Ulcerative colitis: rectal steroids were more effective than oral prednisolone in mild-to-moderate disease.

Clinical bottom line (level 1b)

  1. Patients with mild-to-moderate ulcerative colitis who had a rectal drip compared with oral prednisolone were more likely to be in complete remission (NNT = 3 at 2 weeks) .
  2. Combining rectal drips and oral prednisolone was not clearly better than using rectal drips alone.
Truelove : British Medical Journal 1960; 1: 464-467
Expires May 2003

The study

Unblinded ?concealed randomised trial with intention-to-treat
Setting: university hospital, UK

120 patients (aged ?, ?% male) with mild-to-moderate active ulcerative colitis (diagnosed on sigmoidoscopy)

Excluded if
  • disease confined to rectum and recto-sigmoid junction
  • very severe attacks


    • Control Group: (n = 40, 40 analysed): prednisolone 20 mg po daily
    Experimental Group: (n = 40, 40 analysed): nightly rectal drip: prednisolone 40 mg pr daily or hydrocortisone 100 mg pr daily
    Experimental Group: (n = 40, 40 analysed): nightly rectal drip: prednisolone 20 mg po daily and prednisolone 40 mg pr daily or hydrocortisone 100 mg pr daily

    100% followed for 2 weeks
    Outcome notes:
    • no clinical remission : clinical remission - defined as complete loss of symptoms and improvement on sigmoidoscopy

    The evidence

    oral vs rectal drip
    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    no clinical remission 2 weeks 26
    (65.0%)    		 11
    (27.5%)    		 58%
    (27% to 76%)    		 37.5%
    (17.3% to 57.8%)    		 3
    (2 to 6)

    oral vs rectal drip and oral
    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    no clinical remission 2 weeks 26
    (65.0%)    		 6
    (15.0%)    		 77%
    (50% to 89%)    		 50.0%
    (31.5% to 68.5%)    		 2
    (1 to 3)

    rectal drip vs rectal drip and oral
    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    no clinical remission 2 weeks 11
    (27.5%)    		 6
    (15.0%)    		 45%
    (-33% to 78%)    		 12.5%
    (-5.22% to 30.2%)    		 8
    (NNT = 3 to infinity;
    NNH = 19 to infinity)

    Comments

    1. The study is too small to show any difference between rectal drips and combination therapy.

    Citation

    1. Truelove SC, : systemic and local corticosteroid therapy in ulcerative colitis. British Medical Journal 1960; 1: 464-467
    Contributor: Chris Ball and Clare Wotton, October 2000
    Reviewer:

    Clinical Question.
    Patient ulcerative colitis
    Intervention or Exposure steroids by rectal drip
    Comparison oral steroids
    Outcome remission