Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.

Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.

Catalin205/Thinkstock

In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.

Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.

Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.

The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.

All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.

Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.

“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.

The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.

“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.

The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.

The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.

The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.

Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.

Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.

Catalin205/Thinkstock

In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.

Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.

Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.

The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.

All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.

Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.

“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.

The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.

“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.

The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.

The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.

The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.

Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.

Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.

Catalin205/Thinkstock

In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.

Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.

Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.

The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.

All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.

Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.

“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.

The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.

“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.

The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.

The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.

The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.

For some parents, resuming sexual intimacy after having a baby is a top priority. For others, not so much – and late-night feedings and diaper changes may not be the only hang-ups.

Dyspareunia – pain during sex – occurs in a substantial number of women after childbirth, and recent research sheds light on how psychological and biomedical factors relate to this condition.

Mode of delivery, for instance, may have less of an effect on sexual well-being than some people suspect.

Despite a perception that cesarean delivery might affect sexual function less than vaginal delivery does, how mothers delivered did not affect how often they had sex postpartum or the amount of enjoyment they got from it, according to research published in BJOG.

Eleven years after delivery, however, cesarean delivery was associated with a 74% increased likelihood of pain in the vagina during sex, compared with vaginal delivery, the researchers found (odds ratio, 1.74; 95% confidence interval, 1.46-2.08).

The results suggest that cesarean delivery “may not help protect against sexual dysfunction, as previously thought,” Flo Martin, a PhD student in epidemiology at the University of Bristol, United Kingdom, and lead author of the study, said in a news release.

For their study, Ms. Martin and her colleagues analyzed data from more than 10,300 participants in the Avon Longitudinal Study of Parents and Children, which recruited women in the United Kingdom who were pregnant in 1991 and 1992.

The researchers had data about pain during sex at 11 years. They had data about sexual enjoyment and frequency at 33  months, 5 years, 12 years, and 18 years after delivery.

If women experienced pain during sex years after cesarean delivery, uterine scarring might have been a cause, Ms. Martin and colleagues suggested. Alternatively, women with dyspareunia before delivery may be more likely to have cesarean surgery, which also could explain the association.

Other studies have likewise found that different modes of delivery generally lead to similar outcomes of sexual well-being after birth.

“Several of my own longitudinal studies have shown limited associations between mode of delivery and various aspects of sexual well-being, including sexual satisfaction, sexual function, and sexual desire,” said Natalie O. Rosen, PhD, director of the Couples and Sexual Health Laboratory at Dalhousie University, Halifax, N.S.

Nevertheless, other published studies have yielded conflicting results, so the question warrants further study, she said.
 

Pain catastrophizing

One study by Dr. Rosen’s group, published in Obstetrics & Gynecology, tracked sexual pain in 582 people from mid-pregnancy to 2 years postpartum.

About 21% of participants experienced moderate pain during sex, as determined by an average pain score greater than 4 on scale of 0-10 points. The rest were classified as having “minimal dyspareunia.”

Pain tended to peak at 3 months postpartum and then steadily decrease in both the moderate and minimal pain groups.

Mode of delivery did not affect the odds that a participant would have moderate dyspareunia. Neither did breastfeeding or prior chronic pain.

“But we did find one key thing to look out for: Those who reported a lot of negative thoughts and feelings about pain, something called pain catastrophizing, were more likely to experience moderate persistent pain during sex,” the researchers said in a video about their findings.

Pain catastrophizing 3 months after delivery was associated with significantly increased odds of following a moderate pain trajectory (odds ratio, 1.09; 95% confidence interval, 1.04-1.15).
 

Let’s talk about #postbabyhankypanky

Caring for a newborn while maintaining a romantic relationship can be challenging, and “there is a lack of evidence-based research aimed at helping couples prevent and navigate changes to their sexual well-being postpartum,” Dr. Rosen said.

During the 2-year study, a growing number of participants reported having sex less often over time. The percentage of women who had engaged in sexual activity in the past 4 weeks was 99% at baseline (20-24 weeks of gestation), 83.5% at 32 weeks of gestation, 73.9% at 3 months postpartum, and 69.6% at 2 years postpartum.

“One crucial way that couples sustain their connection is through their sexuality,” Dr. Rosen said. “Unfortunately, most new parents experience significant disruptions to their sexual function,” such as lower sexual desire or more pain during intercourse.

Dr. Rosen’s group has created a series of videos related to this topic dubbed #postbabyhankypanky to facilitate communication about sex postpartum. She encourages women with dyspareunia to talk with a health care provider because treatments such as cognitive-behavioral therapy, pelvic floor physical therapy, and topical medications can help manage pain.
 

‘Reassuring’ data

Veronica Gillispie-Bell, MD, MAS, director of quality for women’s services at the Ochsner Health System, New Orleans, said that she sees patients with postpartum sexual pain frequently.

Patients typically are instructed to have pelvic rest from delivery until 6 weeks after.

At the 6-week appointment, she tells patients to make sure that they are using lots of lubrication, because vaginal dryness related to hormonal changes during pregnancy and breastfeeding can make sex more painful, regardless of mode of delivery.

For many patients, she also recommends pelvic floor physical therapy.

As the medical director for the Louisiana Perinatal Quality Collaborative – a network of care providers, public health officials, and advocates that aims to improve outcomes for birthing persons, families, and newborns – Dr. Gillispie-Bell also is focused on reducing the rate of cesarean deliveries in the state. The BJOG study showing an increased risk for dyspareunia after a cesarean surgery serves as a reminder that there may be “long-term effects of having a C-section that may not be as obvious,” she said.

“C-sections are life-saving procedures, but they are not without risk,” Dr. Gillispie-Bell said.

Leila Frodsham, MBChB, a spokesperson for the Royal College of Obstetricians and Gynaecologists, told Medscape UK that it was “reassuring” to see “no difference in sexual enjoyment or sexual frequency at any time point postpartum between women who gave birth via cesarean section and those who delivered vaginally.”

“Women should be supported to make informed decisions about how they plan to give birth, and it is vital that health care professionals respect their preferences,” Dr. Frodsham added.

Clinicians should also remain aware that sexual pain is also common during periods of subfertility, perimenopause, and initiation of sexual activity.

Combinations of biological, psychological, and social factors can influence pain during sex, and there is an interpersonal element to keep in mind as well, Dr. Rosen noted.

“Pain during sex is typically elicited in the context of a partnered relationship,” Dr. Rosen said. “This means that this is an inherently interpersonal issue – let’s not forget about the partner who is both impacted by and can impact the pain through their own responses.”

A version of this article first appeared on Medscape.com.

For some parents, resuming sexual intimacy after having a baby is a top priority. For others, not so much – and late-night feedings and diaper changes may not be the only hang-ups.

Dyspareunia – pain during sex – occurs in a substantial number of women after childbirth, and recent research sheds light on how psychological and biomedical factors relate to this condition.

Mode of delivery, for instance, may have less of an effect on sexual well-being than some people suspect.

Despite a perception that cesarean delivery might affect sexual function less than vaginal delivery does, how mothers delivered did not affect how often they had sex postpartum or the amount of enjoyment they got from it, according to research published in BJOG.

Eleven years after delivery, however, cesarean delivery was associated with a 74% increased likelihood of pain in the vagina during sex, compared with vaginal delivery, the researchers found (odds ratio, 1.74; 95% confidence interval, 1.46-2.08).

The results suggest that cesarean delivery “may not help protect against sexual dysfunction, as previously thought,” Flo Martin, a PhD student in epidemiology at the University of Bristol, United Kingdom, and lead author of the study, said in a news release.

For their study, Ms. Martin and her colleagues analyzed data from more than 10,300 participants in the Avon Longitudinal Study of Parents and Children, which recruited women in the United Kingdom who were pregnant in 1991 and 1992.

The researchers had data about pain during sex at 11 years. They had data about sexual enjoyment and frequency at 33  months, 5 years, 12 years, and 18 years after delivery.

If women experienced pain during sex years after cesarean delivery, uterine scarring might have been a cause, Ms. Martin and colleagues suggested. Alternatively, women with dyspareunia before delivery may be more likely to have cesarean surgery, which also could explain the association.

Other studies have likewise found that different modes of delivery generally lead to similar outcomes of sexual well-being after birth.

“Several of my own longitudinal studies have shown limited associations between mode of delivery and various aspects of sexual well-being, including sexual satisfaction, sexual function, and sexual desire,” said Natalie O. Rosen, PhD, director of the Couples and Sexual Health Laboratory at Dalhousie University, Halifax, N.S.

Nevertheless, other published studies have yielded conflicting results, so the question warrants further study, she said.
 

Pain catastrophizing

One study by Dr. Rosen’s group, published in Obstetrics & Gynecology, tracked sexual pain in 582 people from mid-pregnancy to 2 years postpartum.

About 21% of participants experienced moderate pain during sex, as determined by an average pain score greater than 4 on scale of 0-10 points. The rest were classified as having “minimal dyspareunia.”

Pain tended to peak at 3 months postpartum and then steadily decrease in both the moderate and minimal pain groups.

Mode of delivery did not affect the odds that a participant would have moderate dyspareunia. Neither did breastfeeding or prior chronic pain.

“But we did find one key thing to look out for: Those who reported a lot of negative thoughts and feelings about pain, something called pain catastrophizing, were more likely to experience moderate persistent pain during sex,” the researchers said in a video about their findings.

Pain catastrophizing 3 months after delivery was associated with significantly increased odds of following a moderate pain trajectory (odds ratio, 1.09; 95% confidence interval, 1.04-1.15).
 

Let’s talk about #postbabyhankypanky

Caring for a newborn while maintaining a romantic relationship can be challenging, and “there is a lack of evidence-based research aimed at helping couples prevent and navigate changes to their sexual well-being postpartum,” Dr. Rosen said.

During the 2-year study, a growing number of participants reported having sex less often over time. The percentage of women who had engaged in sexual activity in the past 4 weeks was 99% at baseline (20-24 weeks of gestation), 83.5% at 32 weeks of gestation, 73.9% at 3 months postpartum, and 69.6% at 2 years postpartum.

“One crucial way that couples sustain their connection is through their sexuality,” Dr. Rosen said. “Unfortunately, most new parents experience significant disruptions to their sexual function,” such as lower sexual desire or more pain during intercourse.

Dr. Rosen’s group has created a series of videos related to this topic dubbed #postbabyhankypanky to facilitate communication about sex postpartum. She encourages women with dyspareunia to talk with a health care provider because treatments such as cognitive-behavioral therapy, pelvic floor physical therapy, and topical medications can help manage pain.
 

‘Reassuring’ data

Veronica Gillispie-Bell, MD, MAS, director of quality for women’s services at the Ochsner Health System, New Orleans, said that she sees patients with postpartum sexual pain frequently.

Patients typically are instructed to have pelvic rest from delivery until 6 weeks after.

At the 6-week appointment, she tells patients to make sure that they are using lots of lubrication, because vaginal dryness related to hormonal changes during pregnancy and breastfeeding can make sex more painful, regardless of mode of delivery.

For many patients, she also recommends pelvic floor physical therapy.

As the medical director for the Louisiana Perinatal Quality Collaborative – a network of care providers, public health officials, and advocates that aims to improve outcomes for birthing persons, families, and newborns – Dr. Gillispie-Bell also is focused on reducing the rate of cesarean deliveries in the state. The BJOG study showing an increased risk for dyspareunia after a cesarean surgery serves as a reminder that there may be “long-term effects of having a C-section that may not be as obvious,” she said.

“C-sections are life-saving procedures, but they are not without risk,” Dr. Gillispie-Bell said.

Leila Frodsham, MBChB, a spokesperson for the Royal College of Obstetricians and Gynaecologists, told Medscape UK that it was “reassuring” to see “no difference in sexual enjoyment or sexual frequency at any time point postpartum between women who gave birth via cesarean section and those who delivered vaginally.”

“Women should be supported to make informed decisions about how they plan to give birth, and it is vital that health care professionals respect their preferences,” Dr. Frodsham added.

Clinicians should also remain aware that sexual pain is also common during periods of subfertility, perimenopause, and initiation of sexual activity.

Combinations of biological, psychological, and social factors can influence pain during sex, and there is an interpersonal element to keep in mind as well, Dr. Rosen noted.

“Pain during sex is typically elicited in the context of a partnered relationship,” Dr. Rosen said. “This means that this is an inherently interpersonal issue – let’s not forget about the partner who is both impacted by and can impact the pain through their own responses.”

A version of this article first appeared on Medscape.com.

For some parents, resuming sexual intimacy after having a baby is a top priority. For others, not so much – and late-night feedings and diaper changes may not be the only hang-ups.

Dyspareunia – pain during sex – occurs in a substantial number of women after childbirth, and recent research sheds light on how psychological and biomedical factors relate to this condition.

Mode of delivery, for instance, may have less of an effect on sexual well-being than some people suspect.

Despite a perception that cesarean delivery might affect sexual function less than vaginal delivery does, how mothers delivered did not affect how often they had sex postpartum or the amount of enjoyment they got from it, according to research published in BJOG.

Eleven years after delivery, however, cesarean delivery was associated with a 74% increased likelihood of pain in the vagina during sex, compared with vaginal delivery, the researchers found (odds ratio, 1.74; 95% confidence interval, 1.46-2.08).

The results suggest that cesarean delivery “may not help protect against sexual dysfunction, as previously thought,” Flo Martin, a PhD student in epidemiology at the University of Bristol, United Kingdom, and lead author of the study, said in a news release.

For their study, Ms. Martin and her colleagues analyzed data from more than 10,300 participants in the Avon Longitudinal Study of Parents and Children, which recruited women in the United Kingdom who were pregnant in 1991 and 1992.

The researchers had data about pain during sex at 11 years. They had data about sexual enjoyment and frequency at 33  months, 5 years, 12 years, and 18 years after delivery.

If women experienced pain during sex years after cesarean delivery, uterine scarring might have been a cause, Ms. Martin and colleagues suggested. Alternatively, women with dyspareunia before delivery may be more likely to have cesarean surgery, which also could explain the association.

Other studies have likewise found that different modes of delivery generally lead to similar outcomes of sexual well-being after birth.

“Several of my own longitudinal studies have shown limited associations between mode of delivery and various aspects of sexual well-being, including sexual satisfaction, sexual function, and sexual desire,” said Natalie O. Rosen, PhD, director of the Couples and Sexual Health Laboratory at Dalhousie University, Halifax, N.S.

Nevertheless, other published studies have yielded conflicting results, so the question warrants further study, she said.
 

Pain catastrophizing

One study by Dr. Rosen’s group, published in Obstetrics & Gynecology, tracked sexual pain in 582 people from mid-pregnancy to 2 years postpartum.

About 21% of participants experienced moderate pain during sex, as determined by an average pain score greater than 4 on scale of 0-10 points. The rest were classified as having “minimal dyspareunia.”

Pain tended to peak at 3 months postpartum and then steadily decrease in both the moderate and minimal pain groups.

Mode of delivery did not affect the odds that a participant would have moderate dyspareunia. Neither did breastfeeding or prior chronic pain.

“But we did find one key thing to look out for: Those who reported a lot of negative thoughts and feelings about pain, something called pain catastrophizing, were more likely to experience moderate persistent pain during sex,” the researchers said in a video about their findings.

Pain catastrophizing 3 months after delivery was associated with significantly increased odds of following a moderate pain trajectory (odds ratio, 1.09; 95% confidence interval, 1.04-1.15).
 

Let’s talk about #postbabyhankypanky

Caring for a newborn while maintaining a romantic relationship can be challenging, and “there is a lack of evidence-based research aimed at helping couples prevent and navigate changes to their sexual well-being postpartum,” Dr. Rosen said.

During the 2-year study, a growing number of participants reported having sex less often over time. The percentage of women who had engaged in sexual activity in the past 4 weeks was 99% at baseline (20-24 weeks of gestation), 83.5% at 32 weeks of gestation, 73.9% at 3 months postpartum, and 69.6% at 2 years postpartum.

“One crucial way that couples sustain their connection is through their sexuality,” Dr. Rosen said. “Unfortunately, most new parents experience significant disruptions to their sexual function,” such as lower sexual desire or more pain during intercourse.

Dr. Rosen’s group has created a series of videos related to this topic dubbed #postbabyhankypanky to facilitate communication about sex postpartum. She encourages women with dyspareunia to talk with a health care provider because treatments such as cognitive-behavioral therapy, pelvic floor physical therapy, and topical medications can help manage pain.
 

‘Reassuring’ data

Veronica Gillispie-Bell, MD, MAS, director of quality for women’s services at the Ochsner Health System, New Orleans, said that she sees patients with postpartum sexual pain frequently.

Patients typically are instructed to have pelvic rest from delivery until 6 weeks after.

At the 6-week appointment, she tells patients to make sure that they are using lots of lubrication, because vaginal dryness related to hormonal changes during pregnancy and breastfeeding can make sex more painful, regardless of mode of delivery.

For many patients, she also recommends pelvic floor physical therapy.

As the medical director for the Louisiana Perinatal Quality Collaborative – a network of care providers, public health officials, and advocates that aims to improve outcomes for birthing persons, families, and newborns – Dr. Gillispie-Bell also is focused on reducing the rate of cesarean deliveries in the state. The BJOG study showing an increased risk for dyspareunia after a cesarean surgery serves as a reminder that there may be “long-term effects of having a C-section that may not be as obvious,” she said.

“C-sections are life-saving procedures, but they are not without risk,” Dr. Gillispie-Bell said.

Leila Frodsham, MBChB, a spokesperson for the Royal College of Obstetricians and Gynaecologists, told Medscape UK that it was “reassuring” to see “no difference in sexual enjoyment or sexual frequency at any time point postpartum between women who gave birth via cesarean section and those who delivered vaginally.”

“Women should be supported to make informed decisions about how they plan to give birth, and it is vital that health care professionals respect their preferences,” Dr. Frodsham added.

Clinicians should also remain aware that sexual pain is also common during periods of subfertility, perimenopause, and initiation of sexual activity.

Combinations of biological, psychological, and social factors can influence pain during sex, and there is an interpersonal element to keep in mind as well, Dr. Rosen noted.

“Pain during sex is typically elicited in the context of a partnered relationship,” Dr. Rosen said. “This means that this is an inherently interpersonal issue – let’s not forget about the partner who is both impacted by and can impact the pain through their own responses.”

A version of this article first appeared on Medscape.com.

The American Academy of Sleep Medicine has issued a health advisory encouraging parents to talk to a health care professional before giving melatonin or any supplement to children.

“While melatonin can be useful in treating certain sleep-wake disorders, like jet lag, there is much less evidence it can help healthy children or adults fall asleep faster,” Muhammad Adeel Rishi, MD, MBBS, vice chair of the AASM public safety committee, said in a news release.
 

Spike in poisoning calls

Research previously published in JAMA suggests that the use of melatonin has increased over the past 2 decades among people of all ages.

With this increased use has come a spike in reports of melatonin overdose, calls to poison control centers, and related emergency department visits for children.

Federal data show that the number of U.S. children who unintentionally ingested melatonin supplements jumped 530% from 2012 to 2021.

More than 4,000 of the reported ingestions led to a hospital stay, and 287 children required intensive care.

The AASM notes that next to multivitamins, melatonin is the second most popular “natural” product parents give to their children.

Melatonin is widely available over the counter. It’s marketed as a sleep aid, but there is little evidence that taking it as a supplement is effective in treating insomnia in healthy children, the AASM cautions.

Because it is regulated by the U.S. Food and Drug Administration as a dietary supplement, melatonin receives less oversight. Research shows that the melatonin content in supplements can vary widely, the AASM points out.

In one study, amounts of melatonin ranged from less than one-half to more than four times the amounts stated on the labels. The greatest variability in melatonin content was in chewable tablets, which are most likely to be used for children.

“The availability of melatonin as gummies or chewable tablets makes it more tempting to give to children and more likely for them to overdose,” said Dr. Rishi, a pulmonology, sleep medicine, and critical care specialist at Indiana University Health Physicians, Indianapolis.

“Parents should talk directly with their child’s health care professional before giving their children melatonin products,” he added.
 

Keep out of reach

The AASM advises that melatonin be managed as any other medication and that it be kept out of reach of children.

Before giving melatonin or any supplement to their children, parents should discuss this decision with a pediatric health care professional.

If use of melatonin is warranted, health care professionals can recommend the appropriate dose and timing in addressing the sleep problem, and they can ensure that the melatonin product that is being used has a USP verified mark.

“Instead of turning to melatonin, parents should encourage children to develop good sleep habits, like setting a regular bedtime and wake time, having a bedtime routine, and limiting screen time as bedtime approaches,” Dr. Rishi said.

A version of this article first appeared on Medscape.com.

The American Academy of Sleep Medicine has issued a health advisory encouraging parents to talk to a health care professional before giving melatonin or any supplement to children.

“While melatonin can be useful in treating certain sleep-wake disorders, like jet lag, there is much less evidence it can help healthy children or adults fall asleep faster,” Muhammad Adeel Rishi, MD, MBBS, vice chair of the AASM public safety committee, said in a news release.
 

Spike in poisoning calls

Research previously published in JAMA suggests that the use of melatonin has increased over the past 2 decades among people of all ages.

With this increased use has come a spike in reports of melatonin overdose, calls to poison control centers, and related emergency department visits for children.

Federal data show that the number of U.S. children who unintentionally ingested melatonin supplements jumped 530% from 2012 to 2021.

More than 4,000 of the reported ingestions led to a hospital stay, and 287 children required intensive care.

The AASM notes that next to multivitamins, melatonin is the second most popular “natural” product parents give to their children.

Melatonin is widely available over the counter. It’s marketed as a sleep aid, but there is little evidence that taking it as a supplement is effective in treating insomnia in healthy children, the AASM cautions.

Because it is regulated by the U.S. Food and Drug Administration as a dietary supplement, melatonin receives less oversight. Research shows that the melatonin content in supplements can vary widely, the AASM points out.

In one study, amounts of melatonin ranged from less than one-half to more than four times the amounts stated on the labels. The greatest variability in melatonin content was in chewable tablets, which are most likely to be used for children.

“The availability of melatonin as gummies or chewable tablets makes it more tempting to give to children and more likely for them to overdose,” said Dr. Rishi, a pulmonology, sleep medicine, and critical care specialist at Indiana University Health Physicians, Indianapolis.

“Parents should talk directly with their child’s health care professional before giving their children melatonin products,” he added.
 

Keep out of reach

The AASM advises that melatonin be managed as any other medication and that it be kept out of reach of children.

Before giving melatonin or any supplement to their children, parents should discuss this decision with a pediatric health care professional.

If use of melatonin is warranted, health care professionals can recommend the appropriate dose and timing in addressing the sleep problem, and they can ensure that the melatonin product that is being used has a USP verified mark.

“Instead of turning to melatonin, parents should encourage children to develop good sleep habits, like setting a regular bedtime and wake time, having a bedtime routine, and limiting screen time as bedtime approaches,” Dr. Rishi said.

A version of this article first appeared on Medscape.com.

The American Academy of Sleep Medicine has issued a health advisory encouraging parents to talk to a health care professional before giving melatonin or any supplement to children.

“While melatonin can be useful in treating certain sleep-wake disorders, like jet lag, there is much less evidence it can help healthy children or adults fall asleep faster,” Muhammad Adeel Rishi, MD, MBBS, vice chair of the AASM public safety committee, said in a news release.
 

Spike in poisoning calls

Research previously published in JAMA suggests that the use of melatonin has increased over the past 2 decades among people of all ages.

With this increased use has come a spike in reports of melatonin overdose, calls to poison control centers, and related emergency department visits for children.

Federal data show that the number of U.S. children who unintentionally ingested melatonin supplements jumped 530% from 2012 to 2021.

More than 4,000 of the reported ingestions led to a hospital stay, and 287 children required intensive care.

The AASM notes that next to multivitamins, melatonin is the second most popular “natural” product parents give to their children.

Melatonin is widely available over the counter. It’s marketed as a sleep aid, but there is little evidence that taking it as a supplement is effective in treating insomnia in healthy children, the AASM cautions.

Because it is regulated by the U.S. Food and Drug Administration as a dietary supplement, melatonin receives less oversight. Research shows that the melatonin content in supplements can vary widely, the AASM points out.

In one study, amounts of melatonin ranged from less than one-half to more than four times the amounts stated on the labels. The greatest variability in melatonin content was in chewable tablets, which are most likely to be used for children.

“The availability of melatonin as gummies or chewable tablets makes it more tempting to give to children and more likely for them to overdose,” said Dr. Rishi, a pulmonology, sleep medicine, and critical care specialist at Indiana University Health Physicians, Indianapolis.

“Parents should talk directly with their child’s health care professional before giving their children melatonin products,” he added.
 

Keep out of reach

The AASM advises that melatonin be managed as any other medication and that it be kept out of reach of children.

Before giving melatonin or any supplement to their children, parents should discuss this decision with a pediatric health care professional.

If use of melatonin is warranted, health care professionals can recommend the appropriate dose and timing in addressing the sleep problem, and they can ensure that the melatonin product that is being used has a USP verified mark.

“Instead of turning to melatonin, parents should encourage children to develop good sleep habits, like setting a regular bedtime and wake time, having a bedtime routine, and limiting screen time as bedtime approaches,” Dr. Rishi said.

A version of this article first appeared on Medscape.com.

Sport climbing can help improve posture in patients with Parkinson’s disease, including older patients, new research suggests.

In a randomized controlled study, those who participated in scaling a wall using ropes and fixed anchors were less stooped at 12 weeks than was a control group that participated in some form of unsupervised physical activity.

The results underscore that it is never too late to learn a new sport or type of movement – and that this type of intervention may have big health payoffs, said study investigator Heidemarie Zach, MD, associate professor of neurology, Medical University of Vienna, Austria.

“There’s no hurdle too high over which you can’t climb, or burden you can’t conquer,”  said Dr. Zach. “As long as you can walk independently and walk up a stair, you can go climbing.”

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

Common feature of Parkinson’s disease

The analysis is part of a larger project that included a 2021 study showing a reduced Unified Parkinson’s Disease Rating Scale Part III (UPDRS-III) score by almost 13 points in patients who participated in sport climbing. The activity was also significantly associated with improved bradykinesia, rigidity, and tremor.

The current analysis focused on stooped posture, which in addition to motor symptoms is a common feature of Parkinson’s disease. This postural deformity can result in significant discomfort, pain, and decreased quality of life.

Pharmaceutical treatments are mostly ineffective for postural deformities, the researchers noted. Physical therapy may help improve symptoms, but only a few randomized studies have examined improved posture in patients with Parkinson’s disease using physiotherapy in general and alternative sports in particular.

Sport climbing is “really unique” in Parkinson’s disease, said Dr. Zach, who has yet to come across other research on this intervention. A climber herself, she recommended it to one of her patients: A 79-year old man with Parkinson’s disease who was a walker and hiker, and who ended up loving the sport. She called him her “pilot patient.”

The single-center study included 48 adult participants up to age 78 years (mean age, 65) with mild to moderate Parkinson’s disease. Most were at Hoehn & Yahr stage 2, with some at stage 3. All had no previous climbing experience. Exclusion criteria included having a condition other than Parkinson’s disease.

The researchers randomly assigned participants to a sport climbing course or to a control group.

The sport climbing group had a 90-minute climbing session each week for 12 weeks in an indoor gym. Under the supervision of an instructor, they were harnessed and connected to ropes with mats placed on the ground for safety.

The climbing wall was about 15 meters (50 feet) high. Participants typically started at 2 or 3 meters (6.5 to 9.5 feet) and worked their way up, Dr. Zach noted.

Those in the control group were asked to participate for 12 weeks in unsupervised physical activity, as recommended by the World Health Organization and the European Physiotherapy Guidelines for Parkinson’s Disease. This included at least 2.5 hours of moderate-intensity activity or 75 minutes of vigorous activity each week.
 

Whole-body workout

The primary outcome was improvement in posture, measured using a “simple” but highly reliable tool, said Dr. Zach. While the patients stood with their backs straight against a wall, researchers measured the distance in centimeters between the C7 sagittal vertical axis (C7SVA) and the wall.

The mean C7SVA at baseline did not significantly differ between the two groups, at 8.2 cm for the climbing group versus  7.7 cm for the control group. However, results showed only sport climbing was associated with significantly lessened forward flexion of the cervical spine.

The climbing group showed a decrease of the C7SVA by 1.7 cm (95% confidence interval [CI], 0.8-2.6 cm). “So climbers were more erect and less stooped after 12 weeks,” Dr. Zach said.

She noted that the mean difference in the control group was 0.5 cm (95% confidence interval [CI], –0.2 to 1.3 cm), which “is almost nothing.”

There did not seem to be any predictor, such as age, sex, or body mass index, for what patient subgroups benefit the most from the intervention, Dr. Zach noted.

In explaining why climbing helps posture, she said it is akin to “a whole-body workout.” The activity increases upper-body strength by using back and shoulder girdle muscles, as well as joint flexibility, Dr. Zach noted. Movements involved in climbing, such as repeated reaching for a distant hold, stretch the muscles of the hip flexors and hip.

As these movements reduce rigidity, the climbing action may also promote an upright posture. And as wall climbing involves planning and executing movements, it trains spatial body awareness, an important component of maintaining and correcting posture, she said.

Dr. Zach noted a motivational group dynamic likely also contributed to the success of the intervention. “They were cheering each other at the bottom” of the climbing wall, she said.

The results show that posture can be added to the improvements in Parkinson’s disease already documented from climbing, including improved motor symptoms, rigidity, and tremor, she said. The next step on the research agenda is to show whether the intervention has a positive impact on gait, Dr. Zach added.
 

‘Quite adventurous’

Commenting on the research, Rebecca Gilbert, MD, PhD, chief scientific officer at the American Parkinson Disease Association, said she welcomes “any new idea” to help patients with Parkinson’s disease – and that sport climbing sounds “quite adventurous.”

“The general concept that you’re asking the body to move in a novel way is a good thing for everyone and especially for people with Parkinson’s disease,” said Dr. Gilbert, who was not involved with the research.

She noted that in Parkinson’s disease, an ideal exercise intervention includes a combination of four modalities: stretching, balance, aerobics, and strengthening. Rope climbing involves many of these, in addition to a cognitive element, Dr. Gilbert said. It’s also important that patients with Parkinson’s disease participate in an activity they enjoy, she added.

However, she stressed that safety has to be “weighed,” especially for patients with stage 3 Parkinson’s disease, who often have balance problems. “It may be difficult to climb a rope if you have balance problems,” Dr. Gilbert said. “The intervention needs to be tailored to the existing disability, and perhaps this activity is more a reasonable thing for patients at milder stages.”

Dr. Zach and Dr. Gilbert have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Sport climbing can help improve posture in patients with Parkinson’s disease, including older patients, new research suggests.

In a randomized controlled study, those who participated in scaling a wall using ropes and fixed anchors were less stooped at 12 weeks than was a control group that participated in some form of unsupervised physical activity.

The results underscore that it is never too late to learn a new sport or type of movement – and that this type of intervention may have big health payoffs, said study investigator Heidemarie Zach, MD, associate professor of neurology, Medical University of Vienna, Austria.

“There’s no hurdle too high over which you can’t climb, or burden you can’t conquer,”  said Dr. Zach. “As long as you can walk independently and walk up a stair, you can go climbing.”

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

Common feature of Parkinson’s disease

The analysis is part of a larger project that included a 2021 study showing a reduced Unified Parkinson’s Disease Rating Scale Part III (UPDRS-III) score by almost 13 points in patients who participated in sport climbing. The activity was also significantly associated with improved bradykinesia, rigidity, and tremor.

The current analysis focused on stooped posture, which in addition to motor symptoms is a common feature of Parkinson’s disease. This postural deformity can result in significant discomfort, pain, and decreased quality of life.

Pharmaceutical treatments are mostly ineffective for postural deformities, the researchers noted. Physical therapy may help improve symptoms, but only a few randomized studies have examined improved posture in patients with Parkinson’s disease using physiotherapy in general and alternative sports in particular.

Sport climbing is “really unique” in Parkinson’s disease, said Dr. Zach, who has yet to come across other research on this intervention. A climber herself, she recommended it to one of her patients: A 79-year old man with Parkinson’s disease who was a walker and hiker, and who ended up loving the sport. She called him her “pilot patient.”

The single-center study included 48 adult participants up to age 78 years (mean age, 65) with mild to moderate Parkinson’s disease. Most were at Hoehn & Yahr stage 2, with some at stage 3. All had no previous climbing experience. Exclusion criteria included having a condition other than Parkinson’s disease.

The researchers randomly assigned participants to a sport climbing course or to a control group.

The sport climbing group had a 90-minute climbing session each week for 12 weeks in an indoor gym. Under the supervision of an instructor, they were harnessed and connected to ropes with mats placed on the ground for safety.

The climbing wall was about 15 meters (50 feet) high. Participants typically started at 2 or 3 meters (6.5 to 9.5 feet) and worked their way up, Dr. Zach noted.

Those in the control group were asked to participate for 12 weeks in unsupervised physical activity, as recommended by the World Health Organization and the European Physiotherapy Guidelines for Parkinson’s Disease. This included at least 2.5 hours of moderate-intensity activity or 75 minutes of vigorous activity each week.
 

Whole-body workout

The primary outcome was improvement in posture, measured using a “simple” but highly reliable tool, said Dr. Zach. While the patients stood with their backs straight against a wall, researchers measured the distance in centimeters between the C7 sagittal vertical axis (C7SVA) and the wall.

The mean C7SVA at baseline did not significantly differ between the two groups, at 8.2 cm for the climbing group versus  7.7 cm for the control group. However, results showed only sport climbing was associated with significantly lessened forward flexion of the cervical spine.

The climbing group showed a decrease of the C7SVA by 1.7 cm (95% confidence interval [CI], 0.8-2.6 cm). “So climbers were more erect and less stooped after 12 weeks,” Dr. Zach said.

She noted that the mean difference in the control group was 0.5 cm (95% confidence interval [CI], –0.2 to 1.3 cm), which “is almost nothing.”

There did not seem to be any predictor, such as age, sex, or body mass index, for what patient subgroups benefit the most from the intervention, Dr. Zach noted.

In explaining why climbing helps posture, she said it is akin to “a whole-body workout.” The activity increases upper-body strength by using back and shoulder girdle muscles, as well as joint flexibility, Dr. Zach noted. Movements involved in climbing, such as repeated reaching for a distant hold, stretch the muscles of the hip flexors and hip.

As these movements reduce rigidity, the climbing action may also promote an upright posture. And as wall climbing involves planning and executing movements, it trains spatial body awareness, an important component of maintaining and correcting posture, she said.

Dr. Zach noted a motivational group dynamic likely also contributed to the success of the intervention. “They were cheering each other at the bottom” of the climbing wall, she said.

The results show that posture can be added to the improvements in Parkinson’s disease already documented from climbing, including improved motor symptoms, rigidity, and tremor, she said. The next step on the research agenda is to show whether the intervention has a positive impact on gait, Dr. Zach added.
 

‘Quite adventurous’

Commenting on the research, Rebecca Gilbert, MD, PhD, chief scientific officer at the American Parkinson Disease Association, said she welcomes “any new idea” to help patients with Parkinson’s disease – and that sport climbing sounds “quite adventurous.”

“The general concept that you’re asking the body to move in a novel way is a good thing for everyone and especially for people with Parkinson’s disease,” said Dr. Gilbert, who was not involved with the research.

She noted that in Parkinson’s disease, an ideal exercise intervention includes a combination of four modalities: stretching, balance, aerobics, and strengthening. Rope climbing involves many of these, in addition to a cognitive element, Dr. Gilbert said. It’s also important that patients with Parkinson’s disease participate in an activity they enjoy, she added.

However, she stressed that safety has to be “weighed,” especially for patients with stage 3 Parkinson’s disease, who often have balance problems. “It may be difficult to climb a rope if you have balance problems,” Dr. Gilbert said. “The intervention needs to be tailored to the existing disability, and perhaps this activity is more a reasonable thing for patients at milder stages.”

Dr. Zach and Dr. Gilbert have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Sport climbing can help improve posture in patients with Parkinson’s disease, including older patients, new research suggests.

In a randomized controlled study, those who participated in scaling a wall using ropes and fixed anchors were less stooped at 12 weeks than was a control group that participated in some form of unsupervised physical activity.

The results underscore that it is never too late to learn a new sport or type of movement – and that this type of intervention may have big health payoffs, said study investigator Heidemarie Zach, MD, associate professor of neurology, Medical University of Vienna, Austria.

“There’s no hurdle too high over which you can’t climb, or burden you can’t conquer,”  said Dr. Zach. “As long as you can walk independently and walk up a stair, you can go climbing.”

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

Common feature of Parkinson’s disease

The analysis is part of a larger project that included a 2021 study showing a reduced Unified Parkinson’s Disease Rating Scale Part III (UPDRS-III) score by almost 13 points in patients who participated in sport climbing. The activity was also significantly associated with improved bradykinesia, rigidity, and tremor.

The current analysis focused on stooped posture, which in addition to motor symptoms is a common feature of Parkinson’s disease. This postural deformity can result in significant discomfort, pain, and decreased quality of life.

Pharmaceutical treatments are mostly ineffective for postural deformities, the researchers noted. Physical therapy may help improve symptoms, but only a few randomized studies have examined improved posture in patients with Parkinson’s disease using physiotherapy in general and alternative sports in particular.

Sport climbing is “really unique” in Parkinson’s disease, said Dr. Zach, who has yet to come across other research on this intervention. A climber herself, she recommended it to one of her patients: A 79-year old man with Parkinson’s disease who was a walker and hiker, and who ended up loving the sport. She called him her “pilot patient.”

The single-center study included 48 adult participants up to age 78 years (mean age, 65) with mild to moderate Parkinson’s disease. Most were at Hoehn & Yahr stage 2, with some at stage 3. All had no previous climbing experience. Exclusion criteria included having a condition other than Parkinson’s disease.

The researchers randomly assigned participants to a sport climbing course or to a control group.

The sport climbing group had a 90-minute climbing session each week for 12 weeks in an indoor gym. Under the supervision of an instructor, they were harnessed and connected to ropes with mats placed on the ground for safety.

The climbing wall was about 15 meters (50 feet) high. Participants typically started at 2 or 3 meters (6.5 to 9.5 feet) and worked their way up, Dr. Zach noted.

Those in the control group were asked to participate for 12 weeks in unsupervised physical activity, as recommended by the World Health Organization and the European Physiotherapy Guidelines for Parkinson’s Disease. This included at least 2.5 hours of moderate-intensity activity or 75 minutes of vigorous activity each week.
 

Whole-body workout

The primary outcome was improvement in posture, measured using a “simple” but highly reliable tool, said Dr. Zach. While the patients stood with their backs straight against a wall, researchers measured the distance in centimeters between the C7 sagittal vertical axis (C7SVA) and the wall.

The mean C7SVA at baseline did not significantly differ between the two groups, at 8.2 cm for the climbing group versus  7.7 cm for the control group. However, results showed only sport climbing was associated with significantly lessened forward flexion of the cervical spine.

The climbing group showed a decrease of the C7SVA by 1.7 cm (95% confidence interval [CI], 0.8-2.6 cm). “So climbers were more erect and less stooped after 12 weeks,” Dr. Zach said.

She noted that the mean difference in the control group was 0.5 cm (95% confidence interval [CI], –0.2 to 1.3 cm), which “is almost nothing.”

There did not seem to be any predictor, such as age, sex, or body mass index, for what patient subgroups benefit the most from the intervention, Dr. Zach noted.

In explaining why climbing helps posture, she said it is akin to “a whole-body workout.” The activity increases upper-body strength by using back and shoulder girdle muscles, as well as joint flexibility, Dr. Zach noted. Movements involved in climbing, such as repeated reaching for a distant hold, stretch the muscles of the hip flexors and hip.

As these movements reduce rigidity, the climbing action may also promote an upright posture. And as wall climbing involves planning and executing movements, it trains spatial body awareness, an important component of maintaining and correcting posture, she said.

Dr. Zach noted a motivational group dynamic likely also contributed to the success of the intervention. “They were cheering each other at the bottom” of the climbing wall, she said.

The results show that posture can be added to the improvements in Parkinson’s disease already documented from climbing, including improved motor symptoms, rigidity, and tremor, she said. The next step on the research agenda is to show whether the intervention has a positive impact on gait, Dr. Zach added.
 

‘Quite adventurous’

Commenting on the research, Rebecca Gilbert, MD, PhD, chief scientific officer at the American Parkinson Disease Association, said she welcomes “any new idea” to help patients with Parkinson’s disease – and that sport climbing sounds “quite adventurous.”

“The general concept that you’re asking the body to move in a novel way is a good thing for everyone and especially for people with Parkinson’s disease,” said Dr. Gilbert, who was not involved with the research.

She noted that in Parkinson’s disease, an ideal exercise intervention includes a combination of four modalities: stretching, balance, aerobics, and strengthening. Rope climbing involves many of these, in addition to a cognitive element, Dr. Gilbert said. It’s also important that patients with Parkinson’s disease participate in an activity they enjoy, she added.

However, she stressed that safety has to be “weighed,” especially for patients with stage 3 Parkinson’s disease, who often have balance problems. “It may be difficult to climb a rope if you have balance problems,” Dr. Gilbert said. “The intervention needs to be tailored to the existing disability, and perhaps this activity is more a reasonable thing for patients at milder stages.”

Dr. Zach and Dr. Gilbert have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Cancer cachexia is a syndrome of weight loss that frequently occurs during cancer treatment. Consequences can include skeletal muscle loss, fatigue, functional impairment, worse quality of life, and worse survival. On the other hand, weight gain during cancer treatment has been tied to better survival.

A new study shows that, among patients with non–small cell lung cancer (NSCLC), weight gain over the course of treatment with standard of care chemotherapy was associated with improved survival in both men and women. Few studies have examined the relationship between weight gain and outcomes by sex.

“The finding that weight gain occurred in subsets of males and females is a new observation. The fact that weight gain occurs in cancer patients during anticancer treatment could confound results of clinical [trials] evaluating novel anticachexia treatments. Simultaneously studying longitudinal body weights and serum and cellular biomarkers in cancer patients might provide insights into mechanisms involved in cachexia. Increased understanding of mechanisms driving cachexia could lead to new therapeutic strategies,” said study coauthor Philip Bonomi, MD, who is an oncologist at Rush Medical College, Chicago.

“This data, although it appears to be very basic, is critically important, especially as we consider our novel interventions in the treatment of cancer cachexia,” said Eric Roeland, MD, during his presentation of the study at the annual meeting of European Society for Medical Oncology. Dr. Roeland is a medical oncologist at Oregon Health & Science University, Portland.

Dr. Roeland is also the lead author of cancer cachexia guidelines published by the American Society of Clinical Oncology in 2020. The guidelines suggest that dietary counseling can be offered to patients, but warns against routine use of enteral feeding tubes and parenteral nutrition. Although no specific drug can be recommended for cancer cachexia, progesterone analogs and corticosteroids used over the short term (weeks) can be used on a trial base to improve appetite and weight gain. While not approved in the United States, anamorelin was approved in 2020 in Japan for cancer cachexia in NSCLC, gastric cancer, pancreatic cancer, and colorectal cancer.

The new study should raise awareness of the importance of adverse effects of cancer treatments, said Karin Jordan, MD, University Hospital Heidelberg (Germany). She served as a discussant following the presentation. “As a medical oncologist, we focus a bit too much on the benefits of antineoplastic therapy, both on cure and on the survival benefit. But what is also very, very important to do is a balanced oncology treatment to focus on the risks of oncology therapies,” she said.

The study is limited by its retrospective nature and potential for bias. “The hypothesis that weight gain leads to improved survival is not really proven as it likewise may be the other way around,” Dr. Jordan said.

However, in oncology research, a phenomenon called the “obesity paradox” is increasingly catching the interest of investigators. Observational studies have shown that overweight patients with certain cancers (specifically, colorectal, endometrial and lung cancer). actually have improved overall survival as compared with normal-weight patients.
 

Details from the new study

The researchers pooled data 1,030 patients who participated in three phase 3 clinical trials conducted between 2005 and 2011. The patients all received platinum-based chemotherapy as part of control arms. 304 were female and 726 were male. The median age was 62. 16.7% were Asian, the mean body mass index was 24.6 kg/m², 88.5% had stage 4 disease, 36.9% had adenocarcinoma, and 86.3% were current or former smokers.

Males and females had similar magnitudes and rate of weight gain over the course of treatment. Any weight gain was associated with improved overall survival in both males (12.7 vs. 8.0 months; hazard ratio, 0.60; P < .001) and females (16.2 vs. 10.1 months; HR, 0.65; P = .0028). Patients who had a weight gain of 2.5% of body weight or more saw an improvement in overall survival in both males (14.0 vs. 8.2 months; HR, 0.57; P < .001) and females (16.7 vs. 11.3 months; HR, 0.61; P = .0041).

Patients with a weight gain of 5% or more was associated with improved survival in males (13.6 vs. 8.9 months; HR, 0.62; P = .0001), but there was no statistically significant association in females (16.7 vs. 12.6 months; HR, 0.69; P = .1107).

Regardless of weight-gain status, males had lower survival rates than females. All of the associations were independent of smoking status.

The study was funded by Pfizer. Dr. Bonomi has received honoraria from Pfizer and Helsinn for participation in scientific advisory boards. Dr. Jordan has consulted for Amgen, Hexal, Riemser, Helsinn, Voluntis, Pfizer, and BD Solution. She has received research funding from Deutsche Krebshilfe. She has received honoraria from MSD, Merck, Amgen, Hexal, Riemser, Helsinn, Voluntis, Pfizer, Pomme-med, PharmaMar, arttemoi, OnkoUpdate, Stemline, and Roche.

Cancer cachexia is a syndrome of weight loss that frequently occurs during cancer treatment. Consequences can include skeletal muscle loss, fatigue, functional impairment, worse quality of life, and worse survival. On the other hand, weight gain during cancer treatment has been tied to better survival.

A new study shows that, among patients with non–small cell lung cancer (NSCLC), weight gain over the course of treatment with standard of care chemotherapy was associated with improved survival in both men and women. Few studies have examined the relationship between weight gain and outcomes by sex.

“The finding that weight gain occurred in subsets of males and females is a new observation. The fact that weight gain occurs in cancer patients during anticancer treatment could confound results of clinical [trials] evaluating novel anticachexia treatments. Simultaneously studying longitudinal body weights and serum and cellular biomarkers in cancer patients might provide insights into mechanisms involved in cachexia. Increased understanding of mechanisms driving cachexia could lead to new therapeutic strategies,” said study coauthor Philip Bonomi, MD, who is an oncologist at Rush Medical College, Chicago.

“This data, although it appears to be very basic, is critically important, especially as we consider our novel interventions in the treatment of cancer cachexia,” said Eric Roeland, MD, during his presentation of the study at the annual meeting of European Society for Medical Oncology. Dr. Roeland is a medical oncologist at Oregon Health & Science University, Portland.

Dr. Roeland is also the lead author of cancer cachexia guidelines published by the American Society of Clinical Oncology in 2020. The guidelines suggest that dietary counseling can be offered to patients, but warns against routine use of enteral feeding tubes and parenteral nutrition. Although no specific drug can be recommended for cancer cachexia, progesterone analogs and corticosteroids used over the short term (weeks) can be used on a trial base to improve appetite and weight gain. While not approved in the United States, anamorelin was approved in 2020 in Japan for cancer cachexia in NSCLC, gastric cancer, pancreatic cancer, and colorectal cancer.

The new study should raise awareness of the importance of adverse effects of cancer treatments, said Karin Jordan, MD, University Hospital Heidelberg (Germany). She served as a discussant following the presentation. “As a medical oncologist, we focus a bit too much on the benefits of antineoplastic therapy, both on cure and on the survival benefit. But what is also very, very important to do is a balanced oncology treatment to focus on the risks of oncology therapies,” she said.

The study is limited by its retrospective nature and potential for bias. “The hypothesis that weight gain leads to improved survival is not really proven as it likewise may be the other way around,” Dr. Jordan said.

However, in oncology research, a phenomenon called the “obesity paradox” is increasingly catching the interest of investigators. Observational studies have shown that overweight patients with certain cancers (specifically, colorectal, endometrial and lung cancer). actually have improved overall survival as compared with normal-weight patients.
 

Details from the new study

The researchers pooled data 1,030 patients who participated in three phase 3 clinical trials conducted between 2005 and 2011. The patients all received platinum-based chemotherapy as part of control arms. 304 were female and 726 were male. The median age was 62. 16.7% were Asian, the mean body mass index was 24.6 kg/m², 88.5% had stage 4 disease, 36.9% had adenocarcinoma, and 86.3% were current or former smokers.

Males and females had similar magnitudes and rate of weight gain over the course of treatment. Any weight gain was associated with improved overall survival in both males (12.7 vs. 8.0 months; hazard ratio, 0.60; P < .001) and females (16.2 vs. 10.1 months; HR, 0.65; P = .0028). Patients who had a weight gain of 2.5% of body weight or more saw an improvement in overall survival in both males (14.0 vs. 8.2 months; HR, 0.57; P < .001) and females (16.7 vs. 11.3 months; HR, 0.61; P = .0041).

Patients with a weight gain of 5% or more was associated with improved survival in males (13.6 vs. 8.9 months; HR, 0.62; P = .0001), but there was no statistically significant association in females (16.7 vs. 12.6 months; HR, 0.69; P = .1107).

Regardless of weight-gain status, males had lower survival rates than females. All of the associations were independent of smoking status.

The study was funded by Pfizer. Dr. Bonomi has received honoraria from Pfizer and Helsinn for participation in scientific advisory boards. Dr. Jordan has consulted for Amgen, Hexal, Riemser, Helsinn, Voluntis, Pfizer, and BD Solution. She has received research funding from Deutsche Krebshilfe. She has received honoraria from MSD, Merck, Amgen, Hexal, Riemser, Helsinn, Voluntis, Pfizer, Pomme-med, PharmaMar, arttemoi, OnkoUpdate, Stemline, and Roche.

Cancer cachexia is a syndrome of weight loss that frequently occurs during cancer treatment. Consequences can include skeletal muscle loss, fatigue, functional impairment, worse quality of life, and worse survival. On the other hand, weight gain during cancer treatment has been tied to better survival.

A new study shows that, among patients with non–small cell lung cancer (NSCLC), weight gain over the course of treatment with standard of care chemotherapy was associated with improved survival in both men and women. Few studies have examined the relationship between weight gain and outcomes by sex.

“The finding that weight gain occurred in subsets of males and females is a new observation. The fact that weight gain occurs in cancer patients during anticancer treatment could confound results of clinical [trials] evaluating novel anticachexia treatments. Simultaneously studying longitudinal body weights and serum and cellular biomarkers in cancer patients might provide insights into mechanisms involved in cachexia. Increased understanding of mechanisms driving cachexia could lead to new therapeutic strategies,” said study coauthor Philip Bonomi, MD, who is an oncologist at Rush Medical College, Chicago.

“This data, although it appears to be very basic, is critically important, especially as we consider our novel interventions in the treatment of cancer cachexia,” said Eric Roeland, MD, during his presentation of the study at the annual meeting of European Society for Medical Oncology. Dr. Roeland is a medical oncologist at Oregon Health & Science University, Portland.

Dr. Roeland is also the lead author of cancer cachexia guidelines published by the American Society of Clinical Oncology in 2020. The guidelines suggest that dietary counseling can be offered to patients, but warns against routine use of enteral feeding tubes and parenteral nutrition. Although no specific drug can be recommended for cancer cachexia, progesterone analogs and corticosteroids used over the short term (weeks) can be used on a trial base to improve appetite and weight gain. While not approved in the United States, anamorelin was approved in 2020 in Japan for cancer cachexia in NSCLC, gastric cancer, pancreatic cancer, and colorectal cancer.

The new study should raise awareness of the importance of adverse effects of cancer treatments, said Karin Jordan, MD, University Hospital Heidelberg (Germany). She served as a discussant following the presentation. “As a medical oncologist, we focus a bit too much on the benefits of antineoplastic therapy, both on cure and on the survival benefit. But what is also very, very important to do is a balanced oncology treatment to focus on the risks of oncology therapies,” she said.

The study is limited by its retrospective nature and potential for bias. “The hypothesis that weight gain leads to improved survival is not really proven as it likewise may be the other way around,” Dr. Jordan said.

However, in oncology research, a phenomenon called the “obesity paradox” is increasingly catching the interest of investigators. Observational studies have shown that overweight patients with certain cancers (specifically, colorectal, endometrial and lung cancer). actually have improved overall survival as compared with normal-weight patients.
 

Details from the new study

The researchers pooled data 1,030 patients who participated in three phase 3 clinical trials conducted between 2005 and 2011. The patients all received platinum-based chemotherapy as part of control arms. 304 were female and 726 were male. The median age was 62. 16.7% were Asian, the mean body mass index was 24.6 kg/m², 88.5% had stage 4 disease, 36.9% had adenocarcinoma, and 86.3% were current or former smokers.

Males and females had similar magnitudes and rate of weight gain over the course of treatment. Any weight gain was associated with improved overall survival in both males (12.7 vs. 8.0 months; hazard ratio, 0.60; P < .001) and females (16.2 vs. 10.1 months; HR, 0.65; P = .0028). Patients who had a weight gain of 2.5% of body weight or more saw an improvement in overall survival in both males (14.0 vs. 8.2 months; HR, 0.57; P < .001) and females (16.7 vs. 11.3 months; HR, 0.61; P = .0041).

Patients with a weight gain of 5% or more was associated with improved survival in males (13.6 vs. 8.9 months; HR, 0.62; P = .0001), but there was no statistically significant association in females (16.7 vs. 12.6 months; HR, 0.69; P = .1107).

Regardless of weight-gain status, males had lower survival rates than females. All of the associations were independent of smoking status.

The study was funded by Pfizer. Dr. Bonomi has received honoraria from Pfizer and Helsinn for participation in scientific advisory boards. Dr. Jordan has consulted for Amgen, Hexal, Riemser, Helsinn, Voluntis, Pfizer, and BD Solution. She has received research funding from Deutsche Krebshilfe. She has received honoraria from MSD, Merck, Amgen, Hexal, Riemser, Helsinn, Voluntis, Pfizer, Pomme-med, PharmaMar, arttemoi, OnkoUpdate, Stemline, and Roche.

A high baseline intake of vitamin B₁₂ is linked to lower risk of developing Parkinson’s disease, new research suggests. “The results leave the door open for the possibility that vitamin B₁₂ may have a beneficial effect in protecting against Parkinson’s disease,” said lead author Mario H. Flores, PhD, a research fellow at Harvard T.H. Chan School of Public Health, Boston.

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

B vitamins and Parkinson’s disease

Previous preclinical studies have suggested that B vitamins protect against Parkinson’s disease by decreasing plasma homocysteine levels and through other neuroprotective effects. However, there have been only two epidemiologic studies of B vitamins in Parkinson’s disease – and their results were inconsistent, Dr. Flores noted.

The new study included 80,965 women from the Nurses’ Health Study and 48,837 men from the Health Professionals Follow-up Study. All completed a food frequency questionnaire at baseline and every 4 years.

Researchers collected information on dietary, supplemental, and total intake of folate, vitamin B₆, and vitamin B₁₂ over the course of about 30 years up to 2012. They estimated hazard ratios and 95% confidence intervals for Parkinson’s disease according to quintiles of cumulative average intake.

During follow-up, 495 women and 621 men were diagnosed with Parkinson’s disease.

The investigators adjusted for potential confounders, including age, year, smoking status, physical activity, intake of alcohol or caffeine, hormone use (in women), intake of dairy and flavonoids, and Mediterranean diet score.

Analyses of cumulative average total folate, B₆, and B₁₂ intake were not associated with Parkinson’s disease risk. “The results of the primary analysis of cumulative intake were not significant for any of the vitamins we looked at,” said Dr. Flores.

Researchers also conducted secondary analyses, including assessment of how the most recent intake of B vitamins related to Parkinson’s disease risk. This analysis also did not find a significant association.

However, when examining baseline intake of vitamin B₁₂, “we saw some suggestion for a potential inverse association with Parkinson’s disease,” Dr. Flores said.

Among individuals with higher total intake of vitamin B₁₂, there was a lower risk for Parkinson’s disease (pooled hazard ratio for top vs. bottom quintile, 0.74; 95% confidence interval [CI], 0.60-0.89; P for trend, .001). Intake from both diet and supplements contributed to this inverse association, the investigators noted.

Dietary sources of vitamin B₁₂ include poultry, meat, fish, and dairy products; however, the main sources in this study were multivitamins/supplements and enriched foods such as cereals, said Dr. Flores.
 

Several limitations

In an attempt to overcome risk for reverse causality, the researchers examined B₁₂ intake during four lagged exposure periods: 8-, 12-, 16- and 20-year lags. They found a significant relationship between intake for the 20-year lag time and development of Parkinson’s disease.

Overall, the study results provide support for a possible protective effect of early intake of vitamin B₁₂ on the development of Parkinson’s disease, Dr. Flores noted.

In addition to being involved in the regulation of homocysteine levels, vitamin B₁₂ may help regulate leucine-rich repeat kinase 2 (LRRK2), an enzyme implicated in the pathogenesis of Parkinson’s disease, he said.

However, the study did not examine how B₁₂ deficiency might relate to risk for Parkinson’s disease, which “is something worth looking at in future studies,” said Dr. Flores.

He added that although findings from a single study cannot translate into recommendations on ideal vitamin B₁₂ intake to prevent or delay Parkinson’s disease onset, the median intake in the highest quintile that the study linked to less Parkinson’s disease risk was 18 mcg/d at baseline. The amount in multivitamins can vary from 5 to 25 mcg.

Dr. Flores said a limitation of the study was that it included U.S. health care professionals, “most of whom arguably have very good nutritional status.”

As well, assessment of vitamin B intake was self-reported, so there might have been measurement error – and there may have been an unmeasured confounding factor that could explain the associations.

Dr. Flores also stressed that the effect of B₁₂ on Parkinson’s disease risk “was very modest,” and the results need to be confirmed in other studies “ideally looking at circulating levels of vitamin B₁₂.”
 

Not ready to recommend

Commenting on the research, Michael S. Okun, MD, medical adviser at the Parkinson’s Foundation and professor and director of the Norman Fixel Institute for Neurological Diseases at the University of Florida, Gainesville, noted that other recent studies have suggested high-dose B₁₂ may be preventive and a possible treatment in Parkinson’s disease.

“Although only a secondary aim of the current study, there was a reported potential benefit” in this new study, too, said Dr. Okun, who was not involved with the research.

However, the evidence is still not strong enough to change prescribing habits, he noted. “We do not recommend high-dose B₁₂ either for those at genetic risk of Parkinson’s or those already with the disease,” Dr. Okun said.

He added that because multiple recent studies have questioned the beneficial effects for multivitamin combinations used to prevent neurologic diseases, “it wasn’t surprising to see results showing a lack of protection against later-onset Parkinson’s disease with [cumulative] folate, B₆, and B₁₂ intake” in the current study.

The study was supported by the NIH. Dr. Flores and Dr. Okun have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A high baseline intake of vitamin B₁₂ is linked to lower risk of developing Parkinson’s disease, new research suggests. “The results leave the door open for the possibility that vitamin B₁₂ may have a beneficial effect in protecting against Parkinson’s disease,” said lead author Mario H. Flores, PhD, a research fellow at Harvard T.H. Chan School of Public Health, Boston.

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

B vitamins and Parkinson’s disease

Previous preclinical studies have suggested that B vitamins protect against Parkinson’s disease by decreasing plasma homocysteine levels and through other neuroprotective effects. However, there have been only two epidemiologic studies of B vitamins in Parkinson’s disease – and their results were inconsistent, Dr. Flores noted.

The new study included 80,965 women from the Nurses’ Health Study and 48,837 men from the Health Professionals Follow-up Study. All completed a food frequency questionnaire at baseline and every 4 years.

Researchers collected information on dietary, supplemental, and total intake of folate, vitamin B₆, and vitamin B₁₂ over the course of about 30 years up to 2012. They estimated hazard ratios and 95% confidence intervals for Parkinson’s disease according to quintiles of cumulative average intake.

During follow-up, 495 women and 621 men were diagnosed with Parkinson’s disease.

The investigators adjusted for potential confounders, including age, year, smoking status, physical activity, intake of alcohol or caffeine, hormone use (in women), intake of dairy and flavonoids, and Mediterranean diet score.

Analyses of cumulative average total folate, B₆, and B₁₂ intake were not associated with Parkinson’s disease risk. “The results of the primary analysis of cumulative intake were not significant for any of the vitamins we looked at,” said Dr. Flores.

Researchers also conducted secondary analyses, including assessment of how the most recent intake of B vitamins related to Parkinson’s disease risk. This analysis also did not find a significant association.

However, when examining baseline intake of vitamin B₁₂, “we saw some suggestion for a potential inverse association with Parkinson’s disease,” Dr. Flores said.

Among individuals with higher total intake of vitamin B₁₂, there was a lower risk for Parkinson’s disease (pooled hazard ratio for top vs. bottom quintile, 0.74; 95% confidence interval [CI], 0.60-0.89; P for trend, .001). Intake from both diet and supplements contributed to this inverse association, the investigators noted.

Dietary sources of vitamin B₁₂ include poultry, meat, fish, and dairy products; however, the main sources in this study were multivitamins/supplements and enriched foods such as cereals, said Dr. Flores.
 

Several limitations

In an attempt to overcome risk for reverse causality, the researchers examined B₁₂ intake during four lagged exposure periods: 8-, 12-, 16- and 20-year lags. They found a significant relationship between intake for the 20-year lag time and development of Parkinson’s disease.

Overall, the study results provide support for a possible protective effect of early intake of vitamin B₁₂ on the development of Parkinson’s disease, Dr. Flores noted.

In addition to being involved in the regulation of homocysteine levels, vitamin B₁₂ may help regulate leucine-rich repeat kinase 2 (LRRK2), an enzyme implicated in the pathogenesis of Parkinson’s disease, he said.

However, the study did not examine how B₁₂ deficiency might relate to risk for Parkinson’s disease, which “is something worth looking at in future studies,” said Dr. Flores.

He added that although findings from a single study cannot translate into recommendations on ideal vitamin B₁₂ intake to prevent or delay Parkinson’s disease onset, the median intake in the highest quintile that the study linked to less Parkinson’s disease risk was 18 mcg/d at baseline. The amount in multivitamins can vary from 5 to 25 mcg.

Dr. Flores said a limitation of the study was that it included U.S. health care professionals, “most of whom arguably have very good nutritional status.”

As well, assessment of vitamin B intake was self-reported, so there might have been measurement error – and there may have been an unmeasured confounding factor that could explain the associations.

Dr. Flores also stressed that the effect of B₁₂ on Parkinson’s disease risk “was very modest,” and the results need to be confirmed in other studies “ideally looking at circulating levels of vitamin B₁₂.”
 

Not ready to recommend

Commenting on the research, Michael S. Okun, MD, medical adviser at the Parkinson’s Foundation and professor and director of the Norman Fixel Institute for Neurological Diseases at the University of Florida, Gainesville, noted that other recent studies have suggested high-dose B₁₂ may be preventive and a possible treatment in Parkinson’s disease.

“Although only a secondary aim of the current study, there was a reported potential benefit” in this new study, too, said Dr. Okun, who was not involved with the research.

However, the evidence is still not strong enough to change prescribing habits, he noted. “We do not recommend high-dose B₁₂ either for those at genetic risk of Parkinson’s or those already with the disease,” Dr. Okun said.

He added that because multiple recent studies have questioned the beneficial effects for multivitamin combinations used to prevent neurologic diseases, “it wasn’t surprising to see results showing a lack of protection against later-onset Parkinson’s disease with [cumulative] folate, B₆, and B₁₂ intake” in the current study.

The study was supported by the NIH. Dr. Flores and Dr. Okun have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A high baseline intake of vitamin B₁₂ is linked to lower risk of developing Parkinson’s disease, new research suggests. “The results leave the door open for the possibility that vitamin B₁₂ may have a beneficial effect in protecting against Parkinson’s disease,” said lead author Mario H. Flores, PhD, a research fellow at Harvard T.H. Chan School of Public Health, Boston.

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

B vitamins and Parkinson’s disease

Previous preclinical studies have suggested that B vitamins protect against Parkinson’s disease by decreasing plasma homocysteine levels and through other neuroprotective effects. However, there have been only two epidemiologic studies of B vitamins in Parkinson’s disease – and their results were inconsistent, Dr. Flores noted.

The new study included 80,965 women from the Nurses’ Health Study and 48,837 men from the Health Professionals Follow-up Study. All completed a food frequency questionnaire at baseline and every 4 years.

Researchers collected information on dietary, supplemental, and total intake of folate, vitamin B₆, and vitamin B₁₂ over the course of about 30 years up to 2012. They estimated hazard ratios and 95% confidence intervals for Parkinson’s disease according to quintiles of cumulative average intake.

During follow-up, 495 women and 621 men were diagnosed with Parkinson’s disease.

The investigators adjusted for potential confounders, including age, year, smoking status, physical activity, intake of alcohol or caffeine, hormone use (in women), intake of dairy and flavonoids, and Mediterranean diet score.

Analyses of cumulative average total folate, B₆, and B₁₂ intake were not associated with Parkinson’s disease risk. “The results of the primary analysis of cumulative intake were not significant for any of the vitamins we looked at,” said Dr. Flores.

Researchers also conducted secondary analyses, including assessment of how the most recent intake of B vitamins related to Parkinson’s disease risk. This analysis also did not find a significant association.

However, when examining baseline intake of vitamin B₁₂, “we saw some suggestion for a potential inverse association with Parkinson’s disease,” Dr. Flores said.

Among individuals with higher total intake of vitamin B₁₂, there was a lower risk for Parkinson’s disease (pooled hazard ratio for top vs. bottom quintile, 0.74; 95% confidence interval [CI], 0.60-0.89; P for trend, .001). Intake from both diet and supplements contributed to this inverse association, the investigators noted.

Dietary sources of vitamin B₁₂ include poultry, meat, fish, and dairy products; however, the main sources in this study were multivitamins/supplements and enriched foods such as cereals, said Dr. Flores.
 

Several limitations

In an attempt to overcome risk for reverse causality, the researchers examined B₁₂ intake during four lagged exposure periods: 8-, 12-, 16- and 20-year lags. They found a significant relationship between intake for the 20-year lag time and development of Parkinson’s disease.

Overall, the study results provide support for a possible protective effect of early intake of vitamin B₁₂ on the development of Parkinson’s disease, Dr. Flores noted.

In addition to being involved in the regulation of homocysteine levels, vitamin B₁₂ may help regulate leucine-rich repeat kinase 2 (LRRK2), an enzyme implicated in the pathogenesis of Parkinson’s disease, he said.

However, the study did not examine how B₁₂ deficiency might relate to risk for Parkinson’s disease, which “is something worth looking at in future studies,” said Dr. Flores.

He added that although findings from a single study cannot translate into recommendations on ideal vitamin B₁₂ intake to prevent or delay Parkinson’s disease onset, the median intake in the highest quintile that the study linked to less Parkinson’s disease risk was 18 mcg/d at baseline. The amount in multivitamins can vary from 5 to 25 mcg.

Dr. Flores said a limitation of the study was that it included U.S. health care professionals, “most of whom arguably have very good nutritional status.”

As well, assessment of vitamin B intake was self-reported, so there might have been measurement error – and there may have been an unmeasured confounding factor that could explain the associations.

Dr. Flores also stressed that the effect of B₁₂ on Parkinson’s disease risk “was very modest,” and the results need to be confirmed in other studies “ideally looking at circulating levels of vitamin B₁₂.”
 

Not ready to recommend

Commenting on the research, Michael S. Okun, MD, medical adviser at the Parkinson’s Foundation and professor and director of the Norman Fixel Institute for Neurological Diseases at the University of Florida, Gainesville, noted that other recent studies have suggested high-dose B₁₂ may be preventive and a possible treatment in Parkinson’s disease.

“Although only a secondary aim of the current study, there was a reported potential benefit” in this new study, too, said Dr. Okun, who was not involved with the research.

However, the evidence is still not strong enough to change prescribing habits, he noted. “We do not recommend high-dose B₁₂ either for those at genetic risk of Parkinson’s or those already with the disease,” Dr. Okun said.

He added that because multiple recent studies have questioned the beneficial effects for multivitamin combinations used to prevent neurologic diseases, “it wasn’t surprising to see results showing a lack of protection against later-onset Parkinson’s disease with [cumulative] folate, B₆, and B₁₂ intake” in the current study.

The study was supported by the NIH. Dr. Flores and Dr. Okun have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Recently an article crossed my screen that drinking 4 cups of tea per day lowered the risk of type 2 diabetes by 17%. As these thing always seem to, it ended with a variant of “further research is needed.”

Encouraging? Sure. Definite? Nope.

That’s the trouble with a lot of research papers. They have some promise, but really nothing definite. I’ve seen plenty of articles suggesting coffee and/or tea have health benefits, though specifically on what varies, from lifespan to lowering the risk of a chronic medical condition (in this case, type 2 diabetes).

There are always numerous variables that aren’t clear. What kind of tea? Decaf or regular? Hot or iced? When you say cup, what do you mean? A lot of people, including me, probably consider anything smaller that a Starbucks grande to be for wimps.

While I can’t think of any off the top of my head, there’s probably a reasonable chance that, if I looked, I could find something that says coffee or tea are bad for you in some way, too.

Not that I’m planning on changing my already caffeinated drinking habits, which is probably the crux of these things for most of us. In a given day I have 1-2 cups of coffee and 3-4 bottles of diet green tea. Maybe 1-2 Diet Cokes in there some days. In winter more hot black tea. I’m probably a poster child for methylyxanthine toxicity.

I have no idea if all that coffee and tea are doing anything besides keeping me awake and alert for my patients. If they are, I certainly hope they’re lowering my risk of something bad.

Articles like this always get attention, and are often picked up by the general media. People love to think something so simple as drinking more tea or coffee would make a big difference in their lives. So it gets forwarded, people never read past the first paragraph or two, and don’t make it to the “further research is needed” line.

If an article ever came out refuting it, it probably wouldn’t get nearly as much press (who wants to read bad news?) and would be quickly forgotten outside of medical circles.

But the reality is that people are really looking for shortcuts. Unless you live under a rock, it’s pretty clear to both medical and lay people that such things as exercise and a healthy diet can help avoid multiple chronic health conditions. This doesn’t mean most of us, myself included, will do such faithfully. It just takes less time and effort to drink more tea than it does to go to the gym, so we want to believe.

That’s just human nature.

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

Recently an article crossed my screen that drinking 4 cups of tea per day lowered the risk of type 2 diabetes by 17%. As these thing always seem to, it ended with a variant of “further research is needed.”

Encouraging? Sure. Definite? Nope.

That’s the trouble with a lot of research papers. They have some promise, but really nothing definite. I’ve seen plenty of articles suggesting coffee and/or tea have health benefits, though specifically on what varies, from lifespan to lowering the risk of a chronic medical condition (in this case, type 2 diabetes).

There are always numerous variables that aren’t clear. What kind of tea? Decaf or regular? Hot or iced? When you say cup, what do you mean? A lot of people, including me, probably consider anything smaller that a Starbucks grande to be for wimps.

While I can’t think of any off the top of my head, there’s probably a reasonable chance that, if I looked, I could find something that says coffee or tea are bad for you in some way, too.

Not that I’m planning on changing my already caffeinated drinking habits, which is probably the crux of these things for most of us. In a given day I have 1-2 cups of coffee and 3-4 bottles of diet green tea. Maybe 1-2 Diet Cokes in there some days. In winter more hot black tea. I’m probably a poster child for methylyxanthine toxicity.

I have no idea if all that coffee and tea are doing anything besides keeping me awake and alert for my patients. If they are, I certainly hope they’re lowering my risk of something bad.

Articles like this always get attention, and are often picked up by the general media. People love to think something so simple as drinking more tea or coffee would make a big difference in their lives. So it gets forwarded, people never read past the first paragraph or two, and don’t make it to the “further research is needed” line.

If an article ever came out refuting it, it probably wouldn’t get nearly as much press (who wants to read bad news?) and would be quickly forgotten outside of medical circles.

But the reality is that people are really looking for shortcuts. Unless you live under a rock, it’s pretty clear to both medical and lay people that such things as exercise and a healthy diet can help avoid multiple chronic health conditions. This doesn’t mean most of us, myself included, will do such faithfully. It just takes less time and effort to drink more tea than it does to go to the gym, so we want to believe.

That’s just human nature.

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

Recently an article crossed my screen that drinking 4 cups of tea per day lowered the risk of type 2 diabetes by 17%. As these thing always seem to, it ended with a variant of “further research is needed.”

Encouraging? Sure. Definite? Nope.

That’s the trouble with a lot of research papers. They have some promise, but really nothing definite. I’ve seen plenty of articles suggesting coffee and/or tea have health benefits, though specifically on what varies, from lifespan to lowering the risk of a chronic medical condition (in this case, type 2 diabetes).

There are always numerous variables that aren’t clear. What kind of tea? Decaf or regular? Hot or iced? When you say cup, what do you mean? A lot of people, including me, probably consider anything smaller that a Starbucks grande to be for wimps.

While I can’t think of any off the top of my head, there’s probably a reasonable chance that, if I looked, I could find something that says coffee or tea are bad for you in some way, too.

Not that I’m planning on changing my already caffeinated drinking habits, which is probably the crux of these things for most of us. In a given day I have 1-2 cups of coffee and 3-4 bottles of diet green tea. Maybe 1-2 Diet Cokes in there some days. In winter more hot black tea. I’m probably a poster child for methylyxanthine toxicity.

I have no idea if all that coffee and tea are doing anything besides keeping me awake and alert for my patients. If they are, I certainly hope they’re lowering my risk of something bad.

Articles like this always get attention, and are often picked up by the general media. People love to think something so simple as drinking more tea or coffee would make a big difference in their lives. So it gets forwarded, people never read past the first paragraph or two, and don’t make it to the “further research is needed” line.

If an article ever came out refuting it, it probably wouldn’t get nearly as much press (who wants to read bad news?) and would be quickly forgotten outside of medical circles.

But the reality is that people are really looking for shortcuts. Unless you live under a rock, it’s pretty clear to both medical and lay people that such things as exercise and a healthy diet can help avoid multiple chronic health conditions. This doesn’t mean most of us, myself included, will do such faithfully. It just takes less time and effort to drink more tea than it does to go to the gym, so we want to believe.

That’s just human nature.

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

CAN WE RETURN TO THE ABCS OF CRAFTING A MEDICAL RECORD NOTE? 

ROBERT L. BARBIERI, MD (OCTOBER 2021)

Physicians can  help provide EMR fixes

I appreciate Dr. Barbieri’s editorials and insight on many issues facing our profession. I would like to offer my comments on a recent article.

If you want your brakes fixed, don’t go to a shoe maker. Physicians seem to have lost our sense of who is most competent in determining the best way to practice and communicate medical care. Somehow we have turned this over to the bureaucrats, who seem to find ways to complicate the lives of both providers and patients. Maybe we are too busy caring for patients and trying to find ways to alleviate the burden placed on our time by the electronic medical record (EMR) system, which was touted as an improvement in medical care and increasing provider efficiency. Most of the time I hear my colleagues describing ways to “work around” an EMR system that has immense deficiencies in providing accurate information in a way that is easily digested by whomever is viewing the record. The universal ability to transfer information is simply not true. One colleague had the same office version of Cerner as was used in the hospital setting but was unable to send information back and forth due to the danger of the potential to corrupt the system. 

Dr. Barbieri mentioned his work around to make the record easier for the patient to read. I ask, what about the coding descriptions, which most systems are now requiring physicians to put in at the time of the encounter? In the past this was done by certified coders, who undergo a 1- to 2-year training program, and is now being performed by physicians who have minimal to no training in coding. (And who, by the way, can be fined for both under- and over coding.) The example Dr. Barbieri put forth for obesity comes to mind and is part of the medical record in all cases. The terminology used by ICD10 is not so kind and requires some imagination when trying to find the right code for many diagnoses.

When will we stop allowing others, who know little about medicine and caring for patients, to tell us how to provide the care that we have trained for 7-12 years on how  best to deliver?

William Sutton, MD

Muncie, Indiana

Dr. Barbieri responds

I thank Dr. Sutton for providing his experience with the electronic medical record. I agree with him that bureaucrats often create health care rules that do more to hinder than help patients. With regard to coding and billing, I use ICD-10 codes and  usually bill based on time, which includes both face-to-face time with the patient and time spent reviewing the patient’s medical records. Now that federal regulations require medical notes to be shared with patients, I craft my history, assessment, and plan with language that is easy for a patient to accept and understand, avoiding medical terms that patients might misinterpret.

Should microscopy  be replaced? 

I agree with many points Dr. Barbieri made in his editorial. However, I do not agree that the microscopic examination of the vaginal discharge should be replaced. NAAT offers some advantages, but it does not offer a complete assessment of the vaginal ecosystem and microbiome. I believe that NAAT should be used in conjunction with the pelvic examination and microscopic examination of the vaginal discharge.

Microscopic examination of the vaginal discharge can reveal:

• whether or not the squamous epithelial cells are estrogenized. The absence of estrogen will, along with physical findings, indicate the possibility that the patient is experiencing atrophic vaginitis.
• the presence of estrogenized squamous epithelial cells. Plus, a finding of erythema of the vaginal epithelium indicates that the patient has an inflammatory condition and vaginitis, suggesting a possible infection in addition to vaginitis. 
• the presence of white blood cells >5/40X magnification, which indicates the possible presence of infection in addition to vaginitis (eg, BV). 

I agree that NAAT can confirm an initial diagnosis or refute it. In the latter case, the physician can change treatment accordingly. In the absence or in conjunction with the presence of a sexually transmitted infection, the composition of the vaginal microbiome is significant (ie, determining if vaginal dysbiosis is present). Performing a comprehensive evaluation, determining if the most common pathogens are present in aerobic vaginitis and/or BV, plus completing a Lactobacillus panel can be expensive. If insurance companies do not pay for such testing, patients will be reluctant to pay out of pocket for these tests. 

My final comment addresses the administration of NAAT for aerobic vaginitis, and for BV, it is probably an ineffective treatment. Vaginal dysbiosis is based on whether the appropriate species of Lactobacillus is present, and the concentration. Treatment most likely will be based on replenishing or restoring the appropriate species of Lactobacillus to dominance. 

Sebastian Faro, MD, PhD

Houston, Texas

Dr. Barbieri responds

I agree with Dr. Faro; when used by highly trained clinicians, microscopy is an excellent tool for evaluating vaginal specimens. Expert clinicians, such as Dr. Faro, with a focus on infectious diseases do not need to rely on NAAT testing except for identifying cases of T vaginalis infection. However, in standard clinical practice, microscopy performs poorly, resulting in misdiagnosis.¹ In the average clinical practice, NAAT testing may help improve patient outcomes. 

1. Gaydos CA, Beqaj S, Schwebke JR, et al. Clinical validation of a test for the diagnosis of vaginitis. Obstet Gynecol. 2017;130:181-189.

A note of thanks

I am a 74-year-old ObGyn who finished training at the University of North Carolina in 1979. Currently, I am working at a rural health group 2 days a week as a source of in-house gyn referral for 17 primary care physicians and mid-level providers. Our patients are almost all underserved and self-pay. The bulk of my work is related to evaluating abnormal uterine bleeding and abnormal Pap tests. Your publication of OBG Management serves now as one of my main sources of information. I just wanted to thank you and let you know that the publication is important. Keep up the good work and best wishes. 

Julian Brantley, MD

Rocky Mountain, North Carolina
 

Dr. Barbieri responds

I thank Dr. Brantley for taking time from a busy practice to write about how OBG Management provides practical information relevant to practice. Each issue of OBG Management is built on a foundation of insights from expert clinicians, which is crafted into a finished product by a superb editorial team. Our goal is to enhance the quality of women’s health care and the professional development of obstetrician-gynecologists and all women’s health care clinicians. ●

CAN WE RETURN TO THE ABCS OF CRAFTING A MEDICAL RECORD NOTE? 

ROBERT L. BARBIERI, MD (OCTOBER 2021)

Physicians can  help provide EMR fixes

I appreciate Dr. Barbieri’s editorials and insight on many issues facing our profession. I would like to offer my comments on a recent article.

If you want your brakes fixed, don’t go to a shoe maker. Physicians seem to have lost our sense of who is most competent in determining the best way to practice and communicate medical care. Somehow we have turned this over to the bureaucrats, who seem to find ways to complicate the lives of both providers and patients. Maybe we are too busy caring for patients and trying to find ways to alleviate the burden placed on our time by the electronic medical record (EMR) system, which was touted as an improvement in medical care and increasing provider efficiency. Most of the time I hear my colleagues describing ways to “work around” an EMR system that has immense deficiencies in providing accurate information in a way that is easily digested by whomever is viewing the record. The universal ability to transfer information is simply not true. One colleague had the same office version of Cerner as was used in the hospital setting but was unable to send information back and forth due to the danger of the potential to corrupt the system. 

Dr. Barbieri mentioned his work around to make the record easier for the patient to read. I ask, what about the coding descriptions, which most systems are now requiring physicians to put in at the time of the encounter? In the past this was done by certified coders, who undergo a 1- to 2-year training program, and is now being performed by physicians who have minimal to no training in coding. (And who, by the way, can be fined for both under- and over coding.) The example Dr. Barbieri put forth for obesity comes to mind and is part of the medical record in all cases. The terminology used by ICD10 is not so kind and requires some imagination when trying to find the right code for many diagnoses.

When will we stop allowing others, who know little about medicine and caring for patients, to tell us how to provide the care that we have trained for 7-12 years on how  best to deliver?

William Sutton, MD

Muncie, Indiana

Dr. Barbieri responds

I thank Dr. Sutton for providing his experience with the electronic medical record. I agree with him that bureaucrats often create health care rules that do more to hinder than help patients. With regard to coding and billing, I use ICD-10 codes and  usually bill based on time, which includes both face-to-face time with the patient and time spent reviewing the patient’s medical records. Now that federal regulations require medical notes to be shared with patients, I craft my history, assessment, and plan with language that is easy for a patient to accept and understand, avoiding medical terms that patients might misinterpret.

Should microscopy  be replaced? 

I agree with many points Dr. Barbieri made in his editorial. However, I do not agree that the microscopic examination of the vaginal discharge should be replaced. NAAT offers some advantages, but it does not offer a complete assessment of the vaginal ecosystem and microbiome. I believe that NAAT should be used in conjunction with the pelvic examination and microscopic examination of the vaginal discharge.

Microscopic examination of the vaginal discharge can reveal:

• whether or not the squamous epithelial cells are estrogenized. The absence of estrogen will, along with physical findings, indicate the possibility that the patient is experiencing atrophic vaginitis.
• the presence of estrogenized squamous epithelial cells. Plus, a finding of erythema of the vaginal epithelium indicates that the patient has an inflammatory condition and vaginitis, suggesting a possible infection in addition to vaginitis. 
• the presence of white blood cells >5/40X magnification, which indicates the possible presence of infection in addition to vaginitis (eg, BV). 

I agree that NAAT can confirm an initial diagnosis or refute it. In the latter case, the physician can change treatment accordingly. In the absence or in conjunction with the presence of a sexually transmitted infection, the composition of the vaginal microbiome is significant (ie, determining if vaginal dysbiosis is present). Performing a comprehensive evaluation, determining if the most common pathogens are present in aerobic vaginitis and/or BV, plus completing a Lactobacillus panel can be expensive. If insurance companies do not pay for such testing, patients will be reluctant to pay out of pocket for these tests. 

My final comment addresses the administration of NAAT for aerobic vaginitis, and for BV, it is probably an ineffective treatment. Vaginal dysbiosis is based on whether the appropriate species of Lactobacillus is present, and the concentration. Treatment most likely will be based on replenishing or restoring the appropriate species of Lactobacillus to dominance. 

Sebastian Faro, MD, PhD

Houston, Texas

Dr. Barbieri responds

I agree with Dr. Faro; when used by highly trained clinicians, microscopy is an excellent tool for evaluating vaginal specimens. Expert clinicians, such as Dr. Faro, with a focus on infectious diseases do not need to rely on NAAT testing except for identifying cases of T vaginalis infection. However, in standard clinical practice, microscopy performs poorly, resulting in misdiagnosis.¹ In the average clinical practice, NAAT testing may help improve patient outcomes. 

1. Gaydos CA, Beqaj S, Schwebke JR, et al. Clinical validation of a test for the diagnosis of vaginitis. Obstet Gynecol. 2017;130:181-189.

A note of thanks

I am a 74-year-old ObGyn who finished training at the University of North Carolina in 1979. Currently, I am working at a rural health group 2 days a week as a source of in-house gyn referral for 17 primary care physicians and mid-level providers. Our patients are almost all underserved and self-pay. The bulk of my work is related to evaluating abnormal uterine bleeding and abnormal Pap tests. Your publication of OBG Management serves now as one of my main sources of information. I just wanted to thank you and let you know that the publication is important. Keep up the good work and best wishes. 

Julian Brantley, MD

Rocky Mountain, North Carolina
 

Dr. Barbieri responds

I thank Dr. Brantley for taking time from a busy practice to write about how OBG Management provides practical information relevant to practice. Each issue of OBG Management is built on a foundation of insights from expert clinicians, which is crafted into a finished product by a superb editorial team. Our goal is to enhance the quality of women’s health care and the professional development of obstetrician-gynecologists and all women’s health care clinicians. ●

CAN WE RETURN TO THE ABCS OF CRAFTING A MEDICAL RECORD NOTE? 

ROBERT L. BARBIERI, MD (OCTOBER 2021)

Physicians can  help provide EMR fixes

I appreciate Dr. Barbieri’s editorials and insight on many issues facing our profession. I would like to offer my comments on a recent article.

If you want your brakes fixed, don’t go to a shoe maker. Physicians seem to have lost our sense of who is most competent in determining the best way to practice and communicate medical care. Somehow we have turned this over to the bureaucrats, who seem to find ways to complicate the lives of both providers and patients. Maybe we are too busy caring for patients and trying to find ways to alleviate the burden placed on our time by the electronic medical record (EMR) system, which was touted as an improvement in medical care and increasing provider efficiency. Most of the time I hear my colleagues describing ways to “work around” an EMR system that has immense deficiencies in providing accurate information in a way that is easily digested by whomever is viewing the record. The universal ability to transfer information is simply not true. One colleague had the same office version of Cerner as was used in the hospital setting but was unable to send information back and forth due to the danger of the potential to corrupt the system. 

Dr. Barbieri mentioned his work around to make the record easier for the patient to read. I ask, what about the coding descriptions, which most systems are now requiring physicians to put in at the time of the encounter? In the past this was done by certified coders, who undergo a 1- to 2-year training program, and is now being performed by physicians who have minimal to no training in coding. (And who, by the way, can be fined for both under- and over coding.) The example Dr. Barbieri put forth for obesity comes to mind and is part of the medical record in all cases. The terminology used by ICD10 is not so kind and requires some imagination when trying to find the right code for many diagnoses.

When will we stop allowing others, who know little about medicine and caring for patients, to tell us how to provide the care that we have trained for 7-12 years on how  best to deliver?

William Sutton, MD

Muncie, Indiana

Dr. Barbieri responds

I thank Dr. Sutton for providing his experience with the electronic medical record. I agree with him that bureaucrats often create health care rules that do more to hinder than help patients. With regard to coding and billing, I use ICD-10 codes and  usually bill based on time, which includes both face-to-face time with the patient and time spent reviewing the patient’s medical records. Now that federal regulations require medical notes to be shared with patients, I craft my history, assessment, and plan with language that is easy for a patient to accept and understand, avoiding medical terms that patients might misinterpret.

Should microscopy  be replaced? 

I agree with many points Dr. Barbieri made in his editorial. However, I do not agree that the microscopic examination of the vaginal discharge should be replaced. NAAT offers some advantages, but it does not offer a complete assessment of the vaginal ecosystem and microbiome. I believe that NAAT should be used in conjunction with the pelvic examination and microscopic examination of the vaginal discharge.

Microscopic examination of the vaginal discharge can reveal:

• whether or not the squamous epithelial cells are estrogenized. The absence of estrogen will, along with physical findings, indicate the possibility that the patient is experiencing atrophic vaginitis.
• the presence of estrogenized squamous epithelial cells. Plus, a finding of erythema of the vaginal epithelium indicates that the patient has an inflammatory condition and vaginitis, suggesting a possible infection in addition to vaginitis. 
• the presence of white blood cells >5/40X magnification, which indicates the possible presence of infection in addition to vaginitis (eg, BV). 

I agree that NAAT can confirm an initial diagnosis or refute it. In the latter case, the physician can change treatment accordingly. In the absence or in conjunction with the presence of a sexually transmitted infection, the composition of the vaginal microbiome is significant (ie, determining if vaginal dysbiosis is present). Performing a comprehensive evaluation, determining if the most common pathogens are present in aerobic vaginitis and/or BV, plus completing a Lactobacillus panel can be expensive. If insurance companies do not pay for such testing, patients will be reluctant to pay out of pocket for these tests. 

My final comment addresses the administration of NAAT for aerobic vaginitis, and for BV, it is probably an ineffective treatment. Vaginal dysbiosis is based on whether the appropriate species of Lactobacillus is present, and the concentration. Treatment most likely will be based on replenishing or restoring the appropriate species of Lactobacillus to dominance. 

Sebastian Faro, MD, PhD

Houston, Texas

Dr. Barbieri responds

I agree with Dr. Faro; when used by highly trained clinicians, microscopy is an excellent tool for evaluating vaginal specimens. Expert clinicians, such as Dr. Faro, with a focus on infectious diseases do not need to rely on NAAT testing except for identifying cases of T vaginalis infection. However, in standard clinical practice, microscopy performs poorly, resulting in misdiagnosis.¹ In the average clinical practice, NAAT testing may help improve patient outcomes. 

1. Gaydos CA, Beqaj S, Schwebke JR, et al. Clinical validation of a test for the diagnosis of vaginitis. Obstet Gynecol. 2017;130:181-189.

A note of thanks

I am a 74-year-old ObGyn who finished training at the University of North Carolina in 1979. Currently, I am working at a rural health group 2 days a week as a source of in-house gyn referral for 17 primary care physicians and mid-level providers. Our patients are almost all underserved and self-pay. The bulk of my work is related to evaluating abnormal uterine bleeding and abnormal Pap tests. Your publication of OBG Management serves now as one of my main sources of information. I just wanted to thank you and let you know that the publication is important. Keep up the good work and best wishes. 

Julian Brantley, MD

Rocky Mountain, North Carolina
 

Dr. Barbieri responds

I thank Dr. Brantley for taking time from a busy practice to write about how OBG Management provides practical information relevant to practice. Each issue of OBG Management is built on a foundation of insights from expert clinicians, which is crafted into a finished product by a superb editorial team. Our goal is to enhance the quality of women’s health care and the professional development of obstetrician-gynecologists and all women’s health care clinicians. ●

The Food and Drug Administration has granted accelerated approval to selpercatinib (Retevmo) in 40-mg and 80-mg capsules for adults with locally advanced or metastatic RET fusion–positive solid tumors that have progressed during or following systemic treatment, or for patients for whom there are no good alternative treatments.

In 2020, selpercatinib received accelerated approval for lung and thyroid RET-positive tumors; that approval transitioned to a regular approval for non–small cell lung cancer on Sept. 21. The latest approval expands the drug label to include an array of RET-positive tumor types, including pancreatic and colorectal cancers.

The approval was based on data from the phase 1/2 LIBRETTO-001 trial, which evaluated 41 patients with RET fusion–positive tumors. Thirty-seven patients (90%) had received prior systemic therapy, with almost one-third receiving three or more. Primary efficacy measures were overall response rate and duration of response.

Among the 41 patients, the overall response rate was 44%, with a duration of response of 24.5 months. Additionally, for 67% of patients, results lasted at least 6 months.

“In the LIBRETTO-001 trial, selpercatinib demonstrated clinically meaningful and durable responses across a variety of tumor types in patients with RET-driven cancers,” Vivek Subbiah, MD, coinvestigator for the trial, said in a press release. “These data and FDA approval of the tumor-agnostic indication underscore the importance of routine, comprehensive genomic testing for patients across a wide variety of tumor types.”

The most common cancers in the study were pancreatic adenocarcinoma (27%), colorectal cancer (24%), and salivary cancer (10%).

The recommended selpercatinib dose, based on body weight, is 120 mg orally twice daily for people who weigh less than 110 pounds or 160 mg orally twice daily for who weigh 110 pounds or more.

The most common adverse reactions were edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has granted accelerated approval to selpercatinib (Retevmo) in 40-mg and 80-mg capsules for adults with locally advanced or metastatic RET fusion–positive solid tumors that have progressed during or following systemic treatment, or for patients for whom there are no good alternative treatments.

In 2020, selpercatinib received accelerated approval for lung and thyroid RET-positive tumors; that approval transitioned to a regular approval for non–small cell lung cancer on Sept. 21. The latest approval expands the drug label to include an array of RET-positive tumor types, including pancreatic and colorectal cancers.

The approval was based on data from the phase 1/2 LIBRETTO-001 trial, which evaluated 41 patients with RET fusion–positive tumors. Thirty-seven patients (90%) had received prior systemic therapy, with almost one-third receiving three or more. Primary efficacy measures were overall response rate and duration of response.

Among the 41 patients, the overall response rate was 44%, with a duration of response of 24.5 months. Additionally, for 67% of patients, results lasted at least 6 months.

“In the LIBRETTO-001 trial, selpercatinib demonstrated clinically meaningful and durable responses across a variety of tumor types in patients with RET-driven cancers,” Vivek Subbiah, MD, coinvestigator for the trial, said in a press release. “These data and FDA approval of the tumor-agnostic indication underscore the importance of routine, comprehensive genomic testing for patients across a wide variety of tumor types.”

The most common cancers in the study were pancreatic adenocarcinoma (27%), colorectal cancer (24%), and salivary cancer (10%).

The recommended selpercatinib dose, based on body weight, is 120 mg orally twice daily for people who weigh less than 110 pounds or 160 mg orally twice daily for who weigh 110 pounds or more.

The most common adverse reactions were edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has granted accelerated approval to selpercatinib (Retevmo) in 40-mg and 80-mg capsules for adults with locally advanced or metastatic RET fusion–positive solid tumors that have progressed during or following systemic treatment, or for patients for whom there are no good alternative treatments.

In 2020, selpercatinib received accelerated approval for lung and thyroid RET-positive tumors; that approval transitioned to a regular approval for non–small cell lung cancer on Sept. 21. The latest approval expands the drug label to include an array of RET-positive tumor types, including pancreatic and colorectal cancers.

The approval was based on data from the phase 1/2 LIBRETTO-001 trial, which evaluated 41 patients with RET fusion–positive tumors. Thirty-seven patients (90%) had received prior systemic therapy, with almost one-third receiving three or more. Primary efficacy measures were overall response rate and duration of response.

Among the 41 patients, the overall response rate was 44%, with a duration of response of 24.5 months. Additionally, for 67% of patients, results lasted at least 6 months.

“In the LIBRETTO-001 trial, selpercatinib demonstrated clinically meaningful and durable responses across a variety of tumor types in patients with RET-driven cancers,” Vivek Subbiah, MD, coinvestigator for the trial, said in a press release. “These data and FDA approval of the tumor-agnostic indication underscore the importance of routine, comprehensive genomic testing for patients across a wide variety of tumor types.”

The most common cancers in the study were pancreatic adenocarcinoma (27%), colorectal cancer (24%), and salivary cancer (10%).

The recommended selpercatinib dose, based on body weight, is 120 mg orally twice daily for people who weigh less than 110 pounds or 160 mg orally twice daily for who weigh 110 pounds or more.

The most common adverse reactions were edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.

A version of this article first appeared on Medscape.com.

Managing children’s cow’s milk allergy is costly to families and to health care systems, largely owing to costs of prescriptions, according to an industry-sponsored study based on data from the United Kingdom.

“This large cohort study provides novel evidence of a significant health economic burden of cow’s milk allergy in children,” Abbie L. Cawood, PhD, RNutr, MICR, head of scientific affairs at Nutricia Ltd in Trowbridge, England, and colleagues wrote in Clinical and Translational Allergy.

“Management of cow’s milk allergy necessitates the exclusion of cow’s milk protein from the diet. Whilst breastmilk remains the ideal nutrient source in infants with cow’s milk allergy, infants who are not exclusively breastfed require a hypoallergenic formula,” added Dr. Cawood, a visiting research fellow at University of Southampton, and her coauthors.

Cow’s milk allergy, an immune‐mediated response to one or more proteins in cow’s milk, is one of the most common childhood food allergies and affects 2%-5% of infants in Europe. Management involves avoiding cow’s milk protein and treating possible related gastrointestinal, skin, respiratory, and other allergic conditions, the authors explained.

In their retrospective matched cohort study, Dr. Cawood and colleagues turned to The Health Improvement Network (THIN), a Cegedim Rx proprietary database of 2.9 million anonymized active patient records. They extracted data from nearly 7,000 case records covering 5 years (2015-2020).

They examined medication prescriptions and health care professional contacts based on diagnosis read-codes and hypoallergenic formula prescriptions and compared health care costs for children with cow’s milk allergy with the costs for those without.

They matched 3,499 children aged 1 year or younger who had confirmed or suspected cow’s milk allergy with the same number of children without cow’s milk allergy. Around half of the participants were boys, and the mean observation period was 4.2 years.
 

Children with cow’s milk allergy need more, costly health care

The researchers found:

• Medications were prescribed to significantly more children with cow’s milk allergy (CMA), at a higher rate, than to those without CMA. In particular, prescriptions for antireflux medication increased by almost 500%.
• Children with CMA needed significantly more health care contacts and at a higher rate than those without CMA.
• CMA was linked with additional potential health care costs of £1381.53 per person per year. Assuming a 2.5% prevalence from the estimated 2%-5% CMA prevalence range and extrapolating to the UK infant population, CMA may have added more than £25.7 million in annual health care costs nationwide.

“Several conditions in infancy necessitate the elimination of cow milk–based formulas and require extensively hydrolyzed or amino acid formulas or, if preferred or able, exclusive breast milk,” Kara E. Coffey, MD, assistant professor of pediatrics at the University of Pittsburgh, said by email.

“This study shows that, regardless of the reason for cow milk–based avoidance, these infants require more healthcare service utilizations (clinic visits, nutritional assessments, prescriptions) than [do] their peers, which is certainly a commitment of a lot of time and money for their families to ensure their ability to grow and thrive,” added Dr. Coffey, who was not involved in the study.

Jodi A. Shroba, MSN, APRN, CPNP, the coordinator for the Food Allergy Program at Children’s Mercy Kansas City, Mo., did not find these numbers surprising.

“Children with food allergies typically have other atopic comorbidities that require more visits to primary care physicians and specialists and more prescriptions,” Ms. Shroba, who was not involved in the study, said by email.

“An intriguing statement is that the U.K. guidelines recommend the involvement of a dietitian for children with cow’s milk allergy,” she noted. “In the United States, having a dietitian involved would be a wonderful addition to care, as avoidance of cow’s milk can cause nutritional and growth deficiencies. But not all healthcare practices have those resources available.

“The higher rate of antibiotic use and the almost 500% increase of antireflux prescriptions by the children with cow’s milk allergy warrant additional research,” she added.

Nutricia Ltd. funded the study. Dr. Cawood and one coauthor are employed by Nutricia, and all other coauthors have been employees of or have other financial relationships with Nutricia. One coauthor is employed by Cegedim Rx, which was funded for this research by Nutricia. Ms. Shroba and Dr. Coffey report no conflicts of interest with the study.

A version of this article first appeared on Medscape.com.

Managing children’s cow’s milk allergy is costly to families and to health care systems, largely owing to costs of prescriptions, according to an industry-sponsored study based on data from the United Kingdom.

“This large cohort study provides novel evidence of a significant health economic burden of cow’s milk allergy in children,” Abbie L. Cawood, PhD, RNutr, MICR, head of scientific affairs at Nutricia Ltd in Trowbridge, England, and colleagues wrote in Clinical and Translational Allergy.

“Management of cow’s milk allergy necessitates the exclusion of cow’s milk protein from the diet. Whilst breastmilk remains the ideal nutrient source in infants with cow’s milk allergy, infants who are not exclusively breastfed require a hypoallergenic formula,” added Dr. Cawood, a visiting research fellow at University of Southampton, and her coauthors.

Cow’s milk allergy, an immune‐mediated response to one or more proteins in cow’s milk, is one of the most common childhood food allergies and affects 2%-5% of infants in Europe. Management involves avoiding cow’s milk protein and treating possible related gastrointestinal, skin, respiratory, and other allergic conditions, the authors explained.

In their retrospective matched cohort study, Dr. Cawood and colleagues turned to The Health Improvement Network (THIN), a Cegedim Rx proprietary database of 2.9 million anonymized active patient records. They extracted data from nearly 7,000 case records covering 5 years (2015-2020).

They examined medication prescriptions and health care professional contacts based on diagnosis read-codes and hypoallergenic formula prescriptions and compared health care costs for children with cow’s milk allergy with the costs for those without.

They matched 3,499 children aged 1 year or younger who had confirmed or suspected cow’s milk allergy with the same number of children without cow’s milk allergy. Around half of the participants were boys, and the mean observation period was 4.2 years.
 

Children with cow’s milk allergy need more, costly health care

The researchers found:

• Medications were prescribed to significantly more children with cow’s milk allergy (CMA), at a higher rate, than to those without CMA. In particular, prescriptions for antireflux medication increased by almost 500%.
• Children with CMA needed significantly more health care contacts and at a higher rate than those without CMA.
• CMA was linked with additional potential health care costs of £1381.53 per person per year. Assuming a 2.5% prevalence from the estimated 2%-5% CMA prevalence range and extrapolating to the UK infant population, CMA may have added more than £25.7 million in annual health care costs nationwide.

“Several conditions in infancy necessitate the elimination of cow milk–based formulas and require extensively hydrolyzed or amino acid formulas or, if preferred or able, exclusive breast milk,” Kara E. Coffey, MD, assistant professor of pediatrics at the University of Pittsburgh, said by email.

“This study shows that, regardless of the reason for cow milk–based avoidance, these infants require more healthcare service utilizations (clinic visits, nutritional assessments, prescriptions) than [do] their peers, which is certainly a commitment of a lot of time and money for their families to ensure their ability to grow and thrive,” added Dr. Coffey, who was not involved in the study.

Jodi A. Shroba, MSN, APRN, CPNP, the coordinator for the Food Allergy Program at Children’s Mercy Kansas City, Mo., did not find these numbers surprising.

“Children with food allergies typically have other atopic comorbidities that require more visits to primary care physicians and specialists and more prescriptions,” Ms. Shroba, who was not involved in the study, said by email.

“An intriguing statement is that the U.K. guidelines recommend the involvement of a dietitian for children with cow’s milk allergy,” she noted. “In the United States, having a dietitian involved would be a wonderful addition to care, as avoidance of cow’s milk can cause nutritional and growth deficiencies. But not all healthcare practices have those resources available.

“The higher rate of antibiotic use and the almost 500% increase of antireflux prescriptions by the children with cow’s milk allergy warrant additional research,” she added.

Nutricia Ltd. funded the study. Dr. Cawood and one coauthor are employed by Nutricia, and all other coauthors have been employees of or have other financial relationships with Nutricia. One coauthor is employed by Cegedim Rx, which was funded for this research by Nutricia. Ms. Shroba and Dr. Coffey report no conflicts of interest with the study.

A version of this article first appeared on Medscape.com.

Managing children’s cow’s milk allergy is costly to families and to health care systems, largely owing to costs of prescriptions, according to an industry-sponsored study based on data from the United Kingdom.

“This large cohort study provides novel evidence of a significant health economic burden of cow’s milk allergy in children,” Abbie L. Cawood, PhD, RNutr, MICR, head of scientific affairs at Nutricia Ltd in Trowbridge, England, and colleagues wrote in Clinical and Translational Allergy.

“Management of cow’s milk allergy necessitates the exclusion of cow’s milk protein from the diet. Whilst breastmilk remains the ideal nutrient source in infants with cow’s milk allergy, infants who are not exclusively breastfed require a hypoallergenic formula,” added Dr. Cawood, a visiting research fellow at University of Southampton, and her coauthors.

Cow’s milk allergy, an immune‐mediated response to one or more proteins in cow’s milk, is one of the most common childhood food allergies and affects 2%-5% of infants in Europe. Management involves avoiding cow’s milk protein and treating possible related gastrointestinal, skin, respiratory, and other allergic conditions, the authors explained.

In their retrospective matched cohort study, Dr. Cawood and colleagues turned to The Health Improvement Network (THIN), a Cegedim Rx proprietary database of 2.9 million anonymized active patient records. They extracted data from nearly 7,000 case records covering 5 years (2015-2020).

They examined medication prescriptions and health care professional contacts based on diagnosis read-codes and hypoallergenic formula prescriptions and compared health care costs for children with cow’s milk allergy with the costs for those without.

They matched 3,499 children aged 1 year or younger who had confirmed or suspected cow’s milk allergy with the same number of children without cow’s milk allergy. Around half of the participants were boys, and the mean observation period was 4.2 years.
 

Children with cow’s milk allergy need more, costly health care

The researchers found:

• Medications were prescribed to significantly more children with cow’s milk allergy (CMA), at a higher rate, than to those without CMA. In particular, prescriptions for antireflux medication increased by almost 500%.
• Children with CMA needed significantly more health care contacts and at a higher rate than those without CMA.
• CMA was linked with additional potential health care costs of £1381.53 per person per year. Assuming a 2.5% prevalence from the estimated 2%-5% CMA prevalence range and extrapolating to the UK infant population, CMA may have added more than £25.7 million in annual health care costs nationwide.

“Several conditions in infancy necessitate the elimination of cow milk–based formulas and require extensively hydrolyzed or amino acid formulas or, if preferred or able, exclusive breast milk,” Kara E. Coffey, MD, assistant professor of pediatrics at the University of Pittsburgh, said by email.

“This study shows that, regardless of the reason for cow milk–based avoidance, these infants require more healthcare service utilizations (clinic visits, nutritional assessments, prescriptions) than [do] their peers, which is certainly a commitment of a lot of time and money for their families to ensure their ability to grow and thrive,” added Dr. Coffey, who was not involved in the study.

Jodi A. Shroba, MSN, APRN, CPNP, the coordinator for the Food Allergy Program at Children’s Mercy Kansas City, Mo., did not find these numbers surprising.

“Children with food allergies typically have other atopic comorbidities that require more visits to primary care physicians and specialists and more prescriptions,” Ms. Shroba, who was not involved in the study, said by email.

“An intriguing statement is that the U.K. guidelines recommend the involvement of a dietitian for children with cow’s milk allergy,” she noted. “In the United States, having a dietitian involved would be a wonderful addition to care, as avoidance of cow’s milk can cause nutritional and growth deficiencies. But not all healthcare practices have those resources available.

“The higher rate of antibiotic use and the almost 500% increase of antireflux prescriptions by the children with cow’s milk allergy warrant additional research,” she added.

Nutricia Ltd. funded the study. Dr. Cawood and one coauthor are employed by Nutricia, and all other coauthors have been employees of or have other financial relationships with Nutricia. One coauthor is employed by Cegedim Rx, which was funded for this research by Nutricia. Ms. Shroba and Dr. Coffey report no conflicts of interest with the study.

A version of this article first appeared on Medscape.com.