Refractory functional dyspepsia (RFD) is a condition characterized by continuous symptoms of discomfort in abdomen, bloating, belching, and nausea. Several guidelines recommend the use of neuromodulators, like imipramine, for the treatment of RFD, but there’s not much data to back the claim. The objective of this study is to assess the effects of low-dose imipramine for RFD.
This is a single-center, double-blind, randomized controlled trial that included a total of 107 patients with treatment-refractory functional dyspepsia, aged 18-80 years. The patients were randomly assigned in a 1:1 ratio to receive low-dose imipramine (25 mg/day for 2 weeks, then 50 mg) or placebo for 12 weeks. The primary outcome of the study was the overall relief from RFD at 12 weeks of follow-up.
Out of 107 patients, 55 were assigned to receive imipramine and 52 to placebo. At 12 weeks of follow-up, relief in RFD symptoms occurred in 35 patients (63.6%) in the imipramine group, compared with 19 (36.5%) in the placebo group. 10 patients (18%) in the imipramine group discontinued the study due to adverse events, like dry mouth, drowsiness, and constipation.
The research concluded that low-dose imipramine could be used as a therapy for patients with refractory functional dyspepsia.