Smoking Cessation: Which Method Works Best?
By Pat McGinley, FNP, MSN
Summary—Smoking is a leading cause of morbidity and mortality in the United States.1 Health care providers need to identify people who smoke, encourage smoking cessation, then offer the most effective method(s) to succeed in the endeavor. A recent study involving 893 subjects indicates use of bupropion or a combination of bupropion with a nicotine patch results in the highest long-term smoking cessation rates with minimal side effects. Abstinence rates were higher in all treatment groups (48% nicotine patch, 60.2% bupropion, and 66.5% combined treatment vs. 33.8% placebo group). Clinicians are urged to ask each patient about tobacco use and to be prepared to offer viable options and support to those expressing a desire to quit.
An estimated 46 million Americans smoke, despite repeated warnings from government health agencies and health care providers about the health risks associated with tobacco.2 These risks include chronic lung disease and cardiovascular disease as well as lung, bladder, and esophageal cancer.3,4 Health care providers and state health care agencies have embarked on campaigns to convince smokers of the need to quit. Prior to the release of nicotine replacement chewing gum or dermal patches, the only options for smokers wanting to quit was a gradual reduction in the number of cigarettes smoked per day or "cold turkey," abruptly stopping all cigarette use. These methods were usually unappealing and often unsuccessful.
Bupropion more effective than the patch alone
The most recent method to aid in the smoking cessation campaign includes the use of nicotine-containing chewing gum or patches and/or the use of oral sustained-release bupropion (Zyban, Glaxo Wellcome, Research Triangle Park, NC; see note at end of article).
The results of a recent two-year study concluded that the use of oral sustained-release bupropion or the combination of the drug with a nicotine patch was more effective in achieving long-term rates of smoking cessation than either the patch alone or placebo.5 Combination therapy using bupropion with the nicotine patch resulted in higher abstinence rates but was not statistically different than bupropion alone. Researchers measured withdrawal symptoms such as cigarette cravings, increased appetite, irritability, nervousness, and anger, as well as changes in weight, depression, and adverse effects of treatment. Use of combination therapy or bupropion alone caused the least depression but had the highest adverse effects. Weight gain was not statistically different in any of the study groups.
Research Methodology
The double-blind multicenter study looked at the efficacy of placebo vs. a nicotine patch alone vs. oral bupropion vs. oral bupropion with a nicotine. Study subjects were recruited by advertisements in local media. To be eligible, subjects had to:
• be 18 years of age or older;
• smoke at least 15 cigarettes per day;
• weigh at least 100 pounds;
• have the desire to quit smoking;
• and speak English.
Subjects were excluded from participation if they:
• had any chronic medical disorders;
• had a current diagnosis of major psychiatric disorder;
• had used a nicotine replacement therapy within the previous six months;
• were pregnant or lactating;
• had abused alcohol or other drugs within the previous year;
• had used a psychoactive drug within one week or an investigational drug within one month of enrollment;
• had used bupropion before;
• were currently using other smoking-cessation treatments;
• and regularly used noncigarette tobacco products.
A total of 893 subjects met the criteria and were enrolled in the study. Subjects were randomly assigned to one of four treatment groups and given either:
1. placebo, either oral tablet or patch (166 subjects); or
2. nicotine patch (Habitrol, Novartis Consumer Health, Summit, NJ; see note at end of article) 21 mg once daily from weeks two through seven, then 14 mg once daily during week eight, followed by 7 mg once daily during week nine (244 subjects); or
3. sustained-release bupropion 150 mg tablet in the morning plus placebo in the evening on days one through three, one 150 mg tablet of sustained release bupropion twice daily from days four through 63 ( 244 subjects); or
4. sustained-release bupropion 150 mg tablet in morning plus placebo in the evening on days one through three, followed by 150 mg sustained release bupropion bid day 4-63 plus nicotine patch 21 mg once daily from weeks two through seven then 4 mg once daily during week eight, followed by 7 mg once daily during week nine (243 subjects).
The actual day to quit smoking was day eight. Treatment lasted nine weeks, during which each participant attended a weekly 15-minute individual counseling session for smoking cessation. Counseling included use of the medication(s), identification of smoking triggers, motivation to quit, weight management, and coping measures. Also, a counselor called each participant three days after the target quit date to provide psychological support.
Each study subject kept a daily diary for 12 weeks. Diary information included cravings, withdrawal symptoms, and smoking status. Vital signs were assessed, and carbon monoxide content of expired air was measured to assess smoking status.
Study Results
Data from the study measured four outcomes: abstinence rates, symptoms of withdrawal and depression, weight change, and safety.
Abstinence rates: Abstinence from smoking was measured at intervals. After four weeks, abstinence rates were higher in all of the treatment groups (48% for the nicotine patch group, 60.2% for the bupropion group, and 66.5% for the combined treatment group) vs. the placebo group (33.8%). Further analyses during the 12-month period found the treatment groups had higher continuous abstinence rates than the placebo groups, but differences among treatment groups was not significant. Abstinence in the two bupropion groups was significantly higher (30.3% in the bupropion group, 35.5% in the combination group) than the group using nicotine patches alone (16.4%). The placebo group’s rate was now only 15.6%. During the study, 311 of the original 893 participants discontinued one or both of the medications due to side effects, including those in the placebo group.
Withdrawal symptoms and depression: All four groups experienced withdrawal symptoms during the first week of treatment. However, the active treatment groups had fewer withdrawal symptoms during the first six days after the "quit date" and for the remainder of the study period. Depression was not significant for any of the study subjects before or during the study period.
Weight change: There was no significant difference in the mean body weight among all study participants at the onset of the study. However, by week seven, subjects in the placebo group gained more weight (2.1 kg) than subjects using either the nicotine patch (1.6 kg.), bupropion alone (1.7 kg), or combined treatment (1.1 kg.). After the seven-week period, no further significant weight changes occurred among any of the groups.
Safety profile: Adverse effects reported include insomnia, anxiety, dizziness, abnormal dreams, and dermatologic reactions and infection. The most commonly reported adverse effect was insomnia, especially in those on combined treatment (47.5%) and bupropion alone (42.4%). Thirty percent of the nicotine patch group experienced insomnia, and 18% had dream abnormalities. The placebo group had the lowest insomnia rate at 19%.
The most serious adverse effects were seen in patients taking bupropion. These included skin rash, pruritus, shortness of breath, and chest tightness. All subjects experiencing those side effects discontinued the study medication and were treated with corticosteroids and antihistamines without additional complications.
Implications for Practice
Every office visit provides an opportunity for health care providers to promote smoking cessation. Ask each patient about tobacco use and the desire to quit. Once a patient expresses desire to stop smoking, the next step is to identify which approach will be most successful. The use of bupropion or the combination of bupropion plus a nicotine patch has proven to be the most effective in long-term smoking cessation.
[For more details, contact Glaxo Wellcome, 5 Moore Drive, Research Triangle Park, NC 27709. Telephone: (800) 334-0089 or (919) 248-2100. Web: http://www.glaxowellcome.com. Novartis Consumer Health Inc., 560 Morris Ave., Summit, NJ 07901-1312. Telephone: (800) 452-0051 or (908) 602-6600. Fax: (908) 273-2869. Web: http://www.norvartis.com.]
References
1. Agency for Health Care Policy and Research. Over view: Smoking Cessation. AHCPR Publication No. 96-0690. Silver Spring, MD; April 1996.
2. Centers for Disease Control and Prevention. Cigarette smoking among adults — United States. MMWR 1997; 51:1217-1220.
3. McQuaid K. Alimentary tract. In: Current Medical Diagnosis & Treatment. Stamford CT: Appleton & Lange; 1997:552.
4. Presti J, Stoller M, Carroll P. Urology. In: Current Medical Diagnosis & Treatment. Stamford CT: Appleton & Lange; 1997:885.
5. Jorenby D, Leischow S, Nides M, et al. A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation. NEJM 1999;340:685-691.
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