Flashes Among Breast Cancer Survivors: A Randomized Placebo-Controlled Trial
Jun J. Mao⇑, Marjorie A. Bowman, Sharon X. Xie, Deborah Bruner, Angela DeMichele and John T. Farrar
+ Author Affiliations -- Jun J. Mao, Sharon X. Xie, Angela DeMichele, and John T. Farrar, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Marjorie A. Bowman, Wright State University Boonshoft School of Medicine, Dayton, OH; and Deborah Bruner, Emory University Nell Hodgson Woodruff School of Nursing, Atlanta, GA. Corresponding author: Jun J. Mao, MD, MSCE, Department of Family Medicine and Community Health, University of Pennsylvania, 227 Blockley Hall/423 Guardian Dr, Philadelphia, PA 19104; e-mail: jun.mao@uphs.upenn.edu.
Abstract -
Purpose Hot flashes are a common and debilitating symptom among survivors of breast cancer. This study aimed at evaluating the effects of electroacupuncture (EA) versus gabapentin (GP) for hot flashes among survivors of breast cancer, with a specific focus on the placebo and nocebo effects.
Patients and Methods We conducted a randomized controlled trial involving 120 survivors of breast cancer experiencing bothersome hot flashes twice per day or greater. Participants were randomly assigned to receive 8 weeks of EA or GP once per day with validated placebo controls (sham acupuncture [SA] or placebo pills [PPs]). The primary end point was change in the hot flash composite score (HFCS) between SA and PP at week 8, with secondary end points including group comparisons and additional evaluation at week 24 for durability of treatment effects.
Results By week 8, SA produced significantly greater reduction in HFCS than did PP (−2.39; 95% CI, −4.60 to −0.17). Among all treatment groups, the mean reduction in HFCS was greatest in the EA group, followed by SA, GP, and PP (−7.4 v −5.9 v −5.2 v −3.4; P = < .001). The pill groups had more treatment-related adverse events than did the acupuncture groups: GP (39.3%), PP (20.0%), EA (16.7%), and SA (3.1%), with P = .005. By week 24, HFCS reduction was greatest in the EA group, followed by SA, PP, and GP (−8.5 v −6.1 v −4.6 v −2.8; P = .002).
Conclusion Acupuncture produced larger placebo and smaller nocebo effects than did pills for the treatment of hot flashes. EA may be more effective than GP, with fewer adverse effects for managing hot flashes among breast cancer survivors. © 2015 by American Society of Clinical Oncology