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Agnus castus fruit extract was safe and effective for relieving symptoms of premenstrual syndrome
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QUESTION: Is agnus castus fruit (Vitex agnus castus L extract Ze 440) effective and safe for treatment of premenstrual syndrome?

Design

Randomised (allocation concealed*), blinded (investigators and patients)*, placebo controlled trial with follow up until the end of the third consecutive menstrual cycle.

Setting

6 outpatient general medicine clinics.

Patients

178 women ≥18 years of age who met DSM—III-R criteria for premenstrual syndrome. Exclusion criteria were participation in other trials, concomitant psychotherapy, pregnancy or breast feeding, inadequate contraception, dementia, alcohol or drug dependence, serious medical condition, hypersensitivity to agnus castus, fever, pituitary disease, or sex hormone use. 170 women (96% follow up) (mean age 36.5 y) were included in the intention to treat analysis.

Intervention

Women were allocated to receive agnus castus fruit, 20 mg dry tablet once daily (n=91) (60% ethanol m/m, extract ratio 6–12:1; …

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Footnotes

  • Source of funding: Zeller A G, through the Clinical Research Organisation Praxis Klinische Arzeimittelforschung, Polheim, Germany.

  • For correspondence: Dr R Schellenberg, Institute for Health Care and Science, 35625 Hüttenberg, Germany. Fax +49 6403 72156.

  • A modified version of this abstract appears in Evidence-Based Nursing.

  • * See glossary.