First time proof of sage's tolerability and efficacy in menopausal women with hot flushes.

BACKGROUND This trial aimed to assess the tolerability and efficacy of a fresh sage preparation in treating hot flushes and other menopausal complaints. Sage (Salvia officinalis) has been traditionally used to treat sweating and menopausal hot flushes, as well as to alleviate associated menopausal symptoms and as a general tonic. However, no clinical studies substantiating the use of sage in menopause have been published previously. METHODS In an open, multicenter clinical trial conducted in eight practices in Switzerland, 71 patients (intent-to-treat population [ITT], n=69; with a mean age of 56.4±4.7 years, menopausal for at least 12 months, and with at least five flushes daily) were recruited and treated with a once-daily tablet of fresh sage leaves for 8 weeks after an introductory baseline week. Parameters for the evaluation of efficacy were the change in intensity and frequency of hot flushes, and total score of the mean number of intensity-rated hot flushes (TSIRHF) as determined by diary protocol over the 2-month treatment period. Other variables included assessment of the Menopause Rating Scale (MRS) by the treating physician at baseline and after 2 months of therapy. RESULTS In the ITT population there was a significant decrease in the TSIRHF by 50% within 4 weeks and by 64% within 8 weeks (P<0.0001). The mean total number of hot flushes per day decreased significantly each week from week 1 to 8. The mean number of mild, moderate, severe, and very severe flushes decreased by 46%, 62%, 79%, and 100% over 8 weeks, respectively. The MRS and its somato-vegetative, psychological, and urogenital subscales decreased significantly by 43%, 43%, 47%, and 20% respectively. The treatment was very well tolerated. CONCLUSION A fresh sage preparation demonstrated clinical value in the treatment of hot flushes and associated menopausal symptoms.