Dataset Information

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

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_1c) 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.

SUBMITTER: Li X

PROVIDER: S-EPMC5490211 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Publications

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

Li Xinger X Liu Haiyan H Feng Huiping H Xian Zhongren Z Chen Yanhong Y Chen Jianping J Tang Chunzhi C Lai Xinsheng X Lan Xiaoling X Huang Huanzhen H Yu Dongdong D

Trials 20170628 1

<h4>Background</h4>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 c ...[more]

PMID: 28659162

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Dataset Information

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

Background

Methods/design

Discussion

Trial registration

Publications

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

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