Ulcerative colitis: azathioprine allowed reduction of steroid doses in chronic disease.

Clinical bottom line (level 1b)

  1. Patients with chronic ulcerative colitis who took azathioprine required less prednisone to control their symptoms after 6 months ( mean ~ 8 mg a day less) compared with placebo.
  2. There was no clear improvement symptomatically or on barium enema.
Rosenberg et al: Gastroenterology 1975; 69 (1): 96-99
Expires May 2003

The study

Double-blinded concealed randomised trial without intention-to-treat
Setting: university hospital, USA

30 patients (aged range 16 to 64 years; mean 31, 50% male) out-patients with chronic ulcerative colitis extending beyond the rectum, who were taking 10 mg or more prednisone po once daily for control of symptoms for > 12 weeks

Excluded if
  • advanced hepatic or renal disease
  • women with an immediate desire for pregnancy


    • Control Group: (n = 14, 12 analysed): placebo
    Experimental Group: (n = 16, 14 analysed): azathioprine 1.5 mg/kg/day for six months
    All patients continued steroids at the same dose, which was gradually tapered if possible.
    100% followed for 6 months

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    no improvement on barium enema 6 months 9
    (75.0%)    		 7
    (50.0%)    		 33%
    (-24% to 64%)    		 25.0%
    (-10.9% to 60.9%)    		 4
    (NNT = 2 to infinity;
    NNH = 9 to infinity)

    Outcome Control Group
    (SD)    		 Experimental Group
    (SD)    		 Mean Difference
    (95% CI)
    mean prednisone dosage at end of study (mg/ day) 15.8
    (11)     		7.9
    (6.7)     		7.9
    (0.79 to 15)

  • No side effects attributable to azathioprine were detected over the study period.
  • No symptomatic improvement could be detected for the patients on azathioprine: data not given.
  • Only thirteen patients were analysed with regards to improvement on barium enema, as one of the x-rays was missing.

    • Comments

    1. The study is too small to show any effect on symptoms or adverse effects from taking azathioprine.

    Citation

    1. Rosenberg JL, Wall AJ, Levin B, et al: a controlled trial of azathioprine in the management of chronic ulcerative colitis. Gastroenterology 1975; 69 (1): 96-99
    Search Terms: colit* in Cochrane
    Contributor: Chris Ball and Clare Wotton, October 2000
    Reviewer:

    Clinical Question.
    Patient chronic ulcerative colitis
    Intervention or Exposure azathioprine
    Comparison placebo
    Outcome steroids required, improvement