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based on data from a randomized trial of more than 300 patients suffering from genitourinary syndrome of menopause (GSM), a constellation of symptoms including pain on vaginal penetration and vaginal dryness.
“Surveys of postmenopausal women demonstrate a preference for effective, nonhormonal therapies, often due to safety concerns,” wrote Caroline M. Mitchell, MD, of Massachusetts General Hospital, Boston, and her colleagues. The report was published in JAMA Internal Medicine. The researchers randomized 302 postmenopausal women with GSM 1:1:1 to a Vagifem 10-microgram estradiol tablet and placebo gel, a placebo tablet and Replens gel, or a placebo tablet and a placebo gel.
The average age of the women was 61 years, 88% were white, and 81% were sexually active.
The primary outcome was a decrease in the most bothersome symptoms reported by the women after 12 weeks of treatment. The most common of these were pain on penetration (60%) and vulvovaginal dryness (21%).
After 12 weeks, the women reported no significant difference in most bothersome symptoms between estradiol or moisturizing gel, compared with placebo products (P = .25 and P = .31, respectively). The average improvement in symptom scores was similar between the estradiol tablet and placebo tablet (P = .64) and between the moisturizer and placebo gels (P = .17).
The study was limited by several factors including the homogenous population and the absence of a head-to-head comparison of treatments, the researchers noted. However, the results suggest that more research is needed about genitourinary syndrome of menopause, but that a nonprescription lubricating gel may be an appropriate estrogen-free choice, and that “treatment choice should be based on individual patient preferences regarding cost and formulation,” they said.
The study was funded by the National Institutes of Health/National Institute on Aging. Dr. Mitchell is a consultant for Symbiomix Therapeutics, and coauthors reported grant support from Bayer and having served on a scientific advisory board for Sermonix.
SOURCE: Mitchell C et al. JAMA Intern Med. 2018 Mar. doi: 10.1001/jamainternmed.2018.0116.
The double-negative finding of the study suggests a potential change in clinical practice as to the value of estrogen for postmenopausal women, Alison J. Huang, MD, and Deborah Grady, MD, wrote in an editorial.
“Based on the results of this study, women and their physicians may want to take this one step further and conclude that postmenopausal women experiencing vulvovaginal symptoms should choose the cheapest moisturizer or lubricant available over the counter – at least until new evidence arises to suggest that there is any benefit to doing otherwise,” they said. The study compared popular active treatments – an estradiol tablet and a nonhormonal moisturizing gel – with placebo and not with each other, which could be considered a limitation, they said. However, the similar effectiveness of the treatments to placebo support a choice of treatments for vulvovaginal symptoms based on cost and patient preference for a particular formulation, they noted (JAMA Intern Med. 2018 Mar. doi: 10.1001/jamainternmed.2018.0094).
Dr. Huang and Dr. Grady are affiliated with the University of California, San Francisco, and the San Francisco Veterans Affairs Health Care System. Dr. Huang disclosed research grants from Pfizer and Astellas Pharma. Dr. Grady has served as a consultant to MenoGeniX.
The double-negative finding of the study suggests a potential change in clinical practice as to the value of estrogen for postmenopausal women, Alison J. Huang, MD, and Deborah Grady, MD, wrote in an editorial.
“Based on the results of this study, women and their physicians may want to take this one step further and conclude that postmenopausal women experiencing vulvovaginal symptoms should choose the cheapest moisturizer or lubricant available over the counter – at least until new evidence arises to suggest that there is any benefit to doing otherwise,” they said. The study compared popular active treatments – an estradiol tablet and a nonhormonal moisturizing gel – with placebo and not with each other, which could be considered a limitation, they said. However, the similar effectiveness of the treatments to placebo support a choice of treatments for vulvovaginal symptoms based on cost and patient preference for a particular formulation, they noted (JAMA Intern Med. 2018 Mar. doi: 10.1001/jamainternmed.2018.0094).
Dr. Huang and Dr. Grady are affiliated with the University of California, San Francisco, and the San Francisco Veterans Affairs Health Care System. Dr. Huang disclosed research grants from Pfizer and Astellas Pharma. Dr. Grady has served as a consultant to MenoGeniX.
The double-negative finding of the study suggests a potential change in clinical practice as to the value of estrogen for postmenopausal women, Alison J. Huang, MD, and Deborah Grady, MD, wrote in an editorial.
“Based on the results of this study, women and their physicians may want to take this one step further and conclude that postmenopausal women experiencing vulvovaginal symptoms should choose the cheapest moisturizer or lubricant available over the counter – at least until new evidence arises to suggest that there is any benefit to doing otherwise,” they said. The study compared popular active treatments – an estradiol tablet and a nonhormonal moisturizing gel – with placebo and not with each other, which could be considered a limitation, they said. However, the similar effectiveness of the treatments to placebo support a choice of treatments for vulvovaginal symptoms based on cost and patient preference for a particular formulation, they noted (JAMA Intern Med. 2018 Mar. doi: 10.1001/jamainternmed.2018.0094).
Dr. Huang and Dr. Grady are affiliated with the University of California, San Francisco, and the San Francisco Veterans Affairs Health Care System. Dr. Huang disclosed research grants from Pfizer and Astellas Pharma. Dr. Grady has served as a consultant to MenoGeniX.
based on data from a randomized trial of more than 300 patients suffering from genitourinary syndrome of menopause (GSM), a constellation of symptoms including pain on vaginal penetration and vaginal dryness.
“Surveys of postmenopausal women demonstrate a preference for effective, nonhormonal therapies, often due to safety concerns,” wrote Caroline M. Mitchell, MD, of Massachusetts General Hospital, Boston, and her colleagues. The report was published in JAMA Internal Medicine. The researchers randomized 302 postmenopausal women with GSM 1:1:1 to a Vagifem 10-microgram estradiol tablet and placebo gel, a placebo tablet and Replens gel, or a placebo tablet and a placebo gel.
The average age of the women was 61 years, 88% were white, and 81% were sexually active.
The primary outcome was a decrease in the most bothersome symptoms reported by the women after 12 weeks of treatment. The most common of these were pain on penetration (60%) and vulvovaginal dryness (21%).
After 12 weeks, the women reported no significant difference in most bothersome symptoms between estradiol or moisturizing gel, compared with placebo products (P = .25 and P = .31, respectively). The average improvement in symptom scores was similar between the estradiol tablet and placebo tablet (P = .64) and between the moisturizer and placebo gels (P = .17).
The study was limited by several factors including the homogenous population and the absence of a head-to-head comparison of treatments, the researchers noted. However, the results suggest that more research is needed about genitourinary syndrome of menopause, but that a nonprescription lubricating gel may be an appropriate estrogen-free choice, and that “treatment choice should be based on individual patient preferences regarding cost and formulation,” they said.
The study was funded by the National Institutes of Health/National Institute on Aging. Dr. Mitchell is a consultant for Symbiomix Therapeutics, and coauthors reported grant support from Bayer and having served on a scientific advisory board for Sermonix.
SOURCE: Mitchell C et al. JAMA Intern Med. 2018 Mar. doi: 10.1001/jamainternmed.2018.0116.
based on data from a randomized trial of more than 300 patients suffering from genitourinary syndrome of menopause (GSM), a constellation of symptoms including pain on vaginal penetration and vaginal dryness.
“Surveys of postmenopausal women demonstrate a preference for effective, nonhormonal therapies, often due to safety concerns,” wrote Caroline M. Mitchell, MD, of Massachusetts General Hospital, Boston, and her colleagues. The report was published in JAMA Internal Medicine. The researchers randomized 302 postmenopausal women with GSM 1:1:1 to a Vagifem 10-microgram estradiol tablet and placebo gel, a placebo tablet and Replens gel, or a placebo tablet and a placebo gel.
The average age of the women was 61 years, 88% were white, and 81% were sexually active.
The primary outcome was a decrease in the most bothersome symptoms reported by the women after 12 weeks of treatment. The most common of these were pain on penetration (60%) and vulvovaginal dryness (21%).
After 12 weeks, the women reported no significant difference in most bothersome symptoms between estradiol or moisturizing gel, compared with placebo products (P = .25 and P = .31, respectively). The average improvement in symptom scores was similar between the estradiol tablet and placebo tablet (P = .64) and between the moisturizer and placebo gels (P = .17).
The study was limited by several factors including the homogenous population and the absence of a head-to-head comparison of treatments, the researchers noted. However, the results suggest that more research is needed about genitourinary syndrome of menopause, but that a nonprescription lubricating gel may be an appropriate estrogen-free choice, and that “treatment choice should be based on individual patient preferences regarding cost and formulation,” they said.
The study was funded by the National Institutes of Health/National Institute on Aging. Dr. Mitchell is a consultant for Symbiomix Therapeutics, and coauthors reported grant support from Bayer and having served on a scientific advisory board for Sermonix.
SOURCE: Mitchell C et al. JAMA Intern Med. 2018 Mar. doi: 10.1001/jamainternmed.2018.0116.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Estradiol tablets had no increased benefit, compared with placebo, for relieving postmenopausal vulvovaginal symptoms.
Major finding: The improvement in vaginal discomfort after 12 weeks was not significantly different between an estradiol tablet and placebo (P = .64) or between a popular vaginal moisturizer and placebo (P = .17).
Study details: The data come from a randomized, clinical trial of 302 postmenopausal women.
Disclosures: The study was funded by the National Institutes of Health/National Institute on Aging. Dr. Mitchell is a consultant for Symbiomix Therapeutics, and coauthors reported grant support from Bayer and having served on a scientific advisory board for Sermonix.
Source: Mitchell C et al. JAMA Intern Med. 2018 Mar. doi: 10.1001/jamainternmed.2018.0116.