Acupuncture Treatment for Menopausal Hot Flashes

July 2004 - June 2006

Project Description – 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 the concept 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.

For this pilot grant, 60 women are being randomly assigned to one of three groups: (1) standardized acupuncture with variation, (2) placebo “sham” acupuncture, or (3) usual care. The 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 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 RO1 in terms of recruiting subjects to the study and retaining subjects throughout the study, (3) to obtain primary 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 an RO1, and (4) to assess the ability to track program costs associated with the intervention and to identify costs borne by participants.

Principal Investigator (PI) – Nancy E. Avis, Ph.D.
NESA Participants: Peter Valaskatgis, MAc (Co-investigator)
Co-Investigators: Wunian Chen, MD (3); Remy Coeytaex, MD (3); Claudine Legault, PhD (1); Jan Shifren, MD (2); May Pian-Smith, MD (2)

Collaborating Institutions: (1) Wake Forest University School of Medicine; (2) Massachussets General Hospital ; (3) University of North Carolina Chapel Hill ; (4) Brigham and Women's Hospital

Funding Agency – National Cancer Institute/NIH---Grant # 5 R21 CA104427-02

Research Faculty and Staff

Ongoing or Completed Studies:

• Seminar Series
• Faculty Publications
• NEWTT (NESA East-West Think Tank)