Effectiveness of Menosan® Salvia officinalis in the treatment of a wide spectrum of menopausal complaints. A double-blind, randomized, placebo-controlled, clinical trial

Abstract

Objective To evaluate efficacy and safety of fresh Salvia officinalis extract tablets in relieving typical symptoms in menopausal women and to gain insight in the mode of action by measuring altered cerebral wave intensities. Methods Randomized 80 menopausal women from 48 – 65 years of age received Menosan® tablets [3′400 mg ethanolic extract of freshly harvested Salvia officinalis L.] or placebo under double-blind conditions for 4 weeks. An efficacy analysis evaluated the developments of the menopausal rating scale [MRS], hot flush severity score [HFS] and quantitative electroencephalography [qEEG] intensities in the per protocol population. Results were further corroborated by data from the intention to treat population including late postmenopausal women. Results Salvia off. distinctly 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 HFS score decreased by 55.3% from 15.9 ± 13.77 to 7.1 ± 7.41, reaching significance on week 3 onwards (p = 0.028). Clinical effects of Salvia off. correlated with relevant reduction of frontal lobe beta2 wave qEEG intensities at electrodes F3/4/7/8 and are underpinned by secondary parameters and ITT analysis. Salvia off. within 4 weeks significantly reduced the somato-vegetative (e.g. hot flushes) and psychological MRS subscale (e.g. physical and mental exhaustion) subscale (p < 0.05) without a significant effect on the genito-urinary subscale. A positive impact of Salvia off. compared to placebo was furthermore seen on sleep quality, discontent and fatigue (p < 0.05) as evidenced by sleep and profile of mood state questionnaires. Tolerability was uniformly rated as very good for Salvia off. extract and placebo, with an overall incidence of three adverse events in total, none of which treatment-related. Conclusion The results support the use of Salvia off. for the specific treatment of a wide range of somato-vegetative and psychological symptoms as experienced by menopausal women and correlate this effect to a restoration of associated dysbalanced brain waves. The study was registered as EudraCT-No 2016-005033-77.