METHODS: A double-blinded randomized controlled trial involving 348 subjects was conducted at a tertiary hospital to evaluate the success rate of OGDS with Acu-TENS. Subjects aged 18-75 years scheduled for their first elective diagnostic OGDS were randomized into the intervention (Acu-TENS) and placebo arms. OGDS success was assessed based on subjects' satisfaction ratings on a Likert scale and procedure's technical adequacy. Secondary measures included subjects' willingness to undergo future OGDS under similar conditions, procedure duration, and the endoscopist's perceived ease of the procedure.
RESULTS: OGDS success rates were significantly higher with Acu-TENS (77.8%) than with the placebo (68.0%; odds ratio [OR] 1.64, 95% confidence interval [CI] 1.01-2.66, p = 0.043). Subjects who received Acu-TENS expressed higher willingness for future OGDS (78.9%) than those who received the placebo (68.6%; OR 1.71, 95% CI 1.04-2.79, p = 0.031). Procedure duration were significantly shorter in the intervention arm (6.0 min) than in the placebo arm (10.0 min; p = 0.002). No adverse effects were reported, and endoscopists perceived similar procedure ease in both arms.
CONCLUSIONS: Acu-TENS improved OGDS success and enhanced patients' experiences during non-sedated OGDS. It demonstrated safety with no side effects and reduced the procedure completion time. It could be used as an adjunct in non-sedated diagnostic OGDS.