Crohn's disease: unclear role for metronidazole and ciprofloxacin in treating active disease.

Clinical bottom line (level 1b-)

  1. Metronidazole and ciprofloxacin were not clearly more effective than steroids at inducing remission in patients with active Crohn's disease, nor did they clearly cause fewer side effects.
Prantera et al: American Journal of Gastroenterology 1996; 91: 328-332
Expires May 2003

The study

Single-blinded concealed randomised trial with intention-to-treat
Setting: acute hospital, Italy

41 patients (aged range 18 to 71 years; mean 38, 68% female) active Crohn's disease localised to ileum and/or colon (CDAI > 200)

Excluded if
  • aged <18 or >75
  • pregnant or lactating
  • significant renal or hepatic disease
  • neoplasia, diabetes mellitus, arterial hypertension, active peptic ulcer disease
  • history of intolerance to steroids, antibiotics
  • current parenteral nutrition or elemental diet
  • active perianal disease
  • intake of corticosteroids for two months or more in the last six months
  • intake of any immunosuppressant within three months


    • Control Group: (n = 19, 19 analysed): methylprednisolone 0.7 to 1 mg/kg/day to a maximum of 40 mg daily, tapering by 4 mg weekly for 12 weeks
    Experimental Group: (n = 22, 22 analysed): ciprofloxacin 500 mg po once daily and metronidazole 250 mg po four times daily for 12 weeks
    No other Crohn's medication was allowed during the study.
    100% followed for 12 weeks
    Outcome notes:
    • no remission : clinical remission: CDAI < 150

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    no remission 12 weeks 7
    (36.8%)    		 12
    (54.6%)    		 -48%
    (-199% to 27%)    		 -17.7%
    (-47.8% to 12.4%)    		 -6
    (NNT = 8 to infinity;
    NNH = 2 to infinity)
    withdrawal from study 12 weeks 5
    (26.3%)    		 11
    (50.0%)    		 -90%
    (-349% to 20%)    		 -23.7%
    (-52.5% to 5.10%)    		 -4
    (NNT = 20 to infinity;
    NNH = 2 to infinity)
    side effects 12 weeks 15
    (79.0%)    		 13
    (59.1%)    		 25%
    (-14% to 51%)    		 19.9%
    (-7.68% to 47.4%)    		 5
    (NNT = 2 to infinity;
    NNH = 13 to infinity)

    Comments

    1. The study is too small to show any difference between steroids and antibiotics in the treatment of active Crohn's disease.

    Citation

    1. Prantera C, et al: An antibiotic regimen for the treatment of active Crohn's disease: a randomised controlled trial of metronidazole plus ciprofloxacin. American Journal of Gastroenterology 1996; 91: 328-332
    Contributor: David Ford and Chris Ball, October 2000
    Reviewer:

    Clinical Question.
    Patient Crohn's disease
    Intervention or Exposure metronidazole and ciprofloxacin
    Comparison steroids
    Outcome remission, side effects