Effect of Catgut Embedding at Acupoints versus Non-acupoints in Abdominal Obesity: Protocol for A Multicenter, Double-Blind, 16-Week Randomized Controlled Trial (Preprint)

BACKGROUND Obesity is an increasing worldwide problem. Previous studies suggested that acupoint catgut embedding (ACE) may be an effective obesity treatment. However, the evidence for the efficacy of ACE in abdominal obesity (AO) remains inadequate due to the paucity of high-quality studies. OBJECTIVE This study aims to investigate the difference in the effectiveness of catgut embedding at acupoints and catgut embedding at non-acupoints in AO patients. METHODS This is a multicenter, double-blind, 16-week randomized controlled trial (RCT). A total of 92 eligible AO participants will be randomly divided into two groups (1:1 allocation ratio). The ACE group will receive catgut embedding at acupoints and the control group will receive catgut embedding at non-acupoints. The intervention will be performed every two weeks for a total of 6 sessions. Follow-up will be performed every two weeks for a total of 2 visits. The primary outcome is waist circumference (WC). Secondary outcomes include body weight (BW), body mass index (BMI), hip circumference (HC), and visual analog scale (VAS) of appetite. RESULTS This trial protocol was approved by the Institutional Review Board in June 2018. The start of recruitment began in August 2019 and is expected to end in September 2023. Upon completion of the trial, we will evaluate the effect of catgut embedding in acupoints or non-acupoints on obesity indicators in patients with AO. For treatment outcomes, an intention-to-treat analysis will be performed. CONCLUSIONS Although studies have been conducted to demonstrate the effectiveness of ACE in the treatment of obesity. However, the evidence for the efficacy of ACE in AO remains insufficient due to the quality of the studies. This rigorous normative randomized controlled trial will verify the effect of catgut embedding in acupoints or non-acupoints for AO. The findings will provide credible evidence as to whether ACE is an effective and durable treatment for AO. CLINICALTRIAL Chinese Clinical Trial Registry: ChiCTR1800016947; http://www.chictr.org.cn/showproj.aspx?proj=28782