Warm-needling acupuncture and medicinal cake-separated moxibustion for hyperlipidemia: study protocol for a randomized controlled trial

Mailan Liu, Qian Zhang, Shan Jiang, Mi Liu, Guoshan Zhang, Zenghui Yue, Qin Chen, Jie Zhou, Yifan Zou, Dan Li, Mingzhu Ma, Guobin Dai, Huan Zhong, Zhihong Wang, Xiaorong Chang, Mailan Liu, Qian Zhang, Shan Jiang, Mi Liu, Guoshan Zhang, Zenghui Yue, Qin Chen, Jie Zhou, Yifan Zou, Dan Li, Mingzhu Ma, Guobin Dai, Huan Zhong, Zhihong Wang, Xiaorong Chang

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.

Keywords: Acupuncture; Hyperlipidemia; Medicinal cake-separated moxibustion; Moxibustion; Randomized controlled trial; Traditional Chinese medicine; Warm-needling acupuncture.

Figures

Fig. 1
Fig. 1
SPIRIT Figure for schedule of enrolment, interventions, and assessments of the AMHRCTstudy
Fig. 2
Fig. 2
Treatment regimen flowchart. This figure demonstrates the treatment regimen and flowchart for intervention of warm needling and medicinal cake-separated moxibustion
Fig. 3
Fig. 3
Trial flowchart. This figure provides an overview of participant flow in this trial

References

    1. Reiner Z. Statins in the primary prevention of cardiovascular disease. Nat Rev Cardiol. 2013;10:453–464. doi: 10.1038/nrcardio.2013.80.
    1. Taylor F, Huffman MD, Macedo AF, et al. Statins for the primary prevention of cardiovascular disease, The Cochrane Library. 2013.
    1. Farnier M, Davignon J. Current and future treatment of hyperlipidemia: the role of statins. Am J Cardiol. 1998;82:3J–10J. doi: 10.1016/S0002-9149(98)00423-8.
    1. Feingold K. Statin therapy in hyperlipidemia: balancing the risk and benefits. 2014.
    1. 张宝珍, 张凯, 刘玉珍. 针灸丰隆治疗高脂血症临床随机对照试验 Meta 分析. 中国中医药信息杂志 2014;21:11-15.
    1. 马明云. 温和灸影响高脂血症患者微循环的临床研究: 南京: 南京中医药大学; 2013.
    1. 许辛寅. 艾灸足三里丰隆对高脂血症模型大鼠干预及临床验证研究: 广州: 广州中医药大学; 2012.
    1. 蒋月琴. 温针灸足三里对高脂血症血脂指标的影响分析. 医学理论与实践 2016;29:3226-3228.
    1. Xiaorong C, Jie Y, Zenghui Y, et al. Effects of medicinal cake-separated moxibustion on plasma 6-keto-PGF1alpha and TXB2 contents in the rabbit of hyperlipemia. J Tradit Chin Med. 2005;25:145–147.
    1. Yue Z-H, He X-Q, Chang X-R, et al. The effect of herb-partition moxibustion on Toll-like receptor 4 in rabbit aorta during atherosclerosis. J Acupunct Meridian Stud. 2012;5:72–79. doi: 10.1016/j.jams.2012.01.005.
    1. Liu M, Hu WH, Xie S, et al. Characteristics of acupoint and meridian selection in acupuncture for hyperlipidemia (Chinese) Chin Acupunct Moxibustion. 2015;35:512–516.
    1. 李光华. 针灸治疗高脂血症的效果分析. 中西医结合心血管病电子杂志. 2016;20.
    1. 陈仲杰. 高脂血症 “温灸和之” 有效性及不同灸治时程对调脂效应的影响: 万方数据资源系统; 2012.
    1. 刘未艾, 常小荣, 刘密, et al. 不同灸量隔药饼灸对高脂血症患者血脂及血液流变学的影响. 辽宁中医杂志 2013;9:1787–1790.
    1. 常小荣, 严洁, 易受乡, et al. 隔药饼灸治疗血脂异常的临床研究. 中华中医药学刊 2010:8–10.
    1. 李爱军. 隔药饼灸治疗高脂血症的临床研究. 广西中医药 2007;30:12–13.
    1. Liu W, Chang X, Liu M, et al. Effects of herbal-cake-separated-moxibustion sized cones at different dosages on blood fat and hemorheology in patients with hyperlipemia. Liaoning Chin Med J. 2013;40:1787–1790.
    1. Liu M, Chen X, Lu X, et al. Systematic review of acupuncture treatment effects on patients with hyperlipidemia. J Hunan Univ Chin Med. 2014;12:015.
    1. Smith SC, Grundy SM. 2013 ACC/AHA guideline recommends fixed-dose strategies instead of targeted goals to lower blood cholesterol. J Am Coll Cardiol. 2014;64:601–612. doi: 10.1016/j.jacc.2014.06.1159.
    1. Program RotNCE. Detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). In: National Institutes of Health; 2001.
    1. NCEPNE Panel Third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III) final report. Circulation. 2002;106:3143.
    1. Cox EE, Ghali WA, Hébert P, et al. Patient safety: a fundamental aspect of clinical trials through a review of a study on Canadian adverse events. Elite Team of Editorial Members . 2014;170:103.
    1. Chang X, Zhou G, Yan J, et al. Effects of cake-separated moxibustion on HDL-C LDL-C of patients with hyperlipidemia (Chinese) Chin J Basic Med Tradit Chin Med. 1999;5:53–55.

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