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Warm-needling acupuncture and medicinal cake-separated moxibustion for hyperlipidemia: study protocol for a randomized controlled trial Liu, Mailan; Zhang, Qian; Jiang, Shan; Liu, Mi; Zhang, Guoshan; Yue, Zenghui; Chen, Qin; Zhou, Jie; Zou, Yifan; Li, Dan; et al.

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.

Item Metadata

Title
Warm-needling acupuncture and medicinal cake-separated moxibustion for hyperlipidemia: study protocol for a randomized controlled trial
Creator
Liu, Mailan; Zhang, Qian; Jiang, Shan; Liu, Mi; Zhang, Guoshan; Yue, Zenghui; Chen, Qin; Zhou, Jie; Zou, Yifan; Li, Dan; Ma, Mingzhu; Dai, Guobin; Zhong, Huan; Wang, Zhihong; Chang, Xiaorong
Publisher
BioMed Central
Date Issued
2017-07-10
Description
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.
Subject
Hyperlipidemia; Acupuncture; Moxibustion; Warm-needling acupuncture; Medicinal cake-separated moxibustion; Traditional Chinese medicine; Randomized controlled trial
Genre
Article
Type
Text
Language
eng
Date Available
2017-07-10
Provider
Vancouver : University of British Columbia Library
Rights
Attribution 4.0 International (CC BY 4.0)
DOI
10.14288/1.0348753
URI
http://hdl.handle.net/2429/62193
Affiliation
Other UBC; Non UBC
Citation
Trials. 2017 Jul 10;18(1):310
Publisher DOI
10.1186/s13063-017-2029-x
Peer Review Status
Reviewed
Scholarly Level
Faculty
Copyright Holder
The Author(s).
Rights URI
http://creativecommons.org/licenses/by/4.0/
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Attribution 4.0 International (CC BY 4.0)