A. Vogel Bioforce AG, Roggwil, Switzerland.
Adv Ther. 2011 Jun;28(6):490-500. doi: 10.1007/s12325-011-0027-z. Epub 2011 May 16.
This trial aimed to assess the tolerability and efficacy of a fresh sage preparation in treating hot flushes and other menopausal complaints. Sage (Salvia officinalis) has been traditionally used to treat sweating and menopausal hot flushes, as well as to alleviate associated menopausal symptoms and as a general tonic. However, no clinical studies substantiating the use of sage in menopause have been published previously.
In an open, multicenter clinical trial conducted in eight practices in Switzerland, 71 patients (intent-to-treat population [ITT], n=69; with a mean age of 56.4±4.7 years, menopausal for at least 12 months, and with at least five flushes daily) were recruited and treated with a once-daily tablet of fresh sage leaves for 8 weeks after an introductory baseline week. Parameters for the evaluation of efficacy were the change in intensity and frequency of hot flushes, and total score of the mean number of intensity-rated hot flushes (TSIRHF) as determined by diary protocol over the 2-month treatment period. Other variables included assessment of the Menopause Rating Scale (MRS) by the treating physician at baseline and after 2 months of therapy.
In the ITT population there was a significant decrease in the TSIRHF by 50% within 4 weeks and by 64% within 8 weeks (P<0.0001). The mean total number of hot flushes per day decreased significantly each week from week 1 to 8. The mean number of mild, moderate, severe, and very severe flushes decreased by 46%, 62%, 79%, and 100% over 8 weeks, respectively. The MRS and its somato-vegetative, psychological, and urogenital subscales decreased significantly by 43%, 43%, 47%, and 20% respectively. The treatment was very well tolerated.
A fresh sage preparation demonstrated clinical value in the treatment of hot flushes and associated menopausal symptoms.
本试验旨在评估一种新鲜鼠尾草制剂治疗热潮红和其他更年期不适的耐受性和疗效。鼠尾草（Salvia officinalis）传统上用于治疗出汗和更年期热潮红，以及缓解相关的更年期症状和作为一般补品。然而，以前没有发表过支持鼠尾草在更年期使用的临床研究。
在瑞士的 8 个诊所进行的一项开放、多中心临床试验中，71 名患者（意向治疗人群 [ITT]，n=69；平均年龄 56.4±4.7 岁，绝经至少 12 个月，每天至少有 5 次热潮红）在引入基线周后，每天服用一次新鲜鼠尾草叶片剂，持续 8 周。评估疗效的参数是热潮红强度和频率的变化，以及通过日记记录协议在 2 个月治疗期间确定的平均强度评定热潮红总数（TSIRHF）的总评分。其他变量包括治疗医生在基线和治疗 2 个月后对更年期评定量表（MRS）的评估。
在 ITT 人群中，4 周内 TSIRHF 显著下降 50%，8 周内下降 64%（P<0.0001）。每天平均热潮红次数每周从第 1 周到第 8 周显著减少。每周轻度、中度、重度和非常重度热潮红的平均数量分别减少 46%、62%、79%和 100%。MRS 及其躯体-植物性、心理和泌尿生殖亚量表分别显著下降 43%、43%、47%和 20%。治疗耐受性非常好。
一种新鲜的鼠尾草制剂在治疗热潮红和相关的更年期症状方面具有临床价值。
