EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study
TL;DR: In smokers not intending to quit, the use of e-cigarettes, with or without nicotine, decreased cigarette consumption and elicited enduring tobacco abstinence without causing significant side effects.
Abstract: Background: Electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide. Users report buying them to help quit smoking, to reduce cigarette consumption, to relieve tobacco withdrawal symptoms, and to continue having a ‘smoking’ experience, but with reduced health risks. Research on e-cigarettes is urgently needed in order to ensure that the decisions of regulators, healthcare providers and consumers are based on science. Methods ECLAT is a prospective 12-month randomized, controlled trial that evaluates smoking reduction/abstinence in 300 smokers not intending to quit experimenting two different nicotine strengths of a popular e-cigarette model (‘Categoria’; Arbi Group Srl, Italy) compared to its non-nicotine choice. GroupA (n=100) received 7.2 mg nicotine cartridges for 12 weeks; GroupB (n=100), a 6-week 7.2 mg nicotine cartridges followed by a further 6-week 5.4 mg nicotine cartridges; GroupC (n=100) received no-nicotine cartridges for 12 weeks. The study consisted of nine visits during which cig/day use and exhaled carbon monoxide (eCO) levels were measured. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed. Results: Declines in cig/day use and eCO levels were observed at each study visits in all three study groups (p,0.001 vs baseline), with no consistent differences among study groups. Smoking reduction was documented in 22.3% and 10.3% at week-12 and week-52 respectively. Complete abstinence from tobacco smoking was documented in 10.7% and 8.7% at week-12 and week-52 respectively. A substantial decrease in adverse events from baseline was observed and withdrawal symptoms were infrequently reported during the study. Participants’ perception and acceptance of the product under investigation was satisfactory. Conclusion: In smokers not intending to quit, the use of e-cigarettes, with or without nicotine, decreased cigarette consumption and elicited enduring tobacco abstinence without causing significant side effects. Trial Registration: ClinicalTrials.gov NCT01164072
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TL;DR: E-cigarettes, with or without nicotine, were modestly effective at helping smokers to quit, with similar achievement of abstinence as with nicotine patches, and few adverse events.
986 citations
TL;DR: E‐cigarettes were more effective for smoking cessation than nicotine‐replacement therapy, when both products were accompanied by behavioral support.
Abstract: Background E-cigarettes are commonly used in attempts to stop smoking, but evidence is limited regarding their effectiveness as compared with that of nicotine products approved as smoking-...
965 citations
TL;DR: E-cigarette products are changing quickly, and many of the findings from studies of older products may not be relevant to the assessment of newer products that could be safer and more effective as nicotine delivery devices, so patterns of use and the ultimate impact on public health may differ.
Abstract: Electronic cigarettes (e-cigarettes) are products that deliver a nicotine-containing aerosol (commonly called vapor) to users by heating a solution typically made up of propylene glycol or glycerol (glycerin), nicotine, and flavoring agents (Figure 1) invented in their current form by Chinese pharmacist Hon Lik in the early 2000s.1 The US patent application describes the e-cigarette device as “an electronic atomization cigarette that functions as substitutes [sic] for quitting smoking and cigarette substitutes ” (patent No. 8,490,628 B2). By 2013, the major multinational tobacco companies had entered the e-cigarette market. E-cigarettes are marketed via television, the Internet, and print advertisements (that often feature celebrities)2 as healthier alternatives to tobacco smoking, as useful for quitting smoking and reducing cigarette consumption, and as a way to circumvent smoke-free laws by enabling users to “smoke anywhere.”3
Figure 1.
Examples of different electronic cigarette (e-cigarette) products. Reproduced from Grana et al.1
There has been rapid market penetration of e-cigarettes despite many unanswered questions about their safety, efficacy for harm reduction and cessation, and total impact on public health. E-cigarette products are changing quickly, and many of the findings from studies of older products may not be relevant to the assessment of newer products that could be safer and more effective as nicotine delivery devices. In addition, marketing and other environmental influences may vary from country to country, so patterns of use and the ultimate impact on public health may differ. The individual risks and benefits and the total impact of these products occur in the context of the widespread and continuing availability of conventional cigarettes and other tobacco products, with high levels of dual use of e-cigarettes and conventional cigarettes at the same time among adults4–8 and youth.9–11 It is important to assess e-cigarette toxicant exposure and …
961 citations
TL;DR: The safety and effect of using ECs to help people who smoke achieve long-term smoking abstinence and the main outcome measure was abstinence from smoking after at least six months follow-up is evaluated.
Abstract: Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. BACKGROUND: Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol formed by heating an e-liquid. People who smoke report using ECs to stop or reduce smoking, but some organisations, 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 review is an update of a review first published in 2014. OBJECTIVES: To evaluate the effect and safety of using electronic cigarettes (ECs) to help people who smoke 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 for relevant records to January 2020, together with reference-checking and contact with study authors. 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. To be included, studies had to report abstinence from cigarettes at six months or longer and/or data on adverse events (AEs) or other markers of safety at one week or longer. 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, AEs, and serious adverse events (SAEs). Secondary outcomes included changes in carbon monoxide, blood pressure, heart rate, blood oxygen saturation, lung function, and levels of known carcinogens/toxicants. We used a fixed-effect Mantel-Haenszel model to calculate the risk ratio (RR) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data from these studies in meta-analyses. MAIN RESULTS: We include 50 completed studies, representing 12,430 participants, of which 26 are RCTs. Thirty-five of the 50 included studies are new to this review update. Of the included studies, we rated four (all which contribute to our main comparisons) at low risk of bias overall, 37 at high risk overall (including the 24 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) 1.69, 95% confidence interval (CI) 1.25 to 2.27; I2 = 0%; 3 studies, 1498 participants). In absolute terms, this might translate to an additional four successful quitters per 100 (95% CI 2 to 8). There was low-certainty evidence (limited by very serious imprecision) of no difference in the rate of adverse events (AEs) (RR 0.98, 95% CI 0.80 to 1.19; I2 = 0%; 2 studies, 485 participants). SAEs occurred rarely, with no evidence that their frequency differed between nicotine EC and NRT, but very serious imprecision led to low certainty in this finding (RR 1.37, 95% CI 0.77 to 2.41: I2 = n/a; 2 studies, 727 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 1.71, 95% CI 1.00 to 2.92; I2 = 0%; 3 studies, 802 participants). In absolute terms, this might again lead to an additional four successful quitters per 100 (95% CI 0 to 12). These trials used EC with relatively low nicotine delivery. There was low-certainty evidence, limited by very serious imprecision, that there was no difference in the rate of AEs between these groups (RR 1.00, 95% CI 0.73 to 1.36; I2 = 0%; 2 studies, 346 participants). There was insufficient evidence to determine whether rates of SAEs differed between groups, due to very serious imprecision (RR 0.25, 95% CI 0.03 to 2.19; I2 = n/a; 4 studies, 494 participants). Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.50, 95% CI 1.24 to 5.04; I2 = 0%; 4 studies, 2312 participants). In absolute terms this represents an increase of six per 100 (95% CI 1 to 14). However, this finding was very low-certainty, due to issues with imprecision and risk of bias. There was no evidence that the rate of SAEs varied, but some evidence that non-serious AEs were more common in people randomized to nicotine EC (AEs: RR 1.17, 95% CI 1.04 to 1.31; I2 = 28%; 3 studies, 516 participants; SAEs: RR 1.33, 95% CI 0.25 to 6.96; I2 = 17%; 5 studies, 842 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 over time with continued use. Very few studies reported data on other outcomes or comparisons and hence evidence for these is limited, with confidence intervals often encompassing clinically significant harm and benefit. AUTHORS' CONCLUSIONS: There is moderate-certainty evidence that ECs with nicotine increase quit rates compared to ECs without nicotine and compared to NRT. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain. More studies are needed to confirm the degree of effect, particularly when using modern EC products. Confidence intervals were wide for data on AEs, SAEs and other safety markers. Overall incidence of SAEs was low across all study arms. We did not detect any clear evidence of harm from nicotine EC, but longest follow-up was two years and the overall 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. Further RCTs are underway. To ensure the review continues to provide up-to-date information for decision-makers, this review is now a living systematic review. We will run searches monthly from December 2020, with the review updated as relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.
731 citations
TL;DR: E-cigarette use and cigarette smoking cessation among adult cigarette smokers, irrespective of their motivation for using e-cigarettes, are associated with significantly less quitting among smokers.
726 citations
References
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TL;DR: Un nouvel inventaire auto-administre destine a mesurer l'anxiete pathologique, le «Beck Anxiety Cheklist» (BAI) est decrit, evalue et compare au «Hamilton Anxiety Rating Scale» (test avec lequel des correlations moderees sont trouvees).
Abstract: Un nouvel inventaire auto-administre destine a mesurer l'anxiete pathologique, le «Beck Anxiety Cheklist» (BAI) est decrit, evalue et compare au «Hamilton Anxiety Rating Scale» (test avec lequel des correlations moderees sont trouvees)
11,139 citations
01 May 2008
TL;DR: The Panel recognized that variations in study inclusion criteria sometimes were warranted and made recommendations based on evidence, which occurred with topics such as tobacco dependence treatment in specific populations, tailoring interventions, and cost-effectiveness of Tobacco dependence treatment.
Abstract: s obtained Abstracts reviewed for inclusion/exclusion criteria by literature reviewerss reviewed for inclusion/exclusion criteria by literature reviewers Update topics chosen by Panel Full copy of each accepted article read and independently coded by at least 3 literature reviewers Evidence tables created by literature reviewers Initial meta-analyses conducted Panel reviewed relevant literature and meta-analytic results Panel formed tentative conclusions, identified need for further analyses Additional literature reviews and meta-analyses conducted Panel reviewed updated evidence and made recommendations based on evidence Manuscript drafted and reviewed by Panel Additional manuscript drafts reviewed by Panel Manuscript draft reviewed by peer reviewers and the public Manuscript revised and reviewed by Panel Manuscript submitted to PHS Overview and Methods 21 comparative effectiveness. Most of these randomized trials, however, were conducted with individuals who proactively sought treatment and who volunteered to fulfill various research requirements. It is possible that these individuals were more highly motivated to quit smoking than the typical smoker encountered in a clinical practice setting. Thus, the percentage abstinent estimates supplied with the meta-analyses may overestimate the actual level of abstinence produced by some of the treatments in real-world settings. Analyses conducted for the previous Guideline editions, though, suggest that the treatment effect sizes (odds ratios or ORs) are relatively stable across individuals seeking treatment (“treatment seekers”) and those recruited via inclusive recruitment strategies (“all-comers”). Randomized controlled trials were exclusively used in meta-analyses. However, the Panel recognized that variations in study inclusion criteria sometimes were warranted. For instance, research on tobacco interventions in adolescents frequently assigns interventions on the basis of larger units, such as schools. These units, rather than individuals, were allowed to serve as units of analysis when analyzing interventions for adolescents. In such cases, studies were combined for inclusion in meta-analyses if the study satisfied other review criteria. A similar strategy was followed in the review of health systems research. In certain areas, research other than randomized clinical trials was evaluated and considered to inform Panel opinion and judgment, though not submitted to meta-analysis. This occurred with topics such as tobacco dependence treatment in specific populations, tailoring interventions, and cost-effectiveness of tobacco dependence treatment. Literature Review and Inclusion Criteria Approximately 8,700 articles were screened to identify evaluable literature. This figure includes approximately 2,700 articles added to the literature since publication of the 2000 Guideline. These articles were obtained through searches of 11 electronic databases and reviews of published abstracts and bibliographies. An article was deemed appropriate for meta-analysis if it met the criteria for inclusion established a priori by the Panel. These criteria were that the article: (a) reported the results of a randomized, placebo/comparison controlled trial of a tobacco use treatment intervention randomized on the patient level (except as noted above); (b) provided followup results at least 5 months after the quit date (except in the case of studies evaluating tobacco dependence treatments Treating Tobacco Use and Dependence: 2008 Update 22 for pregnant smokers); (c) was published in a peer-reviewed journal; (d) was published between January 1975 and June 2007; (e) was published in English; and (f) was one of the 11 topics chosen to be included in the 2008 update (see Table 1.1). It is important to note that the article-screening criteria were updated for the 2008 Guideline update. Additionally, articles were screened for relevance to safety, economic, or health systems issues. As a result of the original and update literature reviews, more than 300 articles were identified for possible inclusion in a meta-analysis, and more than 600 additional articles were examined in detail by the Panel. These latter articles were used in the formulation of Panel recommendations that were not supported by meta-analyses. The literature search for the update project was validated by comparing the results against a search conducted by the CDC and through review by the expert Panel. When individual authors published multiple articles meeting the metaanalytic inclusion criteria, the articles were screened to determine whether they contained unique data. When two articles reported data from the same group of subjects, both articles were reviewed to ensure that complete data were obtained. The data were treated as arising from a single study in meta-analyses. Preparation of Evidence Tables Two Guideline staff reviewers independently read and coded each article that met inclusion criteria. The reviewers coded the treatment characteristics that were used in data analyses (see Tables 6.1 and 6.2 in Chapter 6). The same general coding procedure employed during the 2000 Guideline process was employed during the update. When adjustments to the coding process were made, articles coded with the original process were re-coded to reflect the changed coding (e.g., more refined coding criteria were used for the coding of treatment intensity). A third reviewer then examined the coding of both reviewers and adjudicated any differences. Discrepancies that could not be resolved through this process were adjudicated by the project manager, Panel chair, and/or the Panel’s senior scientist. Finally, each article accepted for a meta-analysis had key fields reviewed by the project manager as a final quality check. The data then were compiled and used in relevant analyses and/or Panel deliberations. Analyses done for the 2000 Guideline revealed that intervention coding categories could be used reliably by independent raters.94 Overview and Methods
3,175 citations
TL;DR: The findings indicate that the FTQ correlates with other proposed measures of nicotine dependence (carbon monoxide, nicotine, and cotinine levels), and the connection between FTQ scores and withdrawal symptoms is weak.
Abstract: In the last decade, the importance of nicotine in maintaining smoking and in cessation difficulty has been acknowledged. Consequently, this has led to efforts to measure nicotine dependence. This paper focuses on a widely used, paper-and-pencil test of nicotine dependence- the Fagerstrom Tolerance Questionnaire (FTQ). The findings indicate that the FTQ correlates with other proposed measures of nicotine dependence (carbon monoxide, nicotine, and cotinine levels). The connection between FTQ scores and withdrawal symptoms is weak. In clinic outcome trials, the FTQ predicted success where no pharmacologic treatment was involved, while nicotine replacement appeared to mask the relation between FTQ scores and outcome. However, the FTQ may predict outcome with nicotine replacement as a function of dose. In placebo-controlled, nicotine replacement trials, FTQ scores were related to success by treatment. Problems with the FTQ are described with focus on item difficulties and analyses of the scale.
1,531 citations
"EffiCiency and Safety of an eLectro..." refers methods in this paper
...Physical dependence and behavioural dependence were measured by Fagerstrom Test for Nicotine Dependence (FTND) [17] and Glover-Nilsson Smoking Behavioral Questionnaire (GN-SBQ) [18], respectively....
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TL;DR: This month, the Clinical Practice Guideline (CPG) column reviews the recently published guideline, Treating Tobacco Use and Dependence, available in a quick reference format and more comprehensive clinician's guide that includes detailed information on the methodology and references used to develop the guidelines.
Abstract: This month, the Clinical Practice Guideline (CPG) column reviews the recently published guideline, Treating Tobacco Use and Dependence. This set of recommendations is available in a quick reference format and a more comprehensive clinician's guide that includes detailed information on the methodology and references used to develop the guidelines. Both are available in electronic and hard copy versions through a variety of sources, including the National Guidelines Clearinghouse, the Centers for Disease Control and Prevention, and the National Cancer Institute.
1,211 citations