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E-cigarettes and nicotine abstinence: a meta-analysis of randomised controlled trials

Reiner Hanewinkel, Kathrin Niederberger, Anya Pedersen, Jennifer B. Unger, Artur Galimov
European Respiratory Review 2022 31: 210215; DOI: 10.1183/16000617.0215-2021
Reiner Hanewinkel
1Institute of Therapy and Health Research, IFT-Nord, Kiel, Germany
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  • ORCID record for Reiner Hanewinkel
  • For correspondence: hanewinkel@ift-nord.de
Kathrin Niederberger
2Clinical Psychology and Psychotherapy, Dept of Psychology, Kiel University, Kiel, Germany
3Institute of Medical Psychology and Medical Sociology, University Medical Center Schleswig-Holstein, Kiel University, Kiel, Germany
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Anya Pedersen
2Clinical Psychology and Psychotherapy, Dept of Psychology, Kiel University, Kiel, Germany
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Jennifer B. Unger
4Institute for Health Promotion and Disease Prevention Research, Dept of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA
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Artur Galimov
4Institute for Health Promotion and Disease Prevention Research, Dept of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA
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  • FIGURE 1
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    FIGURE 1

    Flow diagram of the systematic review process. CENTRAL: Cochrane Central Register of Controlled Trials.

  • FIGURE 2
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    FIGURE 2

    Risk of bias for each study. Studies: Bonevski et al. (2021) [14], Bullen et al. (2013) [17], Hajek et al. (2019) [18], Lee et al. (2018) [20].

  • FIGURE 3
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    FIGURE 3

    Pooled results for nicotine abstinence, allocated product use and smoking cessation. Studies: Bonevski et al. (2021) [14], Bullen et al. (2013) [17], Hajek et al. (2019) [18], Lee et al. (2018) [20]. EC: e-cigarette; df: degree of freedom; M–H: Mantel–Haenszel; NRT: nicotine replacement therapy.

  • FIGURE 4
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    FIGURE 4

    Anticipated absolute effects. NRT: nicotine replacement therapy.

Tables

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  • TABLE 1

    Characteristics of included studies

    Authors (year) [ref.]DesignCountryNumber of participantsEligibility criteriaParticipants’ characteristicsInterventionsMain outcome
    Bonevski et al. (2021) [14]RCT: two parallel groupsNew ZealandTotal n=100: 50 EC, 50 NRT≥18 years old; tobacco smokers and with capacity to provide informed consent67% women, mean age 41 years, smoking 21 (mean) cpdRandomised to nicotine EC and NRT for 12 weeksSelf-reported 6-week continuous abstinence at 12 weeks (not validated)
    Bullen et al. (2013) [17]RCT: three parallel groupsAustraliaTotal n=100: 289 nicotine EC, 295 patch, 73 non-nicotine EC (this group was not included in this review)≥18 years old; smoked ≥10 cpd over past year, and wanted to stop smoking62% women, mean age 42 years, smoking 18 (mean) cpdRandomised to nicotine EC, NRT, and non-nicotine EC for 12 weeksContinuous abstinence 6 months after quit day (biochemically validated)
    Hajek et al. (2019) [18]RCT: two parallel groupsUKTotal n=100: 439 EC, 447 NRT≥18 years old; with no strong preference to EC and NRT, and were currently not using either type of product48% women; median age 41 years, smoking 15 (median) cpdRandomised to nicotine EC and NRT (for at least 4 weeks and up to 3 months)Continuous abstinence 52 weeks after quit day (biochemically validated)
    Lee et al. (2018) [20]RCT: two parallel groupsUSATotal n=100: 20 EC, 30 NRT≥18 years old; currently smoked ≥2 cpd and at least once in the last 7 days10% women; mean age 54 years, smoking 14 (mean) cpdRandomised to nicotine EC (6-week supply) and NRT (5 weeks nicotine patch, 1 week placebo match)7-day point prevalence abstinence at 6 months (biochemically validated)

    cpd: cigarettes per day; EC: e-cigarette; NRT: nicotine replacement therapy; RCT: randomised controlled trial.

    • TABLE 2

      Summary of findings: e-cigarettes versus nicotine replacement therapy (NRT) for nicotine abstinence, allocated product use and smoking cessation

      OutcomesRelative effect (risk ratio (95% CI))Number of participants (studies)Certainty of the evidence (GRADE)Comments
      Nicotine abstinence0.50 (95% CI 0.32–0.77)1568 (three RCTs)ModerateDowngraded one level due to imprecision (i.e. overall, a small number of events)
      Allocated product use among successful tobacco quitters at the end of the trial8.94 (95% CI 3.98–20.07)180 (three RCTs)LowDowngraded two levels due to imprecision (i.e. overall, a small number of events and too wide confidence intervals)
      Smoking cessation1.58 (95% CI 1.20–2.08)1598 (four RCTs)ModerateDowngraded one level due to imprecision (i.e. overall, a small number of events)

      Patient or population: adult current smokers; setting: Australia, New Zealand, UK and USA; intervention: e-cigarettes; comparison: NRT. GRADE: Grading of Recommendations Assessment, Development and Evaluation; RCT: randomised controlled trial. GRADE Working Group grades of evidence [10]: high – the authors have a lot of confidence that the true effect is similar to the estimated effect; moderate – the true effect is probably close to the estimated effect; low – the true effect might be markedly different from the estimated effect; very low – the true effect is probably markedly different from the estimated effect.

      • TABLE 3

        Detailed information on the risk of bias in included studies

        Authors (year) [ref.]Bias in the randomisation processDeviations from intended interventionsMissing outcome dataBias in measurement of the outcomeBias in selection of the reported result
        Bonevski et al. (2021) [14]Low riskLow riskLow riskHigh risk: self-reported abstinence data without biochemical validationLow risk
        Bullen et al. (2013) [17]Low riskSome concerns: adherence to study treatments was significantly higher in the EC group compared to the NRT group due to the trial context: i.e. participants in the EC group were provided with ECs and replacement cartridges, while those in the NRT group were provided with exchange cards redeemable for patches from community pharmaciesLow riskLow riskLow risk
        Hajek et al. (2019) [18]Low riskLow riskLow riskLow riskLow risk
        Lee et al. (2018) [20]Low riskLow riskLow riskLow riskLow risk

        EC: e-cigarette; NRT: nicotine replacement therapy.

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        E-cigarettes and nicotine abstinence: a meta-analysis of randomised controlled trials
        Reiner Hanewinkel, Kathrin Niederberger, Anya Pedersen, Jennifer B. Unger, Artur Galimov
        European Respiratory Review Mar 2022, 31 (163) 210215; DOI: 10.1183/16000617.0215-2021

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        E-cigarettes and nicotine abstinence: a meta-analysis of randomised controlled trials
        Reiner Hanewinkel, Kathrin Niederberger, Anya Pedersen, Jennifer B. Unger, Artur Galimov
        European Respiratory Review Mar 2022, 31 (163) 210215; DOI: 10.1183/16000617.0215-2021
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