Efficacy and safety of Minilase-s on patients with dyspepsia: a randomized placebo-controlled double blind multicenter clinical trial / 中华消化杂志

ABSTRACT

Objective To investigate the efficacy and safety of Minilase-S on patients with dyspepsia.Methods A randomized,placebo-controlled,double blind and multicenter study was conducted.Two hundred and forty patients with dyspepsia symptoms(anorexia,fullness,abdominal discomfort and distension)were collected according to total symptom scores over 20 with visual analog scales.Each patient was randomly received either Minilase-S(2 capsules t.i.d)or placebo(2 capsules t.i.d)for 2 weeks.The symptoms scores were evaluated at treatment week 1,week 2,and 1 week after discontinued therapy.Results Two hundred and sixteen patients(105 patients in Minilase group and 111 patients in placebo group)finished the study.There was no difference in demographic data,anorexia,fullness,discomfort and distension score and the total symptom score between two groups.However,at treatment week 1,week 2 and 1 week after discontinued therapy,symptoms and total symptom score were significantly decreased in Minilase-S group compared to placebo group(all P value＜0.05).The total effective rates in treatment week 1,week 2 and 1 week after discontinued therapy were 64.76%,77.05%and 66.99%,respectinely,which were higer that those in placebo group(27.93%,37.84% and 29.36%,respectively)(P＜0.05).There was no severe side effects in both Minilase-S and placebo groups.Conclusions Minilase-S can significantly improve symptoms in patients with dyspepsia,which may be as one choice in the management of dyspepsia or in combined therapy.