Agnus castus fruit extract was safe and effective for relieving symptoms of premenstrual syndrome
QUESTION: Is agnus castus fruit (Vitex agnus castus L extract Ze 440) effective and safe for treatment of premenstrual syndrome?
Randomised (allocation concealed), blinded (investigators and patients), placebo controlled trial with follow up until the end of the third consecutive menstrual cycle.
6 outpatient general medicine clinics.
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%) (mean age 37 y) were included in the intention to treat analysis.
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; standardised for casticin), or matching placebo (n=87). Study medication was initiated at the start of the first cycle and continued until the end of …