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


CONCLUSIONS
Mosapride was safe and effective in improving the symptoms and gastric empty of functional dyspepsia.
Chen
Shi-yao
SY
Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Wang
Ji-yao
JY
Zhu
Chou-wen
CW
Yuan
Yao-zong
YZ
Zou
Bing
B
Xia
Lu
L
Liu
Ji-yong
JY
Xu
Hong-wei
HW
Zhang
Shang-zhong
SZ
Wang
Qing
Q
Xie
Xiang-jun
XJ
Zhao
Zhi-quan
ZQ
Lin
Lin
L
Hu
Nai-zhong
NZ
Xu
Jian-ming
JM
D000328:Adult; D001549:Benzamides / Q000009:adverse effects / Q000627:therapeutic use*; D004415:Dyspepsia / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D001549:Benzamides; D005765:Gastrointestinal Agents; D009025:Morpholines; C062720:mosapride