Efficacy and safety of Aurantii Fructus Immaturus flavonoid Tablets vs. domperidone for functional dyspepsia: a multicenter, double-blind, double-dummy, randomized controlled phase III trial

Abstract

Background: The clinical management of functional dyspepsia (FD) is challenging. This study evaluated the efficacy and safety of Aurantii Fructus Immaturus flavonoid (AFIF) tablets vs. domperidone for FD. Methods: This multicenter, randomized, double-blind, doubledummy, positive-controlled trial recruited FD patients, who were randomized 1:1 to the AFIF (AFIF and domperidone placebo) and domperidone (domperidone and AFIF placebo) groups. The primary endpoint was the rate of disappearance of all four FD symptoms (postprandial feeling of fullness, early satiety, upper abdominal pain, and upper abdominal burning sensation) after 4 treatment weeks. Results: Totally 120 and 119 patients were included in the AFIF and domperidone groups, respectively. The rates of disappearance of all four symptoms after 4 treatment weeks were 28.33% and 31.93% in the AFIF and domperidone groups, respectively (p=0.5748). The rate of disappearance of all four symptoms 4 weeks after treatment discontinuation was significantly higher in the AFIF (21.05%) compared with the domperidone group (4.39%, p=0.0002). The gastric emptying rates 2h after a meal were significantly increased in both AFIF (7.58%, p<0.0001) and domperidone (6.95%, p=0.0121) groups versus baseline, without a significant between-group difference (p=0.8457). Twenty-two (1 moderate) and 43 (3 moderate) adverse events occurred in the AFIF (19.17%) and domperidone (36.13%) groups, respectively. Conclusion: The efficacy of AFIF tablets is similar to that of domperidone after 4 treatment weeks, while AFIF tablets may have a better safety profile than domperidone. Additionally, AFIF tablets have a significant advantage over domperidone in the rate of symptom disappearance 4 weeks after treatment discontinuation.