First time proof of sage’s tolerability and efficacy in menopausal women with hot flushes
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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.
Keywordsclinical trial hot flushes menopause sage Salvia officinalis
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- 10.EMEA. Guideline on clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women. October 2005. Available at: www.tga.gov.au/docs/pdf/euguide/emea/002197enrev1.pdf. Last accessed April 18, 2011.
- 11.NZGG New Zealand Guidelines Group. Hormone Replacement Therapy. Evidence-based Best Practice Guidelines. Summary updated. March 2004. Available at: www.nzgg.org.nz/guidelines/0078/HRT_summary_web.pdf. Last accessed April 18, 2011.
- 12.Committee on Safety of Medicines, CSM UK. Further advice on safety of hormone replacement therapy: important new information. December 2003. Available at: http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON002044. Last accessed April 8, 2011.
- 14.British Herbal Medicine Association. Salvia. In: British Herbal Pharmacopoeia Bournemouth: British Herbal Medicine Association; 1983:185–186.Google Scholar
- 15.Felter HW. Salvia. In: The Eclectic Materia Medica. Pharmacology and Therapeutics. Cincinnati, OH: Elsevier; 1922:394.Google Scholar
- 16.Felter HW, Lloyd JU. King’s American Dispensatory. 18th edition, 3rd Revision. Cincinnati: Ohio Valley Co.; 1898.Google Scholar
- 17.eNotes.com web site. Encyclopedia of Food & Culture: Herbs and Spices. Available at: http://www.enotes.com/food-encyclopedia/herbs-spices. Accessed April 28, 2011.
- 18.Schulz H. Wirkung und Anwendung der deutschen Arzneipflanzen. [Properties and Application of German Medicinal Plants.] 2nd edition. Leipzig: G Thieme; 1929:177.Google Scholar
- 19.Hoppe HA. Drogenkunde. Volume 1. Angiospermen. Berlin, NY: Walter De Gruyter; 1975;958–963.Google Scholar
- 20.Hager H. Hager’s Handbuch der Pharmazeutischen Praxis. [Hager’s Compendium of Pharmaceutical Praxis.] Volume VI. Chemikalien und Drogen. Part B: R,S. Berlin: Springer Press; 1978:247.Google Scholar
- 21.Oswald EH. Kruiden. Vademecum. Eigenschappen en toepassingen. [Herbs. Manual. Properties and Application.] Den Haag: Koninlijke Bibliotheek; 1991.Google Scholar
- 22.Kooperation Phytopharmaka. Arzneipflanzen in der Traditionellen Medizin. [Medicinal Plants in Traditional Medicine.] Kooperation Phytopharmaka. 1991;100:254.Google Scholar
- 23.Kenner D, Reuqena Y. Botanical medicine. A European professional perspective. Brookline, MA: Paradigm Publications; 1996:232.Google Scholar
- 24.Schlegel B, Böttner H. Über den Einfluss der Salbeidroge auf den unmerklichen Gewichtsverlust des Gesunden. [The Influence of Sage on the Unperceivable Weight Loss in Healthy Volunteers] Z Gesamte Exp Med. 1939;940:267–274.Google Scholar
- 26.Gallagher J. A randomized, double blind, placebo-controlled pilot study to investigate the efficacy of Salvia officinalis in the treatment of peri-menopausal hot flushes. Data on file, Bioforce. Reference: KLC 0088, 2001.Google Scholar
- 27.Lassel M. Gesundheit und Kraft durch Kräutergold. [Health and Strength with Kräutergold.] Rosenheim: M. Lassel Publications; 1958:124Google Scholar
- 35.Blumenthal M (Ed.). The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin, TX: American Botanical Council; 2003:198.Google Scholar
- 36.ESCOP Monographs. The Scientific Foundation for Herbal Medicinal Products. European Scientific Cooperative on Phytotherapy. Stuttgart: Thieme Press; 2003:452–455.Google Scholar
- 39.Jeri A. The use of an isoflavone supplement to relieve hot flushes. Female Patient. 2002;27:35–37.Google Scholar
- 45.Verhoeven MO, van der Mooren MJ, van de Weijer PH, et al; CuraTrial Research Group. Effect of a combination of isoflavones and Actaea racemosa Linnaeus on climacteric symptoms in healthy symptomatic perimenopausal women: a 12-week randomized, placebo-controlled, double-blind study. Menopause. 2005;12:412–420.PubMedCrossRefGoogle Scholar