[Efficacy of compound digestive enzyme tablet for dyspeptic symptoms: a randomized double-blind parallel controlled multicenter clinical trial in China].

ABSTRACT

OBJECTIVE: To explore the clinical efficacy and safety of compound digestive enzyme tablet in the treatment of dyspepsia. METHODS: A randomized, double-blind, double-dummy, positive drug parallel controlled, multicenter clinical trial was conducted for 203 dyspeptic patients from October 2011 to August 2012. And they were randomized into group A (experimental, n = 106) and group B (control, n = 97).Group A received 1 tablet of compound digestive enzyme tablet (Bearse) plus 2 analog capsules of compound digestive enzyme thrice daily. And group B had 2 capsules of compound digestive enzyme capsule (Dages) plus 1 analog tablet of compound digestive enzyme thrice daily. The total duration of drug treatment was 2 weeks. There were 3 follow-up visits (W0, W1, W2). The primary endpoint was the total effective rate of all dyspeptic symptoms. RESULTS: The total efficacy rate of groups A and B were 80.2% (85/106) and 79.4% (77/97) (P > 0.05). The adverse effects were 1.9% (2/106) and 4.1% (4/97) in groups A and B (P > 0.05). The adverse effects were mild in both groups. CONCLUSIONS: Compound digestive enzyme tablet and capsule are effective and safe for patients with dyspepsia. And compound digestive enzymes tablet is comparable to compound digestive enzyme capsule.