Abstract
Objectives This study aimed to examine the efficacy and safety of acupoint catgut embedding (ACE) for obesity over a 16-week treatment period using sham stimulation as the control. Methods A multicenter, randomised, parallel, sham-controlled trial was conducted from February 10, 2017, to May 15, 2018. Men with waistlines ≥85 cm and women with ≥80 cm at three sites were randomised to receive eight sessions (over 16 weeks) of ACE (n = 108) or sham ACE (n = 108) with skin penetration at sham acupoints. The catgut was embedded once every two weeks using two alternating sets of acupoints. The follow-up lasted for an additional 24 weeks. The primary outcome was the percentage waistline reduction from baseline to week 16. Results We included 216 individuals in the intention-to-treat analysis. At 16 weeks, the rate of waistline reduction was 8.80% (95% confidence interval (CI), 7.93% to 9.66%) in the ACE group and 4.09% (95% CI, 3.18% to 5.00%) in the sham control group, with a between-group difference of 4.71% (95% CI, 3.47% to 5.95%; P < 0.0001). This difference persisted throughout the entire follow-up period (between-group difference after 24-week additional weeks, 4.94% (95% CI, 3.58% to 6.30%); P < 0.001). The subgroup analyses of waistline by sex (male/female) revealed treatment effects of 1.93 (95% CI, −0.37 to 4.23, P = 0.1) in the male group and 3.19 (95% CI, 1.99 to 4.39, P < 0.001) in the female group. The adverse event analysis suggested that ACE and laboratory tests confirmed the safety of ACE. Discussion. ACE for 16 weeks could decrease the waistline and weight and was safe for the treatment of obesity. Further research is needed to evaluate the long-term efficacy and sex differences. This trial is registered with NCT02936973.
Highlights
Obesity is a chronic metabolic disease characterised by excessive accumulation or abnormal distribution of fat in the body
Participants were lost to follow-up: 10 (9.3%) in the acupoint catgut embedding (ACE) group and 13 (12.0%) in the sham ACE group. e baseline demographic and clinical characteristics were similar between the two groups, except for a family history of obesity (Table 1)
This study is the largest multicentre, sham-controlled clinical trial to assess the beneficial effect of ACE on obesity within 16 weeks
Summary
Obesity is a chronic metabolic disease characterised by excessive accumulation or abnormal distribution of fat in the body. It is a risk factor for many diseases, including type 2 diabetes mellitus, hypertension, and certain cancers [1,2,3]. It has been projected that there will be 2.16 billion overweight and 1.12 billion obese individuals globally by 2030 [7]. Various strategies, including lifestyle interventions, drug therapy, and metabolic surgery, have been shown to be successful in managing global obesity epidemics [8]. Complementary/alternative therapies, such as acupuncture, have been extensively used to treat obesity [12,13,14]
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