Treatment of premenstrual tension syndrome with Vitex agnus castus controlled, double-blind study versus pyridoxine.

The objective of the present study was to determine the efficacy and tolerability of a new solid formulation (capsules) of Agnolyt®(*)) in a randomized, controlled trial versus pyridoxine in women with PMTS over a period of three treatment cycles (Vitex agnus castus (VAC): 1 capsule + 1 placebo capsule/day, n = 90; pyridoxine (B6): 2 capsules day, n = 85). The therapeutic response was assessed using the premenstrual tension syndrome scale (PMTS scale), the recording of six characteristic complaints of the syndrome, and the clinical global impression scale (CGI scale). Upon completion of the trial, efficacy of the treatment was assessed by the physician as well as by the patient. On the PMTS scale, treatment with VAC and B6 produced a reduction in score points from 15.2 to 5.1 (-47,4%) and from 11.9 to 5.1 (-48%)(*), respectively. In comparison with pyridoxine, VAC caused a considerably more marked alleviation of typical PMTS complaints, such as breast tenderness, edema, inner tension, headache, constipation, and depression. Analogous results were obtained with the CGI scale. In both treatment groups, efficacy was rated as at least adequate by more than 80% of the investigators; however, VAC treatment was rated as excellent by 24.5% and pyridoxine treatment by 12.1% of the investigators. According to the patients' assessment, 36.1% of the cases in the VAC group and 21.3% in the pyridoxine group were free from complaints. Adverse events (gastrointestinal and lower abdominal complaints, skin manifestations and transitory headache) occurred in 5 patients under B6 and in 12 patients under VAC. Serious adverse events were not observed. The results of the present study confirm the efficacy and safety of Agnolyt® capsules in the treatment of PMTS.

RCT Entities:   Population Interventions Outcomes