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
Acupuncture and Tuina School, Hunan University of Chinese Medicine, 300 Xueshi Rd., Yuelu, 410208, Changsha, Hunan, China.
Rural Coordination Center of BC, Vancouver, BC, Canada.
Trials. 2017 Jul 10;18(1):310. doi: 10.1186/s13063-017-2029-x.
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.
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.
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.
ClinicalTrials.gov, NCT02269046 . Registered on 26 September 2014.
在中国临床实践中，针灸已广泛应用于高脂血症治疗，作为他汀类药物的替代疗法。温针和隔药饼灸在多项研究中分别报道了对高脂血症治疗的潜在疗效，但研究方法存在局限性。将这两种疗法结合可能为治疗高脂血症提供更具优势的策略。因此，有必要通过精心设计的随机对照试验（RCT）进行严格评估，以确定其对高脂血症的疗效和安全性。
本研究为多中心、开放标签、随机、分层、活性对照、非劣效性试验，分为两个平行组。高脂血症患者将根据心脏病风险水平分层分组。然后指导他们采用治疗性生活方式改变（TLC）饮食。未达到血脂目标水平的患者将以1:1的比例随机分配接受针灸或辛伐他汀治疗。计划招募130名受试者。本研究的干预持续时间为12周，随后进行4周的治疗后评估。主要结局是低密度脂蛋白胆固醇（LDL-C）从基线到研究结束时的百分比变化。还将次要评估血脂变化、安全性和依从性的其他指标。分析将采用重复测量线性混合效应模型。
针灸可能是治疗高脂血症的一种潜在有效替代疗法。通过将中医方案与标准化西医评估方法相结合，开展了一项精心设计的研究，以评估针灸联合治疗的疗效和安全性。
ClinicalTrials.gov，NCT02269046。于2014年9月26日注册。
