The primary purpose of this study is to determine the effectiveness of acupuncture for treating vasomotor and other symptoms associated with menopause as acupuncture is generally practiced in the ?real world? setting and to obtain a comprehensive assessment of use patterns and symptom relief over time. This study will allow us to determine treatment patterns recommended by practicing acupuncturists, adherence to these treatments, and the effectiveness of different treatment patterns for reducing hot flashes.
The Specific Aims are: 1.) To identify patterns of treatment recommendations (in terms of frequency of treatments) and adherence to these treatment recommendations, 2.) To determine the association between identified patterns as above and acupuncture effectiveness as measured by self-reported hot flashes, and 3.) To compare identified patterns of acupuncture with a no-treatment control group on self-reported hot flashes and other outcomes. Secondary outcomes include objective hot flashes, sleep and other symptoms, and quality of life. A total of 200 women experiencing at least 4 hot flashes per day on average will be recruited, 160 women will be assigned to acupuncture and 40 women to a waitlist control group. Initial eligibility will be determined via a telephone screener. Hot flash eligibility will be verified by a 2-week diary before randomization. Women will be allowed to have up to 20 acupuncture treatments over a 6 month period. The actual number will be determined by the study participant and the acupuncturist. Waitlist women will not receive any acupuncture treatments for 6 months. During the initial 6 months all women will keep daily diaries of their hot flashes and wear a hot flash monitor for 3 days every other month to assess objective hot flashes. Results of this study will provide meaningful information to women in terms of number and frequency of acupuncture treatments likely to be needed to reduce hot flashes.
Acupuncture is a popular alternative treatment for a number of medical conditions including menopausal hot flashes. Even though research has shown that acupuncture may be effective, it is not known how many treatments are needed and the best pattern of treatments to achieve beneficial results. This study seeks to determine how many treatments are needed and how frequently they should be given for women to achieve a reduction in menopausal hot flashes. This study will provide important information for women seeking to use acupuncture to reduce hot flashes.
|Avis, Nancy E; Coeytaux, Remy R; Isom, Scott et al. (2016) Acupuncture in Menopause (AIM) study: a pragmatic, randomized controlled trial. Menopause 23:626-37|
|Avis, Nancy E; Coeytaux, Remy R; Levine, Beverly et al. (2016) Trajectories of response to acupuncture for menopausal vasomotor symptoms: the Acupuncture in Menopause study. Menopause :|