Efficacy of Vitex agnus castus L. extract Ze 440 in patients with pre-menstrual syndrome (PMS)

In a prospective, multicentre trial the efficacy of an Vitex agnus castus L extract Ze 440 was investigated in 50 patients with pre-menstrual syndrome (PMS). The patients were treated daily with one tablet (20 mg native extra ct) during three menstrual cycles. 43 patients completed the study protocol which encompassed 8 menstrual cycles (2 baseline, 3 treatment and 3 post-t reatment), 13/43 patients were receiving concomitant oral contraceptives. 6 patients did not complete the study for reasons not related to study medic ation, and one patient complained of fatigue possibly related to study medi cation. All evaluated patients took at least 85% of the prescribed medicati on. The main effect parameter was the validated Moos' menstrual distress qu estionnaire (MMDQ), and secondary parameters were a visual analogue scale ( VAS; self-assessment) and a global impression scale (GI, self-assessment). The study population was homogenous in age (31.3 +/- 7.7 years) weight (58. 9 +/- 6.9 kg) and cycle length (28.4 +/- 0.3 d). The diagnosis was accordin g to DMS-III. At the end of the study, PMS-related symptoms were reduced by treatment. There was a significant score reduction (42.5%) of the MMDQ as the main effect parameter (p < 0.001). Symptoms gradually returned after tr eatment cessation. However, a difference from baseline remained (20%; p < 0 .001) up to 3 cycles thereafter. 20/43 patients were considered "responders ", with a reduction in MMDQ score by at least 50% relative to baseline. At baseline, the VAS score was elevated in the late luteal phase and low at th e follicular phase, as expected. During treatment, VAS score decreased in t he late luteal phase (47.2%; p < 0.01) and remained 21.7% (p < 0.001) below baseline after 3 cycles post-cessation of treatment. The low VAS score wit hin the follicular phase remained unchanged over the whale observation peri od. 38 patients judged the global efficacy moderate to excellent, 5 patient s indicated no global efficacy. The number of days patients sustained PMS s ymptoms was reduced slightly From 7.5 to 6. Resting levels of blood prolact in remained within the physiological range throughout. No differences were seen between patients on or off oral contraceptives. 20 patients reported 3 7 adverse events (AE). No serious AE were reported. One patint withdrew aft er four days of treatment due to fatigue and headache. Laboratory safety co ntrol parameters were not affected. In conclusion, patients with PMS can be treated successfully with Vitex agnus-castus extract Ze 440, as indicated by clear improvement in the main effect parameter during treatment and the gradual return after cessation of treatment. The main response to treatment seems related to symptomatic relief rather than to the duration of the syn drome.