The fact that hormone replacement therapy has been claimed to increase the risk of breast cancer has made it relevant to search for new non-hormonal treatments of menopausal symptoms. Objectives This study aimed to evaluate whether Femal, a herbal remedy made from pollen extracts, alleviates the symptoms of the menopause, especially hot flushes. Design A randomized, double-blind, placebo-controlled, parallel trial of 64 menopausal women, of whom 54 completed the trial. After an initial run-in

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... ase of 1 month, the women were randomly given either two Femal tablets each morning, or two identical placebo tablets, for 3 months of treatment. On inclusion, and then at 4-week intervals, the patients were asked to evaluate 16 symptoms of the menopause using Menopause Rating Scales (MRS). In addition, every day throughout the study, certain menopausal symptoms were recorded in a diary. Results The two treatment groups were identical regarding demographic data and the initial symptom scores. In the active-treatment group, 65% responded with a reduction in hot flushes compared with 38% in the placebo group (p 5 0.006) and, in this group, the number of hot flushes registered in diaries declined after 3 months by 27% as compared to the placebo group (p 5 0.026). MRS evaluation of hot flushes yielded similar results (p 5 0.031). There were 23% and 22% decreases in hot flushes after 2 and 3 months of treatment, respectively, and after both intervals of time the inter-group comparisons were significantly affected. An overall evaluation of the trend in 15 other 'quality-of-life' parameters showed likewise in favor of the pollen extract (p 5 0.031). Conclusion The pollen extract Femal significantly reduces hot flushes and certain other menopausal symptoms when compared to placebo.