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Previous Volume 330:811-815 March 24, 1994 Number 12 Next

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ABSTRACT

Background Ulcerative colitis is largely a disease of nonsmokers. Because anecdotal reports suggest that smoking and nicotine may improve the symptoms of the disease, we examined the effect of nicotine as a supplemental treatment for ulcerative colitis.

Methods We treated 72 patients with active ulcerative colitis with either transdermal nicotine patches or placebo patches for six weeks in a randomized, double-blind study. Incremental doses of nicotine were given; most patients tolerated doses of 15 to 25 mg per 24 hours. All the patients had been taking mesalamine, and 12 were receiving low doses of glucocorticoids; these medications were continued without change during the study. Clinical, sigmoidoscopic, and histologic assessments were made at base line and at the end of the study; symptoms were recorded daily on a diary card, and the clinician made a global assessment. Side effects and plasma nicotine and cotinine concentrations were monitored throughout the study.

Results Seventeen of the 35 patients in the nicotine group had complete remissions, as compared with 9 of the 37 patients in the placebo group (P = 0.03). The patients in the nicotine group had greater improvement in the global clinical grade of colitis (P<0.001) and the histologic grade (P = 0.03), lower stool frequency (a difference of 1.6 stools daily; P = 0.008), less abdominal pain (P = 0.05), and less fecal urgency (P = 0.009). More patients in the nicotine group had side effects (23, vs. 11 in the placebo group; P = 0.002), the most common of which were nausea, lightheadedness, headache, and sleep disturbance. Withdrawals due to ineffective therapy were more common in the placebo group (3 vs. 8, P = 0.12).

Conclusions The addition of transdermal nicotine to conventional maintenance therapy improves symptoms in patients with ulcerative colitis.

Source Information

From the Department of Gastroenterology, University Hospital of Wales, Cardiff, United Kingdom (R.D.P., J.R., G.A.O.T.); Leigh Infirmary, Leigh, Greater Manchester, United Kingdom (S.G., V.M.); Princess of Wales Hospital, Bridgend, Mid Glamorgan, United Kingdom (J.S.M.); the Departments of Pathology (G.T.W.) and Medical Computing and Statistics (R.G.N.), University of Wales College of Medicine, Cardiff, United Kingdom; the Health Behaviour Unit, Institute of Psychiatry and Maudsley Hospital, London (M.A.H.R.); the Nicotine Laboratory, Poisons Unit, New Cross Hospital, London (C.F.); and Kabi Pharmacia Therapeutics, Helsingborg, Sweden (U.S.).

Address reprint requests to Dr. Rhodes at the Dept. of Gastroenterology, Ward A7, University Hospital of Wales, Heath Park, Cardiff, United Kingdom.

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