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Transdermal Nicotine for Active Ulcerative Colitis
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.
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“early clinical observations suggesting that cigarette smoking might be beneficial to patients with ulcerative colitis led to randomized clinical trials of nicotine administration to patients that demonstrated significant benefit in a subset of patients (76,77).”
From Physiology and immunology of the cholinergic antiinflammatory pathway (2007) · cites this paper as [76]
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Metadata
- Authors
- Pullan, R. D., Rhodes, J., Ganesh, S., Mani, V., Morris, J. S., Williams, G. T., Newcombe, R. G., Russell, M., Feyerabend, C., Thomas, G., & Sawe, U.
- Affiliations
- University Hospital of Wales (GB)
- University of Wales (GB)
- Princess of Wales Hospital (GB)
- New Cross Hospital (GB)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 1994-03-24
- Volume
- 330
- Issue
- 12
- Pages
- 811-815
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2315418290
- Cited by
- 505
- References
- 28
- Citations by year
- 2026: 3 · 2025: 6 · 2024: 9 · 2023: 11 · 2022: 10 · 2021: 10 · 2020: 20 · 2019: 9 · 2018: 14 · 2017: 7 · 2016: 5 · 2015: 11 · 2014: 14 · 2013: 15 · 2012: 9
- FWCI
- 15.58
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Inflammatory Bowel Disease
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Smoking Behavior and Cessation
- Health Sciences › Medicine › Gastroenterology › Microscopic Colitis
- Keywords
- ulcerative colitis, transdermal nicotine, nicotine patch, smoking, nicotine withdrawal, 5-aminosalicylic acid, maintenance therapy, remission, symptom improvement, adverse effects
- MeSH terms
- Administration, Cutaneous, Adult, Affect, Colitis, Ulcerative, Cotinine, Double-Blind Method, Female, Humans, Male, Middle Aged, Nicotine, Treatment Outcome, Drug Monitoring
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