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

Abstract

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 0 400 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 AE 6.87 to 9.3 AE 5.75 and significantly in comparison to placebo (p ¼ 0.002). The HFS score decreased by 55.3% from 15.9 AE 13.77 to 7.1 AE 7.41, reaching significance on week 3 onwards (p ¼ 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.

The Different Phytochemical Profiles of Salvia officinalis Dietary Supplements Labelled for Menopause Symptoms

“…In fact, the community S. officinalis monograph established that the amount of thujone must be specified in a product and the daily exposure must be below 6.0 mg [ 45 ]. Also, in clinical trials, the bioactivity of product M was demonstrated despite thujone depletion in the tested product [ 15 , 23 ]. Due to these safety and efficacy aspects, free-thujone products should be preferred.…”

“…Other potential mechanisms of action of S. officinalis have been reported [ 16 ]. Clinical studies on the treatment of menopausal symptoms demonstrate that S. officinalis improves not only vasomotor symptoms but also exerts a positive impact on somato-vegetative and psychological symptoms, thus addressing a wide range of menopausal disorders [ 15 , 23 ]. The results of a double-blind study on a group of 80 menopausal women randomized to receive tablets of 3400 mg of ethanol extract of S. officinalis or a placebo for 4 weeks showed the effect of S. officinalis on the restoration of unbalanced brain waves [ 23 ].…”

“…Clinical studies on the treatment of menopausal symptoms demonstrate that S. officinalis improves not only vasomotor symptoms but also exerts a positive impact on somato-vegetative and psychological symptoms, thus addressing a wide range of menopausal disorders [ 15 , 23 ]. The results of a double-blind study on a group of 80 menopausal women randomized to receive tablets of 3400 mg of ethanol extract of S. officinalis or a placebo for 4 weeks showed the effect of S. officinalis on the restoration of unbalanced brain waves [ 23 ]. A systematic review and meta-analysis reported the results of four clinical studies (310 patients) on the effect of S. officinalis on hot flushes in postmenopausal women (one study was conducted with the product M analyzed in the present work).…”

Comparison of the Effect of Salvia Officinalis Extract and Vitex Agnus-Castus Extract on Anxiety in Postmenopausal Women: A Randomized, Triple-Blind, Placebo-Controlled Trial

“…Some postmenopausal women are less concerned about their symptoms, which can affect quality of life and the outcome of herbal remedies 41 . The efficacy of Salvia officinalis extract on menopausal symptoms has been reported in several studies but has been limited to menopausal anxiety studies [42][43][44] . The effectiveness of Salvia officinalis extract on menopausal symptoms has been reported in several studies but has been limited to menopausal anxiety studies.…”

Athletes’ State Monitoring under Data Mining and Random Forest

“…β 1 wave shows that the human brain is in a thinking state [17]. β 2 shows that the brain is alert and excited [18]. If the athlete's β waveform fluctuates significantly, the excitability of the athlete's central nervous system gets stronger, his speed and intensity of nerve are strengthened, and his stress ability is improved, forming an excellent state to win in the competition.…”