Ulcerative colitis: active disease: ciprofloxacin reduced treatment failure and colectomies.

Clinical bottom line (level 1b)

  1. Patients with active ulcerative colitis who took ciprofloxacin for 6 months in addition to steroids and mesalamine were less likely to fail treatment (NNT = 4 at 6 months) or require a colectomy (NNT = 4 at 6 months) .
Turunen et al: Gastroenterology 1998; 115: 1072-1078
Expires May 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: university hospital, Finland

83 patients (aged mean 34, 70% male) with active ulcerative colitis (moderate-to-severe endoscopic disease in at least 2 segments of large bowel and confirmed histologically)

Excluded if
  • aged < 16, > 65
  • ulcerative proctitis
  • positive blood cultures requiring systemic antibiotic treatment at any time
  • treatment with systemic antibiotics except metronidazole in previous 2 weeks
  • any condition requiring emergency surgery (peritonitis, fulminating colitis)
  • severe central nervous system disorders or a history of epilepsy
  • renal failure (creatinine > 400 mmol/l) or abnormal liver function tests (> twice upper limit of normal)
  • diabetes or other metabolic disease
  • pregnancy or lactation


    • Note:
  • Half of patients were on steroids and two-thirds on mesalamine or sulfasalazine.


    • Control Group: (n = 45, 45 analysed): prednisone mesalamine and placebo
    Experimental Group: (n = 38, 38 analysed): prednisone 0.75 mg/kg for 4 weeks, 0.5 mg/kg for 4 weeks, then 0.25 mg/kg for up to 12 weeks and then tapered off; mesalamine 800 mg daily by mouth; ciprofloxacin 500 mg if < 70 kg, 750 mg if > 70 kg for at least 6 month

    100% followed for 12 months
    Outcome notes:
    • treatment failure : colonoscopic findings of moderate-to-severe activity in at least 2 segments of the colon after failure to response to regimen; intractable symptoms (diarrhoea more than 10 times a day, blood in stools, fever, hospitalisation); need for urgent colectomy

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    treatment failure 6 months 20
    (44.4%)    		 8
    (21.1%)    		 53%
    (5% to 76%)    		 23.4%
    (3.93% to 42.9%)    		 4
    (2 to 25)
    colectomy 6 months 18
    (40.0%)    		 6
    (15.8%)    		 61%
    (11% to 83%)    		 24.2%
    (5.79% to 42.6%)    		 4
    (2 to 17)

  • Patients initially on steroids had a greater chance of treatment failure (CER = 58%) and a similar relative risk reduction (hence a better NNT ~ 3)

    • Comments

    1. No patients withdrew due to adverse events.

    Citation

    1. Turunen UM, Farkkila MA, Hakala K, et al: Long-term treatment of ulcerative colitis with ciprofloxacin: a prospective double-blind, placebo-controlled study. Gastroenterology 1998; 115: 1072-1078
    Search Terms:
    Contributor: Chris Ball and Bob Phillips, October 1999
    Reviewer:

    Clinical Question.
    Patient active ulcerative colitis
    Intervention or Exposure ciprofloxacin
    Comparison placebo
    Outcome treatment failure, colectomy