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 t olerability of a new solid formulation (capsules) of Agnolyt((R))) in a randomized, controlled trial versus pyridoxine in women with PMTS o ver a period of three treatment cycles (Vitex agnus castus (VAC): 1 ca psule + 1 placebo capsule/day, n = 90; pyridoxine (B6): 2 capsules day , n = 85). The therapeutic response was assessed using the premenstrua l tension syndrome scale (PMTS scale), the recording of six characteri stic complaints of the syndrome, and the clinical global impression sc ale (CGI scale). Upon completion of the trial, efficacy of the treatme nt was assessed by the physician as well as by the patient. On the PMT S scale, treatment with VAC and B6 produced a reduction in score point s from 15.2 to 5.1 (-47,4%) and from 11.9 to 5.1 (-48%)(*), respectiv ely. In comparison with pyridoxine, VAC caused a considerably more mar ked alleviation of typical PMTS complaints, such as breast tenderness, edema, inner tension, headache, constipation, and depression. Analogo us results were obtained with the CGI scale. In both treatment groups, efficacy was rated as at least adequate by more than 80% of the inves tigators; however, VAC treatment was rated as excellent by 24.5% and p yridoxine treatment by 12.1% of the investigators. According to the pa tients' assessment, 36.1% of the cases in the VAC group and 21.3% in t he pyridoxine group were free from complaints. Adverse events (gastroi ntestinal and lower abdominal complaints, skin manifestations and tran sitory headache) occurred in 5 patients under BG and in 12 patients un der VAC. Serious adverse events were not observed. The results of the present study confirm the efficacy and safety of Agnolyt((R)) capsules in the treatment of PMTS.