Search

Background Reducing obesity prevalence among marginalised subgroups with disproportionately high obesity rates is challenging. Given the promise of incentives and group-based programmes we trialled a culturally tailored, team-based weight-loss competition with New Zealand Māori (Indigenous) and Pacific Island people. Methods A quasi-experimental 12-months trial was designed. The intervention consisted of three six-months competitions, each with seven teams of seven members. Eligible participants were aged 16 years and older, with a BMI ≥30 kg/m2 and being at risk of or already diagnosed with type-2 diabetes or cardiovascular disease. Height, weight and waist circumference were measured at baseline, 6 and 12 months. Results Recruitment of a control group (n = 29) versus the intervention (n = 132) was poor and retention rates were low (52 and 27% of intervention participants were followed-up at six and 12 months, respectively). Thus, analysis of the primary outcome of individual percentage weight loss was restricted to the 6-months follow-up data. Although not significant, the intervention group appeared to lose more weight than the control group, in both the intention to treat and complete-case analyses. Conclusions The intervention promoted some behaviour change in eating behaviours, and a resulting trend toward a reduction in waist circumference. Trial registration ACTRN12617000871347 Registered 15/6/2017 Retrospectively registered.

Background Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol formed by heating an e‐liquid. Some people who smoke use ECs to stop or reduce smoking, but some organizations, advocacy groups and policymakers have discouraged this, citing lack of evidence of efficacy and safety. People who smoke, healthcare providers and regulators want to know if ECs can help people quit and if they are safe to use for this purpose. This is an update conducted as part of a living systematic review. Objectives To examine the effectiveness, tolerability, and safety of using electronic cigarettes (ECs) to help people who smoke tobacco achieve long‐term smoking abstinence. Search methods We searched the Cochrane Tobacco Addiction Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO to 1 May 2021, and reference‐checked and contacted study authors. We screened abstracts from the Society for Research on Nicotine and Tobacco (SRNT) 2021 Annual Meeting. Selection criteria We included randomized controlled trials (RCTs) and randomized cross‐over trials, in which people who smoke were randomized to an EC or control condition. We also included uncontrolled intervention studies in which all participants received an EC intervention. Studies had to report abstinence from cigarettes at six months or longer or data on safety markers at one week or longer, or both. Data collection and analysis We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking after at least six months follow‐up, adverse events (AEs), and serious adverse events (SAEs). Secondary outcomes included the proportion of people still using study product (EC or pharmacotherapy) at six or more months after randomization or starting EC use, changes in carbon monoxide (CO), blood pressure (BP), heart rate, arterial oxygen saturation, lung function, and levels of carcinogens or toxicants or both. We used a fixed‐effect Mantel‐Haenszel model to calculate risk ratios (RRs) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data in meta‐analyses. Main results We included 61 completed studies, representing 16,759 participants, of which 34 were RCTs. Five of the 61 included studies were new to this review update. Of the included studies, we rated seven (all contributing to our main comparisons) at low risk of bias overall, 42 at high risk overall (including all non‐randomized studies), and the remainder at unclear risk. There was moderate‐certainty evidence, limited by imprecision, that quit rates were higher in people randomized to nicotine EC than in those randomized to nicotine replacement therapy (NRT) (risk ratio (RR) 1.53, 95% confidence interval (CI) 1.21 to 1.93; I2 = 0%; 4 studies, 1924 participants). In absolute terms, this might translate to an additional three quitters per 100 (95% CI 1 to 6). There was low‐certainty evidence (limited by very serious imprecision) that the rate of occurrence of AEs was similar (RR 0.98, 95% CI 0.80 to 1.19; I2 = 0%; 2 studies, 485 participants). SAEs were rare, but there was insufficient evidence to determine whether rates differed between groups due to very serious imprecision (RR 1.44, 95% CI 0.94 to 2.19: I2 = 0; 3 studies, 1183 participants). There was moderate‐certainty evidence, again limited by imprecision, that quit rates were higher in people randomized to nicotine EC than to non‐nicotine EC (RR 1.94, 95% CI 1.21 to 3.13; I2 = 0%; 5 studies, 1447 participants). In absolute terms, this might lead to an additional seven quitters per 100 (95% CI 2 to 16). There was moderate‐certainty evidence of no difference in the rate of AEs between these groups (RR 1.01, 95% CI 0.91 to 1.11; I2 = 0%; 3 studies, 601 participants). There was insufficient evidence to determine whether rates of SAEs differed between groups, due to very serious imprecision (RR 0.95, 95% CI 0.52 to 1.72; I2 = 0; 6 studies, 1033 participants). Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.61, 95% CI 1.44 to 4.74; I2 = 0%; 6 studies, 2886 participants). In absolute terms this represents an additional six quitters per 100 (95% CI 2 to 15). However, this finding was of very low certainty, due to issues with imprecision and risk of bias. There was some evidence that non‐serious AEs were more common in people randomized to nicotine EC (RR 1.22, 95% CI 1.12 to 1.32; I2 = 41%, low certainty; 4 studies, 765 participants), and again, insufficient evidence to determine whether rates of SAEs differed between groups (RR 1.51, 95% CI 0.70 to 3.24; I2 = 0%; 7 studies, 1303 participants). Data from non‐randomized studies were consistent with RCT data. The most commonly reported AEs were throat/mouth irritation, headache, cough, and nausea, which tended to dissipate with continued use. Very few studies reported data on other outcomes or comparisons, hence evidence for these is limited, with CIs often encompassing clinically significant harm and benefit. Authors' conclusions There is moderate‐certainty evidence that ECs with nicotine increase quit rates compared to NRT and compared to ECs without nicotine. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain. More studies are needed to confirm the effect size. Confidence intervals were for the most part wide for data on AEs, SAEs and other safety markers, with no difference in AEs between nicotine and non‐nicotine ECs. Overall incidence of SAEs was low across all study arms. We did not detect evidence of harm from nicotine EC, but longest follow‐up was two years and the number of studies was small. The main limitation of the evidence base remains imprecision due to the small number of RCTs, often with low event rates, but further RCTs are underway. To ensure the review continues to provide up‐to‐date information to decision‐makers, this review is now a living systematic review. We run searches monthly, with the review updated when relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.

BACKGROUND AND AIMS The majority of smokers accessing the current best treatments continue to smoke. We aimed to test if e-cigarettes (EC) compared with nicotine replacement treatment (NRT) can help such smokers to reduce smoking. DESIGN Randomized controlled trial of EC (n = 68) versus NRT (n = 67) with 6-month follow-up. SETTING Stop smoking service in London, UK. PARTICIPANTS A total of 135 smokers (median age = 40 years, 51% male) previously unable to stop smoking with conventional treatments. INTERVENTIONS Participants received either NRT of their choice (8-week supply) or an EC starter pack and instructions to purchase further e-liquids of strength and flavours of their choice themselves. Products were accompanied by minimal behavioural support. MEASUREMENTS Participants who reported that they stopped smoking or reduced their daily cigarette consumption by at least 50% at 6-month follow-up were invited to provide a carbon monoxide (CO) reading. The primary outcome was biochemically validated reduction in smoke intake of at least 50% at 6 months and the main secondary outcome was sustained validated abstinence at 6 months. Drop-outs were included as 'non-reducers'. FINDINGS Validated smoking reduction (including cessation) was achieved by 26.5 versus 6.0% of participants in the EC and NRT study arms, respectively [relative risk (RR) = 4.4, P = 0.005, 95% confidence interval (CI) = 1.6-12.4]. Sustained validated abstinence rates at 6 months were 19.1 versus 3.0% (RR = 6.4, P = 0.01, 95% CI = 1.5-27.3). Product use was high and equal in both study arms initially, but at 6 months allocated product use was 47% in the EC arm versus 10% in the NRT arm (χ2(1) = 22.0, P

Introduction This study estimates the extent to which individuals’ smoking cessation and relapse patterns are associated with the smoking behavior of their household members. Aims and Methods Longitudinal data on household members’ smoking behavior was sourced from a representative sample of 12 723 Australians who ever reported smoking between 2001 and 2019. Controlling for a rich set of confounders, multivariate regression analyses were used to predict the likelihood of smoking cessation and relapse given other household members’ smoking status and their relationship type. The models were then used to forecast smoking prevalence over 10 years across different household types. Results Individuals living with a smoking spouse were less likely to quit (OR 0.77 [95% CI 0.72;0.83]) and more likely to relapse (OR 1.47 [95% CI 1.28;1.69]) compared to those living with nonsmoking spouses. Subsequently, the proportion of smokers living with other smoking household members increased by 15% between 2011 and 2019. A 10-year forecast using the smoking cessation and relapse models predicts that, on average, smokers living with nonsmokers will reduce by 43%, while those living alone or with a smoking partner will only reduce by 26% and 28% respectively. Conclusions Over time, those who are still smoking are more likely to live with other smokers. Therefore, the current cohort of smokers is increasingly less likely to quit and more likely to relapse. Smoking projection models that fail to account for this dynamic risk may overstate the downstream health benefits and health cost savings. Interventions that encourage smoking cessation at the household level, particularly for spouses, may assist individuals to quit and abstain from smoking. Implications The current and future paradigm shift in the smoking environment suggests that smoking cessation and relapse prevention policies should consider household structure. Policies designed to affect smoking at the household level are likely to be particularly effective. When estimating the long-term benefits of current smoking policies intrahousehold smoking behavior needs to be considered.

Introduction Digital health programmes not only complement existing services, but have the potential to reach populations that existing services are not reaching. Many of these services require people to opt-in to receive them, which presents significant barriers to access. An alternative is to make low-risk digital services opt-out, ensuring appropriate members of the target audience are signed up for a service unless they select to not receive it. Aim This study aimed to investigate how changing enrolment in a low-risk digital health programme from opt-in to opt-out would impact on enrolment and dropout rates. Methods This study involved the retrospective analysis of registration data from txtpēpi, a maternal and child health text-message programme. System-recorded data from enrolments during a 12-month period were obtained. In the first 6 months, users had to opt-in to the service (Period 1), but in the following 6 months, an opt-out process was implemented (Period 2). Results There was a 77% increase in enrolments in Period 2 (n = 113) compared to Period 1 (n = 64) and no significant change in the proportion of enrolments of Māori between time periods (P = 0.508). There was no significant difference in withdrawal rates between time periods at either 2 weeks (5% vs 6%, P = 0.676) or 1 month (9% vs 9%, P = 0.907). Discussion This study has shown switching from an opt-in to an opt-out option resulted in an increase in enrolments in an mHealth programme, but had no impact on withdrawals. This indicates that employing opt-out enrolment for low-risk evidence-based interventions is acceptable and a potential way to make these services more accessible.

Introduction Varenicline and combination nicotine replacement treatment (cNRT) have been recommended as the most effective pharmacotherapies, with equal abstinence rate for smoking cessation in a network meta-analysis of randomized trials, but data from real-world long-term follow-up studies are rare. This study aimed to compare the 12-month sustained abstinence rates of smokers using varenicline versus cNRT in their quit attempt. Methods A total of 3569 smokers were recruited via the Department of Family Medicine outpatient department at Kaohsiung Veteran General Hospital between June 2013 and March 2019. Participants received counseling from a physician and chose either varenicline (N = 2870) or cNRT (N = 699) for smoking cessation. Both varenicline and cNRT users could receive a free 8-week supply and eight clinic visits over 90 days. Participants were followed-up by telephone at 12, 24, and 52 weeks from first visit. The primary outcome measure of the study was self-reported sustained abstinence up to 52 weeks. Results Varenicline users had a significantly higher sustained abstinence rate at weeks 12–52, adjusted for baseline variables (15.2% vs 10.3%, p = .001; adjusted odds ratio = 1.47, 95% confidence interval: 1.05–2.05). Other significant predictors of 52 weeks sustained abstinence were being male, having a higher income, attending more clinical visits, and have lower nicotine dependence. Conclusion Varenicline appears to have higher sustained abstinence rates to 52 weeks compared with cNRT, in a smoking cessation clinic where smokers can choose their medication option. Implications Network meta-analysis of randomized trials suggests that varenicline and cNRT are similarly effective for smoking cessation. This study shows that 1-year sustained abstinence rates were significantly higher among smokers using varenicline, compared with smokers using cNRT, when used as part of a structured smoking cessation program. These findings are highly relevant to policy makers and service providers to help determine provision of smoking cessation treatment.

Background Relapse remains an unresolved issue in smoking cessation. Extended stop smoking medication use can help, but uptake is low and several behavioural relapse prevention interventions have been found to be ineffective. However, opportunistic ‘emergency’ use of fast-acting nicotine replacement treatment or electronic cigarettes may be more attractive and effective, and an online behavioural Structured Planning and Prompting Protocol has shown promise. The present trial aimed to evaluate the clinical effectiveness and cost-effectiveness of these two interventions. Design A randomised controlled trial. Setting English stop smoking services and Australian quitlines, Australian social media and St Vincent’s Hospital Melbourne, Fitzroy, VIC. Participants Ex-smokers abstinent for at least 4 weeks, with some participants in Australia also recruited from 1 week post quit date. The planned sample size was 1400, but the trial was curtailed when 235 participants were recruited. Interventions Participants were randomised in permuted blocks of random sizes to (1) oral nicotine replacement treatment/electronic cigarettes to use if at risk of relapse, plus static text messages (n = 60), (2) the Structured Planning and Prompting Protocol and interactive text messages (n = 57), (3) oral nicotine replacement treatment/electronic cigarettes plus the Structured Planning and Prompting Protocol with interactive text messages (n = 58) or (4) usual care plus static text messages (n = 59). Outcome measures Owing to delays in study set-up and recruitment issues, the study was curtailed and the primary outcome was revised. The original objective was to determine whether or not the two interventions, together or separately, reduced relapse rates at 12 months compared with usual care. The revised primary objective was to determine whether or not number of interventions received (i.e. none, one or two) affects relapse rate at 6 months (not biochemically validated because of study curtailment). Relapse was defined as smoking on at least 7 consecutive days, or any smoking in the last month at final follow-up for both the original and curtailed outcomes. Participants with missing outcome data were included as smokers. Secondary outcomes included sustained abstinence (i.e. no more than five cigarettes smoked over the 6 months), nicotine product preferences (e.g. electronic cigarettes or nicotine replacement treatment) and Structured Planning and Prompting Protocol coping strategies used. Two substudies assessed reactions to interventions quantitatively and qualitatively. The trial statistician remained blinded until analysis was complete. Results The 6-month relapse rates were 60.0%, 43.5% and 49.2% in the usual-care arm, one-intervention arm and the two-intervention arm, respectively (p = 0.11). Sustained abstinence rates were 41.7%, 54.8% and 50.9%, respectively (p = 0.17). Electronic cigarettes were chosen more frequently than nicotine replacement treatment in Australia (71.1% vs. 29.0%; p = 0.001), but not in England (54.0% vs. 46.0%; p = 0.57). Of participants allocated to nicotine products, 23.1% were using them daily at 6 months. The online intervention received positive ratings from 63% of participants at 6 months, but the majority of participants (72%) completed one assessment only. Coping strategies taught in the Structured Planning and Prompting Protocol were used with similar frequency in all study arms, suggesting that these are strategies people had already acquired. Only one participant used the interactive texting, and interactive and static messages received virtually identical ratings. Limitations The inability to recruit sufficient participants resulted in a lack of power to detect clinically relevant differences. Self-reported abstinence was not biochemically validated in the curtailed trial, and the ecological momentary assessment substudy was perceived by some as an intervention. Conclusions Recruiting recent ex-smokers into an interventional study proved problematic. Both interventions were well received and safe. Combining the interventions did not surpass the effects of each intervention alone. There was a trend in favour of single interventions reducing relapse, but it did not reach significance and there are reasons to interpret the trend with caution. Future work Further studies of both interventions are warranted, using simpler study designs. Trial registration Current Controlled Trials ISRCTN11111428. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 68. See the NIHR Journals Library website for further project information. Funding was also provided by the National Health and Medical Research Council, Canberra, ACT, Australia (NHMRC APP1095880). Public Health England provided the funds to purchase the nicotine products in England.

AimsTo examine the association between household members and their tobacco smoking behaviour on patterns of smoking cessation and relapse.Design and participantsData was sourced from 19 waves (years 2001 to 2019) of the nationally representative Household Income and Labour Dynamics in Australia (HILDA) survey, with all household members 15 years or older completing the survey annually. The final sample included, on average, 3,056 ex-smokers and 2,612 smokers per wave.MeasurementsSelf-reported annual smoking status was used to construct measures of smoking cessation and relapse. Information on household structure and relationships was then used to develop variables describing the presence of household members and their smoking status by relationship to the individual (i.e., child, parent, spouse, sibling, or other). Multivariate regression analyses were then used to predict the likelihood of smoking cessation and relapse controlling for the presence of other household members and their smoking status, sociodemographic characteristics, number of cigarettes smoked per day, previous quit attempts, and years abstained from smoking.FindingsIndividuals that lived with non-smokers were more likely to quit [OR1.22 (95%CI 1.11;1.34)] relative to those living alone. However, this favourable association was negated if living with another smoker, which was associated with a reduced likelihood of smoking cessation [OR0.77 (95%CI 0.72;0.83)] and a higher likelihood of relapse [1.37 (95%CI 1.22;1.53)]. In particular, living with a spouse or parent that smoked reduced the likelihood of smoking cessation [OR0.71 (95%CI 0.65;0.78) and OR0.71 (95%CI 0.59;0.84), respectively] and increased the likelihood of relapse [OR1.47 (95%CI 1.28;1.69) and OR1.39 (95%CI 1.00;1.94) respectively] relative to living with their non-smoking counterparts.ConclusionsHousehold composition and intrahousehold smoking behaviour should be considered when delivering, or estimating the benefits of, smoking cessation interventions. Interventions which encourage smoking cessation at the household level may assist individuals to quit and abstain from smoking.

Nicotine replacement therapy, in the form of nicotine patches, is commonly offered to pregnant women who smoke to help them to stop smoking, but this approach has limited efficacy in this population. Electronic cigarettes (e-cigarettes) are also used by pregnant women who smoke but their safety and efficacy in pregnancy are unknown. Here, we report the results of a randomized controlled trial in 1,140 participants comparing refillable e-cigarettes with nicotine patches. Pregnant women who smoked were randomized to e-cigarettes (n = 569) or nicotine patches (n = 571). In the unadjusted analysis of the primary outcome, validated prolonged quit rates at the end of pregnancy in the two study arms were not significantly different (6.8% versus 4.4% in the e-cigarette and patch arms, respectively; relative risk (RR) = 1.55, 95%CI: 0.95–2.53, P = 0.08). However, some participants in the nicotine patch group also used e-cigarettes during the study. In a pre-specified sensitivity analysis excluding abstinent participants who used non-allocated products, e-cigarettes were more effective than patches (6.8% versus 3.6%; RR = 1.93, 95%CI: 1.14–3.26, P = 0.02). Safety outcomes included adverse events and maternal and birth outcomes. The safety profile was found to be similar for both study products, however, low birthweight (P = 0.01). Other adverse events and birth outcomes were similar in the two study arms. E-cigarettes might help women who are pregnant to stop smoking, and their safety for use in pregnancy is similar to that of nicotine patches. ISRCTN62025374.

Aim To evaluate the cost-effectiveness of e-cigarettes as a smoking cessation aid used in routine stop smoking service. Design Cost-effectiveness analysis was performed from the National Health Service (NHS) and Personal Social Services (PSS) perspective for 12 months period and lifetime. Costs, including that of both treatments, other smoking cessation help and healthcare services, and health benefits, estimated from EQ-5D-5L and measured in Quality-adjusted Life years (QALYs), for the 12-month analysis came from a randomised controlled trial. Lifetime analysis was model-based with input from both trial data and published secondary data sources. Cost-effectiveness was measured by an incremental cost-effectiveness ratio (ICER). Setting Three English Stop-Smoking Service sites in England Participants Adult smokers who sought help to quit in the participating sites Intervention and comparator An e-cigarette (EC) starter kit versus provision of nicotine replacement therapy (NRT) for up to three months, both with standard behavioural support. A total of 886 participants were randomised (439 in EC arm, 447 in NRT arm). Excluding one death in each arm, the one-year quit rate was 18.0% and 9.9%, respectively. Measurements Cost of treatments was estimated from treatment log. Costs of other smoking cessation help and healthcare services, and EQ-5D-5L were collected at baseline, six- and 12-month follow-ups. Incremental costs and incremental QALYs were estimated using regression adjusting for baseline covariates and their respective baseline values. Findings The ICER was £1,100 per QALY gained at the 12 months after quit date (87% - 90% probability of cost-effective between £20,000/QALY and £30,000/QALY). Markov model estimated the lifetime ICER of EC to be £65 per QALY (around 85% probability of cost-effective between £20,000/QALY and £30,000/QALY). Conclusion Using e-cigarette as a smoking cessation aid with standard behavioural support in an English Stop-Smoking Service is more cost-effective than using nicotine replacement therapy in the same setting.

Highlights • Between 16% and 23% of pregnant smokers and ex-smokers vape during pregnancy. • Most pregnant vapers also continue to smoke (dual use). • Vaping habits of exclusive vapers is stable during pregnancy and the postpartum. • A third of dual users in early pregnancy are exclusively smoking in the postpartum., Introduction There is limited information about longitudinal patterns of vaping during pregnancy and the postpartum. We describe the prevalence, frequency, and reasons for vaping throughout pregnancy and postpartum. We also describe temporal patterns in pregnant women’s vaping. Methods A longitudinal cohort study across England and Scotland, with questionnaires in early pregnancy (8–24 weeks gestation), late pregnancy (34–38 weeks) and 3 months postpartum. A total of 750 women, aged 16 years or over, who were either current smokers, vapers or had smoked in the 3 months before pregnancy, were recruited between June and November 2017. Results Vaping prevalence was 15.9% (n = 119/750) in early pregnancy: 12.4% (n = 93/750) were dual users and 3.5% (n = 26/750) exclusive vapers. Late pregnancy vaping prevalence was 17.8% (n = 68/383): 12.5% (n = 48/383) were dual users and 5.2% (n = 20/383) exclusive vapers. Postpartum vaping prevalence was 23.1% (n = 95/411): 14.6% (n = 60/411) were dual users and 8.5% (n = 35/411) exclusive vapers. The most frequently reported reason to vape among all vapers was to quit smoking. A total of 316 women completed all three surveys: 2.6% (n = 8/316) were exclusive vapers in early pregnancy with most remaining exclusive vapers postpartum (n = 6/8, 75%). Of the 11.5% (n = 35/316) dual users in early pregnancy, 31.4% (n = 11/35) were exclusive smokers by the postpartum. Conclusion Vaping prevalence was between 15.9% and 23.1% during pregnancy and the postpartum period, and the majority were dual users. Vaping habits of exclusive vapers remains stable throughout pregnancy and the postpartum. However, the vaping habits of dual users varies, with a third exclusively smoking in the postpartum.

Importance Cytisine is more effective than placebo and nicotine replacement therapy for smoking cessation. However, cytisine has not been tested against the most effective smoking cessation medication, varenicline, which is associated with adverse events known to lead to discontinuation of therapy. Objective To examine whether standard cytisine treatment (25 days) was at least as effective as standard varenicline treatment (84 days) for smoking cessation. Design, Setting, and Participants This noninferiority, open-label randomized clinical trial with allocation concealment and blinded outcome assessment was undertaken in Australia from November 2017 through May 2019; follow-up was completed in January 2020. A total of 1452 Australian adult daily smokers willing to make a quit attempt were included. Data collection was conducted primarily by computer-assisted telephone interview, but there was an in-person visit to validate the primary outcome. Interventions Treatments were provided in accordance with the manufacturers’ recommended dosage: cytisine (n = 725), 1.5-mg capsules taken 6 times daily initially then gradually reduced over the 25-day course; varenicline (n = 727), 0.5-mg tablets titrated to 1 mg twice daily for 84 days (12 weeks). All participants were offered referral to standard telephone behavioral support. Main Outcomes and Measures The primary outcome was 6-month continuous abstinence verified using a carbon monoxide breath test at 7-month follow-up. The noninferiority margin was set at 5% and the 1-sided significance threshold was set at .025. Results Among 1452 participants who were randomized (mean [SD] age, 42.9 [12.7] years; 742 [51.1%] women), 1108 (76.3%) completed the trial. Verified 6-month continuous abstinence rates were 11.7% for the cytisine group and 13.3% for the varenicline group (risk difference, −1.62% [1-sided 97.5% CI, −5.02% to ∞];P = .03 for noninferiority). Self-reported adverse events occurred less frequently in the cytisine group (997 events among 482 participants) compared with the varenicline group (1206 events among 510 participants) and the incident rate ratio was 0.88 (95% CI, 0.81 to 0.95;P = .002). Conclusions and Relevance Among daily smokers willing to quit, cytisine treatment for 25 days, compared with varenicline treatment for 84 days, failed to demonstrate noninferiority regarding smoking cessation. Trial Registration anzctr.org.au Identifier:ACTRN12616001654448

ObjectivesPeople suffering from mental health disorder (MHDs) are often under-represented in clinical research though the reasons for their exclusion are rarely recorded. As they have higher rates of smoking and nicotine dependence, it is crucial that they are adequately represented in clinical trials of established pharmacotherapy interventions for smoking cessation. This review aims to examine the practice of excluding smokers with MHDs and reasons for such exclusion in clinical trials evaluating pharmacotherapy treatments for smoking cessation.Data sourceThe Cochrane database of systematic reviews was searched until September 2020 for reviews on smoking cessation using pharmacotherapies.Study selectionRandomised controlled trials (RCTs) within the selected Cochrane reviews were included.Data extractionConducted by one author and independently verified by three authors.Data synthesisWe included 279 RCTs from 13 Cochrane reviews. Of all studies, 51 (18.3%) explicitly excluded participants with any MHDs, 152 (54.5%) conditionally excluded based on certain MHD criteria and 76 (27.2%) provided insufficient information to ascertain either inclusion or exclusion. Studies of antidepressant medications used for smoking cessation were found to be 3.33 times more likely (95% CI 1.38 to 8.01, p=0.007) to conditionally exclude smokers with MHDs than explicitly exclude compared with studies of nicotine replacement therapy.ConclusionSmokers with MHDs are not sufficiently represented in RCTs examining the safety and effectiveness of smoking cessation medications. Greater access to clinical trial participation needs to be facilitated for this group to better address access to appropriate pharmacotherapeutic interventions in this vulnerable population.

Objective The 5:2 diet is a popular intermittent energy restriction method of weight management that awaits further evaluation. We compared the effects of one-off 5:2 instructions with the effects of one-off standard multicomponent weight-management advice; and also examined whether additional behavioural support enhances 5:2 adherence and efficacy compared to one-off instructions. Methods Three hundred adults with obesity were randomised to receive a Standard Brief Advice (SBA) covering diet and physical activity (N = 100); 5:2 self-help instructions (5:2SH) (N = 100); or 5:2SH plus six once-weekly group support sessions (N = 100). Participants were followed up for one year. Results Adherence to 5:2SH was initially high (74% at 6 weeks), but it declined over time (31% at 6 months and 22% at one year). 5:2SH and SBA achieved similar weight-loss at six months (-1.8kg (SD = 3.5) vs -1.7kg (SD = 4.4); b = 0.23, 95%CI:-0.79–1.27, p = 0.7) and at one year (-1.9kg (SD = 4.9) vs -1.8kg (SD = 5.7), b = 0.20, 95%CI:-1.21–1.60, p = 0.79), with 18% vs 15% participants losing ≥5% of their body weight with 5:2SH and SBA, respectively at one year (RR = 0.83, 95%CI:0.44–1.54, p = 0.55). Both interventions received positive ratings, but 5:2SH ratings were significantly higher. 5:2SH had no negative effect on fat and fiber intake and physical activity compared to SBA. Compared to 5:2SH, 5:2G generated a greater weight loss at 6 weeks (-2.3kg vs -1.5kg; b = 0.74, 95%CI:1.37–0.11, p = 0.02), but by one year, the difference was no longer significant (-2.6kg vs -1.9kg, p = 0.37; ≥5% body weight loss 28% vs 18%, p = 0.10). Conclusions Simple 5:2 advice and multicomponent weight management advice generated similar modest results. The 5:2 diet did not undermine other health behaviours, and it received more favourable ratings. Adding initial group support enhanced 5:2 adherence and effects, but the impact diminished over time. Health professionals who provide brief weight management advice may consider including the 5:2 advice as an option. Trial registration ISRCTN registry (ISRCTN79408248).

This narrative review provides a summary of the impact of tobacco smoking on the respiratory system and the benefits of smoking cessation. Tobacco smoking is one of the leading preventable causes of death world-wide and a major risk factor for lung cancer and chronic obstructive pulmonary disease. Smoking is also associated with an increased risk of respiratory infections and appears to be related to poorer outcomes among those with COVID-19. Non-smokers with second-hand smoke exposure also experience significant adverse respiratory effects. Smoking imposes enormous health- and non-health-related costs to societies. The benefits of smoking cessation, in both prevention and management of respiratory disease, have been known for decades and, to this day, cessation support remains one of the most important cost-effective interventions that health professionals can provide to people who smoke. Cessation at any age confers substantial health benefits, even in smokers with established morbidities. As other treatments for chronic respiratory disease advance and survival rates increase, smoking cessation treatment will become even more relevant. While smoking cessation interventions are available, the offer of these by clinicians and uptake by patients remain limited.

OBJECTIVE To estimate prevalence of vaping in pregnancy. Compare characteristics and attitudes between exclusive smokers and vapers, and between exclusive vapers and dual users (smoke and vape). DESIGN Cross-sectional survey. SETTING Hospitals across England and Scotland. POPULATION Pregnant women attending antenatal clinics in 2017. METHODS Women at 8-24 weeks' gestation completed screening questions about their smoking and vaping. Current or recent ex-smokers and/or vapers completed a full detailed survey about vaping and smoking. MAIN OUTCOME MEASURES The prevalence of vaping, characteristics and attitudes of women who vape and/or smoke. RESULTS Of 3360 pregnant women who completed screening questions, 515 (15.3%, 95% CI 14.1-16.6) were exclusive smokers, 44 (1.3%, 95% CI 1.0-1.8) exclusive vapers and 118 (3.5%, 95% CI 2.9-4.2) dual users. In total, 867 (25.8%) women completed the full survey; compared with smokers (n = 434), vapers (n = 140) were more likely to hold higher educational qualifications (odds ratio [OR) 1.51, 95% CI 1.01-2.25). Compared with exclusive vapers (n = 33), dual users (n = 107) were younger (OR 0.91 95% CI 0.85-0.98) and less likely to hold high qualifications (OR 0.43, 95% CI 0.20-0.96). Compared with smokers, dual users were more likely to be planning to quit smoking (OR 2.27, 95% CI 1.24-4.18). Compared with smokers, vapers were more likely to think vaping was safer than smoking (78.6% versus 36.4%). CONCLUSIONS One in 20 pregnant women report vaping, and most also smoke. Dual users are more motivated towards stopping smoking than smokers. Where women have tried but cannot stop smoking, clinicians could encourage them to consider vaping for smoking cessation. TWEETABLE EXTRACT One in 20 women report vaping during pregnancy but of those that do vape, most also smoke, despite having intentions to quit.

To examine factors associated with Quitline and pharmacotherapy utilisation in low socioeconomic status (low-SES) smokers enrolled in a smoking cessation trial.Baseline data was used from a large-scale smoking cessation randomised controlled trial (RCT). Logistic regression models were used to examine predictors of treatment utilisation prior to entering the RCT and perceived effectiveness of past and future use.A total of 1047 smokers consented and prior to enrolment 92% had previously tried to quit smoking, 86% had ever used quit support, 83% had used pharmacotherapy at least once and 38% had ever utilised Quitline. For those who had used pharmacotherapies, 71% used NRT, of which 21% had used dual NRT products. In the last 12-months, 27% utilised Quitline and 50% utilised NRT. Ever use of Quitline was negatively associated with self-efficacy to quit (OR: 0.80; 95% CI: 0.68, 0.94 p .01) and positively associated with being diagnosed with a mental health condition (OR: 1.50; 95% CI: 1.01, 2.25 p .05). Recent use of NRT was positively associated with mental health condition (OR: 1.39; 95% CI: 1.02, 1.90 p .05) and negatively associated with alcohol consumption (OR: 0.69; 95% CI: 0.52, 0.92 p .01).Past use of Quitline and pharmacotherapy treatment was associated with self-efficacy to quit, sociodemographic variables, mental health conditions and alcohol consumption. Community-based strategies that target smoking, mental health and drug and alcohol problems may overcome some of the barriers that prevent low-SES populations from engaging with smoking cessation support.

Recent evidence suggests that e-cigarette users tend to change their puffing behaviors when using e-liquids with reduced nicotine concentrations by taking longer and more frequent puffs. Using puffing regimens modelled on puffing topography data from 19 experienced e-cigarette users who switched between 18 and 6 mg/mL e-liquids with and without power adjustments, differences in daily exposure to carbonyl compounds and estimated changes in cancer risk were assessed by production of aerosols generated using a smoking machine and analyzed using gas and liquid chromatography. Significant differences across conditions were found for formaldehyde and acetaldehyde (p

OBJECTIVETo assess the effectiveness of a 3.5h-training for general practitioners (GPs) in two different methods (ABC, 5As) of giving brief stop-smoking advice during routine consultations.DESIGNPragmatic two-arm cluster randomised controlled trial with pre-post-design for the primary outcome and cluster randomisation for secondary outcomes.SETTINGGeneral practices, North Rhine-Westphalia (German federal state), recruited 2017-2019.PARTICIPANTSPractices were randomised (1:1) to an ABC or 5As training. Tobacco smoking, adult patients, who consulted trained GPs in these practices in the 6 weeks prior to or following the training were eligible to participate. Ineligible were: non-smokers, patients who did not meet the GP in person, or could not provide informed consent.INTERVENTIONSTwo different standardised 3.5h-trainings (ABC or 5As) for GPs in delivering brief stop-smoking advice were carried out per study cycle (six cycles in total). Trainings were moderated by a senior researcher and an experienced GP, and included role-plays with professional actors.MAIN OUTCOME MEASURESPrimary outcome: patient-reported rates of GP-delivered stop-smoking advice prior and following the training, irrespective of the training method. Secondary outcomes: patient-reported receipt of recommendation/prescription of evidence-based smoking cessation treatment: including behavioural support, any pharmacotherapy (nicotine replacement therapy (NRT), varenicline, or bupropion), or a combination therapy; and the effectiveness of ABC versus 5As regarding all outcomes.RANDOMISATION AND MASKINGComputer-generated block randomisation or, if not feasible, randomisation based on the GPs’ temporal availability at training dates. GPs were not fully blinded. Patients were blinded to the nature of the study until data collection ended.RESULTS52 GP practices (27 ABC, 25 5As) with 69 GPs were included. Of 5,406 patients who provided informed consent, 1,937 (35.9%) were current smokers, of whom 1,039 were interviewed prior to and 898 following the training. GP-delivered stop-smoking advice increased from 13.1% (n=136/1,039) to 33.1% (n=297/898) following the training (adjusted odds ratio (aOR)=3.25, 95%CI=2.34 to 4.51). Recommendation/prescription rates of treatment were low (CONCLUSIONSIn GPs in Germany, a single session of training in stop-smoking advice was associated with a three-fold increase in rates of advice giving and a seven-fold increase in offer of support. The ABC method may lead to higher rates of GP-delivered stop-smoking advice during routine consultations. Approaches to further increase the delivery of such advice, and upscaling implementation strategies for the training in general practice, should be evaluated.TRIAL REGISTRATIONGerman Clinical Trials Register: DRKS00012786.WHAT IS ALREADY KNOWN ON THIS TOPICThe implementation of clinical guideline recommendations stating that general practitioners (GPs) should routinely deliver brief stop-smoking advice and offer evidence-based smoking cessation treatment is low in Germany, a country with a smoking prevalence of ∼28%.A strategy is needed to overcome barriers (e.g., lack in knowledge and skills) preventing GPs from routinely delivering stop-smoking advice. No experimental study has evaluated such a strategy in German general practice so far.Two different methods of delivering such advice are recommended in the national guidelines – ABC and 5As – but it is unclear which method can be more effectively implemented by trained GPs.WHAT THIS STUDY ADDSThis cluster randomised controlled trial evaluated the effectiveness of a 3.5h-training for GPs in delivering brief stop-smoking advice and compared two different methods (ABC vs. 5As) regarding the rates of delivery of such advice and recommendations of evidence-based cessation treatment in 1,937 smoking patients from 52 GP practices in Germany.The training, irrespective of the method, was associated with a three-fold increase in rates of advice giving and a seven-fold increase in the offer of support.The data indicate that training according to ABC may be more effective than 5As in increasing the rates of GP-delivered stop-smoking advice.

Context: Use of electronic cigarettes (ECs) is on the rise in most high-income countries. Smoking conventional cigarettes is a known risk factor for urologic malignancy incidence, progression, and mortality, as well as for other urologic health indicators. The potential impact of EC use on urologic health is therefore of clinical interest to the urology community. Objective: To review the available data on current EC use, including potential benefits in urologic patients, potential issues linked to toxicology of EC constituents, and how this might translate into urologic health risks. Evidence acquisition: A Medline search was carried out in August 2016 for studies reporting urologic health outcomes and EC use. Snowballing techniques were also used to identify relevant studies from recent systematic reviews. A narrative synthesis of data around EC health outcomes, toxicology, and potential use in smoking cessation and health policy was carried out. Evidence synthesis: We found no studies to date that have been specifically designed to prospectively assess urologic health risks, even in an observational setting. Generating such data would be an important contribution to the debate on the role of ECs in public health and clinical practice. There is evidence from a recent Cochrane review of RCTs that ECs can support smoking cessation. There are emerging data indicating that potentially harmful components of ECs such as tobacco-specific nitrosamines, polyaromatic hydrocarbons, and heavy metals could be linked to possible urologic health risks. Conclusions: ECs might be a useful tool to encourage cessation of conventional cigarette smoking. However, data collection around the specific impact of ECs on urologic health is needed to clarify the possible patient benefits, outcomes, and adverse events. Patient summary: While electronic cigarettes might help some people to stop smoking, their overall impact on urologic health is not clear. While electronic cigarettes might help some people to stop smoking, it is not clear if they may be bad for urologic health.

Introduction Little is known about effects of smoking cessation on alcohol consumption. Varenicline reduces enjoyment of smoking and cigarette consumption and may also reduce enjoyment and consumption of alcohol. We conducted the first prospective examination of the effects of stopping smoking on alcohol enjoyment and consumption and compared clients using varenicline and nicotine replacement treatment (NRT). Methods Audit of records from clients undergoing routine smoking cessation treatment in three stop-smoking services in London, United Kingdom. The sample comprised smokers who consume alcohol and underwent smoking cessation treatment with either varenicline (N = 230) or NRT (N = 62). Alcohol enjoyment and consumption were reported before and on the target quit day (TQD) and 1 and 4 weeks post-TQD. Results Participants reduced their alcohol consumption in week 1 of their quit attempt (15.0-12.7 units per/week, p = .001).In heavy drinkers, the change remained significant at 4 weeks (32.2-24.8 units per/week, p = .004). The type of medication used had no significant impact on the change. Smokers treated with varenicline versus NRT were more likely to report reduced enjoyment of alcohol on TQD (20% vs. 10%, respectively, p < .001) and at 4 weeks post-TQD (20% vs. 6%, respectively, p = .014). Results were similar for abstainers and those who did not manage to stop smoking. Conclusion Making a stop-smoking attempt is accompanied by a reduction in drinking. The finding has implications for policies concerned with effects of stopping smoking on alcohol use. Varenicline may affect enjoyment of drinking, but its potential to alter drinking behavior is small. Implications The finding that smokers making a quit attempt reduce their alcohol consumption has practical implications for treatment providers who are concerned about the possible effects of smoking cessation on alcohol drinking. Although varenicline may reduce alcohol enjoyment compared to NRT, it does not appear to have a significant impact on alcohol consumption.

Background Significant safety concerns remain surrounding the use of nonsteroidal anti-inflammatory drugs (NSAIDs) following gastrointestinal surgery, leading to wide variation in their use. This study aimed to determine the safety profile of NSAIDs after major gastrointestinal surgery. Methods Consecutive patients undergoing elective or emergency abdominal surgery with a minimum one-night stay during a 3-month study period were eligible for inclusion. The administration of any NSAID within 3 days following surgery was the main independent variable. The primary outcome measure was the 30-day postoperative major complication rate, as defined by the Clavien–Dindo classification (Clavien–Dindo III–V). Propensity matching with multivariable logistic regression was used to produce odds ratios (OR) and 95 % confidence intervals. Results From 9264 patients, 23.9 % (n = 2212) received postoperative NSAIDs. The overall major complication rate was 11.5 % (n = 1067). Following propensity matching and adjustment, use of NSAIDs were not significantly associated with any increase in major complications (OR 0.90, 0.60–1.34, p = 0.560). Conclusions Early use of postoperative NSAIDs was not associated with an increase in major complications following gastrointestinal surgery.

The use of electronic cigarettes (EC) is increasing and the number of EC publications is rapidly growing. While some health organizations focus on the harmful effects of using EC (vaping), others promote the benefits of ECs as a less harmful alternative to smoking tobacco. There is concern that vaping might have adverse respiratory consequences for pediatric patients facing anesthesia and intensive care. This narrative review summarizes current knowledge and recommendations regarding the risks of EC relevant to the anesthesiologist and the use of ECs as a step-down option from tobacco. We provide guidance on the management of vaping patients in the perioperative period.

Background Mobile phone-based smoking cessation support (mCessation) offers the opportunity to provide behavioural support to those who cannot or do not want face-to-face support. In addition, mCessation can be automated and therefore provided affordably even in resource-poor settings. This is an update of a Cochrane Review first published in 2006, and previously updated in 2009 and 2012. Objectives To determine whether mobile phone-based smoking cessation interventions increase smoking cessation rates in people who smoke. Search methods For this update, we searched the Cochrane Tobacco Addiction Group's Specialised Register, along with clinicaltrials.gov and the ICTRP. The date of the most recent searches was 29 October 2018. Selection criteria Participants were smokers of any age. Eligible interventions were those testing any type of predominantly mobile phone-based programme (such as text messages (or smartphone app) for smoking cessation. We included randomised controlled trials with smoking cessation outcomes reported at at least six-month follow-up. Data collection and analysis We used standard methodological procedures described in the Cochrane Handbook for Systematic Reviews of Interventions. We performed both study eligibility checks and data extraction in duplicate. We performed meta-analyses of the most stringent measures of abstinence at six months' follow-up or longer, using a Mantel-Haenszel random-effects method, pooling studies with similar interventions and similar comparators to calculate risk ratios (RR) and their corresponding 95% confidence intervals (CI). We conducted analyses including all randomised (with dropouts counted as still smoking) and complete cases only. Main results This review includes 26 studies (33,849 participants). Overall, we judged 13 studies to be at low risk of bias, three at high risk, and the remainder at unclear risk. Settings and recruitment procedures varied across studies, but most studies were conducted in high-income countries. There was moderate-certainty evidence, limited by inconsistency, that automated text messaging interventions were more effective than minimal smoking cessation support (RR 1.54, 95% CI 1.19 to 2.00; I2 = 71%; 13 studies, 14,133 participants). There was also moderate-certainty evidence, limited by imprecision, that text messaging added to other smoking cessation interventions was more effective than the other smoking cessation interventions alone (RR 1.59, 95% CI 1.09 to 2.33; I2 = 0%, 4 studies, 997 participants). Two studies comparing text messaging with other smoking cessation interventions, and three studies comparing high- and low-intensity messaging, did not show significant differences between groups (RR 0.92 95% CI 0.61 to 1.40; I2 = 27%; 2 studies, 2238 participants; and RR 1.00, 95% CI 0.95 to 1.06; I2 = 0%, 3 studies, 12,985 participants, respectively) but confidence intervals were wide in the former comparison. Five studies compared a smoking cessation smartphone app with lower-intensity smoking cessation support (either a lower-intensity app or non-app minimal support). We pooled the evidence and deemed it to be of very low certainty due to inconsistency and serious imprecision. It provided no evidence that smartphone apps improved the likelihood of smoking cessation (RR 1.00, 95% CI 0.66 to 1.52; I2 = 59%; 5 studies, 3079 participants). Other smartphone apps tested differed from the apps included in the analysis, as two used contingency management and one combined text messaging with an app, and so we did not pool them. Using complete case data as opposed to using data from all participants randomised did not substantially alter the findings. Authors' conclusions There is moderate-certainty evidence that automated text message-based smoking cessation interventions result in greater quit rates than minimal smoking cessation support. There is moderate-certainty evidence of the benefit of text messaging interventions in addition to other smoking cessation support in comparison with that smoking cessation support alone. The evidence comparing smartphone apps with less intensive support was of very low certainty, and more randomised controlled trials are needed to test these interventions.

BackgroundOver the past few years, a large number of smokers in the UK have stopped smoking with the help of e-cigarettes. So far, UK Stop Smoking Services (SSSs) have been reluctant to include e-cigarettes among their treatment options because data on their efficacy compared with the licensed medications are lacking.ObjectiveThe objective was to compare the efficacy of refillable e-cigarettes and nicotine replacement therapy (NRT) products, when accompanied by weekly behavioural support.DesignA randomised controlled trial comparing e-cigarettes and NRT.SettingThree sites that provide local SSSs.ParticipantsThe participants were 886 smokers seeking help to quit smoking, aged ≥ 18 years, not pregnant or breastfeeding, with no strong preference to use or not to use NRT or e-cigarettes in their quit attempt, and currently not using NRT or e-cigarettes. A total of 886 participants were randomised but two died during the study (one in each study arm) and were not included in the analysis.InterventionsThe NRT arm (n = 446) received NRT of their choice (single or combination), provided for up to 12 weeks. The e-cigarette arm (n = 438) received an e-cigarette starter pack and were encouraged to buy addtional e-liquids and e-cigarette products of their choice. Both arms received the same standard behavioural support. Participants attended weekly sessions at their SSS and provided outcome data at 4 weeks. They were then followed up by telephone at 6 and 12 months. Participants reporting abstinence or at least 50% reduction in cigarette consumption at 12 months were invited to attend for carbon monoxide (CO) validation. Participants/researchers could not be blinded to the intervention.Main outcome measuresThe primary outcome was CO-validated sustained abstinence rates at 52 weeks. Participants lost to follow-up or not providing biochemical validation were included as non-abstainers. Secondary outcomes included abstinence at other time points, reduction in smoke intake, treatment adherence and ratings, elicited adverse reactions, and changes in self-reported respiratory health. A cost-efficacy analysis of the intervention was also conducted.ResultsThe 1-year quit rate was 9.9% in the NRT arm and 18.0% in the e-cigarette arm (risk ratio 1.83, 95% confidence interval 1.30 to 2.58;p 2 = 161.4;p LimitationsThe results may not be generalisable to other types of smokers or settings, or to cartridge-based e-cigarettes.ConclusionsWithin the context of multisession treatment for smokers seeking help, e-cigarettes were significantly more effective than NRT. If SSSs provide e-cigarette starter packs, it is likely to boost their success rates and improve their cost-efficacy.Future workThe efficacy of e-cigarettes provided with different levels of support will show whether smokers should be encouraged to switch to vaping within support services or whether e-cigarettes can be recommended with less intensive or no support.Trial registrationCurrent Controlled Trials ISRCTN60477608.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 23, No. 43. See the NIHR Journals Library website for further project information. The trial was supported by the Cancer Research UK Prevention Trials Unit (grant A16893).

Background The German clinical guideline on tobacco addiction recommends that general practitioners (GPs) provide brief stop-smoking advice to their patients according to the “5A” or the much briefer “ABC” method, but its implementation is insufficient. A lack of training is one barrier for GPs to provide such advice. Moreover, the respective effectiveness of a 5A or ABC training regarding subsequent delivery of stop-smoking advice has not been investigated. We developed a training for GPs according to both methods, and conducted a pilot study with process evaluation to optimize the trainings according to the needs of GPs. This study aims at evaluating the effectiveness of both trainings. Methods A pragmatic 2-arm cluster randomised controlled trial with a pre-post data collection will be conducted in 48 GP practices in North Rhine-Westphalia (Germany). GPs will be randomised to receive a 3.5-h-training in delivering either 5A or ABC, including peer coaching and intensive role plays with professional actors. The patient-reported primary outcome (receipt of GP advice to quit: yes/no) and secondary outcomes (recommendation rates of smoking cessation treatments, group comparison (5A versus ABC): receipt of GP advice to quit) will be collected in smoking patients routinely consulting their GP within 4 weeks prior, and 4 weeks following the training. Additional secondary outcomes will be collected at 4, 12 and 26 weeks following the consultation: use of cessation treatments during the last quit attempt (if so) since the GP consultation, and point-prevalence abstinence rates. The primary data analysis will be conducted using a mixed-effects logistic regression model with random effects for the cluster variable. Discussion If the training increases the rates of delivery of stop-smoking advice, it would offer a low-threshold strategy for the guideline implementation in German primary care. Should one method prove superior, a more specific guideline recommendation can be proposed. Trial registration German Clinical Trials Register (DRKS00012786); registered on 22th August 2017, prior to the first patient in. Open-Access-Publikationsfonds 2019

Background: Hypnotherapy is widely promoted as a method for aiding smoking cessation. It is intended to act on underlying impulses to weaken the desire to smoke, or strengthen the will to stop. Objectives: To evaluate the effect and safety of hypnotherapy for smoking cessation. Search Methods: For this update we searched the Cochrane Tobacco Addiction Group Specialized Register, and trial registries (ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform), using the terms "smoking cessation" and "hypnotherapy" or "hypnosis", with no restrictions on language or publication date. The most recent search was performed on 18 July 2018. Selection Criteria: We considered randomized controlled trials that recruited people who smoked and implemented a hypnotherapy intervention for smoking cessation compared with no treatment, or with any other therapeutic interventions. Trials were required to report smoking cessation rates at least six months after the beginning of treatment. Study eligibility was determined by at least two review authors, independently. Data Collection and Analysis: At least two review authors independently extracted data on participant characteristics, the type and duration of hypnotherapy, the nature of the control group, smoking status, method of randomization, and completeness of follow‐up. These authors also independently assessed the quality of the included studies. In undertaking this work, we used standard methodological procedures expected by Cochrane. The main outcome measure was abstinence from smoking after at least six months' follow‐up. We used the most rigorous definition of abstinence in each trial, and biochemically validated abstinence rates where available. Those lost to follow‐up were considered to still be smoking. We summarized effects as risk ratios (RRs) and 95% confidence intervals (CIs). Where possible, we performed meta‐analysis using a fixed‐effect model. We also noted any adverse events reported. Main Results: We included three new trials in this update, which brings the total to 14 included studies that compared hypnotherapy with 22 different control interventions. The studies included a total of 1926 participants. Studies were diverse and a single meta‐analysis was not possible. We judged only one study to be at low risk of bias overall; we judged 10 studies to be at high risk of bias and three at unclear risk. Studies did not provide reliable evidence of a greater benefit from hypnotherapy compared with other interventions or no treatment for smoking cessation. Most individual studies did not find statistically significant differences in quit rates after six months or longer, and studies that did detect differences typically had methodological limitations. Pooling small groups of relatively comparable studies did not provide reliable evidence for a specific effect of hypnotherapy relative to controls. There was low certainty evidence, limited by imprecision and risk of bias, that showed no statistically significant difference between hypnotherapy and attention‐matched behavioural treatments (RR 1.21, 95% CI 0.91 to 1.61; I2 = 36%; 6 studies, 957 participants). Results were similarly imprecise, and also limited by risk of bias, when comparing hypnotherapy to intensive behavioural interventions (not matched for contact time) (RR 0.93, 95% CI 0.47 to 1.82; I2 = 0%; 2 studies, 211 participants; very low certainty evidence). Results from one small study (40 participants) detected a statistically significant benefit of hypnotherapy compared to no intervention (RR 19.00, 95% CI 1.18 to 305.88), but this evidence was judged to be of very low certainty due to high risk of bias and imprecision. No significant differences were detected in comparisons of hypnotherapy with brief behavioural interventions (RR 0.98, 95% CI 0.57 to 1.69; I² = 0%; 2 studies, 269 participants), rapid/focused smoking (RR 1.00, 95% CI 0.43 to 2.33; I2 = 65%; 2 studies, 54 participants), and pharmacotherapies (RR 1.68, 95% CI 0.88 to 3.20; I2 = 5%; 2 studies, 197 participants). When hypnotherapy was evaluated as an adjunct to other treatments, the pooled result from five studies showed a statistically significant benefit in favour of hypnotherapy (RR 2.10, 95% CI 1.31 to 3.35; I² = 62%; 224 participants); however, this result should be interpreted with caution due to the high risk of bias across studies (four had a high risk or bias, one had an unclear risk), and substantial statistical heterogeneity. Most studies did not provide information on whether data specifically relating to adverse events were collected, and whether or not any adverse events occurred. One study that did collect such data did not find a statistically significant difference in the adverse event ‘index’ between hypnotherapy and relaxation. Authors' Conclusions: There is insufficient evidence to determine whether hypnotherapy is more effective for smoking cessation than other forms of behavioural support or unassisted quitting. If a benefit is present, current evidence suggests the benefit is small at most. There is very little evidence on whether hypnotherapy causes adverse effects, but the existing data show no evidence that it does. Further large, high‐quality randomized controlled trials, and more comprehensive assessments of safety, are needed on this topic.

We are grateful for the opportunity to reply to the commentary on our Cochrane review of electronic cigarettes (EC) for smoking cessation [1] posed by Pisinger and Vestbo [2] with subsequent commentary by McAlinden et al. [3]. Footnotes This manuscript has recently been accepted for publication in the European Respiratory Journal . It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article. Conflict of Interest: Caitlin Notley has nothing to disclose. Conflict of Interest: Ailsa Butler reports payments made to institution to fund her role on the living systematic review of e-cigarettes for smoking cessation from Cancer Research UK (CRUK). Conflict of Interest: Nicola Lindson reports that her salary is paid by the University of Oxford through a grant from the UK National Institute for Health Research (NIHR); she is co-PI on a grant to carry out a Living Systematic Cochrane Review of ‘Electronic Cigarettes for Smoking Cessation’ funded by CRUK (current); PI on a programme grant to carry out a systematic review and network meta-analysis to investigate the safety and efficacy of pharmalogical treatments and electronic cigarettes for smoking cessation funded by the NIHR (current); co-applicant on a grant to investigate youth uptake of electronic cigarettes funded by CRUK (current); co-applicant on an Infrastructure grant which funds the Cochrane Tobacco Addiction Group funded by NIHR (current); co-applicant on a grant to investigate the comparative effectiveness of behavioural smoking cessation treatments funded by NIHR (ended Jan 2021); and receives payment for teaching Cochrane Authors how to write Cochrane protocols on behalf of Cochrane UK (not for profit organisation) (current) funded by Oxford Universities NHS Foundation Trust. Conflict of Interest: Chris Bullen reports research grants paid to institution (University of Auckland) from Health Research Council of NZ; contract for smoking cessation guideline review, paid to institution from NZ Ministry of Health; Contract for smokefree plan, paid to institution from Auckland Council; contract for research, paid to institution from Pfizer; research grant paid to institution from Tencent; personal fees for consulting on new NRT product from Johnson & Johnson KK (Japan); lecture fees for Lecture at Ottawa Heart Institute Annual conference, and honoraria for Manuscript writing Simon Fraser University; is President of SRNT-Oceania (unpaid); and Tobacco expert advisory group member, Health Coalition Aotearoa (unpaid). Conflict of Interest: Annika Theodoulou has nothing to disclose. Conflict of Interest: Rachna Begh has nothing to disclose. Conflict of Interest: Hayden McRobbie reports grant payments made to institution from Health Research Council (NZ), NIHR (UK) and NHMRC (AUS), outside the submitted work; and received honoraria from Pfizer for speaking at smoking cessation educational events and an advisory board meeting in Oct 2018. Conflict of Interest: Peter Hajek reports honoraria from Pfizer for contributing to Pfizer Workshop at SRNT Conference. Conflict of Interest: Nancy Rigotti reports contract for clinical trial paid to institution from Achieve Life Sciences; personal royalties for review of e-cigarettes from UpToDate; personal consulting fee from Achieve Life Sciences. Conflict of Interest: Jamie Hartmann-Boyce reports grant funding, including to support the review which this letter refers to paid to institution from Cancer Research UK; grant funding unrelated to this work paid to institution from British Heart Foundation; grant funding, including to support the review which this letter refers to, paid to institution from NIHR.