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Nicotine patch safe but not effective for smoking cessation in pregnancy.
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Jonathan Foulds, PhD posted:
A new study was published in the New England Journal of Medicine last week by Dr Tim Colemen (University of Nottingham, UK) and colleagues, examining whether daytime nicotine patches (initially for one month) increase quit rates among pregnant smokers. This was a large and thoroughly conducted study. The investigators informed around 21,000 women about the trial, screened 2410 women who were initially interested, and finally recruited 1050 pregnant smokers to the study. The women included in the trial had an average age of 26, had smoked 20 cigarettes per day prior to pregnancy and were smoking an average of 14 cigarettes per day when recruited to the study, approximately 16 weeks into the pregnancy. The majority of the women smoked their first cigarette of the day within 15 minutes of waking in the morning, suggesting that most were highly addicted to nicotine. All of the women were given around 45 minutes of face-to-face smoking cessation counseling at the start of the study, and then 2-3 sessions of telephone counseling. All the women were given a month supply of skin patches, but half were given patches containing nicotine, and half received patches not containing nicotine ("placebos"). Neither the women nor the midwives were told which type of patches each woman received ("double blind"). Those women who were quit at one month follow-up were offered another month of patches. The main aim of the study was to find out whether using nicotine patches increased quit rates.
At one month follow-up, more women receiving nicotine patches than placebo patches had quit (21% v 12%). However, only 7% of the nicotine patch group and 3% of the placebo patch group continued with the second month of patches. By delivery of the babies, there was no significant difference in quit rates between the two groups (9% v 8%). The study also measured a range of side effects and pregnancy outcomes and for most of these there were no differences between nicotine and placebo patches. For example, 6% of both groups reported neonatal adverse events, and the birth weight of the babies was very similar in both groups. The authors concluded that adding 15mg daily nicotine patches to brief behavioral counseling for pregnant smokers neither increases the quit rates, nor increases the risk of adverse pregnancy or birth outcomes.
A couple of things are striking about the results. The first is that, despite being seemingly highly motivated to quit smoking, less than one in five managed to quit for a month, and less than 10% were quit at the time of delivery (around 5 months after initially trying to quit). The other striking result is the very low compliance with patch use and the low use of additional counseling. 76% of those given placebo patches and 60% of those given nicotine patches used them for less than 15 days. The lower patch use in the placebo group suggests this was not caused by nicotine-related side-effects. Part of this early termination of patch use may be due to a perception that they were not helping to quit smoking, and part may have been (ironically) due to concerns about potential harm to the baby.(Ironic because there is much greater harm to the baby from continued smoking). In particular, it is likely that women would have stopped using the patches when they had a smoking lapse, because of (misplaced) concern that smoking while using the patch may be particularly harmful. The women were also given the opportunity for additional face-to-face counseling sessions but only around 10% did so. Clearly the search must continue for widely applicable and effective ways to help pregnant smokers to quit.
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Michael_Myers_TTS responded:
Jonathan thanks for your post. I have found that one of the issues that affect compliance may be the techniques utilized in the counseling process regardless of NRT. I have seen much more buy in when the tobacco user is approached using some form of motivational interviewing. Certainly a pregnant smoker often has a unique ability to discontinue smoking for much of the duration of the pregnancy due to an internal connection to the health of the fetus. Interestingly enough many perhaps most continue to smoke after giving birth. I would imagine that positive reinforcement during the third trimester and additional counseling with NRT after the birth of the child could lead to a continuation of cessation. Like with so many people who leave the hospital after a serious illness connected to smoking and continue to smoke, a woman who gives birth has not overcome her desire to smoke and will likely lapse or relapse.
I believe it is at this stage of having moved past the actual "process" of whatever the medical or life change reasons for not smoking, that NRT and respectful confidence building counseling should intensify.


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Jonathan Foulds, PhD. is a Professor of Public Health Sciences at Penn State University, College of Medicine. After obtaining a first class honors deg...More

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