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The evaluation and treatment of tobacco use disorder. (Applied Evidence).


* Brief (5 minutes or less) advice on quitting smoking given by physicians during an office visit achieves higher quit rates than visits with no advice.

* Use of approved pharmacologic treatments for smoking cessation doubles the rates of success.

* Free telephone help lines and Internet-based resources should be used to enhance office-based smoking-cessation services.

Tobacco use is the leading cause of preventable diseases and deaths in the United States, accounting for approximately 435,000 deaths yearly. (1) Smoking is responsible for an estimated $100 billion annually in direct medical and indirect nonmedical costs. (2) Despite widespread efforts to educate the public on the risks of smoking, approximately 50 million American adults still smoke cigarettes. (3) Cigarette smoking is an addiction, as powerful in many respects as cocaine or opiate dependence. (4) Among those who have ever tried even one cigarette, almost one third develop nicotine dependence. (5) Every year, primary care clinicians have access to 70% of smokers. (6,7) One of the goals of Healthy People 2010 (8) is to increase to 75% the proportion of primary care providers who routinely provide smoking cessation counseling.


The Smoking Cessation Clinical Practice Guideline was originally published by the Agency for Healthcare Research and Quality (AHRQ) in 1996 (9) and was updated in 2000 by AHRQ and a consortium of 7 government and nonprofit organizations. (10) The 2000 guideline urged clinicians to treat tobacco use disorder as a chronic disease similar in many respects to other diseases like hypertension, diabetes, and hyperlipidemia and to provide patients with appropriate advice and pharmacotherapy. The updated guideline recommends a 5-step approach (the 5A's: ask, advise, assess, assist, and arrange) to be used by primary care physicians. The first step (ask) is key in the management of tobacco use disorder. Tobacco use status should be asked and documented for all patients at every visit. The AHRQ recommends that tobacco use status be adopted as the "5th vital sign" along with blood pressure, temperature, pulse, and respiration. Data show that only approximately half of physicians in nonresearch settings consistently advise smokers to quit. (11-13)

Because the most common presentation of a smoker in the primary care setting is for general medical care not necessarily related to smoking, the recommendation to ask about tobacco use at every visit is a practical method to ensure early identification of smokers. Asking about tobacco use at every visit has been shown to result in better screening (14-16) and increased cessation rates. (17) Screening can be performed by the nurse or other trained member of the office staff who collects clinical information from the patient before being seen by the physician. Physicians should establish office-wide systems to enhance consistent identification and treatment of smokers in their practices. Organizational system approaches are cost-effective and have been shown to increase delivery of cessation interventions. (18)


After identifying smokers during an office visit (ask), the next step is to strongly urge all smokers to quit (advise). Such initial advice should be given regardless of the patient's state of readiness to quit. The transtheoretical model of stages of change (SOC) (19) is useful for assessing the patient's readiness to quit (assess). The SOC model identifies smoking behavior change as a process involving movement through a series of 5 motivational stages including precontemplation (not planning to quit within next 6 months), contemplation (planning to quit within next 6 months), preparation (planning to quit within next 30 days), action (has quit smoking for less than 6 months), and maintenance (has quit smoking for 6 months or longer). Interventions based on the SOC have been shown to enhance motivation (20) and predict cessation. (21) For patients unwilling to quit, physicians should identify reasons for resistance. For example, patients who are misinformed about the health risks of smoking should be provided with information relevant to their (or their family's) health condition. Patients willing to make a quit attempt should be given specific advice about how to proceed, including setting a quit date and information on pharmacotherapy.

Behavioral interventions are beneficial to the long-term success of smoking cessation. Studies have shown that brief ([greater than or equal to] 5 minutes) advice on quitting given by physicians to smokers during an office visit have resulted in higher quit rates compared with no advice. (22) A review of 20 studies conducted in primary care settings (23) reported that 2% of all smokers who received brief physician advice quit smoking as a direct consequence, compared with less than 1% in smokers who received no advice. With additional encouragement and support (eg, follow-up letters, phone calls, demonstration of spirometry, and additional visits) quit rates increased to 5%. (23,24) A more recent meta-analysis of 7 studies by the Clinical Practice Guideline Panel reported an abstinence rate of 8% when no cessation advice was given, compared with 10% with cessation advice. (17) Although success rates are better with more intensive counseling, brief interventions appear to be more feasible in the primary care setting, given time constraints experienced by primary care physicians during office visits (25) and the Unwillingness of many patients to enter intensive programs. (26)

A recent Cochrane review (27) found that group therapy is more effective than self-help materials but is not consistently better than personal contact. Although groups are theoretically more cost-effective, their usefulness may be limited by participant recruitment and retention problems. (28,29) Current evidence does not support efficacy of acupuncture or hypnosis as treatment for smoking cessation. (17,30)


Because success rates associated with nonpharmacologic treatments are generally lower, pharmacotherapy should be offered to every smoker willing to make a quit attempt unless there is a medical contraindication. (10) The 5 pharmacologic agents approved by the US Food and Drug Administration for treatment of tobacco use disorder include 4 nicotine replacement therapies (NRT)--gum, patch, spray, inhaler--and one non-nicotine therapy, bupropion. All 5 agents promote similar success rates in long-term smoking cessation if they are prescribed to meet the needs of the individual smoker. (31)

Nicotine gum. A meta-analysis of randomized controlled trials among specialized cessation clinics found higher success rates for patients treated with nicotine gum compared with use of placebo gum at 6 months (27% vs 18%). (32) This is in contrast with studies conducted in general medical practices, where success rates (12%) with nicotine gum at 6 months were no different from placebo. (33) Higher quit rates in specialized smoking cessation clinics may be a result of more in-depth counseling, better-trained counselors, and inclusion of smokers with a higher motivation to quit. The gum is available without prescription and comes in 2-mg and 4-mg doses. The 4-mg dose is more efficacious in more dependent smokers. (34) Treatment is recommended for 8 weeks.

Nicotine patches. The patches have been shown to be effective under controlled as well as real-world settings. (35-37) A meta-analysis of 17 randomized trials estimated the efficacy of the nicotine patch as 27% at end of treatment and 22% at 6 months compared with 13% and 9%, respectively, for placebo. (38) Treatment beyond 8 weeks did not increase efficacy. The patches are available in 16-mg and 21-mg dosages (with 14-mg and 7-mg step-down doses). Although weaning is strongly encouraged by most marketers of nicotine patches, current data do not support added beneficial effect for this step-down approach. (38) The highest dose should be used for those who smoke more than 10 cigarettes per day and reduced dosage forms for light smokers. The optimal dosage for light smokers is not known because of limited data in this group. The patches are contraindicated for patients with systemic eczema, unstable angina, and within 1 month of a myocardial infarction.

Nicotine nasal spray. Abstinence rate at 6 months from meta-analysis was 31% for the spray compared with 14% for placebo. (17) A dose is one spray into each nostril; each spray delivers 0.5 mg of nicotine. Patients should use 1 to 2 doses every hour for 6 to 8 weeks. A drawback is that the spray seems to have the highest addictive potential of all NRTs. (39,40) Patients who experience withdrawal symptoms with abrupt cessation of treatment should be considered for 4 to 6 weeks of tapering. Tapering could be achieved by reducing the dose by half every week. The most commonly reported side effects of the nicotine nasal spray include nasal irritation, runny nose, sneezing, throat irritation, coughing, and watery eyes. Patients usually develop tolerance to these effects within the first week.

Nicotine inhaler. A unique feature of the nicotine inhaler is that it mimics the hand-to-mouth routine similar to cigarette smoking and may therefore reduce fears associated with abrupt cessation of the hand-to-mouth ritual. The inhaler consists of a plastic mouthpiece to which a cartridge is attached. The cartridge contains 10 mg (but delivers only 4 mg) of nicotine plus 1 mg of menthol. The inhaler is different from typical inhalers in that patients puff on the mouthpiece, and nicotine is absorbed in the mouth rather than the lungs. Abstinence rates at 6 months were 23% for the inhaler and 11% for placebo. (17) Recommended dosage is 6 to 16 cartridges per day for 8 weeks. Patients should self-titrate their dosing based on severity of withdrawal symptoms experienced. Adverse events are generally mild, consisting of throat irritation and cough.

Bupropion This is an alternative for smokers who either cannot tolerate nicotine replacement therapy or prefer non-nicotine treatment. The efficacy of bupropion for smoking cessation has been demonstrated in 2 randomized controlled trials. (41,42) Abstinence rates at 6 months were approximately 30% for bupropion versus 17% for placebo. Common adverse effects are generally mild, consisting of insomnia and dry mouth; headache and tremors are less common. This drug is contraindicated for patients with history of seizures, anorexia or bulimia, head trauma, or heavy alcohol use, and is category B for pregnancy.

Combination drug therapy. Combining the nicotine patch with a self-administered form of nicotine (eg, gum, spray, inhaler) is more efficacious than a single NRT. (17) One randomized trial also showed that bupropion combined with the patch was more efficacious than the patch alone but not significantly better than bupropion alone. Combination treatments should be considered for smokers unable to quit because of significant craving or withdrawal despite adequate doses of single agents.

Other recommended pharmacotherapies. The 2000 clinical practice guidelines recommended the use of clonidine hydrochloride and nortriptyline hydrochloride as second-line agents. Controlled studies on both agents are limited, (43-48) and neither agent is approved by the United States Food and Drug Administration for smoking cessation. Clonidine or nortriptyline should only be considered for patients who failed the first-line drugs or are unable to use them because of contraindications. Adverse events are generally more than for first-line agents.

Choice of Treatment

Few data exist on the comparative efficacy of the 5 approved pharmacotherapy aids (Table 1). The STEPS (safety, tolerability, efficacy, price, simplicity) approach can be used to guide physicians in the choice of pharmacologic agents. All NRTs are considered generally safe, and adverse effects associated with their use are mild. The NRTs have similar cardiovascular precautions (ie, avoid use in unstable angina and within 1 month of a myocardial infarction), are pregnancy category D (there is evidence of human fetal risk, but use is acceptable if benefits outweigh risks and safer alternatives are unavailable or ineffective), except the gum, which is category C (animal studies have revealed adverse effects on the fetus, but there are no controlled studies in women) and should be used during pregnancy only if nonpharmacologic approaches are unsuccessful. Bupropion is also relatively safe with precaution as discussed earlier. Product-specific characteristics could make some NRTs less suitable for certain patients. For example, the gum is not appropriate for patients with dental or jaw problems and may be difficult to use correctly, since it requires special chewing techniques and high frequency of use. Very humid weather conditions may affect adhesiveness of the patch. The patch should also be avoided in patients with systemic eczema.

The only study that compared the efficacy of various NRTs reported similar results for all 4 NRTs. Although one study reported superior efficacy for bupropion over the patch, (49) this finding has not been replicated. Bupropion costs slightly less than the NRTs (Table 2). Of the NRTs, the patch appears to be the most convenient to use. In one randomized controlled trial, (50) compliance was highest for the patch (82%) compared with the gum (38%), the spray (15%), and the inhaler (11%). A limitation common to all smoking cessation pharmacologic trials is that participants were volunteers with higher motivation to quit smoking and willing to comply with frequent follow-up contacts required in clinical trials. The effectiveness of these medications in real world settings may be lower than that reported in clinical trials. Also, the placebo arms in these trials typically receive substantially more counseling than what happens in real world settings. These factors combined produce higher quit rates in placebo patients than that found in typical unaided quit attempts. Physicians should consider using an algorithm (Figure) to assist them in approach to and treatment of smokers.


Relapse is quite common among smokers trying to quit. On average, it takes 4 to 5 quit attempts before a smoker is successful. (4) For this reason the last step of the AHRQ recommendations (arrange, ie, make arrangement for follow-up care for smoking cessation), is very important. The follow-up contact should occur within 1 week of patient's quit date, because the risk of relapse back to smoking is highest during the first few days of abstinence. (51,52) There are considerable data showing that additional follow-up contact beyond initial brief advice significantly increases quit rates. (23,53,54)

A variety of follow-up methods have been used in clinical trials, including face-to-face contact with a physician or other health care professional, letters, telephone, and self-help materials. Nurses and other office staff could be trained and designated to perform some or all the follow-up contact. (18,55-57) In a recently published randomized trial, (58) office nurses were trained to provide telephone follow-up contacts for low-income Medicaid managed care smokers. Abstinence rates at 3 months were 21% and 8% for telephone follow-up and usual care, respectively.

In addition to office-based telephone and printed self-help resources, physicians should be aware of a growing number of free telephone helplines and Internet-based resources (Table 3) available for people trying to quit smoking. Patients without personal Internet access should be encouraged to make use of such services available at most public libraries.


Smoking cessation significantly reduces most of the increased morbidity and mortality from smoking. (59) The degree of improvement, however, depends on the disease process involved, the amount of damage produced, and the reversibility of this damage at the time of cessation. Former smokers reduce their risk of developing coronary heart disease by 50% within 1 year of quitting. (59) After 4 years, this risk becomes equal to that of people who have never smoked. Improvement in cancer risk varies with the type of cancer involved. The risk of lung cancer in former smokers, for example, always remains higher than that for those who have never smoked. However, this risk decreases progressively and considerably with the number of years of abstinence. (59)

In addition to reduction in morbidity and mortality, smoking cessation is among the most cost-effective measures in primary care. Studies have shown that the cost-effectiveness of physician smoking cessation counseling is similar to the treatment of mild to moderate hypertension or hypercholesterolemia. (60) The estimated cost per year of life saved is $2000 for smoking cessation compared with $50,000 for screening mammography for breast cancer. (61) Given the proven effectiveness of available smoking cessation interventions and the ready access primary care physicians have to smokers, effectively addressing tobacco use in primary care settings has a great potential of reducing tobacco-related morbidity and mortality.


Strength of Recommendation *        Treatment          Quit Rates at
                                                         6 Months, %

A                             Brief advice (17,23)           2-10
A                              Nicotine patch (38)            22

A                              Nicotine spray (17)            30
A                             Nicotine inhaler (17)           23

A                                  Bupropion                  31
                              hydrochloride (41,42)

B                               Nicotine gum (17)             24


A                             Nicotine patch plus             28
                                nicotine gum (64)
B                             Nicotine patch plus          37 (at 3
                               nicotine spray (65)          months)
B                             Nicotine patch plus             25
                               nicotine inhaler (66)
B                             Nicotine patch plus             35
                                  bupropion (42)

Strength of Recommendation *              Comments


A                              5 minutes or less in single visit

A                              Less addictive potential
                               than the gum

A                              Higher addictive potential (39)

A                              Mimics hand-to-mouth routine
                               similar to cigarette smoking

A                              Initial concerns about increased
                               risk of seizures have not been
                               confirmed (62)

B                              Quit rates higher in specialized
                               cessation clinics, than in pri-
                               mary care (32); more addictive
                               potential than the patch (40,63)


A                              Combination more efficacious
                               than either agent alone

B                              Combination more efficacious
                               than either agent alone

B                              Combination more efficacious
                               than either agent alone

B                              Combination more efficacious than
                               patch but not better than
                               bupropion alone

* Adapted from: Levels of Evidence and Grades of Recommendation.
Center for Evidence-based Medicine Web site,
levels.html. Accessed January 31, 2001.

([dagger]) Quit rates cannot be compared across treatment types
because of substantial differences between various studies.


Drug                    How Supplied          Usual Dosage

Nicotine gum       48 or 108 pieces/box    <15 cigarettes/day: 2mg
                                           (1 gum every 1-2 h);
                                           [greater than or equal to]
                                           15 cigarettes/day: 4 mg
                                           (1 gum every 1-2 hrs)

Nicotine patch     7, 14, or 30            21 mg/24 hours for
                   patches/box             4 weeks, then,
                                           14 mg/24 hours
                                           for 2 weeks, then
                                           7 mg/24 hours for 2 weeks--
                                           15 mg/16 hours for 8 weeks

Nicotrol nasal     10-mLbottle             1-2 doses/hr for
spray (McNeil)                             3-6 months

Nicotrol           42 cartridges/box       6-16 cartridges/day

Zyban              30 or 60 tablets/       150 mg/day for 3 days,
(Glaxo-Wellcome)   bottle                  then 150 mg twice/day for
                                           7-12 weeks. Start treatment
                                           1-2 weeks before quit date

Drug                    Cost par Day *

Nicotine gum       $4.54 for 10 2-mg pieces;
                   $5.12 for 10 4-mg pieces

Nicotine patch     $3.29 for each 7-mg patch;
                   $3.47 for each 14-mg patch;
                   $3.65 for each 21-mg patch;
                   $3.08 for each
                   15-mg patch

Nicotrol nasal     $4.90 for 12 doses
spray (McNeil)

Nicotrol           $5.97 for 6 cartridges

Zyban              $3.21

* Average wholesale prices. Prepared on April 10, 2001, by
University of Kansas Medical Center Drug.


The American Lung Association (ALA). 1740 Broadway, New York, NY
10019. Telephone: 1-800-LUNG:USA. Web site:

The American Heart Association. 7272 Greenville Avenue, Dallas,
TX. 75231. Telephone: 1-800-AHA-USA (242-8721). Web site:

The American Cancer Society. 1599 Clifton Road NE, Atlanta, GA 30329.
Telephone: 1-800-ACS-2345. Web site:

National Cancer Institute. 1-800-4-CANCER (422-6237).
Web site:

Nicotine Anonymous. P.O. Box 591777, San Francisco, CA 94159-1777.
Telephone: (415)750-0328. web site:

American Academy of Family Physicians (AAFP). 11400 Tomahawk Creek
Parkway, Leawood, KS 66211-2672. Telephone: 1-800-274-2237, extension
5500. Web site:

Arizona Smokers' Helpline. 1-800-556-6222. Web site:

California's Smokers' Quitline. 1-800-NO-BUTTS. Web site:

Massachusetts Smokers' Quitline. 1-800-879-8678. Web site:


Quit Smoking Support:


Our work was supported by a grant from the Cancer Research Foundation of America (Dr Okuyemi) and a Robert Wood Johnson Foundation Generalist Physician Faculty Scholars Award (Dr Ahluwalia, #032586).

Dr Wadland has received funding in the past from SmithKline-Beecham and Glaxo-Wellcome for nicotine replacement in community clinical trials. Dr Ahluwalia has received honoraria for presentations from Glaxo-Wellcome, Inc and Pharmacia Upjohn, Inc. Dr Okuyemi has received an honorarium for educational purposes from SmithKline Beecham.


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Kansas City, Kansas, and East Lansing, Michigan

* Submitted, revised, September 3, 2001

From the departments of Family Medicine (K.S.O., J.S.A.), Preventive Medicine (K.S.O., J.S.A.), and Internal Medicine (J.S.A.) and the Kansas Cancer Institute (K.S.O., J.S.A.), University of Kansas School of Medicine, Kansas City, and the Department of Family Practice, Michigan State University (W.C.W.), East Lansing. Reprint requests should be addressed to Kolawole S. Okuyemi, MD, MPH, Department of Family Medicine, University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160-7370. E-mail:
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Author:Okuyemi, Kolawole S.; Ahluwalia, Jasjit S.; Wadland, William C.
Publication:Journal of Family Practice
Geographic Code:1USA
Date:Nov 1, 2001
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