Antioxidant therapy in the management of acute, chronic and post-ERCP pancreatitis: A systematic review

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;

²Significant decrease as compared with control;

³No significant difference between groups. PEP: Post endoscopic pancreatitis.