Ulcerative colitis: nicotine patches improved symptoms in chronic active disease.

Clinical bottom line (level 1b)

  1. Patients with ulcerative colitis who relapsed on steroids and ASA compounds, who wore nicotine patches were more likely to go into remission (NNT = 4 at 6 weeks) , but were more likely to have side effects (NNT = 3 at 6 weeks) .
  2. Patients who wore nicotine patches felt better.
Pullan et al: New England Journal of Medicine 1994; 330 (12): 811-815
Expires May 2003

The study

Double-blinded concealed randomised trial without intention-to-treat
Setting: three hospitals, UK

77 patients (aged mean 44 years, 57% male) with left-sided ulcerative colitis who had relapsed

Excluded if
  • enteric infection or other medical problems
  • pregnancy or lactation
  • change in maintenance anticolitis therapy during the past four weeks
  • current smoking


    • Control Group: (n = 37, 37 analysed): placebo patches
    Experimental Group: (n = 40, 35 analysed): transdermal nicotine patches; doses titrated from 5 or 25 mg of nicotine over a 16-hour period
    All patients continued to take the same doses of the anticolitis drugs (mesalamine and steroids) as prior to enrolment.
    94% followed for 6 weeks (81% completed the course of medication)
    Outcome notes:
    • side effects : nausea, light-headedness, headache, sleep disturbance, dizziness, skin irritation, sweating, vomiting, and tremor

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    no remission 6 weeks 28
    (75.7%)    		 18
    (51.4%)    		 32%
    (2% to 53%)    		 24.3%
    (2.68% to 45.8%)    		 4
    (2 to 37)
    withdrawal due to ineffective treatment 6 weeks 8
    (21.6%)    		 3
    (8.57%)    		 60%
    (-38% to 89%)    		 13.1%
    (-3.14% to 29.2%)    		 8
    (NNT = 3 to infinity;
    NNH = 32 to infinity)
    side effects 6 weeks 11
    (29.7%)    		 23
    (65.7%)    		 -121%
    (-283% to -28%)    		 -36.0%
    (-57.5% to -14.4%)    		 -3
    (-7 to -2)

    Outcome Control Group
    (SD)    		 Experimental Group
    (SD)    		 Mean Difference
    (95% CI)
    daily stool frequency 5.1
    (3.6)     		3.7
    (3.4)     		1.4
    (-0.25 to 3.0)
    well-being (scale of 1-10) 6.1
    (2.3)     		7.2
    (1.8)     		1.1
    (0.13 to 2.1)

    Citation

    1. Pullan RD, Rhodes J, Ganesh S, et al: Transdermal nicotine for active ulcerative colitis. New England Journal of Medicine 1994; 330 (12): 811-815
    Search Terms: ulcerative colitis in Best Evidence
    Contributor: Chris Ball and Clare Wotton, October 2000
    Reviewer:

    Clinical Question.
    Patient ulcerative colitis
    Intervention or Exposure nicotine patches
    Comparison placebo patches
    Outcome remission, side effects