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With Comments by Adriane Fugh-Berman, MD
April 2001; Volume 3; 31-32
Source: Schellenberg R, et al. Treatment for the premenstrual syndrome with agnus castus fruit extract: Prospective, randomised, placebo-controlled study. BMJ 2001;322: 134-137.
Design/Setting/Subjects: Randomized, double-blind, placebo-controlled outpatient study of 178 women (170 completed) with premenstrual syndrome.
Intervention: One 20 mg tablet daily Vitex agnus-castus fruit dry extract ZE440 (standardized to casticin, 60% ethanol m/m, extract ratio 6-12:1) vs. placebo for three menstrual cycles.
Outcomes: Mean difference from baseline in combined scores of a visual analog scale that included symptoms of irritability, mood alteration, anger, headache, bloating, and breast fullness. Secondary outcomes included clinical global impression of severity of condition, global improvement or deterioration, and overall treatment assessment.
Results: The treatment was well-tolerated. Mean reduction in self-assessed combined symptom scores were -78.1 in the placebo group and -128.5 in the treated group, a significant difference. There were significant differences between groups favoring vitex on irritability, mood alteration, anger, headache, breast fullness, severity of condition, improvement/deterioration, and overall assessment. There was no difference between groups in symptoms of bloating.
Comment: This is a reasonable trial that shows a benefit of vitex for treating symptoms of premenstrual syndrome. Once again, however, means of scores from a visual analog scale have been compared, an inappropriate (but exceedingly common) use of a parametric test for analyzing ranked scores (see Alternative Therapies in Women’s Health, February 2001, pp. 11-12). These authors will continue to harp on this point until both the alternative and conventional medicine communities straighten up and fly right.
A previous randomized controlled trial compared the effects of vitex extract or vitamin B6 (100 mg bid) during the latter half of the menstrual cycle. Both treatments reduced premenstrual tension syndrome scores significantly, but vitex was superior in relieving breast tenderness, edema, headache, constipation, and depression.
Vitex appears to decrease follicle-stimulating hormone, increase luteinizing hormone, and inhibit prolactin activity in vitro; it has not yet been shown that vitex alone decreases prolactin levels in humans. A combination product containing vitex did reduce prolactin levels in women with mastalgia.1 Vitex appears to be relatively safe; previously reported adverse effects include gastroenteritis, nausea, rashes, and itching. Decreased libido also may occur.
One case of ovarian hyperstimulation apparently caused by ingestion of vitex has been reported.2 A 32-year-old woman with tubal infertility who had developed single follicles with gonadotrophin stimulation in three cycles took vitex prior to and during the early follicular phase of the fourth cycle (no other medications were taken during this cycle). Vaginal ultrasonography on day 6 revealed three developing follicles on the right ovary and one on the left. Vitex should not be used during pregnancy. It is controversial whether it should be used during lactation; prolactin levels are thought to be reduced, but vitex is sometimes used to stimulate milk production.
1. Schulz V, et al. Rational Phytotherapy. 3rd ed. Berlin: Springe-Verlag; 1998:240-242.
2. Cahill DJ, et al. Multiple follicular development associated with herbal medicine. Hum Reprod 1994;9:1469-1470.