Abstract

Background

Acupuncture and moxibustion has been widely applied to hyperlipidemia treatment in clinical practice in China, serving as an alternative treatment to statins. Warm-needling acupuncture and medicinal cake-separated moxibustion have been separately reported with potential therapeutic effects on hyperlipidemia treatment in several studies but with limitations in study methodology. Combining these two modalities may provide a more advantageous strategy in treating hyperlipidemia. Therefore, a strict evaluation through well-designed randomized controlled trials (RCT) is necessary to determine their efficacy and safety on hyperlipidemia.

Methods

The study a multicenter, open-label, randomized, stratified, active-controlled, noninferiority trial with two parallel groups. Subjects with hyperlipidemia will be stratified into different groups by risk levels of heart diseases. They then will be instructed to the Therapeutic Lifestyle Change (TLC) diet. Those who have not reached the target lipid level will be randomly assigned to the treatments of either acupuncture and moxibustion or simvastatin with a 1:1 allocation. One hundred and thirty subjects are aimed to be recruited. The duration of intervention for this study will be 12 weeks, followed by another 4 weeks for post-treatment assessment. The primary outcome is percentage change from baseline to the end of the study in low-density lipoprotein cholesterol (LDL-C). Other indicators in lipid change, safety and adherence will also be assessed secondarily. The repeated measures, linear mixed-effects model will be applied to the analysis.

Discussion

Acupuncture and moxibustion could be a potentially effective treatment alternative for hyperlipidemia. A study with careful design is developed to evaluate the efficacy and safety of combined acupuncture and moxibustion, by integrating the traditional Chinese Medicine (TCM) regimens with the standardized Western medicine appraisal approach.

Trial registration

ClinicalTrials.gov, NCT02269046. Registered on 26 September 2014.

Details

Title
Warm-needling acupuncture and medicinal cake-separated moxibustion for hyperlipidemia: study protocol for a randomized controlled trial
Author
Liu, Mailan 1 ; Zhang, Qian 2 ; Jiang, Shan 3 ; Liu, Mi 1 ; Zhang, Guoshan 1 ; Yue, Zenghui 1 ; Chen, Qin 4 ; Zhou, Jie 4 ; Zou, Yifan 1 ; Li, Dan 1 ; Ma, Mingzhu 1 ; Dai, Guobin 1 ; Zhong, Huan 1 ; Wang, Zhihong 5 ; Chang, Xiaorong 1   VIAFID ORCID Logo 

1  Acupuncture and Tuina School, Hunan University of Chinese Medicine, Changsha, China (GRID:grid.440779.9) 
2  Rural Coordination Center of BC, Vancouver, Canada (GRID:grid.440779.9) 
3  University of British Columbia, Vancouver, Canada (GRID:grid.17091.3e) (ISNI:0000 0001 2288 9830) 
4  The Third Clinical College of Zhejiang Chinese Medical University, Hangzhou, China (GRID:grid.268505.c) (ISNI:0000 0000 8744 8924) 
5  Changchun University of Chinese Medicine, Changchun, China (GRID:grid.440665.5) (ISNI:0000 0004 1757 641X) 
Pages
310
Publication year
2017
Publication date
Dec 2017
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-017-2029-x
ProQuest document ID
2795258437
Copyright
© The Author(s). 2017. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.