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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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... Following title screening, 275 articles were included in the abstract screening and 16 articles were included in the full-text screening, with 12 studies being identified as eligible for extraction. Due to differences between the studies in terms of outcome, study duration, comparison groups, and population, we included five studies in the first meta-analysis and five studies in the second meta-analysis (two studies 33,34 were eligible for both analyses-for one of those studies, 34 one publication 35 reported updated results for a later follow-up which were used in the according analyses), and the rest were qualitatively analyzed. Reasons for exclusion are shown in summary diagram ( Figure 1), and information on all included studies are presented in Supplementary Table 1. ...
... Overall, five studies employed a sampling strategy among patient populations including people reporting mental illness, perioperative patients and patients visiting the pulmonary outpatient clinic or those who visited smoking cessation outpatient services. 34,35,37,39,41,42 Other studies sampled among the general population were mostly recruited through advertisements in local media outlets, 33,34,36,38,43 with two studies using employees of companies out of which one study's participants were involved in a health-promoting program. 40,44 All studies included adults (over 18 years old) with one study only focusing on people aged 21-35 years old, 43 one study focusing on people aged 55 years or older, 34,35 and one study focusing only on male employees. ...
... Overall, five studies employed a sampling strategy among patient populations including people reporting mental illness, perioperative patients and patients visiting the pulmonary outpatient clinic or those who visited smoking cessation outpatient services. 34,35,37,39,41,42 Other studies sampled among the general population were mostly recruited through advertisements in local media outlets, 33,34,36,38,43 with two studies using employees of companies out of which one study's participants were involved in a health-promoting program. 40,44 All studies included adults (over 18 years old) with one study only focusing on people aged 21-35 years old, 43 one study focusing on people aged 55 years or older, 34,35 and one study focusing only on male employees. ...
Article
Background: Reports of the effectiveness of e-cigarettes (ECs) for smoking cessation vary across different studies making implementation recommendations hard to attain. We performed a systematic review and meta-analysis to assess the current evidence regarding effectiveness of ECs for smoking cessation. Methods: PubMed, PsycInfo and Embase databases were searched for randomized controlled trials comparing nicotine ECs with non-nicotine ECs or with established smoking cessation interventions (nicotine replacement therapy (NRT) and or counselling) published between 01/01/2014 and 27/06/2020 Data from eligible studies were extracted and used for random-effects meta-analyses (PROSPERO registration number: CRD42019141414). Results: The search yielded 13950 publications with 12 studies being identified as eligible for systematic review (N=8362) and 9 for random-effects meta-analyses (range: 30 to 6006 participants). The proportion of smokers achieving abstinence was 1.71 [95CI:1.02 to 2.84] times higher in nicotine EC users compared to non-nicotine EC users. The proportion of abstinent smokers was 1.69 [95CI:1.25 to 2.27] times higher in EC users compared to participants receiving NRT. EC users showed a 2.04 [95CI:0.90 to 4.64] times higher proportion of abstinent smokers in comparison with participants solely receiving counselling. Discussion: Our results suggest that nicotine-ECs may be more effective in smoking cessation when compared to placebo ECs or NRT. When compared to counselling alone, nicotine ECs are more effective short-term but its effectiveness appears to diminish with later follow-ups. Given the small number of studies, heterogeneous design and the overall moderate to low quality of evidence, it is not possible to offer clear recommendations. Implications: The results of this study do not allow for a conclusive argument. However, pooling current evidence points towards a potential for e-cigarettes as a smoking cessation tool. Though, given the overall quality of evidence, future studies should aim for more clarity in terms of interventions and larger study populations.
... Study characteristics of the 7 e-cigarette trials are shown in Table 1. All trials were from high-income countries; two from the USA (Halpern et al., 2018;Carpenter et al., 2017), two from Italy (Caponnetto et al., 2013;Masiero et al., 2019), one from New Zealand (Hartmann-Boyce et al., 2018), one from the UK (Hajek et al., 2019), and one from Korea (Lee et al., 2019). Two were multi-arm trials comparing nicotine ecigarette use against a nicotine-free control condition and NRT (Bullen et al., 2013;Halpern et al., 2018); three compared nicotine e-cigarette use against a nicotine-free control condition (Caponnetto et al., 2013; ...
... Carpenter et al., 2017;Masiero et al., 2019) and two compared nicotine e-cigarette use against licensed NRTs(Hajek et al., 2019;Lee et al., 2019). One was a pilot study(Carpenter et al., 2017). ...
... The combined sample size was 5674. Three of the studies had a low risk of bias(Bullen et al., 2013;Hajek et al., 2019;Caponnetto et al., 2013), two had some concerns(Lee et al., 2019;Halpern et al., 2018) and two were classified as high risk(Carpenter et al., 2017;Masiero et al., 2019). Individual domain ratings for the risk of bias assessment are shown in Appendix 4. ...
Article
Aim E-cigarettes, or nicotine vaping products, are potential smoking cessation aids that provide both nicotine and behavioural substitution for combustible cigarette smoking. This review aims to compare the effectiveness of nicotine e-cigarettes for smoking cessation with licensed nicotine replacement therapies (NRT) and nicotine-free based control conditions by using network meta-analysis (NMA). Methods We searched PubMed, Web of Science and PsycINFO for randomised controlled trials (RCTs) that allocated individuals to use nicotine e-cigarettes, compared to those that used licensed NRT (e.g., nicotine patches, nicotine gums, etc), or a nicotine-free control condition such as receiving placebo (nicotine-free) e-cigarettes or usual care. We only included studies of healthy individuals who smoked. Furthermore, we identified the latest Cochrane review on NRT and searched NRT trials that were published in similar periods as the e-cigarette trials we identified. NMA was conducted to compare the effect of e-cigarettes on cessation relative to NRT and control condition. Cochrane risk-of-bias tool for randomized trials Version 2 was used to access study bias. Results For the e-cigarette trials, our initial search identified 4,717 studies and we included 7 trials for NMA after removal of duplicates, record screening and assessment of eligibility (Total N = 5,674). For NRT trials, our initial search identified 1,014 studies and we included 9 trials that satisfied our inclusion criteria (Total N = 6,080). Results from NMA indicated that participants assigned to use nicotine e-cigarettes were more likely to remain abstinent from smoking than those in the control condition (pooled Risk Ratio (RR) = 2.08, 97.5% CI = [1.39, 3.15]) and those who were assigned to use NRT (pooled RR = 1.49, 97.5% CI = [1.04, 2.14]. There was a moderate heterogeneity between studies (I² = 42%). Most of the e-cigarette trials has moderate or high risk of bias. Conclusion Smokers assigned to use nicotine e-cigarettes were more likely to remain abstinent from smoking than those assigned to use licensed NRT, and both were more effective than usual care or placebo conditions. More high quality studies are required to ascertain the effect of e-cigarette on smoking cessation due to risk of bias in the included studies.
... In recent years, Electronic Nicotine Delivery Systems (ENDS), commonly known as e-cigarettes, are newly invented, battery-powered 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). ...
Chapter
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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. ...
Chapter
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.
... The trials were heterogeneous in study population and design. In two studies of smokers motivated to quit, one showed an increase in stopping rates with ecigarettes, with or without nicotine, compared to lowintensity counselling, 33 but the other found no incremental effect when e-cigarettes were added to combined nicotine replacement therapy and counselling. 34 Three studies investigated smokers not motivated to quit. ...
Article
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The TSANZ develops position statements where insufficient data exist to write formal clinical guidelines. In 2018, the TSANZ addressed the question of potential benefits and health impacts of electronic cigarettes (EC). The working party included groups focused on health impacts, smoking cessation, youth issues and priority populations. The 2018 report on the Public Health Consequences of E‐Cigarettes from the United States NASEM was accepted as reflective of evidence to mid‐2017. A search for papers subsequently published in peer‐reviewed journals was conducted in August 2018. A small number of robust and important papers published until March 2019 were also identified and included. Groups identified studies that extended, modified or contradicted the NASEM report. A total of 3793 papers were identified and reviewed, with summaries and draft position statements developed and presented to TSANZ membership in April 2019. After feedback from members and external reviewers, a collection of position statements was finalized in December 2019. EC have adverse lung effects and harmful effects of long‐term use are unknown. EC are unsuitable consumer products for recreational use, part‐substitution for smoking or long‐term exclusive use by former smokers. Smokers who require support to quit smoking should be directed towards approved medication in conjunction with behavioural support as having the strongest evidence for efficacy and safety. No specific EC product can be recommended as effective and safe for smoking cessation. Smoking cessation claims in relation to EC should be assessed by established regulators.
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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Since 2010, several nations with impressive histories of smoking cessation have witnessed the proliferation of Alternative Nicotine Delivery Systems (ANDS). Advocates suggest that ANDS offer an effective and safer substitute for combustible tobacco. Critics fear that ANDS could expose consumers to novel harms, discourage smoking cessation and may even renormalize tobacco use. Different nations have adopted radically different regulatory strategies ranging from outright bans to active encouragement of ANDS-led smoking cessation. Economic, social and political factors also influence rates of smoking and uptake of ANDS. An investigation into the national-specific context for smoking cessation; including the role of ANDS in reducing cigarette consumption, is likely of value to regulators around the world hoping to reduce smoking-related morbidity and mortality in their own communities. Five case studies were conducted to review the evidence from Australia, Canada, Japan, South Korea and the UK, drawing on an interdisciplinary framework for investigation combining sociological, ethnographic, policy analytic and econometric disciplinary approaches into a schema for studying the drivers of smoking cessation at the individual, micro, meso and macro levels. Data on smoking, and cessation from four decades was combined with more recent data on ANDS use, to investigate the relationship between tobacco control policies, ANDS use and smoking cessation, as well as other salient aspects of the national tobacco control landscape. Each case study developed specific recommendations for policy makers and the research agenda. This report summarizes the findings of those studies. Taxation and Stop Smoking Services (SSS) were among the most effective cessation drivers. Smoke-free laws were also found to be of value, though the evidence for their efficacy in reducing smoking prevalence is mixed. Other policies that sought to reduce the appeal or opportunity to smoke such as plain pack legislation and health warnings, etc. were less associated with short term reductions in smoking prevalence, though these may yet reduce national smoking rates by discouraging uptake among future generations. Tobacco use continues to be concentrated in socially and economically disadvantaged groups. Where regulations allowed, ANDS (e-cigarettes and heated tobacco in particular) were associated with smoking cessation. Moreover, instances of tobacco use declining even as e-cigarette use increased suggests that e-cigarettes do not necessarily re-normalize tobacco use as feared. The results demonstrate how policy decisions affect ANDS use and the latter’s value as a cessation mechanism. The authors recommend that regulators continue to increase tobacco taxes carefully and study how to integrate ANDS with well-funded SSS provision. Regulators should also seek policies that differentiate among nicotine products with respect to their harms profiles. Future cessation programs should target socially and economically disadvantaged groups where tobacco harms continue to be concentrated. This research highlights the need for high quality open-access data collection and analysis, especially regarding use of ANDS.
Article
Importance It has been estimated that in 2018 nearly 20% of adults in the US were currently using a tobacco product. Objective To systematically review the effectiveness and safety of pharmacotherapy, behavioral interventions, and electronic cigarettes for tobacco cessation among adults, including pregnant persons, to inform the US Preventive Services Task Force. Data Sources PubMed, PsycInfo, Database of Abstracts of Reviews of Effects, Cochrane Database of Systematic Reviews, Centre for Reviews and Dissemination of Health Technology Assessment; surveillance through September 25, 2020. Study Selection Systematic reviews of tobacco cessation interventions and randomized clinical trials that evaluated the effects of electronic cigarettes (e-cigarettes) or pharmacotherapy among pregnant persons. Data Extraction and Synthesis Independent critical appraisal and data abstraction; qualitative synthesis and random-effects meta-analyses. Main Outcomes and Measures Health outcomes, tobacco cessation at 6 months or more, and adverse events. Results Sixty-seven reviews addressing pharmacotherapy and behavioral interventions were included as well as 9 trials (N = 3942) addressing e-cigarettes for smoking cessation and 7 trials (N = 2285) of nicotine replacement therapy (NRT) use in pregnancy. Combined pharmacotherapy and behavioral interventions (pooled risk ratio [RR], 1.83 [95% CI, 1.68-1.98]), NRT (RR, 1.55 [95% CI, 1.49-1.61]), bupropion (RR, 1.64 [95% CI, 1.52-1.77]), varenicline (RR, 2.24 [95% CI, 2.06-2.43]), and behavioral interventions such as advice from clinicians (RR, 1.76 [95% CI, 1.58-1.96]) were all associated with increased quit rates compared with minimal support or placebo at 6 months or longer. None of the drugs were associated with serious adverse events. Five trials (n = 3117) reported inconsistent findings on the effectiveness of electronic cigarettes on smoking cessation at 6 to 12 months among smokers when compared with placebo or NRT, and none suggested higher rates of serious adverse events. Among pregnant persons, behavioral interventions were associated with greater smoking cessation during late pregnancy (RR, 1.35 [95% CI, 1.23-1.48]), compared with no intervention. Rates of validated cessation among pregnant women allocated to NRT compared with placebo were not significantly different (pooled RR, 1.11 [95% CI, 0.79-1.56], n = 2033). Conclusions and Relevance There is strong evidence that a range of pharmacologic and behavioral interventions, both individually and in combination, are effective in increasing smoking cessation in nonpregnant adults. In pregnancy, behavioral interventions are effective for smoking cessation, but data are limited on the use of pharmacotherapy for smoking cessation. Data on the effectiveness and safety of electronic cigarettes for smoking cessation among adults are also limited and results are inconsistent.
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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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In this review, we discuss current evidence on electronic cigarettes (ECs), a rapidly evolving class of nicotine delivery system, and their role in managing nicotine addiction, specifically in helping smokers to quit smoking and/or reduce the amount of tobacco they smoke. The current evidence base is limited to three randomized trials (only one compares ECs with nicotine replacement therapy) and a growing number of EC user surveys (n=6), case reports (n=4), and cohort studies (n=8). Collectively, these studies suggest modest cessation efficacy and a few adverse effects, at least with the short-term use. On this basis, we provide advice for health care providers on providing balanced information for patients who enquire about ECs. More research, specifically well-conducted large efficacy trials comparing ECs with standard smoking cessation management (eg, nicotine replacement therapy plus behavioral support) and long-term prospective studies for adverse events, are urgently needed to fill critical knowledge gaps on these products.
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Background: Smoking is a global public health problem. For this reason, experts have called smoking dependence a global epidemic. Over the past 5 years, sales of electronic cigarettes, or e-cigarettes, have been growing strongly in many countries. Yet there is only partial evidence that e-cigarettes are beneficial for smoking cessation. In particular, although it has been proven that nicotine replacement devices may help individuals stop smoking and tolerate withdrawal symptoms, e-cigarettes' power to increase the quitting success rate is still limited, ranging from 5% to 20% dependent on smokers' baseline conditions as shown by a recent Cochrane review. Consequently, it is urgent to know if e-cigarettes may have a higher success rate than other nicotine replacement methods and under what conditions. Furthermore, the effects of the therapeutic setting and the relationship between individual characteristics and the success rate have not been tested. This protocol is particularly innovative, because it aims to test the effectiveness of electronic devices in a screening program (the COSMOS II lung cancer prevention program at the European Institute of Oncology), where tobacco reduction is needed to lower individuals' lung cancer risks. Objective: This protocol was designed with the primary aim of investigating the role of tobacco-free cigarettes in helping smokers improve lung health and either quit smoking or reduce their tobacco consumption. In particular, we aim to investigate the impact of a 3-month e-cigarettes program to reduce smoking-related respiratory symptoms (eg, dry cough, shortness of breath, mouth irritation, and phlegm) through reduced consumption of tobacco cigarettes. Furthermore, we evaluate the behavioral and psychological (eg, well-being, mood, and quality of life) effects of the treatment. Methods: This is a prospective, randomized, placebo-controlled, double-blind, three-parallel group study. The study is organized as a nested randomized controlled study with 3 branches: a nicotine e-cigarettes group, a nicotine-free e-cigarettes group, and a control group. The study is nested in a screening program for early lung cancer detection in heavy smokers. Results: The study is open and is still recruiting. Conclusions: Stopping or reducing tobacco consumption should be a main goal of any health organization. However, traditional antismoking programs are expensive and not always effective. Therefore, favoring a partial or complete shift to e-cigarettes in heavy smokers (eg, persons at high risk for a number of diseases) could be considered a moral imperative. However, before following this path, sound and reliable data on large samples and in a variety of contexts are required. Trial registration: Clinicaltrials.gov NCT02422914; https://clinicaltrials.gov/ct2/show/NCT02422914 (Archived by WebCite at http://www.webcitation.org/6etwz1bPL).
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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.