Empirical treatment of outpatients with gastroesophageal reflux disease with proton pump inhibitors: A survey of Chinese patients (the ENLIGHT Study)

Background and AimEmpirical proton pump inhibitor (PPI) treatment is recommended as a diagnostic indicator for gastroesophageal reflux disease (GERD) and as a therapy for symptomatic control, with responses generally seen within 4weeks. However, there are no real-world data assessing the effectiveness of short-term empirical treatment with PPIs in patients with GERD in China. MethodsThe ENLIGHT study was a multicenter, prospective, observational study conducted in China. The primary outcome was the overall response rate after 4weeks' empirical treatment with PPIs. Adult patients aged between 18 and 65years of age, with a gastroesophageal reflux disease questionnaire score of 8, prescribed empirical PPI treatment by their physicians and with no planned endoscopy were eligible to participate. Statistical analyses were primarily descriptive. ResultsOverall, 987 patients were eligible to participate and were included in the full analysis set (FAS); 707 patients were included in the per protocol set. In the FAS, esomeprazole was received by 57.1% of patients and was the most commonly used PPI. After 4-week treatment, 71.1% (95% confidence interval [CI], 67.9% to 74.2%) of patients were considered responders to PPI. The response rate at the end of 2-week PPI treatment reached 57.0% (95% CI, 52.5% to 61.7%). The median time to response was 13days (95% CI, 12 to 15). Response rates at 2 and 4weeks of the per protocol set were similar to those of the FAS. ConclusionsShort-term empirical PPI treatment can provide an effective relief of GERD symptoms in most Chinese patients in real-world practice.