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; Myers Smith, Katie

Abstract

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.

Citation

Hajek, P., Przulj, D., Pesola, F., Griffiths, C., Walton, R., McRobbie, H., Coleman, T., Lewis, S., Whitemore, R., Clark, M., Ussher, M., Sinclair, L., Seager, E., Cooper, S., Bauld, L., Naughton, F., Sasieni, P., Manyonda, I., & Myers Smith, K. (2022). Electronic cigarettes versus nicotine patches for smoking cessation in pregnancy: a randomized controlled trial. Nature Medicine, 28(5), 958-964. https://doi.org/10.1038/s41591-022-01808-0

• Journal Article Type: Article
• Acceptance Date: Mar 31, 2022
• Online Publication Date: May 16, 2022
• Publication Date: May 16, 2022
• Deposit Date: May 8, 2022
• Publicly Available Date: Nov 17, 2022
• Journal: Nature Medicine
• Print ISSN: 1078-8956
• Electronic ISSN: 1546-170X
• Publisher: Nature Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 28
• Issue: 5
• Pages: 958-964
• DOI: https://doi.org/10.1038/s41591-022-01808-0
• Keywords: General Biochemistry, Genetics and Molecular Biology; General Medicine
• Public URL: https://nottingham-repository.worktribe.com/output/8041052
• Publisher URL: https://www.nature.com/articles/s41591-022-01808-0