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Evidence Summary

Other Supporting Document for Tobacco Smoking Cessation in Adults, Including Pregnant Women: Behavioral and Pharmacotherapy Interventions

Preface

By Carrie D. Patnode, PhD, MPH; Jillian T. Henderson, PhD, MPH; Jamie H. Thompson, MPH; Caitlyn A. Senger, MPH;
Stephen P. Fortmann, MD; and Evelyn P. Whitlock, MD, MPH


The information in this article is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This article is intended as a reference and not as a substitute for clinical judgment.

This article may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

This article was published online first at www.annals.org on September 22, 2015. Select for copyright and source information.

Abstract

Background: Tobacco use is the leading cause of preventable death in the United States.

Purpose: To review the effectiveness and safety of pharmacotherapy and behavioral interventions for tobacco cessation.

Data Sources: 5 databases and 8 organizational Web sites were searched through 1 August 2014 for systematic reviews, and PubMed was searched through 1 March 2015 for trials on electronic nicotine delivery systems.

Study Selection: Two reviewers examined 114 articles to identify English-language reviews that reported health, cessation, or adverse outcomes.

Data Extraction: One reviewer abstracted data from good- and fair-quality reviews, and a second checked for accuracy.

Data Synthesis: Fifty-four reviews were included. Behavioral interventions increased smoking cessation at 6 months or more (physician advice had a pooled risk ratio [RR] of 1.76 [95% CI, 1.58 to 1.96]). Nicotine replacement therapy (RR, 1.60 [CI, 1.53 to 1.68]), bupropion (RR, 1.62 [CI, 1.49 to 1.76]), and varenicline (RR, 2.27 [CI, 2.02 to 2.55]) were also effective for smoking cessation. Combined behavioral and pharmacotherapy interventions increased cessation by 82% compared with minimal intervention or usual care (RR, 1.82 [CI, 1.66 to 2.00]). None of the drugs were associated with major cardiovascular adverse events. Only 2 trials addressed efficacy of electronic cigarettes for smoking cessation and found no benefit. Among pregnant women, behavioral interventions benefited cessation and perinatal health; effects of nicotine replacement therapy were not significant.

Limitation: Evidence published after each review's last search date was not included.

Conclusion: Behavioral and pharmacotherapy interventions improve rates of smoking cessation among the general adult population, alone or in combination. Data on the effectiveness and safety of electronic nicotine delivery systems are limited.

Primary Funding Source: Agency for Healthcare Research and Quality.

Introduction

Cigarette smoking and exposure to smoke result in more than 480,000 premature deaths in the United States every year, along with substantial illness.1, 2 Despite considerable progress in tobacco control over the past 50 years, in 2013, an estimated 17.8% of U.S. adults3 and 15.9% of pregnant women aged 15 to 44 years were current cigarette smokers.4 Many tools are available to help smokers quit, including counseling by health care providers, telephone- and print-based interventions, computer and text-messaging interventions, and pharmacologic agents (that is, nicotine replacement therapy [NRT], bupropion hydrochloride sustained release [bupropion], and varenicline).

In 2009, the U.S. Preventive Services Task Force (USPSTF) reaffirmed its 2003 recommendation that clinicians ask all adults about tobacco use and provide interventions for cessation for those who use tobacco products (grade A recommendation).5 The original USPSTF recommendation (2003) and reaffirmation (2009) were based on the Public Health Service's clinical practice guidelines on treating tobacco use and dependence.6, 7 Because there were no plans to update the Public Health Service report, we undertook the current review to assess the benefits and harms of behavioral and pharmacologic interventions for tobacco cessation in adults, including pregnant women, to assist the USPSTF in updating its 2009 recommendation. Because of the rapid increase in the use of electronic nicotine delivery systems (ENDS) and the vigorous debate about the public health effect of these devices and their role in smoking cessation,8-13 our review also synthesized the primary trial evidence on the efficacy and safety related to this technology as a means for quitting conventional smoking.

Methods

We relied primarily on a review-of-reviews method for this update. We did not replicate quality rating or data abstraction for original studies or replicate review-specific analyses. However, we decided a priori to conduct a de novo search for primary evidence related to the effectiveness and safety of ENDS. In addition, we did a bridge search for evidence related to pharmacotherapy interventions among pregnant women because of the limited number of studies included in the available systematic reviews and the length of time that had elapsed since their last search dates.

We developed an analytic framework and 3 key questions with input from the USPSTF (Appendix Figure 1). The final version of the framework and key questions reflects both USPSTF and public input. The full report provides detailed methods.14

Data Sources and Searches

We searched the following databases for relevant reviews from January 2009 to 1 August 2014: PubMed, PsycInfo, the Cochrane Database of Systematic Reviews, the Health Technology Assessment database, and the Database of Abstracts of Reviews of Effects of the Centre for Reviews and Dissemination. We also searched the following organizational Web sites: the Agency for Healthcare Research and Quality, the British Medical Journal Clinical Evidence (through 7 August 2013), the Canadian Agency for Drugs and Technologies in Health, Guide to Community Preventive Services, the Institute of Medicine, the National Institute for Health and Clinical Excellence, the National Health Service Health Technology Assessment Programme, and the Surgeon General. We supplemented our searches with suggestions from experts. We searched PubMed for primary evidence related to ENDS through 1 March 2015 and for pharmacotherapy interventions among pregnant women through 15 August 2014 (the full report outlines the search strategies for these 2 searches).14

Study Selection

Two investigators independently reviewed all identified abstracts and dually reviewed full-text articles against prespecified eligibility criteria.14 We resolved disagreements through discussion. We included systematic reviews—with or without meta-analysis—that examined the effectiveness of interventions for tobacco cessation for adults, including pregnant women, and were linked to primary care or took place in a general adult population. We excluded nonsystematic meta-analyses and narrative reviews. We also excluded reviews that focused on reduction of tobacco harms, interventions for relapse prevention, or cessation medications that were not approved by the U.S. Food and Drug Administration as first-line medications for cessation (such as nortriptyline). We only included the most recent version of updated reviews. We outlined separate selection criteria when considering primary evidence related to ENDS and pharmacotherapy among pregnant women, as described in the full report.14

Data Extraction and Quality Assessment

At least 2 independent reviewers rated the quality of all included systematic reviews using a slightly modified version of the Assessment of Multiple Systematic Reviews tool15, 16 (see the full report for nodifications and methods for determining the overall quality rating of individual reviews).14 We excluded all poor-quality studies.17 One reviewer completed primary data abstraction, and a secondary reviewer checked all data for accuracy and completeness.

Data Synthesis and Analysis

When we found several fair- and good-quality reviews that met the inclusion criteria in a given population and intervention subgroup, we applied criteria (Appendix Table 1) to identify 1 or more reviews that represented the most current and applicable evidence to serve as the basis for the main findings (called “primary reviews”). We reviewed the remaining reviews for complementary or discordant findings. When we encountered discordant bodies of evidence, we sought explanations for these differences by examining the eligibility criteria and included studies within each review.

We used the pooled point estimates presented in the included reviews when appropriate. We did not reanalyze any of the individual study evidence. We evaluated the appropriateness of meta-analytic procedures and used our technical judgment to interpret pooled analyses accounting for limitations or concerns around heterogeneity, statistical approaches,18, 19 and other factors.

Role of the Funding Source

This review was funded by the Agency for Healthcare Research and Quality. Agency staff provided technical oversight for the project. Liaisons from the USPSTF helped resolve issues around the review's scope but were not involved in its conduct.

Results

We reviewed 638 abstracts and 114 full-text reviews for possible inclusion (Appendix Figure 2). We identified 54 systematic reviews that met our eligibility criteria,20-73 and 22 of these served as the basis for the primary findings (Table 1). In general, results across all included reviews were consistent within each population and intervention grouping. Our results are organized by outcomes and subcategories by population and interventions. Eleven of the 54 included reviews synthesized evidence on interventions among specific subpopulations of adults (such as persons with depression and young adults) that are not included here but appear in detail in the full report.14

Behavioral Interventions Among Adults

Eleven reviews served as primary reviews examining the effects of behavioral interventions for smoking cessation among the general adult population (Table 1).21, 22, 31, 37, 55, 58, 60, 61, 67, 71, 78

Health and Cessation Outcomes

Data on health outcomes after behavioral interventions were limited to 1 study79 that was reported in 1 review58 (Table 2). This study reported no statistically significant differences in rates of total mortality, coronary disease mortality, and lung cancer incidence and mortality at 20-year follow-up among men at high risk for cardiorespiratory disease (n = 1445).80 However, at 33-year follow-up, there were significantly fewer deaths from respiratory illnesses among participants who received an intervention than control participants.58

Several behavioral interventions increased smoking cessation at 6 months or more, including physician-,58 and nurse-delivered55 counseling interventions, tailored self-help print materials,37 and telephone counseling,60 when compared with minimal intervention or usual care (Table 2 and Appendix Table 2). Smokers who were offered cessation advice by a physician, for example, were 76% more likely to have quit at 6 months or more than those who received no advice or usual care (risk ratio [RR], 1.76 [95% CI, 1.58 to 1.96]; I2 = 40%; 28 trials; n = 22,239).58 Both minimal and intensive advice (>20 minutes, additional materials beyond a brochure, or >1 follow-up visit) showed statistically significant increases in cessation rates when compared with control participants who did not receive advice. Direct comparisons between intensive and minimal advice in 15 trials suggested that more intensive advice offered a significant advantage (RR, 1.37 [CI, 1.20 to 1.56]; I2 = 32%; 15 trials; n = 9775).58

A separate meta-analysis of 38 randomized, controlled trials (RCTs) done among more than 15,000 smokers found a small relative benefit of adjunctive behavioral support to pharmacotherapy when compared with pharmacotherapy alone (RR, 1.16 [CI, 1.09 to 1.24]).61 Cessation rates were relatively high in both the intervention (21.4%) and control groups (18.3%) because both groups received pharmacotherapy (Appendix Table 2).

There was mixed evidence of improved tobacco cessation after interventions, which included nontailored self-help materials,37 interactive or tailored Internet or computer programs,31 mobile telephones.71 biomedical risk assessment,22 exercise,67 acupuncture,70 and hypnotherapy21 (Appendix Table 2).

Adverse Events

One review reported minor adverse events related to ear acupuncture, ear acupressure, and other auriculotherapy.33 No other reviews found or reported adverse events related to other behavioral or complementary and alternative therapies (Table 2).

Pharmacotherapy Interventions Among Adults

Six reviews served as primary reviews on the effectiveness or harms of NRT, bupropion, or varenicline among current adult tobacco users (Table 1).40, 47, 49, 54, 59, 73

Health and Cessation Outcomes

None of the reviews reported the effects of medications for smoking cessation on mortality, morbidity, or other health outcomes. For cessation outcomes, NRT, bupropion, and varenicline all improved rates of smoking cessation in adults at 6-month follow-up or longer (Table 2). Nicotine replacement therapy was effective in all forms and increased relative cessation rates by 53% to 68% when compared with placebo or no NRT (RR, 1.60 [CI, 1.53 to 1.68]; 117 trials; I2 = 30%; n = 51,265) (Appendix Table 2).59 No differences were found among NRT products (such as patch, gum, and lozenge).59 Combining 2 types of NRT was found to be superior to a single form in 9 direct comparisons (RR, 1.34 [CI, 1.18 to 1.51]; 9 trials; I2 = 34%; n = 4664).59 A pooled analysis of 44 trials, including 13,728 smokers, found that bupropion increased relative cessation rates by roughly 62% at 6 to 12 months (RR, 1.62 [CI, 1.49 to 1.76]).40 A smaller body of evidence (14 trials; n = 6166) compared varenicline with placebo and found relatively larger effects on smoking cessation (RR, 2.27 [CI, 2.02 to 2.55]), which was stringently defined as biochemically verified continuous abstinence73 (Appendix Table 2).

Adverse Events

Pooled results suggested no serious harms from NRT47, 49 or bupropion.40, 49 Nicotine replacement therapy was associated with an increased risk for any cardiovascular event, driven predominantly by minor cardiovascular events, such as tachycardia and arrhythmia.49 Although 2 reviews found no evidence of an increased risk for any or major cardiovascular adverse events for varenicline,49, 54 a separate metaanalysis of 17 trials found an increased risk for 1 or more serious adverse events among participants who received it (RR, 1.36 [CI, 1.03 to 1.81]; I2 = 0%; 17 trials; n = 7725).73

Combined Behavioral and Pharmacotherapy Interventions Among Adults

A meta-analysis of 40 trials found a statistically significant benefit of combined pharmacotherapy (primarily NRT or bupropion) and behavioral interventions on smoking cessation at 6 months or more when compared with controls (RR, 1.82 [CI, 1.66 to 2.00]; I2 = 40%; n = 15,021)57 (Table 2 and Appendix Table 2).

Electronic Nicotine Delivery Systems

On the basis of our search for primary evidence and a review of 25 full-text articles published through 1 March 2015, we identified 2 RCTs that evaluated the effectiveness of ENDS (specifically electronic cigarettes [e-cigarettes]) to help current conventional smokers stop or reduce smoking (Table 2 and Appendix Table 3). In the largest trial, which we rated as fair quality, Bullen and colleagues74 randomly assigned 657 smokers interested in quitting to a 16-mg nicotine e-cigarette, a 21-mg nicotine patch, or a placebo e-cigarette. All participants were also offered telephone-based support via a smoking quit line. At 6 months, this trial reported no statistically significant differences in biochemically verified continuous smoking abstinence between groups. Smoking cessation was generally low in all 3 groups: 7.3% of participants who received e-cigarettes, 5.8% of those who received nicotine patches, and 4.1% of those who received placebo e-cigarettes. Although more serious adverse events occurred in the nicotine e-cigarette group (27 events [19.7%]) than in the patch group (14 events [11.8%]), the difference was not significant.

Another fair-quality RCT done in Italy by Caponnetto and colleagues75 randomly assigned 300 conventional smokers who did not intend to quit smoking to 1 of the 3 following regimens using e-cigarette nicotine cartridges: 7.2 mg for 12 weeks, 7.2 mg for 6 weeks followed by 5.4 mg of for 6 weeks, or cartridges with no nicotine. Cartridge appearance was identical, but it is unclear whether allocation was concealed. At 52 weeks, biochemically verified cessation rates were borderline significantly different (P = 0.04) between participants in both nicotine groups (11%) and those who received the placebo cartridges (4%). The trial did not report comparisons between the individual treatment groups and placebo and reported no difference in the frequency of adverse events among study groups at 12 and 52 weeks. There was substantial loss to follow-up: 36% of participants who received one of the nicotine-containing cartridges and 45% of those who received nonnicotine cartridges did not provide 12-month follow-up data.75

Behavioral Interventions Among Pregnant Women Health Outcomes

A meta-analysis of 19 trials found modestly higher mean birthweight among infants born to women who received a behavioral intervention for smoking cessation than those who received controls (40.78 g [CI, 18.45 to 63.10 g]; I2 = 0%)28 (Table 3 and Appendix Table 4). Evidence of beneficial health outcomes were also seen in the pooled analyses across all interventions and comparators for preterm birth and low birthweight, with an 18% risk reduction for preterm birth before 37 weeks (RR, 0.82 [CI, 0.70 to 0.96]; I2 = 0%; 14 trials) and a similar significant estimate for low birthweight.28

Cessation Outcomes

For smoking cessation, pooled analyses of all behavioral interventions among pregnant women (70 trials) indicated a significant effect during late pregnancy (RR, 1.45 [CI, 1.27 to 1.64]) and moderate to substantial heterogeneity of estimated effects (I2 = 60%) (Table 3 and Appendix Table 5).

Adverse Events

None of the reviews on behavioral interventions among pregnant women reported adverse events related to the interventions.

Pharmacotherapy Interventions Among Pregnant Women

We included 1 additional fair-quality placebocontrolled trial of NRT77 on the basis of our search and evaluation of primary evidence. Adding this trial to the review by Coleman and colleagues32 left 7 trials that evaluated the effects of NRT among pregnant women (Table 3). No trials of bupropion or varenicline among pregnant women met our inclusion criteria.

Health Outcomes

Four NRT placebo-controlled trials reported on preterm birth (delivery at <37 weeks' gestation)77, 81-83 (Table 3). All but the most recent study estimated effects in the direction of a reduced risk for preterm birth with NRT, including the smallest trial, which had a statistically significant result (RR, 0.41 [CI, 0.18 to 0.94]).82 These 4 trials also reported birthweight outcomes, 2 of which found significantly higher birthweights among women allocated to the NRT group.82, 83 However, the largest trials77, 81 did not find a birthweight benefit.

Cessation Outcomes

Meta-analysis of the 5 placebo-controlled efficacy trials among pregnant women (n = 1922) showed a nonsignificant pooled effect of NRT on biochemically validated smoking cessation (RR, 1.24 [CI, 0.95 to 1.64]) with low heterogeneity (I2 = 0%) (Appendix Table 5). Adding the 2 other non–placebo-controlled trials to this analysis increased the estimate of the pooled effect but did not alter the statistical nonsignificance.

Adverse Events

We found no evidence of perinatal harms related to NRT use among pregnant women, but data for assessing rare harms were limited (Table 3). Although the largest trial (n = 1050)81 reported a higher rate of cesarean sections in the NRT group (20% for NRT vs. 15% for placebo; odds ratio, 1.45 [CI, 1.05 to 2.01]), the most recent trial (n = 402) did not find a statistical difference (26% vs. 22%, respectively; odds ratio, 1.21 [CI, 0.76 to 1.91]).77 Miscarriage rates did not differ statistically in the 3 studies included in pooled analyses (RR, 1.24 [CI, 0.37 to 4.17]; I2 = 0%; n = 1407).

Discussion

We did this review of reviews to help the USPSTF update its 2009 recommendation on interventions for tobacco cessation among adults. The included reviews represented more than 800 RCTs, many of which were published since the last syntheses done as part of the Public Health Service guideline (which served as the basis for the 2009 USPSTF recommendation).7, 84 The cumulative evidence suggests that behavioral, pharmacologic, and combined medication and behavioral interventions for smoking cessation that are readily available to primary care patients and clinicians can increase rates of smoking cessation in adults at 6-month follow-up or longer. In particular, behavioral interventions effectively help pregnant women stop smoking and improve perinatal health outcomes. Although evidence on the health outcomes of NRT during pregnancy was somewhat reassuring, it offered limited power to rule out rare potential harms.

Our updated findings are generally consistent with the 2008 Public Health Service guideline.7 We found similar evidence of effectiveness among general adult population for physician advice to quit, varying formats of behavioral interventions (telephone counseling and individual and group counseling), and all 3 first-line medications approved by the U.S. Food and Drug Administration. We also found consistent evidence of effectiveness for behavioral interventions among pregnant women and limited data on the use of medications among pregnant women.

Our findings are also consistent with those of an "overview of reviews" done by Cahill and colleagues85 on the effectiveness and safety of pharmacotherapies for smoking cessation. Both found that NRT, bupropion, and varenicline were superior to placebo for smoking cessation and that none seemed to have an adverse event risk that would negate their use among the general adult population. Our results also correspond with the results and synthesis of a 2013 review of reviews and recommendations for prevention of smoking during pregnancy by the World Health Organization.86

Electronic nicotine delivery systems are relatively new technologies, and none of the specific products have been approved as cessation interventions by the U.S. Food and Drug Administration. Regardless, knowledge about these devices may be important for providers who wish to deliver comprehensive smokingrelated counseling to their patients. On the basis of our primary review of 2 RCTs, we conclude that available data on the use of ENDS for smoking cessation are quite limited and suggest no benefit among smokers intending to quit. The most recent systematic review on this subject87 included the same 2 trials that we summarized, and neither suggested a benefit on cessation rates at 6 months or more. In addition, neither of these trials nor the limited number of observational studies included in the recent review reported any serious adverse events considered to be plausibly related to ENDS use. The paucity of trial data on adverse events is part of the ongoing debate about the appropriateness of their use as a cessation tool.

Our review has several limitations, including our review-of-reviews approach, the methods and quality of the included reviews that synthesized the bodies of evidence, and the limitations of the primary studies themselves. The comprehensiveness of this review is inevitably limited by the comprehensiveness and quality of the source reviews. Although most of the primary reviews that served as the basis for the main results included evidence through at least 2012, there may be evidence on particular population and intervention subsets that have been published since then. Because of the consistency of the effects within each group over time, we expect that any new trials would have little bearing on the overall results of our synthesis, regardless of sample size or effect estimates.

By adopting a review-of-reviews approach, we relied on the data as described and assessed by the original reviewers. In doing this, we presumed that each review generally included the full available and eligible evidence base, that data abstraction was accurate, and that analyses were scientifically sound. We were cautious about reporting pooled results for small numbers of studies or highly heterogeneous bodies of evidence. Because the included reviews were not mutually exclusive in their eligibility criteria and, as a result, were not mutually exclusive in their included studies, some individual trials were represented in more than 1 review or meta-analysis. This is particularly true for trials related to behavioral interventions in adults. Although we could not address this overlap by recalculating all of the estimates reported in the reviews because of the effort involved, we do not expect that such adjustments would alter our conclusions. We probably mitigated this potential shortcoming by basing our estimates on primary reviews rather than reporting results from several reviews.

Our syntheses and source reviews identified many areas where more research is warranted. More research is needed on the different types of mobile telephone– and Internet-based behavioral interventions for smoking cessation, including text messaging and smartphone applications, which have high potential applicability to U.S. primary care. Two relatively large trials found favorable effects for personalized text messages88, 89 and illustrate the particular promise for this new behavioral approach. Direct comparisons among combinations and classes of drugs would be informative (such as use of combinations of NRT and bupropion vs. placebo and NRT or bupropion vs. varenicline). The evidence base for varenicline, although consistent, is smaller than that for NRT and bupropion, and more trials (particularly those that closely monitor harms) would be useful. Further research on the benefit and safety of cessation medications among pregnant women is warranted, including assessment of optimal dosage and treatment timing. A recent pilot RCT on bupropion during pregnancy reported recruitment challenges and suggestions to inform future trials.90 Careful collection of adverse events and systems for deriving long-term consequences of exposure during pregnancy are also needed. Because of the variation and lack of regulatory oversight on the content of ENDS and the limited evidence available from well-designed studies, further research is clearly needed. We identified many current and planned clinical trials on the effectiveness and safety of e-cigarettes as an aid for smoking cessation that are referenced in the full report.14

The extensive evidence on strategies to help persons stop smoking reviewed in this report confirms the effectiveness of a range of behavioral and pharmacologic interventions when used alone or combined. Clinicians may choose from an array of tools to aid their patients' efforts to quit smoking and can directly provide, refer, or prescribe those that patients find most acceptable, with informed consideration of the probable magnitude of benefits for 6-month cessation and beyond. Implementation of these evidence-based interventions for tobacco control and other comprehensive and systems-level interventions can help to end the burden of preventable disease and premature death.

Copyright and Source Information

Note: This review was done by the Kaiser Permanente Research Affiliates Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ). AHRQ staff provided oversight for the project and assisted in the external review of the companion draft evidence synthesis.

Acknowledgment: The authors thank AHRQ and members of the U.S. Preventive Services Task Force. They also thank the following persons and groups for providing expert or federal partner review of the report: Catherine Chamberlain, MScPHP, MPH, BaSc; Michael Fiore, MD, MPH, MBA; Rashelle Hayes, PhD, MS; Jennifer McClure, PhD; Nancy Rigotti, MD; the Centers for Disease Control and Prevention's National Center for Chronic Disease Prevention and Health Promotion and National Institute for Occupational Safety and Health; and the National Cancer Institute. The authors also thank Smyth Lai, MLS; Kevin Lutz, MFA; and Keshia Bigler at Kaiser Permanente Center for Health Research.

Financial Support: By AHRQ (contract no. HHSA-290-2012-00015-I).

Disclosures: Dr. Patnode reports grants from AHRQ during the conduct of the study. Ms. Henderson reports grants from AHRQ during the conduct of the study. Ms. Thompson reports grants from AHRQ during the conduct of the study. Ms. Senger reports grants from AHRQ during the conduct of the study. Dr. Fortmann reports grants from AHRQ during the conduct of the study. Dr. Whitlock reports grants from AHRQ during the conduct of the study. Authors not listed here have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0171.

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54. Prochaska JJ, Hilton JF. Risk of cardiovascular serious adverse events associated with varenicline use for tobacco cessation: systematic review and meta-analysis. BMJ. 2012;344:e2856. [PMID: 22563098]
55. Rice VH, Hartmann-Boyce J, Stead LF. Nursing interventions for smoking cessation. Cochrane Database Syst Rev. 2013;8:CD001188. [PMID: 23939719]
56. Shahab L, McEwen A. Online support for smoking cessation: a systematic review of the literature. Addiction. 2009;104:1792-804. [PMID: 19832783]
57. Stead LF, Lancaster T. Combined pharmacotherapy and behavioural interventions for smoking cessation. Cochrane Database Syst Rev. 2012;10:CD008286. [PMID: 23076944]
58. Stead LF, Buitrago D, Preciado N, Sanchez G, Hartmann-Boyce J, Lancaster T. Physician advice for smoking cessation. Cochrane Database Syst Rev. 2013;5:CD000165. [PMID: 23728631]
59. Stead LF, Perera R, Bullen C, Mant D, Hartmann-Boyce J, Cahill K, et al. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2012;11:CD000146. [PMID: 23152200]
60. Stead LF, Hartmann-Boyce J, Perera R, Lancaster T. Telephone counselling for smoking cessation. Cochrane Database Syst Rev. 2013;8:CD002850. [PMID: 23934971]
61. Stead LF, Lancaster T. Behavioural interventions as adjuncts to pharmacotherapy for smoking cessation. Cochrane Database Syst Rev. 2012;12:CD009670. [PMID: 23235680]
62. Su A, Buttenheim AM. Maintenance of smoking cessation in the postpartum period: which interventions work best in the long-term? Matern Child Health J. 2014;18:714-28. [PMID: 23812798]
63. Tahiri M, Mottillo S, Joseph L, Pilote L, Eisenberg MJ. Alternative smoking cessation aids: a meta-analysis of randomized controlled trials. Am J Med. 2012;125:576-84. [PMID: 22502956]
64. Tran K, Asakawa K, Cimon K, Moulton K, Kaunelis D, Pipe A, et al. Pharmacologic-Based Strategies for Smoking Cessation: Clinical and Cost-Effectiveness Analyses. Ottawa, Ontario: Canadian Agency for Drugs and Technologies in Health; 2010. Accessed at www.cadth.ca/media/pdf/H0486_Smoking_Cessation_tr_e.pdf on 20 August 2015.
65. Tsoi DT, Porwal M, Webster AC. Interventions for smoking cessation and reduction in individuals with schizophrenia. Cochrane Database Syst Rev. 2013;2:CD007253. [PMID: 23450574]
66. Tzelepis F, Paul CL, Walsh RA, McElduff P, Knight J. Proactive telephone counseling for smoking cessation: meta-analyses by recruitment channel and methodological quality. J Natl Cancer Inst. 2011;103:922-41. [PMID: 21666098]
67. Ussher MH, Taylor AH, Faulkner GE. Exercise interventions for smoking cessation. Cochrane Database Syst Rev. 2014;8:CD002295. [PMID: 25170798]
68. van der Meer RM, Willemsen MC, Smit F, Cuijpers P. Smoking cessation interventions for smokers with current or past depression. Cochrane Database Syst Rev. 2013;8:CD006102. [PMID: 23963776]
69. Villanti AC, McKay HS, Abrams DB, Holtgrave DR, Bowie JV. Smoking-cessation interventions for U.S. young adults: a systematic review. Am J Prev Med. 2010;39:564-74. [PMID: 21084078]
70. White AR, Rampes H, Liu JP, Stead LF, Campbell J. Acupuncture and related interventions for smoking cessation. Cochrane Database Syst Rev. 2014;1:CD000009.[PMID:24459016]
71. Whittaker R, McRobbie H, Bullen C, Borland R, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev. 2012;11:CD006611. [PMID: 23152238]
72. Zbikowski SM, Magnusson B, Pockey JR, Tindle HA, Weaver KE. A review of smoking cessation interventions for smokers aged 50 and older. Maturitas. 2012;71:131-41.[PMID:22209349]
73. Cahill K, Stead LF, Lancaster T. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2012;4:CD006103. [PMID: 22513936]
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Table 1. Characteristics of Included Systematic Reviews by Population, Intervention, and Last Search Date

Study, Year (Reference), by Intervention Type Quality Rating Specific Intervention or Population Last Search Date Included Studies, n KQ1:
Health Outcomes
KQ2: Cessation KQ3: Harms
Adults: behavioral interventions (26 systematic reviews; 11 primary reviews)
Behavioral support and counseling
Stead et al, 201358* Good Physician advice January 2013 42  
Rice and Stead, 201355* Good Nursing interventions June 2013 49    
Carr et al, 201226 Good Interventions in dental settings November 2011 14    
Cahill et al, 201025 Good Stage-based interventions August 2010 41    
Hettema and Hendricks, 201038 Fair Motivational interviewing June 2008 23    
Lai et al, 201043 Good Motivational interviewing April 2009 14    
Bodner and Dean, 200923 Fair Health professional advice NR 30    
Mottillo et al, 200950 Fair Counseling August 2007 50    
Behavioral support as an adjunct to pharmacotherapy
Stead and Lancaster, 201261* Good Behavioral support as an adjunct to pharmacotherapy July 2012 38    
Print-based self-help materials
Hartmann-Boyce et al, 201437* Good Print-based self-help materials April 2014 74    
Telephone counseling
Stead et al, 201360* Good Telephone counseling May 2013 77    
Tzelepis et al, 201166 Fair Proactive telephone counseling December 2008 24    
Mobile telephone–based interventions
Whittaker et al, 201271* Fair Mobile telephone May 2012 5    
Computer-based interventions
Civljak et al, 201331* Good Internet-based April 2013 28    
Brown, 201324 Fair Internet-based, young adults February 2011 8    
Chen et al, 201229 Good Computer and electronic aids December 2009 60    
Hutton et al, 201141 Good Internet-based December 2009 21    
Myung et al, 200951 Good Internet- or computer-based August 2008 22    
Shahab and McEwen, 200956 Fair Internet-based December 2008 11    
Biomedical risk assessment
Bize et al, 201222* Good Biomedical risk assessment June 2012 15    
Exercise
Ussher et al, 201467* Fair Exercise May 2014 20    
Complementary and alternative therapies
White et al, 201470* Good Acupuncture October 2013 38    
Di et al, 201433 Good Acupuncture January 2013 25  
Cheng et al, 201230 Fair Acupoint stimulation March 2011 20    
Tahiri et al, 201263 Fair Alternative therapies December 2010 14    
Barnes et al, 201021* Good Hypnotherapy July 2010 11  
Adults: pharmacotherapy interventions (9 systematic reviews; 6 primary reviews)
NRT
Stead et al, 201259* Good NRT July 2012 150    
Varenicline
Cahill et al, 201273* Good Varenicline (nicotine receptor partial agonists) December 2011 20  
Huang et al, 201239 Good Varenicline March 2011 19  
Bupropion SR
Hughes et al, 201440* Good Bupropion SR (antidepressants) July 2013 66  
All pharmacotherapy
Mills et al, 201248 Fair NRT, bupropion SR, varenicline January 2012 146    
Tran et al, 201064 Fair NRT, bupropion SR, varenicline February 2009 143  
All pharmacotherapy harms
Mills et al, 201449* Fair NRT, bupropion SR, varenicline harms March 2013 63    
Varenicline harms
Prochaska and Hilton, 201254* Good Varenicline harms September 2011 22    
NRT harms
Mills et al, 201047* Fair NRT harms November 2009 92    
Adults: combined pharmacotherapy and behavioral interventions (1 systematic review; 1 primary review)
Stead and Lancaster, 201257* Good Combined pharmacotherapy and behavioral support July 2012 41    
Adults: electronic nicotine delivery systems (2 RCTs)
Bullen et al, 201374 Fair Electronic cigarettes NA NA  
Caponnetto et al, 201375 Fair Electronic cigarettes NA NA  
Pregnant women: behavioral interventions (6 systematic reviews; 1 primary review)
Chamberlain et al, 201328* Good Behavioral interventions among pregnant women March 2013 86
Filion et al, 201135 Fair Behavioral interventions among pregnant women June 2010 8    
Hettema and Hendricks, 201038 Fair Behavioral interventions among pregnant women June 2008 8    
Likis et al, 201444 Good Pharmacotherapy and behavioral interventions among pregnant women January 2013 59
Su and Buttenheim, 201362 Fair Pharmacotherapy and behavioral interventions among pregnant women December 2012 32    
Bondurant and Wedge, 200976 Good Pharmacotherapy and behavioral interventions among pregnant women June 2008 72
Pregnant women: pharmacotherapy interventions (6 systematic reviews; 1 primary review)
Coleman et al, 201232* Good Pharmacotherapy among pregnant women March 2012 7§
Myung et al, 201252 Good Pharmacotherapy among pregnant women June 2011 7
Likis et al, 201444 Good Pharmacotherapy and behavioral interventions among pregnant women January 2013 59
Su and Buttenheim, 201362 Fair Pharmacotherapy and behavioral interventions among pregnant women December 2012 32    
Bondurant and Wedge, 200976 Fair Pharmacotherapy and behavioral interventions among pregnant women June 2008 72

KQ = key question; NA = not applicable; NR = not reported; NRT = nicotine replacement therapy; RCT = randomized, controlled trial; SR = sustained release.
* Primary review that served as the basis for the main findings.
Includes adults and pregnant women and is listed twice in this table.
Not based on a review of reviews; we included 2 RCTs based on a primary search for evidence.
§ We conducted a search for primary evidence to extend this review and added 1 fair-quality trial.77

Table 2. Summary of Evidence for the General Adult Population

Intervention Included Reviews, n Summary of Findings Consistency Major Limitations Applicability
KQ1: health outcomes
Behavioral 1 1 trial found favorable effects on all-cause and coronary disease mortality and lung cancer incidence and mortality 20 y after an intensive behavioral intervention, although results were not statistically significant. NA Only 1 review reported the results of 1 intervention among men on health outcomes. Within that trial, the smoking rate among control participants declined steadily over the follow-up period, narrowing the intervention effect. 1 trial conducted among male civil servants aged 40–59 y in the United Kingdom with high risk for cardiorespiratory disease. Intervention took place in the 1970s.
Pharmacotherapy 0 NA NA NA NA
Combined pharmacotherapy and behavioral 0 NA NA NA NA
ENDS 0 NA NA NA NA
KQ2: cessation outcomes
Behavioral 26 Health provider advice and counseling, tailored self-help materials, and telephone counseling showed modest but significant increased smoking cessation at ≥6 mo relative to control participants (18%–96%).

Providing more intense adjunctive behavioral support to smokers receiving pharmacotherapy may increase cessation by 9%–24%. Evidence on the use of mobile phone support, Internet-based interventions, and complementary and alternative therapies was limited and not definitive.

Consistent Individual trials may be represented in >1 review or meta-analysis.

Several of the meta-analyses treated comparisons among different trial groups as separate studies and were not consistent in their reporting or handling of multiple comparisons.

Fixed-effects models were used in nearly all meta-analyses.

Most of the included studies within each review were done in North America and should be applicable to the U.S. health system. Treatment effects seem to be similar in a range of populations, settings, and types of interventions and in smokers with and without other comorbid conditions.

The literature almost exclusively addressed treatment for cigarette smoking as opposed to the use of other forms of tobacco, so results may not be generalizable to all forms of tobacco.

Pharmacotherapy 6 NRT, bupropion SR, and varenicline improve the chances of smoking cessation. Reviews suggested that NRT might increase smoking abstinence at ≥6 mo by 53%–68%, bupropion SR by 49%–76%, and varenicline by 102%–155%.

Absolute cessation differences averaged 7% for NRT, 8.2% for bupropion SR, and 26% for varenicline.

There were no significant differences among different NRT products, and relative rates of abstinence were similar across settings. Use of a combination of NRT products increases cessation rates more than the use of a single NRT product. In general, there were no significant differences among different classes of medications in direct comparisons.

Consistent Possibility of publication bias but unlikely that the presence of additional studies with lower relative risks would alter the findings because of the large number of studies and consistency in findings.

Trials with pharmaceutical funding have been shown to have slightly higher effect sizes than nonindustry-funded studies; because of the number of included trials funded by pharmaceutical companies (particularly for varenicline), the magnitude of the effects may be smaller than estimates suggest.

Most of the included studies within each review were done in North America and should be applicable to the U.S. health system. Treatment effects seem to be similar in a range of populations, settings, and types of interventions and in smokers with and without other comorbid conditions.

The literature almost exclusively addressed treatment for cigarette smoking as opposed to the use of other forms of tobacco, so results may not be generalizable to all forms of tobacco.

Combined pharmacotherapy and behavioral 1 Combined pharmacotherapy and behavioral interventions increase cessation rates by 70%–100% compared with no or minimal treatment. Consistent May be risk of bias due to lack of blinding of participants. Most of the included studies within each review were done in North America and should be applicable to the U.S. health system. Treatment effects seem to be similar in a range of populations, settings, and types of interventions and in smokers with and without other comorbid conditions.

The literature almost exclusively addressed treatment for cigarette smoking as opposed to the use of other forms of tobacco, so results may not be generalizable to all forms of tobacco.

ENDS 2 RCTs 1 trial found no statistically significant difference in biochemically verified abstinence at 6 mo between those receiving e-cigarettes vs. nicotine patch or placebo e-cigarettes (n = 657). The other trial (n = 300) found a borderline significant higher cessation rate among those receiving nicotine-containing e-cigarettes (11%) vs. e-cigarettes without nicotine cartridges (4%) at 12 mo. Consistent Insufficient statistical power to detect differences and differential high loss to follow-up in both trials (22%–40%). 2 trials took place in New Zealand and Italy.

Both trials used older models of e-cigarettes, 1 of which is no longer available.

1 trial was conducted among smokers who did not want to quit.

KQ3: adverse events
Behavioral 2 Minor AEs related to ear acupuncture, ear acupressure, and other auriculotherapy have been reported. AEs related to other behavioral or complementary and alternative therapies have not been documented. NA Only 2 reviews assessed AEs related to behavioral interventions; 1 found no studies that reported AEs. Limited evidence on harms limits applicability.
Pharmacotherapy 8 NRT, bupropion SR, and varenicline are not associated with an increased risk for major CV AEs. NRT is associated with a higher rate of any CV AE largely driven by low-risk events, typically tachycardia.

There was a marginal, nonsignificant increase in serious AEs in participants receiving bupropion SR but no difference for serious psychiatric AEs.

The evidence for the safety of varenicline is still under investigation; 1 review suggested a 36% increased risk for nonfatal serious AEs among those receiving varenicline vs. a control intervention.

Consistent Many trials that report cessation effectiveness do not report AEs, particularly CV- or neuropsychiatric-specific AEs.

AEs are typically measured through passive reporting and are therefore susceptible to underreporting.

Likely applicable across settings and populations.
Combined pharmacotherapy and behavioral 0 NA NA NA NA
ENDS 2 RCTs 2 RCTs reported no serious AEs in the intervention or control groups related to product use and no difference in the frequency of AEs among study groups. 1 trial found a higher proportion of serious AEs among the e-cigarette group vs. the NRT patch group (19.7% vs. 11.8% Consistent Insufficient statistical power to detect differences and differential high loss to follow-up in both trials (22%–40%).

1 study did not report methods for AEs reporting.

2 trials took place in New Zealand and Italy.

Both trials used older models of e-cigarettes, 1 of which is no longer available.

AE = adverse event; CV = cardiovascular; ENDS = electronic nicotine delivery system; KQ = key question; NA = not applicable; NRT = nicotine replacement therapy; RCT = randomized, controlled trial; SR = sustained release.

Table 3. Summary of Evidence for Pregnant Women

Intervention Included Reviews, n Summary of Findings Consistency Major Limitations Applicability
KQ1: health outcomes
Behavioral 3 Statistically significant benefit of behavioral interventions on mean birthweight, low birthweight, and preterm birth vs. usual care or control. Consistent Rare health outcomes and few trials of NRT limited statistical precision and ability to draw conclusions based on the current evidence.

Limited information on the women approached for participation who declined and low participation rates.

Trials mainly conducted in high-income countries, including the United States.

Pharmacotherapy trials were placebo-controlled, and outcomes were based on well-established measures used in routine health care settings.

Because of the stigma of smoking during pregnancy, it was challenging to recruit pregnant smokers. Those who disclose smoking status and are willing to participate in trials may differ from the general population (e.g.,motivation to quit).

Pharmacotherapy 4 Limited evidence of NRT on perinatal and child health benefits. 3 of 4 NRT trials reported fewer preterm births in the intervention group, but only 1 was statistically less than placebo. 2 trials reported higher birthweight in the NRT group; 2 larger trials found no difference. Follow-up data from the largest NRT trial found a higher rate of "survival with no impairment" at 2 y among children of women assigned to the NRT intervention vs. placebo (73% vs. 65%).

No trials of bupropion SR or varenicline among pregnant women.

NA    
KQ2: cessation outcomes
Behavioral 6 Pooled estimates of a range of behavioral interventions from 70 studies suggested benefits for validated smoking cessation, with a similar benefit when limited to the most common intervention (counseling). Heterogeneity was moderate for the pooled effect, but there was no evidence of subgroup effects by intervention type, number of intervention components, or outcome ascertainment approach. Consistent Limited information on the women approached for participation who declined and low participation rates Trials mainly conducted in high-income countries, including the United States.

Pharmacotherapy trials were placebo-controlled, and outcomes were based on well-established measures used in routine health care settings.

Because of the stigma of smoking during pregnancy, it was challenging to recruit pregnant smokers. Those who disclose smoking status and are willing to participate in trials may differ from the general population (e.g., motivation to quit).

Pharmacotherapy 5 No statistical evidence of NRT efficacy for validated smoking cessation in late pregnancy, but power was limited and all trials were in the direction of benefit (pooled analysis based on 5 placebo-controlled trials).

No trials of bupropion SR or varenicline among pregnant women.

Consistent    
KQ3: adverse events
Behavioral 1 No serious AEs reported. NA Inconsistent data collection across trials; most reliant on passive reporting. Trials mainly conducted in high-income countries, including the United States.

Pharmacotherapy trials were placebo-controlled, and outcomes were based on well-established measures used in routine health care settings.

Because of the stigma of smoking during pregnancy, it was challenging to recruit pregnant smokers. Those who disclose smoking status and are willing to participate in trials may differ from the general population (e.g., motivation to quit).

Pharmacotherapy 5 No evidence of perinatal harms from NRT. 1 trial found a higher rate of cesarean delivery for women assigned to NRT; follow-up from the same trial was reassuring for child health outcomes.

No trials of bupropion SR or varenicline among pregnant women.

NA Few trials of NRT, and not all reported consistently on health outcomes and AEs.  

AE = adverse event; KQ = key question; NA = not applicable; NRT = nicotine replacement therapy; SR = sustained release.

Appendix Figure 1. Analytic Framework

KQ = key question.

Text Description.

Appendix Figure 1 is an analytic framework that depicts three key questions described in the Methods section. In general, it illustrates the overarching question of whether tobacco cessation interventions improve mortality, morbidity, and other health outcomes in current adult tobacco users, including pregnant women and individuals with mental health conditions. The analytic framework also illustrates the intermediate step and key questions of whether tobacco cessation interventions achieve tobacco abstinence in current adult tobacco users, including pregnant women and individuals with mental health conditions, and what adverse events are associated with tobacco cessation interventions.

Appendix Table 1. Criteria for Choosing the Primary Existing Systematic Reviews

The search is more up-to-date than other reviews for the same population/intervention group.

The included studies apply inclusion/exclusion criteria that offer the most relevant and credible evidence (i.e., based on included study designs, populations, setting, follow-up >6 mo, and outcomes).

There are relatively more (or equal) included studies of the ideal study design compared with other reviews for the same population/intervention.

Appropriately conducted pooled results are presented, with or without meta-regression or subgroup analysis.

The quality of the review is more favorable than other reviews for the same population/intervention.

Appendix Figure 2. Summary of Evidence Search and Selection


Text Description.

Appendix Figure 2 is a flow chart that summarizes the search and selection of systematic reviews. There were 1,141 citations identified through literature databases. After duplicates were removed, 638 unique citations were screened at the title/abstract stage. The full-text of 114 systematic reviews was examined for inclusion in one or more of the three populations of interest, including adults, pregnant women and individuals with mental health conditions.

Appendix Table 2. Summary of Smoking Abstinence Results (KQ2) From Reviews of Behavioral Counseling and Pharmacotherapy Interventions for Smoking Cessation Among Adults, by Type of Intervention

Intervention Control Studies, n Participants, n Abstinence Measures* Follow-up, mo IG Events, n IG Participants, n IG Cessation
Rate, %
CG Events, n CG
Participants, n
CG Cessation
Rate, %
Risk Ratio
(95% CI)§
I2, %
Behavioral interventions for smoking cessation
Stead et al, 201358
Physician advice No advice/usual care 28 22,239 43% CA
36% BV
≥6 1008 12,583 8.0 462 9656 4.8 1.76 (1.58–1.96) 40
Rice et al, 201355
Nursing interventions Usual care or minimal intervention 35 17,604 29% CA
77% BV
≥6 1273 9589 13.3 906 8015 11.3 1.29 (1.20–1.39) 50
Stead and Lancaster, 201261
Behavioral support as an adjunct to pharmacotherapy Pharmacotherapy (any) 39 15,506 28% CA
79% BV
≥6 1640 7659 21.4 1438 7847 18.3 1.16 (1.09–1.24) 3
Hartmann-Boyce et al, 201437
Tailored print-based self-help materials Control (various) 32 40,890 72% CA
25% BV
≥6 1502 21,017 7.1 1144 19,873 5.8 1.28
(1.18–1.37)
32
Nontailored print-based self-help materials Control (various) 33 29,495 42% CA
55% BV
≥6 1080 15,635 6.9 891 13,860 6.4 1.06 (0.98–1.16) 23
Stead et al, 201360
Proactive telephone counseling among quit line callers Control (various) 12 30,182 75% CA
17% BV
≥6 1980 18,428 10.7 895 11,754 7.6 1.41
(1.20–1.66)
NR
Proactive telephone counseling (no quit line) Control (various) 52 30,246 33% CA
35% BV
≥6 2031 15,478 13.1 1433 14,768 9.7 1.27 (1.20–1.36) 42
Whittaker et al, 201271
Mobile telephone interventions Control (various) 5 9100 Pooled results not presented given small number of studies and considerable heterogeneity (I2 = 79%); results reported narratively.
Civljak et al, 201331
Internet-based interventions No treatment or other non-Internet–based treatments 23 >45,000 Pooled results not presented given small number of studies in subgroup analyses and considerable statistical heterogeneity; results reported narratively.
Bize et al, 201222
Biomedical risk assessment Control (various) 15 8115 Pooled results not presented given small number of studies in each subgroup and substantial statistical heterogeneity; results reported narratively.
Ussher et al, 201467
Exercise alone or as adjunct to interventions for smoking cessation Intervention for smoking cessation alone or usual care 20 5870 No meta-analysis conducted due to small number of studies, small sample sizes, and differences in study design and intervention; results reported narratively.
White et al, 201470
Acupuncture Sham acupuncture 9 1892 33% CA
33% BV
6–12 122 997 12.2 97 895 10.8 1.10 (0.86–1.40) 23
Barnes et al, 201021
Hypnotherapy Brief advice/advice 5 363 Pooled results not presented given small number of studies and clear asymmetry of the results of the included trials, indicating potential publication bias.
Pharmacotherapy interventions for smoking cessation
Stead et al, 201259
NRT, all forms Placebo or no NRT 117 51,265 57% CA
87% BV
≥6 4704 27,258 17.3 2466 24,007 10.3 1.60 (1.53–1.68) 30
NRT, gum Placebo or no NRT 56 22,581 55% CA
82% BV
≥6 1732 10,596 16.3 1196 11,985 10.0 1.49 (1.40–1.60) 40
NRT, patch Placebo or no NRT 43 19,586 58% CA
88% BV
≥6 1873 11,746 15.9 766 7840 9.8 1.64 (1.52–1.78) 19
NRT, tablets/ lozenges Placebo or no NRT 7 3405 29% CA
100% BV
≥6 337 1808 18.6 134 1597 8.4 1.95 (1.61–2.36) 24
2 forms of NRT (dual) 1 form of NRT 9 4664 67% CA
89% BV
≥6 368 1785 20.6 448 2879 15.6 1.34 (1.18–1.51) 34
Hughes et al, 201440
Bupropion SR Placebo or no bupropion SR** 44 13,728 77% CA
95% BV
≥6 1507 7646 19.7 701 6082 11.5 1.62 (1.49–1.76) 18
Bupropion SR Placebo or no bupropion SR** 17 3862 59% CA
100% BV
6 483 2202 21.9 200 1660 12.0 1.69 (1.45–1.97) 0
Bupropion SR Placebo or no bupropion SR** 27 9866 81% CA
93% BV
12 1024 5444 18.8 501 4422 11.3 1.59 (1.44–1.76) 39
Cahill et al, 201273
Varenicline Placebo†† 14 6166 100% CA
100% BV
≥6 954 3412 28.0 331 2754 12.0 2.27 (2.02–2.55) 63
Combined interventions for smoking cessation
Stead and Lancaster, 201257
Combined pharmacotherapy and behavioral interventions Control (various) 40 15,021 56% CA
76% BV
≥6 1134 7810 14.5 597 7211 8.3 1.82 (1.66–2.00) 40

BV = biochemically verified; CA = continuous abstinence; CG = control group; IG = intervention group; KQ = key question; NR = not reported; NRT = nicotine replacement therapy; SR = sustained release.
* Used strictest available criteria to define abstinence (i.e., continuous, sustained, or prolonged abstinence was preferred over point prevalence abstinence, and biochemically validated rates were used where available). "Continuous abstinence" reflects reviews that reported outcomes as continuous (completely abstinent from cessation date with 0–5 cigarettes during that time), "sustained" abstinence (not defined), or prolonged abstinence (allowing a grace period after the cessation date to allow for lapses).
Longest follow-up time point reported.
Weighted average cessation rate.
§ Pooled risk ratios estimated using the Mantel–Haenszel fixed-effects model, unless otherwise noted.
Results from sensitivity analysis using a random-effects model given substantial heterogeneity of fixed-effects model (71%).
The control group in 25/117 trials did not have a matched placebo control; findings were not sensitive to the exclusion of non–placebo-controlled studies.
** The control group in 3/44 trials did not have a matched placebo control.
†† The control group in 1/14 included trials did not have a matched placebo control; a sensitivity analysis excluding it made no appreciable difference to the overall estimate.

Appendix Table 3. Efficacy and Safety of the Use of ENDS for Smoking Cessation

Study Study Design Sample
Size, n
Population Intervention Control Outcomes for Smoking Cessation Other Outcomes AEs
Bullen et al, 201374 RCT; New Zealand Total: 657
IG: 289
CG1: 295
CG2: 73
Aged ≥18 y, had smoked ≥10 cigarettes per day for at least the past year, wanted to stop smoking IG: Elusion e-cigarette (16 mg nicotine) + voluntary quit line behavioral support
Duration: From 1 wk before until 12 wk after chosen cessation date
CG1: NRT patch (21 mg nicotine/24 h)
CG2: Placebo e-cigarette + voluntary quit line behavioral support
Continuous abstinence at 6 mo after cessation date (allowing ≤5 cigarettes); biochemically verified:
IG: 7.3%*
CG1: 5.8%
CG2: 4.1%
Median time to relapse:
IG: 35 d (95% CI, 15–56)
CG1: 14 d (95% CI, 8–18)
CG2: 12 d (95% CI, 5–34)
Mean (SE) cigarette consumption at 6 mo among those smoking ≥1 cigarette in past 7 d:
IG: 9.7 (0.4)
CG1: 7.7 (0.4)
No serious events in any groups were related to product use
Caponnetto et al, 201375
Efficiency and Safety of an Electronic Cigarette (ECLAT)
RCT; Italy Total: 300
IG1: 100
IG2: 100
CG: 100
Aged 18–70 y, had smoked ≥10 cigarettes per day for at least the past 5 y, not currently attempting to quit smoking or wishing to do so in the next 30 d Categoria 401
E-cigarette
IG1: 12 wk of 7.2-mg nicotine cartridges used ad libitum
IG2: 6 wk of 7.2-mg nicotine cartridges and 6 wk of 5.4-mg nicotine cartridges used ad libitum
Baseline visit and 8 follow-up visits (2-, 4-, 6-, 8-, 10-, 12-, 24-, and 52 wk)
Categoria 401
E-cigarette
CG: 12 wk of no-nicotine cartridges used ad libitum
Abstinence (not even a puff) since previous study visit; biochemically verified: 24 wk
IG1: 12.0%§
IG2: 10.0%
CG: 5.0%
52 wk
IG1: 13.0%
IG2: 9.0%
CG: 4.0%
Self-reported number of cigarettes/day: Significant reduction in median value in all 3 groups at each time point; no between-group differences at 12, 24, or 52 wk No difference in frequency of AEs among study groups at each time point

AE = adverse event; CG = control group; IG = intervention group; NR = not reported; NRT = nicotine replacement therapy; RCT = randomized, controlled trial.
* No significant differences between groups. 1- and 3-mo cessation rates also did not differ.
P < 0.0001.
P = 0.002.
§ Test for statistical difference not reported.
Significant difference between IG1 and IG2 (11.0%) and CG (4.0%) (P = 0.04).

Appendix Table 4. Summary of Perinatal Health Outcome Results (KQ1) of Behavioral Interventions for Smoking Cessation Among Pregnant Women*

Intervention Control Studies, n Participants, n Abstinence Measures* Follow-up IG Events, n IG Participants, n CG Events, n CG
Participants, n
RR§ or Mean Difference (95% CI) I2, %
Outcome: mean birthweight
All behavioral interventions Usual care or control 19 9859 21% PPA
68% BV
Late pregnancy, including during hospitalization for delivery NA 4948 NA 4911 40.78 g (18.45–63.10 g) 0
Counseling Usual care or control 12 5392 17% PPA
67% BV
Late pregnancy, including during hospitalization for delivery NA 2619 NA 2773 39.93 g (9.12–70.74 g) 0
Outcome: low birthweight (<2500 g)
All behavioral interventions Usual care or control 14 8562 14% PPA
79% BV
Late pregnancy, including during hospitalization for delivery 304 4298 381 4264 RR: 0.82 (0.71–0.94) 0
Counseling Usual care or control 8 4339 13% PPA
88% BV
Late pregnancy, including during hospitalization for delivery 151 2090 200 2249 RR: 0.83 (0.68–1.01) 0
Outcome: preterm birth (<37 wk)
All behavioral interventions Usual care or control 14 7852 29% PPA
79% BV
Late pregnancy, including during hospitalization for delivery 251 3992 317 3860 RR: 0.82 (0.70–0.96) 0
Counseling Usual care or control 8 3447 25% PPA
89% BV
Late pregnancy, including during hospitalization for delivery 99 1672 117 1775 RR: 0.93 (0.71–1.20) 0
Outcome: stillbirth
All behavioral interventions Usual care or control 7 5414 0% PPA
57% BV
Late pregnancy, including during hospitalization for delivery 38 2676 31 2738 RR: 1.22 (0.76–1.95) 0
Counseling Usual care or control 5 2454 0% PPA
80% BV
Late pregnancy, including during hospitalization for delivery 16 1197 14 1257 RR: 1.14 (0.55–2.33) 0

BV = biochemically verified; CG = control group; IG = intervention group; KQ = key question; NA = not applicable; PPA = point prevalence abstinence; RR = risk ratio.
* Data from reference.28
Used point prevalence abstinence in late pregnancy for primary outcomes and biochemically validated rates where available.
Longest follow-up time point reported.
§ Pooled RRs estimated using the Mantel–Haenszel random-effects model.
Behavioral interventions included counseling, health education, feedback, incentives, and social support.

Appendix Table 5. Summary of Smoking Abstinence Results (KQ2) From Reviews of Interventions for Smoking Cessation Among Pregnant Women

Intervention Control Studies, n Participants, n Abstinence Measures* Follow-up IG Events, n IG Participants, n IG
Cessation
Rate, %
CG Events, n CG
Participants, n
CG
Cessation
Rate, %
Risk Ratio (95% CI)§ I2, %
Chamberlain et al, 201328
Any behavioral interventions Usual care or control 70 21,948 0% CA
79% BV
Late pregnancy, including during hospitalization for delivery 1,691 11,111 15.2 1,213 10,837 11.2 1.45 (1.27–1.64) 60
Counseling Usual care or control 45 17,681 0% CA
82% BV
Late pregnancy, including during hospitalization for delivery 1,283 8,830 14.5 992 8,851 11.2 1.37 (1.17–1.59) 64
Social support Usual care or control 10 1,683 0% CA
70% BV
Late pregnancy, including during hospitalization for delivery 168 845 19.9 128 838 15.3 1.29 (0.97–1.73) 36
Coleman et al, 201232
NRT, all forms Placebo 4 1,520 25% CA
100% BV
Late pregnancy, including during hospitalization for delivery 93 762 12.2 71 758 9.4 1.27 (0.95–1.69) 0
Coleman et al, 201232) + Berlin study identified in bridge search77
NRT, all forms** Placebo 5†† 1,922 40% CA
100% BV
Late pregnancy, including during hospitalization for delivery 104 965 10.8 81 957 8.5 1.24 (0.95–1.64) 0

BV = biochemically verified; CA = continuous abstinence; CG = control group; IG = intervention group; KQ = key question; NRT = nicotine replacement therapy.
* Used strictest available criteria to define abstinence (i.e., continuous, sustained, or prolonged abstinence was preferred over point prevalence abstinence, and biochemically validated rates were used where available).
Longest follow-up time point reported.
Weighted average cessation rate.
§ Pooled risk ratios estimated using the Mantel–Haenszel random-effects model.
Behavioral interventions included counseling, health education, feedback, incentives, and social support.
3/4 trials used nicotine patches.
** 4/5 trials used nicotine patches.
†† Includes 4 trials identified in the Coleman review and 1 additional trial included from our bridge search.

Current as of: September 2015

Internet Citation: Evidence Summary: Tobacco Smoking Cessation in Adults, Including Pregnant Women: Behavioral and Pharmacotherapy Interventions. U.S. Preventive Services Task Force. October 2015.
https://www.uspreventiveservicestaskforce.org/Page/Document/behavioral-counseling-and-pharmacotherapy-interventions-for-/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions1

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