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Vitex more effective than pyridoxine in PMS

Good clinical evidence bears out the strong traditional reputation of Vitex agnus-castus L., Verbenaceae in the treatment of menstrual abnormalities, premenstrual syndrome (PMS), menopausal complaints, and even infertility. Recently, this team of German investigators designed a controlled, double-blind study to evaluate the efficacy and safety of a standardized Vitex capsule formulation (Agnolyt®, Madaus AG) in comparison with pyrodoxine (vitamin B6) in 175 women with PMS. Pyridoxine was chosen for purposes of comparison because earlier research indicates that it can be effective in alleviating various symptoms of PMS, which may include nervousness, irritability, depression, bloating, breast tenderness, weight gain, and skin and digestive problems.

The 175 women were randomized to receive daily treatment with one standardized Vitex extract capsule (reported to be equivalent to 3.5 to 4.2 mg Vitex) plus one placebo capsule (n=90) or two 100 mg capsules of pyridoxine (n=85). Duration of treatment was three menstrual cycles. Therapeutic response was assessed with the premenstrual tension syndrome (PMTS) scale, recording of six typical PMS complaints, and the clinical global impression (CGI) scale. Treatment efficacy was assessed by both patients and physicians. At the end of the trial, 127 subjects were eligible for inclusion in the efficacy analysis; all 175 were included in the safety analysis.

In comparison with pyridoxine, Vitex was associated with "a considerably more marked alleviation of typical PMTS complaints, such as breast tenderness, edema, inner tension, headache, constipation, and depression." Overall, 77.1% of subjects taking Vitex reported improvements, compared to 60.6% of those in the pyridoxine group. With regard to physician assessments, 80% felt that both treatments provided "adequate" efficacy. However, 24.5% rated Vitex treatment as "excellent," compared to only 12.1% with pyridoxine.

Side effects were reported by 5 women in the pyridoxine group and 12 in the Vitex group, including headache, gastrointestinal and lower abdominal complaints, and skin problems. No serious adverse events were seen. Although women wishing to conceive were excluded at the beginning of the study, 5 women taking Vitex became pregnant during the course of the trial. -- Evelyn Leigh, HRF

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[Lauritzen, C., Reuter, H.D., Repges, R., Bohnert, K.-J., Schmidt, U. Treatment of premenstrual tension syndrome with Vitex agnus castus. Controlled, double-blind study versus pyridoxine. 1997. Phytomedicine, Vol. 4, No. 3, 183-189.]

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