Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
BMJ Open. 2024 Mar 8;14(3):e075873. doi: 10.1136/bmjopen-2023-075873.
Obesity has been identified as a significant risk factor for several chronic conditions, including diabetes, tumours and cardiovascular disease, and has been associated with increased mortality rates. Despite the well-established clinical practice of electroacupuncture (EA) as a potential treatment option for obesity, its efficacy remains questionable, primarily due to the paucity of empirical evidence supporting its therapeutic benefits.
The present study aims to investigate the efficacy and safety of EA for weight loss in obese individuals with pre-diabetes, using a randomised, placebo-controlled clinical trial design. A total of 256 eligible patients will be randomly assigned to one of two groups: EA (comprising EA treatment with health education) or superficial acupuncture (SA) (comprising SA treatment with health education). The intervention will be administered three times per week for the initial 12 weeks, two times per week for the subsequent 8 weeks and one time per week for the final 4 weeks, with a 24-week follow-up period. The primary outcome measure will be the percentage of patients who achieve a reduction of 10% or more in their body weight at week 24. Secondary outcome measures will include changes in body weight and body mass index, blood test results, data collected by the body composition analyser, size of adipose tissue scanned by MRI of the abdomen and the Impact of Weight on Quality of Life, the 21-item Three-Factor Eating Questionnaire-Revised and the Food Craving Questionnaire-Trait. The Treatment Emergent Symptom Scale will be employed to monitor every adverse reaction from baseline to follow-up.
This trial has received ethical clearance from the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine under the registration number 2021SHL-KY-74. All participants will provide their written informed consent prior to their enrolment. The findings of this investigation will be disseminated through peer-reviewed publications and scholarly conferences.
NCT05237089.
肥胖已被确定为多种慢性疾病的重要危险因素，包括糖尿病、肿瘤和心血管疾病，并与死亡率的增加有关。尽管电针（EA）作为肥胖治疗的一种潜在选择，已被确立为临床实践，但由于缺乏支持其治疗益处的经验证据，其疗效仍存在疑问。
本研究旨在采用随机、安慰剂对照临床试验设计，探究 EA 治疗肥胖合并糖尿病前期患者的疗效和安全性。共有 256 名符合条件的患者将被随机分配到两组之一：EA（包括 EA 治疗加健康教育）或浅针刺（SA）（包括 SA 治疗加健康教育）。干预措施将在最初的 12 周内每周进行 3 次，在接下来的 8 周内每周进行 2 次，在最后的 4 周内每周进行 1 次，随访期为 24 周。主要结局指标是第 24 周时体重减轻 10%或更多的患者比例。次要结局指标包括体重和体重指数的变化、血液检查结果、身体成分分析仪收集的数据、腹部 MRI 扫描的脂肪组织大小、体重对生活质量的影响、21 项三因素饮食问卷修订版和食物渴望问卷特质。治疗突发症状量表将用于监测从基线到随访的所有不良反应。
本试验已获得上海市中医医院伦理委员会的伦理批准，注册号为 2021SHL-KY-74。所有参与者将在入组前签署书面知情同意书。该研究的结果将通过同行评议的出版物和学术会议进行传播。
NCT05237089。
