A pilot study comparing the initial clinical response to different proton pump inhibitors within first week in treating erosive esophagitis

Abstract

Gastroesophageal reflux disease (GERD) characterized by heartburn and/or acid regurgitation symptoms is one of the most common gastrointestinal disorders. The rapid onset of proton pump inhibitors (PPIs) to improve annoying symptom is an essential need in treating GERD. There was no report about the short‐term clinical effects comparing lansoprazole 30 mg to rabeprazole 20 mg. This pilot study was designed to compare the initial one‐week clinical response of the two drugs in GERD with erosive esophagitis. Total 44 patients with GERD were enrolled in this study and randomized into two groups. The patients had the symptoms of acid regurgitation, heartburn, or feeling of acidity in the stomach and erosive esophagitis proven by endoscopy. They respectively received once‐daily dose of lansoprazole 30 mg (n = 23) and rabeprazole 20 mg (n = 21) for treatment of GERD. The primary end point was complete symptom resolution (CSR). The CSR rate was evaluated by questionnaire including acid regurgitation, heartburn sensation and epigastric pain at day 1, 3 and 7. Two patients in the arm of rabeprazole had poor compliance of drugs and were excluded from analysis. The final patient numbers were 23 in the arm of lansoprazole and 19 in rabeprazole. The baseline characteristics of two groups were similar in age, gender, body mass index (BMI), Helicobacter pylori infection, GERD severity, smoking, alcohol, coffee, spicy, sweet food and laboratory data. The ingestion of tea was the only one variable with significant difference between the two groups (65.2% and 31.58%, p = .03). At day 1, 3 and 7, the CSR rate of lansoprazole and rabeprazole were 21.74% and 26.32% (p = 1.000), 34.78% and 31.58% (p = .827), 47.83% and 47.37% (p = .976), respectively. The other clinical factors, including age, gender, BMI, Helicobacter pylori infection, smoking, alcohol, coffee, tea, spicy, sweet food and laboratory data, have also no significant influence on CSR rates at day 1, 3, 7. However, the patients with GERD C and D had significantly higher CSR rate than patients with GERD A and B at day 1 and 7 (CSR rate at day 1: 50.00% vs. 15.63, p = .040; day 3: 60.00% vs. 25.00%, p = .059; day 7: 90.00% vs. 34.38%, p = .003). In multivariate regression analysis, the patients with GERD C and D still had significantly higher CSR rate than patients with GERD A and B at day 7 (Odds ratio: 28.27, 95% CI: 2.10–380.03, p = .012). The CSR rates between lansoprazole group and rabeprazole group at day 1, 3, 7 were not significantly different, so the difference of PPIs did not play the role on the initial clinical response within 1 week for the erosive GERD patients. However, the patients with more severe erosive GERD on endoscopy had higher CSR rate at day 7.