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| |  Lower Doses of Oestrogen Relieve Symptoms of Menopause Within Weeks: Presented at NAMS By John Otrompke SAN DIEGO -- October 4, 2009 -- A reduced dose of synthetic oestrogen shows efficacy at relieving some of the most common symptoms of menopause within 2 or 3 weeks, according to 2 trials discussed in a poster presentation here at the 20th Annual Meeting of the North American Menopause Society (NAMS). The findings are significant, because while the efficacy of hormone therapy is generally accepted, concerns have been common since the research of the Women’s Health Initiative demonstrated that oestrogen therapy might carry an increased risk of breast cancer, stroke, myocardial infarction, and blood clots. Therefore, shorter durations and lower doses of oestrogen may be recommended. A dose of 0.3 mg relieves menopausal symptoms as early as 2 or 3 weeks after the initiation of therapy, according to poster P-41, “Low-dose synthetic conjugated oestrogens, B exhibit early onset of action in the treatment of vasomotor symptoms and vulvovaginal atrophy associated with menopause.” “The 2 most common problems women face in menopause are vasomotor symptoms, such as night sweats and hot flashes, and vulvovaginal atrophy,” said Dr. David Portman, MD, Columbus Center for Women’s Health Research, Ohio State University College of Medicine, Columbus, Ohio, on October 1. To identify the lowest and earliest effective dose, Dr. Portman and colleagues conducted 2 trials. In the vasomotor symptoms trial, 281 highly symptomatic menopausal women received up to 12 weeks of once-daily oral therapy with 0.3 mg, 0.625 mg, or 1.25 mg of synthetic oestrogen or placebo and recorded the frequency and severity of hot flushes in daily diaries. The second trial randomised 310 women to daily 0.3 mg doses of oral oestrogen or matching placebo for up to 12 weeks and assessed 3 coprimary measurements of vulvovaginal atrophy. In the vasomotor symptoms trial, results for the 0.3 mg dose reached significance at 3 weeks and achieved a 72% reduction from baseline by the end of the study. In the vulvovaginal atrophy study, improvement in all 3 coprimary endpoints (vaginal maturation index, vaginal atrophy, and most bothersome symptom, such as dryness, irritation, or pain with or bleeding after intercourse) was noted by day 14 and sustained throughout the 12-week course of treatment. By day 14, the vaginal maturation index increased by 26.45 in the oestrogen group compared with an increase of 3.7 in the placebo group. The mean vaginal pH was decreased by 1.39 in the oestrogen group compared with a decline of 0.3 in the placebo group at day 14. “These trials have across the board shown a very high placebo response. Women who think they’re getting treatment, and are getting support, feel that they’re doing better, and women who are getting information can get better without treatment,” Dr. Portman added. Funding for this study was provided by Teva Women’s Health Research, Inc. [Presentation title: Low-Dose Synthetic Conjugated Estrogens, B Exhibits Early Onset of Action in the Treatment of Vasomotor Symptoms and Vulvovaginal Atrophy Associated With Menopause. Abstract P-41]
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