IDDF2019-ABS-0118 Electroacupuncture plus on-demand gastrocaine for refractory functional dyspepsia: pragmatic randomized trial

Abstract

Background Treatment options for functional dyspepsia (FD) refractory to pharmacological treatments are limited, but the effectiveness of electroacupuncture (EA) is uncertain. Our aim was to assess the effectiveness of EA combined with on-demand gastrocaine. Methods We conducted a single-centre, assessor-blind, randomized parallel-group 2-arm trial on H. pylori negative FD patients of the postprandial distress syndrome (PDS) subtype refractory to proton pump inhibitor, prokinetics or H2 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 the 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 non-significant. Conclusions For refractory FD, EA provides significant, clinically relevant symptom relief when added to on-demand gastrocaine. (ChiCTR-IPC-15007109)