Clinical study on the efficacy and safety of composite milk clotting enzyme capsules in children with functional dyspepsia

Objective To evaluate the efficacy and safety of composite milk clotting enzyme capsules in children with functional dyspepsia. Methods A multicenter, randomized, open-label clinical trial was carried out in 4 Guangzhou hospitals during Feb.2012 to Mar.2013.Children with functional dyspepsia on basis of Rome Ⅲ criteria were enrolled and treated with composite milk clotting enzyme capsules.Total symptom score and drug-related adverse reactions were evaluated after one-week and two-week therapy.The treatment outcome were divided into very effective, fairly effective and ineffective according to the symptom score changes.Superiority test was done for effectiveness of the treatment based on efficacy difference by 10% regarded as superiority. Results Two hundred and one children were enrolled.One hundred and ninety-six children completed the study as planned.After two-week therapy, better effective rate and total effective rate were 68.88% and 87.76%, higher than those of one-week therapy(27.04%, 76.02%)(U=2.935, P<0.05). The lower limits of 95% confidence interval of difference in symptoms improve rate, better efficacy rate and symptom score decrease rate between two-week and one-week therapy were more than 10%, and two-week therapy was superior to one-week therapy.No significant drug-related adverse reaction was found during the study. Conclusions Composite milk clotting enzyme capsules can improve functional dyspepsia symptoms significantly.The effectiveness of two-week of treatment is better than that of one-week treatment.No obvious drug-related adverse reaction is observed. Key words: Functional dyspepsia; Child; Composite milk clotting enzyme capsules; Fisher