Does melatonin addition to indomethacin decrease post endoscopic retrograde cholangiopancreatography pancreatitis? A...

Area of Science:

• Gastroenterology
• Clinical Trials
• Pharmacology

Background:

• Post-ERCP pancreatitis (PEP) is a frequent complication of endoscopic retrograde cholangiopancreatography (ERCP).
• Melatonin has demonstrated potential protective effects against acute pancreatitis.

Purpose of the Study:

• To evaluate if melatonin, when added to indomethacin, can decrease the occurrence of PEP.
• To compare the efficacy of melatonin plus indomethacin versus indomethacin alone in preventing PEP.

Main Methods:

• A double-blind, randomized clinical trial involving 411 patients undergoing ERCP.
• Patients received either melatonin (3 mg) plus indomethacin (100 mg) or placebo plus indomethacin (100 mg) one hour prior to ERCP.
• PEP occurrence was the primary endpoint, with amylase and lipase levels measured 24 hours post-ERCP.

Main Results:

• No significant differences in patient demographics or ERCP procedure characteristics were observed between groups.
• The rate of PEP was lower in the melatonin group (8.7% ITT, 9.3% PP) compared to the placebo group (11.4% ITT, 13.6% PP).
• Post-ERCP amylase and lipase levels were significantly lower in the melatonin group (P=0.041 and P=0.032, respectively).

Conclusions:

• Administering melatonin (3 mg) with indomethacin (100 mg) one hour before ERCP effectively reduces PEP rates.
• This combination therapy also leads to lower post-ERCP amylase and lipase levels compared to indomethacin alone.