Does melatonin addition to indomethacin decrease post endoscopic retrograde cholangiopancreatography pancreatitis? A randomized double-blind controlled trial

Abstract

Objective Post-ERCP pancreatitis (PEP) is the most prevalent complication of endoscopic retrograde cholangiopancreatography (ERCP). Melatonin has been mentioned as a protective factor against acute pancreatitis. The present study was conducted to determine whether melatonin addition to indomethacin reduces the rate of PEP occurrence. Methods A double-blind randomized clinical trial was conducted on 411 patients undergoing ERCP. Baseline blood samples were collected, and the patients were given melatonin 3 mg tablets plus indomethacin suppository 100 mg or placebo plus indomethacin suppository 100 mg, 1 h before ERCP. The occurrence of PEP was the primary outcome. The concentrations of amylase and lipase were also measured 24 h after ERCP. Results Demographic characteristics of patients, characteristics of ERCP procedures, and baseline levels of amylase and lipase were found to be similar in both groups. The overall rate of PEP was equal to 9.5% in intention-to-treat (ITT) and 11.4% in per-protocol (PP) analyses. There was a significant difference in the rate of PEP between the melatonin and placebo groups (8.7% vs. 11.4% in ITT and 9.3% vs. 13.6% in PP, respectively). In addition, after 24 h, amylase and lipase levels were lower in the melatonin group than in the placebo group (P = 0.041 and 0.032, respectively). Conclusion The results of the present study showed that, administration of melatonin 3 mg tablets plus indomethacin suppository 100 mg 1 h before ERCP could decrease the PEP rate and amylase and lipase levels compared to administration of indomethacin suppository 100 mg alone.

MRI Evaluation of Indomethacin Suppositories in the Prevention of Complications of Pancreatitis and Hyperamylasemia after Choledocholithiasis ERCP Based on Image Denoising Algorithm

“…In addition, MRI imaging technology with denoising algorithm was used to further evaluate the clinical efficacy of the drug. Lay a theoretical foundation for improving the prognosis of patients with choledocholithiasis in clinic [ 11 ].…”

Update in preventing post-endoscopic retrograde cholangiopancreatography pancreatitis

“…An Iranian RCT (280 patients completed the study) investigated the effect of adding melatonin to indomethacin on PEP development. The frequency of PEP in those who received melatonin was 9.3% (n=13/140) vs. 15.6% (n=19/140), respectively (P=0.034) [ 68 ]. The results mean that the antioxidant effect of melatonin may be beneficial in preventing PEP.…”

Pancreatite pós-colangiopancreatografia retrógrada endoscópica: uma revisão narrativa

“…Um outro medicamento que tem gerado análises como fator protetor contra a PPC é a melatonina. No estudo Sadeghi et al (2019), um ensaio clínico randomizado duplocego, com 441 pacientes percebeu-se que houve diferença significativa na incidência no grupo que recebeu melatonina associado ao supositório de indometacina (9,3%), em contraposição dos que receberam placebo associado a indometacina (13,6%).…”