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. 2024 Jan 8;1(1):CD010216. doi: 10.1002/14651858.CD010216.pub8.
BACKGROUND: Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol by heating an e-liquid. 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 safety, tolerability and effectiveness of using electronic cigarettes (ECs) to help people who smoke tobacco achieve long-term smoking abstinence, in comparison to non-nicotine EC, other smoking cessation treatments and no treatment. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group's Specialized Register to 1 February 2023, and Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO to 1 July 2023, and reference-checked and contacted study authors. SELECTION CRITERIA: We included 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 as these studies have the potential to provide further information on harms and longer-term use. Studies had to report an eligible outcome. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods for screening and data extraction. Critical outcomes were abstinence from smoking after at least six months, adverse events (AEs), and serious adverse events (SAEs). 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 pairwise and network meta-analyses (NMA). MAIN RESULTS: We included 88 completed studies (10 new to this update), representing 27,235 participants, of which 47 were randomized controlled trials (RCTs). Of the included studies, we rated ten (all but one contributing to our main comparisons) at low risk of bias overall, 58 at high risk overall (including all non-randomized studies), and the remainder at unclear risk. There is high certainty that nicotine EC increases quit rates compared to nicotine replacement therapy (NRT) (RR 1.59, 95% CI 1.29 to 1.93; I = 0%; 7 studies, 2544 participants). In absolute terms, this might translate to an additional four quitters per 100 (95% CI 2 to 6 more). There is moderate-certainty evidence (limited by imprecision) that the rate of occurrence of AEs is similar between groups (RR 1.03, 95% CI 0.91 to 1.17; I = 0%; 5 studies, 2052 participants). SAEs were rare, and there is insufficient evidence to determine whether rates differ between groups due to very serious imprecision (RR 1.20, 95% CI 0.90 to 1.60; I = 32%; 6 studies, 2761 participants; low-certainty evidence). There is moderate-certainty evidence, limited by imprecision, that nicotine EC increases quit rates compared to non-nicotine EC (RR 1.46, 95% CI 1.09 to 1.96; I = 4%; 6 studies, 1613 participants). In absolute terms, this might lead to an additional three quitters per 100 (95% CI 1 to 7 more). There is 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 is insufficient evidence to determine whether rates of SAEs differ between groups, due to very serious imprecision (RR 1.00, 95% CI 0.56 to 1.79; I = 0%; 9 studies, 1412 participants; low-certainty evidence). Due to issues with risk of bias, there is low-certainty evidence that, compared to behavioural support only/no support, quit rates may be higher for participants randomized to nicotine EC (RR 1.88, 95% CI 1.56 to 2.25; I = 0%; 9 studies, 5024 participants). In absolute terms, this represents an additional four quitters per 100 (95% CI 2 to 5 more). There was some evidence that (non-serious) AEs may be more common in people randomized to nicotine EC (RR 1.22, 95% CI 1.12 to 1.32; I = 41%, low-certainty evidence; 4 studies, 765 participants) and, again, insufficient evidence to determine whether rates of SAEs differed between groups (RR 0.89, 95% CI 0.59 to 1.34; I = 23%; 10 studies, 3263 participants; very low-certainty evidence). Results from the NMA were consistent with those from pairwise meta-analyses for all critical outcomes, and there was no indication of inconsistency within the networks. 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 both 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 due to risk of bias inherent in the study design. 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 the 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. 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。吸烟者、医疗保健提供者和监管机构都想知道电子烟是否有助于人们戒烟,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评价。
目的:检查使用电子烟 (EC) 帮助吸烟的人实现长期戒烟的安全性、耐受性和有效性,与非尼古丁 EC、其他戒烟治疗和无治疗相比。
检索方法:我们检索了 Cochrane 烟草成瘾组的专业注册库至 2023 年 2 月 1 日,以及 Cochrane 中心对照试验注册库 (CENTRAL)、MEDLINE、Embase 和 PsycINFO 至 2023 年 7 月 1 日,并参考和联系了研究作者。
入选标准:我们纳入了将吸烟者随机分配到 EC 或对照组的试验。我们还纳入了所有参与者接受 EC 干预的未对照干预研究,因为这些研究有可能提供关于危害和更长时间使用的进一步信息。研究必须报告合格的结果。
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。关键结果是至少 6 个月后戒烟、不良事件 (AE) 和严重不良事件 (SAE)。我们使用固定效应 Mantel-Haenszel 模型计算了二分类结局的风险比 (RR),置信区间 (CI) 为 95%。对于连续结局,我们计算了平均差异。在适当的情况下,我们在成对和网络荟萃分析 (NMA) 中汇总了数据。
主要结果:我们纳入了 88 项已完成的研究(其中 10 项为本次更新新增),代表了 27235 名参与者,其中 47 项为随机对照试验 (RCT)。纳入的研究中,我们总体上对 10 项(除了一项对我们的主要比较没有贡献)的偏倚风险进行了低风险评估,对 58 项的偏倚风险进行了高风险评估(包括所有非随机研究),其余研究的偏倚风险不明确。有高度确定性证据表明,与尼古丁替代疗法 (NRT) 相比,尼古丁 EC 增加了戒烟率 (RR 1.59, 95% CI 1.29 至 1.93; I = 0%; 7 项研究,2544 名参与者)。从绝对数值来看,这可能意味着每 100 人中额外有 4 人戒烟(95%CI 2 至 6 人更多)。有中度确定性证据(受不准确性限制)表明,各组之间 AE 的发生率相似 (RR 1.03, 95% CI 0.91 至 1.17; I = 0%; 5 项研究,2052 名参与者)。SAE 很少见,由于严重的不准确性,没有足够的证据来确定两组之间的发生率是否不同(RR 1.20, 95% CI 0.90 至 1.60; I = 32%; 6 项研究,2761 名参与者;低确定性证据)。有中度确定性证据,受不准确性限制,与非尼古丁 EC 相比,尼古丁 EC 增加了戒烟率 (RR 1.46, 95% CI 1.09 至 1.96; I = 4%; 6 项研究,1613 名参与者)。从绝对数值来看,这可能导致每 100 人中额外有 3 人戒烟(95%CI 1 至 7 人更多)。有中度确定性证据表明,两组之间的 AE 发生率没有差异 (RR 1.01, 95% CI 0.91 至 1.11; I = 0%; 5 项研究,1840 名参与者)。由于严重的不准确性,没有足够的证据来确定两组之间的 SAE 发生率是否不同(RR 1.00, 95% CI 0.56 至 1.79; I = 0%; 9 项研究,1412 名参与者;低确定性证据)。由于偏倚问题,有低确定性证据表明,与仅接受行为支持或不支持相比,随机分配到尼古丁 EC 的参与者的戒烟率可能更高 (RR 1.88, 95% CI 1.56 至 2.25; I = 0%; 9 项研究,5024 名参与者)。从绝对数值来看,这代表每 100 人中有额外 4 人戒烟(95%CI 2 至 5 人更多)。有一些证据表明(非严重)AE 可能在随机分配到尼古丁 EC 的人中更常见 (RR 1.22, 95% CI 1.12 至 1.32; I = 41%, 低确定性证据;4 项研究,765 名参与者),而且,同样,没有足够的证据来确定两组之间的 SAE 发生率是否不同(RR 0.89, 95% CI 0.59 至 1.34; I = 23%; 10 项研究,3263 名参与者;非常低确定性证据)。NMA 的结果与成对荟萃分析的所有关键结果一致,并且没有网络内不一致的迹象。来自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,这些症状往往会消失。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益处。
作者结论:有高度确定性证据表明,与尼古丁替代疗法相比,电子烟增加了戒烟率,有中度确定性证据表明,与不含尼古丁的电子烟相比,电子烟也增加了戒烟率。与常规护理/无治疗相比,比较尼古丁 EC 的研究也表明有获益,但由于研究设计固有的偏倚风险,证据不太确定。AE、SAE 和其他安全性标志物的数据的置信区间通常较宽,尼古丁和非尼古丁 EC 之间以及尼古丁 EC 和 NRT 之间的 AE 发生率无差异。总体而言,各研究组的 SAE 发生率较低。我们没有发现尼古丁 EC 有严重危害的证据,但最长的随访时间为两年,研究数量较少。证据基础的主要限制仍然是由于 RCT 数量较少且通常事件发生率较低而导致的不准确性。正在进行更多的 RCT。为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。我们每月进行检索,一旦有相关新证据,我们将更新审查。请参考 Cochrane 系统评价数据库以获取本综述的最新状态。
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