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

Electronic Nicotine Delivery Systems Female Humans Nicotine / adverse effects Pregnancy Smoking Cessation Tobacco Use Cessation Devices / adverse effects

Journal

Nature medicine

ISSN: 1546-170X

Titre abrégé: Nat Med

Pays: United States

ID NLM: 9502015

Informations de publication

Date de publication:
05 2022

Historique:

received: 06 09 2021

accepted: 31 03 2022

pubmed: 17 5 2022

medline: 21 5 2022

entrez: 16 5 2022

Statut: ppublish

Résumé

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.

Identifiants

DOI: 10.1038/s41591-022-01808-0 PMID: 35577966 PMC: PMC9117131

pubmed: 35577966

doi: 10.1038/s41591-022-01808-0

pii: 10.1038/s41591-022-01808-0

pmc: PMC9117131

doi:

Substances chimiques

Nicotine 6M3C89ZY6R

Banques de données

ISRCTN

['ISRCTN62025374']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

958-964

Subventions

Organisme : Medical Research Council

ID : MR/S037519/1

Pays : United Kingdom

Organisme : Department of Health

ID : 15/57/85

Pays : United Kingdom

Commentaires et corrections

Type : CommentIn

Type : ErratumIn

Informations de copyright

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