Salvia extract for the treatment of menopausal symptoms: a randomized, controlled, blind clinical trial

Menopausal transition is typically accompanied not only by hot flashes but also by mood alterations and sleep disorders. Salvia officinalis has been traditionally used to treat those symptoms.

Eighty (80) menopausal women between 48 – 65 years of age received Menosan^® tablets [3ʹ400 mg ethanolic extract of Salvia officinalis] or placebo under randomized double-blind conditions for 4 weeks. The primary clinical endpoints menopausal rating scale [MRS] and hot flush severity and incidence [HFS] were monitored throughout therapy and were finally correlated with quantitative electroencephalographic [qEEG] measurements in a per protocol analysis.

Salvia off. potently reduced MRS by 39.2% from 15.3 ± 6.87 to 9.3 ± 5.75 and significantly in comparison to placebo (p=0.002). The somato-vegetative subscale improved by 40.8% from 7.1 ± 2.67 to 4.2 ± 1.84 (p<0.001). The HFS score was reduced by 55.3% from 15.9 ± 13.77 to 7.1 ± 7.41, reaching significance compared to placebo on week 3 onwards ([Fig. 1], p=0.0284). Sleep quality as per qestionnaire [SF-B/R] and fatigue in profile of mood state [POMS] significantly improved with Salvia, whilst the HAMA showed a non-significant trend only. Clinical effects of Salvia off. found a pharmacological correlation in changes of alpha1/2, delta, theta and beta1/2 qEEG values.

Menosan^® Salvia showed a significant and clinically relevant amelioration of the broad complex of menopausal symptoms with a high specificity on hot flushes. It induced a higher mental capacity and a more relaxed state of mind compared to placebo. EEG data documented an impact on central nervous transmitter systems involved in neuroadaptive processes as required by the physiological estrogen decline in menopause.

Fig. 1 Change of hot flush severity score during 4 weeks treatment with Salvia off.