Non-specific Effects of Acupuncture in the Treatment of Hot Flashes

针灸治疗潮热的非特异性作用

• 批准号: 8325589
• 负责人: NANCY E AVIS
• 金额: $ 39.71万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8325589
• 关键词: Acupuncture procedure; Adherence; Control Groups; Diagnosis; Effectiveness; Eligibility Determination; Frequencies; Health; Hot flushes; Measures; Medical; Menopause; Monitor; Outcome; Participant; Patient Self-Report; Pattern; Quality of life; Randomized; Recommendation; Recruitment Activity; Research; Sampling Studies; Sleep; Symptoms; Telephone; Time; Treatment Effectiveness; Vasomotor; Woman; Work; alternative treatment; clinically relevant; diaries; experience; improved; secondary outcome; treatment adherence; treatment duration

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.

本研究的主要目的是确定针灸治疗血管痉挛和其他更年期相关症状的有效性，因为针灸通常在真实的世界中进行，并随着时间的推移对使用模式和症状缓解进行全面评估。这项研究将使我们能够确定实践针灸师推荐的治疗模式，坚持这些治疗，以及不同治疗模式对减少潮热的有效性。具体目标是：（1）。为了确定治疗建议的模式（在治疗频率方面）和对这些治疗建议的依从性，2.）确定上述识别的模式与通过自我报告的潮热测量的针灸有效性之间的关联，以及3.）比较针灸模式与未治疗对照组自我报告的潮热和其他结果。次要结果包括客观潮热、睡眠和其他症状以及生活质量。将招募200名平均每天至少经历4次潮热的女性，160名女性将被分配到针灸组，40名女性将被分配到候补对照组。最初的资格将通过电话筛选确定。将在随机化前通过2周日记验证潮热合格性。妇女将被允许在6个月内接受多达20次针灸治疗。实际数量将由研究受试者和针灸师确定。候补名单上的妇女将不会接受任何针灸治疗6个月。在最初的6个月内，所有女性都将记录每日潮热日记，并每隔一个月佩戴潮热监测仪3天，以评估客观潮热。这项研究的结果将为女性提供有意义的信息，包括可能需要减少潮热的针灸治疗的次数和频率。