Use of a multibotanical (Nutrafem) for the relief of menopausal vasomotor symptoms: a double-blind, placebo-controlled study.

OBJECTIVE

This study aimed to compare the efficacy and safety of a multibotanical (Nutrafem) with those of placebo for the treatment of menopausal vasomotor symptoms.

METHODS

In this phase III, double-blind, randomized, placebo-controlled study, 159 postmenopausal women experiencing at least 21 vasomotor symptoms per week were treated with Nutrafem (Bionutra Pte Ltd, Singapore) or a matched placebo for 12 weeks. Treatment outcome was evaluated by the change from baseline in the average weekly number of vasomotor symptoms.

RESULTS

At the end of the study, Nutrafem reduced the number of vasomotor symptoms by 46% from baseline, and this is significantly superior to placebo (26% from baseline; P = 0.020). Forty-three percent of women taking Nutrafem experienced an at least 50% reduction in the number of symptoms compared with 6% of women taking placebo (P = 0.021; number needed to treat = 2.7). There were no group differences in adverse events, laboratory values, and gynecological data.

CONCLUSIONS

Nutrafem is an effective botanical treatment for vasomotor symptoms in postmenopausal women.