Electronic cigarettes versus nicotine patches for smoking cessation in pregnancy: A randomized controlled trial

Hajek, Peter, Przulj, Dunja, Pesola, Francesca, Griffiths, Chris, Walton, Robert, McRobbie, Hayden, Coleman, Tim, Lewis, Sarah, Whitemore, Rachel, Clark, Miranda, Ussher, Michael, Sinclair, Lesley, Seager, Emily, Cooper, Sue, Bauld, Linda, Naughton, Felix, Sasieni, Peter, Manyonda, Isaac and Myers Smith, Katie (2022) Electronic cigarettes versus nicotine patches for smoking cessation in pregnancy: A randomized controlled trial. Nature Medicine, 28 (5). pp. 958-964. ISSN 1078-8956

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Nicotine replacement therapy, in the form of nicotine patches, is commonly offered to pregnant women who smoke to help them to stop smoking, but this approach has limited efficacy in this population. Electronic cigarettes (e-cigarettes) are also used by pregnant women who smoke but their safety and efficacy in pregnancy are unknown. Here, we report the results of a randomized controlled trial in 1,140 participants comparing refillable e-cigarettes with nicotine patches. Pregnant women who smoked were randomized to e-cigarettes (n = 569) or nicotine patches (n = 571). In the unadjusted analysis of the primary outcome, validated prolonged quit rates at the end of pregnancy in the two study arms were not significantly different (6.8% versus 4.4% in the e-cigarette and patch arms, respectively; relative risk (RR) = 1.55, 95%CI: 0.95–2.53, P = 0.08). However, some participants in the nicotine patch group also used e-cigarettes during the study. In a pre-specified sensitivity analysis excluding abstinent participants who used non-allocated products, e-cigarettes were more effective than patches (6.8% versus 3.6%; RR = 1.93, 95%CI: 1.14–3.26, P = 0.02). Safety outcomes included adverse events and maternal and birth outcomes. The safety profile was found to be similar for both study products, however, low birthweight (<2,500 g) was less frequent in the e-cigarette arm (14.8% versus 9.6%; RR = 0.65, 95%CI: 0.47–0.90, P = 0.01). Other adverse events and birth outcomes were similar in the two study arms. E-cigarettes might help women who are pregnant to stop smoking, and their safety for use in pregnancy is similar to that of nicotine patches. ISRCTN62025374.

Item Type: Article
Additional Information: Acknowledgements: The study was funded by the National Institute of Health Research, Health Technology Programme (ref. no. 15/57/85). The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. The following authors were in receipt of this funding: P.H., D.P., C.G., R.Wa., H.M., T.C., S.L, M.U., L.S., S.C., L.B., F.N., P.S., I.M. and K.M.S. Tim Coleman is a National Institute for Health Research (NIHR) Senior Investigator.
Uncontrolled Keywords: replacement therapy,double-blind,smokers,intervention,exposure,metabolism,tobacco,infant,fetal,biochemistry, genetics and molecular biology(all) ,/dk/atira/pure/subjectarea/asjc/1300
Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Centres > Norwich Institute for Healthy Aging
Faculty of Medicine and Health Sciences > Research Groups > Behavioural and Implementation Science
Faculty of Medicine and Health Sciences > Research Groups > Health Promotion
Faculty of Medicine and Health Sciences > Research Centres > Lifespan Health
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Depositing User: LivePure Connector
Date Deposited: 05 Jul 2022 13:30
Last Modified: 19 Oct 2023 03:22
URI: https://ueaeprints.uea.ac.uk/id/eprint/85960
DOI: 10.1038/s41591-022-01808-0


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