RESEARCH PAPER
Adverse events associated with nicotine replacement therapy (NRT) for smoking cessation. A systematic review and meta-analysis of one hundred and twenty studies involving 177,390 individuals
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1
Faculty of Health Sciences, University of Ottawa, Ottawa, Canada
 
2
Department of Epidemiology, London School of Hygiene & Tropical Medicine, London, UK
 
3
Pfizer Limited, Tadworth, UK
 
4
Ottawa Health Research Institute, Ottawa, Canada
 
5
Mayo Graduate School of Medicine, Mayo Clinic, Rochester, USA
 
 
Submission date: 2010-01-21
 
 
Acceptance date: 2010-07-13
 
 
Publication date: 2010-07-13
 
 
Corresponding author
Edward J Mills   

Faculty of Health Sciences, University of Ottawa, Ottawa, Canada
 
 
Tobacco Induced Diseases 2010;8(July):8
 
KEYWORDS
ABSTRACT
Background:
Nicotine replacement therapy (NRT) is the most common form of smoking cessation pharmacotherapy and has proven efficacy for the treatment of tobacco dependence. Although expectations of mild adverse effects have been observed to be independent predictors of reduced motivation to use NRT, adverse effects associated with NRT have not been precisely quantified.

Objective:
A systematic review and meta-analysis aimed to identify all randomized clinical trials (RCTs) of NRT versus inert controls and all observational studies to determine the magnitude of reported adverse effects with NRT.

Methods:
Searches of 10 electronic databases from inception to November 2009 were conducted. Study selection and data extraction were carried out independently in duplicate. RCTs were pooled using a random effects method with Odds Ratio [OR] as the effect measure, while proportions were pooled from observational studies. A meta-regression analysis was applied to examine whether the nicotine patch is associated with different adverse effects from those common to orally administered NRT.

Results:
Ninety-two RCTs involving 32,185 participants and 28 observational studies involving 145, 205 participants were identified. Pooled RCT evidence of varying NRT formulations found an increased risk of heart palpitations and chest pains (OR 2.06, 95% Confidence Interval [CI] 1.51-2.82, P < 0.001); nausea and vomiting (OR 1.67, 95% CI 1.37-2.04, P < 0.001); gastrointestinal complaints (OR 1.54, 95% CI, 1.25-1.89, P < 0.001); and insomnia (OR 1.42, 95% CI, 1.21-1.66, P < 0.001). Pooled evidence specific to the NRT patch found an increase in skin irritations (OR 2.80, 95% CO, 2.28-3.24, P < 0.001). Orally administered NRT was associated with mouth and throat soreness (OR 1.87, 95% CI, 1.36-2.57, P < 0.001); mouth ulcers (OR 1.49, 95% CI, 1.05-2.20, P < 0.001); hiccoughs (OR 7.68, 95% CI, 4.59-12.85, P < 0.001) and coughing (OR 2.89, 95% CI, 1.92-4.33, P < 0.001). There was no statistically significant increase in anxiety or depressive symptoms associated with NRT use. Non-comparative observational studies demonstrated the prevalence of these events in a broad population.

Conclusion:
The use of NRT is associated with a variety of side effects. In addition to counseling and medical monitoring, clinicians should inform patients of potential side effects which are associated with the use of NRT for the treatment of tobacco dependence.

 
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Jinchun Zeng, Yizu Liao, Xiaojing Wei, Guangxian Chen, Zibin Cai, Min Chen, Yanhua Gou, Guohua Lin
Frontiers in Neurology
 
82.
A systematic review of genetic variation within nicotinic acetylcholine receptor genes and cigarette smoking cessation
Stephanie Jones, Bethany Wolf, Brett Froeliger, Kristin Wallace, Matthew Carpenter, Anthony Alberg
Drug and Alcohol Dependence
 
83.
Understanding Hesitation to Use Nicotine Replacement Therapy: A Content Analysis of Posts in Online Tobacco-Cessation Support Groups
Connor Phillips, Cornelia Pechmann, Douglas Calder, Judith Prochaska
American Journal of Health Promotion
 
84.
Bibliometric analysis of traditional Chinese medicine for smoking cessation
Jingli Xing, Jianping Liu, Mei Han, Yue Jiang, Jiali Jiang, He Huang
Tobacco Induced Diseases
 
85.
An Open-label Pilot Study of NicoBloc as a Novel Smoking Cessation Intervention
Keith Chichester, Michelle Sisson, Sofia Chana, Caitlin Wolford-Clevenger, Mickeah Hugley, Elizabeth Hawes, Paige Palenski, Angela Nguyen, Jennifer Dahne, Peter Hendricks, Karen Cropsey
Journal of Addiction Medicine
 
86.
Design and Preclinical Evaluation of Nicotine–Stearic Acid Conjugate-Loaded Solid Lipid Nanoparticles for Transdermal Delivery: A Technical Note
Jwala Renukuntla, Samuel Peterson-Sockwell, Bradley Clark, Nipunika Godage, Emanuela Gionfriddo, Pradeep Bolla, Sai Boddu
Pharmaceutics
 
87.
Common adverse events of electronic cigarettes compared with traditional nicotine replacement therapies: A systematic review and meta‐analysis
Aathavan Anandan, Janni Leung, Gary Chan, Tianze Sun, Jason Connor, Wayne Hall, Daniel Stjepanović
Drug and Alcohol Review
 
88.
Comparison between cytisine and Nicotine Replacement Therapy in smoking cessation among inpatient psychiatric patients
Maria Tavakoli-Ardakani, Sani Gholamzadeh, Narges Beyraghi, Shadi Najarimoghadam, Ali Kheradmand
Journal of Addictive Diseases
 
89.
Cholinergic modulation of sensory perception and plasticity
Ansley Kunnath, René Gifford, Mark Wallace
Neuroscience & Biobehavioral Reviews
 
90.
Nicotine pouches: a review for the dental team
Jackson M., Anthony Weke, Richard Holliday
British Dental Journal
 
91.
Perceptions, intentions, and actual use of a consumer nicotine gum
Cheryl Olson, Neil Sherwood, Maia Berkane, Karin Gilligan, Willie McKinney
Harm Reduction Journal
 
92.
Nicotine-based Interventions for Adult Smokers with Diabetes: A Systematic Review
Farhana Haseen, Nafis Rahman, As-Saba Hossain, Sohel Rana, Asif Chowdhury, Hasna Mahmud, Joanne Coyle, Sophie Notley, Gabriel Barnard, Neil McKeganey
 
93.
Clinical challenges facing patient participation in cardiac rehabilitation: cigarette smoking
Diann E. Gaalema, Sherrie Khadanga, Quinn R. Pack
Expert Review of Cardiovascular Therapy
 
94.
Type-switching of short-acting nicotine replacement therapy products and its implications for treatment
Scott Veldhuizen, Laurie Zawertailo, Peter Selby
Journal of Substance Use and Addiction Treatment
 
95.
Chronic nicotine exposure is associated with electrophysiological and sympathetic remodeling in the intact rabbit heart
Amanda Guevara, Charlotte E.R. Smith, Jessica L. Caldwell, Lena Ngo, Lilian R. Mott, I-Ju Lee, inivas Tapa, Zhen Wang, Lianguo Wang, William R. Woodward, G. Andre Ng, Beth A. Habecker, Crystal M. Ripplinger
 
96.
The Efficacy of Body Acupuncture Combined with Ear Acupressure versus Frequent Counseling as Adjuvant Therapy for Quitting Smoking – An Intervention Pilot Study
Asmaa Mahmoud Mohammed, Mona Samir Allam, Hend Rashad, Adel F. Hashish
Journal of Public Health and Primary Care
 
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