McNeill Ann, Gravely Shannon, Hitchman Sara C, Bauld Linda, Hammond David, Hartmann-Boyce Jamie
UK Centre for Tobacco and Alcohol Studies, National Addiction Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
University of Waterloo, Waterloo, Ontario, Canada.
Cochrane Database Syst Rev. 2017 Apr 27;4(4):CD011244. doi: 10.1002/14651858.CD011244.pub2.
Tobacco use is the largest single preventable cause of death and disease worldwide. Standardised tobacco packaging is an intervention intended to reduce the promotional appeal of packs and can be defined as packaging with a uniform colour (and in some cases shape and size) with no logos or branding, apart from health warnings and other government-mandated information, and the brand name in a prescribed uniform font, colour and size. Australia was the first country to implement standardised tobacco packaging between October and December 2012, France implemented standardised tobacco packaging on 1 January 2017 and several other countries are implementing, or intending to implement, standardised tobacco packaging.
To assess the effect of standardised tobacco packaging on tobacco use uptake, cessation and reduction.
We searched MEDLINE, Embase, PsycINFO and six other databases from 1980 to January 2016. We checked bibliographies and contacted study authors to identify additional peer-reviewed studies.
Primary outcomes included changes in tobacco use prevalence incorporating tobacco use uptake, cessation, consumption and relapse prevention. Secondary outcomes covered intermediate outcomes that can be measured and are relevant to tobacco use uptake, cessation or reduction. We considered multiple study designs: randomised controlled trials, quasi-experimental and experimental studies, observational cross-sectional and cohort studies. The review focused on all populations and people of any age; to be included, studies had to be published in peer-reviewed journals. We examined studies that assessed the impact of changes in tobacco packaging such as colour, design, size and type of health warnings on the packs in relation to branded packaging. In experiments, the control condition was branded tobacco packaging but could include variations of standardised packaging.
Screening and data extraction followed standard Cochrane methods. We used different 'Risk of bias' domains for different study types. We have summarised findings narratively.
Fifty-one studies met our inclusion criteria, involving approximately 800,000 participants. The studies included were diverse, including observational studies, between- and within-participant experimental studies, cohort and cross-sectional studies, and time-series analyses. Few studies assessed behavioural outcomes in youth and non-smokers. Five studies assessed the primary outcomes: one observational study assessed smoking prevalence among 700,000 participants until one year after standardised packaging in Australia; four studies assessed consumption in 9394 participants, including a series of Australian national cross-sectional surveys of 8811 current smokers, in addition to three smaller studies. No studies assessed uptake, cessation, or relapse prevention. Two studies assessed quit attempts. Twenty studies examined other behavioural outcomes and 45 studies examined non-behavioural outcomes (e.g. appeal, perceptions of harm). In line with the challenges inherent in evaluating standardised tobacco packaging, a number of methodological imitations were apparent in the included studies and overall we judged most studies to be at high or unclear risk of bias in at least one domain. The one included study assessing the impact of standardised tobacco packaging on smoking prevalence in Australia found a 3.7% reduction in odds when comparing before to after the packaging change, or a 0.5 percentage point drop in smoking prevalence, when adjusting for confounders. Confidence in this finding is limited, due to the nature of the evidence available, and is therefore rated low by GRADE standards. Findings were mixed amongst the four studies assessing consumption, with some studies finding no difference and some studies finding evidence of a decrease; certainty in this outcome was rated very low by GRADE standards due to the limitations in study design. One national study of Australian adult smoker cohorts (5441 participants) found that quit attempts increased from 20.2% prior to the introduction of standardised packaging to 26.6% one year post-implementation. A second study of calls to quitlines provides indirect support for this finding, with a 78% increase observed in the number of calls after the implementation of standardised packaging. Here again, certainty is low. Studies of other behavioural outcomes found evidence of increased avoidance behaviours when using standardised packs, reduced demand for standardised packs and reduced craving. Evidence from studies measuring eye-tracking showed increased visual attention to health warnings on standardised compared to branded packs. Corroborative evidence for the latter finding came from studies assessing non-behavioural outcomes, which in general found greater warning salience when viewing standardised, than branded packs. There was mixed evidence for quitting cognitions, whereas findings with youth generally pointed towards standardised packs being less likely to motivate smoking initiation than branded packs. We found the most consistent evidence for appeal, with standardised packs rating lower than branded packs. Tobacco in standardised packs was also generally perceived as worse-tasting and lower quality than tobacco in branded packs. Standardised packaging also appeared to reduce misperceptions that some cigarettes are less harmful than others, but only when dark colours were used for the uniform colour of the pack.
AUTHORS' CONCLUSIONS: The available evidence suggests that standardised packaging may reduce smoking prevalence. Only one country had implemented standardised packaging at the time of this review, so evidence comes from one large observational study that provides evidence for this effect. A reduction in smoking behaviour is supported by routinely collected data by the Australian government. Data on the effects of standardised packaging on non-behavioural outcomes (e.g. appeal) are clearer and provide plausible mechanisms of effect consistent with the observed decline in prevalence. As standardised packaging is implemented in different countries, research programmes should be initiated to capture long term effects on tobacco use prevalence, behaviour, and uptake. We did not find any evidence suggesting standardised packaging may increase tobacco use.
烟草使用是全球最大的单一可预防死亡和疾病原因。标准化烟草包装是一种旨在降低烟包促销吸引力的干预措施，可定义为具有统一颜色（在某些情况下还有形状和尺寸）、除健康警示及其他政府规定信息外无标识或品牌、品牌名称采用规定的统一字体、颜色和尺寸的包装。澳大利亚是2012年10月至12月间首个实施标准化烟草包装的国家，法国于2017年1月1日实施了标准化烟草包装，其他几个国家正在实施或打算实施标准化烟草包装。
评估标准化烟草包装对烟草使用的开始、戒烟和减少的影响。
我们检索了1980年至2016年1月期间的MEDLINE、Embase、PsycINFO及其他六个数据库。我们查阅了参考文献并联系研究作者以识别其他经同行评审的研究。
主要结局包括烟草使用流行率的变化，涵盖烟草使用的开始、戒烟、消费及预防复吸。次要结局包括可测量的、与烟草使用的开始、戒烟或减少相关的中间结局。我们考虑了多种研究设计：随机对照试验、准实验和实验性研究、观察性横断面和队列研究。该综述关注所有人群和任何年龄的人；纳入的研究必须发表在经同行评审的期刊上。我们审查了评估烟草包装变化（如颜色、设计、尺寸和烟包上健康警示的类型）对品牌包装影响的研究。在实验中，对照条件为品牌烟草包装，但可包括标准化包装的变体。
筛选和数据提取遵循Cochrane标准方法。我们针对不同研究类型使用了不同的“偏倚风险”领域。我们以叙述方式总结了研究结果。
51项研究符合我们的纳入标准，涉及约800,000名参与者。纳入的研究多种多样，包括观察性研究、参与者间和参与者内的实验性研究、队列研究和横断面研究以及时间序列分析。很少有研究评估青少年和非吸烟者的行为结局。五项研究评估了主要结局：一项观察性研究评估了澳大利亚700,000名参与者在标准化包装实施后一年的吸烟流行率；四项研究评估了9394名参与者的消费情况，包括对8811名现吸烟者进行的一系列澳大利亚全国横断面调查，以及另外三项规模较小的研究。没有研究评估开始吸烟、戒烟或预防复吸情况。两项研究评估了戒烟尝试。二十项研究检查了其他行为结局，45项研究检查了非行为结局（如吸引力、对危害的认知）。鉴于评估标准化烟草包装存在固有的挑战，纳入的研究中存在一些方法学上的局限性，总体而言，我们判断大多数研究在至少一个领域存在高偏倚风险或偏倚风险不明确。纳入的一项评估标准化烟草包装对澳大利亚吸烟流行率影响的研究发现，在调整混杂因素后，比较包装改变前后，吸烟几率降低了3.7%，即吸烟流行率下降了0.5个百分点。由于现有证据的性质，对这一发现的信心有限，因此根据GRADE标准评级较低。在评估消费情况的四项研究中，结果不一，一些研究未发现差异，一些研究发现有下降的证据；由于研究设计的局限性，根据GRADE标准，这一结局的确定性被评为非常低。一项对澳大利亚成年吸烟者队列（5441名参与者）的全国性研究发现，戒烟尝试从标准化包装实施前的20.2%增加到实施一年后的26.6%。另一项对戒烟热线来电的研究为这一发现提供了间接支持，标准化包装实施后，来电数量增加了78%。同样，这里的确定性也较低。对其他行为结局的研究发现，使用标准化烟包时回避行为增加、对标准化烟包的需求减少以及渴望降低的证据。测量眼动追踪的研究证据表明，与品牌烟包相比，标准化烟包上的健康警示吸引了更多的视觉注意力。评估非行为结局的研究为后一发现提供了佐证证据，总体而言，与品牌烟包相比，观察标准化烟包时警示的显著性更高。关于戒烟认知的证据不一，而关于青少年的研究结果通常表明，标准化烟包比品牌烟包更不容易促使开始吸烟。我们发现关于吸引力的证据最为一致，标准化烟包的评分低于品牌烟包。标准化烟包中的烟草通常也被认为比品牌烟包中的烟草味道更差、质量更低。标准化包装似乎还减少了一些香烟危害较小的误解，但仅当烟包的统一颜色为深色时才会如此。
现有证据表明，标准化包装可能会降低吸烟流行率。在本次综述时只有一个国家实施了标准化包装，因此证据来自一项大型观察性研究，该研究为此效应提供了证据。澳大利亚政府常规收集的数据支持吸烟行为的减少。关于标准化包装对非行为结局（如吸引力）影响的数据更清晰，并提供了与观察到的流行率下降一致的合理作用机制。随着不同国家实施标准化包装，应启动研究项目以了解其对烟草使用流行率、行为和开始吸烟的长期影响。我们未发现任何证据表明标准化包装可能会增加烟草使用。
