1.
Prospective observational study to evaluate the efficacy and safety of the pollen extract Sérélys® in the management of women with menopausal symptoms.
Fait, T, Sailer, M, Regidor, PA
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology. 2019;(4):360-363
Abstract
Safety concerns or contraindications to the use of hormones have resulted in a rise of the use of herbal medicinal products for the management of menopausal symptoms. The pollen extract Sérélys® represents, due to its ingredients and mode of action, a new and innovative alternative for the management of these symptoms. The aim of the present study was to demonstrate the efficacy and safety of Sérélys®. A prospective, open, observational, and multicentre study was performed on 104 menopausal women. The patients received over 3 months the pollen extract Sérélys® containing the extracts PI82 and GC Fem in a dosage of twice 160 mg extract and 5 mg vitamin E. Using a validated menopausal rating score, the improvement of menopausal symptoms was recorded. A significant decrease of different menopausal symptoms was observed between the starting point of the study and after 12 weeks (p < .0001). Hot flashes were reduced by 48.5%, sleep disturbance by 50.1%, depressive mood by 51.2%, irritability by 47.9%, fatigue by 47.8%, vaginal dryness by 39.63% and muscles and joint pain by 27.4%. The pollen extract Sérélys® reduced significant menopausal symptoms showing a very low side effect profile.
2.
A prospective study of DT56a (Femarelle®) for the treatment of menopause symptoms.
Sánchez-Borrego, R, Mendoza, N, Llaneza, P
Climacteric : the journal of the International Menopause Society. 2015;(6):813-6
Abstract
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.