Commentary

Since 1979, obstetric and other health care providers who treat pregnant or potentially pregnant and breastfeeding women have relied heavily on the Food and Drug Administration’s pregnancy labeling categories for pharmaceuticals – the familiar A, B, C, D, X. However, as early as 1997, a public hearing was held that challenged the value of these labels as typically used in clinical practice by both providers and patients.

Now, 17 years later, in December 2014, the FDA has released the “Pregnancy and Lactation Labeling Rule” (also known as PLLR or final rule). In brief, the revised label will require that:

• Contact information be prominently listed for a pregnancy exposure registry for the drug, when one is available.

• Narrative sections be presented that include a risk summary, clinical considerations, and the supporting data.

• A lactation subsection be included that provides information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

• A subsection on females and males of reproductive potential be included, when necessary, with information about the need for pregnancy testing, contraception recommendations, and information about infertility as it relates to the drug.

The labeling changes go into effect on June 30, 2015. Prescription drugs and biologic products submitted for FDA review after that date will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.

Why are these changes needed, and what impact will they likely have for clinical practice?

First a bit of history – the pregnancy label A, B, C, D, X categories were initially introduced in the 1970s, following the recognition that thalidomide was a human teratogen. The intention was to help the clinician deal in a more standardized way with the increasing amount of experimental animal data and human reports generated for drugs that might be used by women of reproductive potential.

However, the letter categories, and their accompanying standard text statements, were frequently misinterpreted in oversimplistic and inaccurate ways (Birth Defects Res. Part A 2007,79:627-30). Clinicians and patients often believe that risk increases as you move across the letter categories; for example, that a category C drug is worse than a category B drug for a given patient.

Clinicians and patients also commonly think that drugs in the same category have the same level of risk, or that there is a similar quantity and quality of information to support that risk category. Frequently cited examples of misinterpretation include those drugs assigned a category X, for example, label text indicating that the drug is “contraindicated in women who are or may become pregnant.” In reality, in some cases, the X category has been applied to drugs with known human teratogenic potential (such as isotretinoin or thalidomide). However, in other cases, the X has been assigned to drugs for which there were no or very limited human data indicating risk (such as ribavirin or leflunomide) or for which the treatment for the underlying condition would not be necessary or advisable in pregnancy (such as statins or some weight loss drugs).

There is no differentiation made in the category X label for varying risks specifically related to dose and timing of exposure in gestation. In each of these situations where there are no clear-cut human data, inadvertent exposure to the drug in an unplanned pregnancy can easily lead to the misunderstanding that the drug is known to cause birth defects in humans.

The immediate impact of the PLLR label revision will be to require narrative sections that describe the actual data, provide a summary of risks, and also present clinical considerations that may include the risk of undertreatment or no treatment with the drug. The new format is intended to provide the clinician (and the patient) with more comprehensive information on which to base decisions.

The downside of the label revision is that clinicians will have to learn to interpret more comprehensive information and deal with the unknowns, which are many.

The other major impact of the label revision will be to highlight the clear lack of sufficient human data for most drugs currently marketed in the United States. A recent review of drugs (both prescription and over the counter) approved by the FDA between 2000 and 2010 found that 73.3% had no human data available that was relevant to pregnancy safety (Am. J. Med. Genet. C. Semin. Med. Genet. 157C:175-82).

In the short term, the learning curve for label writers and the end users of such labels will be steep. However, clinicians and patients can contribute to the compilation of data for most drugs by more proactively engaging in pregnancy and lactation safety studies. Information about the existence of any pregnancy registries in drug labeling has been recommended in the past, but will now be required. Acting on that information by enrolling patients in these studies can ensure that labels can more quickly be populated with evidence-based data that can better inform patient care.

Dr. Chambers is a professor of pediatrics and director of clinical research at Rady Children’s Hospital, and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is director of MotherToBaby California, a past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She has no relevant financial disclosures. To comment, e-mail her at [email protected].

Since 1979, obstetric and other health care providers who treat pregnant or potentially pregnant and breastfeeding women have relied heavily on the Food and Drug Administration’s pregnancy labeling categories for pharmaceuticals – the familiar A, B, C, D, X. However, as early as 1997, a public hearing was held that challenged the value of these labels as typically used in clinical practice by both providers and patients.

Now, 17 years later, in December 2014, the FDA has released the “Pregnancy and Lactation Labeling Rule” (also known as PLLR or final rule). In brief, the revised label will require that:

• Contact information be prominently listed for a pregnancy exposure registry for the drug, when one is available.

• Narrative sections be presented that include a risk summary, clinical considerations, and the supporting data.

• A lactation subsection be included that provides information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

• A subsection on females and males of reproductive potential be included, when necessary, with information about the need for pregnancy testing, contraception recommendations, and information about infertility as it relates to the drug.

The labeling changes go into effect on June 30, 2015. Prescription drugs and biologic products submitted for FDA review after that date will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.

Why are these changes needed, and what impact will they likely have for clinical practice?

First a bit of history – the pregnancy label A, B, C, D, X categories were initially introduced in the 1970s, following the recognition that thalidomide was a human teratogen. The intention was to help the clinician deal in a more standardized way with the increasing amount of experimental animal data and human reports generated for drugs that might be used by women of reproductive potential.

However, the letter categories, and their accompanying standard text statements, were frequently misinterpreted in oversimplistic and inaccurate ways (Birth Defects Res. Part A 2007,79:627-30). Clinicians and patients often believe that risk increases as you move across the letter categories; for example, that a category C drug is worse than a category B drug for a given patient.

Clinicians and patients also commonly think that drugs in the same category have the same level of risk, or that there is a similar quantity and quality of information to support that risk category. Frequently cited examples of misinterpretation include those drugs assigned a category X, for example, label text indicating that the drug is “contraindicated in women who are or may become pregnant.” In reality, in some cases, the X category has been applied to drugs with known human teratogenic potential (such as isotretinoin or thalidomide). However, in other cases, the X has been assigned to drugs for which there were no or very limited human data indicating risk (such as ribavirin or leflunomide) or for which the treatment for the underlying condition would not be necessary or advisable in pregnancy (such as statins or some weight loss drugs).

There is no differentiation made in the category X label for varying risks specifically related to dose and timing of exposure in gestation. In each of these situations where there are no clear-cut human data, inadvertent exposure to the drug in an unplanned pregnancy can easily lead to the misunderstanding that the drug is known to cause birth defects in humans.

The immediate impact of the PLLR label revision will be to require narrative sections that describe the actual data, provide a summary of risks, and also present clinical considerations that may include the risk of undertreatment or no treatment with the drug. The new format is intended to provide the clinician (and the patient) with more comprehensive information on which to base decisions.

The downside of the label revision is that clinicians will have to learn to interpret more comprehensive information and deal with the unknowns, which are many.

The other major impact of the label revision will be to highlight the clear lack of sufficient human data for most drugs currently marketed in the United States. A recent review of drugs (both prescription and over the counter) approved by the FDA between 2000 and 2010 found that 73.3% had no human data available that was relevant to pregnancy safety (Am. J. Med. Genet. C. Semin. Med. Genet. 157C:175-82).

In the short term, the learning curve for label writers and the end users of such labels will be steep. However, clinicians and patients can contribute to the compilation of data for most drugs by more proactively engaging in pregnancy and lactation safety studies. Information about the existence of any pregnancy registries in drug labeling has been recommended in the past, but will now be required. Acting on that information by enrolling patients in these studies can ensure that labels can more quickly be populated with evidence-based data that can better inform patient care.

Dr. Chambers is a professor of pediatrics and director of clinical research at Rady Children’s Hospital, and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is director of MotherToBaby California, a past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She has no relevant financial disclosures. To comment, e-mail her at [email protected].

Since 1979, obstetric and other health care providers who treat pregnant or potentially pregnant and breastfeeding women have relied heavily on the Food and Drug Administration’s pregnancy labeling categories for pharmaceuticals – the familiar A, B, C, D, X. However, as early as 1997, a public hearing was held that challenged the value of these labels as typically used in clinical practice by both providers and patients.

Now, 17 years later, in December 2014, the FDA has released the “Pregnancy and Lactation Labeling Rule” (also known as PLLR or final rule). In brief, the revised label will require that:

• Contact information be prominently listed for a pregnancy exposure registry for the drug, when one is available.

• Narrative sections be presented that include a risk summary, clinical considerations, and the supporting data.

• A lactation subsection be included that provides information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

• A subsection on females and males of reproductive potential be included, when necessary, with information about the need for pregnancy testing, contraception recommendations, and information about infertility as it relates to the drug.

The labeling changes go into effect on June 30, 2015. Prescription drugs and biologic products submitted for FDA review after that date will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.

Why are these changes needed, and what impact will they likely have for clinical practice?

First a bit of history – the pregnancy label A, B, C, D, X categories were initially introduced in the 1970s, following the recognition that thalidomide was a human teratogen. The intention was to help the clinician deal in a more standardized way with the increasing amount of experimental animal data and human reports generated for drugs that might be used by women of reproductive potential.

However, the letter categories, and their accompanying standard text statements, were frequently misinterpreted in oversimplistic and inaccurate ways (Birth Defects Res. Part A 2007,79:627-30). Clinicians and patients often believe that risk increases as you move across the letter categories; for example, that a category C drug is worse than a category B drug for a given patient.

Clinicians and patients also commonly think that drugs in the same category have the same level of risk, or that there is a similar quantity and quality of information to support that risk category. Frequently cited examples of misinterpretation include those drugs assigned a category X, for example, label text indicating that the drug is “contraindicated in women who are or may become pregnant.” In reality, in some cases, the X category has been applied to drugs with known human teratogenic potential (such as isotretinoin or thalidomide). However, in other cases, the X has been assigned to drugs for which there were no or very limited human data indicating risk (such as ribavirin or leflunomide) or for which the treatment for the underlying condition would not be necessary or advisable in pregnancy (such as statins or some weight loss drugs).

There is no differentiation made in the category X label for varying risks specifically related to dose and timing of exposure in gestation. In each of these situations where there are no clear-cut human data, inadvertent exposure to the drug in an unplanned pregnancy can easily lead to the misunderstanding that the drug is known to cause birth defects in humans.

The immediate impact of the PLLR label revision will be to require narrative sections that describe the actual data, provide a summary of risks, and also present clinical considerations that may include the risk of undertreatment or no treatment with the drug. The new format is intended to provide the clinician (and the patient) with more comprehensive information on which to base decisions.

The downside of the label revision is that clinicians will have to learn to interpret more comprehensive information and deal with the unknowns, which are many.

The other major impact of the label revision will be to highlight the clear lack of sufficient human data for most drugs currently marketed in the United States. A recent review of drugs (both prescription and over the counter) approved by the FDA between 2000 and 2010 found that 73.3% had no human data available that was relevant to pregnancy safety (Am. J. Med. Genet. C. Semin. Med. Genet. 157C:175-82).

In the short term, the learning curve for label writers and the end users of such labels will be steep. However, clinicians and patients can contribute to the compilation of data for most drugs by more proactively engaging in pregnancy and lactation safety studies. Information about the existence of any pregnancy registries in drug labeling has been recommended in the past, but will now be required. Acting on that information by enrolling patients in these studies can ensure that labels can more quickly be populated with evidence-based data that can better inform patient care.

Dr. Chambers is a professor of pediatrics and director of clinical research at Rady Children’s Hospital, and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is director of MotherToBaby California, a past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She has no relevant financial disclosures. To comment, e-mail her at [email protected].

Introduction

Both the medical and lay press have directed a lot of attention lately to the treatment of children and adolescents with antipsychotic medications. The literature is clear that the number of children taking this class of medications has risen sharply since their release (Arch. Gen. Psychiatry 2006;63:679-85). What is much less clear is the degree to which this increase represents a reasonable intervention for patients in significant need versus an overuse when other strategies are more appropriate.

Case Summary

Cody is a 6-year-old boy who lives with his younger sister and single mother. The family struggles financially, and the father, who has never had much contact with his son, is currently incarcerated. Since he was a toddler, Cody has been prone to high levels of aggressive behavior and frequent, intense angry outbursts. He was asked to leave his preschool due to his behavior and now is commonly disruptive at school. His pediatrician diagnosed him with attention-deficit/hyperactivity disorder a year ago and began a trial of a psychostimulant, which made him even more irritable, and was discontinued. Cody and his mother now present with concerns that there is “something more” affecting his behavior. The pediatrician now considers whether or not treatment with an antipsychotic medication is reasonable at this point.

Discussion

The above clinical scenario represents a critical and often antagonizing moment in treatment for both the family and the treating physician, yet it is hardly uncommon. The situation often is made more complicated by the fact that what is often the first plan of action, namely referral or consultation with a child psychiatrist, can be very difficult to access.

The American Academy of Child and Adolescent Psychiatry has published online guidelines for the use of antipsychotic medication in youth (http://bit.ly/1eat7e9). Key recommendations and points from this 27-page document and 19 recommendations include the following:

• Patients being considered for treatment with an antipsychotic medication should receive a “meticulous diagnostic assessment” with any medication prescribed being part of a “multidisciplinary” treatment plan (Recommendation 1).

• Prescribers should “regularly check the current literature” regarding the scientific evidence for antipsychotic medication use (Recommendation 2).

• Antipsychotic medications are considered first-line medication treatment for bipolar disorder, schizophrenia, tics/Tourette’s, and autism. (Recommendation 2).

• Antipsychotic medications are not first-line treatment for several other diagnoses and behaviors, including disruptive behavior disorders such as ADHD, aggression, eating disorders, and post-traumatic stress disorder (PTSD). Their use should be considered only after other pharmacologic and nonpharmacologic interventions have failed (Recommendation 2).

• Antipsychotic medications are not advised for preschool-aged patients. (Recommendation 2).

• Dosing should be as low as possible and not exceed the maximum recommended dose for adults (Recommendation 4).

• Simultaneous treatment with multiple antipsychotic medications is not recommended (Recommendation 8).

• Patients should receive regular metabolic monitoring, including lab work, both before and during treatment (Recommendations 11-13).

These are rigorous guidelines that challenge even those who regularly assess and treat children with serious psychiatric disorders. The clinical and legal implications of prescribing antipsychotic medications without adhering to these guidelines will, and probably should, give many physicians pause. Further, the specific point about the need for a thorough psychiatric evaluation underlies the commonly heard recommendation that this class of medicines generally should be avoided by primary care physicians. At the same time, many pediatricians are acutely aware of how dire the clinical situation often is for these families. At this point, it can easily begin to feel very much like a “no-win” situation.

Here are some thoughts that may be useful to consider in these moments:

• Remember that many non-MD mental health professionals can offer a lot of help. Although they can’t do the prescribing themselves, referral to a psychologist or another type of therapist can be useful in getting information about a patient’s diagnosis and the degree to which nonpharmacologic options have been exhausted. If the patient is already seeing a therapist, it is certainly worthwhile to seek their advice as to whether or not antipsychotic medications are now reasonable to consider.

• Look for opportunities to talk “curbside” to a child psychiatrist. Most of us are keenly aware of how inadequate access is to child psychiatry and want to help. Indeed, many states now have specific brief consultation programs in place.

• Get the lab work. A recent study in Pediatrics reported that a baseline glucose was obtained in only 11% of youth receiving antipsychotic medication treatment (Pediatrics 2014;134:e1308-14). In addition to providing important information, this step signals to everyone involved that the decision to use these medications is not something to be taken lightly.

Case follow-up

Cody’s pediatrician decides to get a diagnostic evaluation from a psychologist, who confirms the ADHD diagnosis without associated conditions such as bipolar disorder. The psychologist recommends a course of therapy to build regulatory skills for Cody and provide the mother with some parent behavioral guidance about how to best manage Cody’s challenges and encourage health-promoting behaviors such as physical activity, reading, and a regular sleep routine. The pediatrician decides to try a second line ADHD medication, guanfacine, and the school also begins to institute an incentive plan to reinforce positive behavior. In combination, these efforts significantly reduce the level of aggression and dysregulated behavior.

Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Dr. Rettew said he has no relevant financial disclosures. Follow him on Twitter @pedipsych.

Introduction

Both the medical and lay press have directed a lot of attention lately to the treatment of children and adolescents with antipsychotic medications. The literature is clear that the number of children taking this class of medications has risen sharply since their release (Arch. Gen. Psychiatry 2006;63:679-85). What is much less clear is the degree to which this increase represents a reasonable intervention for patients in significant need versus an overuse when other strategies are more appropriate.

Case Summary

Cody is a 6-year-old boy who lives with his younger sister and single mother. The family struggles financially, and the father, who has never had much contact with his son, is currently incarcerated. Since he was a toddler, Cody has been prone to high levels of aggressive behavior and frequent, intense angry outbursts. He was asked to leave his preschool due to his behavior and now is commonly disruptive at school. His pediatrician diagnosed him with attention-deficit/hyperactivity disorder a year ago and began a trial of a psychostimulant, which made him even more irritable, and was discontinued. Cody and his mother now present with concerns that there is “something more” affecting his behavior. The pediatrician now considers whether or not treatment with an antipsychotic medication is reasonable at this point.

Discussion

The above clinical scenario represents a critical and often antagonizing moment in treatment for both the family and the treating physician, yet it is hardly uncommon. The situation often is made more complicated by the fact that what is often the first plan of action, namely referral or consultation with a child psychiatrist, can be very difficult to access.

The American Academy of Child and Adolescent Psychiatry has published online guidelines for the use of antipsychotic medication in youth (http://bit.ly/1eat7e9). Key recommendations and points from this 27-page document and 19 recommendations include the following:

• Patients being considered for treatment with an antipsychotic medication should receive a “meticulous diagnostic assessment” with any medication prescribed being part of a “multidisciplinary” treatment plan (Recommendation 1).

• Prescribers should “regularly check the current literature” regarding the scientific evidence for antipsychotic medication use (Recommendation 2).

• Antipsychotic medications are considered first-line medication treatment for bipolar disorder, schizophrenia, tics/Tourette’s, and autism. (Recommendation 2).

• Antipsychotic medications are not first-line treatment for several other diagnoses and behaviors, including disruptive behavior disorders such as ADHD, aggression, eating disorders, and post-traumatic stress disorder (PTSD). Their use should be considered only after other pharmacologic and nonpharmacologic interventions have failed (Recommendation 2).

• Antipsychotic medications are not advised for preschool-aged patients. (Recommendation 2).

• Dosing should be as low as possible and not exceed the maximum recommended dose for adults (Recommendation 4).

• Simultaneous treatment with multiple antipsychotic medications is not recommended (Recommendation 8).

• Patients should receive regular metabolic monitoring, including lab work, both before and during treatment (Recommendations 11-13).

These are rigorous guidelines that challenge even those who regularly assess and treat children with serious psychiatric disorders. The clinical and legal implications of prescribing antipsychotic medications without adhering to these guidelines will, and probably should, give many physicians pause. Further, the specific point about the need for a thorough psychiatric evaluation underlies the commonly heard recommendation that this class of medicines generally should be avoided by primary care physicians. At the same time, many pediatricians are acutely aware of how dire the clinical situation often is for these families. At this point, it can easily begin to feel very much like a “no-win” situation.

Here are some thoughts that may be useful to consider in these moments:

• Remember that many non-MD mental health professionals can offer a lot of help. Although they can’t do the prescribing themselves, referral to a psychologist or another type of therapist can be useful in getting information about a patient’s diagnosis and the degree to which nonpharmacologic options have been exhausted. If the patient is already seeing a therapist, it is certainly worthwhile to seek their advice as to whether or not antipsychotic medications are now reasonable to consider.

• Look for opportunities to talk “curbside” to a child psychiatrist. Most of us are keenly aware of how inadequate access is to child psychiatry and want to help. Indeed, many states now have specific brief consultation programs in place.

• Get the lab work. A recent study in Pediatrics reported that a baseline glucose was obtained in only 11% of youth receiving antipsychotic medication treatment (Pediatrics 2014;134:e1308-14). In addition to providing important information, this step signals to everyone involved that the decision to use these medications is not something to be taken lightly.

Case follow-up

Cody’s pediatrician decides to get a diagnostic evaluation from a psychologist, who confirms the ADHD diagnosis without associated conditions such as bipolar disorder. The psychologist recommends a course of therapy to build regulatory skills for Cody and provide the mother with some parent behavioral guidance about how to best manage Cody’s challenges and encourage health-promoting behaviors such as physical activity, reading, and a regular sleep routine. The pediatrician decides to try a second line ADHD medication, guanfacine, and the school also begins to institute an incentive plan to reinforce positive behavior. In combination, these efforts significantly reduce the level of aggression and dysregulated behavior.

Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Dr. Rettew said he has no relevant financial disclosures. Follow him on Twitter @pedipsych.

Introduction

Both the medical and lay press have directed a lot of attention lately to the treatment of children and adolescents with antipsychotic medications. The literature is clear that the number of children taking this class of medications has risen sharply since their release (Arch. Gen. Psychiatry 2006;63:679-85). What is much less clear is the degree to which this increase represents a reasonable intervention for patients in significant need versus an overuse when other strategies are more appropriate.

Case Summary

Cody is a 6-year-old boy who lives with his younger sister and single mother. The family struggles financially, and the father, who has never had much contact with his son, is currently incarcerated. Since he was a toddler, Cody has been prone to high levels of aggressive behavior and frequent, intense angry outbursts. He was asked to leave his preschool due to his behavior and now is commonly disruptive at school. His pediatrician diagnosed him with attention-deficit/hyperactivity disorder a year ago and began a trial of a psychostimulant, which made him even more irritable, and was discontinued. Cody and his mother now present with concerns that there is “something more” affecting his behavior. The pediatrician now considers whether or not treatment with an antipsychotic medication is reasonable at this point.

Discussion

The above clinical scenario represents a critical and often antagonizing moment in treatment for both the family and the treating physician, yet it is hardly uncommon. The situation often is made more complicated by the fact that what is often the first plan of action, namely referral or consultation with a child psychiatrist, can be very difficult to access.

The American Academy of Child and Adolescent Psychiatry has published online guidelines for the use of antipsychotic medication in youth (http://bit.ly/1eat7e9). Key recommendations and points from this 27-page document and 19 recommendations include the following:

• Patients being considered for treatment with an antipsychotic medication should receive a “meticulous diagnostic assessment” with any medication prescribed being part of a “multidisciplinary” treatment plan (Recommendation 1).

• Prescribers should “regularly check the current literature” regarding the scientific evidence for antipsychotic medication use (Recommendation 2).

• Antipsychotic medications are considered first-line medication treatment for bipolar disorder, schizophrenia, tics/Tourette’s, and autism. (Recommendation 2).

• Antipsychotic medications are not first-line treatment for several other diagnoses and behaviors, including disruptive behavior disorders such as ADHD, aggression, eating disorders, and post-traumatic stress disorder (PTSD). Their use should be considered only after other pharmacologic and nonpharmacologic interventions have failed (Recommendation 2).

• Antipsychotic medications are not advised for preschool-aged patients. (Recommendation 2).

• Dosing should be as low as possible and not exceed the maximum recommended dose for adults (Recommendation 4).

• Simultaneous treatment with multiple antipsychotic medications is not recommended (Recommendation 8).

• Patients should receive regular metabolic monitoring, including lab work, both before and during treatment (Recommendations 11-13).

These are rigorous guidelines that challenge even those who regularly assess and treat children with serious psychiatric disorders. The clinical and legal implications of prescribing antipsychotic medications without adhering to these guidelines will, and probably should, give many physicians pause. Further, the specific point about the need for a thorough psychiatric evaluation underlies the commonly heard recommendation that this class of medicines generally should be avoided by primary care physicians. At the same time, many pediatricians are acutely aware of how dire the clinical situation often is for these families. At this point, it can easily begin to feel very much like a “no-win” situation.

Here are some thoughts that may be useful to consider in these moments:

• Remember that many non-MD mental health professionals can offer a lot of help. Although they can’t do the prescribing themselves, referral to a psychologist or another type of therapist can be useful in getting information about a patient’s diagnosis and the degree to which nonpharmacologic options have been exhausted. If the patient is already seeing a therapist, it is certainly worthwhile to seek their advice as to whether or not antipsychotic medications are now reasonable to consider.

• Look for opportunities to talk “curbside” to a child psychiatrist. Most of us are keenly aware of how inadequate access is to child psychiatry and want to help. Indeed, many states now have specific brief consultation programs in place.

• Get the lab work. A recent study in Pediatrics reported that a baseline glucose was obtained in only 11% of youth receiving antipsychotic medication treatment (Pediatrics 2014;134:e1308-14). In addition to providing important information, this step signals to everyone involved that the decision to use these medications is not something to be taken lightly.

Case follow-up

Cody’s pediatrician decides to get a diagnostic evaluation from a psychologist, who confirms the ADHD diagnosis without associated conditions such as bipolar disorder. The psychologist recommends a course of therapy to build regulatory skills for Cody and provide the mother with some parent behavioral guidance about how to best manage Cody’s challenges and encourage health-promoting behaviors such as physical activity, reading, and a regular sleep routine. The pediatrician decides to try a second line ADHD medication, guanfacine, and the school also begins to institute an incentive plan to reinforce positive behavior. In combination, these efforts significantly reduce the level of aggression and dysregulated behavior.

Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Dr. Rettew said he has no relevant financial disclosures. Follow him on Twitter @pedipsych.

While typing this column, I could not recall the last time I saw a patient with “tennis elbow” (lateral epicondylitis) from actual tennis. Lateral epicondylitis peaks between the ages of 30 and 65 years and affects about 1.3% of this group – the vast majority of whom, I am quite suddenly convinced, do not play tennis. Pain is worse with wrist extension and typically affects the dominant hand. The most likely etiology is repeated microtrauma.

The examination is straightforward and about 90% will recover by 1 year without a surgical procedure. The unhappy customers who darken our doorways with worsening or nonimproving symptoms are the ones who make us wonder if we gave them effective conservative measures to begin with.

So what conservative measures are effective?

Sims and colleagues published a meta-analysis evaluating nonsurgical treatments for lateral epicondylitis. The review involved 58 studies (Hand 2014.9:419-46).

The investigators concluded that steroid injections provide relief only for the short term. The authors suggest that this may related to lateral epicondylitis being caused by repeated microtrauma rather than inflammation (perhaps this is why NSAIDs are not always beneficial either). Botulinum A, which works by paralyzing the extensor muscles, thereby allowing them to heal, is comparable to steroids. But patients may not love the experience of extensor muscle paralysis. Prolotherapy, injection of osmotics or irritants to promote inflammation in the target tissue, is also comparable to steroids. Platelet-rich plasma or autologous blood injections have uncertain relative benefit compared to steroids. Bracing with a counterforce brace (i.e., “tennis elbow strap”) or wrist extension splint, physical therapy, and shock wave therapy do not lessen pain or improve function in a dependable way.

This review leaves primary care clinicians who are uncomfortable injecting steroids into the arm with not much in the way of clearly effective evidence-based therapies. Personally, I ask my Ortho Hand colleagues to help me with the injection part. But only when patients fail to respond to what I give them.

So if this is a self-limited disease that gets better in 12-18 months, should we just be offering nothing more than activity modification? Patients will not accept this. My read on the data Sims collected is that there weren’t any quality studies comparing the elbow strap to offering nothing and patients tended to improve with it – although admittedly not clearly more than other therapies such as strengthening exercises. So for now, I will continue to recommend: 1) the elbow strap; 2) home exercises, and 3) lots and lots of reassurance. It’s all I got to give.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.

While typing this column, I could not recall the last time I saw a patient with “tennis elbow” (lateral epicondylitis) from actual tennis. Lateral epicondylitis peaks between the ages of 30 and 65 years and affects about 1.3% of this group – the vast majority of whom, I am quite suddenly convinced, do not play tennis. Pain is worse with wrist extension and typically affects the dominant hand. The most likely etiology is repeated microtrauma.

The examination is straightforward and about 90% will recover by 1 year without a surgical procedure. The unhappy customers who darken our doorways with worsening or nonimproving symptoms are the ones who make us wonder if we gave them effective conservative measures to begin with.

So what conservative measures are effective?

Sims and colleagues published a meta-analysis evaluating nonsurgical treatments for lateral epicondylitis. The review involved 58 studies (Hand 2014.9:419-46).

The investigators concluded that steroid injections provide relief only for the short term. The authors suggest that this may related to lateral epicondylitis being caused by repeated microtrauma rather than inflammation (perhaps this is why NSAIDs are not always beneficial either). Botulinum A, which works by paralyzing the extensor muscles, thereby allowing them to heal, is comparable to steroids. But patients may not love the experience of extensor muscle paralysis. Prolotherapy, injection of osmotics or irritants to promote inflammation in the target tissue, is also comparable to steroids. Platelet-rich plasma or autologous blood injections have uncertain relative benefit compared to steroids. Bracing with a counterforce brace (i.e., “tennis elbow strap”) or wrist extension splint, physical therapy, and shock wave therapy do not lessen pain or improve function in a dependable way.

This review leaves primary care clinicians who are uncomfortable injecting steroids into the arm with not much in the way of clearly effective evidence-based therapies. Personally, I ask my Ortho Hand colleagues to help me with the injection part. But only when patients fail to respond to what I give them.

So if this is a self-limited disease that gets better in 12-18 months, should we just be offering nothing more than activity modification? Patients will not accept this. My read on the data Sims collected is that there weren’t any quality studies comparing the elbow strap to offering nothing and patients tended to improve with it – although admittedly not clearly more than other therapies such as strengthening exercises. So for now, I will continue to recommend: 1) the elbow strap; 2) home exercises, and 3) lots and lots of reassurance. It’s all I got to give.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.

While typing this column, I could not recall the last time I saw a patient with “tennis elbow” (lateral epicondylitis) from actual tennis. Lateral epicondylitis peaks between the ages of 30 and 65 years and affects about 1.3% of this group – the vast majority of whom, I am quite suddenly convinced, do not play tennis. Pain is worse with wrist extension and typically affects the dominant hand. The most likely etiology is repeated microtrauma.

The examination is straightforward and about 90% will recover by 1 year without a surgical procedure. The unhappy customers who darken our doorways with worsening or nonimproving symptoms are the ones who make us wonder if we gave them effective conservative measures to begin with.

So what conservative measures are effective?

Sims and colleagues published a meta-analysis evaluating nonsurgical treatments for lateral epicondylitis. The review involved 58 studies (Hand 2014.9:419-46).

The investigators concluded that steroid injections provide relief only for the short term. The authors suggest that this may related to lateral epicondylitis being caused by repeated microtrauma rather than inflammation (perhaps this is why NSAIDs are not always beneficial either). Botulinum A, which works by paralyzing the extensor muscles, thereby allowing them to heal, is comparable to steroids. But patients may not love the experience of extensor muscle paralysis. Prolotherapy, injection of osmotics or irritants to promote inflammation in the target tissue, is also comparable to steroids. Platelet-rich plasma or autologous blood injections have uncertain relative benefit compared to steroids. Bracing with a counterforce brace (i.e., “tennis elbow strap”) or wrist extension splint, physical therapy, and shock wave therapy do not lessen pain or improve function in a dependable way.

This review leaves primary care clinicians who are uncomfortable injecting steroids into the arm with not much in the way of clearly effective evidence-based therapies. Personally, I ask my Ortho Hand colleagues to help me with the injection part. But only when patients fail to respond to what I give them.

So if this is a self-limited disease that gets better in 12-18 months, should we just be offering nothing more than activity modification? Patients will not accept this. My read on the data Sims collected is that there weren’t any quality studies comparing the elbow strap to offering nothing and patients tended to improve with it – although admittedly not clearly more than other therapies such as strengthening exercises. So for now, I will continue to recommend: 1) the elbow strap; 2) home exercises, and 3) lots and lots of reassurance. It’s all I got to give.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.

Sutures, hemoclips, and electrocautery are the primary means of achieving hemostasis during gynecologic surgery. When these are inadequate or infeasible, topical hemostatic agents can be employed. Use of these agents has increased by 10%-21% since 2000, yet studies evaluating their use in gynecologic surgery are limited (J. Surg. Res. 2014;186:458-66).

Oxidized regenerated cellulose

Oxidized regenerated cellulose (Surgicel) is made from dissolved oxidized cellulose woven into a dry gauze sheet (J. Urol. 2006;176:2367-74). It is applied directly to tissue, creating a scaffold for platelet aggregation and decreasing tissue pH, further activating the clotting cascade (Surg. Infect. (Larchmt.) 2003;4:255-62). It is absorbed in 14 days, but can persist for 1 year.

Oxidized regenerated cellulose (ORC) is easily passed through laparoscopic trocars. One study found ORC efficacious in controlling tubal hemorrhage during laparoscopic sterilization (Int. J. Gynaecol. Obstet. 2003;82:221-2). It has also been shown to have bactericidal activity (Surg. Infect. (Larchmt.) 2003; 4:255-62) and prevent development of peritoneal adhesions (Acta. Chir. Scand. 1978;144:375-8).

Microfibrillar collagen

Microfibrillar collagen (Avitene) is made from bovine collagen in a powder or sponge sheet, and acts as a scaffold for platelet aggregation. It is applied directly to tissue and is absorbed in 3 months. One study found microfibrillar collagen (MC) use during cold knife conization resulted in nonsignificant reduction in operative time and similar hemostatic results compared to Sturmdorf suture (Obstet. Gynecol. 1978;51:118-22). MC also has been used to treat bleeding following uterine perforation and during laparoscopic hysterectomy.

Gelatins

Gelatins (Gelfoam, Surgifoam) are made of porcine collagen in a powder or foam (J. Urol. 2006;176:2367-74). It is applied directly to tissue, acting as a sponge to absorb blood. Pressure for several minutes is necessary for optimal hemostasis. Some surgeons moisten gelatins with topical thrombin prior to use, though no trials exist evaluating the efficacy of this maneuver.

Gelatin is absorbed in 4-6 weeks (J. Urol. 2006;176:2367-74) and can be passed through laparoscopic trocars. No studies have evaluated gelatins in gynecologic surgery so its applications are extrapolated from vascular and urologic surgery (J. Urol. 2006;176:2367-74).

Microporous polysaccharide spheres

Microporous polysaccharide spheres (Arista) form a polysaccharide powder made from potato starch. It absorbs water, concentrating platelets and other proteins to accelerate clot formation. It is applied to a dry surgical field and followed with gentle pressure. MPS is absorbed in 48 hours. No studies specifically evaluate the use of MPS in gynecologic surgery.

Topical thrombins

Thrombin (Thrombin-JMI, Evithrom, Recothrom) is derived from bovine, human, or recombinant sources. It converts fibrinogen to fibrin and activates factor XIII, platelets, and smooth muscle constriction (Biologics 2008;2:593-9). Thrombin is a spray or syringe, and is often used with gelatin foam (Thrombi-Gel) or matrix (FloSeal) (Biologics 2008;2:593-9). FloSeal use has been reported during ovarian cystectomy (J. Minim. Invasive. Gynecol. 2009;16:153-6), hysterotomy repair (J. Obstet. Gynaecol. 2012;32:34-5). During myomectomy, it was associated with decreased blood loss, transfusions, and shorter length of stay (Fertil. Steril. 2009;92:356-60).

Fibrin sealants

Fibrin sealants (Tisseel, TachoSil) are made of thrombin and concentrated fibrinogen from human plasma. They must be mixed prior to application and act by forming a fibrin clot. Tisseel can reduce hemorrhage after loop electrosurgical excision procedure (Gynecol. Obstet. Invest. 2012;74:1-5) and decreases operative time, time to hemostasis, and blood loss during laparoscopic myomectomy (Surg. Endosc. 2012;26:2046-53). Case reports describe the use of fibrin sealants in the management of obstetrical hemorrhage and hysterotomy repair.

Cost and complications

Hemostatic agents vary significantly in cost, but no comparative cost analyses exist. One study found that commercial insurance was associated with topical hemostatic agent use during gynecologic surgery (J. Surg. Res. 2014;186:458-66).

Use of ORC has been associated with postoperative abscess and imitation of abscess without true infection, and MC and gelatins can also increase infection risk. The dry hemostatic agents have been associated with thromboembolism. The complications of thrombins and fibrins are related to immune responses or transmission of pathogens. Recombinant thrombin is believed to be the safest option (J. Am. Coll. Surg. 2007;205:256-65). Floseal has been reported to cause diffuse pelvic inflammation and postoperative small bowel obstruction. Because of possible complications, it is important to use only the needed amount of product, and to dictate use in the operative note.

Despite widespread use of topical hemostatic agents in gynecologic surgery, studies are limited and these agents should be recommended only as adjuncts to conventional methods of achieving hemostasis.

Topical hemostatic agents are recommended for surgical fields that are less amenable to electrocautery, including denuded areas on peritoneal surfaces, and around important heat-sensitive structures such as nerves. The dry matrix agents (ORC, MC, gelatin, and MPS) are most useful in slowly bleeding areas or in patients with a bleeding diathesis. Thrombin and fibrin can be useful in situations when more significant bleeding is encountered. Complications arising from topical hemostatic agents are few.

Given current limited studies, the choice of product continues to depend on patient characteristics and surgeon preference.

Dr. Wysham is currently a fellow in the department of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Roque is a fellow in the gynecologic oncology program at UNC-Chapel Hill. Dr. Soper is a professor of gynecologic oncology at UNC-Chapel Hill.

Sutures, hemoclips, and electrocautery are the primary means of achieving hemostasis during gynecologic surgery. When these are inadequate or infeasible, topical hemostatic agents can be employed. Use of these agents has increased by 10%-21% since 2000, yet studies evaluating their use in gynecologic surgery are limited (J. Surg. Res. 2014;186:458-66).

Oxidized regenerated cellulose

Oxidized regenerated cellulose (Surgicel) is made from dissolved oxidized cellulose woven into a dry gauze sheet (J. Urol. 2006;176:2367-74). It is applied directly to tissue, creating a scaffold for platelet aggregation and decreasing tissue pH, further activating the clotting cascade (Surg. Infect. (Larchmt.) 2003;4:255-62). It is absorbed in 14 days, but can persist for 1 year.

Oxidized regenerated cellulose (ORC) is easily passed through laparoscopic trocars. One study found ORC efficacious in controlling tubal hemorrhage during laparoscopic sterilization (Int. J. Gynaecol. Obstet. 2003;82:221-2). It has also been shown to have bactericidal activity (Surg. Infect. (Larchmt.) 2003; 4:255-62) and prevent development of peritoneal adhesions (Acta. Chir. Scand. 1978;144:375-8).

Microfibrillar collagen

Microfibrillar collagen (Avitene) is made from bovine collagen in a powder or sponge sheet, and acts as a scaffold for platelet aggregation. It is applied directly to tissue and is absorbed in 3 months. One study found microfibrillar collagen (MC) use during cold knife conization resulted in nonsignificant reduction in operative time and similar hemostatic results compared to Sturmdorf suture (Obstet. Gynecol. 1978;51:118-22). MC also has been used to treat bleeding following uterine perforation and during laparoscopic hysterectomy.

Gelatins

Gelatins (Gelfoam, Surgifoam) are made of porcine collagen in a powder or foam (J. Urol. 2006;176:2367-74). It is applied directly to tissue, acting as a sponge to absorb blood. Pressure for several minutes is necessary for optimal hemostasis. Some surgeons moisten gelatins with topical thrombin prior to use, though no trials exist evaluating the efficacy of this maneuver.

Gelatin is absorbed in 4-6 weeks (J. Urol. 2006;176:2367-74) and can be passed through laparoscopic trocars. No studies have evaluated gelatins in gynecologic surgery so its applications are extrapolated from vascular and urologic surgery (J. Urol. 2006;176:2367-74).

Microporous polysaccharide spheres

Microporous polysaccharide spheres (Arista) form a polysaccharide powder made from potato starch. It absorbs water, concentrating platelets and other proteins to accelerate clot formation. It is applied to a dry surgical field and followed with gentle pressure. MPS is absorbed in 48 hours. No studies specifically evaluate the use of MPS in gynecologic surgery.

Topical thrombins

Thrombin (Thrombin-JMI, Evithrom, Recothrom) is derived from bovine, human, or recombinant sources. It converts fibrinogen to fibrin and activates factor XIII, platelets, and smooth muscle constriction (Biologics 2008;2:593-9). Thrombin is a spray or syringe, and is often used with gelatin foam (Thrombi-Gel) or matrix (FloSeal) (Biologics 2008;2:593-9). FloSeal use has been reported during ovarian cystectomy (J. Minim. Invasive. Gynecol. 2009;16:153-6), hysterotomy repair (J. Obstet. Gynaecol. 2012;32:34-5). During myomectomy, it was associated with decreased blood loss, transfusions, and shorter length of stay (Fertil. Steril. 2009;92:356-60).

Fibrin sealants

Fibrin sealants (Tisseel, TachoSil) are made of thrombin and concentrated fibrinogen from human plasma. They must be mixed prior to application and act by forming a fibrin clot. Tisseel can reduce hemorrhage after loop electrosurgical excision procedure (Gynecol. Obstet. Invest. 2012;74:1-5) and decreases operative time, time to hemostasis, and blood loss during laparoscopic myomectomy (Surg. Endosc. 2012;26:2046-53). Case reports describe the use of fibrin sealants in the management of obstetrical hemorrhage and hysterotomy repair.

Cost and complications

Hemostatic agents vary significantly in cost, but no comparative cost analyses exist. One study found that commercial insurance was associated with topical hemostatic agent use during gynecologic surgery (J. Surg. Res. 2014;186:458-66).

Use of ORC has been associated with postoperative abscess and imitation of abscess without true infection, and MC and gelatins can also increase infection risk. The dry hemostatic agents have been associated with thromboembolism. The complications of thrombins and fibrins are related to immune responses or transmission of pathogens. Recombinant thrombin is believed to be the safest option (J. Am. Coll. Surg. 2007;205:256-65). Floseal has been reported to cause diffuse pelvic inflammation and postoperative small bowel obstruction. Because of possible complications, it is important to use only the needed amount of product, and to dictate use in the operative note.

Despite widespread use of topical hemostatic agents in gynecologic surgery, studies are limited and these agents should be recommended only as adjuncts to conventional methods of achieving hemostasis.

Topical hemostatic agents are recommended for surgical fields that are less amenable to electrocautery, including denuded areas on peritoneal surfaces, and around important heat-sensitive structures such as nerves. The dry matrix agents (ORC, MC, gelatin, and MPS) are most useful in slowly bleeding areas or in patients with a bleeding diathesis. Thrombin and fibrin can be useful in situations when more significant bleeding is encountered. Complications arising from topical hemostatic agents are few.

Given current limited studies, the choice of product continues to depend on patient characteristics and surgeon preference.

Dr. Wysham is currently a fellow in the department of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Roque is a fellow in the gynecologic oncology program at UNC-Chapel Hill. Dr. Soper is a professor of gynecologic oncology at UNC-Chapel Hill.

Sutures, hemoclips, and electrocautery are the primary means of achieving hemostasis during gynecologic surgery. When these are inadequate or infeasible, topical hemostatic agents can be employed. Use of these agents has increased by 10%-21% since 2000, yet studies evaluating their use in gynecologic surgery are limited (J. Surg. Res. 2014;186:458-66).

Oxidized regenerated cellulose

Oxidized regenerated cellulose (Surgicel) is made from dissolved oxidized cellulose woven into a dry gauze sheet (J. Urol. 2006;176:2367-74). It is applied directly to tissue, creating a scaffold for platelet aggregation and decreasing tissue pH, further activating the clotting cascade (Surg. Infect. (Larchmt.) 2003;4:255-62). It is absorbed in 14 days, but can persist for 1 year.

Oxidized regenerated cellulose (ORC) is easily passed through laparoscopic trocars. One study found ORC efficacious in controlling tubal hemorrhage during laparoscopic sterilization (Int. J. Gynaecol. Obstet. 2003;82:221-2). It has also been shown to have bactericidal activity (Surg. Infect. (Larchmt.) 2003; 4:255-62) and prevent development of peritoneal adhesions (Acta. Chir. Scand. 1978;144:375-8).

Microfibrillar collagen

Microfibrillar collagen (Avitene) is made from bovine collagen in a powder or sponge sheet, and acts as a scaffold for platelet aggregation. It is applied directly to tissue and is absorbed in 3 months. One study found microfibrillar collagen (MC) use during cold knife conization resulted in nonsignificant reduction in operative time and similar hemostatic results compared to Sturmdorf suture (Obstet. Gynecol. 1978;51:118-22). MC also has been used to treat bleeding following uterine perforation and during laparoscopic hysterectomy.

Gelatins

Gelatins (Gelfoam, Surgifoam) are made of porcine collagen in a powder or foam (J. Urol. 2006;176:2367-74). It is applied directly to tissue, acting as a sponge to absorb blood. Pressure for several minutes is necessary for optimal hemostasis. Some surgeons moisten gelatins with topical thrombin prior to use, though no trials exist evaluating the efficacy of this maneuver.

Gelatin is absorbed in 4-6 weeks (J. Urol. 2006;176:2367-74) and can be passed through laparoscopic trocars. No studies have evaluated gelatins in gynecologic surgery so its applications are extrapolated from vascular and urologic surgery (J. Urol. 2006;176:2367-74).

Microporous polysaccharide spheres

Microporous polysaccharide spheres (Arista) form a polysaccharide powder made from potato starch. It absorbs water, concentrating platelets and other proteins to accelerate clot formation. It is applied to a dry surgical field and followed with gentle pressure. MPS is absorbed in 48 hours. No studies specifically evaluate the use of MPS in gynecologic surgery.

Topical thrombins

Thrombin (Thrombin-JMI, Evithrom, Recothrom) is derived from bovine, human, or recombinant sources. It converts fibrinogen to fibrin and activates factor XIII, platelets, and smooth muscle constriction (Biologics 2008;2:593-9). Thrombin is a spray or syringe, and is often used with gelatin foam (Thrombi-Gel) or matrix (FloSeal) (Biologics 2008;2:593-9). FloSeal use has been reported during ovarian cystectomy (J. Minim. Invasive. Gynecol. 2009;16:153-6), hysterotomy repair (J. Obstet. Gynaecol. 2012;32:34-5). During myomectomy, it was associated with decreased blood loss, transfusions, and shorter length of stay (Fertil. Steril. 2009;92:356-60).

Fibrin sealants

Fibrin sealants (Tisseel, TachoSil) are made of thrombin and concentrated fibrinogen from human plasma. They must be mixed prior to application and act by forming a fibrin clot. Tisseel can reduce hemorrhage after loop electrosurgical excision procedure (Gynecol. Obstet. Invest. 2012;74:1-5) and decreases operative time, time to hemostasis, and blood loss during laparoscopic myomectomy (Surg. Endosc. 2012;26:2046-53). Case reports describe the use of fibrin sealants in the management of obstetrical hemorrhage and hysterotomy repair.

Cost and complications

Hemostatic agents vary significantly in cost, but no comparative cost analyses exist. One study found that commercial insurance was associated with topical hemostatic agent use during gynecologic surgery (J. Surg. Res. 2014;186:458-66).

Use of ORC has been associated with postoperative abscess and imitation of abscess without true infection, and MC and gelatins can also increase infection risk. The dry hemostatic agents have been associated with thromboembolism. The complications of thrombins and fibrins are related to immune responses or transmission of pathogens. Recombinant thrombin is believed to be the safest option (J. Am. Coll. Surg. 2007;205:256-65). Floseal has been reported to cause diffuse pelvic inflammation and postoperative small bowel obstruction. Because of possible complications, it is important to use only the needed amount of product, and to dictate use in the operative note.

Despite widespread use of topical hemostatic agents in gynecologic surgery, studies are limited and these agents should be recommended only as adjuncts to conventional methods of achieving hemostasis.

Topical hemostatic agents are recommended for surgical fields that are less amenable to electrocautery, including denuded areas on peritoneal surfaces, and around important heat-sensitive structures such as nerves. The dry matrix agents (ORC, MC, gelatin, and MPS) are most useful in slowly bleeding areas or in patients with a bleeding diathesis. Thrombin and fibrin can be useful in situations when more significant bleeding is encountered. Complications arising from topical hemostatic agents are few.

Given current limited studies, the choice of product continues to depend on patient characteristics and surgeon preference.

Dr. Wysham is currently a fellow in the department of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Roque is a fellow in the gynecologic oncology program at UNC-Chapel Hill. Dr. Soper is a professor of gynecologic oncology at UNC-Chapel Hill.

Alpinia officinarum (and its close relative Alpinia galanga), a member of the Zingiberaceae family (Zhong Xi Yi Jie He Xue Bao 2011;9:1061-5), has long been used in Chinese medicinals (Bioorg. Med. Chem. 2009;17:6048-53). Specifically, the plant is used in traditional Chinese medicine as an aphrodisiac, abortifacient, carminative, antipyretic, anti-inflammatory, and emmenagogue as well as to treat disorders of the heart and kidneys, bronchitis, chronic enteritis, renal calculus, diabetes, and rheumatism (Zhong Xi Yi Jie He Xue Bao 2011;9:1061-5; Bioorg. Med. Chem. 2009;17:6048-53). Stomach ailments are the most typical application of the herb in traditional Chinese and Thai medicine; it is also used in Ayurveda and Sidda medicine. A. officinarum is widely cultivated throughout Asia, including China, Thailand, India, Sri Lanka, Malaysia, and Indonesia, as well as the Middle East and Northern Africa (Saudi Arabia and Egypt, respectively) (Zhong Xi Yi Jie He Xue Bao 2011;9:1061-5).

The flavonoid galangin (3,5,7-trihydroxyflavone) is the primary active constituent of A. officinarum (Phytother. Res. 2014;28:1533-8; J. Cell Biochem. 2013;114:152-61). In vitro, it has demonstrated a cytotoxic effect on multiple cancer cell lines (J. Cell Biochem. 2013;114[1]:152-61). Traditional Uighur medicine in China has incorporated galangin for the treatment of vitiligo (Phytother. Res. 2014;28:1533-8). Overall, A. officinarum rhizomes have been associated with antiemetic, antigenotoxic, antimutagenic, and antioxidant activity, as well as inhibitory effects on prostaglandin and leukotriene biosynthesis, and modulatory effects on cytochrome P450 enzymes (Bioorg. Med. Chem. 2009;17:6048-53; J. Cell Biochem. 2013;114:152-61). The rhizomes of A. officinarum have been used externally to treat skin infections, gum diseases, and skin cancer (J. Nat. Med. 2008;62:374-8).

Constituents

The rhizomes of the plant, commonly referred to as galangal, contain several key active constituents, including essential oils, tannins, neolignans, phenol, glycosides, monoterpenes, diarylheptanoids, phenylpropanoids, carbohydrates, gallic acid glycoside, galangoisoflavonoid, beta-sitosterol, galangin, alpinin, zerumbone, and kampferide (Zhong Xi Yi Jie He Xue Bao 2011;9:1061-5; Bioorg. Med. Chem. 2009;17:6048-53; J. Nat. Med. 2008;62:374-8).

In 2009, Matsuda et al. reported that the 80% aqueous acetone extract of the rhizomes of A. officinarum suppressed melanogenesis in theophylline-stimulated murine B16 melanoma 4A5 cells. They found that several isolated constituents had significant IC50 values (10-48 mcm) for inhibiting melanogenesis, including four diarylheptanoids (5-hydroxy-1,7-diphenyl-3-heptanone, 7-(4(‘’)-hydroxy-3(‘’)-methoxyphenyl)-1-phenylhept-4-en-3-one, 5-hydroxy-7-(4(‘’)-hydroxy-3(‘’)-methoxyphenyl)-1-phenyl-3-heptanone, and 3,5-dihydroxy-1,7-diphenylheptane) and two flavonol constituents (kaempferide and galangin). The mRNA expression of tyrosinase and tyrosinase-related proteins-1 and -2 was also hindered by 7-(4(‘’)-hydroxy-3(‘’)-methoxyphenyl)-1-phenylhept-4-en-3-one, kaempferide, and galangin, as was the protein level of a microphthalmia-associated transcription factor, the authors noted (Bioorg. Med. Chem. 2009;17:6048-53).

Biologic activity

Penetration enhancement: In 2000, Shen et al. found that volatile oils from galangal, among other herbs, were effective in enhancing the skin permeation of 5-fluorouracil and notably more effective than azone (Zhong Yao Cai 2000;23:697-9).

Anti-inflammatory effects: In 2008, Yasukawa et al. examined the inhibitory effect of galangal in a two-stage in vivo carcinogenesis model in mice. They observed that the A. officinarum rhizomes displayed significant antitumor-promoting activity against 7,12-dimethylbenz[a]anthracene (DMBA)-initiated and 12-O-tetradecanoylphorbol-13-acetate (TPA)–promoted lesions. Seven diarylheptanoids isolated from the active fraction of the methanol extracts demonstrated significant anti-inflammatory effects against TPA-induced inflammation (J. Nat. Med. 2008;62:374-8).

Cancer prevention and pigmentary effects: Heo et al. reported in 2001 that in vitro and in vivo studies have demonstrated that the flavonoid galangin, found in high concentrations in A. officinarum, as well as the bee product propolis, exhibits significant antioxidant activity and can influence enzyme activities and inhibit genotoxicity without introducing a pro-oxidant effect. They concluded that galangin warrants consideration for its potential as a chemical cancer-preventing agent (Mutat. Res. 2001;488:135-50).

In 2007, Lu et al. investigated the whitening effects of the flavonoid components of A. officinarum on melanin biosynthesis in B16 mouse melanoma cells, tyrosinase inhibition, and UV absorption. They found that galangin and the flavonoid mixture both decreased melanin content more than controls and also lowered melanin production, with galangin more effective than the flavonoid mixture. In addition, galangin and the flavonoid mixture exerted greater tyrosinase inhibition at lower concentrations. The A. officinarum constituents also displayed a broad absorption band in the UVB area (270 to 290 nm). The researchers concluded that galangin may be a viable whitening agent with the potential to prevent skin cancer (J. Enzyme Inhib. Med. Chem. 2007;22:433-8).

Six years later, Zhang et al. noted that various doses of galangin resulted in the inhibition of B16F10 melanoma cell proliferation. The investigators also showed that galangin achieved an antimetastatic effect in vivo in C57BL/6J mice, reducing focal adhesion kinase. They concluded that focal adhesion kinase is a viable target in melanoma therapy, with B16F10 melanoma metastasis apparently checked by galangin in mice and in cell cultures (J. Cell Biochem. 2013;114:152-61).

In 2014, Huo et al. tested galangin in a mouse model of vitiligo induced in C57BL/6 mice through the daily topical application of hydroquinone (2.5%) on shaved dorsal skin for 60 days. Thirty days after the final hydroquinone application, investigators began oral administration of galangin for 30 days. Hair grew back after treatment darker than the original color, with histologic analysis revealing that mice treated with galangin and the positive control 8-methoxypsoralen had an increased number of melanin-containing hair follicles, compared with untreated animals. In addition, galangin treatment was associated with significant increases in the number of cutaneous basal layer melanocytes and melanin-containing epidermal cells. Compared with controls, treatment with galangin and 8-methoxypsoralen led to increased serum levels of tyrosinase and decreased levels of malondialdehyde and lower cholinesterase activity. Galangin and 8-methoxypsoralen use also increased the expression of tyrosinase protein in treated skin. The investigators concluded that galangin improved hydroquinone-induced vitiligo in mice and warrants further study as a potential vitiligo treatment in humans (Phytother. Res. 2014 28:1533-8).

Conclusion

Alpinia officinarum is one of many botanical agents with a long history of applications in traditional folk medicine, particularly in Asia. There is a relative paucity of evidence regarding the dermatologic applications of this plant, but recent findings support continued research into its various potential cutaneous benefits, with particular focus on the main active ingredient galangin.

Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). She has contributed to the Cosmeceutical Critique column in Dermatology News since January 2001. Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy,Topix Pharmaceuticals, and Unilever.

Alpinia officinarum (and its close relative Alpinia galanga), a member of the Zingiberaceae family (Zhong Xi Yi Jie He Xue Bao 2011;9:1061-5), has long been used in Chinese medicinals (Bioorg. Med. Chem. 2009;17:6048-53). Specifically, the plant is used in traditional Chinese medicine as an aphrodisiac, abortifacient, carminative, antipyretic, anti-inflammatory, and emmenagogue as well as to treat disorders of the heart and kidneys, bronchitis, chronic enteritis, renal calculus, diabetes, and rheumatism (Zhong Xi Yi Jie He Xue Bao 2011;9:1061-5; Bioorg. Med. Chem. 2009;17:6048-53). Stomach ailments are the most typical application of the herb in traditional Chinese and Thai medicine; it is also used in Ayurveda and Sidda medicine. A. officinarum is widely cultivated throughout Asia, including China, Thailand, India, Sri Lanka, Malaysia, and Indonesia, as well as the Middle East and Northern Africa (Saudi Arabia and Egypt, respectively) (Zhong Xi Yi Jie He Xue Bao 2011;9:1061-5).

The flavonoid galangin (3,5,7-trihydroxyflavone) is the primary active constituent of A. officinarum (Phytother. Res. 2014;28:1533-8; J. Cell Biochem. 2013;114:152-61). In vitro, it has demonstrated a cytotoxic effect on multiple cancer cell lines (J. Cell Biochem. 2013;114[1]:152-61). Traditional Uighur medicine in China has incorporated galangin for the treatment of vitiligo (Phytother. Res. 2014;28:1533-8). Overall, A. officinarum rhizomes have been associated with antiemetic, antigenotoxic, antimutagenic, and antioxidant activity, as well as inhibitory effects on prostaglandin and leukotriene biosynthesis, and modulatory effects on cytochrome P450 enzymes (Bioorg. Med. Chem. 2009;17:6048-53; J. Cell Biochem. 2013;114:152-61). The rhizomes of A. officinarum have been used externally to treat skin infections, gum diseases, and skin cancer (J. Nat. Med. 2008;62:374-8).

Constituents

The rhizomes of the plant, commonly referred to as galangal, contain several key active constituents, including essential oils, tannins, neolignans, phenol, glycosides, monoterpenes, diarylheptanoids, phenylpropanoids, carbohydrates, gallic acid glycoside, galangoisoflavonoid, beta-sitosterol, galangin, alpinin, zerumbone, and kampferide (Zhong Xi Yi Jie He Xue Bao 2011;9:1061-5; Bioorg. Med. Chem. 2009;17:6048-53; J. Nat. Med. 2008;62:374-8).

In 2009, Matsuda et al. reported that the 80% aqueous acetone extract of the rhizomes of A. officinarum suppressed melanogenesis in theophylline-stimulated murine B16 melanoma 4A5 cells. They found that several isolated constituents had significant IC50 values (10-48 mcm) for inhibiting melanogenesis, including four diarylheptanoids (5-hydroxy-1,7-diphenyl-3-heptanone, 7-(4(‘’)-hydroxy-3(‘’)-methoxyphenyl)-1-phenylhept-4-en-3-one, 5-hydroxy-7-(4(‘’)-hydroxy-3(‘’)-methoxyphenyl)-1-phenyl-3-heptanone, and 3,5-dihydroxy-1,7-diphenylheptane) and two flavonol constituents (kaempferide and galangin). The mRNA expression of tyrosinase and tyrosinase-related proteins-1 and -2 was also hindered by 7-(4(‘’)-hydroxy-3(‘’)-methoxyphenyl)-1-phenylhept-4-en-3-one, kaempferide, and galangin, as was the protein level of a microphthalmia-associated transcription factor, the authors noted (Bioorg. Med. Chem. 2009;17:6048-53).

Biologic activity

Penetration enhancement: In 2000, Shen et al. found that volatile oils from galangal, among other herbs, were effective in enhancing the skin permeation of 5-fluorouracil and notably more effective than azone (Zhong Yao Cai 2000;23:697-9).

Anti-inflammatory effects: In 2008, Yasukawa et al. examined the inhibitory effect of galangal in a two-stage in vivo carcinogenesis model in mice. They observed that the A. officinarum rhizomes displayed significant antitumor-promoting activity against 7,12-dimethylbenz[a]anthracene (DMBA)-initiated and 12-O-tetradecanoylphorbol-13-acetate (TPA)–promoted lesions. Seven diarylheptanoids isolated from the active fraction of the methanol extracts demonstrated significant anti-inflammatory effects against TPA-induced inflammation (J. Nat. Med. 2008;62:374-8).

Cancer prevention and pigmentary effects: Heo et al. reported in 2001 that in vitro and in vivo studies have demonstrated that the flavonoid galangin, found in high concentrations in A. officinarum, as well as the bee product propolis, exhibits significant antioxidant activity and can influence enzyme activities and inhibit genotoxicity without introducing a pro-oxidant effect. They concluded that galangin warrants consideration for its potential as a chemical cancer-preventing agent (Mutat. Res. 2001;488:135-50).

In 2007, Lu et al. investigated the whitening effects of the flavonoid components of A. officinarum on melanin biosynthesis in B16 mouse melanoma cells, tyrosinase inhibition, and UV absorption. They found that galangin and the flavonoid mixture both decreased melanin content more than controls and also lowered melanin production, with galangin more effective than the flavonoid mixture. In addition, galangin and the flavonoid mixture exerted greater tyrosinase inhibition at lower concentrations. The A. officinarum constituents also displayed a broad absorption band in the UVB area (270 to 290 nm). The researchers concluded that galangin may be a viable whitening agent with the potential to prevent skin cancer (J. Enzyme Inhib. Med. Chem. 2007;22:433-8).

Six years later, Zhang et al. noted that various doses of galangin resulted in the inhibition of B16F10 melanoma cell proliferation. The investigators also showed that galangin achieved an antimetastatic effect in vivo in C57BL/6J mice, reducing focal adhesion kinase. They concluded that focal adhesion kinase is a viable target in melanoma therapy, with B16F10 melanoma metastasis apparently checked by galangin in mice and in cell cultures (J. Cell Biochem. 2013;114:152-61).

In 2014, Huo et al. tested galangin in a mouse model of vitiligo induced in C57BL/6 mice through the daily topical application of hydroquinone (2.5%) on shaved dorsal skin for 60 days. Thirty days after the final hydroquinone application, investigators began oral administration of galangin for 30 days. Hair grew back after treatment darker than the original color, with histologic analysis revealing that mice treated with galangin and the positive control 8-methoxypsoralen had an increased number of melanin-containing hair follicles, compared with untreated animals. In addition, galangin treatment was associated with significant increases in the number of cutaneous basal layer melanocytes and melanin-containing epidermal cells. Compared with controls, treatment with galangin and 8-methoxypsoralen led to increased serum levels of tyrosinase and decreased levels of malondialdehyde and lower cholinesterase activity. Galangin and 8-methoxypsoralen use also increased the expression of tyrosinase protein in treated skin. The investigators concluded that galangin improved hydroquinone-induced vitiligo in mice and warrants further study as a potential vitiligo treatment in humans (Phytother. Res. 2014 28:1533-8).

Conclusion

Alpinia officinarum is one of many botanical agents with a long history of applications in traditional folk medicine, particularly in Asia. There is a relative paucity of evidence regarding the dermatologic applications of this plant, but recent findings support continued research into its various potential cutaneous benefits, with particular focus on the main active ingredient galangin.

Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). She has contributed to the Cosmeceutical Critique column in Dermatology News since January 2001. Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy,Topix Pharmaceuticals, and Unilever.

Alpinia officinarum (and its close relative Alpinia galanga), a member of the Zingiberaceae family (Zhong Xi Yi Jie He Xue Bao 2011;9:1061-5), has long been used in Chinese medicinals (Bioorg. Med. Chem. 2009;17:6048-53). Specifically, the plant is used in traditional Chinese medicine as an aphrodisiac, abortifacient, carminative, antipyretic, anti-inflammatory, and emmenagogue as well as to treat disorders of the heart and kidneys, bronchitis, chronic enteritis, renal calculus, diabetes, and rheumatism (Zhong Xi Yi Jie He Xue Bao 2011;9:1061-5; Bioorg. Med. Chem. 2009;17:6048-53). Stomach ailments are the most typical application of the herb in traditional Chinese and Thai medicine; it is also used in Ayurveda and Sidda medicine. A. officinarum is widely cultivated throughout Asia, including China, Thailand, India, Sri Lanka, Malaysia, and Indonesia, as well as the Middle East and Northern Africa (Saudi Arabia and Egypt, respectively) (Zhong Xi Yi Jie He Xue Bao 2011;9:1061-5).

The flavonoid galangin (3,5,7-trihydroxyflavone) is the primary active constituent of A. officinarum (Phytother. Res. 2014;28:1533-8; J. Cell Biochem. 2013;114:152-61). In vitro, it has demonstrated a cytotoxic effect on multiple cancer cell lines (J. Cell Biochem. 2013;114[1]:152-61). Traditional Uighur medicine in China has incorporated galangin for the treatment of vitiligo (Phytother. Res. 2014;28:1533-8). Overall, A. officinarum rhizomes have been associated with antiemetic, antigenotoxic, antimutagenic, and antioxidant activity, as well as inhibitory effects on prostaglandin and leukotriene biosynthesis, and modulatory effects on cytochrome P450 enzymes (Bioorg. Med. Chem. 2009;17:6048-53; J. Cell Biochem. 2013;114:152-61). The rhizomes of A. officinarum have been used externally to treat skin infections, gum diseases, and skin cancer (J. Nat. Med. 2008;62:374-8).

Constituents

The rhizomes of the plant, commonly referred to as galangal, contain several key active constituents, including essential oils, tannins, neolignans, phenol, glycosides, monoterpenes, diarylheptanoids, phenylpropanoids, carbohydrates, gallic acid glycoside, galangoisoflavonoid, beta-sitosterol, galangin, alpinin, zerumbone, and kampferide (Zhong Xi Yi Jie He Xue Bao 2011;9:1061-5; Bioorg. Med. Chem. 2009;17:6048-53; J. Nat. Med. 2008;62:374-8).

In 2009, Matsuda et al. reported that the 80% aqueous acetone extract of the rhizomes of A. officinarum suppressed melanogenesis in theophylline-stimulated murine B16 melanoma 4A5 cells. They found that several isolated constituents had significant IC50 values (10-48 mcm) for inhibiting melanogenesis, including four diarylheptanoids (5-hydroxy-1,7-diphenyl-3-heptanone, 7-(4(‘’)-hydroxy-3(‘’)-methoxyphenyl)-1-phenylhept-4-en-3-one, 5-hydroxy-7-(4(‘’)-hydroxy-3(‘’)-methoxyphenyl)-1-phenyl-3-heptanone, and 3,5-dihydroxy-1,7-diphenylheptane) and two flavonol constituents (kaempferide and galangin). The mRNA expression of tyrosinase and tyrosinase-related proteins-1 and -2 was also hindered by 7-(4(‘’)-hydroxy-3(‘’)-methoxyphenyl)-1-phenylhept-4-en-3-one, kaempferide, and galangin, as was the protein level of a microphthalmia-associated transcription factor, the authors noted (Bioorg. Med. Chem. 2009;17:6048-53).

Biologic activity

Penetration enhancement: In 2000, Shen et al. found that volatile oils from galangal, among other herbs, were effective in enhancing the skin permeation of 5-fluorouracil and notably more effective than azone (Zhong Yao Cai 2000;23:697-9).

Anti-inflammatory effects: In 2008, Yasukawa et al. examined the inhibitory effect of galangal in a two-stage in vivo carcinogenesis model in mice. They observed that the A. officinarum rhizomes displayed significant antitumor-promoting activity against 7,12-dimethylbenz[a]anthracene (DMBA)-initiated and 12-O-tetradecanoylphorbol-13-acetate (TPA)–promoted lesions. Seven diarylheptanoids isolated from the active fraction of the methanol extracts demonstrated significant anti-inflammatory effects against TPA-induced inflammation (J. Nat. Med. 2008;62:374-8).

Cancer prevention and pigmentary effects: Heo et al. reported in 2001 that in vitro and in vivo studies have demonstrated that the flavonoid galangin, found in high concentrations in A. officinarum, as well as the bee product propolis, exhibits significant antioxidant activity and can influence enzyme activities and inhibit genotoxicity without introducing a pro-oxidant effect. They concluded that galangin warrants consideration for its potential as a chemical cancer-preventing agent (Mutat. Res. 2001;488:135-50).

In 2007, Lu et al. investigated the whitening effects of the flavonoid components of A. officinarum on melanin biosynthesis in B16 mouse melanoma cells, tyrosinase inhibition, and UV absorption. They found that galangin and the flavonoid mixture both decreased melanin content more than controls and also lowered melanin production, with galangin more effective than the flavonoid mixture. In addition, galangin and the flavonoid mixture exerted greater tyrosinase inhibition at lower concentrations. The A. officinarum constituents also displayed a broad absorption band in the UVB area (270 to 290 nm). The researchers concluded that galangin may be a viable whitening agent with the potential to prevent skin cancer (J. Enzyme Inhib. Med. Chem. 2007;22:433-8).

Six years later, Zhang et al. noted that various doses of galangin resulted in the inhibition of B16F10 melanoma cell proliferation. The investigators also showed that galangin achieved an antimetastatic effect in vivo in C57BL/6J mice, reducing focal adhesion kinase. They concluded that focal adhesion kinase is a viable target in melanoma therapy, with B16F10 melanoma metastasis apparently checked by galangin in mice and in cell cultures (J. Cell Biochem. 2013;114:152-61).

In 2014, Huo et al. tested galangin in a mouse model of vitiligo induced in C57BL/6 mice through the daily topical application of hydroquinone (2.5%) on shaved dorsal skin for 60 days. Thirty days after the final hydroquinone application, investigators began oral administration of galangin for 30 days. Hair grew back after treatment darker than the original color, with histologic analysis revealing that mice treated with galangin and the positive control 8-methoxypsoralen had an increased number of melanin-containing hair follicles, compared with untreated animals. In addition, galangin treatment was associated with significant increases in the number of cutaneous basal layer melanocytes and melanin-containing epidermal cells. Compared with controls, treatment with galangin and 8-methoxypsoralen led to increased serum levels of tyrosinase and decreased levels of malondialdehyde and lower cholinesterase activity. Galangin and 8-methoxypsoralen use also increased the expression of tyrosinase protein in treated skin. The investigators concluded that galangin improved hydroquinone-induced vitiligo in mice and warrants further study as a potential vitiligo treatment in humans (Phytother. Res. 2014 28:1533-8).

Conclusion

Alpinia officinarum is one of many botanical agents with a long history of applications in traditional folk medicine, particularly in Asia. There is a relative paucity of evidence regarding the dermatologic applications of this plant, but recent findings support continued research into its various potential cutaneous benefits, with particular focus on the main active ingredient galangin.

Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). She has contributed to the Cosmeceutical Critique column in Dermatology News since January 2001. Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy,Topix Pharmaceuticals, and Unilever.

The field of body contouring and tissue tightening has expanded over the years, with many new devices appearing on the market that utilize radiofrequency (RF) energy to tighten and rejuvenate the skin. What originally began with a single monopolar RF device has progressed to a world in which there are skin-tightening devices that use bipolar energy and tripolar energy, as well as monopolar, and newer machines that boast five and eight poles of RF energy.

In addition to in-office radiofrequency devices, at-home devices are now available.

Radiofrequency energy uses the tissue’s resistance within the various layers of the skin to transform the RF energy given to the skin into thermal energy. This process induces collagen remodeling and neocollagenesis, resulting in skin tightening. Since RF energy produces an electrical current instead of a light source like lasers, tissue damage can be minimized, and epidermal melanin is not targeted or typically damaged. Therefore, RF energies can be used for patients of all skin types and colors. Adverse events to RF therapy in general may include pain, erythema, swelling, and rare reports of burns or fat atrophy with first-generation devices.

Many at-home devices delivering RF energy have been developed and are now on the market for skin tightening and rejuvenation. These devices range in cost from about $30 to more than $1,000, and are marketed for skin tightening as well as body contouring. Most machines require multiple uses, daily or weekly, to achieve desired results, compared with in-office devices that are typically used once, or not more than once every 6 months. A recent study published in the Journal of Drugs in Dermatology of a newer at-home device that uses phase-controlled multisource radiofrequency technology found statistically significant improvement using a Fitzpatrick wrinkle and elastosis scale of 62 patients when pre- and post-photographs of 62 patients were evaluated by three independent board-certified dermatologists.

At-home devices do not deliver energies as high as in-office devices, and no head-to-head studies comparing in-office versus at-home RF devices are currently available. As even in-office radiofrequency device results can be subtle, or occur over 6 months, patient expectations should be managed, and clinicians should be realistic when counseling patients about the use of these devices. Patient selection is key for successful therapy. If skin laxity is severe enough that the patient warrants a face lift or surgical correction to achieve the desired results, then they may not be the best candidate for RF therapy alone.

Dr. Talakoub and Dr. Wesley are co-contributors to a monthly Aesthetic Dermatology column in Skin & Allergy News. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Wesley.

The field of body contouring and tissue tightening has expanded over the years, with many new devices appearing on the market that utilize radiofrequency (RF) energy to tighten and rejuvenate the skin. What originally began with a single monopolar RF device has progressed to a world in which there are skin-tightening devices that use bipolar energy and tripolar energy, as well as monopolar, and newer machines that boast five and eight poles of RF energy.

In addition to in-office radiofrequency devices, at-home devices are now available.

Radiofrequency energy uses the tissue’s resistance within the various layers of the skin to transform the RF energy given to the skin into thermal energy. This process induces collagen remodeling and neocollagenesis, resulting in skin tightening. Since RF energy produces an electrical current instead of a light source like lasers, tissue damage can be minimized, and epidermal melanin is not targeted or typically damaged. Therefore, RF energies can be used for patients of all skin types and colors. Adverse events to RF therapy in general may include pain, erythema, swelling, and rare reports of burns or fat atrophy with first-generation devices.

Many at-home devices delivering RF energy have been developed and are now on the market for skin tightening and rejuvenation. These devices range in cost from about $30 to more than $1,000, and are marketed for skin tightening as well as body contouring. Most machines require multiple uses, daily or weekly, to achieve desired results, compared with in-office devices that are typically used once, or not more than once every 6 months. A recent study published in the Journal of Drugs in Dermatology of a newer at-home device that uses phase-controlled multisource radiofrequency technology found statistically significant improvement using a Fitzpatrick wrinkle and elastosis scale of 62 patients when pre- and post-photographs of 62 patients were evaluated by three independent board-certified dermatologists.

At-home devices do not deliver energies as high as in-office devices, and no head-to-head studies comparing in-office versus at-home RF devices are currently available. As even in-office radiofrequency device results can be subtle, or occur over 6 months, patient expectations should be managed, and clinicians should be realistic when counseling patients about the use of these devices. Patient selection is key for successful therapy. If skin laxity is severe enough that the patient warrants a face lift or surgical correction to achieve the desired results, then they may not be the best candidate for RF therapy alone.

Dr. Talakoub and Dr. Wesley are co-contributors to a monthly Aesthetic Dermatology column in Skin & Allergy News. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Wesley.

The field of body contouring and tissue tightening has expanded over the years, with many new devices appearing on the market that utilize radiofrequency (RF) energy to tighten and rejuvenate the skin. What originally began with a single monopolar RF device has progressed to a world in which there are skin-tightening devices that use bipolar energy and tripolar energy, as well as monopolar, and newer machines that boast five and eight poles of RF energy.

In addition to in-office radiofrequency devices, at-home devices are now available.

Radiofrequency energy uses the tissue’s resistance within the various layers of the skin to transform the RF energy given to the skin into thermal energy. This process induces collagen remodeling and neocollagenesis, resulting in skin tightening. Since RF energy produces an electrical current instead of a light source like lasers, tissue damage can be minimized, and epidermal melanin is not targeted or typically damaged. Therefore, RF energies can be used for patients of all skin types and colors. Adverse events to RF therapy in general may include pain, erythema, swelling, and rare reports of burns or fat atrophy with first-generation devices.

Many at-home devices delivering RF energy have been developed and are now on the market for skin tightening and rejuvenation. These devices range in cost from about $30 to more than $1,000, and are marketed for skin tightening as well as body contouring. Most machines require multiple uses, daily or weekly, to achieve desired results, compared with in-office devices that are typically used once, or not more than once every 6 months. A recent study published in the Journal of Drugs in Dermatology of a newer at-home device that uses phase-controlled multisource radiofrequency technology found statistically significant improvement using a Fitzpatrick wrinkle and elastosis scale of 62 patients when pre- and post-photographs of 62 patients were evaluated by three independent board-certified dermatologists.

At-home devices do not deliver energies as high as in-office devices, and no head-to-head studies comparing in-office versus at-home RF devices are currently available. As even in-office radiofrequency device results can be subtle, or occur over 6 months, patient expectations should be managed, and clinicians should be realistic when counseling patients about the use of these devices. Patient selection is key for successful therapy. If skin laxity is severe enough that the patient warrants a face lift or surgical correction to achieve the desired results, then they may not be the best candidate for RF therapy alone.

Dr. Talakoub and Dr. Wesley are co-contributors to a monthly Aesthetic Dermatology column in Skin & Allergy News. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Wesley.