Efficacy and safety of electroacupuncture for metabolic dysfunction-associated fatty liver disease: a study protocol for a multicentre, randomised, sham acupuncture-controlled, patient-blinded clinical trial.

BACKGROUND: 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.

DISCUSSION: 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.

TRIAL REGISTRATION NUMBER: www.chictr.org.cn, ChiCTR2200060353. It was registered on 29 May 2022.