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Advances in Therapy

, Volume 28, Issue 6, pp 490–500 | Cite as

First time proof of sage’s tolerability and efficacy in menopausal women with hot flushes

  • S. Bommer
  • P. Klein
  • A. Suter
Original Research

Abstract

Background

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.

Methods

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.

Results

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.

Conclusion

A fresh sage preparation demonstrated clinical value in the treatment of hot flushes and associated menopausal symptoms.

Keywords

clinical trial hot flushes menopause sage Salvia officinalis 

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References

  1. 1.
    Mc Kinlay SM, Brambilla DJ, Posner JG. The normal menopause transition. Am J Hum Biol. 1992;4:37–46.CrossRefGoogle Scholar
  2. 2.
    Freeman EW, Sherif K. Prevalence of hot flushes and night sweats around the world: a systematic review. Climacteric. 2007;10:197–214.PubMedCrossRefGoogle Scholar
  3. 3.
    Col NF, Guthrie JR, Politi M, Dennerstein L. Duration of vasomotor symptoms in middle-aged women: a longitudinal study. Menopause. 2009;16:453–457.PubMedCrossRefGoogle Scholar
  4. 4.
    Ohayon MM. Severe hot flashes are associated with chronic insomnia. Arch Intern Med. 2006;166:1262–1268.PubMedCrossRefGoogle Scholar
  5. 5.
    Freeman EW, Grisso JA, Berlin J, et al. Symptom reports from a cohort of African American and white women in the late reproductive years. Menopause. 2001;8:33–42.PubMedCrossRefGoogle Scholar
  6. 6.
    Genazzani A, Schneider H, Panay N, Nijland E. The European Menopause Survey 2005: Women’s perceptions on the menopause and postmenopausal hormone therapy. Gynecol Endocrinol. 2006;22:369–375.PubMedCrossRefGoogle Scholar
  7. 7.
    Haas JS, Kaplan CP, Gerstenberger EP, Kerlikowske K. Changes in the use of postmenopausal hormone therapy after the publication of clinical trial results. Ann Intern Med. 2004;140:184–188.PubMedGoogle Scholar
  8. 8.
    Cardini F, Lesi G, Lombardo F, van der Sluijs C; MSCG-Menopause Survey Collaborative Group. The use of complementary and alternative medicine by women experiencing menopausal symptoms in Bologna. BMC Womens Health. 2010;10:7.PubMedGoogle Scholar
  9. 9.
    Hersh AL, Stefanick ML, Stafford RS. National use of postmenopausal hormone therapy. JAMA. 2004;291:47–53.PubMedCrossRefGoogle Scholar
  10. 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. 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. 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.
  13. 13.
    Blair YA, Gold EB, Azari RA, et al. Use of conventional and complementary health care during the transition to menopause: longitudinal results from the Study of Women’s Health Across the Nation (SWAN). Menopause. 2005;12:31–39.CrossRefGoogle Scholar
  14. 14.
    British Herbal Medicine Association. Salvia. In: British Herbal Pharmacopoeia Bournemouth: British Herbal Medicine Association; 1983:185–186.Google Scholar
  15. 15.
    Felter HW. Salvia. In: The Eclectic Materia Medica. Pharmacology and Therapeutics. Cincinnati, OH: Elsevier; 1922:394.Google Scholar
  16. 16.
    Felter HW, Lloyd JU. King’s American Dispensatory. 18th edition, 3rd Revision. Cincinnati: Ohio Valley Co.; 1898.Google Scholar
  17. 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. 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. 19.
    Hoppe HA. Drogenkunde. Volume 1. Angiospermen. Berlin, NY: Walter De Gruyter; 1975;958–963.Google Scholar
  20. 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. 21.
    Oswald EH. Kruiden. Vademecum. Eigenschappen en toepassingen. [Herbs. Manual. Properties and Application.] Den Haag: Koninlijke Bibliotheek; 1991.Google Scholar
  22. 22.
    Kooperation Phytopharmaka. Arzneipflanzen in der Traditionellen Medizin. [Medicinal Plants in Traditional Medicine.] Kooperation Phytopharmaka. 1991;100:254.Google Scholar
  23. 23.
    Kenner D, Reuqena Y. Botanical medicine. A European professional perspective. Brookline, MA: Paradigm Publications; 1996:232.Google Scholar
  24. 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
  25. 25.
    De Leo V, Lanzetta D, Cazzavacca R, Morgante G. Treatment of neurovegetative menopausal symptoms with a phytotherapeutic agent. Minerva Ginecol. 1998;50:207–211.PubMedGoogle Scholar
  26. 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. 27.
    Lassel M. Gesundheit und Kraft durch Kräutergold. [Health and Strength with Kräutergold.] Rosenheim: M. Lassel Publications; 1958:124Google Scholar
  28. 28.
    Mishra G, Kuh D. Perceived change in quality of life during the menopause. Soc Sci Med. 2006;62:93–102.PubMedCrossRefGoogle Scholar
  29. 29.
    Briese V, Stammwitz U, Friede M, Henneicke-von Zepelin HH. Black cohosh with or without St. John’s wort for symptom-specific climacteric treatment—results of a large-scale, controlled, observational study. Maturitas. 2007;57:405–414.PubMedCrossRefGoogle Scholar
  30. 30.
    Conde DM, Pinto-Neto AM, Santos-Sá D, Costa-Paiva L, Martinez EZ. Factors associated with quality of life in a cohort of postmenopausal women. Gynecol Endocrinol. 2006;22:441–446.PubMedCrossRefGoogle Scholar
  31. 31.
    Ledésert B, Ringa V, Bréart G. Menopause and perceived health status among the women of the French GAZEL cohort. Maturitas. 1994;20:113–120.PubMedCrossRefGoogle Scholar
  32. 32.
    Scholey AB, Tildesley NT, Ballard CG, et al. An extract of Salvia (sage) with anticholinesterase properties improves memory and attention in healthy older volunteers. Psychopharmacology. 2008;198:127–139.PubMedCrossRefGoogle Scholar
  33. 33.
    Kennedy DO, Pace S, Haskell C, et al. Effects of cholinesterase inhibiting sage (Salvia officinalis) on mood, anxiety and performance on a psychological stressor battery. Neuropsychopharmacology. 2006;31:845–852.PubMedCrossRefGoogle Scholar
  34. 34.
    Tildesley NT, Kennedy DO, Perry EK, et al. Positive modulation of mood and cognitive performance following administration of acute doses of Salvia lavandulaefolia essential oil to healthy young volunteers. Physiol Behav. 2005;83:699–709.PubMedCrossRefGoogle Scholar
  35. 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. 36.
    ESCOP Monographs. The Scientific Foundation for Herbal Medicinal Products. European Scientific Cooperative on Phytotherapy. Stuttgart: Thieme Press; 2003:452–455.Google Scholar
  37. 37.
    Sloan JA, Loprinzi CL, Novotny PJ, et al. Methodologic lessons learned from hot flash studies. J Clin Oncol. 2001;19:4280–4290.PubMedGoogle Scholar
  38. 38.
    van de Weijer PH, Barentsen R. Isoflavones from red clover (Promensil) significantly reduce menopausal hot flush symptoms compared with placebo. Maturitas. 2002;42:187–193.PubMedCrossRefGoogle Scholar
  39. 39.
    Jeri A. The use of an isoflavone supplement to relieve hot flushes. Female Patient. 2002;27:35–37.Google Scholar
  40. 40.
    Faure ED, Chantre P, Mares P. Effects of a standardized soy extract on hot flushes: a multicenter, double-blind, randomized, placebo-controlled study. Menopause. 2002;9:329–334.PubMedCrossRefGoogle Scholar
  41. 41.
    Albertazzi P, Pansini F, Bonaccorsi G, et al. The effect of dietary soy supplementation on hot flushes. Obstet Gynecol. 1998;91:6–11.PubMedCrossRefGoogle Scholar
  42. 42.
    Khaodhiar L, Ricciotti HA, Li L, et al. Daidzein-rich isoflavone aglycones are potentially effective in reducing hot flashes in menopausal women. Menopause. 2008;15:125–132.PubMedGoogle Scholar
  43. 43.
    Rotem C, Kaplan B. Phyto-Female Complex for the relief of hot flushes, night sweats and quality of sleep: randomized, controlled, double-blind pilot study. Gynecol Endocrinol. 2007;23:117–122.PubMedCrossRefGoogle Scholar
  44. 44.
    van Die MD, Burger HG, Bone KM, Cohen MM, Teede HJ. Hypericum perforatum with Vitex agnuscastus in menopausal symptoms: a randomized, controlled trial. Menopause. 2009;16:156–163.PubMedCrossRefGoogle Scholar
  45. 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
  46. 46.
    Jacobson JS, Troxel AB, Evans J, et al. Randomized trial of black cohosh for the treatment of hot flashes among women with a history of breast cancer. J Clin Oncol. 2001;19:2739–2745.PubMedGoogle Scholar
  47. 47.
    Raus K, Brucker C, Gorkow C, Wuttke W. First-time proof of endometrial safety of the special black cohosh extract (Actaea or Cimicifuga racemosa extract) CR BNO 1055. Menopause. 2006;13:678–691.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Healthcare 2011

Authors and Affiliations

  1. 1.A. Vogel Bioforce AGRoggwilSwitzerland
  2. 2.d.s.h. Statistical Services GmbHRohrbachGermany

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