针刺联合中药治疗糖尿病前期：一项随机对照试验的研究方案

Acupuncture paired with herbal medicine for prediabetes: study protocol for a randomized controlled trial.

作者信息

Li Xinger, Liu Haiyan, Feng Huiping, Xian Zhongren, Chen Yanhong, Chen Jianping, Tang Chunzhi, Lai Xinsheng, Lan Xiaoling, Huang Huanzhen, Yu Dongdong

机构信息

The Fifth Affiliated Hospital of Guangzhou Medical University, The Fifth Clinical School of Guangzhou Medical University, Guangzhou, China.

Guangzhou University of Chinese Medicine, Guangzhou, China.

出版信息

Trials. 2017 Jun 28;18(1):297. doi: 10.1186/s13063-017-2014-4.

DOI:10.1186/s13063-017-2014-4

PMID:28659162

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5490211/

Abstract

BACKGROUND

Type-2 diabetes has become a major disease and is known to seriously impair people's health worldwide. Prediabetes includes impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) and is the most critical period for preventing type-2 diabetes, as it can be identified and reversed. Studies in the past decade have indicated that acupuncture and Chinese herbal medicine may be beneficial for treating prediabetes. However, a randomized controlled trial (RCT) should be conducted to obtain more clinical evidence on this topic.

METHODS/DESIGN: An RCT will be implemented in this study, using a72-week study period (24 weeks for the intervention and 48 weeks for follow-up). Participants will be recruited from the Fifth Affiliated Hospital of Guangzhou Medical University in China. Eighty participants will be randomized to the treatment group (acupuncture plus herbal medicine and health education) or the control group (health education only), 40 participants in each. People included in this study must have been diagnosed with prediabetes using Western medicine criteria. The endpoint indices include the incidence of diabetes mellitus and the reversion rate. The primary outcome is fasting plasma glucose (FPG) level, 2-h plasma glucose (2-hPG) level after a 75-g oral glucose tolerance test (OGTT), and glycosylated hemoglobin (HbA) level. Secondary outcomes include the following: Body Mass Index (BMI); hemorheology, including shear rates of whole-blood viscosity and plasma viscosity. Safety indices include hepatic (ALT, AST) and renal function (BUN, Cr) and records of adverse events, including diarrhoea, colds, pharyngitis, and sleep disorders. Quality control will be implemented, including quality control of the laboratory, researchers, participants, investigational drugs, data and documents, occurrence of bias, supervision, among others, according to uniform standard operating procedures (SOPs) which have been established by the Good Clinical Practice (GCP) office of the Fifth Affiliated Hospital of Guangzhou Medical University.

DISCUSSION

The aim of this study is to evaluate the efficacy and safety of acupuncture paired with herbal medicine for the treatment of patients with prediabetes.

TRIAL REGISTRATION

Chinese clinical trials register ChiCTR-INR-16008891 . Registered on 23 July 2016.

摘要

背景

2型糖尿病已成为一种主要疾病，在全球范围内严重损害人们的健康。糖尿病前期包括空腹血糖受损（IFG）和糖耐量受损（IGT），是预防2型糖尿病的最关键时期，因为它可以被识别并逆转。过去十年的研究表明，针灸和中药可能对治疗糖尿病前期有益。然而，需要进行一项随机对照试验（RCT）以获取更多关于该主题的临床证据。

方法/设计：本研究将实施一项随机对照试验，研究周期为72周（干预24周，随访48周）。参与者将从中国广州医科大学附属第五医院招募。80名参与者将被随机分为治疗组（针灸加中药及健康教育）或对照组（仅健康教育），每组40人。纳入本研究的人员必须已根据西医标准被诊断为糖尿病前期。终点指标包括糖尿病发病率和逆转率。主要结局是空腹血糖（FPG）水平、75克口服葡萄糖耐量试验（OGTT）后2小时血糖（2-hPG）水平和糖化血红蛋白（HbA）水平。次要结局包括：体重指数（BMI）；血液流变学，包括全血粘度切变率和血浆粘度。安全性指标包括肝功能（ALT、AST）和肾功能（BUN、Cr）以及不良事件记录，包括腹泻、感冒、咽炎和睡眠障碍。将根据广州医科大学附属第五医院药物临床试验质量管理规范（GCP）办公室制定的统一标准操作规程（SOP）实施质量控制，包括实验室、研究人员、参与者、试验药物、数据和文件、偏倚发生情况、监督等方面的质量控制。