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

Peter Hajek; Dunja Przulj; Francesca Pesola; Chris Griffiths; Robert Walton; Hayden McRobbie; Tim Coleman; Sarah Lewis; Rachel Whitemore; Miranda Clark; Michael Ussher; Lesley Sinclair; Emily Seager; Sue Cooper; Linda Bauld; Felix Naughton; Peter Sasieni; Isaac Manyonda; Katie Myers Smith

doi:10.1038/s41591-022-01808-0

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

Peter Hajek, Dunja Przulj, Francesca Pesola^*, Chris Griffiths, Robert Walton, Hayden McRobbie, Tim Coleman, Sarah Lewis, Rachel Whitemore, Miranda Clark, Michael Ussher, Lesley Sinclair, Emily Seager, Sue Cooper, Linda Bauld, Felix Naughton, Peter Sasieni, Isaac Manyonda, Katie Myers Smith

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

42 Citations (Scopus)

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.

Original language	English
Pages (from-to)	958-964
Number of pages	7
Journal	Nature Medicine
Volume	28
Issue number	5
DOIs	https://doi.org/10.1038/s41591-022-01808-0
Publication status	Published - May 2022

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10.1038/s41591-022-01808-0

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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

@article{f662f31d59a348bb93848c92c69eba0e,

title = "Electronic cigarettes versus nicotine patches for smoking cessation in pregnancy: a randomized controlled trial",

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.",

author = "Peter Hajek and Dunja Przulj and Francesca Pesola and Chris Griffiths and Robert Walton and Hayden McRobbie and Tim Coleman and Sarah Lewis and Rachel Whitemore and Miranda Clark and Michael Ussher and Lesley Sinclair and Emily Seager and Sue Cooper and Linda Bauld and Felix Naughton and Peter Sasieni and Isaac Manyonda and {Myers Smith}, Katie",

note = "Funding Information: P.H. provided consultancy to and received research funding from Pfizer. D.P. received research funding from Pfizer. H.M. has received honoraria for speaking at smoking cessation educational events and sitting on an advisory board organized by Pfizer. All other authors have no competing interests. Funding Information: 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. Publisher Copyright: {\textcopyright} 2022, The Author(s).",

year = "2022",

month = may,

doi = "10.1038/s41591-022-01808-0",

language = "English",

volume = "28",

pages = "958--964",

journal = "Nature Medicine",

issn = "1078-8956",

publisher = "Nature Publishing Group",

number = "5",

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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, vol. 28, no. 5, pp. 958-964. https://doi.org/10.1038/s41591-022-01808-0

TY - JOUR

T1 - Electronic cigarettes versus nicotine patches for smoking cessation in pregnancy

T2 - a randomized controlled trial

AU - Hajek, Peter

AU - Przulj, Dunja

AU - Pesola, Francesca

AU - Griffiths, Chris

AU - Walton, Robert

AU - McRobbie, Hayden

AU - Coleman, Tim

AU - Lewis, Sarah

AU - Whitemore, Rachel

AU - Clark, Miranda

AU - Ussher, Michael

AU - Sinclair, Lesley

AU - Seager, Emily

AU - Cooper, Sue

AU - Bauld, Linda

AU - Naughton, Felix

AU - Sasieni, Peter

AU - Manyonda, Isaac

AU - Myers Smith, Katie

N1 - Funding Information: P.H. provided consultancy to and received research funding from Pfizer. D.P. received research funding from Pfizer. H.M. has received honoraria for speaking at smoking cessation educational events and sitting on an advisory board organized by Pfizer. All other authors have no competing interests. Funding Information: 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. Publisher Copyright: © 2022, The Author(s).

PY - 2022/5

Y1 - 2022/5

N2 - 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.

AB - 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.

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U2 - 10.1038/s41591-022-01808-0

DO - 10.1038/s41591-022-01808-0

M3 - Article

AN - SCOPUS:85130156313

SN - 1078-8956

VL - 28

SP - 958

EP - 964

JO - Nature Medicine

JF - Nature Medicine

IS - 5

ER -

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

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