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1 March 1997 | Volume 126 Issue 5 | Pages 364-371
Background: Ulcerative colitis is predominantly a disease of nonsmokers. Transdermal nicotine may help control clinical manifestations of this condition.
Objective: To determine the efficacy of transdermal nicotine for controlling clinical disease activity in active ulcerative colitis.
Design: Randomized, double-blind, placebo-controlled, single-center clinical trial.
Setting: Multispecialty group serving as an academic tertiary referral center.
Patients: 64 nonsmoking patients with mildly to moderately active ulcerative colitis despite the use of medication.
Intervention: Patients were stratified on the basis of smoking history, extent of disease, and concomitant medical therapy. After stratification, patients were randomly assigned to daily treatment with transdermal nicotine (n = 31) at the highest tolerated dose (11 mg for 1 week and then
Measurements: Clinical features were assessed at baseline and 4 weeks by endoscopy, physician assessment, and a patient diary of daily symptoms. Serum concentrations of nicotine were determined by using gas chromatography and mass spectrometry, and plasma concentrations of cotinine were measured by using high-performance liquid chromatography.
Results: At 4 weeks, 12 of 31 patients (39%) who received nicotine showed clinical improvement compared with 3 of 33 patients (9%) who received placebo (P = 0.007). Four patients receiving nicotine discontinued therapy because of side effects (contact dermatitis [n = 2], nausea [n = 1], and acute pancreatitis [n = 1]). At week 4, the nicotine group had a mean (±SD) trough serum nicotine concentration of 11.3 ± 8.4 ng/mL and a mean trough plasma cotinine concentration of 192 ± 95 ng/mL.
Conclusions: Transdermal nicotine administered at the highest tolerated dosage (
Author and Article Information
From the Mayo Clinic and Mayo Foundation, Rochester, Minnesota.
ARTICLE
Transdermal Nicotine for Mildly to Moderately Active Ulcerative Colitis
A Randomized, Double-Blind, Placebo-Controlled Trial
22 mg for 3 weeks) or placebo (n = 33). 22 mg/d) for 4 weeks is efficacious for controlling clinical manifestations of mildly to moderately active ulcerative colitis.
Acknowledgments: The authors thank Deb Kaul, Therese Johnson, RN, and Betty Steiner, RN, for their invaluable assistance.
Grant Support: By a grant from Elan Pharmaceutical Research Corp., Gainesville, Georgia, and Elan Pharma, Athlone, Ireland.
Requests for Reprints: William J. Sandborn, MD, Mayo Clinic, 200 First Street SW, Rochester, MN 55905.
Current Author Addresses: Drs. Sandborn, Tremaine, Offord, Lawson, Petersen, Batts, Croghan, Dale, and Hurt and Mr. Schroeder: Mayo Clinic, 200 First Street SW, Rochester, MN 55905.
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