Combined pharmacotherapy and behavioural interventions for smoking cessation
Open accessAbstract
BACKGROUND: Both behavioural support (including brief advice and counselling) and pharmacotherapies (including nicotine replacement therapy (NRT), varenicline and bupropion) are effective in helping people to stop smoking. Combining both treatment approaches is recommended where possible, but the size of the treatment effect with different combinations and in different settings and populations is unclear. OBJECTIVES: To assess the effect of combining behavioural support and medication to aid smoking cessation, compared to a minimal intervention or usual care, and to identify whether there are different effects depending on characteristics of the treatment setting, intervention, population treated, or take-up of treatment. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group Specialised Register in July 2015 for records with any mention of pharmacotherapy, including any type of NRT, bupropion, nortriptyline or varenicline. SELECTION CRITERIA: Randomized or quasi-randomized controlled trials evaluating combinations of pharmacotherapy and behavioural support for smoking cessation, compared to a control receiving usual care or brief advice or less intensive behavioural support. We excluded trials recruiting only pregnant women, trials recruiting only adolescents, and trials with less than six months follow-up. DATA COLLECTION AND ANALYSIS: Search results were prescreened by one author and inclusion or exclusion of potentially relevant trials was agreed by two authors. Data was extracted by one author and checked by another.The main outcome measure was abstinence from smoking after at least six months of follow-up. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. We calculated the risk ratio (RR) and 95% confidence interval (CI) for each study. Where appropriate, we performed meta-analysis using a Mantel-Haenszel fixed-effect model. MAIN RESULTS: Fifty-three studies with a total of more than 25,000 participants met the inclusion criteria. A large proportion of studies recruited people in healthcare settings or with specific health needs. Most studies provided NRT. Behavioural support was typically provided by specialists in cessation counselling, who offered between four and eight contact sessions. The planned maximum duration of contact was typically more than 30 minutes but less than 300 minutes. Overall, studies were at low or unclear risk of bias, and findings were not sensitive to the exclusion of any of the six studies rated at high risk of bias in one domain. One large study (the Lung Health Study) contributed heterogeneity due to a substantially larger treatment effect than seen in other studies (RR 3.88, 95% CI 3.35 to 4.50). Since this study used a particularly intensive intervention which included extended availability of nicotine gum, multiple group sessions and long term maintenance and recycling contacts, the results may not be comparable with the interventions used in other studies, and hence it was not pooled in other analyses. Based on the remaining 52 studies (19,488 participants) there was high quality evidence (using GRADE) for a benefit of combined pharmacotherapy and behavioural treatment compared to usual care, brief advice or less intensive behavioural support (RR 1.83, 95% CI 1.68 to 1.98) with moderate statistical heterogeneity (I² = 36%).The pooled estimate for 43 trials that recruited participants in healthcare settings (RR 1.97, 95% CI 1.79 to 2.18) was higher than for eight trials with community-based recruitment (RR 1.53, 95% CI 1.33 to 1.76). Compared to the first version of the review, previous weak evidence of differences in other subgroup analyses has disappeared. We did not detect differences between subgroups defined by motivation to quit, treatment provider, number or duration of support sessions, or take-up of treatment. AUTHORS' CONCLUSIONS: Interventions that combine pharmacotherapy and behavioural support increase smoking cessation success compared to a minimal intervention or usual care. Updating this review with an additional 12 studies (5,000 participants) did not materially change the effect estimate. Although trials differed in the details of their populations and interventions, we did not detect any factors that modified treatment effects apart from the recruitment setting. We did not find evidence from indirect comparisons that offering more intensive behavioural support was associated with larger treatment effects.
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Despite adding nearly 5 more years of research since the previous review, the effect estimates for each pooled comparison have been remarkably stable for at least the past three decades.
“Furthermore, despite adding nearly 5 more years of research since the previous review,[5](#R5),[6](#R6) the effect estimates for each pooled comparison have been remarkably stable for at least the past three decades.”
From Interventions for Tobacco Cessation in Adults, Including Pregnant Persons (2021) · cites this paper as [6]
The review’s “What’s new” section says twelve studies were added in 2016 with “no material change to pooled estimates,” supporting stability since the previous review. Its History section dates that review to 2012, not nearly five years earlier, and does not establish that estimates for each pooled comparison were stable for three decades. (LLM, conf=0.87)
Experimental — accuracy not yet measuredThe pooled risk ratio for smoking abstinence at 6 months or more for combined pharmacotherapy plus behavioral support versus usual care or minimal support control groups was 1.83 (95% CI, 1.68 to 1.98; 52 trials; n=19,488).
“The pooled risk ratio (RR) for smoking abstinence at 6 months or more for combined pharmacotherapy plus behavioral support versus usual care or minimal support control groups was 1.83 (95% confidence interval [CI], 1.68 to 1.98; 52 trials; n=19,488).[58](#R58)”
From Interventions for Tobacco Cessation in Adults, Including Pregnant Persons (2021) · cites this paper as [58]
At the longest follow-up, 15.2% (1529 out of 10070) of participants in the intervention group remained abstinent, compared to 8.6% (808 out of 9418) in the control group.
“At the longest follow‐up, 15.2% (1529 out of 10070) of participants in the intervention group remained abstinent, compared to 8.6% (808 out of 9418) in the control group [40].”
In the general population, interventions that combine pharmacotherapy and behavioral support increase smoking cessation success.
“In the general population, interventions that combine pharmacotherapy and behavioral support increase smoking cessation success.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [188]
A number of studies have demonstrated benefits of combined behavioral therapy and pharmacological cessation aids.
“While a number of studies have demonstrated the benefits of the combined use of behavioral therapy and pharmacological cessation aids (see Fiore et al., 2008; Stead et al., 2016)”
From Hypnotherapy compared to cognitive-behavioral therapy for smoking cessation in a randomized controlled trial (2024) · cites this paper as Stead et al., 2016
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- Authors
- Stead, L. F., Koilpillai, P., Fanshawe, T. R., & Lancaster, T.
- Affiliations
- University of Oxford (GB)
- Dalhousie University (CA)
- ORCID
- Fanshawe, Thomas R
- Venue
- Cochrane Database of Systematic Reviews
- Publisher
- Wiley
- Published
- 2016-03-24
- Volume
- 2016
- Issue
- 3
- Pages
- CD008286-CD008286
- ISSN
- 1361-6137 (ISSN-L)
- 1465-1858
- PMC
- PMC10042551
- OpenAlex
- W2029849221
- Cited by
- 829
- References
- 22
- Citations by year
- 2026: 26 · 2025: 57 · 2024: 75 · 2023: 75 · 2022: 65 · 2021: 79 · 2020: 70 · 2019: 69 · 2018: 73 · 2017: 64 · 2016: 44 · 2015: 48 · 2014: 39 · 2013: 37 · 2012: 6
- FWCI
- 9.77
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Cochrane Database of Systematic Reviews (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Research Portal (King's College London) (submittedVersion)
- Funders
- National Institute on Drug Abuse
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Social Sciences › Psychology › Applied Psychology › Behavioral Health and Interventions
- Keywords
- smoking cessation, nicotine replacement therapy, varenicline, bupropion, nortriptyline, smoking abstinence, treatment effect heterogeneity, risk of bias, healthcare settings, brief advice, demographic factors, treatment intensity
- MeSH terms
- Adult, Behavior Therapy, Combined Modality Therapy, Counseling, Female, Humans, Male, Smoking, Randomized Controlled Trials as Topic, Smoking Cessation, Tobacco Use Cessation Devices
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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