Effects of melatonin on the acute inflammatory response associated with endoscopic retrograde cholangiopancreatography: A randomized, double-blind, placebo-controlled trial.
BACKGROUND
Endoscopic retrograde cholangiopancreatography (ERCP) is associated with an acute inflammatory response and melatonin has a variety of immunomodulatory and antioxidant effects studied experimentally in pancreatobiliary pathology.


OBJECTIVE
The aim of our study was to evaluate the effects of peri-procedural administration of melatonin on the inflammatory response and lipid peroxidation associated with ERCP.


METHODS
In this proof-of-concept clinical trial, 37 patients with a high probability of choledocholithiasis were randomized to receive peri-procedure (ERCP) melatonin or placebo. We measured the serum concentration of tumor necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), vascular endothelial growth factor (VEGF), lipid peroxidation, amylase, and liver function tests 24h before and after the procedure.


RESULTS
We found no pre-procedure or post-procedure differences between the melatonin group or the placebo group (P>.05) in the serum concentrations of TNF-alpha (melatonin: 153.8 vs. 149.4ng/m; placebo: 103.5 vs. 107.3ng/ml), IL-6 (melatonin: 131.8 vs. 133.3ng/ml; placebo: 177.8 vs. 197.8ng/ml), or VEGF (melatonin: 157.3 vs. 157.8pg/ml; placebo: 97.3 vs. 97.8pg/ml), or in relation to lipid peroxidation (melatonin: 39.2 vs. 72.3μg/ml; placebo: 66.4 vs. 90.5μg/ml). After ERCP, a significant decrease in the AST, ALT, and total bilirubin levels was found only in the melatonin group (P<.05). The administration of melatonin was safe and tolerable.


CONCLUSIONS
Melatonin is safe and tolerable in patients undergoing ERCP, but it does not appear to affect inflammatory cytokine concentrations or lipid peroxidation.
Servicio de Gastroenterología y Endoscopia Digestiva, Hospital Universitario «Dr. José E. González», Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México. Electronic address: badir84@hotmail.com.
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Hernández-Velázquez
Departamento de Medicina Interna, Hospital Universitario «Dr. José E. González», Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México.
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Camara-Lemarroy
Servicio de Gastroenterología y Endoscopia Digestiva, Hospital Universitario «Dr. José E. González», Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México.
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González-González
Servicio de Gastroenterología y Endoscopia Digestiva, Hospital Universitario «Dr. José E. González», Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México.
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García-Compean
Servicio de Gastroenterología y Endoscopia Digestiva, Hospital Universitario «Dr. José E. González», Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México.
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Monreal-Robles
Unidad de Hígado, Hospital Universitario «Dr. José E. González», Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México.
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Cordero-Pérez
Unidad de Hígado, Hospital Universitario «Dr. José E. González», Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México.
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Muñoz-Espinosa
D000328:Adult; D000368:Aged; D000975:Antioxidants / Q000009:adverse effects / Q000627:therapeutic use*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D042883:Choledocholithiasis / Q000150:complications / Q000175:diagnosis; D016207:Cytokines / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007249:Inflammation / Q000209:etiology* / Q000517:prevention & control*; D015227:Lipid Peroxidation / Q000187:drug effects; D008297:Male; D008550:Melatonin / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged
D000975:Antioxidants; D016207:Cytokines; D008550:Melatonin
Colangiopancreatografía retrógrada endoscópica; Endoscopic retrograde cholangiopancreatography; Factor de necrosis tumoral alfa; Lipid peroxidation; Melatonin in humans; Melatonina en humanos; Peroxidación lipídica; Tumor necrosis factor-alpha