Table 2.
Controlled clinical trials of antioxidant therapy to prevent post-ERCP pancreatitis
| Ref. | Drug/supplements | Study design | Jadadscore | n |
Treatment (intervention) |
Outcome (results) |
Adverse effects/events | Other comments | ||
| Case | Control | Primary | Other | |||||||
| Romagnuolo et al[30] 2008 | Allopurinol | Randomized; double blind; placebo-controlled | 4 | 586 | 293 patients; 300 mg oral allopurinol 60 min before ERCP | 293 patients; placebo | Rate of PEP3 (5.5% vs 4.1%) | Disease-related adverse events3 Procedure-related complications3 Hospitalization3 | - | In the non-high-risk group (n = 520), the crude PEP rates were 5.4% for allopurinol and 1.5% for placebo (P = 0.017), favoring placebo, indicating harm associated with allopurinol, whereas in the high-risk group (n = 66), the PEP rates were 6.3% for allopurinol and 23.5% for placebo (P = 0.050), favoring allopurinol |
| Milewski et al[31] 2006 | N-acetylcysteine | Randomized; placebo-controlled | 2 | 106 | 55 patients; 600 mg oral N-acetylcysteine 24 and 12 h before ERCP and 1200 mg IV for 2 d after the ERCP | 51 patients; isotonic IV saline twice for 2 d after the ERCP | Rate of PEP3 (7.3% vs 11.8%) | Urine amylase activity3 Serum amylase activity3 | - | - |
| Katsinelos et al[32] 2005 | Allopurinol | Randomized; double blind; placebo-controlled | 4 | 250 | 125 patients; 600 mg oral allopurinol 15 and 3 h before ERCP | 118 patients; placebo | Rate of PEP2 (3.2% vs 17.8%) | Hospitalization2 Severity of pancreatitis2 | - | - |
| Katsinelos et al[33] 2005 | N-acetylcysteine | Randomized; double-blind; placebo-controlled | 3 | 256 | 124 patients; 70 mg/kg 2 h before and 35 mg/kg at 4 h intervals for a total of 24 h after the procedure | 125 patients; placebo (normal saline solution) | Rate of PEP3 Hospitalization3 | - | Nausea; skin rash; diarrhea; vomiting | - |
| Mosler et al[34] 2005 | Allopurinol | Randomized; double blind; placebo- controlled | 4 | 701 | 355 patients; 600 mg 4 h and 300 mg 1 h oral allopurinol before ERCP | 346 patients; placebo | Rate of PEP3 (13.0% vs 12.1%) | Severity of pancreatitis3 | - | - |
| Lavy et al[35] 2004 | Natural β-carotene | Randomized; double-blind; placebo-controlled | 5 | 321 | 141 patients; 2 g oral β-carotene 12 h before ERCP | 180 patients; placebo | Rate of PEP3 (10% vs 9.4%) | Severe pancreatitis2 | - | - |
| Budzyńska et al[36] 2001 | Allopurinol | Randomized; placebo-controlled | 3 | 300 | 99 patients; 200 mg oral allopurinol 15 and 3 h before ERCP | 101 patients; placebo | Rate of PEP3 (12.1% vs 7.9%) | Severity of pancreatitis3 | - | - |
1Significant increase as compared with control;
2
Significant decrease as compared with control;
3
No significant difference between groups. PEP: Post endoscopic pancreatitis.