Mastodynon(R) for Female Infertility. Randomized, Placebo-Controlled, Clinical Double-Blind Study OBJECTIVE AND DESIGN: The effects of Mastodynon(R), an Agnus castus-containing preparation, were investigated in 96 women with fertility disorders in a prospective, randomized, placebo-controlled, double-blind study. PATIENTS AND METHODS: 38 women with secondary amenorrhoea, 31 women with luteal insuffciency and 27 women with idiopathic infertility received 30 drops ofMastodynon or placebo twice a day over a period of 3 months. OUTCOME MEASURE AND RESULTS: The outcome measure, which was pregnancy or spontaneous menstruation in women with amenorrhoea and pregnancy or improved concentrations of luteal hormones in both other groups, was achieved in 31 out of 66 women who were suitable for evaluation. It was achieved more often in the Mastodynon group compared to the placebo group (57.6% versus 36.0%, p = 0.069). 15 women conceived during the observation period (n = 7 with amenorrhoea, n = 4 with idiopathic infertility, n = 4 with luteal insufficiency). In women with amenorrhoea or luteal insufficiency, pregnancy occurred in the Mastodynon group more than twice as often as in the placebo group. Under therapy no hormonal changes were found at a 5% significance level. Only very few undesirable drug effects were observed. CONCLUSION: In women with sterility due to secondary amenorrhoea and luteal insufficiency, a treatment with Mastodynon can be recommended over a period of 3 to 6 months.
RCT Entities:
Mastodynon(R) for Female Infertility. Randomized, Placebo-Controlled, Clinical Double-Blind Study OBJECTIVE AND DESIGN: The effects of Mastodynon(R), an Agnus castus-containing preparation, were investigated in 96 women with fertility disorders in a prospective, randomized, placebo-controlled, double-blind study. PATIENTS AND METHODS: 38 women with secondary amenorrhoea, 31 women with luteal insuffciency and 27 women with idiopathic infertility received 30 drops of Mastodynon or placebo twice a day over a period of 3 months. OUTCOME MEASURE AND RESULTS: The outcome measure, which was pregnancy or spontaneous menstruation in women with amenorrhoea and pregnancy or improved concentrations of luteal hormones in both other groups, was achieved in 31 out of 66 women who were suitable for evaluation. It was achieved more often in the Mastodynon group compared to the placebo group (57.6% versus 36.0%, p = 0.069). 15 women conceived during the observation period (n = 7 with amenorrhoea, n = 4 with idiopathic infertility, n = 4 with luteal insufficiency). In women with amenorrhoea or luteal insufficiency, pregnancy occurred in the Mastodynon group more than twice as often as in the placebo group. Under therapy no hormonal changes were found at a 5% significance level. Only very few undesirable drug effects were observed. CONCLUSION: In women with sterility due to secondary amenorrhoea and luteal insufficiency, a treatment with Mastodynon can be recommended over a period of 3 to 6 months.
Authors: Susan Arentz; Jason Anthony Abbott; Caroline Anne Smith; Alan Bensoussan Journal: BMC Complement Altern Med Date: 2014-12-18 Impact factor: 3.659