[Efficacy and safety of compound azintamide on dyspepsia symptoms in a multicentre self-controlled trial]

Objective: To investigate the efficacy and safety of compound azintamide on dyspepsia symptoms.

Methods: One hundred and eighty dyspepsia patients were divided into two groups according to dyspepsia symptom related with gastrointestinal disease (group A) or biliary system disease (group B), whose dyspepsia symptom were not improved by the Domperidone 10 mg tid for 2 weeks. Two tablets of compound azintamide were administered orally following a meal, tid for 2 weeks. The changes of symptoms score of upper abdominal distention, upper abdominal pain or discomfort anorexia and effective rate as well as adverse events were recorded.

Results: Compound azintamide greatly improved the symptoms of upper abdominal distention, upper abdominal pain or discomfort and anorexia. All symptoms scores were significantly decreased after 2 weeks of compound azintamide (P < 0.01). The effective rate of each symptom and total symptoms score were more than 84.9% and 92.5%. One patient reported mild rash at the fourteenth days, which disappeared 3 days later.

Conclusion: Compound azintamide showed effective and safety in treatment of patient with dyspepsia symptoms when Domperidone therapy is not satisfactory.