Butler Ailsa R, Lindson Nicola, Livingstone-Banks Jonathan, Notley Caitlin, Turner Tari, Rigotti Nancy A, Fanshawe Thomas R, Dawkins Lynne, Begh Rachna, Wu Angela Difeng, Brose Leonie, Conde Monserrat, Simonavičius Erikas, Hartmann-Boyce Jamie
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Addiction Research Group, Norwich Medical School, University of East Anglia, Norwich, UK.
Cochrane Database Syst Rev. 2025 Jan 8;1(1):CD016058. doi: 10.1002/14651858.CD016058.pub2.
There is limited guidance on the best ways to stop using nicotine-containing vapes (otherwise known as e-cigarettes) and ensure long-term abstinence, whilst minimising the risk of tobacco smoking and other unintended consequences. Treatments could include pharmacological interventions, behavioural interventions, or both.
To conduct a living systematic review assessing the benefits and harms of interventions to help people stop vaping compared to each other or to placebo or no intervention. To also assess how these interventions affect the use of combustible tobacco, and whether the effects vary based on participant characteristics.
We searched the following databases from 1 January 2004 to 24 April 2024: CENTRAL; MEDLINE; Embase; PsycINFO; ClinicalTrials.gov (through CENTRAL); World Health Organization International Clinical Trials Registry Platform (through CENTRAL). We also searched the references of eligible studies and abstracts from the Society for Research on Nicotine and Tobacco 2024 conference, and contacted study authors.
Randomised controlled trials (RCTs) recruiting people of any age using nicotine-containing vapes, regardless of tobacco smoking status. Studies had to test an intervention designed to support people to quit vaping, and plan to measure at least one of our outcomes.
Critical outcomes: vaping cessation; change in combustible tobacco use at six months or longer; number of participants reporting serious adverse events (SAEs) at one week or longer.
We used the Cochrane RoB 1 tool to assess bias in the included studies.
We followed standard Cochrane methods for screening and data extraction. We grouped studies by comparisons and outcomes reported, and calculated individual study and pooled effects, as appropriate. We used random-effects Mantel-Haenszel methods to calculate risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes. We used random-effects inverse variance methods to calculate mean differences and 95% CI for continuous outcomes. We assessed the certainty of the evidence using the GRADE approach.
Nine RCTs, representing 5209 participants motivated to stop using nicotine-containing vapes at baseline, are included. In six studies, participants were abstinent from smoking tobacco cigarettes at baseline, although most studies included some participants who had previously smoked. Eight studies included participants aged 18 or older, three included only young adults (18 to 24 years), and one included 13- to 17-year-olds only. We judged three studies at low risk, three at high risk, and three at unclear risk of bias.
Pharmacological interventions for quitting nicotine vaping Studies assessed combination nicotine replacement therapy (NRT), cytisine, and varenicline as pharmacological interventions for quitting vaping in comparison to placebo or no/minimal support (control). The point estimate for combination NRT indicated possible benefit, but the CI incorporated the possibility of no benefit and a potential benefit of control (very low-certainty evidence due to imprecision and risk of bias; RR 2.57, 95% CI 0.29 to 22.93; 1 study, 16 participants). The one study investigating cytisine did not report vaping cessation rates at six months or longer. Varenicline increased vaping cessation rates at six months, but the evidence was low certainty due to imprecision (RR 2.00, 95% CI 1.09 to 3.68; 1 study, 140 participants). Zero participants reported SAEs in the studies of combination NRT versus no/minimal support (1 study, 508 participants; low-certainty evidence due to imprecision) and cytisine versus placebo (1 study, 159 participants; low-certainty evidence due to imprecision). Three studies investigating varenicline measured the number of participants reporting SAEs. However, only one study reported an SAE (in the intervention arm); therefore, the effect estimate was calculated based on that single study (RR 2.60, 95% CI 0.11 to 62.16; 95 participants; low-certainty evidence due to imprecision). Behavioural interventions for quitting nicotine vaping Studies assessed reducing nicotine concentration and vaping behaviour (1 study) and text message-based interventions (3 studies) as behavioural interventions for stopping vaping in comparison to no/minimal support (control). In one study, the point estimate suggested nicotine/vaping reduction increased vaping cessation compared to minimal support at six-month follow-up, but the CI incorporated the possibility of no intervention effect and higher cessation rates in the control arm (RR 3.38, 95% CI 0.43 to 26.30; 17 participants; very low-certainty due to imprecision and risk of bias). There was low-certainty evidence (downgraded two levels due to indirectness) that text message-based interventions may have increased vaping cessation rates compared to control in 13- to 24-year-olds (RR 1.32, 95% CI 1.19 to 1.47; I = 0%; 2 studies, 4091 participants). The one study investigating nicotine/vaping behaviour reduction did not report on SAEs. One of the studies investigating text message-based interventions did report on SAEs; however, zero events were reported in both study arms (508 participants; low-certainty evidence due to imprecision). No studies reported change in combustible tobacco smoking at six-month follow-up or longer.
AUTHORS' CONCLUSIONS: There is low-certainty evidence that text message-based interventions designed to help people stop nicotine vaping may help more youth and young adults to successfully stop than no/minimal support, and low-certainty evidence that varenicline may also help people quit vaping. Data exploring the effectiveness of combination NRT, cytisine, and nicotine/vaping behaviour reduction are inconclusive due to risk of bias and imprecision. Most studies that measured SAEs reported none; however, more data are needed to draw clear conclusions. Of note, data from studies investigating these interventions for quitting smoking have not demonstrated serious concerns about SAEs. No studies assessed the change in combustible tobacco smoking, including relapse to or uptake of tobacco smoking, at six-month follow-up or longer. It is important that future studies measure this so the complete risk profile of relevant interventions can be considered. We identified 20 ongoing RCTs. Their incorporation into the evidence base and the continued identification of new studies is imperative to inform clinical and policy guidance on the best ways to stop vaping. Therefore, we will continue to update this review as a living systematic review by running searches monthly and updating the review when relevant new evidence that will strengthen or change our conclusions emerges.
Cancer Research UK (PRCPJT-Nov22/100012). National Institute of Health Research (NIHR206123) REGISTRATION: Protocol available via DOI: 10.1002/14651858.CD016058.
关于停止使用含尼古丁电子烟(又称电子烟)并确保长期戒烟的最佳方法,同时将吸烟风险和其他意外后果降至最低的指导有限。治疗方法可能包括药物干预、行为干预或两者结合。
进行一项实时系统评价,评估与其他干预措施、安慰剂或无干预相比,帮助人们停止使用电子烟的干预措施的益处和危害。还要评估这些干预措施如何影响可燃烟草的使用,以及效果是否因参与者特征而异。
我们检索了以下数据库,时间范围从2004年1月1日至2024年4月24日:Cochrane系统评价数据库;医学期刊数据库;Embase数据库;心理学文摘数据库;临床试验数据库(通过Cochrane系统评价数据库);世界卫生组织国际临床试验注册平台(通过Cochrane系统评价数据库)。我们还检索了符合条件的研究的参考文献以及尼古丁与烟草研究协会2024年会议的摘要,并联系了研究作者。
随机对照试验(RCT),招募任何年龄使用含尼古丁电子烟的人,无论其吸烟状况如何。研究必须测试旨在支持人们戒烟的干预措施,并计划测量我们的至少一项结果。
关键结果:戒烟;六个月或更长时间内可燃烟草使用的变化;报告严重不良事件(SAE)一周或更长时间的参与者数量。
我们使用Cochrane偏倚风险1工具评估纳入研究中的偏倚。
我们遵循Cochrane的标准方法进行筛选和数据提取。我们根据报告的比较和结果对研究进行分组,并在适当情况下计算个体研究和汇总效应。我们使用随机效应Mantel-Haenszel方法计算二分结果的风险比(RR)和95%置信区间(CI)。我们使用随机效应逆方差方法计算连续结果的平均差和95%CI。我们使用GRADE方法评估证据的确定性。
纳入了9项随机对照试验,代表了5209名在基线时有意停止使用含尼古丁电子烟的参与者。在6项研究中,参与者在基线时不吸烟,尽管大多数研究包括一些以前吸烟的参与者。8项研究纳入了18岁或以上的参与者,3项仅纳入了年轻人(18至24岁),1项仅纳入了13至17岁的青少年。我们判断3项研究偏倚风险低,3项偏倚风险高,3项偏倚风险不明确。
戒烟的药物干预措施 研究评估了联合尼古丁替代疗法(NRT)、金雀花碱和伐尼克兰作为戒烟的药物干预措施,与安慰剂或无/最小支持(对照)相比。联合NRT的点估计表明可能有益,但CI包含了无益处和对照潜在益处的可能性(由于不精确性和偏倚风险,证据确定性极低;RR 2.57,95%CI 0.29至22.93;1项研究,16名参与者)。一项研究金雀花碱的研究未报告六个月或更长时间的戒烟率。伐尼克兰在六个月时提高了戒烟率,但由于不精确性,证据确定性较低(RR 2.00,95%CI 1.09至3.68;1项研究,140名参与者)。在联合NRT与无/最小支持的研究(1项研究,508名参与者;由于不精确性,证据确定性低)和金雀花碱与安慰剂的研究(1项研究,159名参与者;由于不精确性,证据确定性低)中,零名参与者报告了严重不良事件。三项研究伐尼克兰的研究测量了报告严重不良事件的参与者数量。然而,只有一项研究报告了严重不良事件(在干预组);因此,效应估计是基于该单项研究计算的(RR 2.60,95%CI 0.11至62.16;95名参与者;由于不精确性,证据确定性低)。戒烟的行为干预措施 研究评估了降低尼古丁浓度和吸烟行为(1项研究)以及基于短信的干预措施(3项研究)作为与无/最小支持(对照)相比停止吸烟的行为干预措施。在一项研究中,点估计表明,与六个月随访时的最小支持相比,降低尼古丁/吸烟行为增加了戒烟率,但CI包含了无干预效果和对照组更高戒烟率的可能性(RR 3.38,95%CI 0.43至26.30;17名参与者;由于不精确性和偏倚风险,确定性极低)。有低确定性证据(由于间接性下调两级)表明,在13至24岁的人群中,基于短信的干预措施与对照相比可能提高了戒烟率(RR 1.32,95%CI 1.19至1.47;I = 0%;2项研究,4091名参与者)。一项研究降低尼古丁/吸烟行为的研究未报告严重不良事件。一项研究基于短信的干预措施的研究确实报告了严重不良事件;然而,两个研究组均未报告事件(508名参与者;由于不精确性,证据确定性低)。没有研究报告六个月随访或更长时间内可燃烟草吸烟的变化。
有低确定性证据表明,旨在帮助人们停止尼古丁吸烟的基于短信的干预措施可能比无/最小支持更有助于更多青少年和年轻人成功戒烟,有低确定性证据表明伐尼克兰也可能有助于人们戒烟。由于偏倚风险和不精确性,探索联合NRT、金雀花碱和降低尼古丁/吸烟行为有效性的数据尚无定论。大多数测量严重不良事件的研究均未报告;然而,需要更多数据才能得出明确结论。值得注意的是,研究这些戒烟干预措施的数据并未显示出对严重不良事件的严重担忧。没有研究评估六个月随访或更长时间内可燃烟草吸烟的变化,包括复吸或开始吸烟。未来的研究测量这一点很重要,以便可以考虑相关干预措施的完整风险概况。我们确定了20项正在进行的随机对照试验。将它们纳入证据库并持续识别新研究对于为停止吸烟的最佳方法提供临床和政策指导至关重要。因此,我们将继续作为实时系统评价更新本综述,每月进行检索,并在出现将加强或改变我们结论的相关新证据时更新综述。
英国癌症研究(PRCPJT-Nov22/100012)。国家卫生研究院(NIHR206123) 注册:方案可通过DOI:10.1002/14651858.CD016058获得。