Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Tobacco Induced Diseases
Published in: Tobacco Induced Diseases 1/2010

Open Access 01-12-2010 | Research

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

Authors: Edward J Mills, Ping Wu, Ian Lockhart, Kumanan Wilson, Jon O Ebbert

Published in: Tobacco Induced Diseases | Issue 1/2010

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
Peto R, Lopez AD, Boreham J, Thun M, Heath C, Doll R: Mortality from smoking worldwide. Br Med Bull. 1996, 52: 12-21.PubMed
2.
Doll R, Peto R, Wheatley K, Gray R, Sutherland I: Mortality in relation to smoking: 40 years' observations on male British doctors. Bmj. 1994, 309: 901-11.PubMedCentralPubMed
3.
Asaria P, Chisholm D, Mathers C, Ezzati M, Beaglehole R: Chronic disease prevention: health effects and financial costs of strategies to reduce salt intake and control tobacco use. Lancet. 2007, 370: 2044-53. 10.1016/S0140-6736(07)61698-5.PubMed
4.
Wu P, Wilson K, Dimoulas P, Mills EJ: Effectiveness of smoking cessation therapies: a systematic review and meta-analysis. BMC Public Health. 2006, 6: 300-10.1186/1471-2458-6-300.PubMedCentralPubMed
5.
6.
Eisenberg MJ, Filion KB, Yavin D, Belisle P, Mottillo S, Joseph L: Pharmacotherapies for smoking cessation: a meta-analysis of randomized controlled trials. Cmaj. 2008, 179: 135-44.PubMedCentralPubMed
7.
Vjogt F, Hall S, Marteau TM: Understanding why smokers do not want to use nicotine dependence medications to stop smoking: qualitative and quantitative studies. Nicotine Tob Res. 2008, 10: 1405-13. 10.1080/14622200802239280.
8.
Hughes JR: Effects of abstinence from tobacco: valid symptoms and time course. Nicotine Tob Res. 2007, 9: 315-27. 10.1080/14622200701188919.PubMed
9.
Chou R, Helfand M: Challenges in systematic reviews that assess treatment harms. Ann Intern Med. 2005, 142: 1090-9.PubMed
10.
Kuper H, Nicholson A, Hemingway H: Searching for observational studies: what does citation tracking add to PubMed? A case study in depression and coronary heart disease. BMC medical research methodology. 2006, 6: 4-10.1186/1471-2288-6-4.PubMedCentralPubMed
11.
Tonnesen P: Smoking cessation: How compelling is the evidence? A review. Health policy (Amsterdam, Netherlands). 2009, 91 (Suppl 1): S15-25.
12.
Mills EJ, Wu P, Spurden D, Ebbert JO, Wilson K: Efficacy of pharmacotherapies for short-term smoking abstinance: A systematic review and meta-analysis. Harm Reduct J. 2009, 6: 25-10.1186/1477-7517-6-25.PubMedCentralPubMed
13.
Stead LF, Perera R, Bullen C, Mant D, Lancaster T: Nicotine replacement therapy for smoking cessation. Cochrane database of systematic reviews (Online). 2008, CD000146.
14.
Stead LF, Lancaster T: Interventions to reduce harm from continued tobacco use. Cochrane database of systematic reviews (Online). 2007, CD005231.
15.
Cahill K, Stead LF, Lancaster T: Nicotine receptor partial agonists for smoking cessation. Cochrane database of systematic reviews (Online). 2007, CD006103.
16.
Woolacott NF, Jones L, Forbes CA, Mather LC, Sowden AJ, Song FJ: The clinical effectiveness and cost-effectiveness of bupropion and nicotine replacement therapy for smoking cessation: a systematic review and economic evaluation. Health technology assessment (Winchester, England). 2002, 6: 1-245.
17.
Meade MO, Guyatt GH, Cook RJ, Groll R, Kachura JR, Wigg M: Agreement between alternative classifications of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2001, 163: 490-3.PubMed
18.
Sheehe PR: Combination of log relative risk in retrospective studies of disease. Am J Public Health Nations Health. 1966, 56: 1745-50.PubMedCentralPubMed
19.
DerSimonian R, Laird N: Meta-analysis in clinical trials. Control Clin Trials. 1986, 7: 177-88. 10.1016/0197-2456(86)90046-2.PubMed
20.
Fleiss JL: The statistical basis of meta-analysis. Stat Methods Med Res. 1993, 2: 121-45. 10.1177/096228029300200202.PubMed
21.
Higgins JP, Thompson SG: Quantifying heterogeneity in a meta-analysis. Stat Med. 2002, 21: 1539-58. 10.1002/sim.1186.PubMed
22.
Stuart A, Ord JK: Kendall's Advanced Theory of Statistics. 1994, London: Edward Arnold, 6
23.
Borenstin M, Hedges L, Higgins JP, Rothstein H: Introduction to Meta-analysis. 2009, Wiley, Chichester, 312.
24.
Mills EJ, Nachega JB, Bangsberg DR, Singh S, Rachlis B, Wu P: Adherence to HAART: a systematic review of developed and developing nation patient-reported barriers and facilitators. PLoS medicine. 2006, 3: e438-10.1371/journal.pmed.0030438.PubMedCentralPubMed
25.
Rucker G, Schwarzer G, Carpenter JR, Schumacher M: Undue reliance on I(2) in assessing heterogeneity may mislead. BMC medical research methodology. 2008, 8: 79-10.1186/1471-2288-8-79.PubMedCentralPubMed
26.
Malcolm RE, Sillett RW, Turner JA, Ball KP: The use of nicotine chewing gum as an aid to stopping smoking. Psychopharmacology (Berl). 1980, 70: 295-6. 10.1007/BF00427889.
27.
Jarvis MJ, Raw M, Russell MA, Feyerabend C: Randomised controlled trial of nicotine chewing-gum. Br Med J (Clin Res Ed). 1982, 285: 537-40. 10.1136/bmj.285.6341.537.
28.
Fagerstrom KO: A comparison of psychological and pharmacological treatment in smoking cessation. J Behav Med. 1982, 5: 343-51. 10.1007/BF00846161.PubMed
29.
Comparison of four methods of smoking withdrawal in patients with smoking related diseases. Report by a subcommittee of the Research Committee of the British Thoracic Society. Br Med J (Clin Res Ed). 1983, 286: 595-7. 10.1136/bmj.286.6365.595.
30.
Schneider NG, Jarvik ME, Forsythe AB, Read LL, Elliott ML, Schweiger A: Nicotine gum in smoking cessation: a placebo-controlled, double-blind trial. Addict Behav. 1983, 8: 253-61. 10.1016/0306-4603(83)90020-5.PubMed
31.
Jamrozik K, Fowler G, Vessey M, Wald N: Placebo controlled trial of nicotine chewing gum in general practice. Br Med J (Clin Res Ed). 1984, 289: 794-7. 10.1136/bmj.289.6448.794.
32.
Tonnesen P, Fryd V, Hansen M, Helsted J, Gunnersen AB, Forchammer H: Two and four mg nicotine chewing gum and group counselling in smoking cessation: an open, randomized, controlled trial with a 22 month follow-up. Addict Behav. 1988, 13: 17-27. 10.1016/0306-4603(88)90021-4.PubMed
33.
Areechon W, Punnotok J: Smoking cessation through the use of nicotine chewing gum: a double-blind trial in Thailand. Clin Ther. 1988, 10: 183-6.PubMed
34.
Fortmann SP, Killen JD, Telch MJ, Newman B: Minimal contact treatment for smoking cessation. A placebo controlled trial of nicotine polacrilex and self-directed relapse prevention: initial results of the Stanford Stop Smoking Project. Jama. 1988, 260: 1575-80. 10.1001/jama.260.11.1575.PubMed
35.
Harackiewicz JM, Blair LW, Sansone C, Epstein JA, Stuchell RN: Nicotine gum and self-help manuals in smoking cessation: an evaluation in a medical context. Addict Behav. 1988, 13: 319-30. 10.1016/0306-4603(88)90038-X.PubMed
36.
Tonnesen P, Fryd V, Hansen M, Helsted J, Gunnersen AB, Forchammer H: Effect of nicotine chewing gum in combination with group counseling on the cessation of smoking. N Engl J Med. 1988, 318: 15-8. 10.1056/NEJM198801073180104.PubMed
37.
Hughes JR, Gust SW, Keenan RM, Fenwick JW, Healey ML: Nicotine vs placebo gum in general medical practice. Jama. 1989, 261: 1300-5. 10.1001/jama.261.9.1300.PubMed
38.
Blondal T: Controlled trial of nicotine polacrilex gum with supportive measures. Arch Intern Med. 1989, 149: 1818-21. 10.1001/archinte.149.8.1818.PubMed
39.
Abelin T, Ehrsam R, Buhler-Reichert A, Imhof PR, Muller P, Thommen A: Effectiveness of a transdermal nicotine system in smoking cessation studies. Methods Find Exp Clin Pharmacol. 1989, 11: 205-14.PubMed
40.
Hurt RD, Lauger GG, Offord KP, Kottke TE, Dale LC: Nicotine-replacement therapy with use of a transdermal nicotine patch--a randomized double-blind placebo-controlled trial. Mayo Clin Proc. 1990, 65: 1529-37.PubMed
41.
Tonnesen P, Norregaard J, Simonsen K, Sawe U: A double-blind trial of a 16-hour transdermal nicotine patch in smoking cessation. N Engl J Med. 1991, 325: 311-5. 10.1056/NEJM199108013250503.PubMed
42.
Campbell IA, Prescott RJ, Tjeder-Burton SM: Smoking cessation in hospital patients given repeated advice plus nicotine or placebo chewing gum. Respir Med. 1991, 85: 155-7. 10.1016/S0954-6111(06)80295-7.PubMed
43.
Daughton DM, Heatley SA, Prendergast JJ, Causey D, Knowles M, Rolf CN: Effect of transdermal nicotine delivery as an adjunct to low-intervention smoking cessation therapy. A randomized, placebo-controlled, double-blind study. Arch Intern Med. 1991, 151: 749-52. 10.1001/archinte.151.4.749.PubMed
44.
Sutherland G, Stapleton JA, Russell MA, Jarvis MJ, Hajek P, Belcher M: Randomised controlled trial of nasal nicotine spray in smoking cessation. Lancet. 1992, 340: 324-9. 10.1016/0140-6736(92)91403-U.PubMed
45.
Sachs DP, Sawe U, Leischow SJ: Effectiveness of a 16-hour transdermal nicotine patch in a medical practice setting, without intensive group counseling. Arch Intern Med. 1993, 153: 1881-90. 10.1001/archinte.153.16.1881.PubMed
46.
Tonnesen P, Norregaard J, Mikkelsen K, Jorgensen S, Nilsson F: A double-blind trial of a nicotine inhaler for smoking cessation. Jama. 1993, 269: 1268-71. 10.1001/jama.269.10.1268.PubMed
47.
Merz PG, Keller-Stanislawski B, Huber T, Woodcock BG, Rietbrock N: Transdermal nicotine in smoking cessation and involvement of non-specific influences. Int J Clin Pharmacol Ther Toxicol. 1993, 31: 476-82.PubMed
48.
Russell MA, Stapleton JA, Feyerabend C, Wiseman SM, Gustavsson G, Sawe U: Targeting heavy smokers in general practice: randomised controlled trial of transdermal nicotine patches. Bmj. 1993, 306: 1308-12. 10.1136/bmj.306.6888.1308.PubMedCentralPubMed
49.
Westman EC, Levin ED, Rose JE: The nicotine patch in smoking cessation. A randomized trial with telephone counseling. Arch Intern Med. 1993, 153: 1917-23. 10.1001/archinte.153.16.1917.PubMed
50.
Hjalmarson A, Franzon M, Westin A, Wiklund O: Effect of nicotine nasal spray on smoking cessation. A randomized, placebo-controlled, double-blind study. Arch Intern Med. 1994, 154: 2567-72. 10.1001/archinte.154.22.2567.PubMed
51.
Hurt RD, Dale LC, Fredrickson PA, Caldwell CC, Lee GA, Offord KP: Nicotine patch therapy for smoking cessation combined with physician advice and nurse follow-up. One-year outcome and percentage of nicotine replacement. Jama. 1994, 271: 595-600. 10.1001/jama.271.8.595.PubMed
52.
Fiore MC, Kenford SL, Jorenby DE, Wetter DW, Smith SS, Baker TB: Two studies of the clinical effectiveness of the nicotine patch with different counseling treatments. Chest. 1994, 105: 524-33. 10.1378/chest.105.2.524.PubMed
53.
Richmond RL, Harris K, de Almeida Neto A: The transdermal nicotine patch: results of a randomised placebo-controlled trial. Med J Aust. 1994, 161: 130-5.PubMed
54.
Levin ED, Westman EC, Stein RM, Carnahan E, Sanchez M, Herman S: Nicotine skin patch treatment increases abstinence, decreases withdrawal symptoms, and attenuates rewarding effects of smoking. J Clin Psychopharmacol. 1994, 14: 41-9. 10.1097/00004714-199402000-00006.PubMed
55.
Stapleton JA, Russell MA, Feyerabend C, Wiseman SM, Gustavsson G, Sawe U: Dose effects and predictors of outcome in a randomized trial of transdermal nicotine patches in general practice. Addiction. 1995, 90: 31-42. 10.1111/j.1360-0443.1995.tb01007.x.PubMed
56.
Herrera N, Franco R, Herrera L, Partidas A, Rolando R, Fagerstrom KO: Nicotine gum, 2 and 4 mg, for nicotine dependence. A double-blind placebo-controlled trial within a behavior modification support program. Chest. 1995, 108: 447-51. 10.1378/chest.108.2.447.PubMed
57.
Schneider NG, Olmstead R, Mody FV, Doan K, Franzon M, Jarvik ME: Efficacy of a nicotine nasal spray in smoking cessation: a placebo-controlled, double-blind trial. Addiction. 1995, 90: 1671-82. 10.1111/j.1360-0443.1995.tb02837.x.PubMed
58.
Puska PKH, Vartiainen E, Urjanheimo E: Combined use of nicotine patch and gum compared with gum alone in smoking cessation: a clinical trial in North Karelia. Tabacco Control. 1995, 4: 231-5. 10.1136/tc.4.3.231.
59.
Kornitzer M, Boutsen M, Dramaix M, Thijs J, Gustavsson G: Combined use of nicotine patch and gum in smoking cessation: a placebo-controlled clinical trial. Prev Med. 1995, 24: 41-7. 10.1006/pmed.1995.1006.PubMed
60.
Dale LC, Hurt RD, Offord KP, Lawson GM, Croghan IT, Schroeder DR: High-dose nicotine patch therapy. Percentage of replacement and smoking cessation. Jama. 1995, 274: 1353-8. 10.1001/jama.274.17.1353.PubMed
61.
Gourlay SG, Forbes A, Marriner T, Pethica D, McNeil JJ: Double blind trial of repeated treatment with transdermal nicotine for relapsed smokers. Bmj. 1995, 311: 363-6.PubMedCentralPubMed
62.
Leischow SJN, Franzo F, Hill M, Otte A, Merikle P, E P: Efficacy of the Nicotine Inhaler as an Adjunct to Smoking Cessation. American Journal of Health Behavior. 1996, 20: 364-71.
63.
Schneider NG, Olmstead R, Nilsson F, Mody FV, Franzon M, Doan K: Efficacy of a nicotine inhaler in smoking cessation: a double-blind, placebo-controlled trial. Addiction. 1996, 91: 1293-306.PubMed
64.
Paoletti P, Fornai E, Maggiorelli F, Puntoni R, Viegi G, Carrozzi L: Importance of baseline cotinine plasma values in smoking cessation: results from a double-blind study with nicotine patch. Eur Respir J. 1996, 9: 643-51. 10.1183/09031936.96.09040643.PubMed
65.
Blondal T, Franzon M, Westin A: A double-blind randomized trial of nicotine nasal spray as an aid in smoking cessation. Eur Respir J. 1997, 10: 1585-90. 10.1183/09031936.97.10071585.PubMed
66.
Campbell IA, Prescott RJ, Tjeder-Burton SM: Transdermal nicotine plus support in patients attending hospital with smoking-related diseases: a placebo-controlled study. Respir Med. 1996, 90: 47-51. 10.1016/S0954-6111(96)90244-9.PubMed
67.
Hjalmarson A, Nilsson F, Sjostrom L, Wiklund O: The nicotine inhaler in smoking cessation. Arch Intern Med. 1997, 157: 1721-8. 10.1001/archinte.157.15.1721.PubMed
68.
Sonderskov J, Olsen J, Sabroe S, Meillier L, Overvad K: Nicotine patches in smoking cessation: a randomized trial among over-the-counter customers in Denmark. Am J Epidemiol. 1997, 145: 309-18.PubMed
69.
Perng RP, Hsieh WC, Chen YM, Lu CC, Chiang SJ: Randomized, double-blind, placebo-controlled study of transdermal nicotine patch for smoking cessation. J Formos Med Assoc. 1998, 97: 547-51.PubMed
70.
Ahluwalia JS, McNagny SE, Clark WS: Smoking cessation among inner-city African Americans using the nicotine transdermal patch. J Gen Intern Med. 1998, 13: 1-8. 10.1046/j.1525-1497.1998.00001.x.PubMedCentralPubMed
71.
Lewis SF, Piasecki TM, Fiore MC, Anderson JE, Baker TB: Transdermal nicotine replacement for hospitalized patients: a randomized clinical trial. Prev Med. 1998, 27: 296-303. 10.1006/pmed.1998.0266.PubMed
72.
Davidson M, Epstein M, Burt R, Schaefer C, Whitworth G, McDonald A: Efficacy and safety of an over-the-counter transdermal nicotine patch as an aid for smoking cessation. Arch Fam Med. 1998, 7: 569-74. 10.1001/archfami.7.6.569.PubMed
73.
Blondal T, Gudmundsson LJ, Olafsdottir I, Gustavsson G, Westin A: Nicotine nasal spray with nicotine patch for smoking cessation: randomised trial with six year follow up. Bmj. 1999, 318: 285-8.PubMedCentralPubMed
74.
Tonnesen P, Paoletti P, Gustavsson G, Russell MA, Saracci R, Gulsvik A: Higher dosage nicotine patches increase one-year smoking cessation rates: results from the European CEASE trial. Collaborative European Anti-Smoking Evaluation. European Respiratory Society. Eur Respir J. 1999, 13: 238-46. 10.1034/j.1399-3003.1999.13b04.x.PubMed
75.
Hays JT, Croghan IT, Schroeder DR, Offord KP, Hurt RD, Wolter TD: Over-the-counter nicotine patch therapy for smoking cessation: results from randomized, double-blind, placebo-controlled, and open label trials. Am J Public Health. 1999, 89: 1701-7. 10.2105/AJPH.89.11.1701.PubMedCentralPubMed
76.
Jorenby DE, Leischow SJ, Nides MA, Rennard SI, Johnston JA, Hughes AR: A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation. N Engl J Med. 1999, 340: 685-91. 10.1056/NEJM199903043400903.PubMed
77.
Bohadana A, Nilsson F, Rasmussen T, Martinet Y: Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. Arch Intern Med. 2000, 160: 3128-34. 10.1001/archinte.160.20.3128.PubMed
78.
Bolliger CT, Zellweger JP, Danielsson T, van Biljon X, Robidou A, Westin A: Smoking reduction with oral nicotine inhalers: double blind, randomised clinical trial of efficacy and safety. Bmj. 2000, 321: 329-33. 10.1136/bmj.321.7257.329.PubMedCentralPubMed
79.
Garvey AJ, Kinnunen T, Nordstrom BL, Utman CH, Doherty K, Rosner B: Effects of nicotine gum dose by level of nicotine dependence. Nicotine Tob Res. 2000, 2: 53-63. 10.1080/14622200050011303.PubMed
80.
Wallstrom M, Nilsson F, Hirsch JM: A randomized, double-blind, placebo-controlled clinical evaluation of a nicotine sublingual tablet in smoking cessation. Addiction. 2000, 95: 1161-71.PubMed
81.
Wisborg K, Henriksen TB, Jespersen LB, Secher NJ: Nicotine patches for pregnant smokers: A randomized controlled study. Obstet Gynecol. 2000, 96: 967-71. 10.1016/S0029-7844(00)01071-1.PubMed
82.
Etter JF, Laszlo E, Zellweger JP, Perrot C, Perneger TV: Nicotine replacement to reduce cigarette consumption in smokers who are unwilling to quit: a randomized trial. J Clin Psychopharmacol. 2002, 22: 487-95. 10.1097/00004714-200210000-00008.PubMed
83.
Shiffman S, Gorsline J, Gorodetzky CW: Efficacy of over-the-counter nicotine patch. Nicotine Tob Res. 2002, 4: 477-83. 10.1080/1462220021000018416.PubMed
84.
Glover ED, Glover PN, Franzon M, Sullivan CR, Cerullo CC, Howell RM: A comparison of a nicotine sublingual tablet and placebo for smoking cessation. Nicotine Tob Res. 2002, 4: 441-50. 10.1080/1462220021000018443.PubMed
85.
Shiffman S, Dresler CM, Hajek P, Gilburt SJ, Targett DA, Strahs KR: Efficacy of a nicotine lozenge for smoking cessation. Arch Intern Med. 2002, 162: 1267-76. 10.1001/archinte.162.11.1267.PubMed
86.
Hand S, Edwards S, Campbell IA, Cannings R: Controlled trial of three weeks nicotine replacement treatment in hospital patients also given advice and support. Thorax. 2002, 57: 715-8. 10.1136/thorax.57.8.715.PubMedCentralPubMed
87.
Glavas D, Rumboldt M, Rumboldt Z: Smoking cessation with nicotine replacement therapy among health care workers: randomized double-blind study. Croat Med J. 2003, 44: 219-24.PubMed
88.
Wennike P, Danielsson T, Landfeldt B, Westin A, Tonnesen P: Smoking reduction promotes smoking cessation: results from a double blind, randomized, placebo-controlled trial of nicotine gum with 2-year follow-up. Addiction. 2003, 98: 1395-402. 10.1046/j.1360-0443.2003.00489.x.PubMed
89.
Hughes JR, Novy P, Hatsukami DK, Jensen J, Callas PW: Efficacy of nicotine patch in smokers with a history of alcoholism. Alcohol Clin Exp Res. 2003, 27: 946-54.PubMed
90.
Hanson K, Allen S, Jensen S, Hatsukami D: Treatment of adolescent smokers with the nicotine patch. Nicotine Tob Res. 2003, 5: 515-26. 10.1080/14622200307243.PubMed
91.
Molyneux A, Lewis S, Leivers U, Anderton A, Antoniak M, Brackenridge A: Clinical trial comparing nicotine replacement therapy (NRT) plus brief counselling, brief counselling alone, and minimal intervention on smoking cessation in hospital inpatients. Thorax. 2003, 58: 484-8. 10.1136/thorax.58.6.484.PubMedCentralPubMed
92.
Smith SS, Jorenby DE, Leischow SJ, Nides MA, Rennard SI, Johnston JA: Targeting smokers at increased risk for relapse: treating women and those with a history of depression. Nicotine Tob Res. 2003, 5: 99-109. 10.1080/1462220021000060437.PubMed
93.
Schuurmans MM, Diacon AH, van Biljon X, Bolliger CT: Effect of pre-treatment with nicotine patch on withdrawal symptoms and abstinence rates in smokers subsequently quitting with the nicotine patch: a randomized controlled trial. Addiction. 2004, 99: 634-40. 10.1111/j.1360-0443.2004.00711.x.PubMed
94.
Moolchan ET, Robinson ML, Ernst M, Cadet JL, Pickworth WB, Heishman SJ: Safety and efficacy of the nicotine patch and gum for the treatment of adolescent tobacco addiction. Pediatrics. 2005, 115: e407-14. 10.1542/peds.2004-1894.PubMed
95.
Batra A, Klingler K, Landfeldt B, Friederich HM, Westin A, Danielsson T: Smoking reduction treatment with 4-mg nicotine gum: a double-blind, randomized, placebo-controlled study. Clin Pharmacol Ther. 2005, 78: 689-96. 10.1016/j.clpt.2005.08.019.PubMed
96.
Rennard SI, Glover ED, Leischow S, Daughton DM, Glover PN, Muramoto M: Efficacy of the nicotine inhaler in smoking reduction: A double-blind, randomized trial. Nicotine Tob Res. 2006, 8: 555-64. 10.1080/14622200600789916.PubMed
97.
Tonnesen P, Mikkelsen K, Bremann L: Nurse-conducted smoking cessation in patients with COPD using nicotine sublingual tablets and behavioral support. Chest. 2006, 130: 334-42. 10.1378/chest.130.2.334.PubMed
98.
Hotham ED, Gilbert AL, Atkinson ER: A randomised-controlled pilot study using nicotine patches with pregnant women. Addict Behav. 2006, 31: 641-8. 10.1016/j.addbeh.2005.05.042.PubMed
99.
Myung SK, Seo HG, Park S, Kim Y, Kim DJ, Lee do H: Sociodemographic and smoking behavioral predictors associated with smoking cessation according to follow-up periods: a randomized, double-blind, placebo-controlled trial of transdermal nicotine patches. J Korean Med Sci. 2007, 22: 1065-70. 10.3346/jkms.2007.22.6.1065.PubMedCentralPubMed
100.
Covey LS, Glassman AH, Jiang H, Fried J, Masmela J, LoDuca C: A randomized trial of bupropion and/or nicotine gum as maintenance treatment for preventing smoking relapse. Addiction. 2007, 102: 1292-302. 10.1111/j.1360-0443.2007.01887.x.PubMed
101.
Piper ME, Federman EB, McCarthy DE, Bolt DM, Smith SS, Fiore MC: Efficacy of bupropion alone and in combination with nicotine gum. Nicotine Tob Res. 2007, 9: 947-54. 10.1080/14622200701540820.PubMedCentralPubMed
102.
Oncken C, Cooney J, Feinn R, Lando H, Kranzler HR: Transdermal nicotine for smoking cessation in postmenopausal women. Addict Behav. 2007, 32: 296-309. 10.1016/j.addbeh.2006.04.004.PubMed
103.
Uyar M, Filiz A, Bayram N, Elbek O, Herken H, Topcu A: A randomized trial of smoking cessation. Medication versus motivation. Saudi Med J. 2007, 28: 922-6.PubMed
104.
Pollak KI, Oncken CA, Lipkus IM, Lyna P, Swamy GK, Pletsch PK: Nicotine replacement and behavioral therapy for smoking cessation in pregnancy. Am J Prev Med. 2007, 33: 297-305. 10.1016/j.amepre.2007.05.006.PubMedCentralPubMed
105.
Joseph AM, Norman SM, Ferry LH, Prochazka AV, Westman EC, Steele BG: The safety of transdermal nicotine as an aid to smoking cessation in patients with cardiac disease. N Engl J Med. 1996, 335: 1792-8. 10.1056/NEJM199612123352402.PubMed
106.
Buchkremer G, Bents H, Minneker E, Opitz K: Long-term effects of a combination of transdermal nicotine administration with behavior therapy for smoking cessation. Nervenarzt. 1988, 59: 488-90.PubMed
107.
Transdermal nicotine for smoking cessation. Six-month results from two multicenter controlled clinical trials. Transdermal Nicotine Study Group. Jama. 1991, 266: 3133-8. 10.1001/jama.266.22.3133.
108.
Jensen EJ, Schmidt E, Pedersen B, Dahl R: Effect of nicotine, silver acetate, and ordinary chewing gum in combination with group counselling on smoking cessation. Thorax. 1990, 45: 831-4. 10.1136/thx.45.11.831.PubMedCentralPubMed
109.
Hughes JR, Gust SW, Keenan RM, Fenwick JW: Effect of dose on nicotine's reinforcing, withdrawal-suppression and self-reported effects. J Pharmacol Exp Ther. 1990, 252: 1175-83.PubMed
110.
Aubin HJ, Bobak A, Britton JR, Oncken C, Billing CB, Gong J: Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Thorax. 2008, 63: 717-24. 10.1136/thx.2007.090647.PubMedCentralPubMed
111.
Rubinstein ML, Benowitz NL, Auerback GM, Moscicki AB: A randomized trial of nicotine nasal spray in adolescent smokers. Pediatrics. 2008, 122: e595-600. 10.1542/peds.2008-0501.PubMedCentralPubMed
112.
Warner DO, Patten CA, Ames SC, Offord KP, Schroeder DR: Effect of nicotine replacement therapy on stress and smoking behavior in surgical patients. Anesthesiology. 2005, 102: 1138-46. 10.1097/00000542-200506000-00013.PubMed
113.
Murray RP, Bailey WC, Daniels K, Bjornson WM, Kurnow K, Connett JE: Safety of nicotine polacrilex gum used by 3,094 participants in the Lung Health Study. Lung Health Study Research Group. Chest. 1996, 109: 438-45. 10.1378/chest.109.2.438.PubMed
114.
Sun HQ, Guo S, Chen DF, Jiang ZN, Liu Y, Di XL: Family support and employment as predictors of smoking cessation success: a randomized, double-blind, placebo-controlled trial of nicotine sublingual tablets in chinese smokers. Am J Drug Alcohol Abuse. 2009, 35: 183-8. 10.1080/00952990902839794.PubMed
115.
Rigotti NA, Gonzales D, Dale LC, Lawrence D, Chang Y: A randomized controlled trial of adding the nicotine patch to rimonabant for smoking cessation: efficacy, safety and weight gain. Addiction. 2009, 104: 266-76. 10.1111/j.1360-0443.2008.02454.x.PubMed
116.
Shiffman S, Ferguson SG, Strahs KR: Quitting by gradual smoking reduction using nicotine gum: a randomized controlled trial. Am J Prev Med. 2009, 36: 96-104. 10.1016/j.amepre.2008.09.039. e1PubMed
117.
Piper ME, Smith SS, Schlam TR, Fiore MC, Jorenby DE, Fraser D: A randomized placebo-controlled clinical trial of 5 smoking cessation pharmacotherapies. Arch Gen Psychiatry. 2009, 66: 1253-62. 10.1001/archgenpsychiatry.2009.142.PubMedCentralPubMed
118.
Hilleman DE, Mohiuddin SM, Delcore MG: Comparison of fixed-dose transdermal nicotine, tapered-dose transdermal nicotine, and buspirone in smoking cessation. J Clin Pharmacol. 1994, 34: 222-4.PubMed
119.
Orleans CT, Resch N, Noll E, Keintz MK, Rimer BK, Brown TV: Use of transdermal nicotine in a state-level prescription plan for the elderly. A first look at 'real-world' patch users. Jama. 1994, 271: 601-7. 10.1001/jama.271.8.601.PubMed
120.
Smith TM, Winters FD: Smoking cessation: a clinical study of the transdermal nicotine patch. J Am Osteopath Assoc. 1995, 95: 655-6. 61-2PubMed
121.
Martin PD, Robinson GM: The safety, tolerability and efficacy of transdermal nicotine (Nicotinell TTS) in initially hospitalised patients. N Z Med J. 1995, 108: 6-8.PubMed
122.
Fredrickson PA, Hurt RD, Lee GM, Wingender L, Croghan IT, Lauger G: High dose transdermal nicotine therapy for heavy smokers: safety, tolerability and measurement of nicotine and cotinine levels. Psychopharmacology (Berl). 1995, 122: 215-22. 10.1007/BF02246542.
123.
Jorenby DE, Smith SS, Fiore MC, Hurt RD, Offord KP, Croghan IT: Varying nicotine patch dose and type of smoking cessation counseling. Jama. 1995, 274: 1347-52. 10.1001/jama.274.17.1347.PubMed
124.
Smith TA, House RF, Croghan IT, Gauvin TR, Colligan RC, Offord KP: Nicotine patch therapy in adolescent smokers. Pediatrics. 1996, 98: 659-67.PubMed
125.
Hurt RD, Dale LC, Croghan GA, Croghan IT, Gomez-Dahl LC, Offord KP: Nicotine nasal spray for smoking cessation: pattern of use, side effects, relief of withdrawal symptoms, and cotinine levels. Mayo Clin Proc. 1998, 73: 118-25. 10.4065/73.2.118.PubMed
126.
Gourlay SG, Forbes A, Marriner T, McNeil JJ: Predictors and timing of adverse experiences during trandsdermal nicotine therapy. Drug Saf. 1999, 20: 545-55. 10.2165/00002018-199920060-00007.PubMed
127.
Killen JD, Fortmann SP, Davis L, Strausberg L, Varady A: Do heavy smokers benefit from higher dose nicotine patch therapy?. Exp Clin Psychopharmacol. 1999, 7: 226-33. 10.1037/1064-1297.7.3.226.PubMed
128.
Hurt RD, Croghan GA, Beede SD, Wolter TD, Croghan IT, Patten CA: Nicotine patch therapy in 101 adolescent smokers: efficacy, withdrawal symptom relief, and carbon monoxide and plasma cotinine levels. Arch Pediatr Adolesc Med. 2000, 154: 31-7.PubMed
129.
Shiffman S, Rolf CN, Hellebusch SJ, Gorsline J, Gorodetzky CW, Chiang YK: Real-world efficacy of prescription and over-the-counter nicotine replacement therapy. Addiction. 2002, 97: 505-16. 10.1046/j.1360-0443.2002.00141.x.PubMed
130.
Croghan GA, Sloan JA, Croghan IT, Novotny P, Hurt RD, DeKrey WL: Comparison of nicotine patch alone versus nicotine nasal spray alone versus a combination for treating smokers: a minimal intervention, randomized multicenter trial in a nonspecialized setting. Nicotine Tob Res. 2003, 5: 181-7. 10.1080/1462220031000073252.PubMed
131.
Hasford J, Fagerstrom KO, Haustein KO: A naturalistic cohort study on effectiveness, safety and usage pattern of an over-the-counter nicotine patch. Cohort study on smoking cessation. Eur J Clin Pharmacol. 2003, 59: 443-7. 10.1007/s00228-003-0629-8.PubMed
132.
Fiore MC, McCarthy DE, Jackson TC, Zehner ME, Jorenby DE, Mielke M: Integrating smoking cessation treatment into primary care: an effectiveness study. Prev Med. 2004, 38: 412-20. 10.1016/j.ypmed.2003.11.002.PubMed
133.
Carpenter MJ, Hughes JR, Solomon LJ, Callas PW: Both smoking reduction with nicotine replacement therapy and motivational advice increase future cessation among smokers unmotivated to quit. J Consult Clin Psychol. 2004, 72: 371-81. 10.1037/0022-006X.72.3.371.PubMed
134.
Lerman C, Kaufmann V, Rukstalis M, Patterson F, Perkins K, Audrain-McGovern J: Individualizing nicotine replacement therapy for the treatment of tobacco dependence: a randomized trial. Ann Intern Med. 2004, 140: 426-33.PubMed
135.
Hughes JR, Adams EH, Franzon MA, Maguire MK, Guary J: A prospective study of off-label use of, abuse of, and dependence on nicotine inhaler. Tob Control. 2005, 14: 49-54. 10.1136/tc.2004.008367.PubMedCentralPubMed
136.
Marsh HS, Dresler CM, Choi JH, Targett DA, Gamble ML, Strahs KR: Safety profile of a nicotine lozenge compared with that of nicotine gum in adult smokers with underlying medical conditions: a 12-week, randomized, open-label study. Clin Ther. 2005, 27: 1571-87. 10.1016/j.clinthera.2005.10.008.PubMed
137.
Bolliger CT, van Biljon X, Axelsson A: A nicotine mouth spray for smoking cessation: a pilot study of preference, safety and efficacy. Respiration. 2007, 74: 196-201. 10.1159/000097136.PubMed
138.
Stapleton JA, Watson L, Spirling LI, Smith R, Milbrandt A, Ratcliffe M: Varenicline in the routine treatment of tobacco dependence: a pre-post comparison with nicotine replacement therapy and an evaluation in those with mental illness. Addiction. 2008, 103: 146-54. 10.1111/j.1360-0443.2007.02083.x.PubMed
139.
Gunnell D, Irvine D, Wise L, Davies C, Martin RM: Varenicline and suicidal behaviour: a cohort study based on data from the General Practice Research Database. Bmj. 2009, 339: b3805-10.1136/bmj.b3805.PubMedCentralPubMed
140.
Ossip DJ, Abrams SM, Mahoney MC, Sall D, Cummings KM: Adverse effects with use of nicotine replacement therapy among quitline clients. Nicotine Tob Res. 2009, 11: 408-17. 10.1093/ntr/ntp005.PubMed
141.
Steinberg MB, Greenhaus S, Schmelzer AC, Bover MT, Foulds J, Hoover DR: Triple-combination pharmacotherapy for medically ill smokers: a randomized trial. Ann Intern Med. 2009, 150: 447-54.PubMed
142.
Oncken C, Dornelas E, Greene J, Sankey H, Glasmann A, Feinn R: Nicotine gum for pregnant smokers: a randomized controlled trial. Obstet Gynecol. 2008, 112: 859-67.PubMedCentralPubMed
143.
Matthew TP, Herity NA: Acute myocardial infarction soon after nicotine replacement therapy. QJM. 2001, 94: 503-4. 10.1093/qjmed/94.9.503.
144.
Dacosta A, Guy JM, Tardy B, Gonthier R, Denis L, Lamaud M: Myocardial infarction and nicotine patch: a contributing or causative factor?. Eur Heart J. 1993, 14: 1709-11.PubMed
145.
Ottervanger JP, Festen JM, de Vries AG, Stricker BH: Acute myocardial infarction while using the nicotine patch. Chest. 1995, 107: 1765-6. 10.1378/chest.107.6.1765.PubMed
146.
Ottervanger JP, Stricker BH, Klomps HC: Transdermal nicotine: clarifications, side effects, and funding. Jama. 1993, 269: 1940-10.1001/jama.269.15.1940. author reply -1PubMed
147.
Rigotti NA, Eagle KA: Atrial fibrillation while chewing nicotine gum. Jama. 1986, 255: 1018-10.1001/jama.255.8.1018.PubMed
148.
Warner JG, Little WC: Myocardial infarction in a patient who smoked while wearing a nicotine patch. Ann Intern Med. 1994, 120: 695.PubMed
149.
McRobbie H, Hajek P: Nicotine replacement therapy in patients with cardiovascular disease: guidelines for health professionals. Addiction. 2001, 96: 1547-51. 10.1046/j.1360-0443.2001.961115472.x.PubMed
150.
McRobbie H, Hajek P, Gillison F: The relationship between smoking cessation and mouth ulcers. Nicotine Tob Res. 2004, 6: 655-9. 10.1080/14622200410001734012.PubMed
151.
Hughes JR: Smoking and suicide: a brief overview. Drug Alcohol Depend. 2008, 98: 169-78. 10.1016/j.drugalcdep.2008.06.003.PubMedCentralPubMed
152.
Schroeder SA: A 51-year-old woman with bipolar disorder who wants to quit smoking. Jama. 2009, 301: 522-31. 10.1001/jama.2008.982.PubMed
153.
Kyle SD, Morgan K, Espie CA: Insomnia and health-related quality of life. Sleep Med Rev. 2009
154.
Fergusson D, Doucette S, Glass KC, Shapiro S, Healy D, Hebert P: Association between suicide attempts and selective serotonin reuptake inhibitors: systematic review of randomised controlled trials. Bmj. 2005, 330: 396-10.1136/bmj.330.7488.396.PubMedCentralPubMed
155.
Borenstein M, Hedges L, Higgins JP, Rothstein H: Introduction to Meta-analysis. 2009, Wiley, Chichester, 312.
156.
Thomsen T, Tonnesen H, Moller AM: Effect of preoperative smoking cessation interventions on postoperative complications and smoking cessation. Br J Surg. 2009, 96: 451-61. 10.1002/bjs.6591.PubMed
157.
Poldermans D, Bax JJ, Boersma E, De Hert S, Eeckhout E, Fowkes G: Guidelines for pre-operative cardiac risk assessment and perioperative cardiac management in non-cardiac surgery: the Task Force for Preoperative Cardiac Risk Assessment and Perioperative Cardiac Management in Non-cardiac Surgery of the European Society of Cardiology (ESC) and endorsed by the European Society of Anaesthesiology (ESA). Eur Heart J. 2009, 30: 2769-812. 10.1093/eurheartj/ehp337.PubMed
Metadata
Title
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
Authors
Edward J Mills
Ping Wu
Ian Lockhart
Kumanan Wilson
Jon O Ebbert
Publication date
01-12-2010
Publisher
BioMed Central
Published in
Tobacco Induced Diseases / Issue 1/2010
Electronic ISSN: 1617-9625
DOI
https://doi.org/10.1186/1617-9625-8-8

Other articles of this Issue 1/2010

Tobacco Induced Diseases 1/2010 Go to the issue

Research

Lipid and lipoprotein profiles among middle aged male smokers: a study from southern India

Research

Half a pack of cigarettes a day more than doubles DNA breaks in circulating leukocytes

Research

The influence of occupational stress factors on the nicotine dependence: a cross sectional study

Research

"The lobbying strategy is to keep excise as low as possible" - tobacco industry excise taxation policy in Ukraine

Research

Acute effect of smoking on plasma Obestatin levels

Review

Destructive effects of smoking on molecular and genetic factors of periodontal disease
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Reserve your place

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

Read more

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Pediatric Cardiology Video

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

Cardiopulmonary Comorbidity Video

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Valvular Heart Disease Video

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Heart Failure Video

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Heart Failure Video

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.

Watch now

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

16-04-2024 Type 2 Diabetes News

Incentivised to exercise

11-04-2024 Lifestyle Modifications News

New intervention for STEMI-related cardiogenic shock

10-04-2024 Myocardial Infarction News

» View more highlights on the ACC 2024 congress hub page

Image Credits