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: 7845861
• 负责人: NANCY E AVIS
• 金额: $ 43.66万
• 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/7845861
• 关键词: Acupressure; Acupuncture procedure; Address; Area; C-reactive protein; Chinese Traditional Medicine; Clinical Trials; Consent; Control Groups; Effectiveness; Goals; Health Personnel; Health Professional; Health Sciences; Healthcare; Hot flushes; Human; Hydrocortisone; Interleukin-6; Measurable; Medical; Menopause; Meridians; Moods; Needles; Outcome; Patient Outcomes Assessments; Patients; Physiological; Placebos; Quality of life; Randomized; Recruitment Activity; Relative (related person); Reporting; Research; Role; Site; Sleep; Stress; Symptoms; Testing; Traditional Medicine; Treatment Efficacy; Universities; Woman; alternative treatment; base; clinical practice; design; expectation; forest; heart rate variability; patient expectation; public health relevance; research study; theories; treatment as usual

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.

这项研究的主要目的是确定针灸治疗血管舒缩和其他与更年期相关症状的有效性，因为针灸通常在女性中进行。现实世界??这项研究将使我们能够确定执业针灸师推荐的治疗模式、对这些治疗的坚持以及不同治疗模式减少潮热的有效性。是： 1.) 确定治疗建议的模式（就治疗频率而言）以及对这些治疗建议的遵守情况， 2.) 确定上述确定的模式与通过自我报告的潮热测量的针灸疗效之间的关联，和3.) 比较已确定的针灸模式与未治疗对照组在自我报告的潮热和其他结果方面的情况，包括客观潮热、睡眠和其他症状以及生活质量。平均每天至少招募 4 名潮热患者，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。初步资格将通过电话筛查确定。随机分组前的 2 周日记允许女性在 6 个月内接受最多 20 次针灸治疗，实际数量将由研究参与者确定，而候补名单中的女性将不会接受任何针灸治疗。在最初的 6 个月内，所有女性都会记下潮热日记，并每隔一个月佩戴潮热监测仪 3 天，以评估客观的潮热情况。女性可能需要针灸治疗的次数和频率来减少潮热。