OBJECTIVETo observe the therapeutic efficacy of Xiaopi-I on functional dyspepsia and its effects on gastric emptying.

METHODSA total of 134 patients with functional dyspepsia were randomly assigned to 2 groups. The patients in the Xiaopi-I group (66 cases) and the Domperidone group (68 cases) were given Xiaopi-I granules and Domperidone 10 mg, 3 times a day, respectively. Another 20 healthy volunteers were chosen as the negative control group. The severity scores of the symptoms, as well as the gastric emptying, were detected before and after 4-week treatment by barium strip-trial meal.

RESULTSDuring therapy, 6 cases from the Xiaopi-I group and 8 cases from the Domperidone group were lost to follow, and 120 cases finally finished the study. Statistical differences were observed from both groups in terms of the symptoms of postprandial fullness early satiety, epigastric pain, and epigastric burning after 4-week treatment (P<0.01). The symptomatic severity scores of the Xiaopi-I group before and after the treatment were 7.48±1.64 and 2.16±1.26, respectively (P<0.01). Gastric emptying rates were also improved in the patients with delayed gastric emptying, and the effective rates were 91.3% and 75.8% in the Xiaopi-I and Domperidone groups, respectively. No obvious adverse effects were found from both groups.

CONCLUSIONXiaopi-I was an effective and safe agent in the treatment of functional dyspepsia and was worth of further development in clinical.