Treatment of acute exacerbations of chronic obstructive pulmonary disease with acupuncture during hospitalization: a three-arm double-blinded randomized sham-controlled trial

住院期间采用针灸治疗慢性阻塞性肺疾病急性加重:一项三组双盲随机假对照试验

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Abstract

BACKGROUND: Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are a healthcare burden. Acupuncture improves dyspnea in patients with chronic obstructive pulmonary disease (COPD) but, to the best of our knowledge, has not been tested in AECOPD. Here, we evaluated the efficacy and safety of true acupuncture added to standard of care (SOC), as compared with both sham procedure plus SOC and SOC only, for the treatment of AECOPD among inpatients. METHODS: This double-blinded randomized sham-controlled trial was set in a tertiary hospital in Israel. Patients with a clinical diagnosis of AECOPD were assigned to true acupuncture with SOC, sham procedure with SOC or SOC only. The primary outcome was dyspnea improvement as measured daily by the validated modified Borg (mBorg) scale. Secondary outcomes included improvement of other patient-reported outcomes and physiologic features, as well as duration of hospitalization and treatment failure. Acupuncture-related side effects were evaluated by the validated Acup-AE questionnaire. RESULTS: Seventy-two patients were randomized: 26 to acupuncture treatment, 24 to sham and 22 to SOC only arms. Baseline characteristics were similar in the three groups. A statistically significant difference in dyspnea intensity was found from the first day of evaluation after treatment (p = 0.014) until day 3 after treatment. Similar results were found for sputum production, but no statistical significance was found when comparing physiologic features between the three arms. Acupuncture was not associated with adverse events. CONCLUSION: Acupuncture seems to be efficacious in the treatment of AECOPD among inpatients hospitalized in internal medicine departments. TRIAL REGISTRATION NUMBER: NCT03398213 (ClinicalTrials.gov).

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