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

Abstract

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 One hundred and five patients participated but only 56 completed the 16 week study -21 were withdrawn for deterioration of symptoms, 17 for adverse experiences, and 11 for protocol violation.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=0002) and serum orosomucoid (metronidazole 20 mg/kg/day, 49; 10 mg/kg/day, 38; placebo, -9, p=0001)) 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<005). 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. There were no differences in remission rates between metronidazole and placebo treated patients. We conclude that metronidazole warrants further assessment in the treatment of patients with active Crohn's disease.

Association of ATG16L1 and IRGM genes polymorphisms with inflammatory bowel disease: a meta-analysis approach

“…This fact is supported by the therapeutic benefits of antibiotic and probiotic treatment in IBD patients, 40,41 the observation that specific enteric flora are found more commonly in patients than in controls, 42,43 and studies in a variety of murine strains in which 'spontaneous' colitis seems to be entirely dependent on the presence of a luminal flora. [44][45][46] Autophagy has an important role in physiological and pathological processes, such as degradation of cytoplasmic components, cellular response to nutrient starvation and apoptosis.…”

Intestinal Microbes in Inflammatory Bowel Diseases

“…Notably, reductions in the titer of antibody to F. varium appeared to correlate to these improvements. Several groups have demonstrated the benefi t of antibiotics in Crohn ' s colitis and ileocolitis, but not isolated small bowel disease, especially for metronidazole ( 64 ). A recent 402 patient prospective randomized trial reported signifi cant induction of remission of moderately active Crohn ' s disease over 12 weeks by 800 mg b.i.d.…”

Management of Crohn's Disease in Adults

“…Metronidazole, 10 or 20 mg / kg, has been compared with placebo for mild to moderate disease and was not more e ective than placebo for inducing remission (100) . A post hoc subgroup analysis indicated that metronidazole might be e ective in patients with colonic involvement (ileocolitis and colitis) (100) .…”