Gut  1991 Sep;32(9):1071-5 

Double blind, placebo controlled trial of metronidazole in Crohn's disease.

Sutherland L, Singleton J, Sessions J, Hanauer S, Krawitt E, Rankin G, Summers

R, Mekhjian H, Greenberger N, Kelly M, et al.

Department of Medicine, University of Calgary.

A double blind study compared the efficacy of metronidazole in two doses (20

mg/kg, 10 mg/kg) with placebo in patients with Crohn's disease. One hundred and

five patients participated but only 56 completed the 16 week study -21 were

withdrawn for deterioration of symptoms, 17 for adverse experiences, and 11 for

protocol violation. Significant improvement in disease activity as measured by

the Crohn's disease activity index (metronidazole 20 mg/kg, 97 units;

metronidazole 10 mg/kg, 67 units; placebo -1 unit, p = 0.002) and serum

orosomucoid (metronidazole 20 mg/kg/day, 49; 10 mg/kg/day, 38; placebo, -9, p =

0.001)) were detected. Changes in C reactive protein concentrations did not

achieve significance when all three groups were considered but were significant

when all metronidazole treated patients were grouped and compared with the

placebo treated patients (0.8 v -0.9, p less than 0.05). Although patients

receiving metronidazole 20 mg/kg/day had a greater improvement in disease

activity than those receiving 10 mg/kg/day (difference 30 units (95% confidence

intervals -27-87), the small sample size may have precluded the detection of

statistical significance. Preliminary analysis suggests that metronidazole was

more effective in patients with disease confined to the large intestine or

affecting both small and large bowel than in those with small bowel disease

only.(ABSTRACT TRUNCATED AT 250 WORDS)