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Research: LIU and COLLEAGUES,
Listed in Issue 266
Abstract
LIU and COLLEAGUES, 1. Acupuncture and Tuina School, Hunan University of Chinese Medicine, 300 Xueshi Rd., Yuelu, 410208, Changsha, Hunan, China; 2. Rural Coordination Center of BC, Vancouver, BC, Canada; 3. University of British Columbia, Vancouver, BC, Canada; 4. The Third Clinical College of Zhejiang Chinese Medical University, Hangzhou, China; 5. Changchun University of Chinese Medicine, 1035 Boshuo Rd., Jingyue Economic Development District, Changchun, 130117, Jilin Province, China. wzh6172555@126.com ;6. Acupuncture and Tuina School, Hunan University of Chinese Medicine, 300 Xueshi Rd., Yuelu, 410208, Changsha, Hunan, China. xiaorong_chang@126.com conducted a randomized controlled trial (RCT) to determine the efficacy and safety of combined acupuncture and moxibustion on hyperlipidemia.
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.
Methodology
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.
Results
Conclusion
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.
References
Liu M1, Zhang Q2, Jiang S3, Liu M1, Zhang G1, Yue Z1, Chen Q4, Zhou J4, Zou Y1, Li D1, Ma M1, Dai G1, Zhong H1, Wang Z5, Chang X6. Warm-needling acupuncture and medicinal cake-separated moxibustion for hyperlipidemia: study protocol for a randomized controlled trial. Trials. 18(1):310. doi: 10.1186/s13063-017-2029-x. Jul 10 2017.