Acupuncture for dysphagia among patients with acute ischemic stroke: a randomized clinical trial

BACKGROUND: Acupuncture may be effective for post-stroke dysphagia (PSD) after acute ischemic stroke, but the evidence is limited. OBJECTIVE: To assess the effect of acupuncture for PSD after acute ischemic stroke. DESIGN: A multicentre, randomised, sham-controlled trial. (Chinese Clinical Trial Registry, ChiCTR1900028061). METHODS: This trial was conducted across 23 hospitals in China between August 4, 2020, and April 25, 2023. A total of 300 participants diagnosed with PSD following acute ischemic stroke and presenting with Functional Oral Intake Scale levels 2 to 4 were enrolled. They were randomly assigned to receive either verum acupuncture (VA) or sham acupuncture (SA), delivered in 10 sessions over 14 days. The primary outcome was the response rate at day 14, defined as the percentage of participants achieving a Functional Oral Intake Scale level ≥6. Ten Secondary outcomes included swallowing function, quality of life, patient-reported outcome, nutrition, and pneumonia. RESULTS: Of 300 eligible participants, 149 were randomly assigned to SA and 151 were randomly assigned to VA (1 did not diagnose ischemic stroke). At day 14, the VA group exhibited a higher response rate compared to the SA group (117 [78.0%] vs. 85 [57.0%], relative risk, 1.37 [95% CI, 1.16 to 1.61], P < 0.001). Four cases of treatment-related adverse events were reported in the VA group, and 3 were reported in the SA group. All events were mild and transient. CONCLUSIONS: Two weeks of VA demonstrated superior recovery of swallowing function compared to SA in patients with dysphagia after acute ischemic stroke.