Ulcerative colitis: steroids helped induce remission in active disease.

Clinical bottom line (level 1b)

  1. Patients with chronic active ulcerative colitis who took cortisone were more likely to go into remission (NNT = 4 at 6 weeks) .
Truelove and Witts: British Medical Journal 1955; : 1041-1048
Expires May 2003

The study

Single-blinded ?concealed randomised trial without intention-to-treat
Setting: university hospital, UK

213 patients (aged ?, ?% male) with chronic active ulcerative colitis severe enough to require at least six weeks of hospital stay
Control Group: (n = , 101 analysed): placebo
Experimental Group: (n = , 109 analysed): cortisone initially 100 mg po once daily, adjusted according to response for six weeks

99% followed for 2 months
Outcome notes:
  • no clinical remission : remission: two or less stools/ day without blood, no fever, no tachycardia, ESR normal or returning to normal, gaining weight

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
no clinical remission 6 weeks 85
(84.2%)		 64
(58.7%)		 30%
(17% to 42%)		 25.4%
(13.8% to 37.1%)		 4
(3 to 7)
death 2 months 11
(10.9%)		 5
(4.59%)		 58%
(-17% to 85%)		 6.30%
(-0.93% to 13.5%)		 16
(NNT = 7 to infinity;
NNH = 110 to infinity)

Comments

  1. The study is too small to show any difference in the death rate.
  2. This study was performed before the general use of aminosalicylates.
  3. Incidentally this study reported a grading criteria for ulcerative colitis which has subsequently become the standard:
    • severe disease: six or more motions a day with macroscopic blood, fever > 37.8 C on two out of four days, pulse > 90, anaemia < 75% predicted, ESR > 30 mm/hr
    • moderate: not severe or mild
    • mild:four or less motions a day with no more than small amounts of macroscopic blood; no fever; pulse < 90; anaemia not severe; ESR 30 mm/hr or less

Citation

  1. Truelove SC, and Witts LJ: Cortisone in ulcerative colitis: final report on a therapeutic trial. British Medical Journal 1955; : 1041-1048
Search Terms: colit* in Cochrane
Contributor: Chris Ball and Clare Wotton, November 2000
Reviewer:

Clinical Question.
Patient chronic active ulcerative colitis
Intervention or Exposure cortisone
Comparison placebo
Outcome remission