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Interventions for Tobacco Cessation in Adults, Including Pregnant Women: An Evidence Update for the U.S. Preventive Services Task Force

Evidence Synthesis, No. 196

Investigators: , PhD, MPH, , PhD, MPH, , MD, MPH, , MPH, , MPH, and , MPH.

Rockville (MD): Agency for Healthcare Research and Quality (US); .
Report No.: 20-05264-EF-1

Structured Abstract


We undertook this systematic review to support the U.S. Preventive Services Task Force in updating its 2015 recommendation on tobacco cessation interventions for adults, including pregnant women. Our review addressed the effectiveness and safety of pharmacotherapy, behavioral interventions, and electronic cigarettes for tobacco cessation.

Data Sources:

We conducted an overview of reviews for evidence related to pharmacotherapy and behavioral interventions among the general adult population and for behavioral interventions among pregnant women. We searched the following databases and organizations’ websites to identify existing reviews through April 2019: PubMed, PsycInfo, the Database of Abstracts of Reviews of Effects, the Cochrane Database of Systematic Reviews, the Centre for Reviews and Dissemination Health Technology Assessment, the Agency of Healthcare Research and Quality, the Canadian Agency for Drugs and Technologies in Health, Center for Disease Control and Prevention’s Guide to Community Preventive Services, the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine (formerly the Institute of Medicine), the National Health Service Health Technology Assessment Programme, and the Surgeon General. We conducted a search for primary evidence related to the effectiveness and safety of electronic cigarettes (through May 2020) and pharmacotherapy among pregnant women (through May 2020) and did not rely on existing systematic reviews for this evidence. We conducted ongoing surveillance for relevant literature through September 25, 2020.

Study Selection:

For the overview of reviews, we included reviews with or without meta-analysis that were published in the English language that systematically reported the effects of tobacco cessation interventions on health, cessation, or adverse outcomes. We excluded nonsystematic meta-analyses and narrative reviews. For primary evidence related to the effectiveness and safety of electronic cigarettes among adults and pharmacotherapy among pregnant women, we included randomized controlled trials and large observational studies that reported health or cessation outcomes at 6 months or more followup or adverse events at any time point. For all evidence, we conducted critical appraisal of all provisionally included reviews and excluded reviews rated as having “critically low” credibility according to AMSTAR-2 criteria and individual studies rated as “poor” quality according to study design-specific risk-of-bias criteria. Data were abstracted by one reviewer and confirmed by another.

Data Analysis:

We grouped reviews based on population and intervention and identified one or more reviews within each population and intervention subgroup that represented the most current and applicable evidence to serve as the basis for the main findings (“primary” reviews) and discussed complementary and discordant findings from other included reviews as necessary. We did not reanalyze any of the individual study evidence but presented pooled analyses and existing point estimates from included reviews. We narratively synthesized the primary evidence for electronic cigarettes among adults and pregnant women and medications for smoking cessation among pregnant women and where appropriate, conducted random-effects meta-analyses to pool study results.


We included 67 systematic reviews, 33 of which served as the basis for the primary findings. While this review was broadly scoped to include abstinence of all tobacco products, the primary outcome in all cases was abstinence from combustible cigarette smoking. Among adults, combined pharmacotherapy and behavioral interventions significantly increased smoking abstinence by 83 percent versus usual care or minimal support control groups not using medication (risk ratio [RR] 1.83 [95% confidence interval [CI], 1.68 to 1.98]). Furthermore, all seven FDA-approved medications for smoking cessation were found to be effective in increasing smoking quit rates compared with placebo or nondrug arms at 6 or more months followup. The pooled RR for abstinence for nicotine replacement therapy (NRT, all forms) was 1.55 (95% CI, 1.49 to 1.61), for bupropion, 1.64 (95% CI, 1.52 to 1.77), and for varenicline, 2.24 (95% CI, 2.06 to 2.43). Combined NRT versus a single form of NRT showed a statistically significantly greater cessation effect (RR 1.25 [95% CI, 1.15 to 1.36]). Pooled analysis of trials directly comparing NRT and bupropion did not suggest a difference between the two types of pharmacotherapy; however, varenicline has been shown to be superior to both NRT and bupropion in achieving abstinence at 6 months or greater, although there are fewer trials testing these differences. Although less evidence is available, certain medications such as nortriptyline and cytisine used for tobacco cessation have shown potential benefits. None of the drugs were associated with serious adverse events, including major cardiovascular adverse events or serious neuropsychiatric events.

Compared with various controls, behavioral interventions such as in-person advice and support from clinicians including physician advice, nurse advice, individual counseling with a cessation specialist, group behavioral interventions, telephone counseling, mobile phone-based interventions, interactive and tailored internet-based interventions, and the use of incentives had modest but significantly increased relative smoking cessation at 6 or more months (15% to 88% range in relative effects). For example, the pooled RR of physician advice versus no advice was 1.76 (95% CI, 1.58 to 1.96) for smoking cessation at 6 or more months’ followup. There was a lack of clear benefit of motivational interviewing, decision aids, print-based, nontailored self-help materials, real-time video counseling, biofeedback (feedback on smoking exposure, smoking-related disease, or smoking-related harms), exercise, acupuncture, hypnotherapy, and system change interventions compared with controls; however, there was substantially less evidence related to each of these interventions. While some reviews found evidence of potential effect modification by specific intervention, population, or study design characteristics, there was no one factor that consistently predicted greater treatment effects, and nearly every subgroup analysis was found to be statistically significant. Few reviews on behavioral interventions captured information on potential harms, and none suggested serious adverse events that arose.

We identified five trials that addressed the effectiveness and harms of the use of electronic cigarettes among adults. No trials testing the effects of electronic cigarettes for smoking cessation among pregnant women were identified. Results were mixed on smoking cessation effectiveness at 6 to 12 months among smokers intending to quit when compared with placebo devices or NRT. Four additional trials also reported on potential short-term harms of electronic cigarette use for cessation; none suggested relatively higher rates of serious adverse events.

Among pregnant women, smoking cessation during late pregnancy was greater among women receiving any type of behavioral intervention, with evidence most clear for counseling versus controls (RR 1.31 [95% CI, 1.16 to 1.47]). Behavioral interventions were also associated with an increase in mean birthweight of babies as well as a decreased risk of low birth weight. We identified one new trial of NRT among pregnant women, but no new trials testing the effects of bupropion or varenicline in this population. For NRT, rates of validated cessation among women allocated to NRT (5.4% to 28.2%) compared with placebo (5.0% to 25.4%) were not statistically different (pooled RR 1.11 [95% CI, 0.79 to 1.56]). Benefits of NRT on infant health outcomes were seen in a few trials, but that evidence was limited. There was no clear evidence of harms from behavioral interventions or associated with NRT use during pregnancy, but harms also could not be ruled out given sparse reporting, low statistical power for evaluating rare harms, and limitations of observational study comparisons.


The comprehensiveness of our overview of reviews is limited by the recency and quality of the source reviews; with exceptions, we did not describe or cite individual trials because of the large volume of trials represented in the reviews. Furthermore, there are a limited number of trials testing the benefits and harms of electronic cigarettes among adults as well as the use of medications to assist pregnant women stop smoking. Such sparsity in research hampers our ability to make any robust conclusions about their effectiveness and potential harms.


There is strong evidence that a range or pharmacological and behavioral interventions, both individually and in combination, are effective in increasing smoking cessation in adults. Moreover, behavioral interventions can help pregnant women stop smoking. Data on the effectiveness and safety of electronic cigarettes for smoking cessation among adults are limited as are data on the use of tobacco cessation pharmacotherapies among pregnant women. Future research should focus on direct comparisons between different combinations and classes of drugs, adaptations of interventions for diverse populations, and the efficacy and safety of electronic cigarettes.


Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services, 5600 Fishers Lane, Rockville, MD 20857; www.ahrq.gov Contract No. HHSA-290-2015-00007-I-EPC5, Task Order No. 5 Prepared by: Kaiser Permanente Evidence-based Practice Center, Kaiser Permanente Center for Health Research, Portland, OR

Suggested citation:

Patnode CD, Henderson JT, Melnikow J, Coppola EL, Durbin S, Thomas R. Interventions for Tobacco Cessation in Adults, Including Pregnant Persons: An Evidence Update for the U.S. Preventive Services Task Force: Evidence Synthesis No. 196. AHRQ publication No. 20-05264-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2021.

This report is based on research conducted by the Kaiser Permanente Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHSA-290-2015-00007-I-EPC5, Task Order No. 5). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of healthcare services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information (i.e., in the context of available resources and circumstances presented by individual patients).

This report may be used, in whole or in part, as the basis for 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.

Bookshelf ID: NBK567066PMID: 33523610


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