Does nimesulide induce gastric mucosal damage? "A double-blind randomized placebo-controlled trial"

Abstract

Background/aims: In this study, it was aimed to examine the effect of nimesulide, a selective inhibitor of cox-2 enzyme, to the gastric mucosa and to correlate its effect with aspirin.

Methodology: This study was planned as double-blind, randomized and placebo-controlled. Mean age of voluntary persons (n = 32) was 42.3 +/- 2.7. Divided into 3 groups of volunteers were given randomized placebo (n = 10), aspirin (n = 10) (500 mg aspirin, Bayer) and nimesulide (n = 12) (100 mg mesulid, Pfizer) with 50 mL of water after 12 hours fasting period at 08.00 am. Gastroduodenoscopy was performed to the volunteers 3 hours after each therapy.

Results: Endoscopic scores of groups were; placebo: 0.20 +/- 0.13, aspirin: 2.8 +/- 0.46, nimesulide: 1.41 +/- 0.51. Lesion scores both in the aspirin group when compared with nimesulide and placebo groups (P < 0.00002, < 0.03), and in the nimesulide group when compared with the placebo group (P < 0.01) were significantly high. The positivity of Helicobacter pylori of groups was found; 67% in placebo, 72% in aspirin, 71% in nimesulide and there was no statistically significant difference in the groups.

Conclusions: It was shown that nimesulide causes significantly serious gastric mucosal lesion when compared with placebo. The lesion score of nimesulide was found less than aspirin. According to the findings, nimesulide should be given carefully just as other analgesics due to the probability of causing gastric lesion.