Zhou Yu-Mei, Yan Bing, Yuan Wei-Qu, Yu Hai-Bo, Yang Zhuo-Xin
The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen, 518033, GuangDong, China.
Trials. 2019 Nov 27;20(1):644. doi: 10.1186/s13063-019-3730-8.
Obesity has become a major public health hazard with epidemic proportions, affecting adults, adolescents, and children of both genders. Previous studies have suggested that acupoint catgut embedding (ACE) might be a potential therapeutic approach for obesity. The purpose of this study is to conduct a rigorous and normative trial to determine the efficacy of ACE for obesity.
METHODS/DESIGN: A total of 99 eligible patients diagnosed with obesity will be recruited in this study. They will be randomly allocated to either the verum ACE group, sham ACE group, or waiting list (WL) group, with 33 patients in each group. Each patient in the two ACE-based groups will receive eight sessions of treatment, lasting over 8 weeks. The primary outcome is the reduction of body mass index (BMI) after treatment. Secondary outcomes will include waist circumference (WC), hip circumference (HC), waist:hip ratio, body fat percentage, blood lipid level, subcutaneous fat area, visceral fat area, and World Health Organization Quality of Life (WHOQOL). All the outcomes will be evaluated at baseline, at the end of the 8 weeks of treatments, and at 3 months of follow-up. The evaluators and data analyzers will be blinded to group allocation.
The findings of this randomized, sham-, and WL-controlled trial will help to investigate the influence of ACE on clinical variables as well as visceral fat area of obesity, which will provide high-quality evidence on the efficacy of ACE for obesity.
Chinese Clinical Trial Registry, ChiCTR1800020248. Registered on December 21, 2018.
肥胖已成为具有流行趋势的重大公共卫生危害，影响着各年龄段及两性的成年人、青少年和儿童。先前的研究表明，穴位埋线可能是一种治疗肥胖的潜在方法。本研究的目的是进行一项严谨规范的试验，以确定穴位埋线治疗肥胖的疗效。
方法/设计：本研究将招募99例确诊为肥胖的合格患者。他们将被随机分配至真穴位埋线组、假穴位埋线组或等待列表（WL）组，每组33例患者。两个穴位埋线组的每位患者将接受8次治疗，持续8周以上。主要结局是治疗后体重指数（BMI）的降低。次要结局将包括腰围（WC）、臀围（HC）、腰臀比、体脂百分比、血脂水平、皮下脂肪面积、内脏脂肪面积以及世界卫生组织生活质量量表（WHOQOL）。所有结局将在基线、8周治疗结束时以及随访3个月时进行评估。评估者和数据分析者将对分组情况不知情。
这项随机、假手术及等待列表对照试验的结果将有助于研究穴位埋线对肥胖临床变量以及内脏脂肪面积的影响，这将为穴位埋线治疗肥胖的疗效提供高质量证据。
中国临床试验注册中心，ChiCTR1800020248。于2018年12月21日注册。
