Effect of tadospirone citrate on symptom resolution of patients with functional dyspepsia - A double-blind placebo-controlled trial - Effect of Tandospirone Citrate for FD patients

Objective: Functional dyspepsia is a common condition in the general population, however its treatment remains a challenge. The aim of this study was to examine the efficacy of tandospirone citrate, a new partial agonist of the 5-HT1A receptor, in improving the symptoms of patients with functional dyspepsia (FD). Methods: In this double-blind, placebo-controlled, multicenter study, FD patients were randomized treatment with 10 mg tid tandospirone citrate or placebo for 4 weeks. The primary endpoint was change in abdominal symptom scores. The difference in proportion of responders (a total abdominal symptom score of 0 or 1) was also assessed. The quality of life questionnaire, the SF-8 and a psychological test questionnaire, the State-Trait Anxiety Inventory (STAI) were completed at baseline and weekly intervals. Results: Data were available on 144 patients: 73 for tandospirone and 71 for placebo. Improvements in total abdominal scores were significantly larger with tandospirone than placebo at week 1, 2 and 4. Significantly greater improvements in the tandospirone group were observed in upper abdominal pain (p = 0.02) and discomfort (p =0.002) at week 4. The proportion of responders was significantly greater in the active treatment arm at week 3 (p=0.017) and 4 (p = 0.0016). Significant improvements in STAI (p < 0.0001) were reported in both arms as well as in the majority of questions in the SF-8 (p = 0.04). No serious adverse events were reported, with similar rates in both study arms. Conclusions: Despite a considerable placebo effect, the benefits of tandospirone were demonstrated in terms of improvement in abdominal symptom scores.