Abstract
Background: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most prevalent complication of ERCP. Oxidative stress has been mentioned as a cause of PEP. Objectives: As preclinical and clinical studies have shown that CoQ10 has anti-inflammatory and antioxidant effects, the present study was designed to examine whether oral CoQ10 addition to rectal indomethacin decreases the rate/severity of PEP. Methods: A prospective double-blind clinical study was done on 347 patients undergoing ERCP. All participants received 100 mg rectal indomethacin just before ERCP. Also, patients were asked to consume CoQ10 (200 mg) or an identical placebo for 1 h before the procedure. The occurrence and severity of PEP were determined in the participants. The levels of amylase, lipase, and malondialdehyde (MDA) were also measured 12 h after ERCP. Results: The total rate of PEP was equal to 12.1% in intention-to-treat (ITT) and 13% in per-protocol (PP) analyses. A meaningful difference was observed in the rate and severity of PEP between the CoQ10 and placebo arms (9.8% vs 14.4% in ITT and 10.2% vs 15.1% in PP, sequentially). Secondary levels of amylase, lipase, and MDA were lower in the CoQ10 arm than in the placebo arm (P = 0.032, 0.022, and 0.036, sequentially). Conclusions: A combination of oral CoQ (200 mg) plus rectal indomethacin (100 mg) could decrease the PEP rate and severity meaningfully compared to the use of indomethacin alone.