The Effectiveness of the Nicotine Patch Versus Nicotine Gum in Relation to Smoking Cessation in the Adult Population

Marshall D. Stables

East Tennessee State University

Class:  Research in Allied Health, ALHE-4060-504

Instructor:  Dr. Doug Masini

April 30, 2005

Abstract

Effective smoking cessation strategies usually employ the use of nicotine replacement therapy (NRT).  Numerous studies have been conducted comparing the efficacy of NRTs such as nicotine gum, nicotine patch, nicotine inhaler, and nicotine nasal spray.  In most of the studies that I reviewed, it was found that all forms of NRT are beneficial in smoking cessation programs.  Also found was that no single NRT proved to be most effective for all smokers and that there was no significant difference in rates of abstinence between the four types of NRT.  Apparently there are advantages and disadvantages for each type of NRT and these can depend on the physical nature of the person trying to quit smoking.  For example, a physician probably would not recommend nicotine gum for a person who suffers from TMJ.  Nor would he recommend the “patch” to a smoker trying to quit who has highly sensitive skin.  Smoking cessation programs are very important to society because smoking is a major health problem in the U.S. and other countries.

Introduction

“Mark Twain said “Quitting smoking is easy.  I’ve done it a thousand times.”  Maybe you’ve tried to quit too.  Why is quitting and staying quit hard for so many people?  The answer is nicotine” (American Cancer Society, 2005).  Smokers soon become highly addicted both physically and psychologically to nicotine found naturally in tobacco.  Numerous studies have shown that both the physical and psychological aspects of smoking must be overcome before smokers can cease smoking and stay quit.  Today there are numerous therapies to help smokers quit, both prescription drugs and over-the-counter (OTC) drugs.  This paper concerns the two most well known therapy treatments and both are OTC drugs, nicotine gum and nicotine patch (commonly called “the patch”).  These two therapy drugs are only two of many others such as nasal sprays and inhalers (prescription only drugs) which are collectively called nicotine replacement therapy (NRT).  NRT deals with the physical aspects of addiction.  As mentioned above there is also the psychological element of smoking which also must be dealt with in order for a smoker to quit.  Together, NRT and smoking cessation programs have been shown to double the chances of successfully quitting smoking (American Cancer Society, 2005).  I chose this topic because I am truly concerned about the health of smokers.  Respiratory therapy is my chosen field of study and by being better informed about NRTs maybe I can be a better caregiver to some of my future patients.

Problem Statement

Nicotine replacement therapy has proven to be highly beneficial in smoking cessation programs.  Of the four main types of NRTs, the nicotine patch and nicotine gum strike me as possibly being the most successful.  My research question concerns the effectiveness of “the patch” versus gum in relation to smoking cessation in the adult population.  Specifically, I want to find out which of the two is more effective in getting people to quit smoking.  I believe I will find that “the patch” is more effective because people will probably be more compliant with this treatment than with gum.  People find the patch easier to use and it requires less effort to train people in its use. The patch is easily concealed and is applied only once a day; while chewing gum is not as socially acceptable and requires chewing several pieces of gum each day (refer to Appendix A).  This research is very important to all of us because we need to find the most effective method to get people to stop smoking so that smoking cessation rates can be increased.  The importance lies in the fact that smoking is extremely harmful to the health of both smokers and non-smokers who are exposed to smoke.

Review of the Literature

“Tobacco use remains the chief avoidable cause of illness and death in our society; it is responsible for one of every five deaths in the United States today.  Despite this grim statistic, 25% of adult Americans smoke” (Fiore, 1996).  Smoking causes more than 400,000 deaths each year in the U. S. and is a risk factor for chronic obstructive pulmonary disease (COPD), heart disease, stroke, and cancer which are the four leading causes of death.  Among cancer victims in the U.S., lung cancer is the most prevalent of cancer deaths (Karnath, 2002).  These alarming statistics and health facts are cause for alarm among healthcare professionals.  In fact, since 1977 on each third Thursday in November, The Great American Smokeout has been held to bring awareness to the adverse health issues of smoking (The Gale, 2001).

         “Smoking Cessation is the medical term for quitting smoking” (The Gale, 2001).  Smoking cessation can include use of medications, psychotherapy, special classes, and programs, either separately or in combination with one another.  One reason that it is difficult to quit smoking is because it involves several different aspects of a person’s emotions and social life.  Support groups such as stop-smoking programs can reinforce a smoker’s decision to give up smoking by offering emotional support and encouragement.  These groups and programs are very helpful and important as part of an overall quitting strategy in conjunction with medication use (The Gale, 2001).

         Another reason why quitting smoking is so difficult is due to a smoker’s physical addiction to nicotine, a drug found in tobacco.  Nicotine is both a stimulant and relaxant thus providing smokers a very pleasurable feeling and it is as addictive as cocaine or heroin.  On the other hand, withdrawal from nicotine may cause headaches, fatigue, depression, anxiety, restlessness, irritability, anger, inability to concentrate, sleep problems, and an increased appetite (Therapeutics Initiative, 1997). Withdrawal symptoms from smokers trying to quit are both physical and psychological. “Physically, the body is reacting to the absence of nicotine.  Psychologically, the smoker is faced with giving up a habit, which is a major change in behavior.  Both must be dealt with if quitting is to be successful” (American Cancer Society, 2005).

         Many smokers (70-90%) are reluctant to give up cigarettes because they know that they will experience very difficult withdrawal symptoms and cravings.  However, nicotine replacement therapy (NRT) is a treatment that gives smokers small doses of nicotine that helps relieve withdrawal symptoms and also decreases the urge to smoke once a person has quit (American Cancer Society, 2005).

            As of 2001 there have been four NRT products approved by the Food and Drug Administration (FDA) for smoking cessation.  They include nicotine gum, nicotine transdermal patch, nicotine nasal spray and nicotine inhaler (The Gale, 2001).  In 1984 nicotine gum was the first NRT approved by the FDA for smoking cessation, followed by the nicotine patch in 1991 (Shiffman, 2003).  Numerous studies have been conducted comparing the efficacy of these various NRTs.  However, the purpose of this study is to compare the effectiveness of the nicotine patch versus nicotine gum in relation to smoking cessation in the adult population.

            Two studies outlined in the Journal of Respiratory Diseases (2002) compared the efficacy of nicotine replacement products.  A comparative trial found no significant difference in abstinence rates for nicotine patch, gum, nasal spray, and inhaler.  Results of continuous abstinence rates at the end of a 12 week follow-up period were 21% for patch, 20% for gum, 24% for spray, and 24% for inhaler.  Another trial evaluated smoker’s preference for a nicotine replacement product to see if there was a correlation between preference and abstinence rates.  At the end of a 15 week follow-up period there was no significant difference found in smoking cessation rates for study participants who were given their choice of product.  Also at the end of this follow-up period the continuous abstinence rates were 23% for patch, 23% for gum, 23% for spray, and 28% for inhaler (Karnath, 2002).

            An article in the American Family Physician (June, 2001) concerned the evaluation of a comprehensive Cochrane review (meta-analysis) of 94 randomized control trials of NRT.  Again, the types of NRT evaluated included nicotine patch, gum, nasal spray, and inhaler.  Those trials with follow-up of less than six months and those that did not report smoking cessation rates were excluded from the analysis.  Abstinence from smoking after at least six months of follow-up was the principle outcome measure of the review.  Refer to the “Method” section of this paper for more particulars on this study.  This meta-analysis review of 94 NRT control trials involved 32 of nicotine patch and 49 of nicotine gum with 13 trials of other forms of NRT.  Comparison of NRT groups with control groups for smoking abstinence showed an odds ratio of 1.72 (95 percent confidence interval [CI], 1.60 to 1.84).  What this is saying, is that study participants who used any form of NRT were 1.72 times more likely than control subjects to be abstinent at six months or more.  For the various forms of NRT the odds ratios were 1.77 for nicotine patch, 1.63 for gum, 2.27 for nasal spray, and 2.08 for inhalers.  This review concluded that there was no significant difference in abstinence rates for nicotine patch, gum, nasal spray, and inhaler.  In other words, no one form of NRT proved better than another when comparing abstinence rates.  However, this comprehensive meta-analysis review found that NRTs are highly effective in the treatment of smokers with moderate to severe nicotine dependence.  NRT treatments proved to be statistically significant when compared with control and have been shown to increase quit rates approximately 150-200% (David, 2001).

            The June 2003 issue of the Journal of Family Practice reported on a Cochrane Review of 110 trials involving 35,600 smokers for evaluation of effectiveness of NRTs.  This meta-analysis review showed evidence that the use of NRTs in combination might be a better treatment than a single treatment alone.  The researchers discovered that combining treatments that maintain a steady drug level (nicotine patch) with other treatments having more rapid effects (nicotine gum, nasal spray, and inhaler) is more effective than monotherapy.  The odds ratio of combination treatments was 1.9; 95% CI, 1.3-2.6.  The reviewers’ recommendation is that combination therapy should be utilized only by smokers who relapse following monotherapy (Diefenbach, 2003).

            Another meta-analysis study of NRT efficacy was published in Evidence-Based Mental Health (February, 2001).  The reviewers selected studies by searching the Cochrane Tobacco Addiction Group specialized register.  Criteria for selection was randomization or quasirandomization of controlled trials that compared NRT with a control group (placebo or no NRT).  Also, trial duration had to be six months or longer and the measured outcome was smoking abstinence.  Trials selected totaled 88 with 34,734 participants.  This study showed evidence that after 6-12 months of follow-up, smoking cessation rates were higher with NRT than with the control groups when trials of all types were pooled.  The conclusion was that NRTs are effective in realizing smoking abstinence at 6-12 months (Flower, 2001).

Method

I was not fortunate enough to locate in my literature search a particular study on the effectiveness of the nicotine patch versus nicotine gum.  However, I did find a few meta-analysis reviews whose goals were to determine the effectiveness of the different types of nicotine replacement therapy (NRT) in achieving abstinence from cigarette smoking.  These types of NRT included nicotine gum, transdermal patches, inhalers, and nasal spray.  One particular noteworthy article was an evaluation of a comprehensive Cochrane review (meta-analysis) of 94 randomized control trials of NRT.  Selection criteria of the 94 trials involved only those studies in which NRT was compared with placebo or no treatment, or where comparisons of different doses of NRT were compared.  Those trials with follow-up of less than six months and those that did not report smoking cessation rates were excluded from the analysis.  Abstinence from smoking after at least six months of follow-up was the principle outcome measure of the review.  The Cochrane review also sought those trials for their review that used biochemical validation methods such as carbon monoxide breath testing, or urine or serum cotinine levels (David, 2001).  Since I found no previous study to replicate I will explain in this section how I will conduct the study.  The population group that I am concerned with are adult cigarette smokers who have a moderate to severe nicotine dependence.  How do I determine who fits in this category?   Have the target population complete the Fagerstrom Tolerance Questionnaire (FTQ) which assesses the severity of nicotine tolerance and dependence.  Scoring ranges from zero to 11 points and FTQ scores of seven or above reflect a high level of dependence (David, 2001).  Since I am seeking subjects with high nicotine dependence, my subject selection criteria is any adult smoker who scores seven or higher on the FTQ.  For my study I will attempt to recruit as subjects people enrolled in smoking cessation programs in the Tri-Cities area in Tennessee.  Those recruited will have taken the FTQ and scored a seven or higher and will constitute my subpopulation.  Random selection from this subpopulation will involve assigning a number to each person and using a random number chart to select the required number of people for the study.  Random assignment which improves both internal and external validity can now be done by using the random number chart system as mentioned above.  This involves assigning people to my treatment groups of nicotine patch and nicotine gum and to the control group (no treatment).  The type of research design for my study is considered experimental (combination of omitted pre-test and follow-up) under the category of quantitative design.  Standard research notations for research designs will be used where R represents random assignment, 0 represents post-test results, and X represents treatment (Bailey, 1997).

My study design is thus:                     R  X1   O1   O2

                                                         R  X2   O3   O4

                                                         R           O5   O6

This design consists of three randomly assigned groups, two with treatment, and one with no treatment (control group).  The follow-up post-test (O2, O4, and O6) is set at six months and the measured outcome is abstinence (quit rate) from smoking.  Validation of abstinence from smoking will be confirmed by the same biochemical validation methods mentioned in the Cochrane review above.  Standard statistical measurements will be used to determine any significant differences between the treatments.  From the Scales of Measurement and Statistical Procedure Choices chart I have determined that my level of measurement is parametric.  The type of analysis is the difference between two or more groups.  Since the relationship between groups is independent, the appropriate statistical test for my study is Analysis of Variance.

Discussion

         Before I began my research I believed that “the patch” would be proven more effective than nicotine gum in getting people to stop smoking.  Most people find the patch easier to use than gum and  I thought that better compliance would be found with “the patch”.  However, the studies that I reviewed and used in my research paper consistently found that all NRTs are effective in realizing smoking abstinence at a 6-12 month follow-up period.  No significant difference in abstinence rates was found for nicotine patch, gum, nasal spray, and inhaler.  No one type of NRT is best suited for everyone, but if used properly then very similar results may be achieved.

         One revelation I had was that in some instances NRTs have been shown to work best in combination.  If a smoker relapses from abstaining, then a combination treatment of “the patch” and nicotine gum may be the best answer.  Nicotine patch releases a steady drug level and gum has a rapid effect which may be thought of as a “rescue” mechanism.

Conclusion

         Nicotine replacement therapy has proven to be highly beneficial in smoking cessation programs.  My research question was which is more effective, nicotine patch or gum, in getting people to stop smoking.  If “the patch” proved to be superior to nicotine gum then this information needs to get out to physicians and other healthcare providers, and especially to those wanting to quit smoking.  The fewer people that smoke increases the general health of all people. 

         My hypothesis that “the patch” is more effective in smoking cessation than nicotine gum due to the compliance issue was not proven correct from the review of the literature.  In fact, overall, it was found that no one type of NRT is superior to any other type.

         One area of inquiry that probably needs to be studied more is the idea of using NRTs in combination.  The few studies I found on NRT combination treatments show very promising results.

References

American Cancer Society, Inc. (2005). Guide for Quitting Smoking. Retrieved February 25, 2005, from http://www.cancer.org/docroot/ped/content/ped_10_13x_quitting_smoking.asp?

Bailey, D. M. (1997). Research for the Health Professional – A Practical Guide (Second Edition). Philadelphia, PA:  F.A. Davis Company.

David, S.P. (2001, June). Should We Recommend Nicotine Replacement Therapy? American Family Physician, 63(11), 2245.

Diefenbach, L. J. & Smith, P. O. (2003).  What is the most effective nicotine replacement therapy? Journal of Family Practice, 52(6), 492-493.

Fiore, M. C. (1996, April). Chew on this: can smokeless tobacco help smokers quit?  Consultant, 36, 673.

Flower, G., Silagy, C. & Mant, D. (2001, February). Review:  nicotine replacement treatments achieve smoking abstinence at 6-12 months.  Evidence-Based Mental Health, 4(1) 21.

Karnath, B. (2002). Smoking Cessation: the most effective strategies; combination therapy can improve the chances of success.  Journal of Respiratory Diseases, 23(10), 496-497.

McKenna, J. P. & Cox, J. L. (1992).  Transdermal nicotine replacement and smoking cessation.  American Family Physician, 45(6), 2595-2598.

Shiffman, S., Hughes, J.R., Pillitteri, J. L. & Burton, S. L. (2003). Persistent use of nicotine replacement therapy: an analysis of actual purchase patterns in a population based sample.  Tobacco Control, 12(3), p 310-317.

The Gale Encyclopedia of Cancer. (2001). Smoking Cessation. Retrieved March 23, 2005, from http://galenet.galegroup.com

Therapeutics Initiative. (1997, November 19). Effective Clinical Tobacco Intervention.  Retrieved March 19, 2005, from http://www.ti.ubc.ca/pages/letter21.htm

NOTE:  The source above, McKenna (1992), American Family Physician, is 13 years old.  I used this source because of its chart, Comparison of Transdermal Nicotine and Nicotine Gum, which I used as Appendix A in my research paper.  It illustrates the advantages and disadvantages of “the patch” and nicotine gum.

Appendix A

Comparison of Transdermal Nicotine and Nicotine Gum

Transdermal nicotine (“the patch”)

Advantages

May provide up to 24 hours of a steady concentration of nicotine sufficient to prevent withdrawal symptoms

Simple to use correctly and difficult to use incorrectly

No need to anticipate need for replacement

Can sustain nicotine levels during sleep

May be more acceptable than nicotine gum to both patients and physicians

Resembles other transdermal medications

Use not reinforced by other behaviors

May foster increased compliance because of once-daily dosing

No oral side effects

Easier to convince patients to use

Requires no special skills for use

May prevent weight gain associated with smoking cessation

Disadvantages

         Local cutaneous reaction, such as erythema, pruritus and/or edema

         Doses cannot be titrated by patient

         Overdosing is possible

         Allergic reactions to the adhesive may occur

Nicotine gum

Advantages

         Dose is easily titrated

         May satisfy some oral craving

         May be used to prevent relapse

         May decrease weight gain

Disadvantages

         May cause side effects, including bad taste, throat and mouth irritation

         May not be socially acceptable to chew gum

         May cause jaw soreness

         May be difficult/impossible to use with dentures