dispensing MPA for postmenopausal hormone therapy. Dispensing an alternative to MPA, such as micronized progesterone, often requires the patient to make a significant copayment.

Hopefully, health insurance companies, Medicare, and their affiliated pharmacy management administrators will soon stop their current policy of using financial incentives to favor dispensing MPA when hormone therapy is prescribed because alternatives to MPA appear to be associated with fewer health risks for postmenopausal women.

WE WANT TO HEAR FROM YOU! Share your thoughts on this article. Send your Letter to the Editor to: [email protected] 

References

1. The Writing Group for the PEPI Trial. Effects of hormone replacement therapy on endometrial histology in postmenopausal women. The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. JAMA. 1996;275(5):370–375.
2. Manson JE, Chlebowski RT, Stefnick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women’s Health Initiative randomized trials. JAMA. 2013;310(13):1353–1368.
3. Stefanick ML, Anderson GL, Margolis KL, et al; WHI Investigators. Effects of conjugated equine estrogens on breast cancer and mammography screening in postmenopausal women with hysterectomy. JAMA. 2006;295(14):1647–1657.
4. Simon JA. What if the Women’s Health Initiative had used transdermal estradiol and oral progesterone instead? [published online head of print January 6, 2014]. Menopause. PMID: 24398406.
5. Manson JE. Current recommendations: What is the clinician to do? Fertil Steril. 2014;101(4):916–921.
6. Fournier A, Berrino F, Clavel-Chapelon F. Unequal risks for breast cancer associated with different hormone replacement therapies: Results from the E3N cohort study [published correction appears in Breast Cancer Res Treat. 2008;107(2):307–308]. Breast Cancer Res Treat. 2008;107(1):103–111.
7. Renoux C, Dell’aniello S, Garbe E, Suissa S. Transdermal and oral hormone replacement therapy and the risk of stroke: A nested case-control study. BMJ. 2010;340:c2519.
8. Somboonpom W, Panna S, Temtanakitpaisan T, Kaewrudee S, Soontrapa S. Effects of the levonorgestrel-releasing intrauterine system plus estrogen therapy in perimenopausal and postmenopausal women: Systematic review and meta-analysis. Menopause. 2011;18(10):1060–1066.
9. Lyytinen HK, Dyba T, Ylikorkala O, Pukkala EI. A case-control study on hormone therapy as a risk factor for breast cancer in Finland: Intrauterine system carries a risk as well. Int J Cancer. 2010;126(2):483–489.
10. Komm BS, Mirkin S. An overview of current and emerging SERMs. J Steroid Biochem Mol Biol. 2014;143C:207–222.
11. Ethun KF, Wood CE, Cline JM, Register TC, Appt SE, Clarkson TB. Endometrial profile of bazedoxifene acetate alone and in combination with conjugated equine estrogens in a primate model. Menopause. 2013;20(7):777–784.
12. Pinkerton JV, Harvey JA, Lindsay R, et al; SMART-5 Investigators. Effects of bazedoxifene/conjugated estrogens on the endometrium and bone: A randomized trial. J Clin Endocrinol Metab. 2014;99(2):E189–E198.
13. Pinkerton JV, Pickar JH, Racketa J, Mirkin S. Bazedoxifene/conjugated estrogens for menopausal symptom treatment and osteoporosis prevention. Climacteric. 2012;15(5):411–418.
14. Pinkerton JV, Abraham L, Bushmakin AG, et al. Evaluation of the efficacy and safety of bazedoxifene/conjugated estrogens for secondary outcomes including vasomotor symptoms in postmenopausal women by years since menopause in the Selective estrogens, Menopause and Response to Therapy (SMART) trials. J Womens Health (Larchmt). 2014;23(1):18–28.
15. Pinkerton JV, Harvey JA, Pan K, et al. Breast effects of bazedoxifene-conjugated estrogens: A randomized controlled trial. Obstet Gynecol. 2013;121(5):959–968.
16. Lobo RA, Pinkerton JV, Gass ML, et al. Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile. Fertil Steril. 2009;92(3):1025–1038.
17. Harvey JA, Holm MK, Ranganath R, Guse PA, Trott EA, Helzner E. The effects of bazedoxifene on mammographic breast density in postmenopausal women with osteoporosis. Menopause. 2009;16(6):1193–1196.
18. Harvey JA, Pinkerton JV, Baracat EC, Shi H, Chines AA, Mirkin S. Breast density changes in a randomized controlled trial evaluating bazedoxifene/conjugated estrogens. Menopause. 2013;20(2):138–145.
19. Simon JA, Portman DJ, Kaunitz AM, et al. Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms: Two randomized controlled trials. Menopause. 2013;20(10):1027–1035.
20. Simon JA, Portman DJ, Kazempour K, Mekonnen H, Bhaskar S, Lippman J. Safety profile of paroxetine 7.5 mg in women with moderate-to-severe vasomotor symptoms. Obstet Gynecol. 2014;123(suppl 1):132S–133S.
21. Orleans RJ, Li L, Kim MJ, et al. FDA approval of paroxetine for menopausal hot flashes. N Engl J Med. 2014;370(19):1777–1779.
22. Paroxetine (Brisdelle) for hot flashes. Med Lett Drugs Ther. 2013;55(1428):85–86.
23. Freeman EW, Guthrie KA, Caan B, et al. Efficacy of escitalopram for hot flashes in health menopausal women. A randomized controlled trial. JAMA. 2011;305(3):267–274.
24. Ensrud KE, Joffe H, Guthrie KA, et al. Effect of escitalopram on insomnia symptoms and subjective sleep quality in healthy perimenopausal and postmenopausal women with hot flashes: A randomized controlled trial. Menopause. 2012;19(8):848–855.
25. Shams T, Firwana B, Habib F, et al. SSRIs for hot flashes: A systematic review and meta-analysis of randomized trials. J Gen Intern Med. 2014;29(1):204–213.

References

1. The Writing Group for the PEPI Trial. Effects of hormone replacement therapy on endometrial histology in postmenopausal women. The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. JAMA. 1996;275(5):370–375.
2. Manson JE, Chlebowski RT, Stefnick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women’s Health Initiative randomized trials. JAMA. 2013;310(13):1353–1368.
3. Stefanick ML, Anderson GL, Margolis KL, et al; WHI Investigators. Effects of conjugated equine estrogens on breast cancer and mammography screening in postmenopausal women with hysterectomy. JAMA. 2006;295(14):1647–1657.
4. Simon JA. What if the Women’s Health Initiative had used transdermal estradiol and oral progesterone instead? [published online head of print January 6, 2014]. Menopause. PMID: 24398406.
5. Manson JE. Current recommendations: What is the clinician to do? Fertil Steril. 2014;101(4):916–921.
6. Fournier A, Berrino F, Clavel-Chapelon F. Unequal risks for breast cancer associated with different hormone replacement therapies: Results from the E3N cohort study [published correction appears in Breast Cancer Res Treat. 2008;107(2):307–308]. Breast Cancer Res Treat. 2008;107(1):103–111.
7. Renoux C, Dell’aniello S, Garbe E, Suissa S. Transdermal and oral hormone replacement therapy and the risk of stroke: A nested case-control study. BMJ. 2010;340:c2519.
8. Somboonpom W, Panna S, Temtanakitpaisan T, Kaewrudee S, Soontrapa S. Effects of the levonorgestrel-releasing intrauterine system plus estrogen therapy in perimenopausal and postmenopausal women: Systematic review and meta-analysis. Menopause. 2011;18(10):1060–1066.
9. Lyytinen HK, Dyba T, Ylikorkala O, Pukkala EI. A case-control study on hormone therapy as a risk factor for breast cancer in Finland: Intrauterine system carries a risk as well. Int J Cancer. 2010;126(2):483–489.
10. Komm BS, Mirkin S. An overview of current and emerging SERMs. J Steroid Biochem Mol Biol. 2014;143C:207–222.
11. Ethun KF, Wood CE, Cline JM, Register TC, Appt SE, Clarkson TB. Endometrial profile of bazedoxifene acetate alone and in combination with conjugated equine estrogens in a primate model. Menopause. 2013;20(7):777–784.
12. Pinkerton JV, Harvey JA, Lindsay R, et al; SMART-5 Investigators. Effects of bazedoxifene/conjugated estrogens on the endometrium and bone: A randomized trial. J Clin Endocrinol Metab. 2014;99(2):E189–E198.
13. Pinkerton JV, Pickar JH, Racketa J, Mirkin S. Bazedoxifene/conjugated estrogens for menopausal symptom treatment and osteoporosis prevention. Climacteric. 2012;15(5):411–418.
14. Pinkerton JV, Abraham L, Bushmakin AG, et al. Evaluation of the efficacy and safety of bazedoxifene/conjugated estrogens for secondary outcomes including vasomotor symptoms in postmenopausal women by years since menopause in the Selective estrogens, Menopause and Response to Therapy (SMART) trials. J Womens Health (Larchmt). 2014;23(1):18–28.
15. Pinkerton JV, Harvey JA, Pan K, et al. Breast effects of bazedoxifene-conjugated estrogens: A randomized controlled trial. Obstet Gynecol. 2013;121(5):959–968.
16. Lobo RA, Pinkerton JV, Gass ML, et al. Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile. Fertil Steril. 2009;92(3):1025–1038.
17. Harvey JA, Holm MK, Ranganath R, Guse PA, Trott EA, Helzner E. The effects of bazedoxifene on mammographic breast density in postmenopausal women with osteoporosis. Menopause. 2009;16(6):1193–1196.
18. Harvey JA, Pinkerton JV, Baracat EC, Shi H, Chines AA, Mirkin S. Breast density changes in a randomized controlled trial evaluating bazedoxifene/conjugated estrogens. Menopause. 2013;20(2):138–145.
19. Simon JA, Portman DJ, Kaunitz AM, et al. Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms: Two randomized controlled trials. Menopause. 2013;20(10):1027–1035.
20. Simon JA, Portman DJ, Kazempour K, Mekonnen H, Bhaskar S, Lippman J. Safety profile of paroxetine 7.5 mg in women with moderate-to-severe vasomotor symptoms. Obstet Gynecol. 2014;123(suppl 1):132S–133S.
21. Orleans RJ, Li L, Kim MJ, et al. FDA approval of paroxetine for menopausal hot flashes. N Engl J Med. 2014;370(19):1777–1779.
22. Paroxetine (Brisdelle) for hot flashes. Med Lett Drugs Ther. 2013;55(1428):85–86.
23. Freeman EW, Guthrie KA, Caan B, et al. Efficacy of escitalopram for hot flashes in health menopausal women. A randomized controlled trial. JAMA. 2011;305(3):267–274.
24. Ensrud KE, Joffe H, Guthrie KA, et al. Effect of escitalopram on insomnia symptoms and subjective sleep quality in healthy perimenopausal and postmenopausal women with hot flashes: A randomized controlled trial. Menopause. 2012;19(8):848–855.
25. Shams T, Firwana B, Habib F, et al. SSRIs for hot flashes: A systematic review and meta-analysis of randomized trials. J Gen Intern Med. 2014;29(1):204–213.

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Robert Barbieri,hormone therapy,menopause,vasomotor symptoms,hot flashes,medroxyprogesterone acetate,MPA,Provera,estrogen,postmenopausal women,uterus,progestin,endometrial polyps,hyperplasia,cancer,conjugated equine estrogen,CEE,Women’s Health Iniative,WHI,breast cancer,coronary heart disease,myocardial infarction,monotherapy,transdermal estradiol plus micronized progesterone,Prometrium,CEE plus a levonorgestrel-releasing intrauterine system,LNG-IUS,Mirena,bazedoxifene plus CEE, selective serotonin reuptake inhibitors,SSRIs,hysterectomy,selective estrogen receptor modulators,SERMs,bazedoxifene,BZA,BZA/CEE,paroxetine mesylate,Brisdelle,escitalopram,Lexapro
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Robert Barbieri,hormone therapy,menopause,vasomotor symptoms,hot flashes,medroxyprogesterone acetate,MPA,Provera,estrogen,postmenopausal women,uterus,progestin,endometrial polyps,hyperplasia,cancer,conjugated equine estrogen,CEE,Women’s Health Iniative,WHI,breast cancer,coronary heart disease,myocardial infarction,monotherapy,transdermal estradiol plus micronized progesterone,Prometrium,CEE plus a levonorgestrel-releasing intrauterine system,LNG-IUS,Mirena,bazedoxifene plus CEE, selective serotonin reuptake inhibitors,SSRIs,hysterectomy,selective estrogen receptor modulators,SERMs,bazedoxifene,BZA,BZA/CEE,paroxetine mesylate,Brisdelle,escitalopram,Lexapro
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New Agents for the Treatment of Erythematotelangiectatic Rosacea

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New Agents for the Treatment of Erythematotelangiectatic Rosacea

Rosacea is a common chronic disorder that predominantly manifests as facial erythema, telangiectasia, and flushing.1 Other primary clinical features include inflammatory lesions (eg, papules, pustules) and occasionally edema and rhinophyma. Ocular involvement also may occur. Rosacea patients routinely report sensitive skin with symptoms such as stinging, burning, and intolerance to topical agents (eg, medications, moisturizers, cosmetics).2,3

Rosacea affects facial appearance and can impair a patient’s emotional well-being. It may limit social and professional activities. Many patients and nonpatients alike presume the appearance of facial redness suggests alcohol overuse or emotional distress.4-6 A reduction in facial erythema as well as improvements in other clinical signs of rosacea have been shown to reduce patient self-consciousness and lead to increased socialization.7 Facial erythema is a major factor that adversely affects quality of life in rosacea patients.8

Although a number of options are available to successfully treat inflammatory lesions of rosacea, facial erythema has been the most difficult manifestation of the disease to medically treat.2,9 Chronic erythema and episodic flushing may be at least partially related to cutaneous vasomotor responses causing both transient and persistent dilation of facial blood vessels.10-12 The agents used for treating the inflammatory components of rosacea reduce erythema associated with papules and pustules but have little effect on the background erythema that is so noticeable. Oxymetazoline and brimonidine tartrate have been evaluated as potential rapid treatments of facial erythema. Daily application of oxymetazoline solution 0.05% has been shown to reduce facial erythema in rosacea patients.13

Brimonidine tartrate is a highly selective α2-adrenergic receptor agonist with potent vasoconstrictor activity.14 It has been used to treat open-angle glaucoma for more than 15 years with well-documented safety and efficacy.15 Phase 2 and 3 studies for once-daily application of brimonidine tartrate gel 0.5% have confirmed its efficacy and safety for the treatment of facial erythema in rosacea patients,9,12 and it was approved by the US Food and Drug Administration (brimonidine gel 0.33%) for persistent (nontransient) facial erythema of rosacea in late 2013. The effect was shown to occur in some patients as soon as 30 minutes following product application and usually persisted for approximately 9 to 12 hours. Erythema gradually returned as the effect waned, returning to baseline by 24 hours after application.12

Clinical efficacy of brimonidine gel was evaluated by a 2-grade improvement (primary end point) or 1-grade improvement (secondary end point) based on patient and clinician assessments using the patient self-assessment (PSA) and clinical erythema assessment (CEA), respectively, over the course of the 4-week studies. Patients also evaluated their satisfaction with the overall appearance of their facial skin.12 A 2-grade improvement on both PSA and CEA has been noted as a stringent criterion in evaluating the effectiveness of treatment of facial erythema.14 A 1-grade improvement on both PSA and CEA has been recognized as clinically relevant as a measure of effect that is noticeable to both patients and clinicians.12 Patients who achieved either a 1- or 2-grade improvement in both PSA and CEA were substantially more likely to report overall satisfaction with their appearance. A 2-grade improvement in both PSA and CEA scales was accompanied with 80% of patients rating their skin appearance as satisfactory or better. Conversely, few patients (ie, <10%) who did not achieve at least 1-grade composite success were satisfied with their appearance. Adverse effects were uncommon, with no evidence of tachyphylaxis and rare occurrence of rebound erythema.12

In summary, although there are a number of options available to reduce or eliminate inflammatory lesions of rosacea, effective medical treatment of the erythematous component of rosacea, which can be the most distressing aspect of the disease for patients, has been unsatisfactory. With the availability of topical brimonidine tartrate, dermatologists have a proven medication to improve facial redness in rosacea patients. Other options such as oxymetazoline may become available in the future.

References
  1. Crawford GH, Pelle MT, James WD. Rosacea: I. etiology, pathogenesis, and subtype classification. J Am Acad Dermatol. 2004;51:327-341.
  2. Wilkin J, Dahl M, Detmar M, et al. Standard grading system for rosacea: report of the National Rosacea Society expert committee on the classification and staging of rosacea. J Am Acad Dermatol. 2004;50:907-912.
  3. Odom R, Dahl M, Dover J, et al. Standard management options for rosacea, part I: overview and broad spectrum of care. Cutis. 2009;84:43-47.
  4. Baldwin HE. Systemic therapy for rosacea. Skin Therapy Lett. 2007;12:1-5.
  5. Drake L. Rosacea patients feel effects of their condition in social settings. Rosacea Review. Published Fall 2012. http://www.rosacea.org/rr/2012/fall/article_3.php. Accessed May 29, 2014.
  6. Aksoy B, Altaykan-Hapa A, Egemen D, et al. The impact of rosacea on quality of life: effects of demographic and clinical characteristics and various treatment modalities. Br J Dermatol. 2010;163:719-725.
  7. Wolf JE Jr, Del Rosso JQ. The CLEAR trial: results of a large community-based study of metronidazole gel in rosacea. Cutis. 2007;79:73-80.
  8. Nicholson K, Abramova L, Chren MM, et al. A pilot quality-of-life instrument for acne rosacea. J Am Acad Dermatol. 2007;57:213-221.
  9. Fowler J, Jarratt M, Moore A, et al. Once-daily topical brimonidine tartrate gel 0.5% is a novel treatment for moderate to severe facial erythema of rosacea: results of two multicentre, randomized and vehicle-controlled studies. Br J Dermatol. 2012;166:633-641.
  10. Steinhoff M, Buddenkotte J, Aubert J, et al. Clinical, cellular and molecular aspects in the pathophysiology of rosacea. J Investig Dermatol Symp Proc. 2011;15:2-11.
  11. Wilkin JK. Rosacea: pathophysiology and treatment. Arch Dermatol. 1994;130:359-362.
  12. Fowler J, Jackson JM, Moore A, et al. Efficacy and safety of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies. J Drugs Dermatol. 2013;12:650-656.
  13. Del Rosso JQ. The central role, evaluation, and medical management of diffuse and persistent facial erythema of rosacea. J Clin Aesthet Dermatol. 2012;5:26-36.
  14. Rahman MQ, Ramaesh K, Montgomery DNI. Brimonidine for glaucoma. Expert Opin Drug Saf. 2010;9:483-491.
  15. Toris C, Camras C, Yablonski M. Acute versus chronic effects of brimonidine on aqueous humor dynamics in ocular hypertensive patients. Am J Ophthalmol. 1999;128:8-14.
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From the Division of Dermatology, University of Louisville, Kentucky, and Dermatology Specialists Research LLC, Louisville.

Dr. Fowler is a consultant and researcher for Allergan, Inc, and Galderma Laboratories, LP.

Correspondence: Joseph Fowler Jr, MD, 501 S 2nd St, Ste 100, Louisville, KY 40202-1899 ([email protected]).

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Dr. Fowler is a consultant and researcher for Allergan, Inc, and Galderma Laboratories, LP.

Correspondence: Joseph Fowler Jr, MD, 501 S 2nd St, Ste 100, Louisville, KY 40202-1899 ([email protected]).

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Related Articles

Rosacea is a common chronic disorder that predominantly manifests as facial erythema, telangiectasia, and flushing.1 Other primary clinical features include inflammatory lesions (eg, papules, pustules) and occasionally edema and rhinophyma. Ocular involvement also may occur. Rosacea patients routinely report sensitive skin with symptoms such as stinging, burning, and intolerance to topical agents (eg, medications, moisturizers, cosmetics).2,3

Rosacea affects facial appearance and can impair a patient’s emotional well-being. It may limit social and professional activities. Many patients and nonpatients alike presume the appearance of facial redness suggests alcohol overuse or emotional distress.4-6 A reduction in facial erythema as well as improvements in other clinical signs of rosacea have been shown to reduce patient self-consciousness and lead to increased socialization.7 Facial erythema is a major factor that adversely affects quality of life in rosacea patients.8

Although a number of options are available to successfully treat inflammatory lesions of rosacea, facial erythema has been the most difficult manifestation of the disease to medically treat.2,9 Chronic erythema and episodic flushing may be at least partially related to cutaneous vasomotor responses causing both transient and persistent dilation of facial blood vessels.10-12 The agents used for treating the inflammatory components of rosacea reduce erythema associated with papules and pustules but have little effect on the background erythema that is so noticeable. Oxymetazoline and brimonidine tartrate have been evaluated as potential rapid treatments of facial erythema. Daily application of oxymetazoline solution 0.05% has been shown to reduce facial erythema in rosacea patients.13

Brimonidine tartrate is a highly selective α2-adrenergic receptor agonist with potent vasoconstrictor activity.14 It has been used to treat open-angle glaucoma for more than 15 years with well-documented safety and efficacy.15 Phase 2 and 3 studies for once-daily application of brimonidine tartrate gel 0.5% have confirmed its efficacy and safety for the treatment of facial erythema in rosacea patients,9,12 and it was approved by the US Food and Drug Administration (brimonidine gel 0.33%) for persistent (nontransient) facial erythema of rosacea in late 2013. The effect was shown to occur in some patients as soon as 30 minutes following product application and usually persisted for approximately 9 to 12 hours. Erythema gradually returned as the effect waned, returning to baseline by 24 hours after application.12

Clinical efficacy of brimonidine gel was evaluated by a 2-grade improvement (primary end point) or 1-grade improvement (secondary end point) based on patient and clinician assessments using the patient self-assessment (PSA) and clinical erythema assessment (CEA), respectively, over the course of the 4-week studies. Patients also evaluated their satisfaction with the overall appearance of their facial skin.12 A 2-grade improvement on both PSA and CEA has been noted as a stringent criterion in evaluating the effectiveness of treatment of facial erythema.14 A 1-grade improvement on both PSA and CEA has been recognized as clinically relevant as a measure of effect that is noticeable to both patients and clinicians.12 Patients who achieved either a 1- or 2-grade improvement in both PSA and CEA were substantially more likely to report overall satisfaction with their appearance. A 2-grade improvement in both PSA and CEA scales was accompanied with 80% of patients rating their skin appearance as satisfactory or better. Conversely, few patients (ie, <10%) who did not achieve at least 1-grade composite success were satisfied with their appearance. Adverse effects were uncommon, with no evidence of tachyphylaxis and rare occurrence of rebound erythema.12

In summary, although there are a number of options available to reduce or eliminate inflammatory lesions of rosacea, effective medical treatment of the erythematous component of rosacea, which can be the most distressing aspect of the disease for patients, has been unsatisfactory. With the availability of topical brimonidine tartrate, dermatologists have a proven medication to improve facial redness in rosacea patients. Other options such as oxymetazoline may become available in the future.

Rosacea is a common chronic disorder that predominantly manifests as facial erythema, telangiectasia, and flushing.1 Other primary clinical features include inflammatory lesions (eg, papules, pustules) and occasionally edema and rhinophyma. Ocular involvement also may occur. Rosacea patients routinely report sensitive skin with symptoms such as stinging, burning, and intolerance to topical agents (eg, medications, moisturizers, cosmetics).2,3

Rosacea affects facial appearance and can impair a patient’s emotional well-being. It may limit social and professional activities. Many patients and nonpatients alike presume the appearance of facial redness suggests alcohol overuse or emotional distress.4-6 A reduction in facial erythema as well as improvements in other clinical signs of rosacea have been shown to reduce patient self-consciousness and lead to increased socialization.7 Facial erythema is a major factor that adversely affects quality of life in rosacea patients.8

Although a number of options are available to successfully treat inflammatory lesions of rosacea, facial erythema has been the most difficult manifestation of the disease to medically treat.2,9 Chronic erythema and episodic flushing may be at least partially related to cutaneous vasomotor responses causing both transient and persistent dilation of facial blood vessels.10-12 The agents used for treating the inflammatory components of rosacea reduce erythema associated with papules and pustules but have little effect on the background erythema that is so noticeable. Oxymetazoline and brimonidine tartrate have been evaluated as potential rapid treatments of facial erythema. Daily application of oxymetazoline solution 0.05% has been shown to reduce facial erythema in rosacea patients.13

Brimonidine tartrate is a highly selective α2-adrenergic receptor agonist with potent vasoconstrictor activity.14 It has been used to treat open-angle glaucoma for more than 15 years with well-documented safety and efficacy.15 Phase 2 and 3 studies for once-daily application of brimonidine tartrate gel 0.5% have confirmed its efficacy and safety for the treatment of facial erythema in rosacea patients,9,12 and it was approved by the US Food and Drug Administration (brimonidine gel 0.33%) for persistent (nontransient) facial erythema of rosacea in late 2013. The effect was shown to occur in some patients as soon as 30 minutes following product application and usually persisted for approximately 9 to 12 hours. Erythema gradually returned as the effect waned, returning to baseline by 24 hours after application.12

Clinical efficacy of brimonidine gel was evaluated by a 2-grade improvement (primary end point) or 1-grade improvement (secondary end point) based on patient and clinician assessments using the patient self-assessment (PSA) and clinical erythema assessment (CEA), respectively, over the course of the 4-week studies. Patients also evaluated their satisfaction with the overall appearance of their facial skin.12 A 2-grade improvement on both PSA and CEA has been noted as a stringent criterion in evaluating the effectiveness of treatment of facial erythema.14 A 1-grade improvement on both PSA and CEA has been recognized as clinically relevant as a measure of effect that is noticeable to both patients and clinicians.12 Patients who achieved either a 1- or 2-grade improvement in both PSA and CEA were substantially more likely to report overall satisfaction with their appearance. A 2-grade improvement in both PSA and CEA scales was accompanied with 80% of patients rating their skin appearance as satisfactory or better. Conversely, few patients (ie, <10%) who did not achieve at least 1-grade composite success were satisfied with their appearance. Adverse effects were uncommon, with no evidence of tachyphylaxis and rare occurrence of rebound erythema.12

In summary, although there are a number of options available to reduce or eliminate inflammatory lesions of rosacea, effective medical treatment of the erythematous component of rosacea, which can be the most distressing aspect of the disease for patients, has been unsatisfactory. With the availability of topical brimonidine tartrate, dermatologists have a proven medication to improve facial redness in rosacea patients. Other options such as oxymetazoline may become available in the future.

References
  1. Crawford GH, Pelle MT, James WD. Rosacea: I. etiology, pathogenesis, and subtype classification. J Am Acad Dermatol. 2004;51:327-341.
  2. Wilkin J, Dahl M, Detmar M, et al. Standard grading system for rosacea: report of the National Rosacea Society expert committee on the classification and staging of rosacea. J Am Acad Dermatol. 2004;50:907-912.
  3. Odom R, Dahl M, Dover J, et al. Standard management options for rosacea, part I: overview and broad spectrum of care. Cutis. 2009;84:43-47.
  4. Baldwin HE. Systemic therapy for rosacea. Skin Therapy Lett. 2007;12:1-5.
  5. Drake L. Rosacea patients feel effects of their condition in social settings. Rosacea Review. Published Fall 2012. http://www.rosacea.org/rr/2012/fall/article_3.php. Accessed May 29, 2014.
  6. Aksoy B, Altaykan-Hapa A, Egemen D, et al. The impact of rosacea on quality of life: effects of demographic and clinical characteristics and various treatment modalities. Br J Dermatol. 2010;163:719-725.
  7. Wolf JE Jr, Del Rosso JQ. The CLEAR trial: results of a large community-based study of metronidazole gel in rosacea. Cutis. 2007;79:73-80.
  8. Nicholson K, Abramova L, Chren MM, et al. A pilot quality-of-life instrument for acne rosacea. J Am Acad Dermatol. 2007;57:213-221.
  9. Fowler J, Jarratt M, Moore A, et al. Once-daily topical brimonidine tartrate gel 0.5% is a novel treatment for moderate to severe facial erythema of rosacea: results of two multicentre, randomized and vehicle-controlled studies. Br J Dermatol. 2012;166:633-641.
  10. Steinhoff M, Buddenkotte J, Aubert J, et al. Clinical, cellular and molecular aspects in the pathophysiology of rosacea. J Investig Dermatol Symp Proc. 2011;15:2-11.
  11. Wilkin JK. Rosacea: pathophysiology and treatment. Arch Dermatol. 1994;130:359-362.
  12. Fowler J, Jackson JM, Moore A, et al. Efficacy and safety of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies. J Drugs Dermatol. 2013;12:650-656.
  13. Del Rosso JQ. The central role, evaluation, and medical management of diffuse and persistent facial erythema of rosacea. J Clin Aesthet Dermatol. 2012;5:26-36.
  14. Rahman MQ, Ramaesh K, Montgomery DNI. Brimonidine for glaucoma. Expert Opin Drug Saf. 2010;9:483-491.
  15. Toris C, Camras C, Yablonski M. Acute versus chronic effects of brimonidine on aqueous humor dynamics in ocular hypertensive patients. Am J Ophthalmol. 1999;128:8-14.
References
  1. Crawford GH, Pelle MT, James WD. Rosacea: I. etiology, pathogenesis, and subtype classification. J Am Acad Dermatol. 2004;51:327-341.
  2. Wilkin J, Dahl M, Detmar M, et al. Standard grading system for rosacea: report of the National Rosacea Society expert committee on the classification and staging of rosacea. J Am Acad Dermatol. 2004;50:907-912.
  3. Odom R, Dahl M, Dover J, et al. Standard management options for rosacea, part I: overview and broad spectrum of care. Cutis. 2009;84:43-47.
  4. Baldwin HE. Systemic therapy for rosacea. Skin Therapy Lett. 2007;12:1-5.
  5. Drake L. Rosacea patients feel effects of their condition in social settings. Rosacea Review. Published Fall 2012. http://www.rosacea.org/rr/2012/fall/article_3.php. Accessed May 29, 2014.
  6. Aksoy B, Altaykan-Hapa A, Egemen D, et al. The impact of rosacea on quality of life: effects of demographic and clinical characteristics and various treatment modalities. Br J Dermatol. 2010;163:719-725.
  7. Wolf JE Jr, Del Rosso JQ. The CLEAR trial: results of a large community-based study of metronidazole gel in rosacea. Cutis. 2007;79:73-80.
  8. Nicholson K, Abramova L, Chren MM, et al. A pilot quality-of-life instrument for acne rosacea. J Am Acad Dermatol. 2007;57:213-221.
  9. Fowler J, Jarratt M, Moore A, et al. Once-daily topical brimonidine tartrate gel 0.5% is a novel treatment for moderate to severe facial erythema of rosacea: results of two multicentre, randomized and vehicle-controlled studies. Br J Dermatol. 2012;166:633-641.
  10. Steinhoff M, Buddenkotte J, Aubert J, et al. Clinical, cellular and molecular aspects in the pathophysiology of rosacea. J Investig Dermatol Symp Proc. 2011;15:2-11.
  11. Wilkin JK. Rosacea: pathophysiology and treatment. Arch Dermatol. 1994;130:359-362.
  12. Fowler J, Jackson JM, Moore A, et al. Efficacy and safety of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies. J Drugs Dermatol. 2013;12:650-656.
  13. Del Rosso JQ. The central role, evaluation, and medical management of diffuse and persistent facial erythema of rosacea. J Clin Aesthet Dermatol. 2012;5:26-36.
  14. Rahman MQ, Ramaesh K, Montgomery DNI. Brimonidine for glaucoma. Expert Opin Drug Saf. 2010;9:483-491.
  15. Toris C, Camras C, Yablonski M. Acute versus chronic effects of brimonidine on aqueous humor dynamics in ocular hypertensive patients. Am J Ophthalmol. 1999;128:8-14.
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Hospital employment or physician-led ACO?

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Hospital employment or physician-led ACO?

Primary care physicians around the country are facing the largest decision of their lives: Do I stay independent and maybe form an accountable care organization with other independent physicians, or do I become an employee of a hospital or health system?

As accountable care is taking hold, new data may alter historic thinking on this "bet-the-practice" question.

Tired of being overworked, undersatisfied, and overwhelmed with growing regulatory requirements, many primary care physicians have sought the security and strength of hospital employment. They say the pressures to invest in technology, billing, coding, and continued reimbursement pressures are just too great.

Yet, the majority of these physicians miss their days of self-employed autonomy, are on average less productive, and worry that the clocks on their compensation guarantees are ticking down.

Most of the moves by your colleagues, and perhaps you, to hospital employment have been defensive. It was just no longer feasible to stay afloat in the current fee-for-service system. You cannot work any harder, faster, or cheaper. You can no longer spend satisfactory time with your patients.

On the other hand, some of you may have joined a hospital or health system to be proactive and gain a solid platform to prepare for the new value-based payment era.

You may have envisioned being integrated with a critical mass of like-minded physicians and facilities, aided by advanced population management tools and a strong balance sheet, and all linked together on the hospital’s health information technology platform. You read that primary care should be in a leadership position and financially incentivized in any accountable care organization – including a hospital’s. Independent physicians could theoretically form ACOs, too, but lack the up-front capital, know-how, and any spare intellectual bandwidth to do so.

So, from a strategic perspective, becoming employed with other physicians by a health system seemed the way to go.

The pace has quickened of health care’s movement away from fee for service or "pay for volume" to payment for better outcomes at lower overall costs, or "pay for value." The factors that applied to the decision to become employed in the fee-for-service era may be yielding to those in the accountable care era sooner than anticipated.

Independent physician-led ACOs appear to be adapting better than hospitals to this change. Although much better prepared fiscally, hospitals are conflicted, or at least hesitant, to make this switch, because much of the savings comes from avoidable admissions and readmissions. On the other hand, emerging data and experience are showing that physician-led ACOs can be very successful.

There are some very integrated and successful hospital-led ACOs or other value-delivery hospital/physician models. In fact, I believe that if the hospital is willing to right-size and truly commit to value, it can be the most successful model.

However, many physicians signed volume-only physician work relative value unit (wRVU) compensation formulas in their hospital employment agreements, with no incentive payments for value. They have not been involved as partners, much less leaders, in any ACO planning. Even though the fee-for-service days are waning and strains are showing for many hospitals that are not adapting, for many employed physicians, the pace of preparedness for the accountable care era has been disappointing.

New data show that while most of the early ACOs in the Medicare Shared Savings Program were hospital led, there are now more physician-led ACOs than any other. At the same time, early results of some modest primary care–only ACOs have been exciting. The rural primary care physician ACO previously reported on in this column, Rio Grande Valley Health Alliance in McAllen, Tex., is preliminarily looking at 90th-percentile quality results and more than $500,000 in (unofficial) savings per physician in their first year under the Medicare Shared Savings Program.

In fact, in a May 14, 2014, article in JAMA, its authors stated: "Even though most adult primary care physicians may not realize it, they each can be seen as a chief executive officer (CEO) in charge of approximately $10 million in annual revenue" (JAMA 2014;311:1855-6). They noted that primary care receives only 5% of that spending, but can control much of the average of $5,000 in annual spending of their 2,000 or so patients. The independent physician-led Palm Beach ACO is cited as an example, with $22 million in savings their first year. The authors recommend physician-led ACOs as the best way to leverage that "CEO" power.

These new success lessons are being learned and need to be shared. Primary care physicians need to understand that the risk of change is now much less than the risk of maintaining the status quo. You need transparency regarding the realities of all your choices, including hospital employment and physician ACOs.

 

 

As readers of this column know, I heartily endorse the trend recognized in the JAMA article: "[A]n increasing number of primary care physicians see physician-led ACOs as a powerful opportunity to retain their autonomy and make a positive difference for their patient – as well as their practices’ bottom lines."

Mr. Bobbitt is a senior partner and head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He has many years’ experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author at [email protected] or 919-821-6612.

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Primary care physicians around the country are facing the largest decision of their lives: Do I stay independent and maybe form an accountable care organization with other independent physicians, or do I become an employee of a hospital or health system?

As accountable care is taking hold, new data may alter historic thinking on this "bet-the-practice" question.

Tired of being overworked, undersatisfied, and overwhelmed with growing regulatory requirements, many primary care physicians have sought the security and strength of hospital employment. They say the pressures to invest in technology, billing, coding, and continued reimbursement pressures are just too great.

Yet, the majority of these physicians miss their days of self-employed autonomy, are on average less productive, and worry that the clocks on their compensation guarantees are ticking down.

Most of the moves by your colleagues, and perhaps you, to hospital employment have been defensive. It was just no longer feasible to stay afloat in the current fee-for-service system. You cannot work any harder, faster, or cheaper. You can no longer spend satisfactory time with your patients.

On the other hand, some of you may have joined a hospital or health system to be proactive and gain a solid platform to prepare for the new value-based payment era.

You may have envisioned being integrated with a critical mass of like-minded physicians and facilities, aided by advanced population management tools and a strong balance sheet, and all linked together on the hospital’s health information technology platform. You read that primary care should be in a leadership position and financially incentivized in any accountable care organization – including a hospital’s. Independent physicians could theoretically form ACOs, too, but lack the up-front capital, know-how, and any spare intellectual bandwidth to do so.

So, from a strategic perspective, becoming employed with other physicians by a health system seemed the way to go.

The pace has quickened of health care’s movement away from fee for service or "pay for volume" to payment for better outcomes at lower overall costs, or "pay for value." The factors that applied to the decision to become employed in the fee-for-service era may be yielding to those in the accountable care era sooner than anticipated.

Independent physician-led ACOs appear to be adapting better than hospitals to this change. Although much better prepared fiscally, hospitals are conflicted, or at least hesitant, to make this switch, because much of the savings comes from avoidable admissions and readmissions. On the other hand, emerging data and experience are showing that physician-led ACOs can be very successful.

There are some very integrated and successful hospital-led ACOs or other value-delivery hospital/physician models. In fact, I believe that if the hospital is willing to right-size and truly commit to value, it can be the most successful model.

However, many physicians signed volume-only physician work relative value unit (wRVU) compensation formulas in their hospital employment agreements, with no incentive payments for value. They have not been involved as partners, much less leaders, in any ACO planning. Even though the fee-for-service days are waning and strains are showing for many hospitals that are not adapting, for many employed physicians, the pace of preparedness for the accountable care era has been disappointing.

New data show that while most of the early ACOs in the Medicare Shared Savings Program were hospital led, there are now more physician-led ACOs than any other. At the same time, early results of some modest primary care–only ACOs have been exciting. The rural primary care physician ACO previously reported on in this column, Rio Grande Valley Health Alliance in McAllen, Tex., is preliminarily looking at 90th-percentile quality results and more than $500,000 in (unofficial) savings per physician in their first year under the Medicare Shared Savings Program.

In fact, in a May 14, 2014, article in JAMA, its authors stated: "Even though most adult primary care physicians may not realize it, they each can be seen as a chief executive officer (CEO) in charge of approximately $10 million in annual revenue" (JAMA 2014;311:1855-6). They noted that primary care receives only 5% of that spending, but can control much of the average of $5,000 in annual spending of their 2,000 or so patients. The independent physician-led Palm Beach ACO is cited as an example, with $22 million in savings their first year. The authors recommend physician-led ACOs as the best way to leverage that "CEO" power.

These new success lessons are being learned and need to be shared. Primary care physicians need to understand that the risk of change is now much less than the risk of maintaining the status quo. You need transparency regarding the realities of all your choices, including hospital employment and physician ACOs.

 

 

As readers of this column know, I heartily endorse the trend recognized in the JAMA article: "[A]n increasing number of primary care physicians see physician-led ACOs as a powerful opportunity to retain their autonomy and make a positive difference for their patient – as well as their practices’ bottom lines."

Mr. Bobbitt is a senior partner and head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He has many years’ experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author at [email protected] or 919-821-6612.

Primary care physicians around the country are facing the largest decision of their lives: Do I stay independent and maybe form an accountable care organization with other independent physicians, or do I become an employee of a hospital or health system?

As accountable care is taking hold, new data may alter historic thinking on this "bet-the-practice" question.

Tired of being overworked, undersatisfied, and overwhelmed with growing regulatory requirements, many primary care physicians have sought the security and strength of hospital employment. They say the pressures to invest in technology, billing, coding, and continued reimbursement pressures are just too great.

Yet, the majority of these physicians miss their days of self-employed autonomy, are on average less productive, and worry that the clocks on their compensation guarantees are ticking down.

Most of the moves by your colleagues, and perhaps you, to hospital employment have been defensive. It was just no longer feasible to stay afloat in the current fee-for-service system. You cannot work any harder, faster, or cheaper. You can no longer spend satisfactory time with your patients.

On the other hand, some of you may have joined a hospital or health system to be proactive and gain a solid platform to prepare for the new value-based payment era.

You may have envisioned being integrated with a critical mass of like-minded physicians and facilities, aided by advanced population management tools and a strong balance sheet, and all linked together on the hospital’s health information technology platform. You read that primary care should be in a leadership position and financially incentivized in any accountable care organization – including a hospital’s. Independent physicians could theoretically form ACOs, too, but lack the up-front capital, know-how, and any spare intellectual bandwidth to do so.

So, from a strategic perspective, becoming employed with other physicians by a health system seemed the way to go.

The pace has quickened of health care’s movement away from fee for service or "pay for volume" to payment for better outcomes at lower overall costs, or "pay for value." The factors that applied to the decision to become employed in the fee-for-service era may be yielding to those in the accountable care era sooner than anticipated.

Independent physician-led ACOs appear to be adapting better than hospitals to this change. Although much better prepared fiscally, hospitals are conflicted, or at least hesitant, to make this switch, because much of the savings comes from avoidable admissions and readmissions. On the other hand, emerging data and experience are showing that physician-led ACOs can be very successful.

There are some very integrated and successful hospital-led ACOs or other value-delivery hospital/physician models. In fact, I believe that if the hospital is willing to right-size and truly commit to value, it can be the most successful model.

However, many physicians signed volume-only physician work relative value unit (wRVU) compensation formulas in their hospital employment agreements, with no incentive payments for value. They have not been involved as partners, much less leaders, in any ACO planning. Even though the fee-for-service days are waning and strains are showing for many hospitals that are not adapting, for many employed physicians, the pace of preparedness for the accountable care era has been disappointing.

New data show that while most of the early ACOs in the Medicare Shared Savings Program were hospital led, there are now more physician-led ACOs than any other. At the same time, early results of some modest primary care–only ACOs have been exciting. The rural primary care physician ACO previously reported on in this column, Rio Grande Valley Health Alliance in McAllen, Tex., is preliminarily looking at 90th-percentile quality results and more than $500,000 in (unofficial) savings per physician in their first year under the Medicare Shared Savings Program.

In fact, in a May 14, 2014, article in JAMA, its authors stated: "Even though most adult primary care physicians may not realize it, they each can be seen as a chief executive officer (CEO) in charge of approximately $10 million in annual revenue" (JAMA 2014;311:1855-6). They noted that primary care receives only 5% of that spending, but can control much of the average of $5,000 in annual spending of their 2,000 or so patients. The independent physician-led Palm Beach ACO is cited as an example, with $22 million in savings their first year. The authors recommend physician-led ACOs as the best way to leverage that "CEO" power.

These new success lessons are being learned and need to be shared. Primary care physicians need to understand that the risk of change is now much less than the risk of maintaining the status quo. You need transparency regarding the realities of all your choices, including hospital employment and physician ACOs.

 

 

As readers of this column know, I heartily endorse the trend recognized in the JAMA article: "[A]n increasing number of primary care physicians see physician-led ACOs as a powerful opportunity to retain their autonomy and make a positive difference for their patient – as well as their practices’ bottom lines."

Mr. Bobbitt is a senior partner and head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He has many years’ experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author at [email protected] or 919-821-6612.

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