Department of Traditional Chinese Medicine, Beijing Friendship Hospital，Capital Medical University, Beijing, China.
Clinical Center for Metabolic Associated Fatty Liver Disease, Capital Medical University, Beijing, China.
BMJ Open. 2024 Nov 14;14(11):e084768. doi: 10.1136/bmjopen-2024-084768.
Metabolic dysfunction-associated fatty liver disease (MAFLD) is the most common chronic liver disease in the world and carries an increased risk of liver-related events, but no approved medicine. Electroacupuncture has been used to treat non-alcoholic fatty liver disease, but its effect was uncertain because of the poor quality of prior studies. We designed this trial to evaluate the efficacy and safety of electroacupuncture for MAFLD.
METHODS/DESIGN: This is a multicentre, randomised, sham acupuncture-controlled, patient-blinded clinical trial. Participants will take part in a total of 20 weeks of study, containing three phases: a 4-week run-in period, 12-week treatment (36 sessions of acupuncture) and 4-week follow-up. A total of 144 eligible patients diagnosed with MAFLD will be randomly allocated to the electroacupuncture or sham acupuncture groups. The primary outcome is the percentage of relative liver fat reduction on the MRI proton density fat fraction from baseline to 12 weeks. Secondary outcomes include magnetic resonance elastography, liver and metabolic biomarkers, anthropometry parameters, blinding assessment, credibility and expectancy, and adverse events. All patients who receive randomisation will be included in the intent-to-treat analysis.
The finding of this trial will provide evidence of the efficacy and safety of electroacupuncture for the treatment of MAFLD. The results of this study will be published in peer-reviewed journals.
www.chictr.org.cn, ChiCTR2200060353. It was registered on 29 May 2022.
代谢相关脂肪性肝病（MAFLD）是世界上最常见的慢性肝病，会增加肝脏相关事件的风险，但目前尚无获批的药物。电针对非酒精性脂肪性肝病的治疗已有应用，但由于先前研究质量较差，其疗效尚不确定。我们设计了这项试验来评估电针对 MAFLD 的疗效和安全性。
方法/设计：这是一项多中心、随机、假针刺对照、患者盲法临床试验。参与者将参加总共 20 周的研究，分为三个阶段：4 周的预试验期、12 周的治疗期（36 次针刺）和 4 周的随访期。共有 144 名符合 MAFLD 诊断标准的合格患者将被随机分配到电针或假针刺组。主要结局是 MRI 质子密度脂肪分数从基线到 12 周时的相对肝脂肪减少百分比。次要结局包括磁共振弹性成像、肝和代谢生物标志物、人体测量参数、盲法评估、可信度和期望以及不良事件。所有接受随机分组的患者都将纳入意向治疗分析。
该试验的结果将为电针对 MAFLD 治疗的疗效和安全性提供证据。该研究的结果将发表在同行评议的期刊上。
www.chictr.org.cn，ChiCTR2200060353。于 2022 年 5 月 29 日注册。
