OBJECTIVES: Bacteria in the gut lumen may play a role in the etiology and/or the symptoms of Crohn's disease (CD). Although various antibacterial drugs have been employed in clinical practice, few controlled trials have been conducted, and those had conflicting results. The aim of this study was to investigate the efficacy and the safety of a combination of metronidazole and ciprofloxacin, compared with methylprednisolone, in treating 41 consecutive patients with active CD. METHODS:Eligible patients, 13 men and 28 women, mean age 38 yr, were randomly allocated to receive, for 12 wk, ciprofloxacin 500 mg twice daily plus metronidazole 250 mg four times daily or methylprednisolone 0.7-l mg/kg/day, with variable tapering to 40 mg, followed by tapering of 4 mg weekly. RESULTS: Ten of the 22 antibiotic patients (45.5%) and 12 of the 19 steroid patients (63%) obtained clinical remission (Crohn's Disease Activity Index < or = 150) at the end of the 12-wk study (p = NS). Five patients on antibiotics (22.7%) and five patients on steroids (26.3%) were considered treatment failures because of deterioration or persistent symptoms. Six patients receiving antibiotics (27.3%) and two on steroids (10.6%) were withdrawn from the trial because of side effects. One patient on antibiotics was not compliant. CONCLUSIONS:metronidazole and ciprofloxacin could be an alternative to steroids in treating the acute phase of CD.
RCT Entities:
OBJECTIVES: Bacteria in the gut lumen may play a role in the etiology and/or the symptoms of Crohn's disease (CD). Although various antibacterial drugs have been employed in clinical practice, few controlled trials have been conducted, and those had conflicting results. The aim of this study was to investigate the efficacy and the safety of a combination of metronidazole and ciprofloxacin, compared with methylprednisolone, in treating 41 consecutive patients with active CD. METHODS: Eligible patients, 13 men and 28 women, mean age 38 yr, were randomly allocated to receive, for 12 wk, ciprofloxacin 500 mg twice daily plus metronidazole 250 mg four times daily or methylprednisolone 0.7-l mg/kg/day, with variable tapering to 40 mg, followed by tapering of 4 mg weekly. RESULTS: Ten of the 22 antibiotic patients (45.5%) and 12 of the 19 steroidpatients (63%) obtained clinical remission (Crohn's Disease Activity Index < or = 150) at the end of the 12-wk study (p = NS). Five patients on antibiotics (22.7%) and five patients on steroids (26.3%) were considered treatment failures because of deterioration or persistent symptoms. Six patients receiving antibiotics (27.3%) and two on steroids (10.6%) were withdrawn from the trial because of side effects. One patient on antibiotics was not compliant. CONCLUSIONS:metronidazole and ciprofloxacin could be an alternative to steroids in treating the acute phase of CD.