Draft Recommendation Statement
Tobacco Smoking Cessation in Adults and Pregnant Women: Behavioral and Pharmacotherapy Interventions
This opportunity for public comment expired on June 1, 2015 at 8:00 PM EST
Note: This is a Draft Recommendation Statement. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Recommendation Statement will be developed after careful consideration of the feedback received and will include both the Research Plan and Evidence Review as a basis.
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
Draft: Recommendation Summary
The USPSTF recommends that clinicians ask all adults about tobacco use and provide U.S. Food and Drug Administration (FDA)–approved pharmacotherapy or behavioral interventions (alone or in combination) for cessation in adults who use tobacco.
|The USPSTF recommends the service. There is high certainty that the net benefit is substantial.|
The USPSTF recommends that clinicians ask all pregnant women about tobacco use and provide behavioral interventions for cessation in pregnant women who use tobacco.
|The USPSTF recommends the service. There is high certainty that the net benefit is substantial.|
The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of pharmacotherapy interventions for tobacco cessation in pregnant women.
|The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.|
|All adults who smoke tobacco|
The USPSTF concludes that the current evidence is insufficient to recommend electronic nicotine delivery systems (ENDS) for tobacco cessation. The USPSTF recommends that clinicians direct patients who smoke tobacco to other cessation interventions with established effectiveness and safety (see above).
|The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.|
The USPSTF makes recommendations about the effectiveness of specific preventive care services for patients without related signs or symptoms.
It bases its recommendations on the evidence of both the benefits and harms of the service, and an assessment of the balance. The USPSTF does not consider the costs of providing a service in this assessment.
The USPSTF recognizes that clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decisionmaking to the specific patient or situation. Similarly, the USPSTF notes that policy and coverage decisions involve considerations in addition to the evidence of clinical benefits and harms.
Tobacco use is the leading preventable cause of disease, disability, and death in the United States. Cigarette smoking results in more than 480,000 premature deaths each year and accounts for approximately one in every five deaths.1 In pregnant women, smoking increases risk for prenatal complications (such as congenital anomalies, preterm birth, fetal growth restriction, and placental abruption), miscarriage, stillbirth, and impaired lung function in childhood.1-4 An estimated 42.1 million U.S. adults (almost 18% of the population) currently smoke.5
Recognition of Behavior
The benefits of assessing patients’ smoking behavior are well established. Common approaches for clinicians include recording a patient’s smoking status as a vital sign or using the “5 A’s”—1) Ask about smoking; 2) Advise to quit through clear personalized messages; 3) Assess willingness to quit; 4) Assist to quit; and 5) Arrange followup and support. Another approach is “Ask, Advise, Refer,” which encourages clinicians to ask patients about tobacco use, advise patients to quit, and refer patients to quitlines and/or evidence-based cessation interventions.
Benefits of Interventions
The USPSTF found convincing evidence that behavioral interventions alone or in combination with pharmacotherapy substantially improve achievement of tobacco cessation in nonpregnant adults who smoke. The USPSTF found convincing evidence that pharmacotherapy interventions, including nicotine replacement therapy (NRT), bupropion sustained-release (SR), and varenicline, with or without behavioral counseling interventions, substantially improve achievement of tobacco cessation in nonpregnant adults who smoke. The USPSTF also found convincing evidence that using two types of NRT moderately improves achievement of tobacco smoking cessation over using one type of NRT, and that addition of NRT to treatment with bupropion SR provides additional benefit over use of bupropion SR alone. The USPSTF found inadequate evidence to determine the benefit of ENDS on achievement of tobacco smoking cessation.
The USPSTF found convincing evidence that behavioral interventions substantially improve achievement of tobacco abstinence in pregnant women who smoke, improve infant birthweight, and reduce risk for preterm birth. The USPSTF found inadequate evidence on the benefits of NRT, and no evidence on the benefits of bupropion SR or varenicline to achieve tobacco cessation in pregnant women who smoke or to improve perinatal outcomes in infants.
Harms of Interventions
The USPSTF determined that there is adequate evidence to bound the magnitude of harms of behavioral interventions for tobacco cessation in nonpregnant adults who smoke as small to none. The USPSTF found adequate evidence that the harms of NRT, bupropion, or varenicline for tobacco cessation in adults who smoke are small. The USPSTF found inadequate evidence to determine the harms of ENDS.
The USPSTF determined that there is adequate evidence to bound the magnitude of harms of behavioral interventions for tobacco cessation in pregnant women who smoke as small to none. The USPSTF found inadequate evidence on the harms of NRT, and no evidence on the harms of bupropion SR or varenicline for tobacco cessation in pregnant women who smoke.
The USPSTF concludes with high certainty that the net benefit of behavioral interventions and FDA-approved pharmacotherapy for tobacco cessation, alone or in combination, in nonpregnant adults who smoke is substantial.
The USPSTF concludes with high certainty that the net benefit of behavioral interventions for tobacco cessation on perinatal outcomes and smoking abstinence in pregnant women who smoke is substantial.
The USPSTF concludes that the evidence on pharmacotherapy interventions for tobacco cessation in pregnant women is insufficient due to a lack of studies, and the balance of benefits and harms cannot be determined.
The USPSTF concludes that the evidence on the use of ENDS for tobacco cessation is insufficient, and the balance of benefits and harms cannot be determined. The USPSTF has identified the lack of well-designed randomized, controlled trials on ENDS that report smoking abstinence or adverse events as a critical gap in the evidence.
Draft: Clinical Considerations
Patient Population Under Consideration
This recommendation applies to adults age 18 years and older, including pregnant women. The USPSTF previously issued a separate recommendation statement on primary care interventions for tobacco use in children and adolescents (available at www.uspreventiveservicestaskforce.org). While the USPSTF acknowledges that tobacco may be used in other forms and that other substances besides tobacco may be smoked, they are not the focus of this recommendation.
Assessment of Risk
According to the 2012–2013 National Adult Tobacco Survey, smoking prevalence is higher in the following groups: males; young adults ages 25 to 44 years; persons with a race/ethnicity category of “other, non-Hispanic”; persons with a General Educational Development (GED)–level education (vs. graduate-level education); persons with an annual household income of less than $20,000; and persons who are lesbian, gay, bisexual, or transgender.6 Higher rates of smoking have been found in persons with mental health conditions; however, evidence on the benefits and harms of behavioral interventions in this population is limited.7
Implementation Considerations of Behavioral and Pharmacotherapy Interventions
Assessment of Smoking Status
The “5-A’s” framework is a useful strategy for engaging patients in smoking cessation discussions. The “5-A’s” include asking every patient about tobacco use, advising all tobacco users to quit, assessing the willingness of all tobacco users to make a quit attempt, assisting tobacco users with their quit attempt, and arranging followup.10 Similarly, “Ask, Advise, Refer” is another approach that involves asking patients about tobacco use, advising those who smoke to quit, and referring them to evidence-based interventions. Treating smoking status as a vital sign and recording a patient’s smoking status at every health visit is also frequently used to assess smoking status. Since many pregnant women who smoke deny smoking, using multiple choice questions to assess smoking status in pregnant women may improve disclosure.9
Numerous behavioral interventions are available to encourage tobacco smoking cessation in adult patients. Effective behavioral interventions include in-person behavioral support and counseling, telephone counseling, and self-help materials. Behavioral interventions may increase smoking abstinence rates from a baseline range of approximately 5% to 11% (in control groups) to 7% to 13% (in intervention groups).8
- Both minimal (<20 minutes in one visit) and intensive (≥20 minutes plus >1 followup visit) physician advice interventions are effective in increasing the proportion of adults who successfully quit smoking and remain abstinent for at least 6 months.8
- Brief, in-person behavioral counseling sessions (<10 minutes) are effective in increasing the proportion of adults who successfully quit smoking and remain abstinent for 1 year. Although less effective than longer interventions, even minimal interventions (<3 minutes) have been found to increase quit rates in some studies.9
- There is a dose-response relationship between quit rates and the intensity of counseling (i.e., more or longer sessions improve quit rates).9
- Effective interventions can be delivered by various types of primary care providers, including physicians, nurses, psychologists, social workers and cessation counselors.8, 9
- Both individual and group counseling have been found to be effective.9
- Effective counseling interventions provide practical problem-solving skills training and social support.9
- Problem-solving skills training includes helping those who smoke to recognize situations that increase their risk for smoking, develop coping skills to overcome common barriers to quitting, and develop a plan to quit.
- Basic information about smoking and successful quitting should also be provided.
- Complementary practices that improve cessation rates include motivational interviewing, assessing readiness to change, and offering more intensive counseling or referrals.9
- Telephone counseling interventions are also effective.8, 9
- Effective interventions provide at least three telephone calls.8
- Telephone counseling can be provided by professional counselors or health care providers who are trained to offer advice over the telephone.
- Providing self-help materials (primarily print-based) that are tailored to the individual patient (i.e., beyond a brochure that simply describes the health effects of smoking) is also effective in improving smoking abstinence.8 Evidence on nontailored, print-based self-help materials; computer-based programs; and mobile phone–based (e.g., mHealth) interventions was mixed, although several trials show promise.8
- Currently, the only pharmacotherapies approved by the FDA for the treatment of tobacco dependence in adults are bupropion SR, varenicline, and NRT (including nicotine transdermal patches, lozenges, gum, inhalers, or nasal spray).
- Evidence suggests that NRT may increase smoking abstinence rates from about 10% in control groups (placebo or no pharmacotherapy) to 17% in those using any form of NRT, bupropion SR may increase smoking abstinence rates from about 11% in controls (placebo or no bupropion SR) to 19% in those using bupropion SR, and varenicline may increase smoking abstinence rates from about 12% in controls (placebo) to 28% in those taking varenicline.8
- Information on dosing regimens is available in the package inserts of individual medications or at http://betobaccofree.hhs.gov.
Combinations of Pharmacotherapy
- Using two types of NRT has been found to be more effective than using a single type.
- Some studies suggest that NRT in combination with bupropion SR may be more efficacious compared with bupropion SR alone, but not necessarily NRT alone.8
Combinations of Behavioral and Pharmacotherapy Interventions
- Combining behavioral and pharmacotherapy interventions may increase quit rates from approximately 8% to 14%15 compared with usual care or minimal behavioral interventions (such as self-help materials or brief advice on quitting).
- These combination interventions often have behavioral components delivered by specialized cessation counselors or trained staff, and often use NRT.
- Combination interventions often involve multiple sessions (≥4 sessions) and tend to be more successful with more sessions.
- The largest effect was found in interventions that provided eight or more sessions, although the difference in effect between the number of sessions was not statistically significant.
- Contact time ranged from 0 to greater than 300 minutes; interventions lasting 91 to 300 minutes were most common.
- The addition of behavioral support to pharmacotherapy also significantly increased quit rates from about 18% in those using pharmacotherapy alone to 21% in those using a combination of pharmacotherapy and behavioral support.
- Intensity of behavioral support ranged from 0 to greater than 300 minutes of contact; interventions most often involved greater than 91 minutes of contact (about 40% were 91 to 300 minutes and 60% were >300 minutes).
Effective behavioral interventions in pregnant women who smoke include counseling, feedback, health education, incentives, and social support. Compared with usual care or controls, behavioral interventions can increase smoking abstinence rates from approximately 11% to 15% in pregnant women.
- Effective behavioral interventions provided more intensive counseling than minimal advice and other standard components of usual care.9
- Counseling sessions augmented with messages and self-help materials tailored for pregnant woman who smoke increased abstinence rates during pregnancy compared with brief generic counseling interventions alone.9
- Counseling specific to pregnant women should include messages about the effects of smoking on both maternal and fetal health and clear, strong advice to quit as soon as possible. Although tobacco cessation at any point during pregnancy yields substantial health benefits for the expectant mother and baby, quitting early in pregnancy provides the greatest benefit to the fetus.9
Health care system–based strategies that have been shown to improve rates of tobacco cessation counseling and interventions in primary care settings include implementing a tobacco user identification system; providing education, resources, and feedback to promote clinician intervention; and dedicating staff to provide tobacco dependence treatment and assessing the delivery of this treatment in staff performance evaluations.9
Suggestions for Practice Regarding the I Statements
Pharmacotherapy in Pregnant Women
Although smoking prevalence is lower in pregnant women than nonpregnant women of the same age, approximately one in six pregnant women ages 15 to 44 years still smoke.7 Smoking during pregnancy retards fetal growth, doubles the risk for delivering a baby with low birthweight, and increases the risk for fetal death by 25% to 50%. For women for whom behavioral counseling does not work, other options to promote smoking cessation may be beneficial.
A few studies have evaluated the benefit of NRT on perinatal and child health outcomes. While results generally suggest a potential benefit, the overall evidence is too limited to draw any clear conclusions. NRT is a pregnancy category D medication, meaning there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans. However, it has been suggested that NRT is safer than smoking during pregnancy.4, 11 Potential adverse events in pregnant women identified in studies include increased Cesarean delivery rates, slightly increased diastolic blood pressure, and skin reaction to the patch. Potential adverse events reported in nonpregnant adults include higher rates of low-risk cardiovascular events, such as tachycardia. There is no evidence of perinatal harms from NRT, although few trials reported consistently on these adverse events.
The USPSTF identified no studies on bupropion SR or varenicline pharmacotherapy during pregnancy. Bupropion SR and varenicline are both pregnancy category C medications, meaning animal reproduction studies have shown an adverse effect on the fetus, but there are no adequate well-controlled studies in humans.
Approximately 69% of adults who currently smoke daily report interest in quitting smoking, and approximately 43% made a quit attempt in the previous year.1 To date, no manufacturer of an ENDS product has applied for or received FDA approval as a tobacco cessation product. According to a small 2013 study, approximately two thirds of physicians reported that they believed e-cigarettes are a helpful aid for smoking cessation, and 35% recommended them to patients.12 A recent small survey of e-cigarette users found that 56% reported using them to quit/reduce cigarette use, while 26% reported using them to smoke in places where conventional cigarettes are banned.13 Given the common perception by the public and clinicians that ENDS may be used as an option for quitting conventional smoking, the USPSTF reviewed the evidence on ENDS as an aid for tobacco cessation. No studies evaluated the use of ENDS for tobacco cessation in adolescents. The USPSTF identified only two randomized, controlled trials that evaluated the effect of e-cigarettes on smoking abstinence in adults and found mixed results. Neither study reported any serious adverse events related to their use. Although not reported in either study, potential concerns about the use of ENDS include the unknown safety and toxicity of ENDS components and vapors,14, 15 and poisoning in children who mishandle nicotine cartridges.16 Overall, the USPSTF found the evidence on ENDS use as a smoking cessation tool in adults or adolescents to be insufficient.
Additional Approaches to Prevention
Given the public health significance of the consequences of tobacco use, numerous public health interventions aim to prevent tobacco use and promote smoking cessation. The Centers for Disease Control and Prevention (CDC) offers guidance to State and local tobacco control programs (available at www.cdc.gov/tobacco/stateandcommunity/tobacco_control_programs/index.htm). The Community Preventive Services Task Force offers several recommendations on interventions that can be used in community settings (available at www.thecommunityguide.org/tobacco/index.html). The Surgeon General’s report “The Health Consequences of Smoking—50 Years of Progress” discusses initiatives to end the tobacco use epidemic in the United States.1
The USPSTF recommends that primary care clinicians provide interventions, including education or brief counseling, to prevent the initiation of tobacco use among school-aged children and adolescents (available at www.uspreventiveservicestaskforce.org).
Primary care clinicians may find the following resources useful in talking with adults about smoking cessation: CDC fact sheets on quitting smoking (www.cdc.gov/tobacco/data_statistics/fact_sheets/cessation/quitting/index.htm); the U.S. Department of Health and Human Services’ BeTobaccoFree (http://betobaccofree.hhs.gov/quit-now/index.html#professionals); and the Public Health Service’s 2008 clinical practice guidelines, “Treating Tobacco Use and Dependence”.9
In addition, the following resources may be useful to primary care clinicians and practices trying to implement tobacco cessation interventions: the Substance Abuse and Mental Health Services Administration–Health Resources and Services Administration Center for Integrated Health Solutions’ tobacco cessation resources (www.integration.samhsa.gov/health-wellness/wellness-strategies/tobacco-cessation-2); CDC State and community resources for tobacco control programs (www.cdc.gov/tobacco/stateandcommunity/index.htm); and the World Health Organization’s toolkit for delivering brief tobacco interventions in primary care (www.who.int/tobacco/publications/smoking_cessation/9789241506953/en/).
Draft: Other Considerations
Research Needs and Gaps
A large body of evidence on smoking cessation interventions already exists, and the overall benefit of pharmacotherapy and behavioral counseling to promote smoking cessation is well established. However, further research is still needed to elucidate specific effective features of complex behavioral counseling interventions, benefits of pharmacotherapy in specific subpopulations, and the efficacy of newer technology-based interventions. Although numerous smoking cessation behavioral interventions are available to primary care clinicians, further research is needed to better clarify the effects of varying levels of intervention intensity (such as how the number of sessions and number of minutes per session affect continuous abstinence rates), particular settings of behavioral counseling interventions (individual vs. group settings, health vs. community settings, primary care vs. specialty settings), and ways to personalize and tailor self-help materials. Further research is also needed on the benefits and harms of pharmacotherapy in specific subpopulations, such as pregnant women and adults with mental health conditions. Research that directly compares different types of pharmacotherapy in different populations may also help inform providers of which interventions to use with which patients. Additional research is needed to better understand the effectiveness of newer technology platforms for smoking cessation interventions, such as Internet-based programs, mobile/smart phone applications, and text messaging programs. Although no manufacturer of an ENDS product has yet applied for FDA approval as a therapeutic device, given the common perception by both the public and clinicians that ENDS may be used as an option for quitting conventional smoking, further research is needed on their safety and the benefits and harms of using ENDS as a means for quitting conventional smoking.
Burden of Disease
Tobacco use is the leading preventable cause of disease, disability, and death in the United States. Smoking increases risk for all-cause mortality and has been found to cause various types of cancer (lung, liver, and colorectal), respiratory diseases (chronic obstructive pulmonary disease and risk for tuberculosis), cardiovascular disease (increased risk for stroke from secondhand smoke ), diabetes, impaired immune function and autoimmune disease (such as rheumatoid arthritis), eye disease (such as age-related macular degeneration), and erectile dysfunction in men. Smoking early in pregnancy has been found to cause ectopic pregnancy and orofacial clefts in offspring.1.
According to National Health Interview Survey data from 2013, 42.1 million adults in the United States (17.8% of the U.S. adult population) currently smoke cigarettes.5 Rates are higher among males; adults ages 24 to 44 years; lesbian, gay, bisexual, or transgender adults; multiracial groups and American Indians/Alaska Natives; persons whose highest education level attained is a GED; and persons living below the poverty level.5 Adults with mental health conditions have higher smoking rates and tend to smoke a higher average number of cigarettes than adults without mental health conditions. Approximately 27% of persons with a mental health or substance use disorder currently smoke.17 Based on Pregnancy Risk Assessment and Monitoring System data from 2010, 23.2% of women smoked during the 3 months immediately prior to pregnancy.18 Based on data from 2011, 55% of women quit smoking during pregnancy and approximately 10% of pregnant women smoked during the last 3 months of pregnancy; 40% of women relapsed within 6 months of delivery.19
Scope of Review
The current review focused on appraising evidence on primary care–relevant smoking cessation interventions (behavioral interventions, pharmacotherapy, and complementary or alternative therapies) in adults and pregnant women (including pregnant adolescents). Only pharmacotherapy that was approved by the FDA as first-line tobacco cessation agents was included (NRT, bupropion SR, and varenicline). Health outcomes included all-cause mortality, tobacco-related mortality and morbidity, and perinatal mortality and morbidity. Smoking cessation outcomes had to be reported at 6 months or later to be included; findings on smoking reduction (based on frequency or quantity only), intention to quit, and cessation at less than 6 months were excluded. The USPSTF also evaluated adverse events reported at any time point.
Effectiveness of Interventions
The USPSTF reviewed 11 good- or fair-quality systematic reviews on behavioral interventions, including complementary or alternative therapies, and smoking cessation outcomes.8 Evidence on increasing smoking abstinence was strongest for physician and nurse advice, tailored self-help materials, and telephone counseling. Based on a 2013 systematic review of 28 studies (n=22,239),20 smoking abstinence rates at 6 or more months were 8.0% in groups that received physician advice compared with 4.8% in groups that received no advice or usual care (risk ratio [RR], 1.76 [95% confidence interval (CI), 1.56 to 1.96]). Based on pooled analyses of 35 studies from a 2013 systematic review evaluating advice delivered by nurses, 13.3% of participants who received interventions from nurses achieved smoking abstinence at 6 or more months compared with 11.3% of those who received usual care or minimal intervention (RR, 1.29 [95% CI, 1.20 to 1.39]).21 When stratified by level of intensity, both minimal advice (defined as a single session lasting <20 minutes with ≤1 followup session) and intensive advice (defined as a single session lasting ≥20 minutes or >1 followup session) from a physician significantly increased quit rates compared with no advice. In a subset of 15 trials that directly compared intensive versus minimal advice from physicians, intensive advice significantly increased smoking abstinence compared with minimal advice (RR, 1.37 [95% CI, 1.20 to 1.56]).20 Based on pooled analyses of 32 studies from a 2014 review of print-based self-help materials (n=40,890), participants who received tailored self-help materials showed a significantly higher smoking abstinence rate at 6 or more months compared with controls (7.1% vs. 5.8%; RR, 1.28 [95% CI, 1.18 to 1.37]). However, no significant improvement was seen when nontailored materials were compared with no self-help materials (RR, 1.06 [95% CI, 0.98 to 1.16]), based on pooled analyses of 33 studies (n=29,495).22 A 2013 review on telephone counseling interventions found that recruiter-initiated telephone support improved smoking cessation rates at 6 or more months.23 Based on pooled analyses of 12 studies (n=30,182), abstinence rates were significantly higher in participants who received multisession telephone quitline counseling compared with a single session of counseling or self-help materials only (10.7% vs. 7.6%; RR, 1.41 [95% CI, 1.20 to 1.66]). Pooled analyses of 51 studies (n=30,246) found that recruiter-initiated telephone counseling not initiated by calls to helplines also showed a benefit on smoking abstinence rates at 6 or more months compared with controls (13.1% vs. 9.7%; RR, 1.27 [95% CI, 1.20 to 1.36]).
The USPSTF also reviewed the 2008 Public Health Service guidelines on “Treating Tobacco Use and Dependence” for additional details on intensity and content of behavioral interventions, as well as type of staff providing smoking cessation counseling.9 The USPSTF also considered evidence from additional reviews on mobile phone and Internet-based interventions.8 Although findings were suggestive of a benefit, the studies were too few and too heterogeneous to draw any definitive conclusions. The USPSTF also considered evidence from reviews on biomedical risk assessment interventions, exercise, and hypnotherapy for smoking cessation; the studies were too limited to draw any conclusions.8 A 2014 review on acupuncture for smoking cessation (k=9; n=1,892) did not find that acupuncture increased smoking cessation rates at 6 to 12 months.24
The USPSTF reviewed three good-quality systematic reviews on pharmacotherapy for smoking cessation in nonpregnant adults.15
A 2012 systematic review on NRT (k=117; n=51,265)25 found that 17.3% of participants taking any form of NRT achieved abstinence at 6 or more months compared with 10.3% of participants taking placebo or no NRT (RR, 1.60 [95% CI, 1.53 to 1.68]). Those who used two forms of NRT achieved higher abstinence rates than those who used just one (20.6% vs. 15.6%; RR, 1.34 [95% CI, 1.18 to 1.51]). All studies of dual forms of NRT used the patch plus another type of NRT (gum, nasal spray, or inhaler), although studies varied in which form of NRT served as the control. All single forms of NRT significantly improved quit rates at 6 or more months (gum: RR, 1.49 [95% CI, 1.40 to 1.60]; patch: RR, 1.64 [95% CI, 1.52 to 1.78]; tablets/lozenges: RR, 1.95 [95% CI, 1.61 to 2.36]).
A 2014 systematic review on the use of antidepressants for smoking cessation (k=44; n=13,728) found that use of bupropion SR was associated with a significantly higher smoking abstinence rate at 6 or more months compared with placebo or no bupropion SR (19.7% vs. 11.5%; RR, 1.62 [95% CI, 1.49 to 1.76]).26
Based on a smaller number of studies (k=14; n=6,166), a 2012 systematic review27 found that use of varenicline was associated with a higher quit rate compared with placebo (28.0% vs. 12.0%; RR, 2.27 [95% CI, 2.02 to 2.55]).
Pooled analyses found that NRT plus bupropion SR was more effective than bupropion SR alone (RR, 1.24 [95% CI, 1.06 to 1.45]; k=4; n=1,991); however, it was not more effective than NRT alone (RR, 1.19 [95% CI, 0.94 to 1.51]; k=12).8
Smaller subsets of studies from these reviews directly compared types of pharmacotherapy for smoking cessation. There was no statistically significant difference between abstinence rates among participants taking NRT versus bupropion SR at 6 or more months (k=8; n=4,086).26 Two studies compared NRT versus varenicline and found no significant difference (n=778) between groups.27 Four studies evaluated bupropion versus varenicline, and although not all the studies found a significant difference, a pooled estimate (n=1,810) found a lower quit rate with bupropion than varenicline (RR, 0.68 [95% CI, 0.56 to 0.83]).
Combinations of Behavioral Interventions and Pharmacotherapy
Combinations of behavioral counseling and pharmacotherapy for smoking cessation were also effective.8 A 2012 good-quality systematic review (k=40; n=15,021)28 found that participants who received combination pharmacotherapy and intensive behavioral counseling had a higher abstinence rate at 6 or more months compared with controls who received usual care, self-help materials, or brief advice on quitting (which was less intensive than the counseling/support given to the intervention groups) (14.5% vs. 8.3%; RR, 1.82 [95% CI, 1.66 to 2.00]). A majority of the studies (27/40) used NRT as the pharmacotherapy and offered at least four behavioral counseling sessions (33/41). Another good-quality systematic review29 found that abstinence rates at 6 or more months were higher in participants who received behavioral support as an adjunct to pharmacotherapy than in those who received pharmacotherapy alone (21.4% vs. 18.3%; RR, 1.16 [95% CI, 1.09 to 1.24]). The majority of studies (27/38) offered NRT alone as the pharmacotherapy. Participants in the control group may have also received some counseling or support, but it was less intensive than in the intervention group. The majority of studies (28/38) offered at least 91 minutes of total contact time; a large number (16/38) offered greater than 300 minutes.
The USPSTF identified only two fair-quality randomized, controlled trials that reported on the effects of e-cigarettes to stop conventional cigarette smoking.8 One study30 in persons not currently attempting or wishing to quit found a higher abstinence rate at 12 months in participants using e-cigarettes than in the control group (11.0% vs. 4%; p=0.04), while a larger study found no significant difference in abstinence rates at 6 months.31 Neither trial was conducted in the United States.
Based on a 2013 good-quality systematic review of 86 studies,8, 32 the USPSTF found that behavioral interventions in pregnant women (including behavioral counseling, feedback, health education, incentives, and social support) are effective at improving smoking cessation rates as well as perinatal health outcomes. When compared with controls (most often defined as usual care or less intensive interventions), pregnant women who received any type of behavioral intervention prior to the third trimester had higher quit rates late in pregnancy (15.2% vs. 11.2%; RR, 1.45 [95% CI, 1.27 to 1.64]). Their children also had improved mean birthweight (mean difference, 40.78 g [95% CI, 18.45 to 63.10]), rates of low birthweight (RR, 0.82 [95% CI, 0.71 to 0.94]), and rates of preterm birth (RR, 0.82 [95% CI, 0.70 to 0.96]). When analyzed separately, behavioral counseling (the behavioral intervention in the majority of studies) was effective in improving abstinence rates in late pregnancy and mean birthweight in offspring.
The USPSTF found a much smaller body of evidence on pharmacotherapy for smoking cessation in pregnant women. Only five randomized, controlled trials (n=1,1922) evaluating the use of NRT were found; there were no published trials on the use of bupropion SR or varenicline as a smoking cessation intervention in pregnant women.8 Adherence rates reported by the NRT studies were very low (some <25%), which limited the interpretability of findings. Meta-analysis of these five trials showed no significant improvement in smoking abstinence rates late in pregnancy (10.8% vs. 8.5%; RR, 1.24 [95% CI, 0.95 to 1.64]). Given the small number of studies that reported on perinatal health outcomes, meta-analysis of results for these outcomes was not performed. Although results on preterm birth were mostly in the direction of benefit, only one study33 showed a statistically significant benefit. Reported results on mean birthweight and stillbirth were mixed. The largest trial (n=1,050) reported a higher rate of survival with no impairment at 2 years in children of pregnant women who received NRT.34
Potential Harms of Interventions
Evidence on harms of behavioral interventions for smoking cessation is limited. Based on the evidence reviewed by the USPSTF, only minor adverse events related to ear acupuncture, ear acupressure, and other auriculotherapy were identified. Adverse events related to other forms of behavioral interventions were not reported.
A 2014 fair-quality systematic review35 of 21 studies (n=11,647) found that use of NRT was associated with a higher rate of all cardiovascular adverse events (RR, 1.81 [95% CI, 1.35 to 2.43]) compared with placebo. This result seems to be driven by minor events, such as tachycardia and arrhythmia; no statistically significant increase in major cardiovascular adverse events was found (RR, 1.38 [95% CI, 0.58 to 3.26]). An older fair-quality review from 201036 also found higher rates of heart palpitation and chest pain, nausea and vomiting, gastrointestinal symptoms, and insomnia in NRT users than controls. The NRT patch was associated with an increase in skin irritation, and use of oral NRT was associated with throat soreness, mouth ulcers, and hiccups. Based on a subset of eight studies, this older review also found no difference in mortality rates in those taking NRT versus controls (odds ratio, 0.74 [95% CI, 0.33 to 1.67]).
The same systematic review also evaluated the potential harms of bupropion SR for smoking cessation (k=27; n=10,402).35 No significant difference was found between groups receiving bupropion SR versus placebo in all cardiovascular adverse events (RR, 1.03 [95% CI, 0.71 to 1.50]). A trend toward reduction in major cardiovascular adverse events was found in the bupropion group (RR, 0.57 [95% CI, 0.31 to 1.04]). A good-quality review (k=33; n= 9,631) found an increased rate of serious adverse events in bupropion SR users versus those taking placebo or control that was of borderline statistical significance (RR, 1.30 [95% CI ,1.00 to 1.69]). Based on 19 studies, the current USPSTF review found no statistically significant increase in psychiatric serious events with bupropion SR (RR, 0.60 [95% CI, 0.28 to 1.28]). The review found 10 reported cases of seizures among a total of 13,000 study participants. Bupropion SR labels currently include a boxed warning about serious neuropsychiatric events in persons who take bupropion SR for smoking cessation.
Concerns have been raised about varenicline use and potential cardiovascular and neuropsychiatric harms. In 2012, the FDA issued a safety communication indicating a nonstatistically significant increase in major adverse cardiovascular events.37 Based on a 2014 fair-quality systematic review,35 meta-analysis of 18 studies (n=9,072) showed no statistically significant increase in either all cardiovascular adverse events (RR, 1.24 [95% CI, 0.85 to 1.81]) or major cardiovascular adverse events (RR, 1.44 [95% CI, 0.73 to 2.83]). Varenicline labels currently contain a boxed warning about serious neuropsychiatric events; however, none of the evidence reviewed by the USPSTF reported on this outcome. A 2012 good-quality systematic review27 found an increased risk for one or more serious adverse events in participants receiving varenicline compared with placebo (RR, 1.36 [95% CI, 1.03 to 1.81]), but the type of serious adverse event was not specified. Most recently, the FDA has issued a warning and approved updated labeling to describe a potential interaction between varenicline and alcohol, as well as seizures.38
Combinations of Behavioral Interventions and Pharmacotherapy
The USPSTF did not identify any reports of adverse events related to combinations of behavioral interventions and pharmacotherapy.
Neither of the two trials on e-cigarette use for conventional smoking cessation reported any serious adverse events related to product use or any difference in the frequency of adverse events.15 One study30 reported a higher number of serious adverse events in the nicotine e-cigarette group (27 [19.7%]) than in the nicotine patch control group (14 [11.8%]); however, the authors stated that they did not find any evidence on an association with the study product, and there was no difference in overall incidence of any adverse event (serious and nonserious) between groups (incidence rate ratio, 1.05 [95% CI, 0.82 to 1.34]). Although it was not reported in the two trials, concerns have been raised about potentially harmful ingredients in e-cigarettes.14, 15 Given the large number and variation of devices and cartridge fluids that are currently available and the lack of regulation, the toxicity and safety of e-cigarettes and ENDS are extremely difficult to uniformly determine.8 Inadvertent poisoning in children who mishandle nicotine cartridges is also a concern, and the number of calls to poison centers involving e-cigarette liquids containing nicotine has increased from one per month in 2010 to 215 per month in 2014.16 Based on estimates from a recent small survey, dual use of e-cigarettes and conventional cigarettes may be high; 9.4% of persons who currently smoke conventional cigarettes reported concurrently using e-cigarettes, and 76.8% of persons who currently use e-cigarette reported concurrently smoking conventional cigarettes.39 Further research is needed to better understand how dual use of e-cigarettes and conventional cigarettes may affect smoking cessation attempts.
The USPSTF did not find any serious adverse events related to behavioral interventions for smoking cessation in pregnant women. According to one systematic review32 an increase in smoking was reported in four (out of 86) studies.
Evidence on harms from pharmacotherapy interventions for smoking cessation in pregnant women is limited. The USPSTF found no evidence of perinatal harms, although the studies were few and underpowered for rare outcomes.8 Similarly, there were too few studies to make any definitive determination on maternal harms of NRT. Maternal harms of NRT that have been reported in some but not all studies include increased Cesarean delivery rates, slightly increased blood pressure (one study reported a 0.02 mm Hg per day rise in diastolic blood pressure over time40), and skin reaction to the NRT patch.8
Estimate of Magnitude of Net Benefit
The USPSTF found convincing evidence that behavioral interventions (such as physician and nurse advice, tailored self-help materials, and telephone counseling) provided or referred to by primary care providers substantially improve smoking cessation in nonpregnant adults. The USPSTF found adequate evidence that there are no harms of behavioral interventions. The USPSTF concludes with high certainty that the net benefit of providing behavioral interventions for smoking cessation in nonpregnant adults is substantial.
The USPSTF found convincing evidence that pharmacotherapy with NRT, bupropion SR, or varenicline substantially improves smoking cessation in nonpregnant adults. Evidence was also convincing that using two types of NRT moderately improves smoking cessation over single forms, and that the addition of NRT to treatment with bupropion SR provides additional benefit over use of bupropion SR alone. The USPSTF found adequate evidence that the harms of pharmacotherapy, including serious cardiovascular adverse events and neuropsychiatric events, are small. The USPSTF concludes with high certainty that the net benefit of providing pharmacotherapy for smoking cessation in nonpregnant adults is substantial.
Combinations of Behavioral and Pharmacotherapy Interventions
The USPSTF found convincing evidence that providing combinations of behavioral plus pharmacotherapy interventions substantially increase smoking cessation in nonpregnant adults. The USPSTF found adequate evidence that the harms of combined behavioral and pharmacotherapy interventions are small. The USPSTF concludes with high certainty that the net benefit of providing combined behavioral and pharmacotherapy interventions for smoking cessation in nonpregnant adults is substantial.
The USPSTF concludes that the current evidence on ENDS for conventional smoking cessation is insufficient. Evidence is lacking and conflicting, and the balance of benefits and harms cannot be determined. Given the established safety and effectiveness of behavioral and pharmacotherapy interventions, the USPSTF recommends that primary care providers direct patients who currently smoke to these other interventions.
The USPSTF found convincing evidence that behavioral interventions (such as behavioral counseling, feedback, health education, incentives, and social support) substantially improve smoking cessation in pregnant women who smoke, as well as substantially increasing birthweight and decreasing preterm birth in their children. The USPSTF found convincing evidence that there are no harms of behavioral interventions. The USPSTF concludes with high certainty that the net benefit of providing behavioral interventions for smoking cessation in pregnant women who smoke is substantial.
The USPSTF concludes that the current evidence on pharmacotherapy for smoking cessation in pregnant women who smoke is insufficient. Evidence on NRT is limited and conflicting, evidence on other forms of pharmacotherapy is lacking, and the balance of benefits and harms cannot be determined.
How Does Evidence Fit With Biological Understanding?
Given the well-established health benefits of smoking cessation,1, 9 most of the current research on smoking cessation interventions focuses on cessation (rather than health outcomes) as a primary outcome. The current review identified one study in middle-aged men at high risk for cardiorespiratory disease that found a significantly smaller number of deaths from respiratory illness at 33 years in participants who received advice from medical practitioners. The study also found favorable effects on all-cause mortality, coronary disease mortality, and lung cancer incidence and mortality at 20 years, although these effects were not statistically significant.41
Draft: Update of Previous USPSTF Recommendation
In 2009, the USPSTF recommended that clinicians ask all adults about tobacco use and provide tobacco cessation interventions for those who use tobacco products (A recommendation) and that clinicians ask all pregnant women about tobacco use and provide augmented, pregnancy-tailored counseling for those who smoke (A recommendation). The current recommendation updates and is consistent with the 2009 recommendation. In addition, the USPSTF reviewed evidence on ENDS, a newer cigarette platform that has recently emerged, but found insufficient evidence to recommend for or against its use for tobacco cessation. The USPSTF also reviewed updated evidence on pharmacotherapy interventions for tobacco cessation in pregnant women who smoke and found the evidence is still insufficient to make a recommendation.
Draft: Recommendations of Others
Numerous professional societies and health organizations, including the American College of Physicians,42 American College of Preventive Medicine,43 American Heart Association,44 and American Congress of Obstetricians and Gynecologists45 recommend that clinicians screen for tobacco use and provide interventions to those who smoke. More recently, with the emergence and increased use of e-cigarettes, some organizations have incorporated statements about e-cigarettes into their guidelines. Both the American Congress of Obstetricians and Gynecologists45 and the American Heart Association44 recommend that e-cigarettes be included in tobacco screening questions; the American Heart Association also concludes that there is not yet enough evidence to counsel patients on the use of e-cigarettes as a primary cessation aid. The American Academy of Family Physicians is currently updating its recommendations.46
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Internet Citation: Draft Recommendation Statement: Tobacco Smoking Cessation in Adults, Including Pregnant Women: Behavioral and Pharmacotherapy Interventions. U.S. Preventive Services Task Force. May 2015.