LAUSR

BACKGROUND Besides hot-flushes, the sleep disturbances increase around the menopause impacting on quality of life. When hormone replacement therapy is contraindicated, it is necessary to provide alternative treatments. OBJECTIVES This study aimed to observe the effects of an herbal remedy from pollen extracts and soy isoflavones for menopausal complaints, particularly on sleep disorders. METHODS A six-month prospective observational study was performed in women in natural menopause suffering from menopausal symptoms and sleep disturbances. Three groups were compared: 57 women receiving two tablets/day containing an herbal remedy from pollen extracts (group A), 60 women receiving one tablet/day containing isoflavones 60 mg (group B), 47 women not receiving any treatment (group C). At 3 (T3) and 6 months (T6), the daily number of hotflushes, Kupperman index for menopausal symptoms, Pittsburgh Sleep Quality Index (PSQI) test were assessed. RESULTS Both group A and B showed a significant improvement of hot flushes (p<0.001) and Kuppermann Index (p<0.001) from T0 to T3 and from T0 to T6. No significant differences between treatment groups were found at T3, while at T6 group A showed greater decrease of daily hot flashes and better improvement of Kupperman Index as compare to group B (respectively, -48.8% versus -18.4% and -24.4% versus -15.4%; p<0.001). Improvement of global sleep quality was more evident in the pollen treated group compared to isoflavones group at both three (-24.7% versus -9.3%, p<0.001) and six (-52.9% vs -4.0%; p<0.001) months, mainly for the scores related to subjective sleep quality, sleep latency and habitual sleep efficiency. CONCLUSIONS Non-hormonal treatments can effectively be used in symptomatic menopausal women: among these, after six months of treatment, pollen extracts might achieve a better improvement of hot flushes, sleep disturbances and menopause-related symptoms than soy isoflavones. Herbal remedy from pollen extracts is mainly effective when quality of sleep is the most disturbing complaint.