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Appears in Collections:Faculty of Health Sciences and Sport Journal Articles
Peer Review Status: Refereed
Title: Helping pregnant smokers quit: a multi-centre randomised controlled trial of electronic cigarettes versus nicotine replacement therapy
Author(s): Przulj, Dunja
Pesola, Francesca
Myers Smith, Katie
McRobbie, Hayden
Coleman, Tim
Lewis, Sarah
Griffith, Christopher
Walton, Robert
Whitemore, Rachel
Clark, Miranda
Ussher, Michael
Sinclair, Lesley
Seager, Emily
Cooper, Sue
Bauld, Linda
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Keywords: Health Policy
Issue Date: 1-Jul-2023
Date Deposited: 16-Feb-2024
Citation: Przulj D, Pesola F, Myers Smith K, McRobbie H, Coleman T, Lewis S, Griffith C, Walton R, Whitemore R, Clark M, Ussher M, Sinclair L, Seager E, Cooper S & Bauld L (2023) Helping pregnant smokers quit: a multi-centre randomised controlled trial of electronic cigarettes versus nicotine replacement therapy. <i>Health Technology Assessment</i>, 27 (13), pp. 1-53.
Abstract: Background Some pregnant smokers try e-cigarettes, but effectiveness and safety of such use are unknown. Objectives To compare effectiveness and safety of nicotine patches and e-cigarettes in pregnancy. Design A pragmatic multi-centre randomised controlled trial. Setting Twenty-three hospitals across England, and a Stop Smoking Service in Scotland. Participants One thousand one hundred and forty pregnant daily smokers (12–24 weeks’ gestation) motivated to stop smoking, with no strong preference for using nicotine patches or e-cigarettes. Interventions Participants in the e-cigarette arm were posted a refillable e-cigarette device with two 10 ml bottles of tobacco-flavoured e-liquid (18 mg nicotine). Participants in the nicotine patches arm were posted a 2-week supply of 15 mg/16-hour nicotine patches. Supplies were provided for up to 8 weeks. Participants sourced further supplies themselves as needed. Participants in both arms received support calls prior to their target quit date, on the quit date, and weekly for the next 4 weeks. Outcome measures The primary outcome was validated prolonged abstinence at the end of pregnancy. Participants lost to follow-up or not providing biochemical validation were included as non-abstainers. Secondary outcomes included self-reported abstinence at different time points, treatment adherence and safety outcomes. Results Only 55% of self-reported abstainers mailed back useable saliva samples. Due to this, validated sustained abstinence rates were low (6.8% vs. 4.4% in the e-cigarettes and nicotine patches arms, respectively, risk ratio = 1.55, 95% confidence interval 0.95 to 2.53; Bayes factor = 2.7). In a pre-specified sensitivity analysis that excluded abstainers using non-allocated products, the difference became significant (6.8% vs. 3.6%, risk ratio = 1.93, 95% confidence interval 1.14 to 3.26; Bayes factor = 10). Almost a third of the sample did not set a target quit date and the uptake of support calls was low, as was the initial product use. At end of pregnancy, 33.8% versus 5.6% of participants were using their allocated product in the e-cigarettes versus nicotine patches arm (risk ratio = 6.01, 95% confidence interval 4.21 to 8.58). Regular use of e-cigarettes in the nicotine patches arm was more common than use of nicotine replacement products in the e-cigarette arm (17.8% vs. 2.8%). Rates of adverse events and adverse birth outcomes were similar in the two study arms, apart from participants in the e-cigarette arm having fewer infants with low birthweight (<2500 g) (9.6% vs. 14.8%, risk ratio = 0.65, 95% confidence interval 0.47 to 0.90; Bayes factor = 10.3). Limitations Low rates of validation reduced the study power. A substantial proportion of participants did not use the support on offer sufficiently to test its benefits. Sample size may have been too small to detect differences in less frequent adverse effects. Conclusions E-cigarettes were not significantly more effective than nicotine patches in the primary analysis, but when e-cigarettes use in the nicotine patches arm was accounted for, e-cigarettes were almost twice as effective as patches in all abstinence outcomes. In pregnant smokers seeking help, compared to nicotine patches, e-cigarettes are probably more effective, do not pose more risks to birth outcomes assessed in this study and may reduce the incidence of low birthweight. Future work Routine monitoring of smoking cessation and birth outcomes in pregnant women using nicotine patches and e-cigarettes and further studies are needed to confirm these results. Trial registration This trial is registered as ISRCTN62025374 and Eudract 2017-001237-65. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 13. See the NIHR Journals Library website for further project information
DOI Link: 10.3310/agth6901
Rights: Copyright © 2023 Przulj et al. This work was produced by Przulj et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaption in any medium and for any purpose provided that it is properly attributed. See: For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.
Notes: Additional authors: Felix Naughton; Peter Sasieni; Isaac Manyonda; Peter Hajek
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