Randomized clinical trial: the effects of mirtazapine in functional dyspepsia patients.

Background: Functional dyspepsia (FD) is one of the most common gastrointestinal disorders worldwide. Currently, anti-gastric drugs, gastric acid inhibitors, prokinetic drugs, and mucosal protective drugs are widely used in FD patients, however, only a small proportion of patients benefit from these drugs. Studies reported mirtazapine may improve symptoms of FD patients but the efficacy and safety of mirtazapine in the treatment of FD is unclear. Objectives: To investigate the efficacy and safety of mirtazapine in FD patients. Design: We performed a prospective, single-randomized, two-group parallel clinical trial involving 120 FD patients with poor traditional drug treatment outcomes to evaluate the efficacy and safety of mirtazapine. Methods: Qualified patients identified through the screening assessments were randomly divided into two groups: mirtazapine group ( Results: At the end of 8-week treatment, dyspeptic symptoms in the mirtazapine group were significantly relieved compared with the baseline (7.95 ± 1.86 vs 11.17 ± 2.14, Conclusion: Compared with control group, 8-week administration of mirtazapine significantly improved the overall severity of symptoms of dyspepsia (such as individual symptoms of postprandial fullness, early satiation, nausea, and vomiting), gastrointestinal-specific anxiety, quality of life, and increased weight in FD patients. This study provided clues to clinicians that mirtazapine may be a good choice for the treatment of FD patients. Trial registration: This study was registered in the Chinese clinical trial registry (https://www.chictr.org.cn/index.html, protocol No. ChiCTR2100048304).