AIM: To compare the efficacy of ranitidine with that of ranitidine plus octreotide in the treatment of non-variceal upper gastrointestinal (UGI) bleeding. DESIGN: Prospective, randomised, open study. PATIENTS AND METHODS: Upper GI endoscopy was carried out during the first 24 hours in all patients with UGI bleeding who had been admitted within a period of 18 months. Patients with variceal bleeding, and those who had undergone any type of gastric operation, were excluded. Eighty-four patients (58 men and 26 women) aged 21-92 years (mean age: 61.2 +/- 15.0 SD) were included. Patients were randomised to receive ranitidine 50 mg tid intravenously alone (Group A: 44 patients, 29 men), or in combination with octreotide 100 micrograms tid subcutaneously, the second drug given for three days only (Group B: 40 patients, 29 men). The study end-points were discharge without operation, emergency surgical intervention or death. The number of blood units given and the days of hospitalization were also recorded. RESULTS:Aspirin and non-aspirin NSAID use before bleeding was reported by 16/44 (36%) patients in Group A and by 19/40 (47.5%) patients in Group B (p = 0.38, OR = 0.63, 95% CI = 0.26-1.51). The endoscopically detected pathology and bleeding stigmata did not differ between the groups (p = 0.86, p = 0.64, OR = 0.78, 95% CI = 0.3-1.99, respectively). Mean use of blood units (p = 0.16) and days of hospitalization (p = 0.25) did not differ. Three patients in Group A (6.8%) and three in Group B (7.5%) required surgical intervention (p = 1.0, OR = 1.1, 95% CI = 0.21-5.84). CONCLUSION:Ranitidine plus subcutaneous octreotide is not superior to ranitidine alone in the management of patients with acute non-variceal UGI bleeding.
RCT Entities:
AIM: To compare the efficacy of ranitidine with that of ranitidine plus octreotide in the treatment of non-variceal upper gastrointestinal (UGI) bleeding. DESIGN: Prospective, randomised, open study. PATIENTS AND METHODS: Upper GI endoscopy was carried out during the first 24 hours in all patients with UGI bleeding who had been admitted within a period of 18 months. Patients with variceal bleeding, and those who had undergone any type of gastric operation, were excluded. Eighty-four patients (58 men and 26 women) aged 21-92 years (mean age: 61.2 +/- 15.0 SD) were included. Patients were randomised to receive ranitidine 50 mg tid intravenously alone (Group A: 44 patients, 29 men), or in combination with octreotide 100 micrograms tid subcutaneously, the second drug given for three days only (Group B: 40 patients, 29 men). The study end-points were discharge without operation, emergency surgical intervention or death. The number of blood units given and the days of hospitalization were also recorded. RESULTS:Aspirin and non-aspirin NSAID use before bleeding was reported by 16/44 (36%) patients in Group A and by 19/40 (47.5%) patients in Group B (p = 0.38, OR = 0.63, 95% CI = 0.26-1.51). The endoscopically detected pathology and bleeding stigmata did not differ between the groups (p = 0.86, p = 0.64, OR = 0.78, 95% CI = 0.3-1.99, respectively). Mean use of blood units (p = 0.16) and days of hospitalization (p = 0.25) did not differ. Three patients in Group A (6.8%) and three in Group B (7.5%) required surgical intervention (p = 1.0, OR = 1.1, 95% CI = 0.21-5.84). CONCLUSION:Ranitidine plus subcutaneous octreotide is not superior to ranitidine alone in the management of patients with acute non-variceal UGI bleeding.