Objective: To investigate the feasibility of conducting a randomized trial of the effect of acupuncture in decreasing hot flashes in peri- and postmenopausal women.
Design: Fifty-six women ages 44 to 55 with no menses in the past 3 months and at least four hot flashes per day were recruited from two clinical centers and randomized to one of three treatment groups: usual care (n = 19), sham acupuncture (n = 18), or Traditional Chinese Medicine acupuncture (n = 19). Acupuncture treatments were scheduled twice weekly for 8 consecutive weeks. The sham acupuncture group received shallow needling in nontherapeutic sites. The Traditional Chinese Medicine acupuncture group received one of four treatments based on a Traditional Chinese Medicine diagnosis. Usual care participants were instructed to not initiate any new treatments for hot flashes during the study. Daily diaries were used to track frequency and severity of hot flashes. The mean daily index score was based on the number of mild, moderate, and severe hot flashes. Follow-up analyses were adjusted for baseline values, clinical center, age, and body mass index.
Results: There was a significant decrease in mean frequency of hot flashes between weeks 1 and 8 across all groups (P = 0.01), although the differences between the three study groups were not significant. However, the two acupuncture groups showed a significantly greater decrease than the usual care group (P < 0.05), but did not differ from each other. Results followed a similar pattern for the hot flash index score. There were no significant effects for changes in hot flash interference, sleep, mood, health-related quality of life, or psychological well-being.
Conclusions: These results suggest either that there is a strong placebo effect or that both traditional and sham acupuncture significantly reduce hot flash frequency.
There was a significant decrease in mean frequency of hot flashes between weeks one and eight across all groups, although the differences between the three study groups was not significant. The two acupuncture groups showed a significantly greater decrease than the usual care group, but did not differ from each other.
From the 1Department of Social Sciences and Health Policy, Division of Public Health Sciences; 2Department of Biostatistical Sciences, Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC; 3University of North Carolina at Chapel Hill, Chapel Hill, NC; 4Massachusetts General Hospital, and Harvard Medical School, Boston, MA; and 5New England School of Acupuncture, Newton, MA.
Received December 13, 2007; revised and accepted February 12, 2008.
Funding/support: Research supported by grant R21 CA104427 from the National Cancer Institute. Support was provided at Massachusetts General Hospital by Grant Number M01-RR-0166, National Institutes of Health, National Center for Research Resources, General Clinical Research Centers Program and at the University of North Carolina by Grant RR000046 at the Verne S. Caviness General Clinical Research Center at UNC School of Medicine.
Financial disclosure: None reported.
Address correspondence to: Nancy E. Avis, PhD, Wake Forest University School of Medicine, Division of Public Health Sciences, Department of Social Sciences and Health Policy, Piedmont Plaza II, 2nd Floor, Winston-Salem, NC 27157-1063. E-mail: email@example.com