Electroacupuncture for patients with refractory functional dyspepsia: A randomized controlled trial

Abstract

Background: To test the efficacy of electroacupuncture for patients with refractory functional dyspepsia (FD). Methods: A 24-week, 2-arm, single-blind, randomized controlled trial was conducted at three hospitals in China. Patients with refractory FD were randomly assigned to receive 20 sessions of authentic or sham electroacupuncture in a treatment duration of 4 weeks. The primary outcome was complete absence of dyspeptic symptoms at 16 weeks after initiation of acupuncture (week 16). The secondary outcomes included adequate relief of dyspeptic symptoms, Leeds Dyspepsia Questionnaire (LDQ), Nepean Dyspepsia Index (NDI), and adverse events. Intention-to-treat analysis was performed. Key Results: Two hundred patients were included, of which 196 (98%) completed follow-up data at week 24. At week 16, 17 (17%) patients in the authentic electroacupuncture group vs 6 (6%) patients in the sham group achieved the primary outcome (P =.014). Sixty-two (62%) patients had adequate relief in the authentic electroacupuncture group, as compared to 22 (22%) in the sham group (P =.001). The scores of LDQ and NDI were significantly improved in both groups at week 16, and patients in the authentic electroacupuncture group have more improvements (LDQ, mean difference, −2.2, 95% confidence interval, −2.3 to −2.1, P