The Cochrane database of systematic reviewsApr 29, 2021

Using Electronic Cigarettes to Help People Stop Smoking

Psychedelic Science Weekly Brief ↗PubMed ↗DOI ↗

Updated Mar 25, 2026

Abstract

Moderate-certainty evidence suggests that nicotine electronic cigarettes (ECs) may increase quit rates compared to non-nicotine ECs and nicotine replacement therapy (NRT).

Quit rates were higher in individuals using nicotine EC compared to those using NRT, with a risk ratio of 1.69, suggesting an additional four successful quitters per 100.
There was also moderate-certainty evidence that nicotine ECs yielded higher quit rates than non-nicotine ECs, with a risk ratio of 1.70, indicating a potential increase of four successful quitters per 100.
Compared to behavioral support or no support, nicotine ECs were associated with a significantly higher quit rate, with a risk ratio of 2.70, representing an increase of seven successful quitters per 100.
The overall incidence of serious adverse events (SAEs) was low across all study groups, with no clear evidence of harm from nicotine ECs.
Most commonly reported adverse events included throat/mouth irritation, headache, cough, and nausea, which diminished over time with continued use.

Simplified

BACKGROUND: 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 organizations, 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.

OBJECTIVES: To examine the effectiveness, tolerability, and safety of using electronic cigarettes (ECs) to help people who smoke achieve long-term smoking abstinence.

SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group's Specialized 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.

SELECTION CRITERIA: We included randomized controlled trials (RCTs) and randomized 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.

MAIN RESULTS: 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 randomized to nicotine replacement therapy (NRT) (risk ratio (RR) 1.69, 95% confidence interval (CI) 1.25 to 2.27; I= 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; I= 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: I= 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; I= 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; I= 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; I= n/a; 4 studies, 494 participants). Compared to behavioral support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.70, 95% CI 1.39 to 5.26; I= 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; I= 41%, low certainty; 4 studies, 765 participants; SAEs: RR 1.17, 95% CI 0.33 to 4.09; I= 5%; 6 studies, 1011 participants, very low certainty). 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 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. 2 2 2 2 2 2 2 2 2

AUTHORS' CONCLUSIONS: 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.

Funding

Competing interests

RB holds an NIHR grant, however this did not directly fund this current work. She is principal investigator of an ongoing study listed in this review. CB was principal investigator on the ASCEND e‐cigarette trial reported in the Cochrane review and a co‐investigator on the ASCEND II trial and several other studies included in the review. CB has provided consultancy for J&J KK (Japan) on NRT products. CB reports research grants from the Health Research Council of NZ, the Heart Foundation of NZ and the NZ Ministry of Health. He has recently led a project funded by Pfizer (NZ) on chronic disease management. ARB's work on this review has been supported by Cancer Research UK Project Award funding. This is not deemed a conflict of interest. PH provided consultancy for and received research funding from Pfizer, a manufacturer of stop‐smoking medications. He was principal investigator on one of the trials included in this review and co‐investigator on other relevant studies. JHB has received support for this work from the Cochrane Review Support Programme and the University of Oxford's Returning Carer's Fund. Neither of these are deemed conflicts of interest. NL has received payment for lectures on systematic review methodology, and has been an applicant on project funding to carry out priority setting and systematic reviews in the area of tobacco control (NIHR funded). None of this is deemed a conflict of interest. HM has received honoraria for speaking at smoking cessation educational events and sitting on an advisory board organized by Pfizer. CN has no known conflicts of interest. NR has received royalties from UpToDate, Inc., for chapters on electronic cigarettes and occasional fees from academic hospitals or professional medical societies for lectures on smoking cessation that include discussion of electronic cigarettes. Dr. Rigotti was an member of the committee that produced the 2018 National Academies of Science, Engineering, and Medicine's Consensus Study Report on the Public Health Benefits of E‐cigarettes. She was unpaid for this work. Outside the topic of e‐cigarettes, Dr. Rigotti has received honoraria from Achieve Life Sciences for consulting about cytisine. NR is a consultant for Achieve LifeSciences, which is developing an investigational smoking cessation medication for FDA approval (cytisine) and her institution (MGH) receives a grant from the company as a site for a clinical trial testing the safety and efficacy of cytisine. NR has received travel reimbursement (but no honoraria) from Pfizer for attending advisory boards regarding varenicline. NR holds grants from NIH for research work. AT's work on this review has been supported by the Cochrane Review Support Programme and the University of Oxford's Returning Carer's Fund. Neither of these are deemed conflicts of interest. TT has no known conflicts of interest.

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Using Electronic Cigarettes to Help People Stop Smoking

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