Background: Vitex agnus-castus is a herbal drug with antiprolactin effect and it is effective in premenstrual syndrome and hypermenorrhea. The purpose of this study was to evaluate vitex agnus-castus extract (chaste tree) in comparison with placebo in treating patients with mastalgia, and evaluation of its acceptability and side effects. Methods: In a double-blind, randomized clinical trial, 117 women with mastalgia, aged 15-50 years old, referring to women’s health centers, were divided into two groups. One group (55 patients) received 60 drops of vitex agnus-castus daily for three months and the control group (62 patients) received placebo for the same period of time. Results: By the end of the treatment, 88.4% of the vitex agnus-castus group and 17/7% of the placebo group showed positive response (P=0.0001). vitex agnus-castus was well tolerated and caused no side effects. Conclusion: Vitex agus-castus is an effective herbal drug with few side effects in treating mastalgia and it is well tolerated.

Keywords: mastalgia, Vitex agnus castus, prolactin, herbal drug

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