Efficacy of electroacupuncture in the treatment of Acute Exacerbation of Chronic Obstructive Pulmonary disease: study protocol for a multicenter, randomized, sham-controlled trial.

Background: Chronic obstructive pulmonary disease (COPD) is one of the most common chronic respiratory diseases worldwide. Recurrent acute exacerbations severely impact patients' quality of life and impose a significant economic burden. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend acupuncture as an adjunctive therapy for patients with advanced COPD. However, evidence regarding its efficacy during the acute exacerbation phase remains insufficient, particularly from high-quality clinical trials. This study aims to evaluate the efficacy and safety of electroacupuncture in treating patients with acute exacerbation of COPD (AECOPD), establish a standardized electroacupuncture treatment protocol for AECOPD, and preliminarily explore the association between electroacupuncture and airway mucus hypersecretion. Methods: This is a multicenter, randomized, sham-controlled trial. A total of 336 eligible patients with AECOPD will be recruited and randomly allocated in a 1:1 ratio to either an electroacupuncture group or a sham acupuncture group. Participants will receive treatment once daily for 7 consecutive days and will then be followed up for 13 weeks. The primary outcome measure is the COPD Assessment Test (CAT). Secondary outcomes include the Cough and Sputum Assessment Questionnaire (CASA-Q), the modified Medical Research Council Dyspnea Scale (mMRC), clinical symptom and sign scores, the number of exacerbations, and arterial blood gas. All rating scales will be evaluated at baseline, 4 days after treatment, 7 days after treatment, 5 weeks of follow-up and 13 weeks of follow-up. Arterial blood gas analysis and alveolar lavage fluid collection will be performed at baseline and after 7 days of treatment. The number of acute exacerbations during the follow-up period will be recorded at 5 and 13 weeks of follow-up. Adverse events related to acupuncture will be recorded throughout the study period. Conclusion: This study will evaluate the efficacy and safety of electroacupuncture in treating patients with AECOPD, establish a standardized electroacupuncture treatment protocol for AECOPD, and preliminarily explore the association between electroacupuncture and airway mucus hypersecretion. Clinical trial registration: ClinicalTrials.gov [NCT06869525].