Evaluating therapeutic effect in symptoms of moderate-to-severe premenstrual syndrome with Vitex agnus castus (BNO 1095) in Chinese women.

OBJECTIVES

To assess therapeutic effect of an extract of Vitex agnus castus (VAC, BNO 1095) in premenstrual syndrome (PMS) in Chinese women.

DESIGN

It was a prospective, randomised, double-blind, placebo-controlled study carried out in China. Eligible patients were treated with VAC extract or placebo for three cycles. Symptoms were documented with PMS diary (PMSD), a daily rating scale with 17 items. Main efficacy variable was the reduction percentage of 17 symptom score documented in PMSD during the luteal phase of the third treatment cycle.

RESULTS

A total of 67 patients were enrolled and randomly assigned to VAC group or placebo group. Of these, 64 patients completed the study (31 vs. 33). All the 17 symptoms showed a significantly greater improvement with VAC than placebo (P < 0.05) except lower abdominal cramping (P > 0.05).

CONCLUSION

Vitex agnus castus is more effective than placebo in the treatment of moderate-to-severe PMS in Chinese women, especially in symptoms of negative effect and insomnia.