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

Advances in Therapy

Volumn 28, Issue 6, 2011, Pages 490-500

  Bommer, S ^a   Klein, P ^b   Suter, A ^a  

^a A Vogel Bioforce AG   (Switzerland)

^b Dsh Statistical Services GmbH   (Germany)

Author keywords

clinical trial; hot flushes; menopause; sage; Salvia officinalis

Indexed keywords

SALVIA OFFICINALIS EXTRACT;

ABDOMINAL PAIN; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; CREATININE BLOOD LEVEL; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ERYTHROCYTE COUNT; ERYTHROCYTE SEDIMENTATION RATE; FEMALE; GLUCOSE BLOOD LEVEL; HEMATOCRIT; HEMOGLOBIN BLOOD LEVEL; HOT FLUSH; HUMAN; LEUKOCYTE COUNT; MAJOR CLINICAL STUDY; MEAN CORPUSCULAR HEMOGLOBIN; MEAN CORPUSCULAR VOLUME; MENOPAUSE; MULTICENTER STUDY; QUALITY OF LIFE; SIDE EFFECT; THROMBOCYTE COUNT; TREATMENT DURATION; TREATMENT RESPONSE;

FEMALE; HOT FLASHES; HUMANS; MENOPAUSE; MIDDLE AGED; PHYTOTHERAPY; PLANT EXTRACTS; SALVIA OFFICINALIS; SWITZERLAND;

EID: 79958188914     PISSN: 0741238X     EISSN: 18658652     Source Type: Journal    
DOI: 10.1007/s12325-011-0027-z     Document Type: Article

References (47)

1. Mc Kinlay SM, Brambilla DJ, Posner JG. The normal menopause transition. Am J Hum Biol. 1992;4:37-46.
2. Freeman EW, Sherif K. Prevalence of hot flushes and night sweats around the world: a systematic review. Climacteric. 2007;10:197-214.
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.
4. Ohayon MM. Severe hot flashes are associated with chronic insomnia. Arch Intern Med. 2006;166:1262-1268. (Pubitemid 43967577)
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.
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.
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.
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.
9. Hersh AL, Stefanick ML, Stafford RS. National use of postmenopausal hormone therapy. JAMA. 2004;291:47-53.
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 18, 2011.
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. (Pubitemid 40204891)
14. British Herbal Medicine Association. Salvia. In: British Herbal Pharmacopoeia Bournemouth: British Herbal Medicine Association; 1983:185-186.
15. Felter HW. Salvia. In: The Eclectic Materia Medica. Pharmacology and Therapeutics. Cincinnati, OH: Elsevier; 1922:394.
16. Felter HW, Lloyd JU. King's American Dispensatory. 18th edition, 3rd Revision. Cincinnati: Ohio Valley Co.; 1898.
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.
19. Hoppe HA. Drogenkunde. Volume 1. Angiospermen. Berlin, NY: Walter De Gruyter ; 1975;958-963.
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.
21. Oswald EH. Kruiden. Vademecum. Eigenschappen en toepassingen. [Herbs. Manual. Properties and Application.] Den Haag: Koninlijke Bibliotheek; 1991.
22. Kooperation Phytopharmaka. Arzneipflanzen in der Traditionellen Medizin. [Medicinal Plants in Traditional Medicine.] Kooperation Phytopharmaka. 1991;100:254.
23. Kenner D, Reuqena Y. Botanical medicine. A European professional perspective. Brookline, MA: Paradigm Publications; 1996:232.
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.
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. (Pubitemid 28331864)
26. Gallagher J. A randomized, double blind, placebocontrolled pilot study to investigate the efficacy of Salvia officinalis in the treatment of perimenopausal hot flushes. Data on file, Bioforce. Reference: KLC0088, 2001.
27. Lassel M. Gesundheit und Kraft durch Kräutergold. [Health and Strength with Kräutergold.] Rosenheim: M. Lassel Publications; 1958:124.
28. Mishra G, Kuh D. Perceived change in quality of life during the menopause. Soc Sci Med. 2006;62:93-102. (Pubitemid 41728107)
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.
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. (Pubitemid 44521834)
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.
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.
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.
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. (Pubitemid 40091602)
35. Blumenthal M (Ed.). The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin, TX: American Botanical Council; 2003:198.
36. ESCOP Monographs. The Scientific Foundation for Herbal Medicinal Products. European Scientific Cooperative on Phytotherapy. Stuttgart: Thieme Press; 2003:452-455.
37. Sloan JA, Loprinzi CL, Novotny PJ, et al. Methodologic lessons learned from hot flash studies. J Clin Oncol. 2001;19:4280-4290. (Pubitemid 33096775)
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. (Pubitemid 34876810)
39. Jeri A. The use of an isoflavone supplement to relieve hot flushes. Female Patient. 2002;27:35-37.
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. (Pubitemid 36701892)
41. Albertazzi P, Pansini F, Bonaccorsi G, et al. The effect of dietary soy supplementation on hot flushes. Obstet Gynecol. 1998;91:6-11. (Pubitemid 28042324)
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.
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. (Pubitemid 46481021)
44. van Die MD, Burger HG, Bone KM, Cohen MM, Teede HJ. Hypericum perforatum with Vitex agnus-castus in menopausal symptoms: a randomized, controlled trial. Menopause. 2009;16:156-163.
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.
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. (Pubitemid 32441380)
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. (Pubitemid 44079538)