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Acupuncture in Menopause (AIM) study: a pragmatic, randomized controlled trial

Avis, Nancy E. PhD; Coeytaux, Remy R. MD, PhD; Isom, Scott MS; Prevette, Kristen BA; Morgan, Timothy PhD

doi: 10.1097/GME.0000000000000597
Original Articles

Objective: The aim of the study was to evaluate the short and long-term effects of acupuncture on vasomotor symptoms (VMS) and quality of life-related measures.

Methods: A total of 209 perimenopausal and postmenopausal women aged 45 to 60 years, experiencing four or more VMS per day, were recruited from the community and randomized to receive up to 20 acupuncture treatments within the first 6 months (acupuncture group) or the second 6 months (waitlist control group) of the 12-month study period. The primary outcome was mean daily frequency of VMS. Secondary outcomes were VMS interference with daily life, sleep quality, depressive symptoms, somatic and other symptoms, anxiety, and quality of life.

Results: The VMS frequency declined by 36.7% at 6 months in the acupuncture group and increased by 6.0% in the control group (P < 0.001 for between-group comparison). At 12 months, the reduction from baseline in the acupuncture group was 29.4% (P < 0.001 for within-group comparison from baseline to 12 months), suggesting that the reduction was largely maintained after treatment. Statistically significant clinical improvement was observed after three acupuncture treatments, and maximal clinical effects occurred after a median of eight treatments. Persistent improvements were seen in many quality of life-related outcomes in the acupuncture group relative to the control group.

Conclusions: We found that a course of acupuncture treatments was associated with significant reduction in VMS, and several quality-of-life measures, compared with no acupuncture, and that clinical benefit persisted for at least 6 months beyond the end of treatment.

1Department of Social Sciences and Health Policy

2Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC

3Department of Community and Family Medicine and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.

Address correspondence to: Nancy E. Avis, PhD, Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Blvd, Winston-Salem, NC 27157-1063. E-mail: navis@wakehealth.edu

Received 7 August, 2015

Revised 19 October, 2015

Accepted 19 November, 2015

Funding/support: The research was supported by grant R01AT005854 from the National Center for Complementary and Integrative Health (NCCIM).

Clinical trial registration: https://clinicaltrials.gov, identifier: NCT01276028.

Financial disclosure/conflicts of interest: Dr Coeytaux has a financial interest in two organizations involved in recruiting study participants and administering acupuncture treatments at one of the two study sites. A conflict of interest management plan was developed by Duke University and is available upon request.

© 2016 by The North American Menopause Society.