Ulcerative colitis: using oral and rectal mesalamine reduced rectal bleeding better than either alone

Clinical bottom line (level 1b)

  1. Patients with active distal ulcerative colitis who took oral and rectal mesalamine compared with either alone were more likely to stop rectal bleeding .
  2. Patients on combination therapy stopped rectal bleeding sooner (on average 13 days).
  3. There was no clear difference in the number of adverse effects.
Safdi et al: American Journal of Gastroenterology 1997; 92 (10): 1867-1871
Expires May 2003

The study

Double-blinded ?concealed randomised trial without intention-to-treat
Setting: 8 gastroenterology clinics, USA

60 patients (aged mean 38, 50% female) with active distal ulcerative colitis (confirmed on endoscopy at least 5 cm above anal verge and no more than 50 cm; a negative stool culture; no ova or parasites; a negative Clostridium difficile toxin; and a score of 4-10 on a disease activity index)

Excluded if
  • history of substance abuse
  • bowel resection, diverticulitis
  • bisulfite or salicylate allergies
  • previous allergic reaction or intolerance to study drugs
  • used topical or oral ulcerative colitis therapies within 1 week of study


    • Control Group: (n = 18, 17 analysed): mesalamine 4g rectal suspension nightly and placebo
    Experimental Group: (n = 22, 18 analysed): mesalamine 800 mg by mouth three times a day and placebo
    Experimental Group: (n = 20, 19 analysed): mesalamine enema and tablets

    90% followed for 6 weeks
    Outcome notes:
    • cessation of rectal bleeding : absence of blood in stools for at least 4 days and until the end of the study

    The evidence

    combination (experimental) v. oral mesalamine or rectal mesalamine (control)
    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    cessation of rectal bleeding 6 weeks 21
    (60.0%)    		 16
    (84.2%)    		 40%
    (1% to 96%)    		 24.2%
    (1.14% to 47.3%)    		 4
    (2 to 88)
    adverse effects 6 weeks 12
    (34.3%)    		 9
    (47.4%)    		 -38%
    (-170% to 29%)    		 -13.1%
    (-40.5% to 14.3%)    		 -8
    (NNT = 7 to infinity;
    NNH = 2 to infinity)

    Comments

    1. The study was too small to show any difference between oral and rectal mesalamine.
    2. Patients given combination therapy stopped rectal bleeding sooner than patients on single route therapy (on average by 13 days).

    Citation

    1. Safdi M, DeMicco M, Sninisky C, et al: A double-blind comparison of oral versus rectal mesalamine versus combination therapy in the treatment of distal ulcerative colitis. American Journal of Gastroenterology 1997; 92 (10): 1867-1871
    Contributor: Chris Ball and Bob Phillips, October 1999
    Reviewer:

    Clinical Question.
    Patient ulcerative colitis
    Intervention or Exposure mesalamine
    Outcome recurrence