BACKGROUND/ PURPOSE: Chronic pancreatitis is a debilitating condition of which pain is a predominant feature, and, at present, only putative treatments, beyond analgesics, exist. Evidence suggests that leukotrienes may play a role in both acute and chronic pancreatitis and that cells involved in their signalling are implicated in both conditions and pain production in chronic pancreatitis. We thus performed a study of a cysteinyl leukotriene receptor antagonist of proven benefit in chronic asthma (montelukast sodium) in patients with chronic pancreatitis. METHODS: A double-blind, placebo-controlled crossover trial of daily montelukast sodium (10 mg), of 8 months' duration, was performed in those suffering from painful chronic pancreatitis. Daily visual analogue pain scores and analgesic diaries were completed throughout the trial, as were monthly quality-of-life questionnaires and blood taken for inflammatory markers. Visual analogue pain scores were the primary outcome measure. RESULTS: In crossover analysis of mean visual analogue pain scores there was no significant difference between the groups (t = 1.51; P = 0.156). All baseline C-reactive protein results were 13 mg/l or less. Soluble tumor necrosis factor receptor results showed no significant difference pre- and post-treatment. CONCLUSIONS: In both primary and secondary outcome measures there was no significant effect for the cysteinyl leukotriene receptor antagonist, montelukast sodium in chronic pancreatitis in humans.
RCT Entities:
BACKGROUND/ PURPOSE:Chronic pancreatitis is a debilitating condition of which pain is a predominant feature, and, at present, only putative treatments, beyond analgesics, exist. Evidence suggests that leukotrienes may play a role in both acute and chronic pancreatitis and that cells involved in their signalling are implicated in both conditions and pain production in chronic pancreatitis. We thus performed a study of a cysteinyl leukotriene receptor antagonist of proven benefit in chronic asthma (montelukast sodium) in patients with chronic pancreatitis. METHODS: A double-blind, placebo-controlled crossover trial of daily montelukast sodium (10 mg), of 8 months' duration, was performed in those suffering from painful chronic pancreatitis. Daily visual analogue pain scores and analgesic diaries were completed throughout the trial, as were monthly quality-of-life questionnaires and blood taken for inflammatory markers. Visual analogue pain scores were the primary outcome measure. RESULTS: In crossover analysis of mean visual analogue pain scores there was no significant difference between the groups (t = 1.51; P = 0.156). All baseline C-reactive protein results were 13 mg/l or less. Soluble tumornecrosis factor receptor results showed no significant difference pre- and post-treatment. CONCLUSIONS: In both primary and secondary outcome measures there was no significant effect for the cysteinyl leukotriene receptor antagonist, montelukast sodium in chronic pancreatitis in humans.
Authors: Søren S Olesen; Jacob Juel; Carina Graversen; Yuri Kolesnikov; Oliver H G Wilder-Smith; Asbjørn M Drewes Journal: World J Gastroenterol Date: 2013-11-14 Impact factor: 5.742