Extracts from the seed of the horse chestnut (Aesculus hippocastanum L.) have traditionally been used to treat patients with chronic venous insufficiency and to alleviate its associated symptoms, including lower leg swelling. The efficacy of preparations that contain horse chestnut seed extract (HCSE) is believed to be due largely to an inhibitory effect on the catalytic breakdown of capillary wall proteoglycans. Aesculaforce is a fresh plant HCSE that is available as an oral tincture, as tablets (20 mg or 50 mg), and as topical gel. Four clinical trials in patients with chronic venous insufficiency and 1 study in patients with varicose veins demonstrated the effectiveness of these preparations through the objective measure of reduction in lower leg edema and the subjective alleviation of leg pain, heaviness, and itching. Safe, well tolerated, and acceptable to patients, the fresh plant HCSE preparation Aesculaforce offers a real alternative in the treatment of patients with mild to moderate venous insufficiency.
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.
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