A randomized, double-blind, placebo-controlled trial to assess the essentiality of acid inhibitors for abdominal pain after gastroscopic mucosal biopsy

作者：Yang, Jie; Ling-Hu, En-Qiang^*; Li, Hui-Kai; Feng, Xiu-Xue; Zhang, You; Bu, Bao-Guo; Wu, Bei

来源：Turkish Journal of Gastroenterology, 2013, 24(3): 197-203.

DOI：10.4318/tjg.2013.0556

• Randomized controlled trial
• placebo
• gastroscopy
• mucosal biopsy
• abdominal pain
• treatment

Background/aims: Gastroscopy and gastroscopic mucosal biopsy techniques have become increasingly used as of late for evaluating symptoms presumed to be originated in the upper gastrointestinal tract. Patients often complain however of abdominal pain post-gastroscopic mucosal biopsy, and this study aimed to explore the necessity of acid inhibitors when abdominal pain worsened. Materials and Methods: In this randomized, double-blinded, placebo-controlled study, we screened 272 participants, and ultimately enrolled 200 into the study. These 200 participants were randomly assigned in a 1:1 ratio to receive acid inhibitors (esomeprazole, treatment group, n=100; dose, 20 mg/d) or matched placebo (control group, n=100) for 3 days post-gastroscopic mucosal biopsy. The presence of abdominal pain was observed pre-and post-gastroscopy, and the therapeutic effect of esomeprazole was assessed. This study was registered at the Chinese clinical trial registry as ChiCTR-TRC-00000500. Results: Ten subjects were lost to followup (4 in treatment group; 6 in the control group). There was no significant difference in, the number of subjects with aggravating abdominal pain (treatment 29.2% vs. control 22.3%; p>0.05) between the two groups. Esomeprazole did not significantly (p>0.05) affect the rate of abdominal pain within 24 h (treatment 27.1% vs. control 19.1%), 48 h (treatment 40.6% vs. control 27.7%), and 96 h (treatment 43.8% vs. control 34.0%) on abdominal pain in all in the evaluated subjects. Between the two groups however, a statistically significant difference (p<0.05) was found on overall effective treatment rates at 48 h (treatment 92.9% vs. control 66.7%) and at 96 h (treatment 100% vs. control 81%) in the subjects with worsened abdominal pain. Conclusions: The study suggests that routine prophylaxis with acid inhibitors is not recommended for all patients post-gastroscopic mucosal biopsy, however acid inhibitors should be administered for patients with aggravating abdominal pain.

• 出版日期2013
• 单位中国人民解放军总医院