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Additional behavioural support as an adjunct to pharmacotherapy for smoking cessation. BACKGROUND: Pharmacotherapies for smoking cessation increase the likelihood of achieving abstinence in a quit attempt. It is plausible that providing support, or, if support is offered, offering more intensive support or support including particular components may increase abstinence further. OBJECTIVES: To evaluate the effect of adding or increasing the intensity of behavioural support for people using smoking cessation medications, and to assess whether there are different effects depending on the type of pharmacotherapy, or the amount of support in each condition. We also looked at studies which directly compare behavioural interventions matched for contact time, where pharmacotherapy is provided to both groups (e.g. tests of different components or approaches to behavioural support as an adjunct to pharmacotherapy). SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group Specialised Register, clinicaltrials.gov, and the ICTRP in June 2018 for records with any mention of pharmacotherapy, including any type of nicotine replacement therapy (NRT), bupropion, nortriptyline or varenicline, that evaluated the addition of personal support or compared two or more intensities of behavioural support. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials in which all participants received pharmacotherapy for smoking cessation and conditions differed by the amount or type of behavioural support. The intervention condition had to involve person-to-person contact (defined as face-to-face or telephone). The control condition could receive less intensive personal contact, a different type of personal contact, written information, or no behavioural support at all. We excluded trials recruiting only pregnant women and trials which did not set out to assess smoking cessation at six months or longer. DATA COLLECTION AND ANALYSIS: For this update, screening and data extraction followed standard Cochrane methods. 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 random-effects model. MAIN RESULTS: Eighty-three studies, 36 of which were new to this update, met the inclusion criteria, representing 29,536 participants. Overall, we judged 16 studies to be at low risk of bias and 21 studies to be at high risk of bias. All other studies were judged to be at unclear risk of bias. Results were not sensitive to the exclusion of studies at high risk of bias. We pooled all studies comparing more versus less support in the main analysis. Findings demonstrated a benefit of behavioural support in addition to pharmacotherapy. When all studies of additional behavioural therapy were pooled, there was evidence of a statistically significant benefit from additional support (RR 1.15, 95% CI 1.08 to 1.22, I² = 8%, 65 studies, n = 23,331) for abstinence at longest follow-up, and this effect was not different when we compared subgroups by type of pharmacotherapy or intensity of contact. This effect was similar in the subgroup of eight studies in which the control group received no behavioural support (RR 1.20, 95% CI 1.02 to 1.43, I² = 20%, n = 4,018). Seventeen studies compared interventions matched for contact time but that differed in terms of the behavioural components or approaches employed. Of the 15 comparisons, all had small numbers of participants and events. Only one detected a statistically significant effect, favouring a health education approach (which the authors described as standard counselling containing information and advice) over motivational interviewing approach (RR 0.56, 95% CI 0.33 to 0.94, n = 378). AUTHORS' CONCLUSIONS: There is high-certainty evidence that providing behavioural support in person or via telephone for people using pharmacotherapy to stop smoking increases quit rates. Increasing the amount of behavioural support is likely to increase the chance of success by about 10% to 20%, based on a pooled estimate from 65 trials. Subgroup analysis suggests that the incremental benefit from more support is similar over a range of levels of baseline support. More research is needed to assess the effectiveness of specific components that comprise behavioural support.

Additional behavioural support as an adjunct to pharmacotherapy for smoking cessation. BACKGROUND: Effective pharmacotherapies are available to help people who are trying to stop smoking, but quitting can still be difficult and providing higher levels of behavioural support may increase success rates further. OBJECTIVES: To evaluate the effect of increasing the intensity of behavioural support for people using smoking cessation medications, and to assess whether there are different effects depending on the type of pharmacotherapy, or the amount of support in each condition. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group Specialised Register in May 2015 for records with any mention of pharmacotherapy, including any type of nicotine replacement therapy (NRT), bupropion, nortriptyline or varenicline that evaluated the addition of personal support or compared two or more intensities of behavioural support. SELECTION CRITERIA: Randomized or quasi-randomized controlled trials in which all participants received pharmacotherapy for smoking cessation and conditions differed by the amount of behavioural support. The intervention condition had to involve person-to-person contact. The control condition could receive less intensive personal contact, or just written information. We did not include studies that used a contact-matched control to evaluate differences between types or components of 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: One author prescreened search results and two authors agreed inclusion or exclusion of potentially relevant trials. One author extracted data and another checked them.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: Forty-seven studies met the inclusion criteria with over 18,000 participants in the relevant arms. There was little evidence of statistical heterogeneity (I² = 18%) so we pooled all studies in the main analysis. There was evidence of a small but statistically significant benefit from more intensive support (RR 1.17, 95% CI 1.11 to 1.24) for abstinence at longest follow-up. All but four of the included studies provided four or more sessions of support to the intervention group. Most trials used NRT. We did not detect significant effects for studies where the pharmacotherapy was nortriptyline (two trials) or varenicline (one trial), but this reflects the absence of evidence.In subgroup analyses, studies that provided at least four sessions of personal contact for the intervention and no personal contact for the control had slightly larger estimated effects (RR 1.25, 95% CI 1.08 to 1.45; 6 trials, 3762 participants), although a formal test for subgroup differences was not significant. Studies where all intervention counselling was via telephone (RR 1.28, 95% CI 1.17 to 1.41; 6 trials, 5311 participants) also had slightly larger effects, and the test for subgroup differences was significant, but this subgroup analysis was not prespecified. In this update, the benefit of providing additional behavioural support was similar for the subgroup of trials in which all participants, including controls, had at least 30 minutes of personal contact (RR 1.18, 95% CI 1.06 to 1.32; 21 trials, 5166 participants); previously the evidence of benefit in this subgroup had been weaker. This subgroup was not prespecified and a test for subgroup differences was not significant. We judged the quality of the evidence to be high, using the GRADE approach. We judged a small number of trials to be at high risk of bias on one or more domains, but findings were not sensitive to their exclusion. AUTHORS' CONCLUSIONS: Providing behavioural support in person or via telephone for people using pharmacotherapy to stop smoking has a small but important effect. Increasing the amount of behavioural support is likely to increase the chance of success by about 10% to 25%, based on a pooled estimate from 47 trials. Subgroup analysis suggests that the incremental benefit from more support is similar over a range of levels of baseline support.