Borud Einar K, Alraek Terje, White Adrian, Fonnebo Vinjar, Grimsgaard Sameline
National Research Center in Complementary and Alternative Medicine, University of Tromsoe, N-9037 Tromsoe, Norway.
BMC Complement Altern Med. 2007 Feb 26;7:6. doi: 10.1186/1472-6882-7-6.
After menopause, 10-20% of all women have nearly intolerable hot flushes. Long term use of hormone replacement therapy involves a health risk, and many women seek alternative strategies to relieve climacteric complaints. Acupuncture is one of the most frequently used complementary therapies in Norway. We designed a study to evaluate whether Traditional Chinese Medicine acupuncture-care together with self-care is more effective than self-care alone to relieve climacteric complaints.
METHODS/DESIGN: The study is a multi-centre pragmatic randomised controlled trial with two parallel arms. Participants are postmenopausal women who document > or =7 flushes/24 hours and who are not using hormone replacement therapy 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 Traditional Chinese Medicine acupuncture-care and self-care; the control group will engage in self-care only. A team of experienced Traditional Chinese Medicine acupuncturists give acupuncture treatments.
The study tests acupuncture as a complete treatment package including the 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, assessed by the Women's Health Questionnaire. We also collect data on Traditional Chinese Medicine diagnoses, and we examine treatment experiences using a qualitative approach. Finally we measure biological variables, to examine potential mechanisms for the effect of acupuncture. The study is funded by The Research Council of Norway.
绝经后，10% - 20%的女性会出现几乎难以忍受的潮热。长期使用激素替代疗法存在健康风险，许多女性寻求替代策略来缓解更年期不适。针灸是挪威最常用的补充疗法之一。我们设计了一项研究，以评估中医针灸护理与自我护理相结合是否比单纯自我护理更有效地缓解更年期不适。
方法/设计：该研究是一项多中心实用随机对照试验，有两个平行组。参与者为绝经后女性，记录到每天潮热次数≥7次，且未使用激素替代疗法或其他可能影响潮热的药物。根据功效计算，需要200名女性才能检测到潮热次数减少50%，总共将招募286名女性以考虑30%的失访率。治疗组接受10次中医针灸护理和自我护理；对照组仅进行自我护理。由一组经验丰富的中医针灸师进行针灸治疗。
该研究将针灸作为一个完整的治疗方案进行测试，包括治疗关系和期望。干预期持续12周，在6个月和12个月时进行随访。主要终点是两组从基线到12周每日潮热频率的变化；次要终点是通过女性健康问卷评估的与健康相关的生活质量。我们还收集中医诊断数据，并采用定性方法检查治疗体验。最后，我们测量生物学变量，以研究针灸效果的潜在机制。该研究由挪威研究理事会资助。
