Treatment for premenstrual syndrome with Vitex agnus castus: A prospective, randomized, multi-center placebo controlled study in China

Objectives: To investigate the efficacy and safety of VAC BNO 1095 extract in Chinese women suffering from moderate to severe premenstrual syndrome (PMS). Methods: Prospective, double-blind, placebo controlled, parallel-group, multi-center clinical trial design was employed. After screening and preparation phase lasting three cycles, Eligible patients were randomly assigned into treatment or placebo groups and had treatment with VAC extract or placebo for up to three cycles. Efficacy was assessed using the Chinese version PMS-diary (PMSD) and PMTS. Results: Two hundred and seventeen women were eligible to enter the treatment phase (TP) and were randomly assigned into the treatment group (108) or the placebo group (109), 208 provided the efficacy data (treatment 104, placebo 104), and 202 completed the treatment phase (treatment 101, placebo 101). The mean total PMSD score decreased from 29.23 at baseline (0 cycle) to 6.41 at the termination (3rd cycle) for the treatment group and from 28.14 at baseline (0 cycle) to 12.64 at the termination (3rd cycle) for the placebo group. The total PMSD score of 3rd cycle was significantly lower than the baseline in both groups (p < 0.0001). The difference in the mean scores from the baseline to the 3rd cycle in the treatment group (22.71 +/- 10.33) was significantly lower than the difference in the placebo group (15.50 +/- 12.94, p < 0.0001). Results of PMTS were similar, the total scores for PMTS were significantly lower between the two groups (p < 0.01) and within each group (p < 0.01). The score was decreased from 26.17 +/- 4.79 to 9.92 +/- 9.01 for the treatment group, and from 27.10 +/- 4.76 to 14.59 +/- 10.69 for the placebo group. A placebo effect of 50% was found in the present study. No serious adverse event (SAE) occurred in both groups. Conclusion: Vitex agnus castus (VAC BNO 1095 corresponding to 40 mg herbal drug) is a safe, well tolerated and effective drug of the treatment for Chinese women with the moderate to severe PMS. (C) 2009 Elsevier Ireland Ltd. All rights reserved.