Lindson-Hawley Nicola, Hartmann-Boyce Jamie, Fanshawe Thomas R, Begh Rachna, Farley Amanda, Lancaster Tim
Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, Oxfordshire, UK, OX2 6GG.
Cochrane Database Syst Rev. 2016 Oct 13;10(10):CD005231. doi: 10.1002/14651858.CD005231.pub3.
BACKGROUND: Although smoking cessation is currently the only guaranteed way to reduce the harm caused by tobacco smoking, a reasonable secondary tobacco control approach may be to try and reduce the harm from continued tobacco use amongst smokers unable or unwilling to quit. Possible approaches to reduce the exposure to toxins from smoking include reducing the amount of tobacco used, and using less toxic products, such as pharmaceutical, nicotine and potential reduced-exposure tobacco products (PREPs), as an alternative to cigarettes. OBJECTIVES: To assess the effects of interventions intended to reduce the harm to health of continued tobacco use, we considered the following specific questions: do interventions intended to reduce harm have an effect on long-term health status?; do they lead to a reduction in the number of cigarettes smoked?; do they have an effect on smoking abstinence?; do they have an effect on biomarkers of tobacco exposure?; and do they have an effect on biomarkers of damage caused by tobacco? SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group Trials Register (CRS) on the 21st October 2015, using free-text and MeSH terms for harm reduction, smoking reduction and cigarette reduction. SELECTION CRITERIA: Randomized or quasi-randomized controlled trials of interventions to reduce the amount smoked, or to reduce harm from smoking by means other than cessation. We include studies carried out in smokers with no immediate desire to quit all tobacco use. Primary outcomes were change in cigarette consumption, smoking cessation and any markers of damage or benefit to health, measured at least six months from the start of the intervention. DATA COLLECTION AND ANALYSIS: We assessed study eligibility for inclusion using standard Cochrane methods. We pooled trials with similar interventions and outcomes (> 50% reduction in cigarettes a day (CPD) and long-term smoking abstinence), using fixed-effect models. Where it was not possible to meta-analyse data, we summarized findings narratively. MAIN RESULTS: Twenty-four trials evaluated interventions to help those who smoke to cut down the amount smoked or to replace their regular cigarettes with PREPs, compared to placebo, brief intervention, or a comparison intervention. None of these trials directly tested whether harm reduction strategies reduced the harms to health caused by smoking. Most trials (14/24) tested nicotine replacement therapy (NRT) as an intervention to assist reduction. In a pooled analysis of eight trials, NRT significantly increased the likelihood of reducing CPD by at least 50% for people using nicotine gum or inhaler or a choice of product compared to placebo (risk ratio (RR) 1.75, 95% confidence interval (CI) 1.44 to 2.13; 3081 participants). Where average changes from baseline were compared for different measures, carbon monoxide (CO) and cotinine generally showed smaller reductions than CPD. Use of NRT versus placebo also significantly increased the likelihood of ultimately quitting smoking (RR 1.87, 95% CI 1.43 to 2.44; 8 trials, 3081 participants; quality of the evidence: low). Two trials comparing NRT and behavioural support to brief advice found a significant effect on reduction, but no significant effect on cessation. We found one trial investigating each of the following harm reduction intervention aids: bupropion, varenicline, electronic cigarettes, snus, plus another of nicotine patches to facilitate temporary abstinence. The evidence for all five intervention types was therefore imprecise, and it is unclear whether or not these aids increase the likelihood of smoking reduction or cessation. Two trials investigating two different types of behavioural advice and instructions on reducing CPD also provided imprecise evidence. Therefore, the evidence base for this comparison is inadequate to support the use of these types of behavioural advice to reduce smoking. Four studies of PREPs (cigarettes with reduced levels of tar, carbon and nicotine, and in one case delivered using an electronically-heated cigarette smoking system) showed some reduction in exposure to some toxicants, but it is unclear whether this would substantially alter the risk of harm. We judged the included studies to be generally at a low or unclear risk of bias; however, there were some ratings of high risk, due to a lack of blinding and the potential for detection bias. Using the GRADE system, we rated the overall quality of the evidence for our cessation outcomes as 'low' or 'very low', due to imprecision and indirectness. 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. AUTHORS' CONCLUSIONS: People who do not wish to quit can be helped to cut down the number of cigarettes they smoke and to quit smoking in the long term, using NRT, despite original intentions not to do so. However, we rated the evidence contributing to the cessation outcome for NRT as 'low' by GRADE standards. There is a lack of evidence to support the use of other harm reduction aids to reduce the harm caused by continued tobacco smoking. This could simply be due to the lack of high-quality studies (our confidence in cessation outcomes for these aids is rated 'low' or 'very low' due to imprecision by GRADE standards), meaning that we may have missed a worthwhile effect, or due to a lack of effect on reduction or quit rates. It is therefore important that more high-quality RCTs are conducted, and that these also measure the long-term health effects of treatments.
背景:尽管目前戒烟是减少吸烟危害的唯一可靠方法,但一种合理的二级烟草控制方法可能是尝试减少那些无法或不愿戒烟的吸烟者持续吸烟所造成的危害。减少吸烟毒素暴露的可能方法包括减少烟草使用量,以及使用毒性较小的产品,如药用、尼古丁和潜在的低暴露烟草产品(PREP),以替代香烟。 目的:为评估旨在减少持续吸烟对健康危害的干预措施的效果,我们考虑了以下具体问题:旨在减少危害的干预措施对长期健康状况有影响吗?它们会导致吸烟量减少吗?它们对戒烟有影响吗?它们对烟草暴露生物标志物有影响吗?以及它们对烟草造成的损害生物标志物有影响吗? 检索方法:我们于2015年10月21日检索了Cochrane烟草成瘾组试验注册库(CRS),使用了关于减少危害、减少吸烟和减少香烟的自由文本和医学主题词。 选择标准:干预措施的随机或半随机对照试验,旨在减少吸烟量,或通过戒烟以外的其他方法减少吸烟危害。我们纳入了对没有立即戒烟意愿的吸烟者进行的研究。主要结局是从干预开始至少六个月时测量的香烟消费量变化、戒烟情况以及任何健康损害或益处的标志物。 数据收集与分析:我们使用标准的Cochrane方法评估纳入研究的资格。我们将具有相似干预措施和结局(每天吸烟量减少>50%(CPD)和长期戒烟)的试验进行合并,使用固定效应模型。在无法对数据进行荟萃分析的情况下,我们对研究结果进行叙述性总结。 主要结果:与安慰剂、简短干预或对照干预相比,有24项试验评估了旨在帮助吸烟者减少吸烟量或用PREP替代其常规香烟的干预措施。这些试验均未直接测试减少危害策略是否能降低吸烟对健康造成的危害。大多数试验(14/24)测试了尼古丁替代疗法(NRT)作为辅助减少吸烟的干预措施。在对八项试验的汇总分析中,与安慰剂相比,使用尼古丁口香糖、吸入器或多种产品选择的人群中,NRT显著增加了将CPD至少减少50%的可能性(风险比(RR)1.75,95%置信区间(CI)1.44至2.13;3081名参与者)。当比较不同测量方法与基线的平均变化时,一氧化碳(CO)和可替宁的减少通常比CPD小。与安慰剂相比,使用NRT也显著增加了最终戒烟的可能性(RR 1.87,95%CI 1.43至2.44;8项试验,3081名参与者;证据质量:低)。两项比较NRT和行为支持与简短建议的试验发现对减少吸烟有显著效果,但对戒烟无显著效果。我们发现一项试验研究了以下每种减少危害干预辅助措施:安非他酮、伐尼克兰、电子烟、口含烟,外加一项关于尼古丁贴片以促进临时戒烟的试验。因此,所有这五种干预类型的证据都不精确,尚不清楚这些辅助措施是否会增加减少吸烟或戒烟的可能性。两项研究两种不同类型的减少CPD行为建议和指导的试验也提供了不精确的证据。因此,这种比较的证据基础不足以支持使用这些类型的行为建议来减少吸烟。四项关于PREP的研究(焦油、碳和尼古丁含量降低的香烟,以及在一个案例中使用电子加热吸烟系统提供的香烟)显示某些有毒物质的暴露有所减少,但尚不清楚这是否会实质性改变危害风险。我们判断纳入的研究总体上处于低或不清楚的偏倚风险;然而,由于缺乏盲法和检测偏倚的可能性,存在一些高风险评级。使用GRADE系统,由于证据不精确和间接性,我们将戒烟结局的总体证据质量评为“低”或“非常低”。“低”等级意味着进一步的研究很可能对我们对效应估计的信心产生重要影响,并可能改变估计值。“非常低”等级意味着我们对估计值非常不确定。 作者结论:使用NRT可以帮助那些不想戒烟的人减少吸烟量并长期戒烟,尽管他们原本没有这样的意愿。然而,根据GRADE标准,我们将支持NRT戒烟结局的证据评为“低”。缺乏证据支持使用其他减少危害辅助措施来减少持续吸烟造成的危害。这可能仅仅是由于缺乏高质量的研究(根据GRADE标准,由于不精确性,我们对这些辅助措施戒烟结局的信心评为“低”或“非常低”),这意味着我们可能遗漏了一个有价值的效应,或者是由于对减少吸烟或戒烟率没有影响。因此,进行更多高质量的随机对照试验非常重要,并且这些试验还应测量治疗的长期健康影响。
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