Chen Xia, Huang Wei, Wei Dan, Ding De-Guang, Jiao Yang, Pan Hong-Ling, Jin Yi-Ting, Zheng Yi-Wei, Zhang Yan-Ji, Zhang Ying-Rong, Liu Yi-Ran, Zhou Zhong-Yu
Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine.
Hubei Province Academy of Traditional Chinese Medicine.
Medicine (Baltimore). 2020 Nov 25;99(48):e23390. doi: 10.1097/MD.0000000000023390.
Catgut implantation at acupoints (CIA) is a subtype of acupuncture that has been widely used to treat simple obesity, but evidence for its effectiveness remains scarce. The aim of this study is to evaluate the efficacy and safety of treating simple obesity with CIA.
This clinical trial aims to evaluate the effectiveness and safety of CIA used for treatment of simple obesity.
This is a multicentre, randomized, parallel, sham-controlled clinical trial. A total of 216 patients with simple obesity will be recruited. They will be randomly assigned in a 1:1 ratio to either the CIA group or the sham control group. All treatments will be given once every 2 weeks. The primary outcome measure is the rate of waistline reduction. Secondary outcome measures are the rates of reduction of body measurements, including weight, body mass index (BMI), hipline, waist-hip-ratio (WHR) and body fat percentage (BFP), the changes in scores on scales, including the Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite), Short Form 36 (SF-36), the Hospital Anxiety and Depression Scale (HAD) and the Self-Esteem Scale (SES), Outcomes will be evaluated at baseline and at weeks 4, 8, 12, 16, 28, and 40, respectively. All adverse events that occur during this study will be recorded. If any participant withdraws from the trial, an intention-to-treat analysis (ITT) will be performed.
This is a randomized, sham-controlled trial of CIA treatment for simple obesity. The results of this trial will provide more evidence on whether CIA is efficacious and safe for treating obesity.
ClinicalTrials.gov Identifier: NCT02936973. Registered on October 18, 2016.
穴位埋线是针灸的一种亚型，已被广泛用于治疗单纯性肥胖，但关于其有效性的证据仍然稀少。本研究的目的是评估穴位埋线治疗单纯性肥胖的疗效和安全性。
本临床试验旨在评估穴位埋线治疗单纯性肥胖的有效性和安全性。
这是一项多中心、随机、平行、假手术对照的临床试验。共招募216例单纯性肥胖患者。他们将按1:1的比例随机分配到穴位埋线组或假手术对照组。所有治疗每2周进行一次。主要观察指标是腰围减少率。次要观察指标是身体测量指标的减少率，包括体重、体重指数（BMI）、臀围、腰臀比（WHR）和体脂百分比（BFP），量表评分的变化，包括体重对生活质量问卷（IWQOL-Lite）、简明健康调查问卷（SF-36）、医院焦虑抑郁量表（HAD）和自尊量表（SES）。分别在基线以及第4、8、12、16、28和40周评估结果。记录本研究期间发生的所有不良事件。如果有任何参与者退出试验，将进行意向性分析（ITT）。
这是一项关于穴位埋线治疗单纯性肥胖的随机、假手术对照试验。本试验结果将为穴位埋线治疗肥胖是否有效和安全提供更多证据。
ClinicalTrials.gov标识符：NCT02936973。于2016年10月18日注册。
