BACKGROUND: Traditionally, proton pump inhibitors are used primarily for patients with esophagitis. However, patients with nonerosive reflux disease may also benefit from these powerful medications. OBJECTIVE: To compare the safety and symptom relief efficacy of lansoprazole with ranitidine therapy and with placebo. METHODS: In 2 randomized, double-blind, multicenter trials of 901 patients with symptomatic reflux disease, which was confirmed by endoscopy to be nonerosive, receivedlansoprazole, 15 or 30 mg once daily; ranitidine, 150 mg twice daily; or placebo for 8 weeks. RESULTS: Analysis of daily diary data during the first 4 weeks and for the entire 8 weeks of treatment revealed that patients who were treated with either dosage of lansoprazole reported significantly (P<.05) lower percentages of days and nights with heartburn, less pain severity of both day and night heartburn, fewer days of antacid use, and smaller amounts of antacid use compared with patients who were treated with ranitidine or placebo. The incidence of possible or probable treatment-related adverse reactions was comparable among the treatment groups; abdominal pain and diarrhea were the most commonly reported adverse events. No statistically significant differences were noted between treatment groups in laboratory analyses. CONCLUSION:Lansoprazole therapy is more effective than standard dosages of ranitidine or placebo in relieving symptoms in patients with endoscopically confirmed non-erosive reflux esophagitis.
RCT Entities:
BACKGROUND: Traditionally, proton pump inhibitors are used primarily for patients with esophagitis. However, patients with nonerosive reflux disease may also benefit from these powerful medications. OBJECTIVE: To compare the safety and symptom relief efficacy of lansoprazole with ranitidine therapy and with placebo. METHODS: In 2 randomized, double-blind, multicenter trials of 901 patients with symptomatic reflux disease, which was confirmed by endoscopy to be nonerosive, received lansoprazole, 15 or 30 mg once daily; ranitidine, 150 mg twice daily; or placebo for 8 weeks. RESULTS: Analysis of daily diary data during the first 4 weeks and for the entire 8 weeks of treatment revealed that patients who were treated with either dosage of lansoprazole reported significantly (P<.05) lower percentages of days and nights with heartburn, less pain severity of both day and night heartburn, fewer days of antacid use, and smaller amounts of antacid use compared with patients who were treated with ranitidine or placebo. The incidence of possible or probable treatment-related adverse reactions was comparable among the treatment groups; abdominal pain and diarrhea were the most commonly reported adverse events. No statistically significant differences were noted between treatment groups in laboratory analyses. CONCLUSION:Lansoprazole therapy is more effective than standard dosages of ranitidine or placebo in relieving symptoms in patients with endoscopically confirmed non-erosive reflux esophagitis.