Objectives: To assess efficacy of the extract of Vitex agnus castus (VAC, BNO 1095) in the treatment of Chinese women suffering from moderate to severe premenstrual syndrome (PMS).
Methods: It was a prospective randomised double-blind placebo-controlled study conducted in Chinese women. Eligible patients were randomly assigned into VAC or placebo group. Symptoms were documented with a daily rating scale with four symptom factors (negative affect, water retention, food cravings and pain).
Results: Sixty-seven patients were enrolled and randomly assigned to receive one tablet of VAC or placebo once a day. The premenstrual syndrome diary (PMSD) sum score decreased from 29.38 +/- 7.63 score points at baseline to 4.28 +/- 5.76 at the 3rd cycle in the treatment group, while it decreased from 28.76 +/- 8.23 to 11.79 +/- 11.78 in the placebo group. All the four symptom factor scores were significantly reduced by the 3rd treatment cycle. There was significant difference in PMSD sum score, score of negative affect and water retention between two groups at cycle 3 (P < 0.05). PMSD sum scores decreased 60% was defined as efficacy, and the efficacy rate in treatment group was significantly higher than that in placebo group at the 3rd treatment cycle.
Conclusion: Vitex agnus castus extract BNO 1095 shows effective in treating moderate to severe PMS in Chinese women, especially in symptoms of negative affect and water retention.