Side effects and complications (acute phase) | SMS + Is-5-Mn | SMS + placebo | Statistical analysis |
Hepatic encephalopathy | 6/30 (20) | 5/30 (17) | NS |
Pneumonia | 2/30 (7) | 0 | NS |
Urinary tract infection | 0 | 0 | NS |
Spontaneous bacterial peritonitis | 3/30 (10) | 0 | NS |
Bacteraemia | 1/30 (3) | 1/30 (3) | NS |
Infectious side effects (total) | 6/30 (20) | 1/30 (3) | NS |
Hepatorenal syndrome | 2/30 (7) | 0 | NS |
Withdrawal syndrome | 2/30 (7) | 1/30 (3) | NS |
Headache | 6/30 (20) | 3/30 (10) | NS |
Hypotension | 5/30 (17) | 3/30 (10) | NS |
Ascites | 5/30 (17) | 0 | NS (p=0.052) |
Oligoanuria | 2/30 (7) | 0 | NS |
Respiratory distress | 1/30 (3) | 0 | NS |
Atrial fibrillation | 1/30 (3) | 0 | NS |
Values are number (%).
SMS, somatostatin; Is-5-Mn, isosorbide 5-mononitrate.