Electro-acupuncture for central obesity: randomized, patient-assessor blinded, sham-controlled clinical trial protocol

Linda L D Zhong,Tsz Fung Lam,Peihua Cao,Zhaoxiang Bian,Emily Yen Wong,Ying Ping Wong,Xingyao Wu,Shipping Zhang

doi:10.1186/s12906-021-03367-2

Abstract

BackgroundObesity is a common medical condition. Among all the classifications of obesity, central obesity is considered to be a significant threat on the health of individuals. Scientific researches have demonstrated that the accumulation of intra-abdominal fat is associated with higher metabolic and cardiovascular disease risks independently from Body Mass Index (BMI). Our previous research found that the combination of electro-acupuncture and auricular acupressure could significantly reduce the body weight and the BMI compared to sham control group.Methods/designThis is a patient-assessor blinded, randomized, sham-controlled clinical trial on electro-acupuncture for central obesity. One hundred sixty-eight participants with central obesity will be randomly assigned to two groups, which are the acupuncture group and the sham control group. The whole study duration will be 8-week treatment plus 8-week follow up. The primary outcome is the change in waist circumference before and after the treatment. The secondary outcomes include the changes in hip circumference, waist-to-hip circumference ratio, BMI and body fat percentage during the treatment and follow-up.ConclusionThe trial will evaluate the efficacy and safety of electro-acupuncture for central obesity compared with sham acupuncture. The study may provide the solid evidence of electro-acupuncture on central obesity in Hong Kong.Trial registrationClinicalTrials.gov Identifier: NCT03815253,Registered 24 Jan 2019.

Highlights

Waist circumference is a significant indicator of body fat distribution and an important measurement method for central obesity [29, 30]. We conduct this clinical study to provide the solid evidence for acupuncture on central obesity. The objective of this proposed study is to evaluate the efficacy and safety of the electro-acupuncture in the treatment of central obesity compared with sham acupuncture
The Traditional Chinese Medicine (TCM) practitioners will be aware of the allocation of each patient,but the participants and assessor will be blinded to the group allocation.168 participants with central obesity will be recruited from the public through advertisement
Research on integrated treatments with electroacupuncture, Chinese Herbal Medicine (CHM), diet plan, physical exercises for central obesity and research on the influence of electroacupuncture to serum glucose, cholesterol, blood pressure or psychological condition such as mood-influenced satiety can be developed with the data from this clinical trial

Summary

Introduction

Scientific researches have demonstrated that the accumulation of intra-abdominal fat is associated with higher metabolic and cardiovascular disease risks independently from Body Mass Index (BMI). 39% of adults aged 18 years and over were overweight, and 13% were obese in 2016 [2]. Obesity is a chronic condition in prevalence which is related to metabolic diseases with serious morbidity and mortality [5]. Obesity can be divided into two types, subcutaneous fat type or systemic obesity and abdominal obesity or central obesity. The latter one is defined as accumulation of fat in internal organs and mesenteric membrane in the abdominal cavity [8,9,10]

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