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Transdermal Nicotine for Mildly to Moderately Active Ulcerative Colitis: A Randomized, Double-Blind, Placebo-Controlled Trial

William J. Sandborn, MD; William J. Tremaine, MD; Kenneth P. Offord, MS; George M. Lawson, PhD; Bret T. Petersen, MD; Kenneth P. Batts, MD; Ivana T. Croghan, PhD; Lowell C. Dale, MD; Darrell R. Schroeder, MS; and Richard D. Hurt, MD
[+] Article and Author Information

From the Mayo Clinic and Mayo Foundation, Rochester, Minnesota. 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.


Copyright ©2004 by the American College of Physicians


Ann Intern Med. 1997;126(5):364-371. doi:10.7326/0003-4819-126-5-199703010-00004
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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 ≤ 22 mg for 3 weeks) or placebo (n = 33).

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 (≤ 22 mg/d) for 4 weeks is efficacious for controlling clinical manifestations of mildly to moderately active ulcerative colitis.

Figures

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Figure 1.
Percentage of patients with clinically improved ulcerative colitis at week 4.PTop left.PTop right.PBottom left.PBottom right.P

The Fisher exact test was used to calculate all values. According to treatment group ( = 0.007). According to treatment group and history of smoking status ( = 0.125 for the patients who never smoked and 0.061 for the patients who formerly smoked). According to treatment group (placebo group, diagonally striped bars; nicotine group, white bars) and concomitant therapy ( > 0.2 for the patients who received 5-aminosalicylate [5-ASA] and 0.008 for the patients who received both 5-aminosalicylate and steroids). According to treatment group and extent of disease ( = 0.075 for the patients with left-sided colitis and 0.093 for the patients with extensive colitis).

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Figure 2.
Mean scores on the ulcerative colitis clinical disease activity index for each treatment group at each study visit.PP

Vertical bars at 0 and 4 weeks represent SDs. = 0.009 (two-sample rank-sum test) for scores in the nicotine group at week 4 compared with scores in the placebo group at week 4 (two-sample rank-sum test). = 0.001 (one-sample signed-rank test) for scores in the nicotine group at baseline compared with those at week 4.

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