Therapeutic efficacy of both treatments
| Results | SMS + Is-5-Mn | SMS + placebo | Statistical analysis | 95% CI for difference (SMS+ Is-5-Mn to SMS+placebo) |
| Arrest of bleeding3-150 | 18/30 ( 60%) | 26/30 (86.7%) | p=0.039 | −5.3 to −48.0 |
| Persistence of bleeding3-150 | 9/30 (30%) | 2/30 (7%) | p= 0.042 | +4.7 to +42.0 |
| Rebleeding3-150 | 3/30 (10%) | 2/30 (7%) | NS | −17.3 to +10.6 |
| New bleeding episode (week 1) | 2/30 (7%) | 1/30 (3%) | NS | −14.3 to +7.7 |
| Mean transfusion requirements (packed red cells units) | 2.6 (2.19) | 1.8 (1.64) | NS (p=0.115) | −0.2 to +1.8 |
| Total fluid replacement (ml/72 hours) | 7851 (909) | 7818 (1424) | NS | −584 to +650 |
| Evolution (weeks 2–4) | ||||
| New bleeding episode | 5/30 (17%) | 6/30 (20%) | NS | −22.9 to +16.2 |
| New bleeding episodes (total) | 7/30 (23%) | 7/30 (23%) | NS | −21.4 to +21.4 |
| Mortality | 2/30 (7%) | 2/30 (7%) | NS | −12.6 to +12.6 |
Values are mean (SD).
↵3-150 During the first 72 hours.
SMS, somatostatin; Is-5-Mn, isosorbide 5-mononitrate.