A multicentre open clinical trial to assess the tolerability and efficacy of Sage tablets in menopausal patients with hot flushes
Hot flushes figure amongst the most common symptoms in general medical practice and alternatives to HRT are of growing interest. Sage has been traditionally used to treat menopausal symptoms. In this study including 71 women aged 50–65, menopausal since at least half a year, with a minimum of 5 flushes daily, a proprietary Sage mono-product (Salvia off, folium rec. T., spissum extract, DER 1:17) applied once daily during 8 weeks proved to be well tolerated and efficacious in reducing intensity and frequency of hot flushes and menopausal symptoms assessed via patient diary and Menopause Rating Scale (MRS), respectively. The decrease over the treatment period of 8 weeks was statistically significant for the global MRS Score and each of the related Subscores: MRS by about 6.4±0.9 score points, and Somato-vegetative, Psychological and Urogenital subscale by about 3.3±0.4 2.7±0.5, and 0.3±0.1 score points, respectively. The total score of the mean number of hot flushes (TSNMH) decreased significantly compared to the previous week from week 1 to week 8. Tolerability was rated as very good or good by 87.3% of the physicians and by 87.3% of the patients. The evaluation of the safety laboratory parameters also demonstrated a high degree of safety and tolerability. In this clinical trial Sage tablets clearly demonstrated good clinical value in terms of efficacy, safety and tolerability in the treatment of menopausal hot flushes and climacteric symptoms. Overall, the results suggest that Sage tablets are a promising herbal treatment alternative for menopausal women with climacteric complaints and a safe and effective herbal approach for the treatment of hot flushes in menopause.