Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.
Cochrane Database Syst Rev. 2022 Nov 17;11(11):CD010216. doi: 10.1002/14651858.CD010216.pub7.
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; I = 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; I = 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; I = 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; I = 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; I = 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; I = 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; I = 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; I = 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; I = 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.
背景:电子烟是一种通过加热电子液体产生气溶胶的手持电子吸烟装置。一些吸烟的人使用电子烟来停止或减少吸烟,尽管一些组织、倡导团体和政策制定者劝阻了这种做法,理由是缺乏疗效和安全性的证据。吸烟者、医疗保健提供者和监管机构想知道电子烟是否可以帮助人们戒烟,以及它们是否可以安全地用于此目的。这是作为一项正在进行的系统评价的一部分进行的更新审查。
目的:检查使用电子烟(EC)帮助吸烟的人实现长期戒烟的有效性、耐受性和安全性。
检索方法:我们检索了 Cochrane 烟草成瘾组的专着登记册、Cochrane 中心对照试验注册库(CENTRAL)、MEDLINE、Embase 和 PsycINFO,截至 2022 年 7 月 1 日,并参考了文献和联系了研究作者。
选择标准:我们纳入了随机对照试验(RCT)和随机交叉试验,其中吸烟者被随机分配到 EC 或对照组。我们还纳入了所有参与者接受 EC 干预的非对照干预研究。研究必须报告至少 6 个月或更长时间的戒烟率,或 1 周或更长时间的安全性标志物数据,或两者兼有。
数据收集和分析:我们遵循了 Cochrane 标准的筛选和数据提取方法。我们的主要结局测量指标是至少 6 个月随访后戒烟的情况、不良事件(AE)和严重不良事件(SAE)。次要结局包括在随机分组后 6 个月或更长时间或开始使用 EC 时仍在使用研究产品(EC 或药物治疗)的人数、一氧化碳(CO)、血压(BP)、心率、动脉血氧饱和度、肺功能以及致癌物或有毒物质的水平,或两者兼有。我们使用固定效应 Mantel-Haenszel 模型计算具有 95%置信区间(CI)的二分类结局的风险比(RR)。对于连续结局,我们计算了平均差异。在适当的情况下,我们对数据进行了荟萃分析。
主要结果:我们纳入了 78 项已完成的研究,涉及 22052 名参与者,其中 40 项为 RCT。纳入的研究中有 17 项是本次综述更新的新研究。纳入的研究中,我们总体上对 10 项(除了一项均有助于我们的主要比较)的偏倚风险评价为低,50 项总体上为高(包括所有非随机研究),其余的为不确定。有高度确定性证据表明,与尼古丁替代疗法(NRT)相比,随机分配到尼古丁 EC 的人戒烟率更高(RR 1.63,95%CI 1.30 至 2.04;I = 10%;6 项研究,2378 名参与者)。从绝对数值来看,这可能意味着每 100 人中会额外有 4 人戒烟(95%CI 2 至 6)。有中等确定性证据(受限于不精确性)表明,两组之间的 AE 发生率相似(RR 1.02,95%CI 0.88 至 1.19;I = 0%;4 项研究,1702 名参与者)。SAE 很少见,但由于严重的不精确性,无法确定两组之间的发生率是否存在差异(RR 1.12,95%CI 0.82 至 1.52;I = 34%;5 项研究,2411 名参与者)。有中等确定性证据,受限于不精确性,与非尼古丁 EC 相比,随机分配到尼古丁 EC 的人戒烟率更高(RR 1.94,95%CI 1.21 至 3.13;I = 0%;5 项研究,1447 名参与者)。从绝对数值来看,这可能导致每 100 人中会额外有 7 人戒烟(95%CI 2 至 16)。有中等确定性证据表明,两组之间的 AE 发生率无差异(RR 1.01,95%CI 0.91 至 1.11;I = 0%;5 项研究,1840 名参与者)。由于严重的不精确性,无法确定两组之间的 SAE 发生率是否存在差异(RR 1.00,95%CI 0.56 至 1.79;I = 0%;8 项研究,1272 名参与者)。与仅接受行为支持或不支持相比,随机分配到尼古丁 EC 的参与者的戒烟率更高(RR 2.66,95%CI 1.52 至 4.65;I = 0%;7 项研究,3126 名参与者)。从绝对数值来看,这代表每 100 人中会额外有 2 人戒烟(95%CI 1 至 3)。然而,由于存在不精确性和偏倚风险,这一发现的确定性非常低。有一些证据表明(非严重)AE 在随机分配到尼古丁 EC 的人中更为常见(RR 1.22,95%CI 1.12 至 1.32;I = 41%,低确定性;4 项研究,765 名参与者),而且,由于严重的不精确性,我们仍然无法确定两组之间的 SAE 发生率是否存在差异(RR 1.03,95%CI 0.54 至 1.97;I = 38%;9 项研究,1993 名参与者)。非随机研究的数据与 RCT 数据一致。最常报告的 AE 是喉咙/口腔刺激、头痛、咳嗽和恶心,随着 EC 的持续使用,这些症状往往会减轻。很少有研究报告其他结局或比较的数据,因此这些证据有限,置信区间通常包含临床相关的危害和获益。
作者结论:有高度确定性证据表明,含尼古丁的 EC 可提高与 NRT 相比的戒烟率,并有中等确定性证据表明与不含尼古丁的 EC 相比可提高戒烟率。比较尼古丁 EC 与常规护理/无治疗的证据也表明有益,但更不确定。需要更多的研究来证实效果大小。AE、SAE 和其他安全性标志物的数据的置信区间通常很宽,尼古丁和非尼古丁 EC 之间以及尼古丁 EC 和 NRT 之间的 AE 无差异。各研究组的 SAE 总发生率较低。我们没有发现尼古丁 EC 有严重危害的证据,但最长随访时间为两年,且研究数量较少。证据基础的主要局限性仍然是由于 RCT 数量少,通常事件发生率低,导致不精确性,但正在进行更多的 RCT。为了确保审查继续为决策者提供最新信息,本审查是一项正在进行的系统评价。我们每月进行搜索,并且在有相关新证据时,会及时更新审查。请参考 Cochrane 系统评价数据库以了解该综述的最新状态。
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