Published online Jun 14, 2015. doi: 10.3748/wjg.v21.i22.6965
Peer-review started: October 28, 2014
First decision: December 26, 2014
Revised: January 19, 2015
Accepted: February 11, 2015
Article in press: February 11, 2015
Published online: June 14, 2015
Processing time: 233 Days and 13.7 Hours
AIM: To compare symptom control with esomeprazole regimens for non-erosive reflux disease and chronic gastritis in patients with a negative endoscopy.
METHODS: This randomized, open-label study was designed in line with clinical practice in China. Patients with typical reflux symptoms for ≥ 3 mo and a negative endoscopy who had a Gastroesophageal Reflux Disease Questionnaire score ≥ 8 were randomized to initial treatment with esomeprazole 20 mg once daily either for 8 wk or for 2 wk. Patients with symptom relief could enter another 24 wk of maintenance/on-demand treatment, where further courses of esomeprazole 20 mg once daily were given if symptoms recurred. The primary endpoint was the symptom control rate at week 24 of the maintenance/on-demand treatment period. Secondary endpoints were symptom relief rate, success rate (defined as patients who had symptom relief after initial treatment and after 24 wk of maintenance treatment), time-to-first-relapse and satisfaction rate.
RESULTS: Based on the data collected in the modified intention-to-treat population (MITT; patients in the ITT population with symptom relief after initial esomeprazole treatment, n = 262), the symptom control rate showed a small but statistically significant difference in favor of the 8-wk regimen (94.9% vs 87.3%, P = 0.0473). Among the secondary endpoints, based on the data collected in the ITT population (n = 305), the 8-wk group presented marginally better results in symptom relief after initial esomeprazole treatment (88.3% vs 83.4%, P = 0.2513) and success rate over the whole study (83.8% vs 72.8%, P = 0.0258). The 8-wk regimen was found to provide a 46% reduction in risk of relapse vs the 2-wk regimen (HR = 0.543; 95%CI: 0.388-0.761). In addition, fewer unscheduled visits and higher patient satisfaction supported the therapeutic benefits of the 8-wk regimen over the 2-wk regimen. Safety was comparable between the two groups, with both regimens being well tolerated.
CONCLUSION: Chinese patients diagnosed with chronic gastritis achieved marginally better control of reflux symptoms with an 8-wk vs a 2-wk esomeprazole regimen, with a similar safety profile.
Core tip: In China, physicians tend to perform endoscopies on patients presenting with typical symptoms of gastro-esophageal reflux disease, such as reflux or heartburn. If endoscopy findings are negative, patients are usually diagnosed with chronic gastritis rather than non-erosive reflux disease (NERD) and treated with a 2-wk course of proton pump inhibitors (PPIs). We compared symptom control rates when patients were treated with a 2-wk course of PPIs vs an 8-wk course, as recommended for patients with NERD. In this multicenter, randomized, open-label study, the 8-wk PPI regimen provided marginally better symptom control and relief rates than the 2-wk regimen, with a similar safety profile.