Hot flashes and/or night sweats are the most common and troubling symptoms associated with menopause. For many women these symptoms can be frequent and severe enough to become debilitating and interfere with daily activity. They often occur at night, waking women from sleep and leading to daytime irritability, fatigue and depressed mood. Relief from hot flashes and night sweats has been shown to be the primary reason that women initiate hormone therapy (HT). Hot flashes are a particular problem for women who have had treatment for breast cancer. Currently, the gold standard for treatment of vasomotor symptoms is estrogen therapy. HT, however, is associated with a number of risks and is often contraindicated for women at high risk for breast cancer and those who have had breast cancer. Given the risks and side effects associated with HT, many women have sought alternative treatments for hot flashes. Unfortunately, many of these treatments have a high incidence of side effects or have not been shown to be effective. Modern theories of neurophysiologic and neurohumoral mechanisms, as well as concepts of Traditional Chinese Medicine (TCM) suggest that acupuncture may be an effective method to control menopausal hot flashes. A few small pilot studies, as well as clinical practice, have provided some support for acupuncture as an effective treatment. The goal of this R21 pilot grant is to demonstrate the feasibility of conducting a randomized clinical trial to test the effectiveness of acupuncture for treating menopause-related hot flashes. Following this pilot grant, we plan to seek R01 funding to conduct a fully powered randomized trial. For this pilot grant, 60 women will be randomly assigned to one of 3 groups: (1) standardized acupuncture with variation, (2) placebo "sham" acupuncture, or (3) usual care. Our primary outcome will be a reduction in hot flash frequency and severity. Secondary outcomes will include improvement in sleep, mood, and overall quality of life. The purpose of this pilot study is to establish the acupuncture treatment and the placebo acupuncture protocols and to demonstrate the feasibility of recruiting and retaining subjects to the study. The study is organized with Wake Forest University School of Medicine (WFUSM) serving as the Coordinating Center and Massachusetts General Hospital (MGH) and the University of North Carolina at Chapel Hill (UNC) serving as the clinical sites. The specific aims of this pilot grant are: (1) to develop and refine the acupuncture protocols, (2) to determine the feasibility of conducting the proposed R01 in terms of recruiting subjects to the study and retaining subjects throughout the study, (3) to obtain preliminary data on the effectiveness of acupuncture on hot flash frequency and severity, as well as to obtain data on these outcomes to determine sample size calculations for the R01, and (4) to assess our ability to track program costs associated with the intervention and to identify costs borne by participants.

R21CA104427

2004-06-18

2006-11-30