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Treatment of Vasomotor Symptoms of Menopause with Black Cohosh, Multibotanicals, Soy, Hormone Therapy, or Placebo
A Randomized Trial
- Katherine M. Newton, PhD;
- Susan D. Reed, MD, MPH;
- Andrea Z. LaCroix, PhD;
- Louis C. Grothaus, MS;
- Kelly Ehrlich, MS; and
- Jane Guiltinan, ND
- From Group Health Center for Health Studies, the University of Washington, and Fred Hutchinson Cancer Research Center, Seattle, Washington, and Bastyr University, Kenmore, Washington.
Abstract
Background: Herbal supplements are widely used for vasomotor symptoms.
Objective: To test the efficacy of 3 herbal regimens and hormone therapy for relief of vasomotor symptoms compared with placebo.
Design: 1-year randomized, double-blind, placebo-controlled trial conducted from May 2001 to September 2004.
Setting: Group Health, Washington State.
Participants: 351 women age 45 to 55 years with 2 or more vasomotor symptoms per day; 52% of the women were in menopausal transition and 48% were postmenopausal.
Measurements: Rate and intensity of vasomotor symptoms (1 = mild to 3 = severe), and Wiklund Vasomotor Symptom Subscale.
Interventions: 1) Black cohosh, 160 mg daily; 2) multibotanical with black cohosh, 200 mg daily, and 9 other ingredients; 3) multibotanical plus dietary soy counseling; 4) conjugated equine estrogen, 0.625 mg daily, with or without medroxyprogesterone acetate, 2.5 mg daily; or 5) placebo.
Results: Vasomotor symptoms per day, symptom intensity, Wiklund Vasomotor Symptom Subscale score did not differ between the herbal interventions and placebo at 3, 6, or 12 months or for the average over all the follow-up time points (P > 0.05 for all comparisons) with 1 exception: At 12 months, symptom intensity was significantly worse with the multibotanical plus soy intervention than with placebo (P = 0.016). The difference in vasomotor symptoms per day between placebo and any of the herbal treatments at any time point was less than 1 symptom per day; for the average over all the follow-up time points, the difference was less than 0.55 symptom per day. The difference for hormone therapy versus placebo was −4.06 vasomotor symptoms per day for the average over all the follow-up time points (95% CI, −5.93 to −2.19 symptoms per day; P < 0.001).
Limitations: The trial did not simulate the whole-person approach used by naturopathic physicians. Differences between treatment groups smaller than 1.5 Vasomotor symptoms per day cannot be ruled out.
Conclusion: Black cohosh used in isolation, or as part of a multibotanical regimen, shows little potential as an important therapy for relief of vasomotor symptoms.
Clinical Trials Registration number: NCT00169299.
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Article and Author Information
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Acknowledgments: The authors acknowledge all those who contributed significantly to this work, especially the 351 dedicated women who participated in this study. In particular, they thank Linda Palmer, RN, and Jill Seymour, RN, ARNP, for their outstanding work with study participants; David Carrell and Nirmala Sandhu for their excellent programming and data management; Sheree Miller, PharmD, Lead Pharmacist, Investigational Drug Services, University of Washington Medical Center, for packaging and assuring blinding of study medications; and the late Natalie Koether, JD, Pure World, Inc., South Hackensack, New Jersey, for providing black cohosh. The authors also thank the members of the Data and Safety Monitoring Committee: Drs. Gregory Burke (Chair), Ellen Gold, Susan Johnson, and Barry Storer.
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Grant Support: This project was funded by the National Institute on Aging and the National Center for Complementary and Alternative Medicine (grant R01AG17057) and by an administrative supplement from the National Institute on Aging (Alternative Therapies For Menopause—A Randomized Trial: Herbal Alternatives Quality Control Supplement).
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Potential Financial Conflicts of Interest: None disclosed.
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Requests for Single Reprints: Katherine M. Newton, PhD, Center for Health Studies, Group Health Cooperative, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101; e-mail, newton.k{at}ghc.org.
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Current Author Addresses: Dr. Newton: Center for Health Studies, Group Health Cooperative, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101.
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Dr. Reed: Obstetrics and Gynecology, Harborview Medical Center, P.O. Box 359865, Seattle, WA 98104.
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Dr. LaCroix: Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, Seattle, Washington 98109.
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Mr. Grothaus and Ms. Ehrlich: Group Health Center for Health Studies, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101.
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Dr. Guiltinan: Bastyr University, 3670 Stone Way North, Seattle, WA 98103.
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Author Contributions: Conception and design: K.M. Newton, S.D. Reed, A.Z. LaCroix, L.C. Grothaus, K. Ehrlich, J. Guiltinan.
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Analysis and interpretation of the data: K.M. Newton, S.D. Reed, A.Z. LaCroix, L.C. Grothaus, J. Guiltinan.
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Drafting of the article: K.M. Newton, S.D. Reed, A.Z. LaCroix, L.C. Grothaus, J. Guiltinan.
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Critical revision of the article for important intellectual content: K.M. Newton, S.D. Reed, A.Z. LaCroix, L.C. Grothaus, K. Ehrlich, J. Guiltinan.
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Final approval of the article: K.M. Newton, S.D. Reed, A.Z. LaCroix, K. Ehrlich.
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Provision of study materials or patients: S.D. Reed.
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Statistical expertise: A.Z. LaCroix, L.C. Grothaus.
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Obtaining of funding: K.M. Newton, S.D. Reed, A.Z. LaCroix.
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Administrative, technical, or logistic support: K. Ehrlich.
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Collection and assembly of data: K.M. Newton, L.C. Grothaus, K. Ehrlich.
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