1. Electroacupuncture plus on-demand gastrocaine for refractory functional dyspepsia: Pragmatic randomized trial.
- Author
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Chung VC, Wong CH, Wu IX, Ching JY, Cheung WK, Yip BH, Chan KL, Cheong PK, and Wu JC
- Subjects
- Adult, Aluminum Hydroxide administration & dosage, Aminobenzoates administration & dosage, Atropine administration & dosage, Combined Modality Therapy, Drug Administration Schedule, Drug Combinations, Electroacupuncture adverse effects, Female, Humans, Magnesium Compounds administration & dosage, Male, Middle Aged, Prospective Studies, Single-Blind Method, Treatment Outcome, Aluminum Hydroxide therapeutic use, Aminobenzoates therapeutic use, Atropine therapeutic use, Dyspepsia drug therapy, Electroacupuncture methods, Magnesium Compounds therapeutic use
- Abstract
Background and Aim: Treatment options for functional dyspepsia (FD) refractory to pharmacological treatments are limited but the effectiveness of electroacupuncture (EA) is uncertain. We assessed the effectiveness of EA combined with on-demand gastrocaine., Methods: We conducted a single-center, assessor-blind, randomized parallel-group 2-arm trial on Helicobacter pylori negative FD patients of the postprandial distress syndrome subtype refractory to proton pump inhibitor, prokinetics, or H
2 antagonists. Enrolled participants were block randomized in a 1:1 ratio, with concealed random sequence. The treatment and control groups both received on-demand gastrocaine for 12 weeks, but only those in treatment group were offered 20 sessions of EA over 10 weeks. The primary endpoint was the between-group difference in proportion of patients achieving adequate relief of symptoms at week 12., Results: Of 132 participants randomly assigned to EA plus on-demand gastrocaine (n = 66) or on-demand gastrocaine alone (n = 66), 125 (94.7%) completed all follow-up at 12 weeks. The EA group had a compliance rate 97.7%. They had a significantly higher likelihood in achieving adequate symptom relief at 12 weeks, with a clinically relevant number needed to treat (NNT) value of 2.36 (95% CI: 1.74, 3.64). Among secondary outcomes, statistically and clinically significant improvements were observed among global symptom (NNT = 3.85 [95% CI: 2.63, 7.69]); postprandial fullness and early satiation (NNT = 5.00 [95% CI: 2.86, 25.00]); as well as epigastric pain, epigastric burning, and postprandial nausea (NNT = 4.17 [95% CI: 2.56, 11.11]). Adverse events were minimal and nonsignificant., Conclusion: For refractory FD, EA provides significant, clinically relevant symptom relief when added to on-demand gastrocaine (ChiCTR-IPC-15007109)., (© 2019 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)- Published
- 2019
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