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Nicotine patches fail to boost quit rates in pregnant women

Nicotine patches do not seem to promote smoking cessation or increase infant birthweight when used by pregnant smokers, a randomised placebo-controlled trial has found.

Irrespective of whether women used a nicotine patch or a placebo patch, just one in 20 managed to abstain from smoking during pregnancy and the average time to the first cigarette smoked after target quit date was 15 days.

Writing in the BMJ (2014;348:g1622), Ivan Berlin, senior lecturer at Pitié-Salpêtrière University Hospital, and co-authors call the results of their study “disappointing”. They write: “In the absence of evidence-based drug interventions, behavioural support remains the core intervention to help pregnant smokers to quit.”

Dr Berlin and team recruited 402 pregnant women who were at 12 to 20 weeks’ gestation and smoked at least five cigarettes per day. The women were randomly assigned to use a 16-hour nicotine or placebo patch from a predetermined “quit day” until delivery. Nicotine patch doses were individually adjusted to match women’s nicotine intake when smoking. All women also received monthly behavioural support.

Self-report together with analysis of exhaled carbon monoxide levels indicated that 5.5 per cent of women using nicotine patches achieved abstinence versus 5.1 per cent of women using placebo patches, a non-significant difference.

By week 2 after the target quit day, 62 per cent of women had relapsed, and the median time to the first cigarette smoked was 15 days in both groups. Birth and delivery outcomes did not differ between the groups, with an average birthweight of 3,065g in the nicotine patch group and 3,015g in the placebo group.

Interestingly, however, birthweight among women who were abstinent was significantly higher than in those who continued to smoke, at 3,364g versus 3,021g.

In an accompanying editorial (ibid, g1808), Leonie Brose, from the Institute of Psychiatry at King’s College London, suggests that nicotine replacement therapy may need to start earlier in pregnancy — ie, before the second trimester — in order to aid quitting.

She also notes that there was a two-week gap between the first and second sessions of behavioural support and NRT dose-adjustment. “This time delay is crucial as it covers the period when smokers are generally at most risk of relapse, borne out by figures in this study,” she remarks.

Publication of the trial coincides with national No Smoking Day.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11135780

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  • Pregnant woman smoking (Mystock88photo/

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