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Background: Current treatments for premenstrual syndrome (PMS) appear to offer, at best, a 25% to 50% reduction in symptoms, and many of these treatments have substantial side effects. Femal, an herbal remedy containing a pollen extract, a pollen and pistil extract, and Royal Jelly, has been used in Scandinavia for the treatment of PMS for >4 years.Objective: The aim of this study was to assess the effect of Femal on the symptoms of PMS.Methods: This was a randomized, double-blind, placebo-controlled, crossover trial of the effects of Femal in women with PMS. The symptoms of PMS were evaluated using well-established questionnaires and daily body weight measurement.Results: Thirty-two women (mean age, 39.4 years; range, 27–50 years) with regular menstrual cycles of 24 to 34 days entered the trial. Three women dropped out of the study, leaving 29 for final evaluation. Two months of active treatment lowered overall symptom indices significantly and lowered 6 of 9 individual symptom scores by 27% to 57%. Evidence for a slow onset of action and protracted effect was provided by the finding that all symptom indices studied declined significantly (by 48%–88%) in the group that received placebo before Femal (P < 0.01). In contrast, the group that received Femal before placebo showed no significant differences between Femal and placebo, except in sleep quality (P < 0.04). Premenstrual weight gain was reduced 50% by active treatment compared with placebo. There were no reported unwanted or adverse effects during Femal treatment.Conclusion: The findings suggest that the herbal therapy Femal provided substantial symptomatic relief of PMS to the women in this study, with minimal risk of unwanted or adverse effects. [Copyright &y& Elsevier]