Treatment of Premenstrual Syndrome: Comparison of Vitex agnus castus and Pyridoxine in a Controlled, Double-Blind Study

Treatment of Premenstrual Syndrome: Comparison of Vitex agnus castus and Pyridoxine in a Controlled, Double-Blind Study

The etiology of premenstrual syndrome (PMS) has yet to be determined. Some causal factors, among others, are discussed: a progesterone-estrogen imbalance, a dysfunction of the mineral balance, disturbances in the renin-angiotensin system, pyridoxine deficiency, hypoglycemic conditions, disturbances in the prostaglandin metabolism, disturbances in serotonin synthesis, and thyroid gland dysfunction. Based on empirical evidence, vitamin B6 and extracts of Vitex agnus castus (VAC) are used to treat PMS. It has been proven without a doubt that VAC has an effect on the pituitary-gonad system in humans in vitro and in vivo. By increasing production and distribution of gonadotropins, VAC influences a woman's ovarian function. The efficacy and harmlessness of the phytopharmaceutical Agnolyt(R) (in the form of a VAC tincture) were proven in a series of studies on and observations of over 3,000 women.

The goal of this study was to test the efficacy and tolerance of a solid (and therefore, new) galenic form of Agnolyt(R) in a randomized, controlled investigation, and to compare its effect to pyridoxine on women with PMS over a period of period of 3 treatment cycles (VAC: 175 mg/day; n = 90; B6:200 mg/day; n = 85). To evaluate the success of the treatment, the following were used: the premenstrual tension syndrome scale (PMTS scale), observation of six characteristic symptoms, and the clinical global impressions scale (CGI scale). At the end of the study the efficacy of the treatment was evaluated by the doctor and the patient.

According to the PMTS scale, symptoms following treatment using either VAC or B6 showed a decrease from 15.2 to 5.1 and 11.9 to 5.1 points, respectively. The PMS-typical symptoms such as breast tenderness, edemas, abdominal tension, headaches, constipation and depressed mood were reduced much more significantly by VAC than by pyridoxine. The CGI scale evaluation indicated similar results. For both medication groups, over 80% of the physician evaluations had an assessment of at least "satisfactory." The evaluations indicated an "excellent" assessment for 24.5% of the cases in the VAC group and for 12.1% of the B6 group. In the patient evaluations, there were no complaints for 36.1% of the VAC group and for 21.3% in the pyridoxine group. Five patients in the B6 group amd 12 patients in the VAC group had mild side effects (gastrointestinal and lower abdominal complaints, skin eruptions and short-term headaches). Serious undesired results were not observed. The results of the study show the efficacy and safety of therapeutic use of Agnolyt(R) capsules for premenstrual syndrome.

Natural Product Research Consultants, Inc.

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By A. Clay and R. Reichert

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