Carolyn Ee, MBBS; Charlie Xue, PhD; Patty Chondros, PhD; Stephen P. Myers, PhD; Simon D. French, PhD; Helena Teede, PhD; Marie Pirotta, PhD
Note: Dr. Ee confirms, as primary and corresponding author, that she had full access to all of the study data and takes responsibility for its integrity and the accuracy of the data analysis.
Acknowledgment: The authors thank the research assistants, Kitty Novy, Mary Kyriakides, and others, for their hard work and dedication to the day-to-day running of the project; Melanie Gibson for assistance with recruitment and survey management; Annie Rahilly and the staff at Jean Hailes for Women's Health for assistance with recruitment; Ben Metcalf for designing the randomization spread sheet; Dr. Zhen Zheng, Professor Caroline Smith, and the other acupuncture experts for providing expert opinions on the treatment protocol; Vincent Cheong for producing the DVD on the Park sham device; Dr. Vicki Kotsirilos for providing a consultation space for Chinese medicine interviews; and Johannah Shergis for replacing Dr. Ee while Dr. Ee was on maternity leave. They also thank Mary-Jo Bevin, George Dellas, Suzy McCleary, John McDonald, Melanie Wells, Tanya Wilson, Richard Zeng, and all other project acupuncturists, as well as the study participants.
Grant Support: By the National Health and Medical Research Council (NHMRC) of Australia (project grant APP 1004406). Dr. Pirotta is supported by an NHMRC Career Development Fellowship. Dr. Ee is supported by an NHMRC Postgraduate Scholarship. Dr. Teede is supported by an NHMRC Practitioner Fellowship.
Disclosures: Dr. Pirotta reports grants and other from the NHMRC during the conduct of the study. Authors not named here have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterest Forms.do?msNum=M15-1380.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
Reproducible Research Statement:Study protocol: Available at www.trialsjournal.com/content/15/1/224. Statistical code: Available from Dr. Pirotta (e-mail, firstname.lastname@example.org). Data set: Certain portions of the analytic data set are available from Dr. Pirotta (e-mail, email@example.com).
Requests for Single Reprints: Carolyn Ee, MBBS, Department of General Practice, University of Melbourne, 200 Berkeley Street, Carlton, 3053 Victoria, Australia; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Ee, Chondros, and Pirotta: Department of General Practice, University of Melbourne, 200 Berkeley Street, Carlton, 3053 Victoria, Australia.
Dr. Xue: Professor, School of Health Sciences, Royal Melbourne Institute of Technology (RMIT) University, PO Box 71, Bundoora, 3083 Victoria, Australia.
Dr. Myers: NatMed Research Unit, Southern Cross University, PO Box 157, Lismore, Queensland, Australia.
Dr. French: Associate Professor, School of Rehabilitation Therapy, Queen's University, Louise D. Acton Building, 31 George Street, Kingston, Ontario K7L 3N6, Canada.
Dr. Teede: Director, Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Level 1, 43-51 Kanooka Grove, Clayton, 3168 Victoria, Australia.
Author Contributions: Conception and design: C. Ee, C. Xue, P. Chondros, S.P. Myers, S.D. French, H. Teede, M. Pirotta.
Analysis and interpretation of the data: C. Ee, C. Xue, P. Chondros, S.P. Myers, S.D. French, H. Teede, M. Pirotta.
Drafting of the article: C. Ee, C. Xue, P. Chondros, S.D. French, H. Teede, M. Pirotta.
Critical revision of the article for important intellectual content: C. Ee, C. Xue, P. Chondros, S.P. Myers, S.D. French, H. Teede, M. Pirotta.
Final approval of the article: C. Ee, C. Xue, P. Chondros, S.P. Myers, S.D. French, H. Teede, M. Pirotta.
Provision of study materials or patients: C. Ee, C. Xue.
Statistical expertise: P. Chondros.
Obtaining of funding: C. Ee, C. Xue, P. Chondros, S.P. Myers, S.D. French, H. Teede, M. Pirotta.
Administrative, technical, or logistic support: C. Ee, H. Teede.
Collection and assembly of data: C. Ee, P. Chondros, M. Pirotta.
Hot flashes (HFs) affect up to 75% of menopausal women and pose a considerable health and financial burden. Evidence of acupuncture efficacy as an HF treatment is conflicting.
To assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal HFs.
Stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. (Australia New Zealand Clinical Trials Registry: ACTRN12611000393954)
Community in Australia.
Women older than 40 years in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency.
10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat kidney yin deficiency or noninsertive sham acupuncture.
The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models.
327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment were 15.36 in the acupuncture group and 15.04 in the sham group (mean difference, 0.33 [95% CI, −1.87 to 2.52]; P = 0.77). No serious adverse events were reported.
Participants were predominantly Caucasian and did not have breast cancer or surgical menopause.
Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs.
National Health and Medical Research Council.
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Ee C, Xue C, Chondros P, Myers SP, French SD, Teede H, et al. Acupuncture for Menopausal Hot Flashes: A Randomized Trial. Ann Intern Med. 2016;164:146-154. doi: 10.7326/M15-1380
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Published: Ann Intern Med. 2016;164(3):146-154.
Published at www.annals.org on 19 January 2016
Cardiology, Heart Failure, Nephrology.
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