Vitex agnus castus: Successful treatment of moderate to severe premenstrual syndrome

ObjectivesTo assess efficacy and tolerability of a special extract of Vitex agnus castus (VAC, BNO 1095) in the treatment of women suffering from premenstrual syndrome (PMS) with moderate to severe complaints.MethodsProspective, open, non-comparative, monocentre study. After a run-in phase lasting three cycles, eligible patients were treated for up to three cycles with VAC extract. Efficacy was assessed using a PMS-Diary (primarily) and the PMTS score.ResultsOne hundred and twenty-one patients were enrolled, 118 provided efficacy data (full analysis set), and 109 completed the treatment phase. The severity of the PMS symptoms consistently decreased during treatment, on average from 22.8 score points during the baseline cycle to 10.2 during the third cycle. The mean decrease was 12.6 score points (95% CI: 10.9–14.4, p < 0.0001, Student's t-test). Response to treatment was found in 67.8% of the women during the third treatment cycle (95% CI: 58.6–77.0). Results for the PMTS were similar with a decrease on average from 22.5 to 11.0 score points, i.e. mean change −11.4 (95% CI: 10.1–12.8, p < 0.0001).ConclusionVitex agnus castus extract BNO 1095 is effective and well tolerated in the treatment of moderate to severe PMS.