BACKGROUND:Nonsteroidal anti-inflammatory drugs (NSAIDs) cause a high frequency of mucosal injuries in the small intestine. However, no reliable intervention, other than cessation of NSAIDs, has been established. OBJECTIVE: To evaluate whether irsogladine maleate reduces these injuries while continuing NSAID therapy. DESIGN: Prospective, interventional, endoscopist-blinded, randomized, controlled trial (RCT). SETTING:University hospital. PATIENTS: Patients regularly taking conventional NSAIDs for more than 4 weeks. INTERVENTIONS: We initially examined small-intestinal mucosal injuries by capsule endoscopy (CE) and screened participants for the RCT. In the RCT, patients with any mucosal injury were randomly assigned to the irsogladine group (4 mg/day) or the control group. MAIN OUTCOME MEASUREMENTS: The primary endpoint was the rate of mucosal injury improvement after 4 weeks of treatment monitored with a second CE. RESULTS: Sixty-one patients were evaluated with the first CE. Small intestine mucosal injuries were found in 41 patients (67.2%) and erosive or ulcerative lesions in 21 patients (34.4%). The injury prevalence was not different with gastroprotective drug treatment. Of 41 patients enrolled, 39 (19 patients in the irsogladine group and 20 in the control group) completed the study. The improvement rate was significantly higher in the irsogladine group (16/19 patients; 84.2%) than in the control group (9/20 patients; 45.0%; P = .02). LIMITATIONS: Asymptomatic lesions, single-institution data, and single-blind setting. CONCLUSION:Irsogladine maleate was effective for reducing NSAID-induced small-intestinal mucosal injury. (University Hospital Medical Information Network Clinical Trials Registry number UMIN000001507.).
RCT Entities:
BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs) cause a high frequency of mucosal injuries in the small intestine. However, no reliable intervention, other than cessation of NSAIDs, has been established. OBJECTIVE: To evaluate whether irsogladine maleate reduces these injuries while continuing NSAID therapy. DESIGN: Prospective, interventional, endoscopist-blinded, randomized, controlled trial (RCT). SETTING: University hospital. PATIENTS: Patients regularly taking conventional NSAIDs for more than 4 weeks. INTERVENTIONS: We initially examined small-intestinal mucosal injuries by capsule endoscopy (CE) and screened participants for the RCT. In the RCT, patients with any mucosal injury were randomly assigned to the irsogladine group (4 mg/day) or the control group. MAIN OUTCOME MEASUREMENTS: The primary endpoint was the rate of mucosal injury improvement after 4 weeks of treatment monitored with a second CE. RESULTS: Sixty-one patients were evaluated with the first CE. Small intestine mucosal injuries were found in 41 patients (67.2%) and erosive or ulcerative lesions in 21 patients (34.4%). The injury prevalence was not different with gastroprotective drug treatment. Of 41 patients enrolled, 39 (19 patients in the irsogladine group and 20 in the control group) completed the study. The improvement rate was significantly higher in the irsogladine group (16/19 patients; 84.2%) than in the control group (9/20 patients; 45.0%; P = .02). LIMITATIONS: Asymptomatic lesions, single-institution data, and single-blind setting. CONCLUSION:Irsogladine maleate was effective for reducing NSAID-induced small-intestinal mucosal injury. (University Hospital Medical Information Network Clinical Trials Registry number UMIN000001507.).