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AAP report aims to educate providers on female genital mutilation/cutting
Although female genital mutilation or cutting (FGM/C) is outlawed in much of the world, it still occurs for cultural reasons despite having no medical benefit, according to a clinical report from the American Academy of Pediatrics.
FGM/C is mainly performed on children and adolescents, but most of the research and teaching to date has addressed the impact of FGM/C on women of childbearing age and management during pregnancy and post partum, wrote Janine Young, MD, of the University of Colorado Denver in Aurora and colleagues. They are members of the AAP section on global health, committee on medical liability and risk management, or the committee on bioethics.
Published in Pediatrics, the report provides “the first comprehensive summary of FGM/C in children and includes education regarding a standard-of-care approach for examination of external female genitalia at all health supervision examinations, diagnosis, complications, management, treatment, culturally sensitive discussion and counseling approaches, and legal and ethical considerations,” they wrote.
The World Health Organization categorizes FGM/C into four subtypes. “Type I includes cutting of the glans or part of the body of the clitoris and/or prepuce; type II includes excision of the clitoris and labia minora, with or without excision of the labia majora; type III, infibulation, includes cutting and apposing the labia minora and/or majora over the urethral meatus and vaginal opening to significantly narrow it and may include clitoral excision; and type IV includes piercing, scraping, nicking, stretching, or otherwise injuring the external female genitalia without removing any genital tissue and includes practices that do not fall into the other three categories,” the authors wrote. Of these, type III is associated with the greatest long-term morbidity.
Data suggest that the prevalence and type of FGM/C varies by region, with the highest prevalence of type III in East Africa, where 82%-99% of girls reported FGM/C and 34%-79% of these cases involved type III, the authors reported.
Generally, pediatric health care providers in the United States have limited knowledge of FGM/C in the absence of any required courses on diagnosis or treatment for most primary care specialties. However, clinicians should be aware of possible risk factors, including a mother or sibling with a history of FGM/C, or patients with a country of origin, birth country, or travel history to a country where FGM/C is practiced, Dr. Young and associates noted.
They recommend that but acknowledged the challenges in raising the topic and addressing it in a culturally sensitive way. “Experts suggest that health care providers ask the patient or parent the term they use to name female genital cutting” and avoid the term mutilation, which may be offensive or misunderstood.
Many girls who have undergone FGM/C were too young to remember, the authors note. “Instead, it is advisable that the FGM/C clinical history taking include both the girl and parent or guardian once rapport has been established.”
Review potential medical complications if FGM/C is identified, and plans should be made for follow-up visits to monitor development of complications, the authors said. In addition, engage in a culturally sensitive discussion with teenagers, who may or may not have known about their FGM/C. In some cases, parents and caregivers may not have known about the FGM/C, which may be a community practice in some cultures with decisions made by other family members or authority figures.
“It is important for health care providers to assess each patient individually and make no assumptions about her and her parents’ beliefs regarding FGM/C,” Dr. Young and associates emphasized. “Mothers and fathers may or may not hold discordant views about FGM/C, and some clinical experts suggest that mothers who have themselves undergone FGM/C may nonetheless oppose subjecting their daughters to this practice. Instead, treating patients and caregivers with respect, sensitivity, and professionalism will encourage them to return and supports health-seeking behavior.”
The report presents 11 specific recommendations, including that health care providers should not perform any type of FGM/C and actively counsel families against such practices. In addition, children should have external genitalia checked at all health supervision examinations (with the consent of the guardian and/or child), and an assessment for FGM/C should be documented in the health records of patients with risk factors.
Notably, “[i]f genital examination findings are equivocal for the presence of FGM/C and risk factors for FGM/ C are present, a specialist trained in identification of FGM/C should be consulted,” Dr. Young and associates recommended. They also recommended defibulation for all girls and teenagers with type III FGM/C, especially for those with complications, and the procedure should be performed by an experienced pediatric gynecologist, gynecologist, urologist, or urogynecologist.
Finally, “[i]f FGM/C is suspected to have occurred in the United States, or as vacation cutting after immigration to the United States, the child should be evaluated for potential abuse. ... Expressed intention to engage in FGM/C, either in the United States or abroad, should also prompt a report to CPS [child protective services] if the child’s parent or caregiver cannot be dissuaded,” the authors wrote.
The report also includes case examples and expert analyses from legal and medical ethics experts to provide additional guidance for clinicians.
“This work seeks to educate pediatric health care providers on the occurrence of FGM/C, and the broader applications to the patients/population it impacts as well as the intersecting issues of diagnosis, complications, treatment, counseling needs, and the ethical and legal implications,” M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview.
However, challenges in implementing the recommendations “relate to the complexity of the issue and also the need for greater education of primary providers,” Dr. Jay said. “The overall message for providers, I believe, is a greater understanding of the practice [of FGM/C] as most providers have limited knowledge of this practice in the United States.”
“I believe the case-based presentations allow for a better understanding of how best to approach patients and families,” she added.
Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said, “I think one of largest barriers to implementing the strategies [from] this report is the limited knowledge of FGM/C by most clinicians.”
“In general, many pediatricians are uncomfortable with genital examinations,” she said in an interview. “I suspect most feel uncomfortable with identifying FGM/C versus other genital pathology and may not have ready access to FGM/C experts. Additionally, having these difficult conversations with families about this sensitive topic may be challenging,” said Dr. Curran. “Fortunately, this report is incredibly comprehensive, providing extensive background into FGM/C, effectively using diagrams and pictures, and explaining the legal and ethical issues that arise in the care of these patients.”
“Ultimately, I think there will need to be more education within medical training and further research into FGM/C,” Dr. Curran added. “Clinicians should be knowledgeable about FGM/C, including prevalence, identification, health complications, and treatment, as well as legal and ethical implications.” However, “in addition to knowledge, clinicians must be able to navigate counseling patients and their families around this culturally sensitive topic.”
The report is thorough and well written, yet “there still remains significant gaps in knowledge about FGM/C in children and adolescents,” she said. “I think future research into prevalence, along with the health effects of FGM/C, including its impact on mental and sexual health, in the pediatric population will be essential.”
The study received no outside funding. Coauthor Christa Johnson-Agbakwu, MD, disclosed a grant relationship with Arizona State University from the 2018 copyright of “Female Genital Mutilation/Cutting (FGM/C): A Visual Reference and Learning Tool for Health Care Professionals.” The other researchers had no financial conflicts to disclose. Dr. Jay and Dr. Curran had no relevant financial conflicts to disclose. They are members of the Pediatric News editorial advisory board.
SOURCE: Young J et al. Pediatrics. 2020 Jul 27. doi: 10.1542/peds.2020-1012.
Although female genital mutilation or cutting (FGM/C) is outlawed in much of the world, it still occurs for cultural reasons despite having no medical benefit, according to a clinical report from the American Academy of Pediatrics.
FGM/C is mainly performed on children and adolescents, but most of the research and teaching to date has addressed the impact of FGM/C on women of childbearing age and management during pregnancy and post partum, wrote Janine Young, MD, of the University of Colorado Denver in Aurora and colleagues. They are members of the AAP section on global health, committee on medical liability and risk management, or the committee on bioethics.
Published in Pediatrics, the report provides “the first comprehensive summary of FGM/C in children and includes education regarding a standard-of-care approach for examination of external female genitalia at all health supervision examinations, diagnosis, complications, management, treatment, culturally sensitive discussion and counseling approaches, and legal and ethical considerations,” they wrote.
The World Health Organization categorizes FGM/C into four subtypes. “Type I includes cutting of the glans or part of the body of the clitoris and/or prepuce; type II includes excision of the clitoris and labia minora, with or without excision of the labia majora; type III, infibulation, includes cutting and apposing the labia minora and/or majora over the urethral meatus and vaginal opening to significantly narrow it and may include clitoral excision; and type IV includes piercing, scraping, nicking, stretching, or otherwise injuring the external female genitalia without removing any genital tissue and includes practices that do not fall into the other three categories,” the authors wrote. Of these, type III is associated with the greatest long-term morbidity.
Data suggest that the prevalence and type of FGM/C varies by region, with the highest prevalence of type III in East Africa, where 82%-99% of girls reported FGM/C and 34%-79% of these cases involved type III, the authors reported.
Generally, pediatric health care providers in the United States have limited knowledge of FGM/C in the absence of any required courses on diagnosis or treatment for most primary care specialties. However, clinicians should be aware of possible risk factors, including a mother or sibling with a history of FGM/C, or patients with a country of origin, birth country, or travel history to a country where FGM/C is practiced, Dr. Young and associates noted.
They recommend that but acknowledged the challenges in raising the topic and addressing it in a culturally sensitive way. “Experts suggest that health care providers ask the patient or parent the term they use to name female genital cutting” and avoid the term mutilation, which may be offensive or misunderstood.
Many girls who have undergone FGM/C were too young to remember, the authors note. “Instead, it is advisable that the FGM/C clinical history taking include both the girl and parent or guardian once rapport has been established.”
Review potential medical complications if FGM/C is identified, and plans should be made for follow-up visits to monitor development of complications, the authors said. In addition, engage in a culturally sensitive discussion with teenagers, who may or may not have known about their FGM/C. In some cases, parents and caregivers may not have known about the FGM/C, which may be a community practice in some cultures with decisions made by other family members or authority figures.
“It is important for health care providers to assess each patient individually and make no assumptions about her and her parents’ beliefs regarding FGM/C,” Dr. Young and associates emphasized. “Mothers and fathers may or may not hold discordant views about FGM/C, and some clinical experts suggest that mothers who have themselves undergone FGM/C may nonetheless oppose subjecting their daughters to this practice. Instead, treating patients and caregivers with respect, sensitivity, and professionalism will encourage them to return and supports health-seeking behavior.”
The report presents 11 specific recommendations, including that health care providers should not perform any type of FGM/C and actively counsel families against such practices. In addition, children should have external genitalia checked at all health supervision examinations (with the consent of the guardian and/or child), and an assessment for FGM/C should be documented in the health records of patients with risk factors.
Notably, “[i]f genital examination findings are equivocal for the presence of FGM/C and risk factors for FGM/ C are present, a specialist trained in identification of FGM/C should be consulted,” Dr. Young and associates recommended. They also recommended defibulation for all girls and teenagers with type III FGM/C, especially for those with complications, and the procedure should be performed by an experienced pediatric gynecologist, gynecologist, urologist, or urogynecologist.
Finally, “[i]f FGM/C is suspected to have occurred in the United States, or as vacation cutting after immigration to the United States, the child should be evaluated for potential abuse. ... Expressed intention to engage in FGM/C, either in the United States or abroad, should also prompt a report to CPS [child protective services] if the child’s parent or caregiver cannot be dissuaded,” the authors wrote.
The report also includes case examples and expert analyses from legal and medical ethics experts to provide additional guidance for clinicians.
“This work seeks to educate pediatric health care providers on the occurrence of FGM/C, and the broader applications to the patients/population it impacts as well as the intersecting issues of diagnosis, complications, treatment, counseling needs, and the ethical and legal implications,” M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview.
However, challenges in implementing the recommendations “relate to the complexity of the issue and also the need for greater education of primary providers,” Dr. Jay said. “The overall message for providers, I believe, is a greater understanding of the practice [of FGM/C] as most providers have limited knowledge of this practice in the United States.”
“I believe the case-based presentations allow for a better understanding of how best to approach patients and families,” she added.
Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said, “I think one of largest barriers to implementing the strategies [from] this report is the limited knowledge of FGM/C by most clinicians.”
“In general, many pediatricians are uncomfortable with genital examinations,” she said in an interview. “I suspect most feel uncomfortable with identifying FGM/C versus other genital pathology and may not have ready access to FGM/C experts. Additionally, having these difficult conversations with families about this sensitive topic may be challenging,” said Dr. Curran. “Fortunately, this report is incredibly comprehensive, providing extensive background into FGM/C, effectively using diagrams and pictures, and explaining the legal and ethical issues that arise in the care of these patients.”
“Ultimately, I think there will need to be more education within medical training and further research into FGM/C,” Dr. Curran added. “Clinicians should be knowledgeable about FGM/C, including prevalence, identification, health complications, and treatment, as well as legal and ethical implications.” However, “in addition to knowledge, clinicians must be able to navigate counseling patients and their families around this culturally sensitive topic.”
The report is thorough and well written, yet “there still remains significant gaps in knowledge about FGM/C in children and adolescents,” she said. “I think future research into prevalence, along with the health effects of FGM/C, including its impact on mental and sexual health, in the pediatric population will be essential.”
The study received no outside funding. Coauthor Christa Johnson-Agbakwu, MD, disclosed a grant relationship with Arizona State University from the 2018 copyright of “Female Genital Mutilation/Cutting (FGM/C): A Visual Reference and Learning Tool for Health Care Professionals.” The other researchers had no financial conflicts to disclose. Dr. Jay and Dr. Curran had no relevant financial conflicts to disclose. They are members of the Pediatric News editorial advisory board.
SOURCE: Young J et al. Pediatrics. 2020 Jul 27. doi: 10.1542/peds.2020-1012.
Although female genital mutilation or cutting (FGM/C) is outlawed in much of the world, it still occurs for cultural reasons despite having no medical benefit, according to a clinical report from the American Academy of Pediatrics.
FGM/C is mainly performed on children and adolescents, but most of the research and teaching to date has addressed the impact of FGM/C on women of childbearing age and management during pregnancy and post partum, wrote Janine Young, MD, of the University of Colorado Denver in Aurora and colleagues. They are members of the AAP section on global health, committee on medical liability and risk management, or the committee on bioethics.
Published in Pediatrics, the report provides “the first comprehensive summary of FGM/C in children and includes education regarding a standard-of-care approach for examination of external female genitalia at all health supervision examinations, diagnosis, complications, management, treatment, culturally sensitive discussion and counseling approaches, and legal and ethical considerations,” they wrote.
The World Health Organization categorizes FGM/C into four subtypes. “Type I includes cutting of the glans or part of the body of the clitoris and/or prepuce; type II includes excision of the clitoris and labia minora, with or without excision of the labia majora; type III, infibulation, includes cutting and apposing the labia minora and/or majora over the urethral meatus and vaginal opening to significantly narrow it and may include clitoral excision; and type IV includes piercing, scraping, nicking, stretching, or otherwise injuring the external female genitalia without removing any genital tissue and includes practices that do not fall into the other three categories,” the authors wrote. Of these, type III is associated with the greatest long-term morbidity.
Data suggest that the prevalence and type of FGM/C varies by region, with the highest prevalence of type III in East Africa, where 82%-99% of girls reported FGM/C and 34%-79% of these cases involved type III, the authors reported.
Generally, pediatric health care providers in the United States have limited knowledge of FGM/C in the absence of any required courses on diagnosis or treatment for most primary care specialties. However, clinicians should be aware of possible risk factors, including a mother or sibling with a history of FGM/C, or patients with a country of origin, birth country, or travel history to a country where FGM/C is practiced, Dr. Young and associates noted.
They recommend that but acknowledged the challenges in raising the topic and addressing it in a culturally sensitive way. “Experts suggest that health care providers ask the patient or parent the term they use to name female genital cutting” and avoid the term mutilation, which may be offensive or misunderstood.
Many girls who have undergone FGM/C were too young to remember, the authors note. “Instead, it is advisable that the FGM/C clinical history taking include both the girl and parent or guardian once rapport has been established.”
Review potential medical complications if FGM/C is identified, and plans should be made for follow-up visits to monitor development of complications, the authors said. In addition, engage in a culturally sensitive discussion with teenagers, who may or may not have known about their FGM/C. In some cases, parents and caregivers may not have known about the FGM/C, which may be a community practice in some cultures with decisions made by other family members or authority figures.
“It is important for health care providers to assess each patient individually and make no assumptions about her and her parents’ beliefs regarding FGM/C,” Dr. Young and associates emphasized. “Mothers and fathers may or may not hold discordant views about FGM/C, and some clinical experts suggest that mothers who have themselves undergone FGM/C may nonetheless oppose subjecting their daughters to this practice. Instead, treating patients and caregivers with respect, sensitivity, and professionalism will encourage them to return and supports health-seeking behavior.”
The report presents 11 specific recommendations, including that health care providers should not perform any type of FGM/C and actively counsel families against such practices. In addition, children should have external genitalia checked at all health supervision examinations (with the consent of the guardian and/or child), and an assessment for FGM/C should be documented in the health records of patients with risk factors.
Notably, “[i]f genital examination findings are equivocal for the presence of FGM/C and risk factors for FGM/ C are present, a specialist trained in identification of FGM/C should be consulted,” Dr. Young and associates recommended. They also recommended defibulation for all girls and teenagers with type III FGM/C, especially for those with complications, and the procedure should be performed by an experienced pediatric gynecologist, gynecologist, urologist, or urogynecologist.
Finally, “[i]f FGM/C is suspected to have occurred in the United States, or as vacation cutting after immigration to the United States, the child should be evaluated for potential abuse. ... Expressed intention to engage in FGM/C, either in the United States or abroad, should also prompt a report to CPS [child protective services] if the child’s parent or caregiver cannot be dissuaded,” the authors wrote.
The report also includes case examples and expert analyses from legal and medical ethics experts to provide additional guidance for clinicians.
“This work seeks to educate pediatric health care providers on the occurrence of FGM/C, and the broader applications to the patients/population it impacts as well as the intersecting issues of diagnosis, complications, treatment, counseling needs, and the ethical and legal implications,” M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview.
However, challenges in implementing the recommendations “relate to the complexity of the issue and also the need for greater education of primary providers,” Dr. Jay said. “The overall message for providers, I believe, is a greater understanding of the practice [of FGM/C] as most providers have limited knowledge of this practice in the United States.”
“I believe the case-based presentations allow for a better understanding of how best to approach patients and families,” she added.
Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said, “I think one of largest barriers to implementing the strategies [from] this report is the limited knowledge of FGM/C by most clinicians.”
“In general, many pediatricians are uncomfortable with genital examinations,” she said in an interview. “I suspect most feel uncomfortable with identifying FGM/C versus other genital pathology and may not have ready access to FGM/C experts. Additionally, having these difficult conversations with families about this sensitive topic may be challenging,” said Dr. Curran. “Fortunately, this report is incredibly comprehensive, providing extensive background into FGM/C, effectively using diagrams and pictures, and explaining the legal and ethical issues that arise in the care of these patients.”
“Ultimately, I think there will need to be more education within medical training and further research into FGM/C,” Dr. Curran added. “Clinicians should be knowledgeable about FGM/C, including prevalence, identification, health complications, and treatment, as well as legal and ethical implications.” However, “in addition to knowledge, clinicians must be able to navigate counseling patients and their families around this culturally sensitive topic.”
The report is thorough and well written, yet “there still remains significant gaps in knowledge about FGM/C in children and adolescents,” she said. “I think future research into prevalence, along with the health effects of FGM/C, including its impact on mental and sexual health, in the pediatric population will be essential.”
The study received no outside funding. Coauthor Christa Johnson-Agbakwu, MD, disclosed a grant relationship with Arizona State University from the 2018 copyright of “Female Genital Mutilation/Cutting (FGM/C): A Visual Reference and Learning Tool for Health Care Professionals.” The other researchers had no financial conflicts to disclose. Dr. Jay and Dr. Curran had no relevant financial conflicts to disclose. They are members of the Pediatric News editorial advisory board.
SOURCE: Young J et al. Pediatrics. 2020 Jul 27. doi: 10.1542/peds.2020-1012.
FROM PEDIATRICS
Patients with COPD plus sleep problems should be screened for mood disorders
A study has shown a strong link between sleeping disturbances and depression in patients with chronic obstructive pulmonary disease.
Adults with clinically stable COPD who reported sleep problems were significantly more likely to report depression or anxiety, poor self-efficacy, and poor health-related quality of life, compared with those not reporting sleep problems, according to the findings from a study of 245 patients.
Sleep problems are common in patients with COPD and have been associated with poor COPD-related outcomes, wrote Sang Hee Lee, MD, of Wonkwang University Sanbon Hospital, Gunpo-si, South Korea, and colleagues.
“However, there is a lack of research on factors associated with sleep disturbance in patients with COPD,” they wrote.
In a prospective, multicenter, cross-sectional study published in the Clinical Respiratory Journal, the researchers enrolled 245 adults with COPD who completed the COPD and Asthma Impact Scale (CASIS) to determine sleep impairment. The CASIS was developed to measure sleep-related problems associated with respiratory disease, and scored on a scale of 1-100, with higher scores indicating greater sleep impairment. The average CASIS score was 40.9. The average age of the patients was 67 years, and 92% were men.
Patients’ health-related quality of life, anxiety/depression, and self-efficacy were assessed using the St. George’s Respiratory Questionnaire (SGRQ), the 36-item Short-Form Health Survey (SF-36), Hospital Anxiety and Depression Scale (HADS), and the COPD Self-Efficacy Scale (CSES). The average scores on these measures were 36.0 for the SGRQ; 48.1 and 50.6, respectively, for the physical and mental components of the SF-36; 3.8 and 6.4, respectively, for the HADS-A and HADS-D measures of anxiety and depression; and 3.3 on the CSES.
Worse sleep in these patients was associated with worse scores on measures of mood. In a multivariate analysis, higher scores on all four measures of health-related quality of life were significantly associated with higher CASIS scores (P = .006 for SGRQ; P = .037 for SF-36, P < .001 for HADS, and P = .010 for CSES).
Although the CASIS did not allow for measurement of symptom severity and did not include many items related to breathing problems, the test “shows good internal consistency, test-retest reproducibility, and construct validity according to previous studies,” the researchers wrote. “The CASIS may be a good tool for evaluating sleep disturbances in COPD patients, and further study is needed,” they added.
The study findings were limited by several factors including the cross-sectional study design, lack of data on obstructive sleep apnea, and lack of information on specific treatments such as at-home oxygen use or high-dose steroid use, the researchers noted. However, the results were strengthened by the use of a disease-specific sleep measure, and the study is the first known to include self-efficacy in relation to sleep quality in COPD patients, they reported.
The results highlight the association between depression, poor quality of life, and self-efficacy in relation to poor sleep, and suggest that “Sleep quality could be improved by enhancing HRQL and self-efficacy,” the researchers said. “Screening for mood disorder in patients with COPD is also needed,” they concluded.
The study was supported by the Basic Science Research Program of the National Research Foundation of Korea (NRF) funded by the Ministry of Education, Science and Technology. The researchers had no financial conflicts to disclose.
SOURCE: Lee SH et al. Clin Respir J. 2020 Jul 24. doi: 10.1111/crj.13235.
A study has shown a strong link between sleeping disturbances and depression in patients with chronic obstructive pulmonary disease.
Adults with clinically stable COPD who reported sleep problems were significantly more likely to report depression or anxiety, poor self-efficacy, and poor health-related quality of life, compared with those not reporting sleep problems, according to the findings from a study of 245 patients.
Sleep problems are common in patients with COPD and have been associated with poor COPD-related outcomes, wrote Sang Hee Lee, MD, of Wonkwang University Sanbon Hospital, Gunpo-si, South Korea, and colleagues.
“However, there is a lack of research on factors associated with sleep disturbance in patients with COPD,” they wrote.
In a prospective, multicenter, cross-sectional study published in the Clinical Respiratory Journal, the researchers enrolled 245 adults with COPD who completed the COPD and Asthma Impact Scale (CASIS) to determine sleep impairment. The CASIS was developed to measure sleep-related problems associated with respiratory disease, and scored on a scale of 1-100, with higher scores indicating greater sleep impairment. The average CASIS score was 40.9. The average age of the patients was 67 years, and 92% were men.
Patients’ health-related quality of life, anxiety/depression, and self-efficacy were assessed using the St. George’s Respiratory Questionnaire (SGRQ), the 36-item Short-Form Health Survey (SF-36), Hospital Anxiety and Depression Scale (HADS), and the COPD Self-Efficacy Scale (CSES). The average scores on these measures were 36.0 for the SGRQ; 48.1 and 50.6, respectively, for the physical and mental components of the SF-36; 3.8 and 6.4, respectively, for the HADS-A and HADS-D measures of anxiety and depression; and 3.3 on the CSES.
Worse sleep in these patients was associated with worse scores on measures of mood. In a multivariate analysis, higher scores on all four measures of health-related quality of life were significantly associated with higher CASIS scores (P = .006 for SGRQ; P = .037 for SF-36, P < .001 for HADS, and P = .010 for CSES).
Although the CASIS did not allow for measurement of symptom severity and did not include many items related to breathing problems, the test “shows good internal consistency, test-retest reproducibility, and construct validity according to previous studies,” the researchers wrote. “The CASIS may be a good tool for evaluating sleep disturbances in COPD patients, and further study is needed,” they added.
The study findings were limited by several factors including the cross-sectional study design, lack of data on obstructive sleep apnea, and lack of information on specific treatments such as at-home oxygen use or high-dose steroid use, the researchers noted. However, the results were strengthened by the use of a disease-specific sleep measure, and the study is the first known to include self-efficacy in relation to sleep quality in COPD patients, they reported.
The results highlight the association between depression, poor quality of life, and self-efficacy in relation to poor sleep, and suggest that “Sleep quality could be improved by enhancing HRQL and self-efficacy,” the researchers said. “Screening for mood disorder in patients with COPD is also needed,” they concluded.
The study was supported by the Basic Science Research Program of the National Research Foundation of Korea (NRF) funded by the Ministry of Education, Science and Technology. The researchers had no financial conflicts to disclose.
SOURCE: Lee SH et al. Clin Respir J. 2020 Jul 24. doi: 10.1111/crj.13235.
A study has shown a strong link between sleeping disturbances and depression in patients with chronic obstructive pulmonary disease.
Adults with clinically stable COPD who reported sleep problems were significantly more likely to report depression or anxiety, poor self-efficacy, and poor health-related quality of life, compared with those not reporting sleep problems, according to the findings from a study of 245 patients.
Sleep problems are common in patients with COPD and have been associated with poor COPD-related outcomes, wrote Sang Hee Lee, MD, of Wonkwang University Sanbon Hospital, Gunpo-si, South Korea, and colleagues.
“However, there is a lack of research on factors associated with sleep disturbance in patients with COPD,” they wrote.
In a prospective, multicenter, cross-sectional study published in the Clinical Respiratory Journal, the researchers enrolled 245 adults with COPD who completed the COPD and Asthma Impact Scale (CASIS) to determine sleep impairment. The CASIS was developed to measure sleep-related problems associated with respiratory disease, and scored on a scale of 1-100, with higher scores indicating greater sleep impairment. The average CASIS score was 40.9. The average age of the patients was 67 years, and 92% were men.
Patients’ health-related quality of life, anxiety/depression, and self-efficacy were assessed using the St. George’s Respiratory Questionnaire (SGRQ), the 36-item Short-Form Health Survey (SF-36), Hospital Anxiety and Depression Scale (HADS), and the COPD Self-Efficacy Scale (CSES). The average scores on these measures were 36.0 for the SGRQ; 48.1 and 50.6, respectively, for the physical and mental components of the SF-36; 3.8 and 6.4, respectively, for the HADS-A and HADS-D measures of anxiety and depression; and 3.3 on the CSES.
Worse sleep in these patients was associated with worse scores on measures of mood. In a multivariate analysis, higher scores on all four measures of health-related quality of life were significantly associated with higher CASIS scores (P = .006 for SGRQ; P = .037 for SF-36, P < .001 for HADS, and P = .010 for CSES).
Although the CASIS did not allow for measurement of symptom severity and did not include many items related to breathing problems, the test “shows good internal consistency, test-retest reproducibility, and construct validity according to previous studies,” the researchers wrote. “The CASIS may be a good tool for evaluating sleep disturbances in COPD patients, and further study is needed,” they added.
The study findings were limited by several factors including the cross-sectional study design, lack of data on obstructive sleep apnea, and lack of information on specific treatments such as at-home oxygen use or high-dose steroid use, the researchers noted. However, the results were strengthened by the use of a disease-specific sleep measure, and the study is the first known to include self-efficacy in relation to sleep quality in COPD patients, they reported.
The results highlight the association between depression, poor quality of life, and self-efficacy in relation to poor sleep, and suggest that “Sleep quality could be improved by enhancing HRQL and self-efficacy,” the researchers said. “Screening for mood disorder in patients with COPD is also needed,” they concluded.
The study was supported by the Basic Science Research Program of the National Research Foundation of Korea (NRF) funded by the Ministry of Education, Science and Technology. The researchers had no financial conflicts to disclose.
SOURCE: Lee SH et al. Clin Respir J. 2020 Jul 24. doi: 10.1111/crj.13235.
FROM THE CLINICAL RESPIRATORY JOURNAL
Updated EULAR/ACR criteria identify more lupus patients
Use of the 2019 EULAR/ACR criteria for systemic lupus erythematosus identified an additional 17% of lupus patients in a cohort of 133 women with undifferentiated connective tissue disease.
Several studies have applied the 2019 EULAR/ACR criteria for systemic lupus erythematosus (SLE) to different patient populations, wrote Massimo Radin, MD, of S. Giovanni Bosco Hospital, Turin, Italy, and colleagues.
“However, it is unknown if the new classifications criteria for SLE might impact on the categorization of patients previously diagnosed with undifferentiated connective tissue disease (UCTD),” they said in a brief report published in Arthritis Care & Research.
In addition, “being classified or not as having SLE may pose clinical and logistic consequences, as patients with a diagnosis of ‘SLE’ might be followed up according to a specific local protocol and have in-label access to certain medications (such as biologics) or may be eligible for the participation in clinical trials,” they wrote.
The investigators applied the 2019 EULAR/ACR criteria to a cohort of 133 women with UCTD but no other diagnosis. The average age of the women was 38 years; the average disease duration was 10 years. Patients who scored 10 points or more on positive clinical and immunological domains at the start of the study were classified as SLE under the 2019 EULAR/ACR criteria.
Overall, 22 patients (17%) met the classification criteria for SLE at the time of their first pregnancy.
Compared with the other patients in the cohort who were not classified as SLE, patients classified as SLE under the 2019 EULAR/ACR criteria had significantly higher frequency of mucocutaneous manifestations (5% vs. 23%), arthritis (17% vs. 59%), isolated urine abnormalities (1% vs. 18%), and highly specific antibodies (15% vs. 50%).
In addition, patients who met the 2019 EULAR/ACR SLE criteria were significantly more likely to meet the ACR 1997 and SLICC criteria after an average follow-up of 9 years compared with the rest of the cohort (18.2% vs. 1.8%). Patients who met the 2019 EULAR/ACR criteria also had significantly shorter disease duration than that of the other patients in the UCTD cohort (8.23 years vs. 10.7 years) and were significantly more likely to develop preeclampsia during pregnancy (18% vs. 0%).
The findings were limited by several factors including the retrospective design of the study and possible lack of generalizability to male patients, the researchers noted.
The results support the need for improved classification criteria for UCTD, as early identification of specific conditions can help guide treatment and reduce the risk of more severe symptoms and complications, the authors said.
“When discriminating between conditions with a marked overlap, such as SLE and UCTD, the proposal of new classification criteria should balance specificity and sensitivity,” the researchers wrote. “When developing new classification criteria, one approach is to select patients and the control groups as representative as possible of the settings (the medical practices) in which these criteria will be used.”
The study received no outside funding. The researchers had no financial conflicts to disclose.
SOURCE: Radin M et al. Art
Use of the 2019 EULAR/ACR criteria for systemic lupus erythematosus identified an additional 17% of lupus patients in a cohort of 133 women with undifferentiated connective tissue disease.
Several studies have applied the 2019 EULAR/ACR criteria for systemic lupus erythematosus (SLE) to different patient populations, wrote Massimo Radin, MD, of S. Giovanni Bosco Hospital, Turin, Italy, and colleagues.
“However, it is unknown if the new classifications criteria for SLE might impact on the categorization of patients previously diagnosed with undifferentiated connective tissue disease (UCTD),” they said in a brief report published in Arthritis Care & Research.
In addition, “being classified or not as having SLE may pose clinical and logistic consequences, as patients with a diagnosis of ‘SLE’ might be followed up according to a specific local protocol and have in-label access to certain medications (such as biologics) or may be eligible for the participation in clinical trials,” they wrote.
The investigators applied the 2019 EULAR/ACR criteria to a cohort of 133 women with UCTD but no other diagnosis. The average age of the women was 38 years; the average disease duration was 10 years. Patients who scored 10 points or more on positive clinical and immunological domains at the start of the study were classified as SLE under the 2019 EULAR/ACR criteria.
Overall, 22 patients (17%) met the classification criteria for SLE at the time of their first pregnancy.
Compared with the other patients in the cohort who were not classified as SLE, patients classified as SLE under the 2019 EULAR/ACR criteria had significantly higher frequency of mucocutaneous manifestations (5% vs. 23%), arthritis (17% vs. 59%), isolated urine abnormalities (1% vs. 18%), and highly specific antibodies (15% vs. 50%).
In addition, patients who met the 2019 EULAR/ACR SLE criteria were significantly more likely to meet the ACR 1997 and SLICC criteria after an average follow-up of 9 years compared with the rest of the cohort (18.2% vs. 1.8%). Patients who met the 2019 EULAR/ACR criteria also had significantly shorter disease duration than that of the other patients in the UCTD cohort (8.23 years vs. 10.7 years) and were significantly more likely to develop preeclampsia during pregnancy (18% vs. 0%).
The findings were limited by several factors including the retrospective design of the study and possible lack of generalizability to male patients, the researchers noted.
The results support the need for improved classification criteria for UCTD, as early identification of specific conditions can help guide treatment and reduce the risk of more severe symptoms and complications, the authors said.
“When discriminating between conditions with a marked overlap, such as SLE and UCTD, the proposal of new classification criteria should balance specificity and sensitivity,” the researchers wrote. “When developing new classification criteria, one approach is to select patients and the control groups as representative as possible of the settings (the medical practices) in which these criteria will be used.”
The study received no outside funding. The researchers had no financial conflicts to disclose.
SOURCE: Radin M et al. Art
Use of the 2019 EULAR/ACR criteria for systemic lupus erythematosus identified an additional 17% of lupus patients in a cohort of 133 women with undifferentiated connective tissue disease.
Several studies have applied the 2019 EULAR/ACR criteria for systemic lupus erythematosus (SLE) to different patient populations, wrote Massimo Radin, MD, of S. Giovanni Bosco Hospital, Turin, Italy, and colleagues.
“However, it is unknown if the new classifications criteria for SLE might impact on the categorization of patients previously diagnosed with undifferentiated connective tissue disease (UCTD),” they said in a brief report published in Arthritis Care & Research.
In addition, “being classified or not as having SLE may pose clinical and logistic consequences, as patients with a diagnosis of ‘SLE’ might be followed up according to a specific local protocol and have in-label access to certain medications (such as biologics) or may be eligible for the participation in clinical trials,” they wrote.
The investigators applied the 2019 EULAR/ACR criteria to a cohort of 133 women with UCTD but no other diagnosis. The average age of the women was 38 years; the average disease duration was 10 years. Patients who scored 10 points or more on positive clinical and immunological domains at the start of the study were classified as SLE under the 2019 EULAR/ACR criteria.
Overall, 22 patients (17%) met the classification criteria for SLE at the time of their first pregnancy.
Compared with the other patients in the cohort who were not classified as SLE, patients classified as SLE under the 2019 EULAR/ACR criteria had significantly higher frequency of mucocutaneous manifestations (5% vs. 23%), arthritis (17% vs. 59%), isolated urine abnormalities (1% vs. 18%), and highly specific antibodies (15% vs. 50%).
In addition, patients who met the 2019 EULAR/ACR SLE criteria were significantly more likely to meet the ACR 1997 and SLICC criteria after an average follow-up of 9 years compared with the rest of the cohort (18.2% vs. 1.8%). Patients who met the 2019 EULAR/ACR criteria also had significantly shorter disease duration than that of the other patients in the UCTD cohort (8.23 years vs. 10.7 years) and were significantly more likely to develop preeclampsia during pregnancy (18% vs. 0%).
The findings were limited by several factors including the retrospective design of the study and possible lack of generalizability to male patients, the researchers noted.
The results support the need for improved classification criteria for UCTD, as early identification of specific conditions can help guide treatment and reduce the risk of more severe symptoms and complications, the authors said.
“When discriminating between conditions with a marked overlap, such as SLE and UCTD, the proposal of new classification criteria should balance specificity and sensitivity,” the researchers wrote. “When developing new classification criteria, one approach is to select patients and the control groups as representative as possible of the settings (the medical practices) in which these criteria will be used.”
The study received no outside funding. The researchers had no financial conflicts to disclose.
SOURCE: Radin M et al. Art
FROM ARTHRITIS CARE & RESEARCH
Do chocolate lovers have healthier arteries?
Adults who ate chocolate more than once a week or more than 3.5 times a month were significantly less likely to develop coronary artery disease than were those who ate less chocolate, according to data from a meta-analysis of more than 300,000 individuals.
Consumption of chocolate has shown beneficial effects on blood pressure and endothelial function, wrote Chayakrit Krittanawong, MD, of Baylor College of Medicine, Houston, and colleagues in the European Journal of Preventive Cardiology. “However, the potential benefit of increased chocolate consumption reducing coronary artery disease (CAD) risk is not known,” they said.
The investigators reviewed data from 5 decades of research, including six studies with a total of 336,289 individuals who reported chocolate consumption. The study participants experienced 14,043 cases of CAD, 4,667 myocardial infarctions, 2,735 cerebrovascular accidents, and 332 cases of heart failure over an average follow-up period of 8.78 years.
Overall, higher chocolate consumption (defined as more than once a week or more than 3.5 times a month) was significantly associated with a decreased CAD risk (pooled risk ratio, 0.94; P < .001) compared to eating no chocolate or eating chocolate less than once a week.
The cardioprotective effects of chocolate may be linked to several nutrients, the researchers noted. Chocolate’s flavenols (epicatechin, catechin, and procyanidins) have demonstrated an ability to reduce myocardial infarct size in an animal study and to reduce platelet aggregation and improve endothelial function in humans with and without CAD. In addition, methylxanthines have demonstrated beneficial effects on cardiovascular function, polyphenols have been shown to facilitate nitric oxide synthesis, and stearic acid has been associated with reduced mean platelet volume, they wrote.
“The benefits of nutrients in chocolate appear promising and chocolate consumption at least once a week may be beneficial for CAD prevention,” the researchers suggested, although they cautioned that the effects of supplemental calories and the impact of fats, milk, and sugar in commercial chocolate must be taken into account.
The study findings were limited by several factors, including the potential dietary confounders such as total energy intake and the type of chocolate consumed (milk, dark, or white) and the relatively homogeneous study population, which included mainly individuals from Europe and the United States.
Additional long-term, double-blind, randomized trials are needed to identify the cardioprotective effects of chocolate, and “studies to determine the role of genetic potential and the beneficial effects of chocolate on CAD may be needed,” the researchers noted.
However, the current study results suggest that “consumption of chocolates at least once a week is associated with a reduction in the risk of CAD,” they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
SOURCE: Krittanawong C et al. Eur J Prev Cardiol. 2020 Jul 23. doi: 10.1177/2047487320936787.
Adults who ate chocolate more than once a week or more than 3.5 times a month were significantly less likely to develop coronary artery disease than were those who ate less chocolate, according to data from a meta-analysis of more than 300,000 individuals.
Consumption of chocolate has shown beneficial effects on blood pressure and endothelial function, wrote Chayakrit Krittanawong, MD, of Baylor College of Medicine, Houston, and colleagues in the European Journal of Preventive Cardiology. “However, the potential benefit of increased chocolate consumption reducing coronary artery disease (CAD) risk is not known,” they said.
The investigators reviewed data from 5 decades of research, including six studies with a total of 336,289 individuals who reported chocolate consumption. The study participants experienced 14,043 cases of CAD, 4,667 myocardial infarctions, 2,735 cerebrovascular accidents, and 332 cases of heart failure over an average follow-up period of 8.78 years.
Overall, higher chocolate consumption (defined as more than once a week or more than 3.5 times a month) was significantly associated with a decreased CAD risk (pooled risk ratio, 0.94; P < .001) compared to eating no chocolate or eating chocolate less than once a week.
The cardioprotective effects of chocolate may be linked to several nutrients, the researchers noted. Chocolate’s flavenols (epicatechin, catechin, and procyanidins) have demonstrated an ability to reduce myocardial infarct size in an animal study and to reduce platelet aggregation and improve endothelial function in humans with and without CAD. In addition, methylxanthines have demonstrated beneficial effects on cardiovascular function, polyphenols have been shown to facilitate nitric oxide synthesis, and stearic acid has been associated with reduced mean platelet volume, they wrote.
“The benefits of nutrients in chocolate appear promising and chocolate consumption at least once a week may be beneficial for CAD prevention,” the researchers suggested, although they cautioned that the effects of supplemental calories and the impact of fats, milk, and sugar in commercial chocolate must be taken into account.
The study findings were limited by several factors, including the potential dietary confounders such as total energy intake and the type of chocolate consumed (milk, dark, or white) and the relatively homogeneous study population, which included mainly individuals from Europe and the United States.
Additional long-term, double-blind, randomized trials are needed to identify the cardioprotective effects of chocolate, and “studies to determine the role of genetic potential and the beneficial effects of chocolate on CAD may be needed,” the researchers noted.
However, the current study results suggest that “consumption of chocolates at least once a week is associated with a reduction in the risk of CAD,” they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
SOURCE: Krittanawong C et al. Eur J Prev Cardiol. 2020 Jul 23. doi: 10.1177/2047487320936787.
Adults who ate chocolate more than once a week or more than 3.5 times a month were significantly less likely to develop coronary artery disease than were those who ate less chocolate, according to data from a meta-analysis of more than 300,000 individuals.
Consumption of chocolate has shown beneficial effects on blood pressure and endothelial function, wrote Chayakrit Krittanawong, MD, of Baylor College of Medicine, Houston, and colleagues in the European Journal of Preventive Cardiology. “However, the potential benefit of increased chocolate consumption reducing coronary artery disease (CAD) risk is not known,” they said.
The investigators reviewed data from 5 decades of research, including six studies with a total of 336,289 individuals who reported chocolate consumption. The study participants experienced 14,043 cases of CAD, 4,667 myocardial infarctions, 2,735 cerebrovascular accidents, and 332 cases of heart failure over an average follow-up period of 8.78 years.
Overall, higher chocolate consumption (defined as more than once a week or more than 3.5 times a month) was significantly associated with a decreased CAD risk (pooled risk ratio, 0.94; P < .001) compared to eating no chocolate or eating chocolate less than once a week.
The cardioprotective effects of chocolate may be linked to several nutrients, the researchers noted. Chocolate’s flavenols (epicatechin, catechin, and procyanidins) have demonstrated an ability to reduce myocardial infarct size in an animal study and to reduce platelet aggregation and improve endothelial function in humans with and without CAD. In addition, methylxanthines have demonstrated beneficial effects on cardiovascular function, polyphenols have been shown to facilitate nitric oxide synthesis, and stearic acid has been associated with reduced mean platelet volume, they wrote.
“The benefits of nutrients in chocolate appear promising and chocolate consumption at least once a week may be beneficial for CAD prevention,” the researchers suggested, although they cautioned that the effects of supplemental calories and the impact of fats, milk, and sugar in commercial chocolate must be taken into account.
The study findings were limited by several factors, including the potential dietary confounders such as total energy intake and the type of chocolate consumed (milk, dark, or white) and the relatively homogeneous study population, which included mainly individuals from Europe and the United States.
Additional long-term, double-blind, randomized trials are needed to identify the cardioprotective effects of chocolate, and “studies to determine the role of genetic potential and the beneficial effects of chocolate on CAD may be needed,” the researchers noted.
However, the current study results suggest that “consumption of chocolates at least once a week is associated with a reduction in the risk of CAD,” they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
SOURCE: Krittanawong C et al. Eur J Prev Cardiol. 2020 Jul 23. doi: 10.1177/2047487320936787.
FROM THE EUROPEAN JOURNAL OF PREVENTIVE CARDIOLOGY
FDA allows qualified claims for UTI risk reduction with cranberry products
The Food and Drug Administration will not object to qualified health claims that consumption of certain cranberry juice products and cranberry supplement products may reduce the risk of recurrent urinary tract infections in otherwise healthy women.
In a letter of enforcement discretion issued on July 21, the FDA responded to a health claim petition submitted by Ocean Spray Cranberries. “A health claim characterizes the relationship between a substance and a disease or health-related condition,” according to the FDA. Ocean Spray Cranberries asked the FDA for an authorized health claim regarding the relationship between the consumption of cranberry beverages and supplements and a reduction in the risk of recurrent urinary tract infections (UTIs) in healthy women.
After reviewing the evidence, the FDA determined that the existing science did not support an authorized health claim, but did allow for a qualified health claim for certain cranberry juice beverages and supplements. A qualified health claim does not constitute an FDA approval; the FDA instead issues a Letter of Enforcement Discretion that includes language reflecting the level of scientific evidence for the claim.
The currently available scientific evidence for a relationship between cranberry and recurrent UTIs includes five intervention studies, according to the FDA letter. Two of these were high-quality, randomized, controlled trials in which daily consumption of a cranberry juice beverage was significantly associated with a reduced risk of recurrent UTIs. Another randomized, controlled trial yielded mixed results, and two other intervention studies that were moderate-quality, randomized, controlled trials showed no effect of cranberry juice consumption on UTI risk reduction.
The FDA’s letter of enforcement discretion states that, with regard to cranberry juice beverages, “Limited and inconsistent scientific evidence shows that by consuming one serving (8 oz) each day of a cranberry juice beverage, healthy women who have had a urinary tract infection may reduce their risk of recurrent UTI.”
Similarly, for cranberry dietary supplements, the FDA states that “Limited scientific evidence shows that, by consuming 500 mg each day of cranberry dietary supplement, healthy women who have had a urinary tract infection may reduce their risk of recurrent UTI.”
The qualified health claims apply specifically to cranberry juice beverages that contain at least 27% cranberry juice, and cranberry dietary supplements containing at least 500 mg of cranberry fruit powder. “The claims do not include other conventional foods or food products made from or containing cranberries, such as dried cranberries or cranberry sauce,” according to the FDA statement.
“With recurrent UTI, a major concern is the frequent use of antibiotics,” Constance Bohon, MD, an ob.gyn. in private practice in Washington and an assistant clinical professor at George Washington University, Washington, said in an interview.
“The challenge is to identify habits and/or nonantibiotic treatment to prevent recurrent UTI and decrease the need for antibiotics,” she said. “The regular use of cranberry can decrease the frequency of UTI in some, but not all, people.
“It does not appear to mask the symptoms of a UTI, so if it is not effective to prevent the infection, the presumptive diagnosis can be made based on the common symptoms,” she explained.
Dr. Bohon said that she has recommended the use of cranberry to some of her patients who have recurrent UTIs and has had success with many of them.
“I think it is important to make it clear that cranberry can be beneficial for some patients to decrease the frequency of UTI. It will not be effective for everyone who has frequent UTI, but for those who use it and have fewer UTIs, there will be less frequent exposure to antibiotics,” she emphasized. “What we need to know is who benefits the most from cranberry to prevent recurrent UTIs; whether age, race, coexisting health problems [such as diabetes], and use of hormonal contraception or menopause impact on its success.”
Dr. Bohon had no relevant financial conflicts to disclose.
The Food and Drug Administration will not object to qualified health claims that consumption of certain cranberry juice products and cranberry supplement products may reduce the risk of recurrent urinary tract infections in otherwise healthy women.
In a letter of enforcement discretion issued on July 21, the FDA responded to a health claim petition submitted by Ocean Spray Cranberries. “A health claim characterizes the relationship between a substance and a disease or health-related condition,” according to the FDA. Ocean Spray Cranberries asked the FDA for an authorized health claim regarding the relationship between the consumption of cranberry beverages and supplements and a reduction in the risk of recurrent urinary tract infections (UTIs) in healthy women.
After reviewing the evidence, the FDA determined that the existing science did not support an authorized health claim, but did allow for a qualified health claim for certain cranberry juice beverages and supplements. A qualified health claim does not constitute an FDA approval; the FDA instead issues a Letter of Enforcement Discretion that includes language reflecting the level of scientific evidence for the claim.
The currently available scientific evidence for a relationship between cranberry and recurrent UTIs includes five intervention studies, according to the FDA letter. Two of these were high-quality, randomized, controlled trials in which daily consumption of a cranberry juice beverage was significantly associated with a reduced risk of recurrent UTIs. Another randomized, controlled trial yielded mixed results, and two other intervention studies that were moderate-quality, randomized, controlled trials showed no effect of cranberry juice consumption on UTI risk reduction.
The FDA’s letter of enforcement discretion states that, with regard to cranberry juice beverages, “Limited and inconsistent scientific evidence shows that by consuming one serving (8 oz) each day of a cranberry juice beverage, healthy women who have had a urinary tract infection may reduce their risk of recurrent UTI.”
Similarly, for cranberry dietary supplements, the FDA states that “Limited scientific evidence shows that, by consuming 500 mg each day of cranberry dietary supplement, healthy women who have had a urinary tract infection may reduce their risk of recurrent UTI.”
The qualified health claims apply specifically to cranberry juice beverages that contain at least 27% cranberry juice, and cranberry dietary supplements containing at least 500 mg of cranberry fruit powder. “The claims do not include other conventional foods or food products made from or containing cranberries, such as dried cranberries or cranberry sauce,” according to the FDA statement.
“With recurrent UTI, a major concern is the frequent use of antibiotics,” Constance Bohon, MD, an ob.gyn. in private practice in Washington and an assistant clinical professor at George Washington University, Washington, said in an interview.
“The challenge is to identify habits and/or nonantibiotic treatment to prevent recurrent UTI and decrease the need for antibiotics,” she said. “The regular use of cranberry can decrease the frequency of UTI in some, but not all, people.
“It does not appear to mask the symptoms of a UTI, so if it is not effective to prevent the infection, the presumptive diagnosis can be made based on the common symptoms,” she explained.
Dr. Bohon said that she has recommended the use of cranberry to some of her patients who have recurrent UTIs and has had success with many of them.
“I think it is important to make it clear that cranberry can be beneficial for some patients to decrease the frequency of UTI. It will not be effective for everyone who has frequent UTI, but for those who use it and have fewer UTIs, there will be less frequent exposure to antibiotics,” she emphasized. “What we need to know is who benefits the most from cranberry to prevent recurrent UTIs; whether age, race, coexisting health problems [such as diabetes], and use of hormonal contraception or menopause impact on its success.”
Dr. Bohon had no relevant financial conflicts to disclose.
The Food and Drug Administration will not object to qualified health claims that consumption of certain cranberry juice products and cranberry supplement products may reduce the risk of recurrent urinary tract infections in otherwise healthy women.
In a letter of enforcement discretion issued on July 21, the FDA responded to a health claim petition submitted by Ocean Spray Cranberries. “A health claim characterizes the relationship between a substance and a disease or health-related condition,” according to the FDA. Ocean Spray Cranberries asked the FDA for an authorized health claim regarding the relationship between the consumption of cranberry beverages and supplements and a reduction in the risk of recurrent urinary tract infections (UTIs) in healthy women.
After reviewing the evidence, the FDA determined that the existing science did not support an authorized health claim, but did allow for a qualified health claim for certain cranberry juice beverages and supplements. A qualified health claim does not constitute an FDA approval; the FDA instead issues a Letter of Enforcement Discretion that includes language reflecting the level of scientific evidence for the claim.
The currently available scientific evidence for a relationship between cranberry and recurrent UTIs includes five intervention studies, according to the FDA letter. Two of these were high-quality, randomized, controlled trials in which daily consumption of a cranberry juice beverage was significantly associated with a reduced risk of recurrent UTIs. Another randomized, controlled trial yielded mixed results, and two other intervention studies that were moderate-quality, randomized, controlled trials showed no effect of cranberry juice consumption on UTI risk reduction.
The FDA’s letter of enforcement discretion states that, with regard to cranberry juice beverages, “Limited and inconsistent scientific evidence shows that by consuming one serving (8 oz) each day of a cranberry juice beverage, healthy women who have had a urinary tract infection may reduce their risk of recurrent UTI.”
Similarly, for cranberry dietary supplements, the FDA states that “Limited scientific evidence shows that, by consuming 500 mg each day of cranberry dietary supplement, healthy women who have had a urinary tract infection may reduce their risk of recurrent UTI.”
The qualified health claims apply specifically to cranberry juice beverages that contain at least 27% cranberry juice, and cranberry dietary supplements containing at least 500 mg of cranberry fruit powder. “The claims do not include other conventional foods or food products made from or containing cranberries, such as dried cranberries or cranberry sauce,” according to the FDA statement.
“With recurrent UTI, a major concern is the frequent use of antibiotics,” Constance Bohon, MD, an ob.gyn. in private practice in Washington and an assistant clinical professor at George Washington University, Washington, said in an interview.
“The challenge is to identify habits and/or nonantibiotic treatment to prevent recurrent UTI and decrease the need for antibiotics,” she said. “The regular use of cranberry can decrease the frequency of UTI in some, but not all, people.
“It does not appear to mask the symptoms of a UTI, so if it is not effective to prevent the infection, the presumptive diagnosis can be made based on the common symptoms,” she explained.
Dr. Bohon said that she has recommended the use of cranberry to some of her patients who have recurrent UTIs and has had success with many of them.
“I think it is important to make it clear that cranberry can be beneficial for some patients to decrease the frequency of UTI. It will not be effective for everyone who has frequent UTI, but for those who use it and have fewer UTIs, there will be less frequent exposure to antibiotics,” she emphasized. “What we need to know is who benefits the most from cranberry to prevent recurrent UTIs; whether age, race, coexisting health problems [such as diabetes], and use of hormonal contraception or menopause impact on its success.”
Dr. Bohon had no relevant financial conflicts to disclose.
Levonorgestrel IUDs offer safe, effective care for disabled adolescents
for menstrual management and contraception, based on data from a retrospective study of 159 patients.
“Desire for menstrual management or suppression is common in young women with special needs, including complex medical conditions and physical, intellectual, and developmental disabilities,” and many of these patients require estrogen-free options because of comorbidities, medication interactions, or decreased mobility, wrote Beth I. Schwartz, MD, and colleagues at Cincinnati Children’s Hospital Medical Center. Dr. Schwartz currently is of Thomas Jefferson University, Philadelphia.
In a study published in Pediatrics, the researchers identified 159 nulliparous patients aged 22 years and younger with physical, intellectual, or developmental disabilities who received levonorgestrel IUDs at a tertiary care children’s hospital between July 1, 2004, and June 30, 2014.
A total of 185 levonorgestrel IUDs were placed. The patients ranged in age from 9 to 22 years with a mean age of 16 years; 4% had ever been sexually active.
Overall, the IUD continuation rate was 95% after 1 year and 73% after 5 years. Most of the IUDs (96%) were inserted in the operating room.
Device malposition and expulsion accounted for a 5% rate of complications. Of the five expulsions, four were completely expelled from the uterus, and a fifth was partial and identified on ultrasound. No cases of pelvic inflammatory disease, pregnancy, or uterine perforation were reported, and the amenorrhea rate was approximately 60%.
Unique concerns regarding the use of IUDs in the disabled population include the appropriateness of IUDs as a first strategy for menstrual management or contraception, as well as potential distress related to bleeding and cramping that patients might find hard to articulate, the researchers said. However, the high continuation rate and low reports of side effects in the study suggests that the devices were well tolerated, and the data show that complications were minimal and manageable, they said.
The study findings were limited primarily by the retrospective design, “which involved loss of patients to follow-up, missing data, and reliance on adequate documentation,” Dr. Schwartz and associates noted. However, the study is the largest to date on levonorgestrel IUD use in young people with disabilities, and provides needed data on the safety and benefits of IUDs for menstrual management and contraception in this population, they said. Prospective studies are needed to assess continuation, outcomes, and long-term satisfaction with IUDs.
“However, these data are promising and should be used to allow more accurate counseling of adolescents with special needs and their families,” and it should be considered as an option for them, Dr. Schwartz and colleagues concluded.
“Clinicians should recognize that adolescents with disabilities have a range of decision-making capacities,” Cynthia Robbins, MD, and Mary A. Ott, MD, of Indiana University, Indianapolis, wrote in an accompanying editorial. Adolescents with disabilities may be left out of reproductive health discussions even if they are able, and the decisions are made by parents and caregivers.
For adolescents with mild disability, a shared decision-making approach is appropriate, in which providers and adolescents discuss reproductive health, with parent involvement as needed; “the adolescent is supported by the provider to express their preferences,” the editorialists wrote.
For those with more significant disability, they advised supported decision-making, in which the adolescent identifies a parent, family member, or caregiver as a trusted adult. “This supportive adult helps the adolescent communicate their goals and understand the decision and assists the provider in communication with the adolescent,” they said. For adolescents with a profound disability, the risks of placement and use of IUDs “should be thought of in a similar manner as other procedures that are routinely done to improve quality of life.”
“As clinicians, it is up to us to highlight these adolescents’ abilities to exercise their rights to sexual and reproductive health,” Dr. Robbins and Dr. Ott conclude.
The study was supported by a Bayer Healthcare Investigator-Initiated Research grant for women’s health to Dr. Schwartz and coauthor Lesley L. Breech, MD. The researchers had no other financial conflicts to disclose.
Dr. Ott disclosed providing expert consultation to Bayer, and that her spouse is employed Eli Lilly. Dr. Robbins had no relevant financial conflicts to disclose. They received no external funding for their editorial.
SOURCE: Schwartz BI et al. Pediatrics. 2020 Jul 23. doi: 10.1542/peds.2020-0016. Robbins C and Ott MA. Pediatrics. 2020 Jul 23. doi: 10.1542/peds.2020-006296.
for menstrual management and contraception, based on data from a retrospective study of 159 patients.
“Desire for menstrual management or suppression is common in young women with special needs, including complex medical conditions and physical, intellectual, and developmental disabilities,” and many of these patients require estrogen-free options because of comorbidities, medication interactions, or decreased mobility, wrote Beth I. Schwartz, MD, and colleagues at Cincinnati Children’s Hospital Medical Center. Dr. Schwartz currently is of Thomas Jefferson University, Philadelphia.
In a study published in Pediatrics, the researchers identified 159 nulliparous patients aged 22 years and younger with physical, intellectual, or developmental disabilities who received levonorgestrel IUDs at a tertiary care children’s hospital between July 1, 2004, and June 30, 2014.
A total of 185 levonorgestrel IUDs were placed. The patients ranged in age from 9 to 22 years with a mean age of 16 years; 4% had ever been sexually active.
Overall, the IUD continuation rate was 95% after 1 year and 73% after 5 years. Most of the IUDs (96%) were inserted in the operating room.
Device malposition and expulsion accounted for a 5% rate of complications. Of the five expulsions, four were completely expelled from the uterus, and a fifth was partial and identified on ultrasound. No cases of pelvic inflammatory disease, pregnancy, or uterine perforation were reported, and the amenorrhea rate was approximately 60%.
Unique concerns regarding the use of IUDs in the disabled population include the appropriateness of IUDs as a first strategy for menstrual management or contraception, as well as potential distress related to bleeding and cramping that patients might find hard to articulate, the researchers said. However, the high continuation rate and low reports of side effects in the study suggests that the devices were well tolerated, and the data show that complications were minimal and manageable, they said.
The study findings were limited primarily by the retrospective design, “which involved loss of patients to follow-up, missing data, and reliance on adequate documentation,” Dr. Schwartz and associates noted. However, the study is the largest to date on levonorgestrel IUD use in young people with disabilities, and provides needed data on the safety and benefits of IUDs for menstrual management and contraception in this population, they said. Prospective studies are needed to assess continuation, outcomes, and long-term satisfaction with IUDs.
“However, these data are promising and should be used to allow more accurate counseling of adolescents with special needs and their families,” and it should be considered as an option for them, Dr. Schwartz and colleagues concluded.
“Clinicians should recognize that adolescents with disabilities have a range of decision-making capacities,” Cynthia Robbins, MD, and Mary A. Ott, MD, of Indiana University, Indianapolis, wrote in an accompanying editorial. Adolescents with disabilities may be left out of reproductive health discussions even if they are able, and the decisions are made by parents and caregivers.
For adolescents with mild disability, a shared decision-making approach is appropriate, in which providers and adolescents discuss reproductive health, with parent involvement as needed; “the adolescent is supported by the provider to express their preferences,” the editorialists wrote.
For those with more significant disability, they advised supported decision-making, in which the adolescent identifies a parent, family member, or caregiver as a trusted adult. “This supportive adult helps the adolescent communicate their goals and understand the decision and assists the provider in communication with the adolescent,” they said. For adolescents with a profound disability, the risks of placement and use of IUDs “should be thought of in a similar manner as other procedures that are routinely done to improve quality of life.”
“As clinicians, it is up to us to highlight these adolescents’ abilities to exercise their rights to sexual and reproductive health,” Dr. Robbins and Dr. Ott conclude.
The study was supported by a Bayer Healthcare Investigator-Initiated Research grant for women’s health to Dr. Schwartz and coauthor Lesley L. Breech, MD. The researchers had no other financial conflicts to disclose.
Dr. Ott disclosed providing expert consultation to Bayer, and that her spouse is employed Eli Lilly. Dr. Robbins had no relevant financial conflicts to disclose. They received no external funding for their editorial.
SOURCE: Schwartz BI et al. Pediatrics. 2020 Jul 23. doi: 10.1542/peds.2020-0016. Robbins C and Ott MA. Pediatrics. 2020 Jul 23. doi: 10.1542/peds.2020-006296.
for menstrual management and contraception, based on data from a retrospective study of 159 patients.
“Desire for menstrual management or suppression is common in young women with special needs, including complex medical conditions and physical, intellectual, and developmental disabilities,” and many of these patients require estrogen-free options because of comorbidities, medication interactions, or decreased mobility, wrote Beth I. Schwartz, MD, and colleagues at Cincinnati Children’s Hospital Medical Center. Dr. Schwartz currently is of Thomas Jefferson University, Philadelphia.
In a study published in Pediatrics, the researchers identified 159 nulliparous patients aged 22 years and younger with physical, intellectual, or developmental disabilities who received levonorgestrel IUDs at a tertiary care children’s hospital between July 1, 2004, and June 30, 2014.
A total of 185 levonorgestrel IUDs were placed. The patients ranged in age from 9 to 22 years with a mean age of 16 years; 4% had ever been sexually active.
Overall, the IUD continuation rate was 95% after 1 year and 73% after 5 years. Most of the IUDs (96%) were inserted in the operating room.
Device malposition and expulsion accounted for a 5% rate of complications. Of the five expulsions, four were completely expelled from the uterus, and a fifth was partial and identified on ultrasound. No cases of pelvic inflammatory disease, pregnancy, or uterine perforation were reported, and the amenorrhea rate was approximately 60%.
Unique concerns regarding the use of IUDs in the disabled population include the appropriateness of IUDs as a first strategy for menstrual management or contraception, as well as potential distress related to bleeding and cramping that patients might find hard to articulate, the researchers said. However, the high continuation rate and low reports of side effects in the study suggests that the devices were well tolerated, and the data show that complications were minimal and manageable, they said.
The study findings were limited primarily by the retrospective design, “which involved loss of patients to follow-up, missing data, and reliance on adequate documentation,” Dr. Schwartz and associates noted. However, the study is the largest to date on levonorgestrel IUD use in young people with disabilities, and provides needed data on the safety and benefits of IUDs for menstrual management and contraception in this population, they said. Prospective studies are needed to assess continuation, outcomes, and long-term satisfaction with IUDs.
“However, these data are promising and should be used to allow more accurate counseling of adolescents with special needs and their families,” and it should be considered as an option for them, Dr. Schwartz and colleagues concluded.
“Clinicians should recognize that adolescents with disabilities have a range of decision-making capacities,” Cynthia Robbins, MD, and Mary A. Ott, MD, of Indiana University, Indianapolis, wrote in an accompanying editorial. Adolescents with disabilities may be left out of reproductive health discussions even if they are able, and the decisions are made by parents and caregivers.
For adolescents with mild disability, a shared decision-making approach is appropriate, in which providers and adolescents discuss reproductive health, with parent involvement as needed; “the adolescent is supported by the provider to express their preferences,” the editorialists wrote.
For those with more significant disability, they advised supported decision-making, in which the adolescent identifies a parent, family member, or caregiver as a trusted adult. “This supportive adult helps the adolescent communicate their goals and understand the decision and assists the provider in communication with the adolescent,” they said. For adolescents with a profound disability, the risks of placement and use of IUDs “should be thought of in a similar manner as other procedures that are routinely done to improve quality of life.”
“As clinicians, it is up to us to highlight these adolescents’ abilities to exercise their rights to sexual and reproductive health,” Dr. Robbins and Dr. Ott conclude.
The study was supported by a Bayer Healthcare Investigator-Initiated Research grant for women’s health to Dr. Schwartz and coauthor Lesley L. Breech, MD. The researchers had no other financial conflicts to disclose.
Dr. Ott disclosed providing expert consultation to Bayer, and that her spouse is employed Eli Lilly. Dr. Robbins had no relevant financial conflicts to disclose. They received no external funding for their editorial.
SOURCE: Schwartz BI et al. Pediatrics. 2020 Jul 23. doi: 10.1542/peds.2020-0016. Robbins C and Ott MA. Pediatrics. 2020 Jul 23. doi: 10.1542/peds.2020-006296.
FROM PEDIATRICS
Medications may drive postmenopausal weight gain
based on data from more than 76,000 individuals in the Women’s Health Initiative.
“Many of the medications prescribed to treat obesity-related comorbidities such as hypertension, type 2 diabetes, and depression have been linked to weight gain,” but the impact of such medications in relation to changes in body mass index (BMI) and waist circumference in postmenopausal women in particular has not been studied, wrote Fatima Cody Stanford, MD, of Harvard Medical School, Boston, and colleagues.
“Postmenopausal women are of significant interest as those who have obesity and normal weight central obesity are at increased risk for conditions such as invasive breast cancer, sleep disturbances, and type 2 diabetes, as well as mortality,” they wrote.
In a study published in the journal Menopause, the researchers identified 76,252 postmenopausal women aged 50-79 years and measured body mass index at baseline and after 3 years. Medication use was determined by a medication inventory of pill bottles brought to baseline and year-3 visits.
During a 3-year follow-up period, the average BMI increase was 0.37 kg/m2 in women taking at least one weight-promoting medication, compared with an average increase of 0.27 kg/m2 in women not taking such medications (P = .0045). Weight-promoting medications in the study included antidepressants, beta-blockers, insulin, and/or glucocorticosteroids. The researchers used generalized linear models to assess the impact of these medications on increased BMI and waist circumference.
In addition, the average increase in waist circumference was 1.10 cm in women taking at least one weight-promoting medication, compared with 0.89 cm (P = .0077) for women not on such medications.
“Type of medication, dosage, and race/ethnicity may have important interrelationships,” in postmenopausal weight gain, as do individual susceptibility and genetics, the researchers noted. “Options to mitigate the weight gain may include proactive lifestyle modifications, reduction in dose, change to another agent, or discontinuation of the medication altogether. If alternative medications are not an option, lifestyle factors such as diet quality, physical activity level, and sleep quality and duration warrant emphasis.”
The study findings were limited by several factors, including a lack of data on indications and underlying health conditions surrounding the prescription of various medications, notably psychotropics and antipsychotics, the researchers wrote.
However, the data “may help to inform clinical decision-making and support increased attention to lifestyle modifications and other strategies” to mitigate the potential for weight gain in a population already at risk for overweight and obesity over time, they concluded.
“Given the obesity epidemic, addressing factors contributing to weight gain in midlife [a time associated with weight gain] women is critical,” Stephanie S. Faubion, MD, of the Mayo Clinic in Jacksonville, Fla., said in an interview. Dr. Faubion said that the study findings were not surprising given the widespread use of known weight-promoting medications by midlife women for such as hypertension, diabetes, and depression.
“Clinicians need to ensure that they prescribe medications that are truly needed and utilize the lowest dose required to achieve treatment goals,” Dr. Faubion said. “When possible, alternative therapies that do not cause weight gain should be considered. In addition, patients should be warned of the potential for weight gain, and clinicians should advocate for lifestyle measures aimed at mitigating these effects.”
The findings do not encourage the use of alternative therapies for menopausal symptoms per se, added Dr. Faubion, who is also medical director of the North American Menopause Society. “Hormone therapy is not associated with weight gain, and if anything, it is weight favorable and associated with less weight around the midsection. It is the alternative strategies for management of hot flashes that are associated with weight gain, such as antidepressants and gabapentin.
“We need to focus efforts on strategies to prevent weight gain in midlife to avoid the development of conditions that necessitate initiation of many of these weight-promoting medications,” Dr. Faubion said.
The study was supported by the National Institutes of Health and Massachusetts General Hospital Executive Committee on Research, the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases. The researchers had no financial conflicts to disclose. Dr. Faubion had no financial conflicts to disclose.
SOURCE: Stanford FC et al. Menopause. 2020 Jul 13. doi: 10.1097/GME.0000000000001589.
based on data from more than 76,000 individuals in the Women’s Health Initiative.
“Many of the medications prescribed to treat obesity-related comorbidities such as hypertension, type 2 diabetes, and depression have been linked to weight gain,” but the impact of such medications in relation to changes in body mass index (BMI) and waist circumference in postmenopausal women in particular has not been studied, wrote Fatima Cody Stanford, MD, of Harvard Medical School, Boston, and colleagues.
“Postmenopausal women are of significant interest as those who have obesity and normal weight central obesity are at increased risk for conditions such as invasive breast cancer, sleep disturbances, and type 2 diabetes, as well as mortality,” they wrote.
In a study published in the journal Menopause, the researchers identified 76,252 postmenopausal women aged 50-79 years and measured body mass index at baseline and after 3 years. Medication use was determined by a medication inventory of pill bottles brought to baseline and year-3 visits.
During a 3-year follow-up period, the average BMI increase was 0.37 kg/m2 in women taking at least one weight-promoting medication, compared with an average increase of 0.27 kg/m2 in women not taking such medications (P = .0045). Weight-promoting medications in the study included antidepressants, beta-blockers, insulin, and/or glucocorticosteroids. The researchers used generalized linear models to assess the impact of these medications on increased BMI and waist circumference.
In addition, the average increase in waist circumference was 1.10 cm in women taking at least one weight-promoting medication, compared with 0.89 cm (P = .0077) for women not on such medications.
“Type of medication, dosage, and race/ethnicity may have important interrelationships,” in postmenopausal weight gain, as do individual susceptibility and genetics, the researchers noted. “Options to mitigate the weight gain may include proactive lifestyle modifications, reduction in dose, change to another agent, or discontinuation of the medication altogether. If alternative medications are not an option, lifestyle factors such as diet quality, physical activity level, and sleep quality and duration warrant emphasis.”
The study findings were limited by several factors, including a lack of data on indications and underlying health conditions surrounding the prescription of various medications, notably psychotropics and antipsychotics, the researchers wrote.
However, the data “may help to inform clinical decision-making and support increased attention to lifestyle modifications and other strategies” to mitigate the potential for weight gain in a population already at risk for overweight and obesity over time, they concluded.
“Given the obesity epidemic, addressing factors contributing to weight gain in midlife [a time associated with weight gain] women is critical,” Stephanie S. Faubion, MD, of the Mayo Clinic in Jacksonville, Fla., said in an interview. Dr. Faubion said that the study findings were not surprising given the widespread use of known weight-promoting medications by midlife women for such as hypertension, diabetes, and depression.
“Clinicians need to ensure that they prescribe medications that are truly needed and utilize the lowest dose required to achieve treatment goals,” Dr. Faubion said. “When possible, alternative therapies that do not cause weight gain should be considered. In addition, patients should be warned of the potential for weight gain, and clinicians should advocate for lifestyle measures aimed at mitigating these effects.”
The findings do not encourage the use of alternative therapies for menopausal symptoms per se, added Dr. Faubion, who is also medical director of the North American Menopause Society. “Hormone therapy is not associated with weight gain, and if anything, it is weight favorable and associated with less weight around the midsection. It is the alternative strategies for management of hot flashes that are associated with weight gain, such as antidepressants and gabapentin.
“We need to focus efforts on strategies to prevent weight gain in midlife to avoid the development of conditions that necessitate initiation of many of these weight-promoting medications,” Dr. Faubion said.
The study was supported by the National Institutes of Health and Massachusetts General Hospital Executive Committee on Research, the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases. The researchers had no financial conflicts to disclose. Dr. Faubion had no financial conflicts to disclose.
SOURCE: Stanford FC et al. Menopause. 2020 Jul 13. doi: 10.1097/GME.0000000000001589.
based on data from more than 76,000 individuals in the Women’s Health Initiative.
“Many of the medications prescribed to treat obesity-related comorbidities such as hypertension, type 2 diabetes, and depression have been linked to weight gain,” but the impact of such medications in relation to changes in body mass index (BMI) and waist circumference in postmenopausal women in particular has not been studied, wrote Fatima Cody Stanford, MD, of Harvard Medical School, Boston, and colleagues.
“Postmenopausal women are of significant interest as those who have obesity and normal weight central obesity are at increased risk for conditions such as invasive breast cancer, sleep disturbances, and type 2 diabetes, as well as mortality,” they wrote.
In a study published in the journal Menopause, the researchers identified 76,252 postmenopausal women aged 50-79 years and measured body mass index at baseline and after 3 years. Medication use was determined by a medication inventory of pill bottles brought to baseline and year-3 visits.
During a 3-year follow-up period, the average BMI increase was 0.37 kg/m2 in women taking at least one weight-promoting medication, compared with an average increase of 0.27 kg/m2 in women not taking such medications (P = .0045). Weight-promoting medications in the study included antidepressants, beta-blockers, insulin, and/or glucocorticosteroids. The researchers used generalized linear models to assess the impact of these medications on increased BMI and waist circumference.
In addition, the average increase in waist circumference was 1.10 cm in women taking at least one weight-promoting medication, compared with 0.89 cm (P = .0077) for women not on such medications.
“Type of medication, dosage, and race/ethnicity may have important interrelationships,” in postmenopausal weight gain, as do individual susceptibility and genetics, the researchers noted. “Options to mitigate the weight gain may include proactive lifestyle modifications, reduction in dose, change to another agent, or discontinuation of the medication altogether. If alternative medications are not an option, lifestyle factors such as diet quality, physical activity level, and sleep quality and duration warrant emphasis.”
The study findings were limited by several factors, including a lack of data on indications and underlying health conditions surrounding the prescription of various medications, notably psychotropics and antipsychotics, the researchers wrote.
However, the data “may help to inform clinical decision-making and support increased attention to lifestyle modifications and other strategies” to mitigate the potential for weight gain in a population already at risk for overweight and obesity over time, they concluded.
“Given the obesity epidemic, addressing factors contributing to weight gain in midlife [a time associated with weight gain] women is critical,” Stephanie S. Faubion, MD, of the Mayo Clinic in Jacksonville, Fla., said in an interview. Dr. Faubion said that the study findings were not surprising given the widespread use of known weight-promoting medications by midlife women for such as hypertension, diabetes, and depression.
“Clinicians need to ensure that they prescribe medications that are truly needed and utilize the lowest dose required to achieve treatment goals,” Dr. Faubion said. “When possible, alternative therapies that do not cause weight gain should be considered. In addition, patients should be warned of the potential for weight gain, and clinicians should advocate for lifestyle measures aimed at mitigating these effects.”
The findings do not encourage the use of alternative therapies for menopausal symptoms per se, added Dr. Faubion, who is also medical director of the North American Menopause Society. “Hormone therapy is not associated with weight gain, and if anything, it is weight favorable and associated with less weight around the midsection. It is the alternative strategies for management of hot flashes that are associated with weight gain, such as antidepressants and gabapentin.
“We need to focus efforts on strategies to prevent weight gain in midlife to avoid the development of conditions that necessitate initiation of many of these weight-promoting medications,” Dr. Faubion said.
The study was supported by the National Institutes of Health and Massachusetts General Hospital Executive Committee on Research, the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases. The researchers had no financial conflicts to disclose. Dr. Faubion had no financial conflicts to disclose.
SOURCE: Stanford FC et al. Menopause. 2020 Jul 13. doi: 10.1097/GME.0000000000001589.
FROM MENOPAUSE
New oral anticoagulants drive ACC consensus on bleeding
Patients on oral anticoagulants who experience a bleeding event may be able to discontinue therapy if certain circumstances apply, according to updated guidance from the American College of Cardiology.
The emergence of direct-acting oral anticoagulants (DOACs) to prevent venous thromboembolism and the introduction of new reversal strategies for factor Xa inhibitors prompted the creation of an Expert Consensus Decision Pathway to update the version from 2017, according to the ACC. Expert consensus decision pathways (ECDPs) are a component of the solution sets issued by the ACC to “address key questions facing care teams and attempt to provide practical guidance to be applied at the point of care.”
In an ECDP published in the Journal of the American College of Cardiology, the writing committee members developed treatment algorithms for managing bleeding in patients on DOACs and vitamin K antagonists (VKAs).
Bleeding was classified as major or nonmajor, with major defined as “bleeding that is associated with hemodynamic compromise, occurs in an anatomically critical site, requires transfusion of at least 2 units of packed red blood cells [RBCs]), or results in a hemoglobin drop greater than 2 g/dL. All other types of bleeding were classified as nonmajor.
The document includes a graphic algorithm for assessing bleed severity and managing major versus nonmajor bleeding, and a separate graphic describes considerations for reversal and use of hemostatic agents according to whether the patient is taking a VKA (warfarin and other coumarins), a direct thrombin inhibitor (dabigatran), the factor Xa inhibitors apixaban and rivaroxaban, or the factor Xa inhibitors betrixaban and edoxaban.
Another algorithm outlines whether to discontinue, delay, or restart anticoagulation. Considerations for restarting anticoagulation include whether the patient is pregnant, awaiting an invasive procedure, not able to receive medication by mouth, has a high risk of rebleeding, or is being bridged back to a vitamin K antagonist with high thrombotic risk.
In most cases of GI bleeding, for example, current data support restarting oral anticoagulants once hemostasis is achieved, but patients who experience intracranial hemorrhage should delay restarting any anticoagulation for at least 4 weeks if they are without high thrombotic risk, according to the document.
The report also recommends clinician-patient discussion before resuming anticoagulation, ideally with time allowed for patients to develop questions. Discussions should include the signs of bleeding, assessment of risk for a thromboembolic event, and the benefits of anticoagulation.
“The proliferation of oral anticoagulants (warfarin and DOACs) and growing indications for their use prompted the need for guidance on the management of these drugs,” said Gordon F. Tomaselli, MD, chair of the writing committee, in an interview. “This document provides guidance on management at the time of a bleeding complication. This includes acute management, starting and stopping drugs, and use of reversal agents,” he said. “This of course will be a dynamic document as the list of these drugs and their antidotes expand,” he noted.
“The biggest change from the previous guidelines are twofold: an update on laboratory assessment to monitor drug levels and use of reversal agents,” while the acute management strategies have otherwise remained similar to previous documents, said Dr. Tomaselli.
Dr. Tomaselli said that he was not surprised by the biological aspects of recent research while developing the statement. However, “the extent of the use of multiple anticoagulants and antiplatelet agents was a bit surprising and complicates therapy with each of the agents,” he noted.
The way the pathways are presented may make them challenging to follow in clinical practice, said Dr. Tomaselli. “The pathways are described linearly and in practice often many things have to happen at once,” he said. “The other main issue may be limitations in the availability of some of the newer reversal agents,” he added.
“The complication of bleeding is difficult to avoid,” said Dr. Tomaselli, and for future research, “the focus needs to continue to refine the indications for anticoagulation and appropriate use with other drugs that predispose to bleeding. We also need better methods and testing to monitor drugs levels and the effect on coagulation,” he said.
In accordance with the ACC Solution Set Oversight Committee, the writing committee members, including Dr. Tomaselli, had no relevant relationships with industry to disclose.
SOURCE: Tomaselli GF et al. J Am Coll Cardiol. 2020. doi: 10.1016/j.jacc.2020.04.053.
Patients on oral anticoagulants who experience a bleeding event may be able to discontinue therapy if certain circumstances apply, according to updated guidance from the American College of Cardiology.
The emergence of direct-acting oral anticoagulants (DOACs) to prevent venous thromboembolism and the introduction of new reversal strategies for factor Xa inhibitors prompted the creation of an Expert Consensus Decision Pathway to update the version from 2017, according to the ACC. Expert consensus decision pathways (ECDPs) are a component of the solution sets issued by the ACC to “address key questions facing care teams and attempt to provide practical guidance to be applied at the point of care.”
In an ECDP published in the Journal of the American College of Cardiology, the writing committee members developed treatment algorithms for managing bleeding in patients on DOACs and vitamin K antagonists (VKAs).
Bleeding was classified as major or nonmajor, with major defined as “bleeding that is associated with hemodynamic compromise, occurs in an anatomically critical site, requires transfusion of at least 2 units of packed red blood cells [RBCs]), or results in a hemoglobin drop greater than 2 g/dL. All other types of bleeding were classified as nonmajor.
The document includes a graphic algorithm for assessing bleed severity and managing major versus nonmajor bleeding, and a separate graphic describes considerations for reversal and use of hemostatic agents according to whether the patient is taking a VKA (warfarin and other coumarins), a direct thrombin inhibitor (dabigatran), the factor Xa inhibitors apixaban and rivaroxaban, or the factor Xa inhibitors betrixaban and edoxaban.
Another algorithm outlines whether to discontinue, delay, or restart anticoagulation. Considerations for restarting anticoagulation include whether the patient is pregnant, awaiting an invasive procedure, not able to receive medication by mouth, has a high risk of rebleeding, or is being bridged back to a vitamin K antagonist with high thrombotic risk.
In most cases of GI bleeding, for example, current data support restarting oral anticoagulants once hemostasis is achieved, but patients who experience intracranial hemorrhage should delay restarting any anticoagulation for at least 4 weeks if they are without high thrombotic risk, according to the document.
The report also recommends clinician-patient discussion before resuming anticoagulation, ideally with time allowed for patients to develop questions. Discussions should include the signs of bleeding, assessment of risk for a thromboembolic event, and the benefits of anticoagulation.
“The proliferation of oral anticoagulants (warfarin and DOACs) and growing indications for their use prompted the need for guidance on the management of these drugs,” said Gordon F. Tomaselli, MD, chair of the writing committee, in an interview. “This document provides guidance on management at the time of a bleeding complication. This includes acute management, starting and stopping drugs, and use of reversal agents,” he said. “This of course will be a dynamic document as the list of these drugs and their antidotes expand,” he noted.
“The biggest change from the previous guidelines are twofold: an update on laboratory assessment to monitor drug levels and use of reversal agents,” while the acute management strategies have otherwise remained similar to previous documents, said Dr. Tomaselli.
Dr. Tomaselli said that he was not surprised by the biological aspects of recent research while developing the statement. However, “the extent of the use of multiple anticoagulants and antiplatelet agents was a bit surprising and complicates therapy with each of the agents,” he noted.
The way the pathways are presented may make them challenging to follow in clinical practice, said Dr. Tomaselli. “The pathways are described linearly and in practice often many things have to happen at once,” he said. “The other main issue may be limitations in the availability of some of the newer reversal agents,” he added.
“The complication of bleeding is difficult to avoid,” said Dr. Tomaselli, and for future research, “the focus needs to continue to refine the indications for anticoagulation and appropriate use with other drugs that predispose to bleeding. We also need better methods and testing to monitor drugs levels and the effect on coagulation,” he said.
In accordance with the ACC Solution Set Oversight Committee, the writing committee members, including Dr. Tomaselli, had no relevant relationships with industry to disclose.
SOURCE: Tomaselli GF et al. J Am Coll Cardiol. 2020. doi: 10.1016/j.jacc.2020.04.053.
Patients on oral anticoagulants who experience a bleeding event may be able to discontinue therapy if certain circumstances apply, according to updated guidance from the American College of Cardiology.
The emergence of direct-acting oral anticoagulants (DOACs) to prevent venous thromboembolism and the introduction of new reversal strategies for factor Xa inhibitors prompted the creation of an Expert Consensus Decision Pathway to update the version from 2017, according to the ACC. Expert consensus decision pathways (ECDPs) are a component of the solution sets issued by the ACC to “address key questions facing care teams and attempt to provide practical guidance to be applied at the point of care.”
In an ECDP published in the Journal of the American College of Cardiology, the writing committee members developed treatment algorithms for managing bleeding in patients on DOACs and vitamin K antagonists (VKAs).
Bleeding was classified as major or nonmajor, with major defined as “bleeding that is associated with hemodynamic compromise, occurs in an anatomically critical site, requires transfusion of at least 2 units of packed red blood cells [RBCs]), or results in a hemoglobin drop greater than 2 g/dL. All other types of bleeding were classified as nonmajor.
The document includes a graphic algorithm for assessing bleed severity and managing major versus nonmajor bleeding, and a separate graphic describes considerations for reversal and use of hemostatic agents according to whether the patient is taking a VKA (warfarin and other coumarins), a direct thrombin inhibitor (dabigatran), the factor Xa inhibitors apixaban and rivaroxaban, or the factor Xa inhibitors betrixaban and edoxaban.
Another algorithm outlines whether to discontinue, delay, or restart anticoagulation. Considerations for restarting anticoagulation include whether the patient is pregnant, awaiting an invasive procedure, not able to receive medication by mouth, has a high risk of rebleeding, or is being bridged back to a vitamin K antagonist with high thrombotic risk.
In most cases of GI bleeding, for example, current data support restarting oral anticoagulants once hemostasis is achieved, but patients who experience intracranial hemorrhage should delay restarting any anticoagulation for at least 4 weeks if they are without high thrombotic risk, according to the document.
The report also recommends clinician-patient discussion before resuming anticoagulation, ideally with time allowed for patients to develop questions. Discussions should include the signs of bleeding, assessment of risk for a thromboembolic event, and the benefits of anticoagulation.
“The proliferation of oral anticoagulants (warfarin and DOACs) and growing indications for their use prompted the need for guidance on the management of these drugs,” said Gordon F. Tomaselli, MD, chair of the writing committee, in an interview. “This document provides guidance on management at the time of a bleeding complication. This includes acute management, starting and stopping drugs, and use of reversal agents,” he said. “This of course will be a dynamic document as the list of these drugs and their antidotes expand,” he noted.
“The biggest change from the previous guidelines are twofold: an update on laboratory assessment to monitor drug levels and use of reversal agents,” while the acute management strategies have otherwise remained similar to previous documents, said Dr. Tomaselli.
Dr. Tomaselli said that he was not surprised by the biological aspects of recent research while developing the statement. However, “the extent of the use of multiple anticoagulants and antiplatelet agents was a bit surprising and complicates therapy with each of the agents,” he noted.
The way the pathways are presented may make them challenging to follow in clinical practice, said Dr. Tomaselli. “The pathways are described linearly and in practice often many things have to happen at once,” he said. “The other main issue may be limitations in the availability of some of the newer reversal agents,” he added.
“The complication of bleeding is difficult to avoid,” said Dr. Tomaselli, and for future research, “the focus needs to continue to refine the indications for anticoagulation and appropriate use with other drugs that predispose to bleeding. We also need better methods and testing to monitor drugs levels and the effect on coagulation,” he said.
In accordance with the ACC Solution Set Oversight Committee, the writing committee members, including Dr. Tomaselli, had no relevant relationships with industry to disclose.
SOURCE: Tomaselli GF et al. J Am Coll Cardiol. 2020. doi: 10.1016/j.jacc.2020.04.053.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Limit customized compounded hormones to special circumstances
The use of compounded bioidentical hormone therapies should be limited to patients who are not able to use a hormone therapy product approved by the Food and Drug Administration for reasons of allergy or dosage, according to a new report from the National Academies of Sciences, Engineering, and Medicine.
In recent years, compounded bioidentical hormone therapies (cBHTs) have been “marketed as a personalized and natural approach to enhanced wellness using tailored preparations that address a myriad of symptoms, including those associated with menopause and aging,” wrote Donald R. Mattison, MD, of the University of Ottawa, and chair of the committee charged with producing the report, and colleagues.
Although both cBHTs and bioidentical hormone therapies (BHTs) contain hormones that are structurally and chemically identical to those in the human body, cBHTs have not undergone the safety, efficacy, and quality control tests of approved FDA products, according to the report.
In addition, cBHTs have no standardization when it comes to medication doses, and the products often are available in topicals such as creams or ointments, as well as pills or pellets. The lack of standards in dosing or form can contribute to the risk of overdose, the report emphasized.
Various cBTH products continue to be marketed to the public for age-related hormone symptoms including hot flashes associated with menopause and decreased muscle mass associated with decreased testosterone. However, cBHTs are not approved by the FDA in part because the individually mixed products are not tested to verify the amount of hormone that may be absorbed.
In response to the increased use of cBHTs, the National Academies convened a Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy and commissioned a report.
The two typical reasons to prescribe cBHT are either to provide a medication in an alternate dose not available in approved products or to omit components of a medication to which a patient is allergic, according to the report.
The report includes an algorithm to help guide clinicians in prescribing FDA-approved products, including off-label use of approved products, before cBHT products. “There is a dearth of high-quality evidence ... available to establish whether cBHT preparations are safe or efficacious for their prescribed uses,” the report states.
Of note, the committee also found no guidelines to recommend the use of cBHT products as a substitute for off-label use of FDA-approved BHT products for patients with female sexual dysfunction or gender dysphoria, two conditions for which no FDA-approved BHT products exist.
“The North American Menopause Society applauds the efforts of the National Academies of Sciences, Engineering, and Medicine (NASEM) and endorses their recommendations on compounded bioidentical hormone therapy,” Stephanie S. Faubion, MD, medical director of The North American Menopause Society, wrote in a statement. “As a society, we remain committed to improving the care of midlife women through the promotion of evidence-based research, education, and clinical care.”
A report on the use of cBHTs was important at this time because of the widespread and largely unregulated use of these products with little data to support their safety and efficacy, Dr. Faubion said in an interview.
“There are no indications for use of custom compounded hormone therapy aside from an allergy to a component in the FDA-approved products or lack of availability of the needed dose, which would be exceedingly rare given the variety of forms and doses available with FDA-approved products,” she said.
Main concerns regarding the use of cBHTs are the lack of safety and efficacy data, Dr. Faubion emphasized. “Women believe these products are safer than FDA-approved products because they do not receive a package insert outlining potential risks as they do with FDA-approved products.” A lack of data and safety monitoring of cBHTs means that adverse effects are not monitored and reported, she said. Also, safety concerns persist regarding some forms of cBHTs such as pellets, which were specifically highlighted in the report.
Dr. Faubion said that she “absolutely” agrees with the report’s limited circumstances in which the used of cBHTs would be appropriate. “There are very few reasons why women would need to use compounded hormones instead of the FDA-approved versions, which are regulated for quality, efficacy and safety, readily available in the local pharmacy, and often covered by insurance.”
In terms of the future, “we need more education for women as consumers and for medical providers on this topic,” Dr. Faubion noted. Also, “clearly, there is a dearth of research on the true efficacy and safety of these compounded hormone therapy products.”
The statement from the National Academies crystallizes what experts have been saying for decades, according to Lubna Pal, MBBS, director of the menopause program at Yale University, New Haven, Conn.
The formal recommendations to limit the use of cBHTs “are not novel, but certainly needed,” and the statement “offers guidance regardless of your specialty,” Dr. Pal said in an interview.
There is often a disconnect between consumers’ understanding of compounding and the reality of safety concerns, she said. “We are in a tabloid era,” and education is key to guiding patients toward the FDA-approved treatments with safety data and demonstrated effectiveness, she said. “Safety should be the driving factor.” In compounded products, “there is no consistency that what you get today is the same as what you get tomorrow,” and the lack of standardization of cBHTs increases the risk for adverse events, she emphasized.
For patients with special needs such as allergies or other specialized dosing requirements, as noted in the National Academies statement, clinicians should discuss the options with patients and monitor them regularly to head off potential adverse events such as the development of uterine cancer, said Dr. Pal, who is a member of the Ob.Gyn. News editorial advisory board.
The research involved in creating the report was supported by the Food and Drug Administration.
Dr. Faubion had no financial conflicts to disclose. Dr. Pal had no relevant financial disclosures.
SOURCE: Mattison DR et al.; National Academies of Sciences, Engineering, and Medicine. The clinical utility of compounded bioidentical hormone therapy: A review of safety, effectiveness, and use. (Washington, DC: The National Academies Press. 2020.)
The use of compounded bioidentical hormone therapies should be limited to patients who are not able to use a hormone therapy product approved by the Food and Drug Administration for reasons of allergy or dosage, according to a new report from the National Academies of Sciences, Engineering, and Medicine.
In recent years, compounded bioidentical hormone therapies (cBHTs) have been “marketed as a personalized and natural approach to enhanced wellness using tailored preparations that address a myriad of symptoms, including those associated with menopause and aging,” wrote Donald R. Mattison, MD, of the University of Ottawa, and chair of the committee charged with producing the report, and colleagues.
Although both cBHTs and bioidentical hormone therapies (BHTs) contain hormones that are structurally and chemically identical to those in the human body, cBHTs have not undergone the safety, efficacy, and quality control tests of approved FDA products, according to the report.
In addition, cBHTs have no standardization when it comes to medication doses, and the products often are available in topicals such as creams or ointments, as well as pills or pellets. The lack of standards in dosing or form can contribute to the risk of overdose, the report emphasized.
Various cBTH products continue to be marketed to the public for age-related hormone symptoms including hot flashes associated with menopause and decreased muscle mass associated with decreased testosterone. However, cBHTs are not approved by the FDA in part because the individually mixed products are not tested to verify the amount of hormone that may be absorbed.
In response to the increased use of cBHTs, the National Academies convened a Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy and commissioned a report.
The two typical reasons to prescribe cBHT are either to provide a medication in an alternate dose not available in approved products or to omit components of a medication to which a patient is allergic, according to the report.
The report includes an algorithm to help guide clinicians in prescribing FDA-approved products, including off-label use of approved products, before cBHT products. “There is a dearth of high-quality evidence ... available to establish whether cBHT preparations are safe or efficacious for their prescribed uses,” the report states.
Of note, the committee also found no guidelines to recommend the use of cBHT products as a substitute for off-label use of FDA-approved BHT products for patients with female sexual dysfunction or gender dysphoria, two conditions for which no FDA-approved BHT products exist.
“The North American Menopause Society applauds the efforts of the National Academies of Sciences, Engineering, and Medicine (NASEM) and endorses their recommendations on compounded bioidentical hormone therapy,” Stephanie S. Faubion, MD, medical director of The North American Menopause Society, wrote in a statement. “As a society, we remain committed to improving the care of midlife women through the promotion of evidence-based research, education, and clinical care.”
A report on the use of cBHTs was important at this time because of the widespread and largely unregulated use of these products with little data to support their safety and efficacy, Dr. Faubion said in an interview.
“There are no indications for use of custom compounded hormone therapy aside from an allergy to a component in the FDA-approved products or lack of availability of the needed dose, which would be exceedingly rare given the variety of forms and doses available with FDA-approved products,” she said.
Main concerns regarding the use of cBHTs are the lack of safety and efficacy data, Dr. Faubion emphasized. “Women believe these products are safer than FDA-approved products because they do not receive a package insert outlining potential risks as they do with FDA-approved products.” A lack of data and safety monitoring of cBHTs means that adverse effects are not monitored and reported, she said. Also, safety concerns persist regarding some forms of cBHTs such as pellets, which were specifically highlighted in the report.
Dr. Faubion said that she “absolutely” agrees with the report’s limited circumstances in which the used of cBHTs would be appropriate. “There are very few reasons why women would need to use compounded hormones instead of the FDA-approved versions, which are regulated for quality, efficacy and safety, readily available in the local pharmacy, and often covered by insurance.”
In terms of the future, “we need more education for women as consumers and for medical providers on this topic,” Dr. Faubion noted. Also, “clearly, there is a dearth of research on the true efficacy and safety of these compounded hormone therapy products.”
The statement from the National Academies crystallizes what experts have been saying for decades, according to Lubna Pal, MBBS, director of the menopause program at Yale University, New Haven, Conn.
The formal recommendations to limit the use of cBHTs “are not novel, but certainly needed,” and the statement “offers guidance regardless of your specialty,” Dr. Pal said in an interview.
There is often a disconnect between consumers’ understanding of compounding and the reality of safety concerns, she said. “We are in a tabloid era,” and education is key to guiding patients toward the FDA-approved treatments with safety data and demonstrated effectiveness, she said. “Safety should be the driving factor.” In compounded products, “there is no consistency that what you get today is the same as what you get tomorrow,” and the lack of standardization of cBHTs increases the risk for adverse events, she emphasized.
For patients with special needs such as allergies or other specialized dosing requirements, as noted in the National Academies statement, clinicians should discuss the options with patients and monitor them regularly to head off potential adverse events such as the development of uterine cancer, said Dr. Pal, who is a member of the Ob.Gyn. News editorial advisory board.
The research involved in creating the report was supported by the Food and Drug Administration.
Dr. Faubion had no financial conflicts to disclose. Dr. Pal had no relevant financial disclosures.
SOURCE: Mattison DR et al.; National Academies of Sciences, Engineering, and Medicine. The clinical utility of compounded bioidentical hormone therapy: A review of safety, effectiveness, and use. (Washington, DC: The National Academies Press. 2020.)
The use of compounded bioidentical hormone therapies should be limited to patients who are not able to use a hormone therapy product approved by the Food and Drug Administration for reasons of allergy or dosage, according to a new report from the National Academies of Sciences, Engineering, and Medicine.
In recent years, compounded bioidentical hormone therapies (cBHTs) have been “marketed as a personalized and natural approach to enhanced wellness using tailored preparations that address a myriad of symptoms, including those associated with menopause and aging,” wrote Donald R. Mattison, MD, of the University of Ottawa, and chair of the committee charged with producing the report, and colleagues.
Although both cBHTs and bioidentical hormone therapies (BHTs) contain hormones that are structurally and chemically identical to those in the human body, cBHTs have not undergone the safety, efficacy, and quality control tests of approved FDA products, according to the report.
In addition, cBHTs have no standardization when it comes to medication doses, and the products often are available in topicals such as creams or ointments, as well as pills or pellets. The lack of standards in dosing or form can contribute to the risk of overdose, the report emphasized.
Various cBTH products continue to be marketed to the public for age-related hormone symptoms including hot flashes associated with menopause and decreased muscle mass associated with decreased testosterone. However, cBHTs are not approved by the FDA in part because the individually mixed products are not tested to verify the amount of hormone that may be absorbed.
In response to the increased use of cBHTs, the National Academies convened a Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy and commissioned a report.
The two typical reasons to prescribe cBHT are either to provide a medication in an alternate dose not available in approved products or to omit components of a medication to which a patient is allergic, according to the report.
The report includes an algorithm to help guide clinicians in prescribing FDA-approved products, including off-label use of approved products, before cBHT products. “There is a dearth of high-quality evidence ... available to establish whether cBHT preparations are safe or efficacious for their prescribed uses,” the report states.
Of note, the committee also found no guidelines to recommend the use of cBHT products as a substitute for off-label use of FDA-approved BHT products for patients with female sexual dysfunction or gender dysphoria, two conditions for which no FDA-approved BHT products exist.
“The North American Menopause Society applauds the efforts of the National Academies of Sciences, Engineering, and Medicine (NASEM) and endorses their recommendations on compounded bioidentical hormone therapy,” Stephanie S. Faubion, MD, medical director of The North American Menopause Society, wrote in a statement. “As a society, we remain committed to improving the care of midlife women through the promotion of evidence-based research, education, and clinical care.”
A report on the use of cBHTs was important at this time because of the widespread and largely unregulated use of these products with little data to support their safety and efficacy, Dr. Faubion said in an interview.
“There are no indications for use of custom compounded hormone therapy aside from an allergy to a component in the FDA-approved products or lack of availability of the needed dose, which would be exceedingly rare given the variety of forms and doses available with FDA-approved products,” she said.
Main concerns regarding the use of cBHTs are the lack of safety and efficacy data, Dr. Faubion emphasized. “Women believe these products are safer than FDA-approved products because they do not receive a package insert outlining potential risks as they do with FDA-approved products.” A lack of data and safety monitoring of cBHTs means that adverse effects are not monitored and reported, she said. Also, safety concerns persist regarding some forms of cBHTs such as pellets, which were specifically highlighted in the report.
Dr. Faubion said that she “absolutely” agrees with the report’s limited circumstances in which the used of cBHTs would be appropriate. “There are very few reasons why women would need to use compounded hormones instead of the FDA-approved versions, which are regulated for quality, efficacy and safety, readily available in the local pharmacy, and often covered by insurance.”
In terms of the future, “we need more education for women as consumers and for medical providers on this topic,” Dr. Faubion noted. Also, “clearly, there is a dearth of research on the true efficacy and safety of these compounded hormone therapy products.”
The statement from the National Academies crystallizes what experts have been saying for decades, according to Lubna Pal, MBBS, director of the menopause program at Yale University, New Haven, Conn.
The formal recommendations to limit the use of cBHTs “are not novel, but certainly needed,” and the statement “offers guidance regardless of your specialty,” Dr. Pal said in an interview.
There is often a disconnect between consumers’ understanding of compounding and the reality of safety concerns, she said. “We are in a tabloid era,” and education is key to guiding patients toward the FDA-approved treatments with safety data and demonstrated effectiveness, she said. “Safety should be the driving factor.” In compounded products, “there is no consistency that what you get today is the same as what you get tomorrow,” and the lack of standardization of cBHTs increases the risk for adverse events, she emphasized.
For patients with special needs such as allergies or other specialized dosing requirements, as noted in the National Academies statement, clinicians should discuss the options with patients and monitor them regularly to head off potential adverse events such as the development of uterine cancer, said Dr. Pal, who is a member of the Ob.Gyn. News editorial advisory board.
The research involved in creating the report was supported by the Food and Drug Administration.
Dr. Faubion had no financial conflicts to disclose. Dr. Pal had no relevant financial disclosures.
SOURCE: Mattison DR et al.; National Academies of Sciences, Engineering, and Medicine. The clinical utility of compounded bioidentical hormone therapy: A review of safety, effectiveness, and use. (Washington, DC: The National Academies Press. 2020.)
Doctors hesitated to embrace biosimilar infliximab in first 2 years
Physicians have been slow to embrace biosimilar versions of infliximab, but are more likely to prescribe it to new patients, based on data from a review of nearly 50,000 infliximab claims through Medicare in the first 2 years that biosimilars were available in the United States.
“Although biosimilar versions are as safe and effective as the biologic, patients and physicians may be more reluctant to switch from a working biologic regimen in a chronic setting than an acute one,” wrote Alice J. Chen, PhD, of the University of Southern California, Los Angeles, and colleagues.
In a research letter published in JAMA Internal Medicine, the investigators examined prescribing patterns of physicians switching between the originator infliximab (Remicade) and two of its biosimilars (Inflectra and Renflexis).
They reviewed infliximab use and reimbursement in the 100% Medicare Part B quarterly claims database from Jan. 1, 2017, to Dec. 31, 2018. The study population included Medicare patients classified as new if they had no infliximab claims in the prior 6 months; those with claims were considered returning patients.
In a comparison of claims reflecting 49,771 patients and 4,289 physicians in 2018, a total of 1,418 new patients (17.4%) and 4,495 (10.8%) returning patients used a biosimilar. “Of returning patients, half used the biosimilar version exclusively, whereas the other half switched between biologic and biosimilar versions,” the researchers noted.
Of the 4,289 physicians who prescribed infliximab, 3,124 prescribed no biosimilars, 1,015 prescribed both biologics and biosimilars, and 150 prescribed biosimilars only. Of the physicians who prescribed both, approximately 61% switched some patients from the biologic to the biosimilar; “the remainder kept individual patients on only 1 version of the drug but treated patients with both versions,” the researchers wrote.
The adoption of biosimilars may be slower for chronic vs. acute conditions, the researchers noted. “Prescribers may hesitate to switch clinically stable chronic patients from biologic regimens if they are unfamiliar with the biosimilar or face financial disincentives from prescribing it.”
The study findings were limited by several factors including the use of only 2 years of data and a focus only on Medicare Part B. Switching medications may have been influenced by factors such as lower copays for patients and rebates or discounts for physicians; however, “further research is needed to better understand biosimilar pricing dynamics and the barriers to adopting biosimilars for chronic conditions,” they concluded.
The study was supported by the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California, Los Angeles, and the National Institute on Aging. Lead author Dr. Chen also disclosed receiving personal fees from Amgen outside of the current study.
SOURCE: Chen AJ et al. JAMA Intern Med. 2020 July 20. doi: 10.1001/jamainternmed.2020.3188.
Help your patients understand biologics and biosimilars by using AGA resources for providers and patients available at www.gastro.org/biosimilars.
Physicians have been slow to embrace biosimilar versions of infliximab, but are more likely to prescribe it to new patients, based on data from a review of nearly 50,000 infliximab claims through Medicare in the first 2 years that biosimilars were available in the United States.
“Although biosimilar versions are as safe and effective as the biologic, patients and physicians may be more reluctant to switch from a working biologic regimen in a chronic setting than an acute one,” wrote Alice J. Chen, PhD, of the University of Southern California, Los Angeles, and colleagues.
In a research letter published in JAMA Internal Medicine, the investigators examined prescribing patterns of physicians switching between the originator infliximab (Remicade) and two of its biosimilars (Inflectra and Renflexis).
They reviewed infliximab use and reimbursement in the 100% Medicare Part B quarterly claims database from Jan. 1, 2017, to Dec. 31, 2018. The study population included Medicare patients classified as new if they had no infliximab claims in the prior 6 months; those with claims were considered returning patients.
In a comparison of claims reflecting 49,771 patients and 4,289 physicians in 2018, a total of 1,418 new patients (17.4%) and 4,495 (10.8%) returning patients used a biosimilar. “Of returning patients, half used the biosimilar version exclusively, whereas the other half switched between biologic and biosimilar versions,” the researchers noted.
Of the 4,289 physicians who prescribed infliximab, 3,124 prescribed no biosimilars, 1,015 prescribed both biologics and biosimilars, and 150 prescribed biosimilars only. Of the physicians who prescribed both, approximately 61% switched some patients from the biologic to the biosimilar; “the remainder kept individual patients on only 1 version of the drug but treated patients with both versions,” the researchers wrote.
The adoption of biosimilars may be slower for chronic vs. acute conditions, the researchers noted. “Prescribers may hesitate to switch clinically stable chronic patients from biologic regimens if they are unfamiliar with the biosimilar or face financial disincentives from prescribing it.”
The study findings were limited by several factors including the use of only 2 years of data and a focus only on Medicare Part B. Switching medications may have been influenced by factors such as lower copays for patients and rebates or discounts for physicians; however, “further research is needed to better understand biosimilar pricing dynamics and the barriers to adopting biosimilars for chronic conditions,” they concluded.
The study was supported by the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California, Los Angeles, and the National Institute on Aging. Lead author Dr. Chen also disclosed receiving personal fees from Amgen outside of the current study.
SOURCE: Chen AJ et al. JAMA Intern Med. 2020 July 20. doi: 10.1001/jamainternmed.2020.3188.
Help your patients understand biologics and biosimilars by using AGA resources for providers and patients available at www.gastro.org/biosimilars.
Physicians have been slow to embrace biosimilar versions of infliximab, but are more likely to prescribe it to new patients, based on data from a review of nearly 50,000 infliximab claims through Medicare in the first 2 years that biosimilars were available in the United States.
“Although biosimilar versions are as safe and effective as the biologic, patients and physicians may be more reluctant to switch from a working biologic regimen in a chronic setting than an acute one,” wrote Alice J. Chen, PhD, of the University of Southern California, Los Angeles, and colleagues.
In a research letter published in JAMA Internal Medicine, the investigators examined prescribing patterns of physicians switching between the originator infliximab (Remicade) and two of its biosimilars (Inflectra and Renflexis).
They reviewed infliximab use and reimbursement in the 100% Medicare Part B quarterly claims database from Jan. 1, 2017, to Dec. 31, 2018. The study population included Medicare patients classified as new if they had no infliximab claims in the prior 6 months; those with claims were considered returning patients.
In a comparison of claims reflecting 49,771 patients and 4,289 physicians in 2018, a total of 1,418 new patients (17.4%) and 4,495 (10.8%) returning patients used a biosimilar. “Of returning patients, half used the biosimilar version exclusively, whereas the other half switched between biologic and biosimilar versions,” the researchers noted.
Of the 4,289 physicians who prescribed infliximab, 3,124 prescribed no biosimilars, 1,015 prescribed both biologics and biosimilars, and 150 prescribed biosimilars only. Of the physicians who prescribed both, approximately 61% switched some patients from the biologic to the biosimilar; “the remainder kept individual patients on only 1 version of the drug but treated patients with both versions,” the researchers wrote.
The adoption of biosimilars may be slower for chronic vs. acute conditions, the researchers noted. “Prescribers may hesitate to switch clinically stable chronic patients from biologic regimens if they are unfamiliar with the biosimilar or face financial disincentives from prescribing it.”
The study findings were limited by several factors including the use of only 2 years of data and a focus only on Medicare Part B. Switching medications may have been influenced by factors such as lower copays for patients and rebates or discounts for physicians; however, “further research is needed to better understand biosimilar pricing dynamics and the barriers to adopting biosimilars for chronic conditions,” they concluded.
The study was supported by the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California, Los Angeles, and the National Institute on Aging. Lead author Dr. Chen also disclosed receiving personal fees from Amgen outside of the current study.
SOURCE: Chen AJ et al. JAMA Intern Med. 2020 July 20. doi: 10.1001/jamainternmed.2020.3188.
Help your patients understand biologics and biosimilars by using AGA resources for providers and patients available at www.gastro.org/biosimilars.
FROM JAMA INTERNAL MEDICINE