Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2006; 11: 05–6
Long-term use of hormone replacement therapy (HRT) involves a health risk, and many women seek alternative strategies to relieve climacteric complaints. We designed a multicentred pragmatic randomised controlled trial with two parallel arms to determine whether traditional Chinese medicine (TCM) acupuncture care together with self-care is more effective than self-care alone to relieve climacteric complaints.
Participants are postmenopausal women who document ≥ seven flushes/24 h and who are not using HRT or other medication that may influence flushes. According to power calculations 200 women are needed to detect a 50% reduction in flushes, and altogether 286 women will be recruited to allow for a 30% dropout rate. The treatment group receives 10 sessions of TCM acupuncture care and self-care; the control group engage in self-care only. A team of experienced TCM acupuncturists give acupuncture treatments. The study tests acupuncture as a complete treatment package, including therapeutic relationship and expectation. The intervention period lasts for 12 weeks with follow-up at 6 and 12 months. Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health-related quality of life. We also collect data on TCM diagnoses and we examine treatment experiences using a qualitative approach. Finally, we measure biological variables to examine potential mechanisms for effect of acupuncture.
The study is funded by the Research Council of Norway.
