BACKGROUND: The usefulness of nonsteroidal anti-inflammatory drugs (NSAIDs) is limited by adverse gastrointestinal tract events. OBJECTIVE: To identify the optimal antisecretory therapy for healing of gastric ulcer in patients using NSAIDs and the impact of concurrent Helicobacter pylori infection on ulcer healing. DESIGN: Prospective, double-blind, multicenter, parallel-group study. SETTING:Gastroenterology practices in ambulatory and referral center settings. PATIENTS: Three hundred fifty-three patients with an active, nonmalignant gastric ulcer at least 5 mm in diameter confirmed by endoscopy and biopsy and who continued to receive stable doses of NSAIDs. INTERVENTION: Patients were randomized to receive ranitidine hydrochloride, 150 mg twice daily, or lansoprazole, 15 mg or 30 mg once daily, for 8 weeks. MEASUREMENTS: Healing was assessed by endoscopy at 4 and 8 weeks in an intent-to-treat population. Helicobacter pylori status was assessed by histological examination. RESULTS: After 8 weeks of treatment, healing was observed in 61 (53%) of 115, 81 (69%) of 118, and 85 (73%) of 117 patients receiving ranitidine lansoprazole, 15 mg, and lansoprazole, 30 mg, respectively (P<.05 for ranitidine vs both lansoprazole doses; 95% confidence interval, 3.2-28.0 for ranitidine vs lansoprazole, 15 mg, and 7.4-31.8 for ranitidine vs lansoprazole, 30 mg). The gastric ulcer healing rates were similar between H pylori-infected and -noninfected patients, with a statistically significant increase with the use of lansoprazole vs ranitidine. CONCLUSIONS: In patients who require continuous treatment with NSAIDs, lansoprazole is superior to ranitidine for healing of NSAID-associated gastric ulcers. Healing is not delayed by the presence of H pylori infection.
RCT Entities:
BACKGROUND: The usefulness of nonsteroidal anti-inflammatory drugs (NSAIDs) is limited by adverse gastrointestinal tract events. OBJECTIVE: To identify the optimal antisecretory therapy for healing of gastric ulcer in patients using NSAIDs and the impact of concurrent Helicobacter pyloriinfection on ulcer healing. DESIGN: Prospective, double-blind, multicenter, parallel-group study. SETTING: Gastroenterology practices in ambulatory and referral center settings. PATIENTS: Three hundred fifty-three patients with an active, nonmalignant gastric ulcer at least 5 mm in diameter confirmed by endoscopy and biopsy and who continued to receive stable doses of NSAIDs. INTERVENTION: Patients were randomized to receive ranitidine hydrochloride, 150 mg twice daily, or lansoprazole, 15 mg or 30 mg once daily, for 8 weeks. MEASUREMENTS: Healing was assessed by endoscopy at 4 and 8 weeks in an intent-to-treat population. Helicobacter pylori status was assessed by histological examination. RESULTS: After 8 weeks of treatment, healing was observed in 61 (53%) of 115, 81 (69%) of 118, and 85 (73%) of 117 patients receiving ranitidine lansoprazole, 15 mg, and lansoprazole, 30 mg, respectively (P<.05 for ranitidine vs both lansoprazole doses; 95% confidence interval, 3.2-28.0 for ranitidine vs lansoprazole, 15 mg, and 7.4-31.8 for ranitidine vs lansoprazole, 30 mg). The gastric ulcer healing rates were similar between H pylori-infected and -noninfected patients, with a statistically significant increase with the use of lansoprazole vs ranitidine. CONCLUSIONS: In patients who require continuous treatment with NSAIDs, lansoprazole is superior to ranitidine for healing of NSAID-associated gastric ulcers. Healing is not delayed by the presence of H pylori infection.