A randomized controlled Multi-center clinical trial on mosapride in the treatment of functional dyspepsia

Shi yao Chen, Ji yao Wang, Chou wen Zhu, Yao zong Yuan, Bing Zou, L. Xia, Ji yong Liu, Hong wei Xu, Shang zhong Zhang, Qing Wang, Xiang jun Xie, Zhi quan Zhao, Lin Lin, Nai zhong Hu, Jian ming Xu

Research output: Contribution to journalArticlepeer-review

Abstract

OBJECTIVE: To evaluate the effectiveness and safety of mosapride on treatment of functional dyspepsia. METHODS: Randomized controlled clinical trial was conducted and patients suffered from functional dyspepsia were included. 5 mg mosapride was given three times daily for 4 weeks in the treatment group. 10 mg domperidone was given three times daily for 4 weeks as control. Changes on symptom score, gastric empty or new occurring events were included as outcomes. RESULTS: 231 patients suffered from functional dyspepsia were selected by inclusion and exclusion criteria from August 15 to Oct 22, 1999. Of these, 108 (46.8%) were males, versus 123 (53.2%) females and 118 (51.2%) in the treatment group and 113 (48.9%) as controls. 222 (96.1%) patients were followed up. Results showed that the total efficacy rates in early satiety and abdominal distension were 84.5% and 90.1% in mosapride after the 2 weeks of treatment. Mosapride seemed to be more effective in improving symptoms of belching and heartburn than that in controls (P < 0.05). In 4 weeks, the total efficacy in improving symptoms of abdominal distention and belching showed more effective in mosapride than that in controls (P < 0.05). Decrease of symptoms score was more in mosapride than that in controls (P < 0.05). Mosapride was less effective in controls in improving the gastric empty in terms of proportion (46.2% vs. 25.9%, P = 0.020) and range (46.2% vs. 24.0%, P = 0.003). Side effects would include diarrhea, constipation, headache, dizziness, insomnia, skin scare and the like. There was no significant difference between the two groups (9.6% in mosapride vs. 14.0% in controls). CONCLUSION: Mosapride was safe and effective in improving the symptoms and gastric empty of functional dyspepsia.

Original languageEnglish (US)
Pages (from-to)165-168
Number of pages4
JournalZhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi
Volume25
Issue number2
StatePublished - Feb 2004

ASJC Scopus subject areas

  • Medicine(all)

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