A double-blind placebo-controlled trial of a leukotriene receptor antagonist in chronic pancreatitis in humans.
OBJECTIVE
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.
Cartmell
Mark T
MT
Academic Department of Surgery, Derriford Hospital, Plymouth, PL6 8DH, UK.
O'Reilly
Derek A
DA
Porter
Christine
C
Kingsnorth
Andrew N
AN
D000085:Acetates / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D002097:C-Reactive Protein / Q000032:analysis; D002908:Chronic Disease; D018592:Cross-Over Studies; D003521:Cyclopropanes; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D020024:Leukotriene Antagonists / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010195:Pancreatitis / Q000097:blood / Q000188:drug therapy*; D011804:Quinolines / Q000627:therapeutic use*; D013440:Sulfides; D017211:Treatment Failure
D000085:Acetates; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; D002097:C-Reactive Protein; C093875:montelukast