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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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“Patients who smoke intermittently often experience an improvement in their colitis symptoms during the periods when they smoke [9,12].”
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Rüssel, M. G., Volovics, A., Schoon, E. J., van Wijlick, E. H. J., Logan, R. F., Shivananda, S., & Stockbriigger, R. W. (1998) · Inflammatory Bowel Diseases · doi:10.1097/00054725-199808000-00002 · Cited by 128
Manthorpe, R., Benoni, C., Jacobsson, L., Kirtava, Z., Larsson, Å., Liedholm, R., Nyhagen, C., Tabery, H., & Theander, E. (2000) · Annals of the Rheumatic Diseases · doi:10.1136/ard.59.1.54 · Cited by 118
“The reason for this protective effect is not known. Nicotine has proved effective only when added to standard treatments in moderately active disease”
BackgroundRegueiro, M. D., Loftus, E. V., Steinhart, H., & Cohen, R. D. (2006) · Inflammatory Bowel Diseases · doi:10.1097/01.mib.0000231495.92013.5e · Cited by 117
“These effects and the paucity of clinical efficacy data have not supported uniform use of nicotine for UC.(88,90,92) Among ex-smokers, however, a trial may be warranted in those not responding to more conventional treatments.”
BackgroundMechanisms of Disease: nicotine—a review of its actions in the context of gastrointestinal disease
Thomas, G. A. O., Rhodes, J., & Ingram, J. R. (2005) · Nature Clinical Practice Gastroenterology & Hepatology · doi:10.1038/ncpgasthep0316 · Cited by 111
“There is clinical evidence to suggest that nicotine is responsible for this difference, as transdermal nicotine patches have been used with beneficial effects in patients with active disease”
BackgroundSelf-citationCholinergic agonists regulate JAK2/STAT3 signaling to suppress endothelial cell activation
Chatterjee, P. K., Al‐Abed, Y., Sherry, B. A., & Metz, C. N. (2009) · American Journal of Physiology-Cell Physiology · doi:10.1152/ajpcell.00160.2009 · Cited by 112
“Inflammatory bowel disease is a condition that can be treated with the cholinergic agonist nicotine experimentally (59) and clinically (14, 16, 44, 52), as well as with anti-IL-6R antibody (24).”
BackgroundGalitovskiy, V., Qian, J., Chernyavsky, A. I., Marchenko, S. A., Gindi, V., Edwards, R. A., & Grando, S. A. (2011) · The Journal of Immunology · doi:10.4049/jimmunol.1002711 · Cited by 110
Romagnuolo, J., Fedorak, R. N., Dias, V. C., Bamforth, F. J., & Teltscher, M. (2001) · The American Journal of Gastroenterology · doi:10.1016/s0002-9270(01)02513-8 · Cited by 109
The Influence of Cigarette Smoking on Cytokine Levels in Patients with Inflammatory Bowel Disease
Sher, M. E., Bank, S., Greenberg, R., Sardinha, T. C., Weissman, S., Bailey, B., Gilliland, R., & Wexner, S. D. (1999) · Inflammatory Bowel Diseases · doi:10.1097/00054725-199905000-00001 · Cited by 107
Inflammatory Bowel Disease and Smoking--A Review
Thomas, G. A. O., Rhodes, J., & Green, J. T. (1998) · The American Journal of Gastroenterology · doi:10.1111/j.1572-0241.1998.00144.x · Cited by 107
Self-citationSympathetic overactivity in active ulcerative colitis: effects of clonidine
Furlan, R., Ardizzone, S., Palazzolo, L., Rimoldi, A., Perego, F., Barbic, F., Bevilacqua, M. T., Vago, L., Porro, G. B., & Malliani, A. (2005) · American Journal of Physiology-Regulatory, Integrative and Comparative Physiology · doi:10.1152/ajpregu.00442.2005 · Cited by 107
“On the other hand, the increase of parasympathetic drive to the organs by nicotine patch was found to ameliorate the inflammatory state in UC patients (32).”
BackgroundSystematic review: interventions for abdominal pain management in inflammatory bowel disease
Norton, C. S., Czuber‐Dochan, W., Artom, M., Sweeney, L., & Hart, A. L. (2017) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.14108 · Cited by 110
“In another RCT, 72 participants with active UC were randomised into a transdermal nicotine patch or placebo group and the effects on symptom improvement were examined.(44) Over a 6 week period, participants were given patches releasing 5 mg or 15 mg of nicotine”
Farsalinos, K. E., Eliopoulos, E., Leonidas, D. D., Papadopoulos, G. E., Tzartos, S. J., & Poulas, K. A. (2020) · International Journal of Molecular Sciences · doi:10.3390/ijms21165807 · Cited by 99
MEDICAL THERAPY FOR INFLAMMATORY BOWEL DISEASE
Stein, R. B., & Hanauer, S. B. (1999) · Gastroenterology Clinics of North America · doi:10.1016/s0889-8553(05)70058-3 · Cited by 94
Medical therapy for ulcerative colitis
Jani, N. D., & Regueiro, M. D. (2002) · Gastroenterology Clinics of North America · doi:10.1016/s0889-8553(01)00010-3 · Cited by 93
Inflammatory bowel disease: Is there any relation between smoking status and disease presentation?
Rüssel, M. G., Volovics, A., Schoon, E. J., van Wijlick, E. H. J., Logan, R. F., Shivananda, S., & Stockbrügger, R. W. (2007) · Inflammatory Bowel Diseases · doi:10.1002/ibd.3780040303 · Cited by 92
Cytokines in inflammatory bowel disease
Beck, P., & Wallace, J. L. (1997) · Mediators of Inflammation · doi:10.1080/09629359791785 · Cited by 90
“For several years, nicotine has been suggested to decrease activity in UC and recently it has been found to be effective in the treatment of active UC (but not in the maintenance of remission).(17,18) The mechanism of action of nicotine in the treatment of UC is not well understood, but it has been suggested to be due…”
BackgroundEtiopathogenesis of Inflammatory Bowel Disease: The Importance of the Pediatric Perspective
Oliva‐Hemker, M. M., & Fiocchi, C. (2002) · Inflammatory Bowel Diseases · doi:10.1097/00054725-200203000-00008 · Cited by 88
Role of smoking in inflammatory bowel disease: implications for therapy
Thomas, G. A. O., Rhodes, J., Green, J. T., & Richardson, C. (2000) · Postgraduate Medical Journal · doi:10.1136/pmj.76.895.273 · Cited by 87
Self-citationFatahzadeh, M. (2009) · Oral Surgery Oral Medicine Oral Pathology Oral Radiology and Endodontology · doi:10.1016/j.tripleo.2009.07.035 · Cited by 87
Nicotine Monitoring with a Wearable Sweat Band
Tai, L., Ahn, C. H., Nyein, H. Y. Y., Ji, W., Bariya, M., Lin, Y., Li, L., & Javey, A. (2020) · ACS Sensors · doi:10.1021/acssensors.0c00791 · Cited by 87
Nicotine exposure altersin vivohuman responses to endotoxin
Wittebole, X., Hahm, S. J., Coyle, S. M., Kumar, A., Calvano, S. E., & Lowry, S. F. (2006) · Clinical & Experimental Immunology · doi:10.1111/j.1365-2249.2006.03248.x · Cited by 86
Neuro‐glial crosstalk in inflammatory bowel disease
Neunlist, M., Landeghem, L. V., Bourreille, A., & Savidge, T. (2008) · Journal of Internal Medicine · doi:10.1111/j.1365-2796.2008.01963.x · Cited by 82
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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