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The Real Story Behind the Nicotine Patch and Smoking Cessation
By: Amy Renshaw
Smoking is one of the most preventable causes of disease and death in the United States. Statistics show that approximately 500,000 North Americans die each year of smoking related diseases, and that smoking cuts life expectancy by more than 14 years. Yet approximately 1/3 of the adult population of the world (1.1 billion) continues this addictive and dangerous habit (Picard).
According to the U.S. Department of Health and Human services, just a few of the risks of smoking include:
· diminished or extinguished sense of smell and taste
· frequent colds
· smoker's cough
· gastric ulcers
· chronic bronchitis
· increase in heart rate and blood pressure
· premature and more abundant face wrinkles
· heart disease
· cancer of the mouth, larynx, pharynx, esophagus, lungs, pancreas, cervix, uterus, and bladder
As if that wasn’t enough, the monetary costs really add up. Assuming that the average pack of cigarettes costs $3.00, a person smoking a pack a day spends nearly $1100 in a single year – and that doesn’t even begin to include the costs of the health care to go along with it!
In response to the vast amount of people who need and want to quit smoking, there are a plethora of well-known products that claim to help smokers quit faster, easier, and more comfortably than ever before. These include herbal remedies, hypnosis, and various types of nicotine replacement treatments (NRT’s) like inhalers, gum, and patches.
One of the most widely used treatments seems to be the nicotine patch, but the question remains, “Is the patch a useful treatment for smoking cessation?”
Nicoderm, Habitrol, Nicotrol, and Prostep all manufacture forms of the patch, which works by continuously passing nicotine (in low doses) through the skin and into the bloodstream. Supposedly this helps the body fight cravings for nicotine that are present after quitting, which is the symptom (ranging from grouchiness to severe headaches) that usually causes would-be quitters to return to their old habits.
According to the NicodermCQ website the patch consists of a 10 week plan with 3 different levels of nicotine patches. The catch is that you must stop smoking before beginning the program, or else your blood will get too much nicotine in it. The first 6 weeks use the 21mg patch, then for the next 2 weeks it decreases to 14mg, and the final 2 weeks have a 7mg patch. This simulates a gradual weaning from the nicotine, hopefully producing fewer side effects. The instructions are very precise, and the site indicates that you must follow the instructions carefully in order for it to work. It is very clear that the program only works once the person has made a personal commitment to stop smoking as well – the patch cannot override the mind. Committed Quitters is a support plan offered by the site to be used in conjunction with the patch, and simultaneous use “increases chances of quitting by 26%.” (Nicoderm CQ) The approximate retail cost of the 10 week program is $175, although www.stopsmokingtoday.com advertises the package for $91.12 (that’s cheaper than smoking a pack a day for 10 weeks by more than $100!) The downside is that there is no money back guarantee, nor are there any statistics offered on the success rates of those who use the patch. Essentially the site is trying to get smokers to buy their product without any evidence (other than their “good word”) that it works.
There are several important questions which need to be addressed in evaluating the patch:
· What are the success rates in comparison to a placebo patch?
· What are the success rates in comparison to no intervention at all?
· What are the success rates in comparison to other NRT’s?
· Are there any health risks or side effects that go along with it?
Since the patch has become a widely used form of NRT there have been multiple studies completed on its effectiveness, and often their data is compiled into reviews in order to get a better grasp on all the information available. Sadly, many of these articles are not readily available in their full text forms, so much of this information has been gathered from abstracts. From this point, quitting is determined to be for those who self report as being abstinent, and the only studies used are those who biochemically tested participants and they had carbon monoxide levels lower than 10p.p.m.
Most studies were examining the success rates of over the counter patch use, approximating a real world setting. In order to determine the efficacy of nicotine patch therapy a study was conducted with a placebo patch, blind active patch (meaning the participant didn’t know whether it was a placebo or active), and open label patch (the participant knew they were getting the patch and was in fact paying for it). The results were:
At 6 weeks
At 24 weeks
(Hays et al.)
Davidson et al. used a randomized double blind study with placebo control, and at 6 weeks found that 19.5% of participants in the active patch group had quit, compared to 7.5% in the placebo group. After 24 weeks of treatment, 8.2% of the active patch group were still non-smokers as compared to 4.0% in the placebo group (Davidson et al.) A similar study was performed in Denmark, but it had much higher success rates of both patch treatment and placebo control groups; at 4 weeks 44.1% of patch users had quit, but so had 37.3% of the placebo group. However, there was a significant increase in smoking cessation rates after 8 weeks in those who started on the 21mg patches (or those who previously smoked more than 20 cigarettes a day). (Sonderskov et al.) These differing findings indicate that there is something inconsistent in the data, which makes the review of information by Fiore et al. very useful. Looking at 11 different studies with placebo control, double blind methodology, there was a range in quit rates of 18-77% at the end of treatment (presumably 10 weeks) and 22-42% after 6 months. The placebo participants effectively quit smoking in 5-28% of the samples. While the patch success was generally about twice that of placebo, the high variability of success indicated that further intervention such as counseling would be very influential (Fiore et al.)
Information regarding the attempts of people to quit smoking without intervention is difficult to come by because if there is no treatment then it is difficult to find the population to study. Although too complex for the extent of this article, issues of this are addressed by John Polito at http://whyquit.com/whyquit/A_OTCPatch.html. This site includes a summary of the guidelines for treating tobacco dependence that was published by the U.S. Department of Health and Human Services, and through complex manipulation calculation comes up with an 11.5% “on your own” quit rate compared to the average patch success of 9.3%. This seems very illogical, but my statistics background is fairly nonexistent and I have no rebuttal – this is the information presented, albeit by only one person.
Now the real test: How effective is the patch in comparison to other methods of smoking cessation? In a large scale review of 3,000 interventions, simple advice from a physician raised long term quit-rates from 7.9% to 10.2%. (If this is the basis for comparison, then perhaps it is assumed people quit on their own at a rate of 7.9%.) The authors cite “a recent study found a 24 week abstinence rate of 11.0% with a nicotine patch, compared with a rate of 4.2% with a placebo patch.” Other forms of NRT’s were not compared to the patch, but Bupropion (a non-nicotinic medication) was found to have abstinence rates of 30.3% after a year, compared to the patch at 16.4%. However, the combination of the patch and medication was found to be the most effective at 35.5% (Westmaas & Brandon). This introduces an interesting possibility as to the added benefits of combining treatments.
In a review of Cochrane Tobacco Addiction Group trials from April 2001, the effectiveness of NRT’s compared to controls was 1.73 times more effective. The various subtypes were 1.66 for gum, 1.76 for patches, 2.27 for nasal spray, 2.08 for inhaler, and 1.73 for nicotine tablet (Silagy et al.) The patch is average in its effectiveness, and it seems that the inhaler and the nasal spray are both more effective.
A comparison of patch and gum effectiveness under both prescription(Rx) and over the counter(OTC) treatments was made by Shiffman et al. They found the efficacy of the patch under OTC conditions to be 19.0% at 6 weeks and 9.2% at 6 months, and that of the gum to be 16.1% at 6 weeks and 8.4% at 6 months (Shiffman et al. p.509). This still indicates that the patch is more effective than the gum , and they also found that the OTC use of the patch was more effective than the Rx, probably due to rates of compliance. Basically, the more people chose to be on the treatment, no matter what it was, the more effective it became.
Finally, what are the potential side effects of using the patch? Information from the American Lung Association lists potential side effects as
· Upset stomach
· Blurred vision
· Vivid dreams
· Mild itching and burning on the skin
(American Lung Association)
The OTC participants in the Shiffman et al. study reported side effects at a rate of 22.8%, the most common being application site reaction at 3.6%, abnormal dreams at 3.3%, headaches and rash both at 3.2%, insomnia at 2.5%, itchiness at 2.4%, and nausea at 2.0%. For comparison, 50.2% of the gum users reported at least one side effect (Shiffman et al. p .512)
Essentially, we know that the nicotine patch has a variability of effectiveness rates depending on the study, but it does in fact seem to be 1.5 to 2 times more effective than a placebo patch in most cases. This does not mean that it is more effective than attempting to quit on your own. The patch does seem to be more effective than the gum in the long term, but there are other alternatives like inhalers or bupropion that may be more effective than the patch. The potential for combination therapy gives hope for somewhat more effective treatments, although more research needs to be done. In addition, although it may have side effects, the data indicate that they occur less than 4% of the time per side effect (at least for the Shiffman study). If compliance is assumed the patch is at least worth a try, because if nothing else it’s much cheaper than the cost of a pack a day for 10 weeks!
American Lung Association (n.d.). Fact Sheet Nicotine Replacement Therapy (NRT). Retrieved September 24, 2003 from http://www.lungusa.org/tobacco/replacement_factsheet99.html..
Davidson, M., Epstein, M., Burt, R., Schaefer, C., Whitworth, G. & McDonald, A. (1998). Efficacy and safety of an over-the-counter transdermal nicotine patch as an aid for smoking cessation. Archives of Family Medicine, 7(6), 569-574. Abstract obtained from PubMed ID No. 9821833.
Fiore, M.C., Jorenby, D.E., Baker, T.B. & Kenford, S.L. (1993). Tobacco dependence and the nicotine patch. Clinical guidelines for effective use. JAMA, 268(19), 2687-2694. Abstract obtained from PubMed ID no. 1304736.
Hays, J.T., Croghan, I.T., Schroeder, D.R., Offord, K.P., Hurt, R.D., Wolter, T.D. et al. (1999). Over-the-counter nicotine patch therapy for smoking cessation: Results from randomized, double blind, placebo-controlled, and open label trials [Electronic version – ProQuest ID 46115895]. American Journal of Public Health, 89(11), 1701-1707.
Nicoderm CQ (n.d.). Retrieved September 24, 2003 from http://www.nicodermcq.quit.com.
Picard, A. (2002, April 14). Cigarette smokers costly to economy, data show. Globe and Mail. Retrieved September 24, 2003 from http://asap911tobacco.com/bbcigscost.htm.
Polito, J.R. (2002, April 8). Does the over-the-counter nicotine patch really double your chances of quitting? Retrieved September 24, 2003 from http://whyquit.com/whyquit/A_OTCPatch.html.
Shiffman, S., Rolf, C., Hellebusch, S.J., Gorsline, J., Gorodetzky, C.W., Chiang, Y. et al. (2001). Real world efficacy of prescription and over-the counter nicotine replacement therapy. Addiction, 97, 505-516.
Silagy, C., Lancaster, T., Stead, L., Mant, D. & Fowler, G. (2001) Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev, 2001, ID 000146. Abstract obtained from http://www.medscape.com/viewarticle/422867.
Sonderskov, J., Olsen, J., Sabroe, S., Meillier, L. & Overvad, K. (1997). Nicotine patches in smoking cessation: a randomized trial among the over the counter customers in Denmark. American Journal of Epidemiology, 145(4), 309-318. Abstract obtained from PubMed ID no. 9054234.
Stopmokingtoday.com (n.d.). NicabateCQ / Nicoderm / Niquitin Patch Combo. Retrieved September 24, 2003 from http://www.stopsmokingtoday.com/product/2/23/Patches/NicabateCQ_Nicoderm_Niquitin_Patch_Combo/.
U.S. Department of Health and Human Services, Alcohol and Drug Information (n.d.). Straight facts about drugs and alcohol. Retrieved September 24, 2003 from http://www.health.org/govpubs/rpo884/#cigarettes
Westmaas, J.L. & Brandon, T.H. (2000). Contemporary Smoking Cessation [Electronic Version http://www.medscape.com/viewarticle/408968_5.] Cancer Control, 7(1), 56-62.
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