艾灸联合中医特色生活方式干预治疗腹型肥胖：一项随机对照试验的研究方案

Moxibustion combined with characteristic lifestyle intervention of Traditional Chinese Medicine in the treatment of abdominal obesity: A study protocol for a randomized controlled trial.

作者信息

Wang Li-Hua, Huang Wei, Zhou Wei, Zhou Li, Zhou Xiao-Li, Zhou Peng, Yan Yan, Zhou Zhong-Yu, Wang Hua

机构信息

College of Acupuncture and Orthopedics, Hubei University of Chinese Medicine/Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibustion.

Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine.

出版信息

Medicine (Baltimore). 2020 Oct 23;99(43):e22855. doi: 10.1097/MD.0000000000022855.

DOI:10.1097/MD.0000000000022855

PMID:33120822

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7581175/

Abstract

BACKGROUND

Abdominal obesity occurs when excessive visceral and subcutaneous fat is built up around the abdomen and stomach, which negatively impacts human health. Moxibustion, arose from Traditional Chinese Medicine (TCM), has been widely applied in the treatment of abdominal obesity. Several studies have shown the positive effects of moxibustion in prevention and treatment of endocrine issues and excess body weight. In this context, our study aims to examine the safety and efficacy of the combination of moxibustion and characteristic lifestyle intervention of TCM in the treatment of abdominal obesity.

METHODS/DESIGN: This study will be a multicenter, randomized, controlled trial conducted from September 2020 to January 2022 that includes 150 participants who have abdominal obesity and meet the eligibility criteria. The participants will be randomly divided into 3 groups in a 2:2:1 allocation ratio. The intervention group will receive moxibustion combined with characteristic lifestyle intervention of TCM; the other group will receive moxibustion combined with lifestyle intervention; the control group will receive lifestyle intervention only. Eight-week moxibustion sessions will be provided to participants assigned to the 2 intervention groups. The characteristic lifestyle intervention of TCM will also last 8 weeks, whereas the lifestyle intervention will last 12 weeks including 8-week treatment period, 4-week follow-up period. The primary outcome is the waist circumference measured by a tape measure. The secondary outcomes include obesity-related indicators, serum biochemical indexs, blood pressure, conversion score of physical symptoms, and measurement of the scale. Adverse events will be recorded during the treatment and follow-up period.

DISCUSSION

The results are expected to provide clinical evidence for the application of the combination of moxibustion and characteristic lifestyle intervention of TCM in patients with abdominal obesity.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT04501198, Registered on 9 June 2020.

摘要

背景

当腹部和胃部周围积聚过多内脏脂肪和皮下脂肪时，就会出现腹型肥胖，这会对人类健康产生负面影响。艾灸起源于传统中医，已广泛应用于腹型肥胖的治疗。多项研究表明艾灸在预防和治疗内分泌问题及体重超标方面具有积极作用。在此背景下，我们的研究旨在探讨艾灸与中医特色生活方式干预相结合治疗腹型肥胖的安全性和有效性。

方法/设计：本研究将是一项多中心、随机、对照试验，于2020年9月至2022年1月进行，纳入150名患有腹型肥胖且符合入选标准的参与者。参与者将按2:2:1的分配比例随机分为3组。干预组将接受艾灸结合中医特色生活方式干预；另一组将接受艾灸结合生活方式干预；对照组仅接受生活方式干预。将为分配到2个干预组的参与者提供为期8周的艾灸疗程。中医特色生活方式干预也将持续8周，而生活方式干预将持续12周，包括8周治疗期和4周随访期。主要结局是用卷尺测量的腰围。次要结局包括肥胖相关指标、血清生化指标、血压、身体症状转化评分和量表测量。在治疗和随访期间将记录不良事件。