Efficacy and safety of nicotine replacement therapy for smoking cessation in pregnancy: systematic review and meta-analysis
Article first published online: 4 NOV 2010
© 2010 The Authors, Addiction © 2010 Society for the Study of Addiction
Volume 106, Issue 1, pages 52–61, January 2011
How to Cite
Coleman, T., Chamberlain, C., Cooper, S. and Leonardi-Bee, J. (2011), Efficacy and safety of nicotine replacement therapy for smoking cessation in pregnancy: systematic review and meta-analysis. Addiction, 106: 52–61. doi: 10.1111/j.1360-0443.2010.03179.x
- Issue published online: 10 DEC 2010
- Article first published online: 4 NOV 2010
- Submitted 12 August 2010; initial review completed 19 August 2010; final version accepted 23 August 2010
- Clinical trials;
- nicotine replacement therapy;
- smoking cessation;
- systematic review
Aims To determine the efficacy and safety of nicotine replacement therapy (NRT) with or without behavioural support when used to support smoking cessation in pregnancy.
Design, Setting and Participants A systematic review of randomized controlled trials (RCTs) in which NRT was used with or without behavioural support to promote smoking cessation; trials providing unequal behavioural support to different trial groups were excluded.
Measurements Efficacy: self-reported smoking cessation in later pregnancy, validated where possible by biochemical measures with appropriate cut-points; infants' safety: mean and low birth weights (LBW), preterm birth, fetal demise and neonatal intensive care unit (NICU) admissions.
Findings Five trials, enrolling 695 pregnant, regular smokers were included in the review. The pooled risk ratio (RR) and 95% confidence Interval (CI) for smoking cessation in later pregnancy after using NRT was 1.63 (0.85, 3.14). Subgroup analysis comparing studies at lower risk of bias (placebo-RCTs) with those at higher risk of bias (non-placebo-RCTs) found that efficacy estimates varied with trial design [RR (95% CI) for cessation in placebo-RCTs 1.17 (0.83, 1.65) versus 7.81 (1.51, 40.35) for non-placebo-RCTs]. Five of the seven safety outcomes were more positive among infants born to women who had used NRT, but none of the observed differences between trial groups reached statistical significance.
Conclusions There is currently insufficient evidence to determine whether or not nicotine replacement therapy is effective or safe when used in pregnancy for smoking cessation; further research and, in particular, placebo-randomized controlled trials are required.