A prospective study of DT56a (Femarelle®) for the treatment of menopause symptoms.

BACKGROUND DT56a (Femarelle®) is a natural medication that contains a variety of phytoestrogens derived from tofu. Treatment with DT56a affects bones, vascular tissues and the nervous system in a manner similar to that of estrogen but DT56a acts as an estrogen antagonist in breast and uterine tissues. AIM The objective of this study was to analyze the efficacy of DT56a in the reduction of menopause symptoms in Spanish women who participated in the Post Marketing Menopausal Symptoms International Survey (POMMSIS). PATIENTS AND METHODS A total of 631 Spanish menopausal or perimenopausal women with vasomotor symptoms who took DT56a for 4 weeks participated in this study. This study was an observational, questionnaire-based investigation that consisted of a baseline questionnaire, a hot flushes daily diary and a feedback questionnaire. RESULTS A statistically significant (p < 0.01) reduction in the number and intensity of hot flushes was experienced after 2 and 4 weeks of DT56a treatment. After 4 weeks of treatment with DT56a, 80.7% of the patients reported that their hot flushes were 'better' or 'much better'. The severity of hot flushes was also reduced by 38% in all study participants and by 36% in women who had experienced more than seven hot flushes per day initially, before treatment. CONCLUSION Treatment with DT56a resulted in a significant reduction in the number and intensity of hot flushes in postmenopausal women, especially in those with frequent symptoms, and these effects were observed within the first month of treatment.