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The Acupuncture on Hot Flushes Among Menopausal Women (ACUFLASH) study, a randomized controlled trial

Borud, Einar Kristian MD, MPH1; Alraek, Terje PhD1; White, Adrian MD, PhD2; Fonnebo, Vinjar MD, MSc, PhD1; Eggen, Anne Elise PhD3; Hammar, Mats MD, PhD4; Åstrand, Lotta Lindh RN4; Theodorsson, Elvar MD, PhD4; Grimsgaard, Sameline MD, MPH, PhD1,5

doi: 10.1097/gme.0b013e31818c02ad
Articles

Objective: This study compared the effectiveness of individualized acupuncture plus self-care versus self-care alone on hot flashes and health-related quality of life in postmenopausal women.

Methods: This study involved a multicenter, pragmatic, randomized, controlled trial with two parallel arms. Participants were postmenopausal women experiencing, on average, seven or more hot flashes per 24 hours during seven consecutive days. The acupuncture group received 10 acupuncture treatment sessions and advice on self-care, and the control group received advice on self-care only. The frequency and severity (0-10 scale) of hot flashes were registered in a diary. Urine excretion of calcitonin gene-related peptide was assessed at baseline and after 12 weeks. The primary endpoint was change in mean hot flash frequency from baseline to 12 weeks. The secondary endpoint was change in health-related quality of life measured by the Women's Health Questionnaire.

Results: Hot flash frequency decreased by 5.8 per 24 hours in the acupuncture group (n = 134) and 3.7 per 24 hours in the control group (n = 133), a difference of 2.1 (P < 0.001). Hot flash intensity decreased by 3.2 units in the acupuncture group and 1.8 units in the control group, a difference of 1.4 (P < 0.001). The acupuncture group experienced statistically significant improvements in the vasomotor, sleep, and somatic symptoms dimensions of the Women's Health Questionnaire compared with the control group. Urine calcitonin gene-related peptide excretion remained unchanged from baseline to week 12.

Conclusions: Acupuncture plus self-care can contribute to a clinically relevant reduction in hot flashes and increased health-related quality of life in postmenopausal women.

The use of acupuncture plus self-care can contribute to a clinically relevant reduction in hot flashes and increased health-related quality of life in postmenopausal women.

From the 1The National Research Center in Alternative and Complementary Medicine, University of Tromsø, Tromsø, Norway; 2Department of General Practice and Primary Care, Peninsula Medical School, Universities of Exeter and Plymouth, UK; 3Institute of Community Medicine, Faculty of Medicine, University of Tromsø, Tromsø, Norway; 4Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Linköping, Sweden; and 5Clinical Research Center, University Hospital of North Norway, Tromsø, Norway.

Received June 21, 2008; revised and accepted August 26, 2008.

Funding/support: This project was funded by The Research Council of Norway. The principal investigator was funded by the University Hospital of North Norway.

Financial disclosure: None reported.

Role of the sponsor: The funding agencies had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of this manuscript.

Address correspondence to: Einar Kristian Borud, MD, MPH, The National Research Center in Complementary and Alternative Medicine, University of Tromsø, N-9037 Tromsø, Norway. E-mail: einar.borud@fagmed.uit.no

©2009The North American Menopause Society