Randomized Controlled Pilot Study of Acupuncture for Menopausal Hot Flashes

Abstract and Introduction

Abstract

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.

Introduction

Hot flashes and/or night sweats are the most common and troubling symptoms associated with menopause.^[1,2] Hot flashes generally begin early in the menopausal transition and peak just before a woman's last menstrual period.^[3,4] Although some women report going through the menopausal transition without experiencing any hot flashes,^[5] for other women, these symptoms can be frequent and severe enough to become debilitating and interfere with daily activities and quality of life.^{[6,7,8,9,10,11,12]} Relief from hot flashes and night sweats has been shown to be the primary reason that women begin hormone therapy (HT).^[13,14,15]

Estrogen therapy, alone or in combination with progesterone, is currently the gold standard for treatment of vasomotor symptoms. HT, however, is associated with a number of risks such as thromboembolic events and breast cancer, and some troublesome side effects such as breast tenderness and irregular bleeding.^[16,17,18] The wide publicity of the Women's Health Initiative results has heightened women's concerns about taking HT. Given the risks and side effects associated with HT, many women either cannot or choose not to take HT and have sought alternatives.^{[19,20,21,22]} These alternatives include other pharmaceutical agents, herbal or dietary remedies, and behavioral therapies. Unfortunately, many of these agents have a high incidence of side effects or have not been shown to be effective.^{[21,23,24,25,26]}

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 hot flashes.^[27] Evidence suggests that changes in levels of ß-endorphins and other neurotransmitters affect the thermoregulatory center in the hypothalamus and that acupuncture alters these central neuromodulators.^[28,29,30] TCM differential diagnosis and treatment strategies for menopausal syndrome are currently taught in TCM colleges in China and in nationally accredited acupuncture schools in the United States.

Studies of acupuncture and hot flashes have been conducted with mixed results. Several uncontrolled studies have shown positive effects of acupuncture.^[31,32,33] Studies that include sham acupuncture controls have shown beneficial effects in both true and sham acupuncture groups^[34,35] or in the true acupuncture group only.^[36]

Except for Nir et al,^[36] most studies use a set of standard acupuncture points. The TCM approach, however, tends to rely on more individualized treatments. This article describes the results of a randomized clinical trial pilot study to test the effectiveness of acupuncture for treating menopausal hot flashes. A three-group design was used that compared usual care (UC) to both sham acupuncture (SA) and standardized individual acupuncture based on TCM principles. The primary outcomes were a decrease in hot flash frequency and severity. Secondary outcomes included improvement in hot flash interference, sleep, mood, and overall quality of life.

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