TRANSDERMAL NICOTINE FOR ACTIVE ULCERATIVE-COLITIS

Background. Ulcerative colitis is largely a disease of nonsmokers. Bec ause anecdotal reports suggest that smoking and nicotine may improve t he symptoms of the disease, we examined the effect of nicotine as a su pplemental treatment for ulcerative colitis. Methods. We treated 72 pa tients with active ulcerative colitis with either transdermal nicotine patches or placebo patches for six weeks in a randomized, double-blin d study. Incremental doses of nicotine were given; most patients toler ated doses of 15 to 25 mg per 24 hours. All the patients had been taki ng mesalamine, and 12 were receiving low doses of glucocorticoids; the se medications were continued without change during the study. Clinica l, sigmoidoscopic, and histologic assessments were made at base line a nd at the end of the study; symptoms were recorded daily on a diary ca rd, and the clinician made a global assessment. Side effects and plasm a nicotine and cotinine concentrations were monitored throughout the s tudy. Results. Seventeen of the 35 patients in the nicotine group had complete remissions, as compared with 9 of the 37 patients in the plac ebo group (P = 0.03). The patients in the nicotine group had greater i mprovement in the global clinical grade of colitis (P<0.001) and the h istologic 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 fe cal 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 place bo group (3 vs. 8, P = 0.12). Conclusions. The addition of transdermal nicotine to conventional maintenance therapy improves symptoms in pat ients with ulcerative colitis.