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 One hundred and five patients participated but only 56 completed the 16 week study -21 were withdrawn for deterioration of symptoms, 17 for adverse experiences, and 11 for protocol violation.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.

We studied the natural history of ulcerative colitis (UC) by following 1116 patients in whom UC had been diagnosed or confirmed at The Cleveland Clinic Foundation between 1960 and 1983. Data before 1973 were obtained retrospectively. Criteria for inclusion in the study were: a diagnosis of UC confirmed by clinical, radiographic, endoscopic, and histologic examination; disease location that could be defined as one of three categories (proctosigmoiditis, pancolitis, or left-sided colitis); and a follow-up of at least five years (mean = 12.7 years). Mean age at diagnosis was 32 years. Of the 1116 patients, 46.2% (516) had proctosigmoiditis; 36.7% (410) had pancolitis (colitis of the entire large intestine); and 17.0% (190) had left-sided colitis (from the dentate line to the splenic flexure). Early complications (within two years of diagnosis) included colonic hemorrhage (16.7%) and toxic colitis (12.7%). Complications were highest among patients with pancolitis. Surgery was required for 37.6% of the patients. Primary indications for surgery included chronic or intractable disability (40.2%), fulminating medical failure (16.9%), and colonic dilatation (18.4%). At the most recent follow-up, the disease had extended (progressed to a more serious category) in 53.8% of the patients, although 67.2% were asymptomatic and only 37.0% were on medications. Both the final disease destination and the initial diagnosis impacted cumulative colectomy-ileostomy rates. Factors associated with extension were toxic colitis (P < 0.0001); extent of disease at diagnosis (P < 0.0001); joint symptoms (P = 0.0008); younger age at diagnosis (P = 0.06); and severe bleeding (P = 0.07).

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