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E-Cigarettes May Support Smokers With High Smoking-Related Risk Awareness to Stop Smoking in the Short Run: Preliminary Results by Randomized Controlled Trial

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Abstract

IntroductionE-cigarettes may be positively used in tobacco cessation treatments. However, neither the World Health Organization nor the American Food and Drug Administration has recognized them as effective cessation aids. Data about the efficacy and safety of e-cigarettes are still limited and controversial.MethodsThis was a double-blind randomized controlled study. The main aim was to assess the efficacy of the use of e-cigarettes in a tobacco cessation program with a group of chronic smokers voluntarily involved in long-term lung cancer screening. Participants were randomized into three arms: e-cigarettes (Arm 1), placebo (Arm 2), and control (Arm 3). All subjects also received a low-intensity counseling.ResultsAbout 25% of participants who followed a cessation program based on the use of e-cigarettes (Arm 1 and Arm 2) were abstinent after 3 months. Conversely, only about 10% of smokers in Arm 3 stopped. Participants in Arm 1 also reported a higher reduction rate (M = −11.6441, SD = 7.574) than pa
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THIS IS A PRE-PRINT PARTIAL VERSION
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Full article may be find in:
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Nicotine & Tobacco Research, nty047,https://doi.org/10.1093/ntr/nty047
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Nicotine & Tobacco Research (2018). DOI: 10.1093/ntr/nty047.
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Nicotine & Tobacco Research, nty175, https://doi.org/10.1093/ntr/nty175
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CORRECTED PROOF
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E-Cigarettes May Support Smokers With High
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Smoking-Related Risk Awareness to Stop
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Smoking in the Short Run: Preliminary
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Results by Randomized Controlled Trial
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Marianna Masiero Claudio Lucchiari Ketti Mazzocco Giulia VeronesiPatrick
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Maisonneuve Costantino Jemos Emanuela Omodeo Salè Stefania SpinaRaffaella
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Bertolotti Gabriella Pravettoni
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Abstract
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Method: The main focus of this article is on a secondary outcome of the study, that is,
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the assessment of effectiveness and safety of e-cigarettes in achieving smoking cessation
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in a group of chronic smokers voluntarily involved in long-term lung cancer screening.
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Participants were randomized into three arms with a 1:1:1 ratio: e-cigarettes (arm 1),
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placebo (arm 2), and control (arm 3). All subjects also received a low intensity
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counseling.
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Results: Two hundred ten smokers were randomized (70 to nicotine e-cigarettes, 70 to
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nicotine-free placebo e-cigarettes, and 70 to control groups). About 25% of participants
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who followed a cessation program based on the use of e-cigarettes (arms 1 and 2) were
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abstinent after 3 months. Conversely, only about 10% of smokers in arm 3 stopped. A
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KruskalWallis test showed significant differences in daily cigarettes smoking across the
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three arms (K-W = 6.277, p = .043). In particular, participants in arm 1 reported a higher
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reduction rate (M = −11.6441, SD = 7.574) than participants in arm 2 (M =
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−10.7636, SD = 8.156) and arm 3 (M = −9.1379, SD = 8.8127).
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The primary outcome of this trial was the assessment of the impact of a 3-month e-
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cigarettes program to reduce smoking-related respiratory symptoms (dry cough, breath
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shortness, mouth irritation, and phlegm) as a consequence of reduced tobacco cigarette
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consumption. The secondary outcomes included the assessment of the success rate of
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smoking cessation attempts and daily smoking reduction in the three arms, and the
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monitoring of safety and toxicity during the study in arms 1 and 2. The present work
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illustrates data at 3 months, where the primary outcome was not measured yet. So, we
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focused here on smoking stopping, smoking reduction, and safety issues.
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We hypothesized that e-cigarette filled with nicotine liquid (arm 1) would be more
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effective than nicotine-free e-cigarette (arm 2) and the control group (arm 3) for smoking
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reduction and would have no greater risk of side-effects.
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A sample size of 210 participants was chosen to assess smoking reduction. Starting with
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the expected intrinsic motivation of participants, the study aimed to have at least 80%
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retention at 6 months and 70% at 12 months. Considering these figures, we expected to
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maintain a statistical power to detect a reduction of 5 cigarettes/day in our smokers
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(being the cigarettes per day mean about 20 in the COSMOS population). Thus, using a
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two-sided two-sample t-test with a significance level (alpha) of 0.05, a sample size of 49
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participants per arm we expected to achieve 80% power to detect a mean reduction of 5
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cigarettes/day between any of the two experimental arms and the control arm, assuming
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a mean consumption of 20 cigarettes/day in the control arm and common standard
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deviation within group of 8.7.
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Results
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At the baseline, the levels of anxiety and depression were not significantly different
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between the three groups. Generally, participants reported normal values, indicating the
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absence of clinical depression. Likewise, no differences among groups were found in the
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physical and psychological domains based on the LCQ scores. Some common e-
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cigarette side effects were reported.
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At month 3, we collected complete data about 170 participants. No statistical differences
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in the number of missing data were present between arms (χ2(2) = .835, p = .659).
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Participants in Arm 1 and Arm 2 had a similar compliance in the use of e-cigarettes. In
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fact, considering the number of empty flacons they gave back at the end of the study we
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dind’t find any significant difference, though the placebo group used on average less
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liquid (Arm 1 M = 10.9 empty flacons; Arm 2 M = 9.8 empty flacons).
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Across study arms, 20% of participants (N = 34) stopped smoking at month 3. The
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percentage was significantly higher in the nicotine (N = 15; 25.4%) and nicotine-free (N
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= 13; 23.4%) e-cigarette groups than in the control group (N = 6; 10.34%) (χ2(2) =
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4.899, p = .044).
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Next, we compared reduction of cigarette consumption in participants who had used e-
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cigarettes (Arm 1 and Arm 2) and those who only received counseling (Arm 3). The
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Mann-Whitney U test reported significant differences between conditions (e-cigarettes
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vs. control) at month 1 (U = 2.508, p < .010) and at month 3 (U = 2.130, p < .022). The
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use of the electronic device actually helped participants reduce daily cigarettes. At
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month 3, also the reduction rate showed interesting results. Participants in Arm 3
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reported smoking an average of 10.034 cigarettes/day, while participants in Arm 1 and
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Arm 2 showed a lower consumption (7.671 and 9.091, respectively). However, while the
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difference between Arm 1 and Arm 3 was statistically significant, differences between
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Arms 1 and 2 and between Arms 2 and 3 were not.
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Considering the mean difference in cigarette consumption between the baseline and
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month 3, the Kruskal-Wallis H test for 3 independent samples showed a significant
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difference among Arms 1, 2, and 3 (see table 2): Participants in Arm 1 reported a higher
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reduction rate (M = -11.644, SD = 7.574) than participants in Arm 2 (M = -10.763, SD =
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8.156) and Arm 3 (M = -9.138, SD = 8.8127).
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Table 2 here
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However, excluding from the reduction analysis the participants who discontinued
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smoking, we failed to find any statistical difference, even though in Arm 1 we found the
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highest reduction (M = - 9.164 in Arm1; M = -8.262 in Arm2; M = -7.875 in Arm3).
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Considering respiratory symptoms, a significant reduction in all conditions was found,
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probably due to the decreased number of daily cigarettes smoked by most participants,
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independent of study arms. In particular, about 21.5% of participants reported a decrease
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in coughing, about 18.50% reported less catarrh, and about 14.5% reported an
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improvement in breathing.
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Focusing on e-cigarettes tolerability, our participants reported few side effects (see table
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3). In particular, at month 1 the most relevant complain was “burning throat”. It was
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reported by about 23% of participants using liquid containing nicotine (while only about
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4% of participant reported the same complain using nicotine-free liquid). However, at
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month 3 we observed a drastic decrease of the symptom. Cough was also reported at
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month 1 by about 10% of participants, both using nicotine and nicotine-free liquid. Also
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in this case, the symptom decreased during time.
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Discussion
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In this study, we tested the efficacy of e-cigarettes as cessation treatment in a sample of
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chronic smokers involved in a screening program. Our main result is that the use of e-
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cigarettes helped participant stop smoking since about one-quarter of participants who
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followed a cessation program based on e-cigarettes (both with and without nicotine) and
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a low-intensity counseling were abstinent after three months. Conversely, about 10% of
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smokers stopped following a program based only on a low-intensity counseling.
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Furthermore, e-cigarettes increased the reduction rate in participants who continued
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smoking. In fact, although all participants reported a significant reduction of daily
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cigarette consumption compared to the baseline, the use of e-cigarettes (including those
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without nicotine) allowed smokers achieving a better result. The few side effects
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reported, which were also reported in other studies,36-39 were well managed by
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participants and showed no increase during the treatment. Consequently, our findings
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confirm the efficacy as well as the safety of e-cigarettes in a short-term period.
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Although participants in Arm 1 generally achieved better results, the placebo condition
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was effectively as well, in some case leading to comparable outcomes. This result has
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not been described before and provides suggestions for potentially fruitful new lines of
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research.
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Future studies should analyze costs and benefits related to the use of nicotine-free e-
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cigarettes in high-risk patients who smoke. In particular, the efficacy of combining
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clinical counseling and nicotine-free e-cigarettes for high-risk patients should be
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discussed. In our view, it could have pivotal implications in clinical practice. We believe
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that nicotine-free e-cigarettes might be a first-line choice, particularly for subjects who
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have severe diseases (for example, those with heart problems) and cannot use nicotine or
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receive other medical treatments. However, the lack of differences between nicotine and
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nicotine-free device effects on smoking might also be linked to the low dosage of
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nicotine we adopted. In fact, using a device working at 10 W with an 8 mg/mL nicotine
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concentration we obtained quite a low dosage (less than 0.1 mg per puff) with respect to
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the nicotine normally assumed daily by a chronic smoker40. This may explain why
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results in Arm 1 (nicotine e-cigarettes) and Arm 2 (nicotine-free e-cigarettes) are so
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similar. Increasing nicotine concentration probably may enlarge this difference, although
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we need targeted research to establish which protocol may optimize the risk/benefits
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ratio.
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In conclusion, taking into consideration the perspective of personalized medicine, e-
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cigarettes based protocols associated with new ICT-driven models of self-management
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may be implemented to support people to better handle behavioral changes and side
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effects.41-45 This is true for ready-to-quit smokers (such as our participants) but could
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also be advantageous for less motivated smokers engaged in clinical settings.
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Limits of the Study
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The number of initial dropouts, i.e., participants who explicitly declared the willingness
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not to continue within the first month (1 participant in Arm 1, 2 in Arm 2, and 6 in Arm
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3) was particularly high in in the control group. It might suggest that motivation to
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participate to the study was related to the possibility of using the e-cigarettes rather than
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an actual willingness to stop smoking. During the study we had some missing data
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(12.4% at month 1; 21.9% at month 2; 18.1% at month 3) that limit our results.
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Monthly, we monitored the use of e-cigarettes during the counseling calls and the
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follow-up to manage potential problems. However, we didn’t assess systemically any
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quantitative measure about the actual use. For this reason, only qualitative considerations
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can be done about the different use of e-cigarettes between subjects in Arm 1 and Arm 2.
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Furthermore, the number of smoked cigarettes was recorded as participants’ self-reports,
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which might have led to a measurement bias. The impossibility of assessing carbon
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monoxide in an expired breath at month 3 because of the study design cannot
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disambiguate the aforementioned possible explanation. However, if present, this effect
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was constant in all 3 arms, thus not affecting the exhibited effects. Finally, this paper
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focused on a secondary outcome, since the primary one was supposed to be assessed at
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six months.
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Protocol
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Clinicaltrials.gov NCT02422914; https://clinicaltrials.gov/ct2/show/NCT02422914
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Funding
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This study was supported by a grant from Fondazione Umberto Veronesi (FUV).
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... Data exist to support the effectiveness of e-cigarettes in the context of lung cancer screening, with significantly higher 3-month abstinence with both nicotine e-cigarettes (25.4%) and nicotine-free e-cigarettes (23.4%) compared with a control (10.34%). 26 These findings, coupled with the recent announcement from the UK's Medicines and Healthcare Products Regulatory Agency that it will support the medicinal licensing of e-cigarettes for smoking cessation, 27 suggest that providers of cessation interventions within a screening context in the United Kingdom should be prepared to support people using this form of nicotine replacement. ...
... Third, the loss to follow-up observed within the population (28%) was slightly higher than anticipated, although it was similar to that in other studies. 11,26 Importantly, sensitivity analysis, taking the cautious assumption that all those lost to follow-up continued to smoke, did not alter the study findings. ...
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(275 words) Background Lung cancer screening programs provide an opportunity to support people who smoke to quit, but the most appropriate model for delivery remains to be determined. Immediate face to face smoking cessation support for people undergoing screening can increase quit rates, but it is not known whether remote delivery of immediate smoking cessation counselling and pharmacotherapy in this context is also effective. Research Question Does an immediate telephone smoking cessation intervention increase quit rates, compared with usual care among a population enrolled in a Targeted Lung Health Check? Study Design and Methods In a single-blind randomised controlled trial, people who smoke aged 55-75 years attending a Targeted Lung Health Check (TLHC) were allocated by day of attendance to receive either immediate telephone smoking cessation support (TSI) (starting immediately and lasting for 6 weeks) with appropriate pharmacotherapy, or usual care (very brief advice to quit and signposting to smoking cessation services) (UC). The primary outcome was self-reported 7-day point prevalence smoking abstinence at three months. Differences between groups were assessed using logistic regression. Results 315 people taking part in the screening programme who reported current smoking, mean (SD) age 63(5.4) years, 48% female, were randomised to telephone smoking cessation (n=152) or usual care (n=163). The two groups were well-matched at baseline. Self-reported quit rates were higher in the intervention arm, 21.1% vs 8.9% (odds ratio [OR]: 2.83, 95% CI 1.44-5.61, p=0.002). Controlling for participant demographics, baseline smoking characteristics or the discovery of abnormalities on low dose CT scanning did not modify the effect of the intervention. Interpretation Immediate provision of an intensive telephone-based smoking cessation intervention, delivered within a targeted lung screening context, is associated with increased smoking abstinence at three months.
... In this specific case, the e-cigarette is probably used by smokers as an 'aid' for facilitating smoking cessation. A recent randomized clinical trial in a sample of high-risk patients motivated to quit and enrolled in a lung cancer screening program highlighted that nicotine-free e-cigarettes might help to cut down the number of daily cigarettes in the short-run period (Masiero et al., 2019;Lucchiari et al., 2020Lucchiari et al., , 2022. ...
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The word 'vaping' is used to define the usage of electronic cigarettes or other instruments to inhale a wide variety of heated and aerosolized substances. Although proposed as a less dangerous and oncogenic alternative than standard nicotine products, e-cigarettes and vaping devices are quite far from being considered benign. In fact, although vaping devices do not generate carcinogenic agents as polycyclic aromatic hydrocarbons produced by the combustion of standard cigarettes and their liquids do not present tobacco-related carcinogens like nitrosamines, there is nowadays clear evidence that they produce dangerous products during their use. Several different molecular mechanisms have been proposed for the oncogenic impact of vaping fluids - by means of their direct chemical action or derivative products generated by pyrolysis and combustion ranging from epithelial-mesenchymal transition, redox stress and mitochondrial toxicity to DNA breaks and fragmentation. In this review we focus on vaping devices, their potential impact on lung carcinogenesis, vaping-associated lung injury and other clinical implications on cardiovascular, cerebrovascular and respiratory diseases, as well as on the psychological implication of e-cigarettes both on heavy smokers trying to quit smoking and on younger non-smokers approaching vaping devices because they are considered as a less dangerous alternative to tobacco cigarettes.
... In this context, it is important to investigate long-term use of ECs in successful quit attempts (i.e., ongoing exposure to addictive and potential harmful ingredients) and dual use of ECs and tobacco in unsuccessful attempts (i.e., exposure to two sources of harm). In addition, there is a need for further evidence on the effectiveness of non-nicotine ECs for smoking cessation, as the existing evidence is inadequate (9). ...
Article
Background: Our primary aim was to assess-in the German population-the effectiveness of e-cigarettes (ECs; with or without nicotine), nicotine replacement therapy (NRT), and no use of evidence-based aids in smoking cessation. Methods: Analysis of cross-sectional data from a representative survey of the population (age 14‒96 years) conducted in 2016‒2021. All current smokers and recent ex-smokers (<12 months since quitting) who had made ≥1 attempt to quit in the past 12 months (n = 2740) were included. They were asked about use of cessation aids in their most recent quit attempt and their current smoking status. Results: 239 respondents had used ECs, 168 NRT, and 2333 no aid. After adjustment for potential confounders, the odds of abstinence were 1.78 times higher for smokers who had used ECs in their quit attempt than in the group that had used no aids (95% confidence interval [1.09; 2.92]; p = 0.02) and 1.46 times higher than in the NRT group ([0.68; 3.13]; p = 0.34, Bayes Factor = 1.26). Compared with the unaided group, the odds of abstinence were 2.34 times higher ([1.21; 4.53]; p = 0.01) in the subgroup using ECs with nicotine and 1.48 times higher ([0.68; 3.26]; p = 0.33) in the subgroup using ECs without nicotine. The unadjusted abstinence rates in people who had started their quit attempt >6 months earlier were 15.6% [9.4; 23.8] in the ECs group and 13.8% [7.3; 22.9] in the NRT group. Conclusion: In Germany, use of ECs in an attempt to quit smoking is associated with a higher rate of abstinence than attempting to quit unaided.
... In recent years, Electronic Nicotine Delivery Systems (ENDS), commonly known as e-cigarettes, are newly invented, batterypowered tobacco products that emit aerosol containing fine particles of nicotine and other chemicals, popularized as a replacement of tobacco cigarettes (Arnett et al., 2019;Bhatnagar, 2016). The impact of ENDS on long-term cardiovascular health and on general health is not well understood, but current literature suggests that ENDS use appears to help prior smokers in reducing daily consumptions of tobacco cigarettes as well as smoking cessation (Masiero et al., 2019). ...
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Cardiovascular disorders are the leading causes of death in developed countries. The chapter provides an overview of behavioral and psychosocial influences on cardiovascular disorders, with an emphasis on coronary heart disease (CHD) and hypertension. This chapter reviews the pathophysiology of CHD, the role played by standard biological, behavioral, and psychosocial risk factors, including social determinants of health, environmental and psychological stress, individual psychological characteristics, and psychosocial protective factors such as social support. The chapter provides a summary of research examining the utility of interventions targeted at reducing risks of cardiovascular disease associated with psychosocial risk factors.
... ab 18 Jahre, 18-70 Jahre). Leider ging in die Metaanalyse nur eine Studie mit Schwerpunkt auf Ältere ab 55 Jahren ein, die zum einen Personen mit kardiovaskulären oder respiratorischen Vorerkrankungen oder mit regulärer Medikamenteneinnahme ausschloss und die zum anderen nur geringen bis keinen Nutzen der nikotinhaltigen E-Zigarette im Vergleich zur nikotinfreien E-Zigarette plus Beratung aufwies (Lucchiari et al., 2016;Lucchiari et al., 2020;Masiero et al., 2019;Masiero et al., 2020;NCT02422914, 2015). Eine kürzlich erschienene Metaanalyse von Wang und Kollegen (2021) fand Belege für einen zusätzlichen Nutzen von E-Zigaretten in der Rauchentwöhnung, wenn diese kostenlos angeboten und in den jeweiligen Versuchsgruppen zusätzliche Informationen zur Tabakentwöhnung (Halpern et al., 2018) oder zur Unterstützung von Verhaltensänderungen (Hajek et al., 2019;Lucchiari et al., 2020;Walker et al., 2020;Wang/Bhadriraju/Glantz, 2021) angeboten wurden. ...
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DO SENIORS’ VAPE OR SMOKE? COMPARISON OF SMOKING AND VAPING IN THE OLDER POPULATION IN 26 EUROPEAN COUNTRIES AND ISRAEL. DATA FROM THE SHARE SURVEY 2019/ 2020 (WAVE 8) Significance. Currently, only moderately informative data on the use of e-cigarettes and tobacco products are available for Europe’s oldest population. The present study describes the distribution of e-cigarette and tobacco product use in the elderly population in 26 European countries and Israel. Methods. Wave 8 (release 1.0.0) of the SHARE Survey on Health, Aging and Retirement in Europe served as data basis. A total of n = 46,077 persons aged 50 years and older (42.6 percent male, 57.4 percent female) were interviewed about their smoking behavior. The mean age was 71.3 years (minimum = 50 years, maximum = 104 years). For the extrapolation to the population, we used calibrated cross-sectional weights. Results. Overall, the sample’s prevalence for e-cigarette use was 0.45 percent (extrapolated to 811,000 persons aged 50 and above in the 26 European countries and Israel). The proportion of e-cigarette users was found to decline with age. Among those aged 50 to 69, 0.64 percent (extrapolated to 725,000) used e-cigarettes; among those aged 70 to 79, 0.16 percent (extrapolated to 62,000) used e-cigarettes; and among those aged 80 and older, 0.1 percent (extrapolated to 23,000) used e-cigarettes. The overall prevalence for the use of tobacco products was 43.9 percent in the sample (extrapolated to 80 million). Tobacco product use also declined as age increased. For example, among those aged 50 to 69, 49.1 percent (extrapolated to 55 million) used tobacco products; among those aged 70 to 79, 41.3 percent (extrapolated to 17 million) used tobacco products; and among those aged 80 and older, 27.7 percent (extrapolated to 8 million) used tobacco products. Conclusion. As of late 2020, e-cigarette use is far from a mass phenomenon among older persons. However, it could become significant if it were suitable for the cessation of the more widespread tobacco smoking.
Article
HINTERGRUND: Primäres Ziel war es, die Effektivität von E-Zigaretten (EZ, mit oder ohne Nikotin), Nikotinersatztherapie (NET) und keiner Nutzung evidenzbasierter Unterstützung bei der Tabakentwöhnung in der Bevölkerung Deutschlands zu untersuchen. METHODE: Analyse von Querschnittsdaten aus einer repräsentativen Befragung der Bevölkerung (Alter 14–96 Jahre), erhoben 2016–2021. Eingeschlossen wurden alle aktuellen Raucherinnen und Raucher sowie neuen Ex-Raucher (< 12 Monate rauchfrei), die in den vergangenen zwölf Monaten ≥ 1 Rauchstoppversuch unternommen hatten (N = 2 740). Diese wurden nach der Nutzung von Rauchstoppmethoden bei ihrem letzten Rauchstoppversuch sowie nach ihrem aktuellen Rauchstatus gefragt. ERGEBNISSE: 239 Personen hatten EZ genutzt, 168 NET und 2 333 keine Unterstützung. Nach Adjustierung für potenzielle Störvariablen lag die Wahrscheinlichkeit, rauchfrei zu sein, bei Rauchern, die mit einer EZ den Rauchstopp unterstützt hatten, 1,78-fach höher (95-%-Konfidenzintervall: [1,09; 2,92]; p = 0,02) als in der Gruppe ohne Unterstützung und 1,46-fach höher ([0,68; 3,13]; p = 0,34, Bayes-Faktor = 1,26) als in der NET Gruppe. Die Wahrscheinlichkeit, rauchfrei zu sein, war 2,34-fach höher ([1,21; 4,53]; p = 0,01) in der Subgruppe der Nutzerinnen und Nutzer von EZ mit Nikotin und 1,48-fach höher ([0,68; 3,26]; p = 0,33) in der Subgruppe der Nutzer von EZ ohne Nikotin als in der Gruppe ohne Unterstützung. Die unadjustierten Rauchstoppraten bei Personen, deren Rauchstoppversuch vor > 6 Monaten begann, lagen bei 15,6 % [9,4; 23,8] in der EZ-Gruppe und 13,8 % [7,3; 22,9] in der NET-Gruppe. SCHLUSSFOLGERUNG: In Deutschland ist gegenüber dem nichtassistierten Versuch die Nutzung von EZ bei einem Rauchstoppversuch mit einer höheren Abstinenzrate assoziiert.
Article
Background: Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol by heating an e-liquid. Some people who smoke use ECs to stop or reduce smoking, although 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 smoking, and if they are safe to use for this purpose. This is a review 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 July 2022, and reference-checked and contacted 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. 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 78 completed studies, representing 22,052 participants, of which 40 were RCTs. Seventeen of the 78 included studies were new to this review update. Of the included studies, we rated ten (all but one contributing to our main comparisons) at low risk of bias overall, 50 at high risk overall (including all non-randomized studies), and the remainder at unclear risk. There was high certainty that quit rates were higher in people randomized to nicotine EC than in those randomized to nicotine replacement therapy (NRT) (RR 1.63, 95% CI 1.30 to 2.04; I2 = 10%; 6 studies, 2378 participants). In absolute terms, this might translate to an additional four quitters per 100 (95% CI 2 to 6). There was moderate-certainty evidence (limited by imprecision) that the rate of occurrence of AEs was similar between groups (RR 1.02, 95% CI 0.88 to 1.19; I2 = 0%; 4 studies, 1702 participants). SAEs were rare, but there was insufficient evidence to determine whether rates differed between groups due to very serious imprecision (RR 1.12, 95% CI 0.82 to 1.52; I2 = 34%; 5 studies, 2411 participants). There was moderate-certainty evidence, 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%; 5 studies, 1840 participants). There was insufficient evidence to determine whether rates of SAEs differed between groups, due to very serious imprecision (RR 1.00, 95% CI 0.56 to 1.79; I2 = 0%; 8 studies, 1272 participants). Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.66, 95% CI 1.52 to 4.65; I2 = 0%; 7 studies, 3126 participants). In absolute terms, this represents an additional two quitters per 100 (95% CI 1 to 3). 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 1.03, 95% CI 0.54 to 1.97; I2 = 38%; 9 studies, 1993 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 EC 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 high-certainty evidence that ECs with nicotine increase quit rates compared to NRT and moderate-certainty evidence that they increase quit rates 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 nor between nicotine ECs and NRT. Overall incidence of SAEs was low across all study arms. We did not detect evidence of serious 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 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.
Article
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 1.30, 95% CI 0.89 to 1.90: I2 = 0; 4 studies, 1424 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 1.06, 95% CI 0.47 to 2.38; I2 = 0; 5 studies, 792 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.
Article
Introduction: Identifying predictors of electronic nicotine product (ENP) cessation can inform ENP cessation interventions. High rates of co-occurring ENP and cigarette (dual) use and transitions between these products underscore the importance of considering cigarette smoking status when assessing and addressing ENP cessation. Methods: We analyzed waves 3 (W3) and 4 (W4) of the Population Assessment of Tobacco and Health (PATH) study to identify (i) W3 socio-demographics, tobacco and ENP use characteristics, and psychosocial correlates of W3 cigarette smoking status (non-smoker, former and current) among W3 adult ENP users, and (ii) W3 predictors of W4 combined ENP and cigarette smoking abstinence relative to use of one or both products. Results: At W3, 65.6% of ENP users concurrently smoked cigarettes. Adjusted multinomial regression results indicated that different W3 socio-demographics, tobacco and ENP use characteristics and psychosocial correlates were significantly associated with distinct W3 cigarette use profiles. At W4, 9.9% of individuals were abstinent from both products. These individuals were less likely to: (i) be current smokers (vs non-smokers) or be advised to quit using tobacco, compared to cigarette only or dual users, and (ii) use ENPs daily or live in a household allowing ENP use, compared to ENP only or dual users (p's <0.05). Conclusions: ENP cessation approaches need to be tailored to the distinct cigarette use profiles of ENP users. Dual users and daily ENP users may require more intensive interventions to achieve cessation of both products. Supportive physical environments, such as home vape-free policies, may facilitate ENP cessation. Implications: This analysis contributes to advancing the nascent literature on predictors of electronic nicotine product (ENP) cessation, which can guide the development of ENP cessation interventions by indicating which populations, psychosocial and environmental constructs and co-occurring behaviors interventions should target. This research also highlights the importance of considering cigarette smoking status when designing ENP cessation interventions and defining intervention outcomes.
Article
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 of a review first published in 2014. Objectives: To examine the effectiveness, tolerability, 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 to 1 February 2021, 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, adverse events (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 included 56 completed studies, representing 12,804 participants, of which 29 were RCTs. Six of the 56 included studies were new to this review update. Of the included studies, we rated five (all contributing to our main comparisons) at low risk of bias overall, 41 at high risk overall (including the 25 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) 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 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 1.70, 95% CI 1.03 to 2.81; I2 = 0%; 4 studies, 1057 participants). In absolute terms, this might again lead to an additional four successful quitters per 100 (95% CI 0 to 11). These trials mainly used older EC with relatively low nicotine delivery. 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 0.60, 95% CI 0.15 to 2.44; I2 = n/a; 4 studies, 494 participants). Compared to behavioral support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.70, 95% CI 1.39 to 5.26; I2 = 0%; 5 studies, 2561 participants). In absolute terms this represents an increase of seven per 100 (95% CI 2 to 17). However, this finding was of very low certainty, due to issues with imprecision and risk of bias. There was no evidence that the rate of SAEs differed, but some evidence that non-serious AEs were more common in people randomized to nicotine EC (AEs: RR 1.22, 95% CI 1.12 to 1.32; I2 = 41%, low certainty; 4 studies, 765 participants; SAEs: RR 1.17, 95% CI 0.33 to 4.09; I2 = 5%; 6 studies, 1011 participants, very low certainty). 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 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 size of effect, particularly when using modern EC products. Confidence intervals were for the most part wide for data on AEs, SAEs and other safety markers, though evidence indicated no difference in AEs between nicotine and non-nicotine ECs. 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 evidence is limited mainly by 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, 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.
Article
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Background E-cigarettes have grown popular. The most common pattern is dual use with conventional cigarettes. Dual use has raised concerns that it might delay quitting of cigarette smoking. This study examined the relationship between long-term use of e-cigarettes and smoking cessation in a 2-year period. Methods A nationally representative sample of 2028 US smokers were surveyed in 2012 and 2014. Long-term e-cigarette use was defined as using e-cigarettes at baseline and follow-up. Use of e-cigarettes only at baseline or at follow-up was defined as short-term use. Non-users did not use e-cigarettes at either survey. Quit attempt rates and cessation rates (abstinent for 3 months or longer) were compared across the three groups. Results At 2-year follow-up, 43.7% of baseline dual users were still using e-cigarettes. Long-term e-cigarette users had a higher quit attempt rate than short-term or non-users (72.6% vs 53.8% and 45.5%, respectively), and a higher cessation rate (42.4% vs 14.2% and 15.6%, respectively). The difference in cessation rate between long-term users and non-users remained significant after adjusting for baseline variables, OR=4.1 (95% CI 1.5 to 11.4) as did the difference between long-term users and short-term users, OR=4.8 (95% CI 1.6 to 13.9). The difference in cessation rate between short-term users and non-users was not significant, OR=0.9 (95% CI 0.5 to 1.4). Among those making a quit attempt, use of e-cigarettes as a cessation aid surpassed that of FDA-approved pharmacotherapy. Conclusions Short-term e-cigarette use was not associated with a lower rate of smoking cessation. Long-term use of e-cigarettes was associated with a higher rate of quitting smoking.
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Background: Electronic cigarettes (ECs) are electronic devices that heat a liquid - usually comprising propylene glycol and glycerol, with or without nicotine and flavours, stored in disposable or refillable cartridges or a reservoir - into an aerosol for inhalation. Since ECs appeared on the market in 2006 there has been a steady growth in sales. Smokers report using ECs to reduce risks of smoking, but some healthcare organisations have been reluctant to encourage smokers to switch to ECs, citing lack of evidence of efficacy and safety. Smokers, healthcare providers and regulators are interested to know if these devices can reduce the harms associated with smoking. In particular, healthcare providers have an urgent need to know what advice they should give to smokers enquiring about ECs. Objectives: To examine the efficacy of ECs in helping people who smoke to achieve long-term abstinence; to examine the efficacy of ECs in helping people reduce cigarette consumption by at least 50% of baseline levels; and to assess the occurrence of adverse events associated with EC use. Search methods: We searched the Cochrane Tobacco Addiction Groups Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and two other databases for relevant records from 2004 to July 2014, together with reference checking and contact with study authors. Selection criteria: We included randomized controlled trials (RCTs) in which current smokers (motivated or unmotivated to quit) were randomized to EC or a control condition, and which measured abstinence rates or changes in cigarette consumption at six months or longer. As the field of EC research is new, we also included cohort follow-up studies with at least six months follow-up. We included randomized cross-over trials and cohort follow-up studies that included at least one week of EC use for assessment of adverse events. Data collection and analysis: One review author extracted data from the included studies and another checked them. Our main outcome measure was abstinence from smoking after at least six months follow-up, and we used the most rigorous definition available (continuous, biochemically validated, longest follow-up). For reduction we used a dichotomous approach (no change/reduction < 50% versus reduction by 50% or more of baseline cigarette consumption). We used a fixed-effect Mantel-Haenszel model to calculate the risk ratio (RR) with a 95% confidence interval (CI) for each study, and where appropriate we pooled data from these studies in meta-analyses. Main results: Our search identified almost 600 records, from which we include 29 representing 13 completed studies (two RCTs, 11 cohort). We identified nine ongoing trials. Two RCTs compared EC with placebo (non-nicotine) EC, with a combined sample size of 662 participants. One trial included minimal telephone support and one recruited smokers not intending to quit, and both used early EC models with low nicotine content. We judged the RCTs to be at low risk of bias, but under the GRADE system the overall quality of the evidence for our outcomes was rated 'low' or 'very low' because of imprecision due to the small number of trials. A 'low' grade means that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. A 'very low' grade means we are very uncertain about the estimate. Participants using an EC were more likely to have abstained from smoking for at least six months compared with participants using placebo EC (RR 2.29, 95% CI 1.05 to 4.96; placebo 4% versus EC 9%; 2 studies; GRADE: low). The one study that compared EC to nicotine patch found no significant difference in six-month abstinence rates, but the confidence intervals do not rule out a clinically important difference (RR 1.26, 95% CI: 0.68 to 2.34; GRADE: very low). A higher number of people were able to reduce cigarette consumption by at least half with ECs compared with placebo ECs (RR 1.31, 95% CI 1.02 to 1.68, 2 studies; placebo: 27% versus EC: 36%; GRADE: low) and compared with patch (RR 1.41, 95% CI 1.20 to 1.67, 1 study; patch: 44% versus EC: 61%; GRADE: very low). Unlike smoking cessation outcomes, reduction results were not biochemically verified.None of the RCTs or cohort studies reported any serious adverse events (SAEs) that were considered to be plausibly related to EC use. One RCT provided data on the proportion of participants experiencing any adverse events. Although the proportion of participants in the study arms experiencing adverse events was similar, the confidence intervals are wide (ECs vs placebo EC RR 0.97, 95% CI 0.71 to 1.34; ECs vs patch RR 0.99, 95% CI 0.81 to 1.22). The other RCT reported no statistically significant difference in the frequency of AEs at three- or 12-month follow-up between the EC and placebo EC groups, and showed that in all groups the frequency of AEs (with the exception of throat irritation) decreased significantly over time. Authors' conclusions: There is evidence from two trials that ECs help smokers to stop smoking long-term compared with placebo ECs. However, the small number of trials, low event rates and wide confidence intervals around the estimates mean that our confidence in the result is rated 'low' by GRADE standards. The lack of difference between the effect of ECs compared with nicotine patches found in one trial is uncertain for similar reasons. ECs appear to help smokers unable to stop smoking altogether to reduce their cigarette consumption when compared with placebo ECs and nicotine patches, but the above limitations also affect certainty in this finding. In addition, lack of biochemical assessment of the actual reduction in smoke intake further limits this evidence. No evidence emerged that short-term EC use is associated with health risk.