Vitex More Effective Than Pyridoxine in PMS

Good clinical evidence bears out the strong traditional reputation of chaste tree fruits (Vitex agnus-castus L., Verbenaceae) in the treatment of menstrual abnormalities, premenstrual syndrome (PMS), menopausal complaints, and even infertility. Recently, a team of German investigators conducted a controlled, double-blind study to evaluate the efficacy and safety of a Vitex capsule formulation (Agnolyt(R), Madaus AG, Cologne, Germany) compared to pyridoxine (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 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 capsule containing 3.5 to 4.2 mg dried Vitex extract (9.58-11.5:1) 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 percent of subjects taking Vitex reported improvements, compared to 60.6 percent of those in the pyridoxine group. With regard to physician assessments, 80 percent felt that both treatments provided "adequate" efficacy. However, 24.5 percent rated Vitex treatment as "excellent," compared to only 12.1 percent with pyridoxine.

Side effects were reported by five 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, five women taking Vitex became pregnant during the course of the trial.

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

American Botanical Council.


By Evelyn Leigh

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