A Randomized Double-blind Comparative Study of the Efficacy of Eradication Therapy and Motilitone for Functional Dyspepsia

Background/Aims Helicobacter pylori (H. pylori) infection is one of the etiologies of functional dyspepsia (FD). The aim of this study was to compare the efficacy of H. pylori eradication therapy and motilitone monotherapy in patients with FD. Materials and Methods We prospectively performed a multicenter randomized double-blind study between August 2014 and June 2017. FD patients with H. pylori infection randomly received either the standard triple therapy or motilitone. Global and individual symptom improvements, and changes in quality of life score were assessed. Results We failed to enroll as many candidates as we had planned. A study to evaluate the efficacy of medications in FD patients according to the Rome III criteria is difficult to perform in Korea because of the early medication therapy at local hospitals and reluctance to discontinue digestive medications. Of the 35 patients enrolled, 30 (18 in the H. pylori eradication group and 12 in the motilitone group) completed the trial. The success rate of H. pylori eradication was 44.4% (8/18). The symptom improvement rate using the 7-point Likert scale at week 12 was 66.7% (12/18) in the H. pylori eradication group and 91.7% (11/12) in the motilitone group (P=0.193). At week 12, the symptom improvement rate was not significantly different between the patients with successful eradication (87.5%, 7/8) and those in the motilitone group (91.7%, 11/12; P=1.000). Conclusions Eradication therapy could be an effective treatment for H. pylori-positive FD. However, our results should be cautiously interpreted, as we failed to recruit the intended number of subjects.