Putting Evidence Into Practice Smoking Cessation

Putting evidence into practice: Smoking cessation
Klara Brunnhuber K. Michael Cummings Sheila Feit Scott Sherman James Woodcock
Summer 2007
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This report was commissioned by the United Health Foundation. The BMJ Publishing Group Limited (BMJPG) is a world leader in medical publishing. Its journals and online products address major specialties, lead the debate on health care, and deliver innovative knowledge and best practices to doctors, health professionals, researchers and patients, when and where they need it. The BMJPG publishes BMJ Clinical Evidence, an evidence-based compendium of therapies, which is an authoritative resource for informing treatment decisions and improving patient care.
Funding
This report was funded by the United Health Foundation.
Disclaimer
The information contained in this publication is intended for medical professionals. We rely on studies to confirm the accuracy of the information presented, and to describe generally accepted practices, and therefore we cannot warrant its accuracy. Readers should be aware that professionals in the field may have different opinions. Because of this fact and also because of regular advances in medical research, we strongly recommend that readers independently verify specified treatments and drugs, including manufacturers guidance. Ultimately, it is the readers responsibility to make their own professional judgements, so as to appropriately advise and treat their patients. Description of reference to a product or publication does not imply endorsement of that product or publication, unless it is owned by the BMJ Publishing Group Limited. To the fullest extent permitted by law, BMJ Publishing Group Limited and its authors and editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, product liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication. BMJ Publishing Group Limited 2007
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Authors
Klara Brunnhuber, MD Clinical Editor, BMJ Publishing Group Limited K. Michael Cummings, PhD, MPH (Public policy on smoking) Chair, Department of Health Behavior, Division of Cancer Prevention and Population Sciences, Roswell Park Cancer Institute, Buffalo, NY Sheila Feit, MD Deputy Editor, Point of Care, BMJ Publishing Group Limited Scott Sherman, MD, MPH (Toolkit: 12-step guide to a primary care systems approach for smoking cessation) Associate Professor, Department of Medicine, NYU Medical Center, NY James Woodcock, MSc Product Development Editor, BMJ Publishing Group Limited
Acknowledgments
Dr Nicholas Gaudin (Head of Communications IARC, WHO, Lyon, France) for providing pre-publication access to Tobacco Control, Vol. 11: Reversal of Risk After Quitting Smoking Dr Beth Nash (Product Development Manager, BMJ Publishing Group Limited) for her help with planning and reviewing the paper Sam Martin (Information Specialist, BMJ Publishing Group Limited) and Alex McNeil (Information Specialist, BMJ Publishing Group Limited) for conducting literature searches and assisting with appraisal of studies Polly Brown (Freelance Scientific Editor, BMJ Publishing Group Limited) and Dr Karen Devries (PhD, London School of Hygiene and Tropical Medicine) for writing evidence summaries Tricia Lawrence (Copy Editor, BMJ Publishing Group Limited) for copyediting the paper
Advisory board and peer review

K. Michael Cummings, PhD, MPH Chair, Department of Health Behavior, Division of Cancer Prevention and Population Sciences, Roswell Park Cancer Institute, Buffalo, NY Michael Fischer, MD, MS Associate Physician in the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Womens Hospital; Instructor in Medicine, Harvard Medical School, Boston, MA Nancy Rigotti, MD Associate Professor, Department of Medicine, Harvard Medical School; Associate Professor, Department of Health and Social Behavior, Harvard School of Public Health; Director, Tobacco Research and Treatment Unit, Massachusetts General Hospital, Boston, MA Scott Sherman MD, MPH Associate Professor, Department of Medicine, NYU Medical Center, NY
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Additional peer reviewers

Carolyn Dresler, MD, MPA Associate Professor of Health Policy and Management Department of Health Policy and Management, University of Arkansas for Medical Sciences, Fayetteville, AR Nancy Lee Clinical Pharmacist, University of California, UCLA Medical Center, Los Angeles, CA Maria Leon-Roux, MPH Tobacco and Cancer Team, Lifestyle, Environment and Cancer Group, IARC, WHO, Lyon, France
Competing interests
K. Michael Cummings, PhD, MPH has been paid by the Pfizer Corporation to give lectures to doctors about their new stop-smoking medication, Chantix. The Pfizer Corporation and GlaxoSmithKline have also supported continuing medical education (CME) programs for health care professionals that he has helped to organize. He is co-author of six articles that are referenced in this report. Carolyn Dresler, MD was the medical director for research and development for the Smoking Control Category (Nicotine replacement products) for GlaxoSmithKline Consumer Healthcare from June 1998 to June 2004. Maria Leon-Roux, MPH is one of the officers overseeing a comprehensive review referenced in this report. Nancy Rigotti, MD has consulted for the Pfizer Corporation and Sanofi-Aventis regarding smoking cessation treatments. The Tobacco Research and Treatment Center that she directs has received research grants from the Pfizer Corporation, Sanofi-Aventis, and Nabi Biopharmaceuticals to study smoking cessation treatments. She is co-author of four articles that are referenced in this report.
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Contents
Introduction......................................................................................................................1 Demographics .................................................................................................................2 Disease burden from smoking ........................................................................................3 Health benefits of cessation............................................................................................4 Predictors of quitting and maintained cessation ...........................................................12 Public policy on smoking...............................................................................................13 Interventions for smoking cessation..............................................................................15 Economic issues in smoking cessation ........................................................................26 References ....................................................................................................................28 Appendix: Methodology .................................................................................................34 Toolkit: 12-step guide to a primary care systems approach for smoking cessation .......................................................................................................................38
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Most smokers want to quit.1 But most attempts fail and new smokers are constantly recruited, so about 45 million American adults still smoke.2,3 Cigarette smoking remains the single most avoidable cause of death and disability in the United States.2 Sequelae of smoking include cardiovascular and respiratory disease, cancer (e.g., lung, larynx, esophagus, mouth, bladder, cervix, pancreas, kidneys), and infant deaths related to maternal smoking.1,2 Increasingly, the dangers of secondhand smoke, such as cardiac disease and lung cancer, are also recognized by researchers and policy makers.2,4 In the long run, the most effective way to eliminate smoking-related illness is to prevent people from starting use of tobacco. For those who already smoke, discontinuing use is the best and surest option for reducing health risks. + Motivation to quit smoking is important, but its not enough. Most people think they can quit on their own, but although some smokers succeed, most attempts fail. About 40% of smokers stop for at least a day in an attempt to quit each year.3,5 Many need encouragement, assistance, and guidance. + Smoking can be thought of as a chronic illness, with exacerbations and remissions.6 A brief tobacco use assessment can help identify those people who are highly nicotine-dependent, or lack motivation and confidence to quit, in order to tailor treatment to individual needs. + Medications treat the addiction component of smoking. Drugs are available that increase the chance of a successful quit attempt. Trials have generally included behavioral support and most have excluded people with serious medical or psychiatric illnesses. + Behavioral counseling addresses the habit. Smoking is both a habit and a coping strategy. Although no method is proven to prevent relapse, patients can try to identify triggers and plan or rehearse responsive strategies. At follow-up, patients can discuss difficult situations and how to handle them. + A systems approach may help to identify and treat smokers. [See Toolkit: 12-step guide to a primary care systems approach for smoking cessation] Office visits and any contact with the health care system (e.g., pregnancy, acute respiratory illness, hospitalization, or pediatric visits) are opportunities to relay smoking cessation information. Considering smoking status a vital sign can highlight its importance.7 Electronic tools may be a promising component of delivering smoking cessation interventions efficiently. Encouraging smoking cessation is now recognized as an important part of medical care and public health. This paper will examine the disease burden related to smoking and the health benefits of quitting. It will present the evidence for interventions to help adults quit smoking, and provide a practical toolkit for putting the evidence into everyday practice.
Introduction
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Demographics
The prevalence of smoking has decreased by about 50% over the past 50 years to around one fifth of the U.S. population. Currently about 58% of Americans have never smoked.
Figure 1. Changes in prevalence of smoking among adults in the United States8
The remainder of the population is about evenly split between former (21%) and current (21%) smokers.8 More men smoke than women (23% vs. 19%). Among people of different ancestries, smoking is most common among American Indians/Native Alaskans (33%) and least common among Asians/Pacific Islanders (11.3%) and Hispanics (15%). The prevalence of smoking for both blacks and whites is 21%.8 About 22% to 24% of adults aged 18 to 64 are smokers, compared to about 8.8% of people aged 65 or older. Length of education is associated with lower smoking rates, ranging from 26% in people with less than 12 years of education to 10% in those with 16 years or more. Therefore, smoking is an important contributor to health disparities. Smoking rates are higher among young adults (aged 18 to 24) than older ones. The highest percentage of young adult smokers is in men with less than 12 years of education (40%). Overall, 26% of young adult men and 22% of young adult women smoke.8 Smoking is more common among lower socioeconomic groups. About 21% of people at or above the poverty line ($9,645 in 2004) smoke, compared to 29% of those below the poverty line.8 Levels in all of these groups are above the U.S. governments Healthy People 2010 goal: an adult smoking rate of less than 12%.9
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Smoking is the biggest preventable cause of premature mortality in the United States and is a major factor in many diseases and adverse health events, such as cardiovascular disease, lung cancer, respiratory diseases and harmful effects on reproduction. Smoking also adversely impacts wound healing in patients who have undergone surgery. Evidence is still being accumulated for other harms of smoking. Exposure to secondhand tobacco smoke is a significant health risk for nonsmokers, especially those with pre-existing respiratory and cardiac conditions. Health care professionals should routinely question all their patients about exposure to secondhand smoke and advise their patients to adopt a smoke-free home and car policy. According to the 2004 Surgeon Generals Report there is sufficient evidence that smoking causes the following conditions:10,11 + Cancers: lung, oral (laryngeal), GI (esophageal, stomach, liver, pancreatic), GU (bladder, kidney, cervical), hematologic (myeloid leukemia) + Cardiovascular disease: atherosclerosis, cerebrovascular and coronary heart disease (CHD), abdominal aortic aneurysm + Respiratory disease: chronic obstructive pulmonary disease (COPD), increased susceptibility to pneumonia, and impaired lung growth during childhood and adolescence + Reproductive effects: decreased fertility in women, complications of pregnancy such as premature rupture of the membranes, placenta previa, or placental abruption, miscarriage, still birth, low birth weight, reduced lung function in infants, sudden infant death syndrome (SIDS) + Other: hip fractures, low bone density, peptic ulcer disease, cataracts, diminished health status In 2000, smoking was responsible for 269,000 deaths among men and 243,000 deaths among women in the United States (see figures 2 and 3). However, many more people are harmed by tobacco use than is indicated by mortality statistics. In 2000, an estimated 8.6 (95% CI 6.9 to 10.5) million people in the United States had disease attributable to smoking.13 For current smokers, chronic bronchitis was the most prevalent condition (49%), followed by emphysema (24%). For former smokers, the three most prevalent conditions were chronic bronchitis (26%), emphysema (24%), and previous heart attack (24%).
Disease burden from smoking
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Figures 2. and 3. Number of deaths attributable to smoking in men and women in 200012
Stopping smoking reduces the risk of many of the conditions associated with smoking. However, lag times differ among conditions between smoking and development of disease. Although for some conditions the risk falls off quickly after quitting toward the level of a never smoker, for others there remains an elevated risk for many decades. Individual risk often depends on previous duration and intensity of smoking and varies between those with and without pre-existing evidence of disease. This means that it is important to promote smoking cessation as early as possible among young smokers who have the greatest chance of avoiding adverse smoking-related events. As these populations are usually in good health and have limited contact with the medical community, all opportunities need to be taken. Although the largest potential benefits
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Health benefits of cessation
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Figure 4. Timeline of health benefits after smoking cessation14
COPD: chronic obstructive pulmonary disease; CHD: coronary heart disease
are in young smokers, there are benefits from quitting even among elderly smokers and people with considerable comorbidities. These groups should also be encouraged to quit. The best evidence on benefits of cessation comes from a new systematic review by the International Agency for Research on Cancer (IARC).14
Mortality
There is strong and consistent evidence from cohort and case control studies that sustained smoking cessation reduces mortality compared with ongoing smoking. Some of the longest term data has come from 50 years follow-up of 34,439 male British doctors.15 This study found a difference in life expectancy of 10 years between continuing smokers and never smokers for men born between 1900 and 1930. There
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were substantial benefits from cessation. Gains in life expectancy were 3 years at age 60, 6 years at age 50, 9 years at age 40, and 10 years at age 30. In the study, overall mortality decreased among nonsmokers over the second half of the 20th century. However, as a result of earlier and more intensive smoking, this change was not observed among cigarette smokers, resulting in an increased smoker to nonsmoker death rate ratio. As Figure 5 shows, cessation is extremely beneficial for all age groups, and the earlier smokers quit, the closer will their chances of survival resemble that of never smokers. Less good data exist for women, in part because of historically lower smoking levels. In the past, female smokers started later and smoked smaller amounts than men, which may have produced a lower loss of life. However, this difference increasingly no longer applies. A population-based cohort study in Norway followed 24,505 women and 25,034 men over 26 years and collected smoking status at multiple time points.16 For women, it found that mortality was approximately halved in smokers who stopped before the age of 40 compared with continuing smokers (risk of dying in middle age 9.4% vs. 19.4%). Lung cancer rates, which had been adjusted for amount smoked and age started, were similar in women and men, but middle-aged women had lower cardiovascular mortality leading to less all-cause mortality from smoking. Evidence from observational studies has been supplemented by recent evidence from a large randomized trial with long-term follow-up that found benefits from cessation even though only a minority of the population successfully quit.17 The Lung Health Study in 10 clinical centers in the United States and Canada followed 5,887 middle-aged volunteers with asymptomatic airway obstruction and compared an intensive smoking cessation intervention versus usual care. It found that all-cause mortality was significantly lower in the intervention group (8.83 per 1000 person-years vs. 10.38 per 1000 person-years; P = 0.03).
Lung cancer represents the biggest cause of smoking-related cancer mortality. According to the Centers for Disease Control and Prevention (CDC), smoking-related lung cancer accounts for more than 10 times the number of years of potential life lost (YLL) in the United States compared with any other smoking-related cancer (based on data from 1997 to 2001: 1,113,600 YLL in men and 740,200 YLL in women.10 Because of the time lag between cigarette smoke-related cell mutation, and disease detection, a difference in lung cancer risk between smokers and former smokers is not to be expected before around 2 years after quitting. Because of the high relative risk for lung cancer from smoking and the high disease burden, the impact of cessation is relatively easy to study. One systematic review found 34 studies with results in men, 21 in women, and 6 in both sexes.14 It concluded that most of the increased risk is avoided by those who stop smoking before middle age, but that there is a smaller but still substantial gain among those who quit in middle or older age. However, the absolute annual risk of developing or dying from lung cancer does not decrease after stopping smoking. Table 1 summarizes a meta-analysis of U.S. studies for the relative reduction in risk for quitters compared with persistent smokers.14
Cancer risk
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Figure 5. Impact of smoking and smoking cessation on survival in men15
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Table 1. Changes in relative risk (RR) for lung cancer after cessation between former and persistent smokers14
Years since cessation < 10 RR in men RR in women 0.78 (95% CI 0.670.92) 0.73 (95% CI 0.580.92) 1019 0.28 (95% CI 0.150.51) 0.23 (95% CI 0.130.40) 2029 0.20 (95% CI 0.180.22) 0.14 (95% CI 0.040.42) 3039 0.10 (95% CI 0.080.13) 0.10 (95% CI 0.080.12)
A systematic review found that smoking cessation was associated with a reduction in the risk of all the major histologic types of lung cancer.18 However, the risk for adenocarcinoma and large cell carcinoma fell off less rapidly than for small cell lung cancer and squamous cell carcinoma. The subsequent review supported these findings.14 As described in Table 2, other types of cancer are also causally linked to smoking. Table 2. Cancer types other than lung cancer and their association with smoking
Cancer type Esophageal cancer Disease burden from smoking, additional risk factors, and health benefits from cessation + Second biggest cause of years of life lost (YLL) through cancer from smoking among men (101,100 YLL), and the third among women (25,000 YLL) + Good evidence of reduced risk for ex-smokers compared with current smokers for squamous cell esophageal cancer;14 after 10 years of cessation the risk among ex-smokers was still twice the risk of never smokers, and an increased risk was probably maintained for at least 20 years + Evidence on adenocarcinoma was more limited with no clear reduction of risk on cessation.14 Oral cancer + Third biggest cause of years of life lost through cancer among men (63,200 YLL) and the fifth among women (19,700 YLL) + Strong interaction between alcohol and smoking + The best evidence came from a study of 177,903 veterans aged 30 years or older. 14,19 It found that former smokers had significantly less than half (44%) of the risk of current smokers. A recent systematic review concluded that the risk remained elevated compared with never smokers up to 20 years after cessation.14 Pancreatic cancer + Second biggest cause of smoking-related years of life lost from smoking among women (51,600 YLL) + There is good evidence of risk reduction following cessation.14 The risk is likely to remain elevated for at least 15 years after cessation. Urinary tract cancer + There is good evidence of reduced risk among former compared with persistent smokers.14 However, the risk remained elevated for at least 25 years after cessation. + Following cessation, the relative risk returned rapidly to the level of never smokers. 20 BMJ Publishing Group 2007
Cervical cancer
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Stomach cancer
+ Smoking has recently been found to be causally associated with stomach cancer. + Helicobacter pylori infection and alcohol consumption are other important risk factors. + Reduced relative risk compared with persistent smokers, but insufficient evidence to assess whether the risk ever fell to that of never smokers.14
Laryngeal cancer
+ Rapid reduction in risk (about 60% at 10 to 15 years compared with persistent smokers), and continuing to fall, although an elevated risk remains compared with never smokers for at least 20 years.14 However, caution is warranted as the cohort studies measured smoking status only at enrollment. + Inconclusive evidence to assess the benefits of cessation for the risk of myeloid leukemia.14
Myeloid leukemia
A recent study summarized the effects of smoking on cancer treatment efficacy in people with malignancies.21 It found that most oncology clinical trials did not collect data on smoking history and status, particularly in cancers that are not widely acknowledged as smoking-related. If collected, smoking status was monitored in very few trials and infrequently reported or included as potential moderator of outcomes. It found that smoking was associated with pulmonary complications during and following surgery, poorer wound healing, and increased complications from radiation therapy. Other studies have associated smoking cessation with increased survival times in breast cancer and non-small cell lung cancer.22,23,24
Cardiovascular risk
Smoking operates at different stages in the development of coronary heart disease (CHD). It both reduces the ability of the blood to carry oxygen and causes progressive atherosclerosis with endothelial injury and thrombotic processes that may lead to acute infarction.10,14 A systematic review found that smoking cessation decreased the RR for reinfarction or death by 36% among people with CHD.25 Three subsequent cohort studies confirmed the benefit from cessation in people with CHD.2628 The IARC review found some studies showing that RR falls to that of never smokers 10 to 15 years after cessation, although other studies found that RR was still 10% to 20% elevated 10 to 20 years after quitting.14 As a result of possible confounding through misclassification of smoking status, reverse causation, and overall healthier behavior by quitters, it is not possible to assess with the current body of evidence if any long-term residual risk remains.
Coronary heart disease
The evidence base for association of smoking with cerebrovascular disease is less good than for cardiovascular disease. However, it is clear from the IARC review that the RR decreases with cessation and may reach that of never smokers following 5 to 10 years of abstinence, although there could still be some elevated risk.14 In part this probably depends on past smoking habits, with light smokers (< 20 cigarettes/day) reaching the risk of never smokers within 5 years, whereas heavier smokers may never reach it.
Cerebrovascular disease
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Smoking is the dominant risk factor for peripheral artery disease (PAD). The reduction in RR is slower than for cerebrovascular and CHD, with elevated risk observed even after 20 years.14 However, there is evidence of a clearer and more rapid benefit in people with advanced PAD who quit smoking. A meta-analysis of 4 randomized controlled trials (RCTs) and 12 prospective studies included in a systematic review found that smoking increased graft failure 3.09-fold (95% CI 2.344.08; P < 0.00001) in people with PAD who were undergoing arterial reconstructive surgery in the lower extremities, with no difference in patency rates between autogenous and polyester grafts.29 It demonstrated a clear dose response relationship, with reduced patency in heavy smokers compared with moderate smokers. After quitting, patency failure rates returned to the level of never smokers.
Peripheral artery disease
The IARC review found that the general decline in lung function with age reverted to that of never smokers within 5 years of cessation.14 The strongest evidence for benefit is in people with mild COPD. One RCT, the Lung Health Study, which included people with mild to moderate COPD, found an increase in FEV1 in the first year following smoking cessation.30 Subsequently the rate of decline in sustained quitters was half that of continuing smokers.31 Limited evidence in people with severe COPD suggested also a large benefit.14 Long-term studies suggested a substantial reduction in mortality compared with continuing smokers. The British doctors study, after 50 years of observation, found age-standardized mortality rates per 1000 man-years for COPD of 0.11 for never smokers, 0.64 for former smokers, and 1.56 for current smokers.15 Given the long time lag between first symptoms and death from COPD, reverse causality may lead to underestimatation of the benefits of cessation.
Chronic obstructive pulmonary disease
Although there is good evidence of a dose response effect from smoking from studies of both intensity and duration, the evidence on reduced smoking is less clear than the evidence for benefit from smoking cessation on mortality, lung cancer, and cardiovascular disease. Recent long-term studies from Norway (24,959 men and 26,251 women aged 2049 years) and Denmark (19,732 people with a mean follow-up of 15.5 years) found no evidence of reduced mortality in smokers who reduced smoking.32,33 However, reduced cigarette consumption may be useful as a step toward cessation, with lower cigarette dependency being associated with a greater chance of successful quitting.34
Reduced cigarette consumption
Secondhand smoke is now a recognized carcinogen, containing over 50 harmful chemicals, such as formaldehyde, benzene, vinyl chloride, arsenic, ammonia, and hydrogen cyanide.4 Concentrations of many harmful chemicals are higher in secondhand smoke than in that inhaled by smokers. Difficulties studying the link between secondhand smoke and disease incidence include the need to examine large numbers of people for long time lengths, a lack of controlled study conditions and recall bias on the part of study participants. However, breathing secondhand smoke has been found to be immediately detrimental to the cardiovascular system.4 There is a prothrombotic effect with increased platelet stickiness, decreased
Secondhand smoke
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coronary flow reserves, and reduced heart rate variability. Pooled evidence has indicated a causal relationship between secondhand smoke and both lung cancer and CHD. Nonsmokers exposed to secondhand smoke at home or at work have about a 25% to 30% increased risk of heart disease and 20% to 30% increased risk of lung cancer. A recent systematic review and meta-analysis looked specifically at workplace exposure to tobacco smoke, excluding studies that featured former smokers.35 The analysis stratified studies depending on level of exposure and weighted evidence on several key issues including geographic location, gender, and level of exposure to other lung carcinogens such as coal heating fumes. Most of the included studies (20 of 25) found an increased lung cancer risk among never smokers exposed to workplace secondhand smoke. Meta-analysis found that relative risk increased on average by 24%, with people in the highest workplace exposure categories being twice as likely to develop lung cancer compared with nonexposed people. Despite declining smoking rates, millions of Americans continue to be exposed to secondhand smoke, including 60% of children aged 3 to 11 years.4 Millions of indoor workers are still not covered by smoke-free workplace rules. Secondhand smoke exposure varies by occupation, gender, and ethnicity, but exposure tends to be higher in lower socioeconomic groups. People who work in entertainment jobs, restaurants, or bars are at highest risk. Homes and vehicles also remain important places of exposure. Infants and young children are considered especially vulnerable. Maternal exposure during pregnancy is associated with a small decrease in birth weight and persistent adverse effects on lung function throughout childhood. Parental smoke is linked to ever having asthma, and exposure in children has been associated with increased risk for sudden infant death syndrome (SIDS), acute respiratory infections, ear problems, and increased severity of asthma. The Surgeon General has concluded that there is no safe level for secondhand smoke exposure. Mechanical ventilation or separation of smokers does not fully eliminate the risk. Air cleaning systems leave behind small particles. Heating and cooling systems may distribute smoke throughout a building. A final frontier is the restriction of smoking in cars and homes. Custody and foster arrangements may be affected by parental smoking; some residential buildings are now smoke-free; and, a few regions have introduced fines for smoking in cars with children.4,36,37
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There are two aspects to cessation: making a quit attempt and maintaining cessation. Two prospective studies (including over 13,000 smokers) found that nicotine dependence was the key predictor of cessation success, as assessed by length of time to first cigarette of the day and number of cigarettes smoked per day.34,38 Table 3. Predictors of quit attempts and cessation success
Predictive factor Low nicotine dependence34,38,39 Definition Low Heaviness of Smoking Index (variable of number of cigarettes smoked per day and time to first cigarette) or smoking less than daily Quit date set or strong desire to quit Longest time off smoking in the past 6 months Tried to quit during previous year Assessed by length of education or income No smoking within 2 weeks of attempt Increased quit attempts + Increased cessation success +
Predictors of quitting and maintained cessation
High motivation34,38,39 Longer prior attempt38,39 Prior quit attempts38,39 Higher socioeconomic status34 Initial success38,40
+ + + + No data
Small effect + + +
The recent International Tobacco Control (ITC) Four Country Survey and the Community Intervention Trial for Smoking Cessation (COMMIT) trial found some evidence for higher successful cessation rates among men.34,38,39 However, a systematic review did not show that the relative benefits of different smoking cessation interventions varied by sex.41
Gender as a predictor of success
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Efforts to increase smoking cessation at the population level involve interventions that convince smokers to make quit attempts, and encourage those who do try to quit to use treatments that will increase their odds of staying quit.42 Fortunately, effective treatments for tobacco use are available, with several new treatments in the pipeline.43 However, the potential impact of current and emerging treatments for tobacco use will depend not only on their efficacy, but also the extent to which these treatments reach those who might benefit from them. Not much evidence is available to support the idea that therapies for treating tobacco use have dramatically influenced rates of smoking on a population level.44 The main reason for this failure is the generally low utilization of these therapies, which is in part the result of a need for health care workers to more aggressively assist their tobacco-using patients in quitting. Health care providers have an important role to play in creating practice environments that promote cessation treatment as part of routine care.45 Medicare currently covers cessation counseling benefits, and its prescription drug benefit (Part D) plan also covers smoking cessation treatments, though not over-the-counter (OTC) products such as nicotine patches and gum.46,47 Other strategies that can increase the reach, appeal, and use of effective interventions include the promotion of a national quit line number on cigarette packs and the availability of more consumer-appealing cessation treatments.46,47 These hold great untapped potential to reduce overall adult smoking prevalence and growing disparities in tobacco use in the future. Interventions that have the greatest chance of reducing tobacco use in the population are those that reach the most smokers. This is one of the reasons why past research has shown that the most potent demand-reducing influences on tobacco use have been interventions that impact all smokers repeatedly, such as higher taxes on tobacco products, comprehensive advertising bans, pack warnings, hard-hitting anti-tobacco education campaigns, and smoke-free policies.4850 Studies have found that rewardbased (quit and win) campaigns may increase quit rates, but misreporting cessation makes studying them difficult.51 Smoking is more widespread among lower socioeconomic groups and is a major contributor to health inequities. This means successful cessation can be more difficult as a result of greater exposure to cues for smoking. Furthermore, low-income smokers may have lower access to pharmacotherapy and other treatments that improve cessation. A systematic review looked at the effect of reducing the cost of smoking cessation treatments for smokers.52 A meta-analysis of four studies found that such a policy helped an additional 2% (95% CI 05%) of smokers to quit. One large subsequent controlled study found that sending free nicotine replacement therapy to smokers who called a quit line substantially increased cessation.53 Similarly, another recent trial found that giving away vouchers for nicotine replacement therapy (NRT) to smokers as part of a broader campaign increased quit rates,54 although a study of NRT and telephone counseling found no benefit.55 Moreover, population-based studies have found that women with low educational levels were particularly responsive to media messages and were more sensitive to price increases than more educated women (elasticity near 1 for the period 1992 to 2002, implying that a 10% increase in price would reduce smoking by 10%).56 Comprehensive tobacco control measures can prove effective across the population. California was the first U.S. state to begin a comprehensive tobacco control program,
Public policy on smoking
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including price increases and mass media campaigns, and spent considerably more than other states per head on tobacco control during the 1990s. This resulted in higher rates of cessation among younger and to a lesser extent middle-aged smokers than in other states.57 In New York, increased cigarette taxes, smoke-free legislation, increased provision of cessation services, including a free nicotine patch program, and education were credited with reducing the prevalence of smoking, which fell from 21.6% to 19.2% during 2002 and 2003, across both sexes and among all age groups, ethnicities, and educational levels.48 The study found that increased taxation accounted for most of the reduction, although out-of-state purchase of tobacco reduced the benefit. Simulation modeling found that the largest reductions in smoking prevalence in the United States between 1993 and 2003 have come from price increases, because other interventions have not been implemented to the degree necessary to achieve major change.58 Projections predict that a total smoking ban in workplaces, restaurants, and public places would reduce the prevalence of smoking by 3.4% by 2010. In May 2007, the Institute of Medicine (part of the National Academy of Sciences) issued a report recommending a two-pronged approach to reducing tobacco use in the United States.59 The first proposed step was to strengthen traditional tobacco control measures and the second to change the current regulatory landscape. The Institute supported local efforts, but also advised giving regulatory authority to a federal agency such as the U.S. Food and Drug Administration (FDA). Suggested actions included stepped-up health warnings, limitations on advertising, increased funding and coordination of state activities, decreased nicotine content of cigarettes, higher tobacco taxes, and a national ban on indoor smoking. In order to establish an environment conducive to reducing tobacco use, over 140 countries have ratified the Framework Convention on Tobacco Control (FCTC), which is the first global health treaty negotiated under the auspices of the World Health Organization (WHO). The FCTC commits countries to implement a comprehensive range of policies (see table 4).60 Table 4. Key policy provisions of the Framework Convention on Tobacco Control (FCTC)
+ + + + + Increase tobacco taxes Protect citizens from exposure to tobacco smoke in workplaces, public transport, and indoor public places Enact comprehensive bans on tobacco advertising, promotion, and sponsorship Regulate the packaging and labeling of tobacco products to prevent the use of misleading and deceptive terms such as light and mild Regulate the packaging and labeling of tobacco products to ensure appropriate product warnings are communicated to consumers; for example, obligate the placement of rotating health warnings on tobacco packaging that cover at least 30% (but ideally 50% or more) of the principal display areas and include pictures or pictograms Regulate the testing and disclosure of the content and emissions of tobacco products Promote public awareness of tobacco control issues by ensuring broad access to effective comprehensive educational and public awareness programs on the health risks of tobacco and exposure to tobacco smoke Promote and implement effective programs aimed at promoting the cessation of tobacco use Combat smuggling, including the placing of final destination markings on packs Implement legislation and programs to prohibit the sale of tobacco products to minors Implement policies to support economically viable alternative sources of income for tobacco workers, growers, and individual sellers
+ + + + + +
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Interventions for smoking cessation

Both nicotine- and nonnicotine-based therapies can increase the chances of successful smoking cessation.61 Nicotine-based therapies are available as transdermal patch, gum, nasal spray, inhaler, or lozenge. FDA-approved nonnicotine-based drug treatments include bupropion and varenicline. Other effective drugs include nortriptyline or clonidine, but side effects may limit their use. Table 5. Comparison of FDA-approved drug therapies for smoking cessation
Mechanism of action Efficacy compared with: placebo or control therapy NRT increases odds of smoking cessation 1.5- to 2-fold.62 Bupropion increases odds of smoking cessation 2-fold.64 N/A NRT* bupropion varenicline
Effectiveness of drug treatments
NRT
Reduces nicotine withdrawal symptoms
NRT and bupropion seem equally efficacious 63
No RCTs
Bupropion
Antidepressant or independent neurologic effects64
Bupropion and NRT seem equally efficacious63
N/A
Varenicline increases odds of smoking cessation about 1.7-fold compared to bupropion**65 N/A
Varenicline
Partial nicotine receptor agonist
Varenicline increases odds of smoking cessation 3-fold**65
No RCTs
Varenicline increases odds of smoking cessation about 1.7-fold compared to bupropion**65
* NRT: nicotine replacement therapy ** All studies included in this systematic review, although of high quality, received industry funding from the varenicline manufacturer Pfizer.65
Nicotine replacement therapy (NRT) reduces the withdrawal symptoms associated with smoking cessation, such as anger, anxiety, craving, difficulty concentrating, hunger, impatience, or restlessness.6,62,66 Two recent high-quality systematic reviews found all forms of NRT to be effective.6,62 The first review, with follow-up of at least 6 months, found that NRT achieved an overall
Nicotine replacement
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abstinence rate of about 17% compared with 10% in the control groups.62 However, there was considerable variation in control group abstinence rates, depending on the length of follow-up, how cessation was assessed, and the population included in the trial. The second review looked at a follow-up of more than 1 year after the start of treatment.6 Relative efficacy of NRT over and above placebo fell from 11% at 1 year to 7% at an average of 4.3 years of follow-up. Relapse rates did not differ between NRT and control groups over time or depend upon length of initial NRT treatment or length of final follow-up. The low relapse rates after the second year showed that NRT had a permanent effect on smoking cessation. However, using only 6 to 12 months of results, as usually reported in reviews and guidelines, will result in overestimating the lifetime benefits and cost savings from NRT by about 30%. The first review observed that the main factor determining the effectiveness of NRT on quit rates was the level of nicotine dependence.62 It found little good evidence that NRT was effective for people who smoke fewer than 10 to 15 cigarettes daily. An additional cohort study found that nicotine patches were more effective in achieving long-term cessation (52 weeks) in smokers with moderate nicotine dependence compared with those with mild or high dependence.40 The review found no evidence that one form of NRT is preferable or that additional counseling offered any benefit, although most trials of NRT have included some type of nonpharmacologic support.6,62 An additional trial looked at nicotine patches compared with nasal spray and found no significant difference in abstinence between the two treatments at 6 months.67 However, it found that positive predictors for the patch were different compared with the nasal spray: low to moderate dependency smokers with white ancestry and a BMI less than 30 kg/m2 were more successful with the patch, whereas highly dependent obese people from a nonwhite background had higher cessation rates with the spray. Another trial compared four different formats of NRT and found that women were more successful with inhaler compared with gum and men vice versa.68 Side effects of NRT include local irritation, the manifestation of which depends on route of administration. NRT appears to be generally safe in patients with a history of stable cardiovascular disease.62 As a result of concerns regarding the sympathomimetic effects of nicotine, most studies have excluded people with unstable cardiac disease. NRT has an FDA Category D rating in pregnancy.69 Higher doses of the patch (> 22 mg/day or > 15 mg/16 hours) may be slightly more efficacious than standard dosage. One multicenter European trial, which looked at higher doses and longer durations of treatment, also found increased 1-year success rates associated with a higher dose patch, but treatment beyond 8 to 12 weeks did not improve efficacy.70 Higher doses may be useful for heavy smokers ( 30 cigarettes/day) or patients relapsing with withdrawal symptoms on standard dosage.62 Patient preference, costs, or side effects may be considerations when choosing NRT. In current clinical practice, the patch, with its long-acting effect because of stable nicotine blood levels, is generally used as the base product, with other shorter-acting forms used as add-ons.
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Table 6. Nicotine replacement therapy*

Pre scription only Dose/Regime** Side effects Approximate cost of 30 days of treatment***71 9 to 24 doses per day: + Generic 2 mg: $54 to $144; 4 mg: $68 to $180 + Nongeneric 2 mg: $93 to $248; 4 mg: $105 to $279 1 patch per day: + Generic 7, 14 or 21 mg: $67.00 + Nongeneric 7, 14, or 21 mg: $97.00 + 2 mg if < 25 cigarettes per day or + 4 mg if 25 cigarettes per day + 1 every 12 hours for 6 weeks; 1 every 24 hours for weeks 79; 1 every 48 hours for weeks 1012; maximum: 24 pieces per day7275 + >10 cigarettes per day: 21 mg per day for 46 weeks; 14 mg per day for 2 weeks; 7 mg per day for 2 weeks + 10 cigarettes/day: 14 mg per day for 6 weeks; 7 mg per day for 2 weeks7274 Mouth irritation, bad taste, nausea, dyspepsia, hiccups
76,79
Over-thecounter Bad taste, mouth irritation, hiccoughs, gastrointestinal disturbances, jaw pain, orodental problems62,76 Skin irritation62,76; nocturnal use of patch may be associated with sleep disturbances: consider removal of patch at night 77
Gum
Patch

+ 2 mg if smokes first cigarette > 30 minutes after waking up or + 4 mg if smokes first cigarette within 30 minutes after waking up + 1 every 12 hours for 6 weeks; 1 every 24 hours for weeks 79; 1 every 48 hours for weeks 1012 + Maximum dose: 5 lozenges in 6 hours or 20 lozenges per day72, 78 Nasal/sinus irritation, runny nose62,81 9 to 20 lozenges per day: + Generic 2 mg: $150 to $334; 4 mg: $128 to $284 + Nongeneric 2 or 4 mg: $152 to $338 8 to 40 doses per day: + Nongeneric: $82 to $408 + One dose equals 2 sprays (1 per nostril) (0.5 mg per spray or 1 mg nicotine per dose) + 1 or 2 doses per hour for 6 to 8 weeks, but at least 8 doses per day + Gradually reduce over weeks 914 + Maximum dose: 5 doses per hour or 40 doses per day72,79 + + + + One 10-mg cartridge delivers 4 mg nicotine 6 to 16 cartridges per day for weeks 112 Gradually reduce over next 6 to 12 weeks Maximum dose: 16 cartridges per day72,82 Throat irritation, cough, oral burning, dyspepsia62,83 6 to 16 cartridges per day: + Nongeneric: $148.00 to $395
Lozenge
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Nasal spray
Oral inhalator (for buccal absorption)
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*in the United States
** dosing in this table is based on manufacturers recommendations
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*** Prices should be used for comparative purposes only; some insurance plans cover the cost of smoking cessation treatments
There is weak evidence that combination NRT may be more effective than single forms.62 Overall, abstinence rates were 1.4-fold higher with combination than monotherapy. Possible benefits include sensory effects of multiple delivery systems, higher nicotine substitution, or other factors.84 Table 7. One-year abstinence rates with combined NRT delivery *
Combination used Patch + gum vs. patch alone Combination therapy 18% Monotherapy or no therapy 13% P value 0.2 Abstinence rates Significantly higher with combination early on, but no significant difference between groups at 1 year62 Significantly higher with combination at 12 weeks; trend continued but no significant difference between groups at 1 year62 Significantly higher with combination at 1 year62 Trend continued but no significant difference between groups at 6 years85 No significant difference between groups at 6 months62 Significantly higher with combination at 12 weeks; trend continued but no significant difference between groups at 1 year62 No significant difference between groups at 1 year62 No significant difference between groups at 1 year62
Combination NRT
Patch + gum vs. gum alone
24%
17%
0.2
Patch + nasal spray vs. patch alone
27%
11%
0.002
16% (at 6 years)
9% (at 6 years)
0.077
Patch + nasal spray vs. either alone
9.1% (at 6 months)
+ 7.8% (patch) + 6.9% (spray) (at 6 months) 14%
0.3
Patch + inhaler vs. inhaler alone
19.5%
0.1
Patch + inhaler vs. either alone
3%
7%
0.2
Patch + inhaler vs. no therapy
15%
14%
0.8
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*based on trials including 100 to 500 smokers; exceptions to 1-year time frame noted in table
Two small studies suggest that adding mecamylamine, a nicotine receptor antagonist, to NRT may be superior to NRT alone.86 A benefit from adding antidepressants to NRT has not been shown.64 The opioid antagonist naltrexone is under investigation as an adjunct to treatment such as NRT and may attenuate smoking cessation-associated weight gain.8789 There is no good evidence about combining NRT with varenicline, anxiolytics, or clonidine.
Combining NRT with other drug treatments
Although the absolute chances of quitting increase when NRT is used in conjunction with additional support, a systematic review found the relative benefit of NRT to be mostly independent of length of therapy, intensity of other support, or setting in which NRT was given.62 One trial showed that NRT plus physician training improved quit rates over physician training alone.90
Adding NRT to nondrug therapy
Monotherapy with either bupropion or nortriptyline approximately doubles the odds of smoking cessation at 6 months.64 Bupropion is a selective serotonin/norepinephrine uptake inhibitor (SSNRI) and nortriptyline is a tricyclic antidepressant (TCA). Possible, but unproven, mechanisms of action include: + improving depressive symptoms precipitated by quitting smoking + substituting for possible antidepressant effects of nicotine + independent neurologic effect(s), such as nicotine receptor antagonism. Bupropion has been shown to be effective in varied populations and settings, in people with and without depression, and in combination with different types of behavioral support. A recent trial has shown it to be effective and safe in people with acute cardiovascular disease.91 It decreases depressive symptoms in highly nicotinedependent smokers, but symptoms rebound when bupropion is discontinued.92 Extended therapy with bupropion to prevent relapse has not been found to be beneficial.64 Nortriptyline has been studied in fewer trials than bupropion. Bupropion and nortriptyline appear to be about equally efficacious with NRT, but direct comparisons are few.63 There is also insufficient evidence about combining an antidepressant and NRT. One small trial found that bupropion was associated with higher smoking cessation rates at 6 months compared with nortriptyline or placebo when each was added to intensive counseling therapy.93 Initial trials suggest that bupropion may be less efficacious than varenicline, although so far all relevant high-quality trials have received industry funding from vareniclines manufacturer.65 Since May 2006, bupropion has an FDA Pregnancy Category C rating. As for many older drugs, nortriptyline has not been rated by its manufacturer but has received Pregnancy Category C listings.94,95 One cohort study of predictors of abstinence in people who were receiving long-term sustained release bupropion, found that older age and minimal early weight gain were
Antidepressants
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positive predictive factors for long-term abstinence (52 weeks).96 One randomized control trial found that risk factors for relapse in people treated with bupropion and counseling (in varying dosages and intensities) were younger age, female sex, high levels of nicotine dependence, shorter previous quit attempts, previous use of NRT, and self-reported depression.97 One cohort study looked at bupropion and nicotine patches in combination and concluded that positive predictive factors for continued abstinence at 1 year were:98 + Absent history of COPD + Having effectively quit after the first week of treatment + In people with COPD: lower value for mid-range forced expiratory flow (FEF 2575) Antidepressants such as selective serotonin uptake inhibitors (SSRIs) or monoamine oxidase (MAO) inhibitors have not been shown to help smoking cessation.64,99,100,101
Varenicline increases smoking cessation approximately 3-fold at 1 year compared with placebo.65,102 It is not clear whether further lengthening the duration of therapy would be beneficial or whether varenicline may help prevent relapse.103,60 A systematic review found that compared with bupropion, varenicline increased the odds of smoking cessation approximately 1.7-fold at 1 year, although this result is based on studies that have received industry funding.65 The main side effect has been nausea, which usually improves over time.60,104 Direct comparisons with NRT are lacking. Varenicline has been given an FDA Pregnancy Category C rating. Cytisine is the natural chemical from which varenicline was developed. Like varenicline, it works as a nicotine partial receptor agonist, but has a considerably lower price. It is currently only available in Europe, is less well studied but may also aid smoking cessation.105 There have been no good quality trials about a third partial nicotine agonist, lobeline.106 Table 8. Nonnicotine drugs for smoking cessation
FDAapproved for indication Bupropion SR Dose Side effects
Nicotine partial receptor agonists
+ Set target quit date for during second week of treatment. + 150 mg daily x 3 days, then 150 mg twice daily + Continue treatment total 712 weeks107 + Total dosage in studies has generally been 75100 mg daily for 612 weeks64
+ Dry mouth, sedation 108,109 + Seizure (1/1000 when used for smoking cessation)64 + Has not been linked to increased risk of suicide,64 but all antidepressants are labeled with a Black Box warning about possibly increased risk + Sedation, constipation, urinary retention, risk of arrhythmia64
Nortriptyline
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FDAapproved for indication Varenicline
Dose
Side effects
+ Set a target quit date for 1 week after starting treatment + 0.5 mg once daily for 3 days then twice daily days 47 + Increase to 1 mg twice daily from day 8 through end of 12 weeks total therapy104
+ Nausea, sleep disturbances, headache60,104
Other drug therapies

+ Clonidine, a centrally acting antihypertensive agent, has been studied mostly in conjunction with behavioral counseling. Based on limited data, it increased smoking cessation approximately 2-fold, but had side effects, especially dry mouth and sedation, which limit its use.108 Tapering of dosing at the end of therapy is recommended to avoid withdrawal effects of clonidine.69,110 Hypertensive patients in particular are at risk for rebound hypertension upon abrupt cessation. + Limited evidence from four trials identified by a systematic review found no significant long-term benefit for smoking cessation from the opioid antagonist naltrexone compared with placebo.87 Adding naltrexone to NRT did not attenuate weight gain in smoking cessation. However, the confidence intervals were compatible with both clinically significant benefit and possible negative effect (OR 1.26, 95% CI 0.802.01). + There have been no systematic reviews or good quality trials evaluating the efficacy of rimonabant (a CB1 cannabinoid receptor antagonist) for smoking cessation. It is marketed in Europe, but in June 2007 the FDA refused approval for its use as a weight loss aid, based on concern about psychiatric side effects. + Silver acetate gum, lozenge, or spray causes an unpleasant taste when combined with cigarettes.111 Limited data do not support a role for it, possibly because of reportedly poor compliance. + There is no consistent evidence that anxiolytics aid smoking cessation.112 In one trial, buspirone improved smoking abstinence in high-anxiety smokers, but only for the duration of therapy.113
Many smoking cessation devices or aids are sold OTC in the United States. If not specifically marketed as a cessation tool, they may bypass regulatory oversight and are not regulated by the FDA. Products include smokeless inhalers, nicotine filtering devices, and a water-soluble gel containing tobacco extracts. We found no high-quality evidence that these products work.
OTC devices and aids for smoking cessation
The purpose of current drug therapies for smoking cessation is to either replace nicotine from cigarettes with nicotine in safer forms or try to otherwise reduce
Under investigation: Nicotine conjugate vaccine
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withdrawal symptoms. A vaccine currently in development aims to induce nicotinespecific antibodies in order to prevent nicotines passage into the brain.114 Vaccine is conjugated because ordinarily nicotine is a small, nonimmunogenic molecule. In one small study, patients received either a nicotine conjugate vaccine given as one of 3 doses (50, 100, or 200 g) intramuscularly or placebo at approximately 0, 1, 2, and 6 months.115 Vaccine immunogenicity and 30-day abstinence rates were dose-related. Nicotine conjugate vaccine is currently in Phase IIb trials in the United States but achieving adequate antibody response and duration of antibodies remain challenges in its development.
Nonpharmacologic measures can be used singly, in combination, or along with drug therapies. There is good evidence that combining brief practical advice to quit with pharmacotherapy increases success rates. Similarly, delivery systems such as doctor counseling and/or quit lines with access to drug treatments are significantly more effective than nondrug treatments alone. + Self-help materials and brief advice both increase the chances of smoking cessation. The benefit per patient is low, but because of the high number of contacts with health care professionals, self-help materials and brief advice both offer an important opportunity to promote cessation with potentially large population effects. However, self-help materials may not offer additional benefit when more intensive interventions are used. + Individual, group, and telephone counseling are effective at a patient level and are recommended for those willing to accept them. When provided with NRT, individual counseling offers a lower relative benefit than on its own, but the absolute benefit may be similar. Self-help materials and group behavioral counseling may not offer additional benefit when added to NRT. + Internet- and computer-based programs may offer some benefit, but more research is needed to identify effective programs. + Exercise reduces symptoms of withdrawal. Although evidence for long-term cessation is less clear, given the additional benefits, it can be recommended. + There is no good evidence that biomedical risk assessment, hypnotherapy, or acupuncture increase cessation. + Providing telephone quit lines increases cessation. + It is not clear which interventions reduce relapse. + The effectiveness of rapid (aversive) smoking is unproven. Training health professionals may offer some benefit, particularly if the importance of follow-up is emphasized.
Effectiveness of nondrug treatments for smoking cessation
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Table 9. Nondrug treatments for smoking cessation

Intervention Evidence Clinical implications
Self-help materials
+ In one review, self-help materials, whether tailored or not, increased long-term abstinence about 1.5-fold compared with no intervention (absolute difference about 2%).116 Tailored materials might be more effective than standard materials, but the evidence was not conclusive. + However, there was no evidence that self-help materials would be of benefit when added to NRT or face-to-face contact. + In one review, brief advice increased the odds of quitting approximately 1.7-fold (absolute increase of about 2.5%) compared with no advice (or usual care).117 + The absolute benefit in trials of brief advice is lower than in trials involving highly motivated people. + There appeared to be a small advantage of intensive advice (longer, defined as > 20 minutes, more visits, or a self-help manual) over minimal advice. + There is possibly a small benefit to follow-up visits. + The review did not look at potential harms from physician counseling.
+ Self-help materials are an easy intervention, and should be readily available in the office and offered to all smokers.
Brief advice
+ Any interaction with a health care professional is an opportunity to provide brief advice. Most studies have been conducted in a primary care setting.117 Brief advice may be given by a physician or nurse. + Brief advice is an easy intervention and has the potential to have a large population impact. + Forty smokers would need to be given intensive rather than minimal advice to produce one extra quitter after 6 to 12 months. + Individual counseling by physicians seems to be most effective, followed by multidisciplinary teams, dentists, and nurses.120
Individual counseling
+ One review found that individual counseling by nurses increased quit rates about 1.5-fold.118 NRT use in the trials varied considerably. Nurse counseling offered a larger relative benefit for inpatients with cardiovascular disease and when offered as part of cardiac rehabilitation, whereas there was no evidence of benefit in other hospitalized smokers. + One recent subsequent UK trial found no significant difference between basic and weekly support added to NRT.119 + One review found that individual counseling by a trained smoking cessation counselor providing one or more face-to-face sessions outside of usual care increased cessation about 1.5-fold.121 Although the relative benefit appeared lower when used in conjunction with NRT, the absolute benefit appeared to be similar in trials with and without NRT. + The review found no evidence that intensive counseling was more effective than shorter sessions, although the evidence was not conclusive. The review did not report on harms. + One subsequent trial found that individual counseling (primarily in person but allowing phone counseling) was more effective than advice and minimal support for abstinence at 6 months.122 + Another subsequent RCT found 5-fold higher cessation after 6 and 12 months with motivational interviewing than with brief advice.123
Smoking cessation counselor
+ Most trials were conducted with inpatients.121
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Intervention
Evidence
Clinical implications
Telephone counseling
+ One recent systematic review found that smokers who received additional call back counseling after phoning a quit line were about 1.4-fold more likely to quit (absolute difference about 3%).124 Similar results were found for telephone counseling not initiated by calls to help lines. The study suggested that increasing the number of calls increased the benefit. + There was a small benefit from adding telephone counseling to NRT. + The number of calls, their content, and duration varied considerably between different quit lines. + One review found limited evidence that providing a telephone hotline helped 1 in 50 extra smokers to quit.124 + In early studies, mailing computer-generated feedback reports was associated with improved quit rates.126 It is not yet clear how well more recent interactive computer systems work. + Among visitors to a smoking cessation website, counseling letters and email reminders based on psychological and addiction theory, which include information on health risks and coping strategies, may be more effective than a shorter program with more information on nicotine replacement therapy and nicotine dependence127 + In one review, group programs were about twice as effective as self-help programs or no intervention.128 + The evidence is not conclusive on how group programs compare with individual counseling. + The review suggested that adding group behavior therapy to NRT provided no additional benefit, but the control groups included behavioral components that may have affected the results. + A single session of exercise seems to temporarily reduce cigarette craving,129 but a systematic review found only weak evidence that exercise improved quit rates, alone or added to a smoking cessation program.130 + One trial identified by the systematic review suggested that adding exercise to NRT may be of benefit.
+ A meta-analysis suggested that younger, male, light smokers benefited the most from telephone counseling initiated by health care personnel and added to other minimal interventions.125
Telephone quit lines Internet
+ More research is needed about which patients benefit, how to add internet to other interventions and use of the internet in sophisticated or interactive ways.126
Group behavior therapy
+ Patient acceptance of group therapy may vary.128 + Evidence is lacking about specific psychological methods aside from usual support. + Cost effectiveness compared with individual counseling is not clear. + Studies have been small and heterogeneous.130 + Exercise reduces post-smoking cessation weight-gain.131 + Even with weak evidence of effectiveness of increased smoking cessation, exercise offers a wide range of other benefits. + More research is needed to evaluate the efficacy of biomedical risk assessment. + These measures cannot be recommended for smoking cessation on the basis of current evidence.
Exercise
Biomedical risk assessment
+ Evidence is limited about biomedical risk assessment (e.g., exhaled carbon monoxide, spirometry).132
Complementary interventions
+ There is no evidence that hypnotherapy,133 acupuncture, acupressure, laser therapy, or electrostimulation help quit rates.134,135
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Intervention Nondrug treatments for relapse prevention
Evidence + There is no evidence that skills training (e.g., avoidance of triggers) or other specific interventions prevent relapse136,137 + The studies in one review mostly included only brief or written interventions, so a benefit from more intensive face-to-face contact can not be excluded.136 + The available evidence does not allow determination of the effectiveness of rapid (aversive) smoking.138
Clinical implications + Many patients relapse, thus effective strategies are greatly needed.136
Aversive smoking
+ There is sufficient indication of promise to warrant further evaluation of this technique.138
Interventions aimed at health professionals

+ Training health professionals on a group basis and offering prompts may increase the chance of smoking cessation interventions being offered to patients.62,117 + In one review, prompts increased how often smoking cessation interventions were offered. It is not clear if this improves quit rates.90 The trial with the most promising result emphasized follow-up more than other trials and physicians were paid for follow-up visits. Another review found limited evidence that tools (e.g., questionnaires, chart stickers, checklists, flow charts, reminder letters) and teamwork increased rates and effectiveness of counseling and increased quit rates.139 [See Toolkit: 12-step guide to a primary care systems approach for smoking cessation]
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The massive toll of smoking measured in morbidity and mortality is reflected in a large economic burden on society. In the United States, this has been estimated for 1998 at $75.5 billion in health care costs alone. Beyond this, there are costs in terms of lost productivity estimated at $81.9 billion as the annual average between 1995 and 1999.140 Smoking cessation can reduce some of this burden and studies have consistently found that effective interventions for smoking cessation are cost effective. However, assessing cost effectiveness can be difficult because of variations in study populations and their motivation to quit, as well as extrapolation of relapse rates and baseline cessation rates. For those populations without pre-existing disease, the benefits may be measurable only decades down the line. This makes calculations particularly sensitive to how future costs and benefits are discounted. Cost effectiveness of smoking cessation can be analyzed from the perspective of the individual, the health provider or society. The individual saves through reduced expenditure on cigarettes, lower private health care costs, and increased income. The health industry benefits from reduced expenditure attributable to both primary and secondhand smoke, whereas society profits from increased productivity, reduced cost of cleaning up after smokers, and fewer smoking-related fires. Studies have approached these issues in different ways and are not always clear about their perspective and which costs they have included. Furthermore, the outcome measures in clinical studies of cessation are varied and sometimes difficult to assess. Results based on these measures provide a key input into cost-effectiveness analyses, which makes it hard to reach and interpret definitive conclusions. This has not supported informed decision making. A systematic review of cost-effectiveness studies of smoking cessation recalculated the cost effectiveness from a societal perspective (using Dutch price levels but in U.S. dollars) and found that standardizing the measures used in studies often increased the cost-effectiveness ratios substantially.141 Despite this, smoking interventions still remained clearly cost effective. The review identified a self-help manual written for a specific subgroup of pregnant women as the most cost-effective intervention, with a cost of $0 per year of life saved. It found that counseling or self help (with smokers choosing between them) cost $2340 per year of life saved, whereas NRT plus counseling cost $8794. Although the least intensive interventions may offer the best cost effectiveness ratio, their low cost and the extremely large potential gains do not mean they should be selected in preference to more intensive interventions. These interventions do not have large effects and the extra investment in intensive interventions can achieve additional benefit and offer a superior return compared with many interventions that are routinely paid for in other fields. A review looking at U.S. cost effectiveness from a third-party payer perspective found that in 2003, the cost per year of life saved with nicotine treatments and bupropion across different age groups fell substantially below the generally accepted thresholds for cost effectiveness in the United States.142
Economic issues in smoking cessation
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Table 10. Cost per life year saved for different drug therapies by age in the United States in 2003.142
Cost per year of life saved by age group ($) Age group (years) 20 34 35 49 50 64 Nicotine replacement Gum Men 5976 5008 6637 Women 10,758 7840 8309 Men 3661 3068 4066 Patch Women 6591 4803 5090 Men 6230 5221 6920 Spray Women 11,217 8174 8663 Men 6008 5035 6673 Inhaler Women 10,816 7882 8354 Men 2284 1914 2537 Women 4112 2997 3176 Bupropion
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This report carries on the BMJ Publishing Groups longstanding tradition of addressing the health implications of tobacco use. Please see www.bmj.com and www.tobaccocontrol.bmj.com for other high-quality publications on tobacco use and smoking cessation. For this paper, we have presented the results of a systematic review on the effectiveness of interventions to increase smoking cessation among adults, based on the BMJ Clinical Evidence search and appraisal methodology described at http:// www.clinicalevidence.com/ceweb/about/search_process.jsp. We included the best evidence available, focusing on systematic reviews and randomized studies for the effectiveness of interventions. We excluded trials with self-reported cessation as these routinely overestimate biochemically validated cessation. We only included trials with a follow-up of at least 6 months after the start of the intervention. Resuming smoking before that time can be considered part of the quit attempt rather than a subsequent relapse. On the other hand, differences in longer term cessation rates may be diluted by smokers who have made subsequent quit attempts. We extracted information from trials on the study population, patients readiness to quit, and other demographic data. We specifically noted trials conducted in specific populations and settings and investigated whether interventions were differentially effective for these groups. We did not systematically search for papers on predictive factors for successful quit attempts, but extracted relevant information from our systematic treatment searches, other important articles, and from discussions with our expert panel.
Appendix: Methodology
We searched MEDLINE, EMBASE, the Cochrane Library, the NHS Centre for Reviews and Dissemination (CRD), the Database of Abstracts of Reviews of Effects (DARE), the Health Technology Assessment (HTA), Turning Research into Practice (TRIP), and the National Institute of Health and Clinical Excellence (NICE) guidance databases for relevant systematic reviews, randomized controlled trials and other studies throughout December 2006. Some additional searches were carried out in January and February 2007. For the background sections on incidence and prevalence, disease burden of smoking, benefits of cessation, guidelines, legal, policy and economic issues of interventions, we searched MEDLINE, EMBASE, the National Guideline Clearinghouse, Action on Smoking and Health, and the U.S. Department of Health and Human Services in January and February 2007. We referred to high-quality systematic reviews when they were available and references recommended by experts. In addition, findings from reputable, objective sources based on large, controlled surveys or guidelines were included. After gathering the research, we summarized the studies found and described the conclusions reached by authors of the systematic reviews. Where research was lacking or poor in quality, we reported this. Individual sections were sent to advisors and editors for review. We commissioned two sections, the first one on public policy (written by K. Michael Cummings) and a second on a smoking cessation toolkit for clinicians (written by Sherman). The draft document was sent out to the following panel of expert clinicians for peer review in June 2007 and the text revised in view of their comments and queries.
Our approach
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+ K. Michael Cummings, PhD, MPH (Chair, Department of Health Behavior, Division of Cancer Prevention and Population Sciences, Roswell Park Cancer Institute, Buffalo, NY) + Carolyn Dresler, MD, MPA (Associate Professor of Health Policy and Management Department of Health Policy and Management, University of Arkansas for Medical Sciences, Fayetteville, AR) + Michael Fisher, MD, MS (Associate Physician in the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Womens Hospital; Instructor in Medicine, Harvard Medical School, Boston, MA) + Nancy Lee (Clinical Pharmacist, University of California, UCLA Medical Center, Los Angeles, CA) + Maria Leon-Roux, MPH (Tobacco and Cancer Team, Lifestyle, Environment and Cancer Group, IARC, WHO, Lyon, France) + Nancy Rigotti, MD (Associate Professor, Department of Medicine, Harvard Medical School; Associate Professor, Department of Health and Social Behavior, Harvard School of Public Health; Director, Tobacco Research and Treatment Unit, Massachusetts General Hospital, Boston, MA) + Scott Sherman, MD, MPH (Associate Professor, Department of Medicine, NYU Medical Center, NY)
Methodologic challenges of assessing the literature

Our aim, like that of BMJ Clinical Evidence, was to summarize and synthesize evidence from high-quality systematic reviews and large well-designed RCTs, and other studies when these are not available. Because the health benefits of smoking cessation can be a long time in the future and in most trials the quit rate is low, we have followed a two-stage process: First providing the evidence on the health benefits of successful cessation and then summarizing up-to-date, high-quality research on the effectiveness of interventions aimed at achieving cessation.
Appraising studies on treatments
Disease burden of smoking
The harms of smoking have been repeatedly and convincingly demonstrated in many thousands of studies. However, research is still finding new harms from smoking and quantified estimates of harms will continue to develop as exposures and populations change and study methods develop. Using relative risk to measure disease burden The relative risk (RR) for a disease does not always give the best measure of the societal disease burden of smoking. For example, the RR for smokers for lung cancer is far higher than that for coronary heart disease (CHD), but the overall disease burden from smoking-related lung cancer and CHD is similar, because of the low baseline risk in never smokers. Age differences are also important, in older age groups the RR from smoking for CHD is smaller than for younger people, but because CHD is far more common among older people, the smoking-related disease burden is far higher in the elderly. Attempting to ascertain if a residual elevated risk persists after quitting in the
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long term is more difficult for conditions with a lower elevated relative risk (e.g., CHD) than for those with a higher one (e.g., lung cancer), even if the smoking-related disease burden is similar.
Health benefits from smoking cessation

Which population groups to compare The effects of smoking cessation are most usefully compared between quitters and continuing smokers, because this reflects the real choice that smokers or recent quitters face, rather than risks if they had never smoked. Confounders Quantification of the benefits of cessation mainly rests on the large evidence base from cohort and case control studies. These have found strong evidence of a reduction in mortality and risk of smoking-related disease following smoking cessation, compared with persistent smoking. However, some methodologic problems remain in quantifying the size of benefits. + Reverse causation: Smokers with symptoms of pre-existing disease, including undiagnosed disease, tend to be more likely to quit than asymptomatic smokers. This means that higher rates of disease will often be observed among recent quitters than among persistent smokers. This effect can have a long term impact for conditions as chronic obstructive pulmonary disease (COPD) and CHD with a long time lag between first symptoms and morality and can lead to a potentially substantial underestimate of the benefits of cessation. + Relapse: Another potential cause of bias is that many people who have recently stopped smoking cessation relapse. This means studies measuring cessation at only one point during the study may underestimate the benefits of ongoing cessation. + Population trends: A related problem is the reduction in smoking rates seen in many Western populations over time. This means that many of those initially assessed as smokers will subsequently quit and gain some of the benefits of cessation. Again, studies that assess smoking status only once may underestimate the effect compared with studies that assess smoking status at multiple points. + Health behavior: However, other unadjusted confounders may lead to overestimation of the benefits, as it is likely that people who have quit smoking will display other healthy behaviors compared with persistent smokers.
Effectiveness of interventions for smoking cessation

Best available evidence We have selected well-conducted systematic reviews and randomized controlled trials as our primary evidence source as these provide the best evidence of effectiveness for treatments. Public policy interventions are more difficult to study and are usually based on interrupted time series data or other observational studies. How to measure cessation Simply asking people whether they currently smoke will identify a fair number that quit just a few days previously, and are more likely to relapse. With better questions (e.g., Have you smoked any cigarettes in the last 30 days?) the rate of overreporting can be
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held at 5% to 10%, although it is higher in a few special populations, such as adolescents, pregnant smokers, and people enrolled in randomized smoking cessation trials.143,144 Biochemical measures are used in smoking cessation studies rather than in routine clinical practice. One of the available biochemical measures is exhaled carbon monoxide (Table 8). Measurements are not specific to cigarettes and half-life is short (3 to 5 hours). Levels fall to normal in 24 hours. Table 11. Exhaled carbon monoxide in nonsmokers and smokers145
Smoking intensity Nonsmoker Light Moderate Heavy Exhaled carbon monoxide (ppm) 06 710 1020 > 20
Another biochemical marker of smoking is cotinine, the primary metabolite of nicotine, which can be detected in serum, saliva, and urine. It has a long half-life (16 hours) and can detect smoking in the preceding 3 to 4 days, but requires laboratory analysis.145 Cotinine will generate a false-positive test result in patients using nicotine replacement. How to assess smoking intensity Heavy, light, and moderate smoking is defined and assessed differently in the included studies. We have not prioritized any one method but listed results for subgroups as presented in each study. Length of follow-up Smoking cessation is a process rather than a state. Similar to many chronic conditions where cure is rare, tobacco use is a relapsing and remitting condition. Even failing quit attempts matter as they reduce exposure to tobacco smoke and may be a predictor of future success. Most relapses occur within days after quitting which imply treatment may need to be most intense early in the process. A lapse, which is smoking one or two cigarettes, is a strong predictor of relapse and implies the need for enhancing the treatment. Most relapses occur within 3 months of the original quit day, which is why most treatment programs are focused on the first 12 weeks of the quit process. The longer one abstains from cigarettes continuously, the greater the odds of remaining smoke-free. Follow-up of 1 or 2 years would be more desirable, but with too few studies providing such long-term data, in this review we have focused on studies that reported cessation measure at a minimum of 6 months.
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Toolkit: 12-step guide to a primary care systems approach for smoking cessation
All of a health care sites activities aimed at helping people to quit smoking can be grouped together as tobacco control. This may range from the traditional, but still underutilized, physician counseling to environmental tools (posters, pamphlets, etc.) to reminder systems that guide practice. The purpose of this toolkit is to help develop a comprehensive plan to improve tobacco control efforts at your site, ultimately leading to fewer smokers and less subsequent tobacco-related morbidity and mortality. This toolkit is based on a practice with one or more physicians, along with additional office staff (e.g., clerk, nurse). The main reason why most office-based efforts fail is that they rely too much on the physician. To excel at smoking cessation, delegation is key. Every smoker interested in quitting should receive three things: 1) medications, 2) counseling, and 3) follow-up. The following 12-step approach is aimed at helping to consistently deliver evidence-based cessation services to each and every smoker.
Goal: To improve tobacco control efforts in medical practice
Someone should be appointed to be in charge of smoking cessation. Make it part of his/her duties. Set measurable goals. Determine what rewards (including a financial bonus) the person will receive for success.
Step 1: Identify a coordinator
The coordinator should develop a multidimensional plan to improve tobacco control efforts, which will be further refined in conjunction with the physician(s) and all office staff. In a multi-physician practice, it may help to identify one physician most responsible for smoking cessation to act as a clinical resource for the coordinator.
Step 2: Create a plan
Step 3: Create a supportive environment
Review the waiting room and all exam rooms. Obtain posters, flyers, and cards that promote cessation. If there is a government or other telephone quit line, ensure that there are handouts available. Any forms needed by staff (e.g., fax referral forms) should be stocked in every room where they are needed and checked on a regular basis. Consider getting buttons for all staff that say, for example, Interested in quitting smoking? Ask meI can help.
This is the second most important step. Treatment cannot be offered to all smokers unless they are identified. Identification should be clear, obvious, and consistent. Common approaches are colored stickers on the outside of charts or a flag in an electronic medical record.
Step 4: Identify all smokers
Step 5: Make smoking status part of checking in
If patients fill out a questionnaire for each visit, ensure that tobacco use is part of it. Along with verifying address and insurance information, clerical staff should verify smoking status. Current smokers can be given a handout encouraging them to quit (Ask your doctor . . .), and any free offers (e.g., free medications through the quit line) should be mentioned.
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In most settings, a nurse or health technician sees each patient before the physician and records vital signs. Adding smoking to the list of vital signs increases cessation rates. Staff can also assess interest in quitting, advise each patient to quit, and describe available options.
Step 6: Make smoking assessment and advice a vital sign
Patients often identify advice from their physician as a key factor in helping them quit. In the interest of efficiency, this should be kept brief30 to 60 seconds. Advice should be clear, strong, and personalized. With patients interested in quitting (determined in Step 6), a physician might say, Its great that youre interested in quitting smoking. As your doctor, I think its one of the most important things you can do for your health. It will particularly help you because <tailor to each patient>. I am going to ask _______ to talk to you some more about quitting. Also, I strongly encourage you to let us give you a medication to help you quit, as it doubles your chance of success.
Step 7: Brief physician advice
A staff member in your office or practice needs to provide additional counseling to supplement the physicians brief advice. It need not take longup to 10 minutes is sufficient. In many settings, it will be the nurse providing this advice, but it could be a health educator, a pharmacist, or even a clerk. The key tasks are: 1) to set a quit date, 2) to coordinate dispensing of smoking cessation medications, and 3) to provide brief counseling. Many people find it helpful to provide a handout to augment the counseling, although it does not lead to higher quit rates.
Step 8: Post-physician advice
If at all possible, there should be some way to track what services were provided. Was the patient screened by the clerk at check-in? Did the physician provide brief advice? Were medications offered? This can be done in several different wayswith the electronic medical record, a paper smoking cessation log, or simply a smoking cessation stamp or template on each smokers visit note. If the stamp is used, the clerk could stamp the note initially and then each successive person could check or initial if their part was done.
Step 9: Record services provided
This is by far the most important step. It is exceedingly difficult to improve if performance is not monitored. This is precisely why recording the services provided (Step 9) is important. It does not matter how performance is measured electronically or on paperas long as it is done. Identify the key processes to be measured. Some typical ones are: whether each smoker was advised to quit, offered smoking cessation medications, and offered referral to an available smoking cessation program or telephone quit line. On a regular basis (e.g., monthly or quarterly), all staff should go over the measured results.
Step 10: Measure
A staff member from the office should call all smokers in follow-up. An ideal minimum is 2 calls. The first should be 1 to 2 weeks after the patients quit date (if one was set), to provide counseling during this most vulnerable period. The second call should be at 6 months, to assess smoking status and to offer people who are still smoking another chance to quit. Its important to remember to document the calls and the outcomes.
Step 11: Follow-up
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System redesign is hard work. Looking over the results in Step 10 is very helpful to keep staff motivated, but financial measures are also important. Everyone can be rewarded for good performance. Some ideas include singling out top performers for an extra bonus or having a party to celebrate when you reach a certain number of long-term (6 months) nonsmokers. Put up posters to celebrate your success and to remind patients of what is available.
Step 12: Reward yourselves
Toll-free quit lines

+ National Network of Tobacco Cessation: 1800-QUITNOW (1-800-784-8669) and 1-800-332-8615 + National Cancer Institute: 1-877-44U-QUIT (1-877-448-7848)
Additional resources
+ Centers for Disease Control and Prevention: Smoking & tobacco use (U.S. Department of Health and Human Services) http://www.cdc.gov/tobacco/ + MedlinePlus: Smoking cessation (a service of the U.S. National Library of Medicine and the U.S. National Institutes of Health) http://www.nlm.nih.gov/medlineplus/smokingcessation.html + National Cancer Institute: Quitting smoking, smoking prevention (U.S. National Institutes of Health) http://www.cancer.gov/cancertopics/smoking/quitting
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Putting Evidence Into Practice Smoking Cessation

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Putting evidence into practice: Smoking cessation

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Advisory board and peer review

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Additional peer reviewers

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Figure 1. Changes in prevalence of smoking among adults in the United States8

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Disease burden from smoking

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Health benefits of cessation

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Figure 4. Timeline of health benefits after smoking cessation14

COPD: chronic obstructive pulmonary disease; CHD: coronary heart disease

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Figure 5. Impact of smoking and smoking cessation on survival in men15

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Coronary heart disease

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Peripheral artery disease

Chronic obstructive pulmonary disease

Reduced cigarette consumption

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Predictors of quitting and maintained cessation

Gender as a predictor of success

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Public policy on smoking

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Interventions for smoking cessation

Effectiveness of drug treatments

Reduces nicotine withdrawal symptoms

NRT and bupropion seem equally efficacious 63

Antidepressant or independent neurologic effects64

Bupropion and NRT seem equally efficacious63

Partial nicotine receptor agonist

Varenicline increases odds of smoking cessation 3-fold**65

Varenicline increases odds of smoking cessation about 1.7-fold compared to bupropion**65

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Table 6. Nicotine replacement therapy*

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Oral inhalator (for buccal absorption)

*in the United States

** dosing in this table is based on manufacturers recommendations

Patch + gum vs. gum alone

Patch + nasal spray vs. patch alone