A new trial from the University of East Anglia will see smokers attending emergency departments in five hospitals across the United Kingdom given e-cigarette starter packs to help them quit. The initiative came as a Cochrane Review – led by the University of Oxford – about vaping was updated on 29 April 2021.
The new Cochrane Review involving Oxford and the University of East Anglia (UEA), shows how nicotine electronic cigarettes could increase the number of people who stop smoking compared to nicotine replacement therapy – such as chewing gum and patches – and compared to electronic cigarettes that do not contain nicotine.
The Cochrane Review is the international gold standard for high quality, trusted health information.
According to a UEA article, the new trial will offer stop smoking advice and an e-cigarette ‘starter pack’ to patients attending hospital emergency departments for any reason, to try to encourage and support them to quit smoking – even for those who might not have considered it before.
The trial is funded by the National Institute for Health Research (NIHR) and will be run by the Norwich Clinical Trials Unit at UEA.
Professor Caitlin Notley, from UEA’s Norwich Medical School, said: “Many people who smoke want to quit, but find it difficult to succeed in the long term.
“Electronic cigarettes mimic the experience of cigarette smoking because they are hand-held and generate a smoke-like vapour when used. They can be an attractive option for helping people switch from smoking, even if they have tried and failed in the past.
“We know that they are much less harmful than smoking tobacco, and that they have been shown to help smokers quit.”
Trial co-lead Dr Ian Pope, also from UEA’s Norwich Medical School and an emergency physician, said: “Emergency departments in England see over 24 million people each year of whom around a quarter are current smokers.
“Attending the emergency department offers a valuable opportunity for people to be supported to quit smoking, which will improve their chances of recovery from whatever has brought them to hospital, and also prevent future illness.”
The study will run over 30 months across five hospitals in England and Scotland – at the Norfolk and Norwich University Hospital, the Royal London Hospital and Homerton University Hospital in London, Leicester Royal Infirmary and the Royal Infirmary of Edinburgh.
Smokers who agree to take part will be randomly assigned to receive either smoking advice during their emergency department wait, an e-cigarette starter pack and referral to local stop smoking services, or just written information about locally available stop smoking services.
Both groups of patients will be asked if they are still smoking one, three and six months after they attended hospital.
The research team hope to eventually recruit around 1,000 smokers to the trial.
Notley said: “We’ll be looking at the number of people who successfully quit smoking across both groups, to see which intervention works best. We’ll also work out how much it would cost to roll the scheme out nationally,” she added.
Electronic cigarettes for smoking cessation
Jamie Hartmann-Boyce, Hayden McRobbie, Nicola Lindson, Chris Bullen, Rachna Begh, Annika Theodoulou, Caitlin Notley, Nancy A Rigotti, Tari Turner, Ailsa R Butler, Thomas R Fanshawe and Peter Hajek
Author affiliations: University of East Anglia; University of Oxford; University of New South Wales in Australia; University of Auckland in New Zealand; Massachusetts General Hospital; Harvard Medical School; Monash University in Melbourne, Australia; and Queen Mary University of London.
Published by the Cochrane Library on 29 April 2021.
Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol formed by heating an e‐liquid. Some people who smoke use ECs to stop or reduce smoking, but some organisations, 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 and if they are safe to use for this purpose. This is an update of a review first published in 2014.
To examine the effectiveness, tolerability and safety of using electronic cigarettes (ECs) to help people who smoke achieve long‐term smoking abstinence.
We searched the Cochrane Tobacco Addiction Group's Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO to 1 February 2021, together with reference‐checking and contact with study authors.
We included randomized controlled trials (RCTs) and randomised 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.
To be included, studies had to report abstinence from cigarettes at six months or longer and/or data on adverse events (AEs) or other markers of safety at one week or longer.
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 changes in carbon monoxide, blood pressure, heart rate, blood oxygen saturation, lung function, and levels of known carcinogens/toxicants.
We used a fixed‐effect Mantel‐Haenszel model to calculate the risk ratio (RR) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data from these studies in meta‐analyses.
We included 56 completed studies, representing 12,804 participants, of which 29 were RCTs. Six of the 56 included studies were new to this review update. Of the included studies, we rated five (all contributing to our main comparisons) at low risk of bias overall, 41 at high risk overall (including the 25 non‐randomized studies), and the remainder at unclear risk.
There was moderate‐certainty evidence, limited by imprecision, that quit rates were higher in people randomized to nicotine EC than in those randomised to nicotine replacement therapy (NRT) (risk ratio (RR) 1.69, 95% confidence interval (CI) 1.25 to 2.27; I2 = 0%; 3 studies, 1498 participants). In absolute terms, this might translate to an additional four successful quitters per 100 (95% CI 2 to 8).
There was low‐certainty evidence (limited by very serious imprecision) that the rate of occurrence of AEs was similar) (RR 0.98, 95% CI 0.80 to 1.19; I2 = 0%; 2 studies, 485 participants). SAEs occurred rarely, with no evidence that their frequency differed between nicotine EC and NRT, but very serious imprecision led to low certainty in this finding (RR 1.37, 95% CI 0.77 to 2.41: I2 = n/a; 2 studies, 727 participants).
There was moderate‐certainty evidence, again limited by imprecision, that quit rates were higher in people randomized to nicotine EC than to non‐nicotine EC (RR 1.70, 95% CI 1.03 to 2.81; I2 = 0%; 4 studies, 1057 participants). In absolute terms, this might again lead to an additional four successful quitters per 100 (95% CI 0 to 11).
These trials mainly used older EC with relatively low nicotine delivery. 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; I2 = 0%; 3 studies, 601 participants). There was insufficient evidence to determine whether rates of SAEs differed between groups, due to very serious imprecision (RR 0.60, 95% CI 0.15 to 2.44; I2 = n/a; 4 studies, 494 participants).
Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.70, 95% CI 1.39 to 5.26; I2 = 0%; 5 studies, 2561 participants). In absolute terms this represents an increase of seven per 100 (95% CI 2 to 17).
However, this finding was of very low certainty, due to issues with imprecision and risk of bias. There was no evidence that the rate of SAEs differed, but some evidence that non‐serious AEs were more common in people randomized to nicotine EC (AEs: RR 1.22, 95% CI 1.12 to 1.32; I2 = 41%, low certainty; 4 studies, 765 participants; SAEs: RR 1.17, 95% CI 0.33 to 4.09; I2 = 5%; 6 studies, 1011 participants, very low certainty).
Data from non‐randomised 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 use. Very few studies reported data on other outcomes or comparisons and hence evidence for these is limited, with confidence intervals often encompassing clinically significant harm and benefit.
There is moderate‐certainty evidence that ECs with nicotine increase quit rates compared to ECs without nicotine and compared to NRT. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain.
More studies are needed to confirm the size of effect, particularly when using modern EC products. Confidence intervals were for the most part wide for data on AEs, SAEs and other safety markers, though evidence indicated no difference in AEs between nicotine and non‐nicotine ECs.
Overall incidence of SAEs was low across all study arms. We did not detect any clear evidence of harm from nicotine EC, but longest follow‐up was two years and the overall number of studies was small.
The evidence is limited mainly by 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, this review is now 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.
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