Nicotine Patches Failed to Help Pregnant Smokers Quit

Janis C. Kelly

March 19, 2014

Nicotine patches were no better than placebo at helping pregnant women quit smoking, according to a large, randomized controlled trial published online March 11 in the BMJ. However, the study design left most patients without behavioral support during a crucial early period and might have obscured whatever benefit the patches might provide in a different context, an expert notes in an accompanying editorial.

"[T]here was a gap of two weeks after the first session before the next session of behavioural support and adjustment of [nicotine replacement therapies]. 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. This delay perhaps explains why both groups had low success rates," Leonie S. Brose, PhD, lecturer in addictions at the UK Centre for Tobacco and Alcohol Studies, Institute of Psychiatry, King's College London, writes in the editorial.

The research team, led by Ivan Berlin, MD, senior lecturer, Département de Pharmacologie, Hôpital Pitié-Salpêtrière-Université, Faculté de Médecine, Paris, France, assessed the efficacy of 16-hour nicotine patches among 402 pregnant women older than 18 years and between 12 and 20 weeks' gestation who smoked at least 5 cigarettes a day and had been unable to quit unaided. Patients were drawn from 23 maternity wards in France.

The researchers randomly assigned women to receive either nicotine patches (n = 203) or identical placebo patches (n = 199) up to the time of delivery. Doses were individually adjusted to saliva cotinine levels to match participants' nicotine intake to that achieved by smoking. Dose adjustment is important because the metabolism of nicotine is accelerated during pregnancy, which might render standard nicotine patch doses less effective, the researchers write.

Physicians or midwives who had received a diploma in smoking cessation provided counseling at each monthly visit, and the strongest support was at the 1-hour randomization visit. At each monthly visit after that, the investigators were expected to deliver at least 10 minutes of counseling, but this was not monitored.

"Although the personalised, individual behavioural interventions were not specifically standardised, and the participating maternity wards could use their discretion to apply their own standard methods, these interventions were based on the national consensus document," the authors write.

Primary outcome measures were complete abstinence from quit date to delivery (confirmed by levels of carbon monoxide in expired air) and birth weight. Secondary outcomes were point prevalence of abstinence, time to lapse (a few puffs) or relapse, and delivery and birth characteristics.

The researchers found no significant differences in outcome in the nicotine patch vs placebo group. Slightly more than 5% of women in each group achieved complete smoking abstinence, and the average time to the first cigarette smoked after the target "quit" date was 15 days for each group.

Infant birth weights, z scores, head circumference, and other delivery outcomes were also similar in the nicotine patch and placebo patch groups.

Diastolic blood pressure increased significantly more in the nicotine patch group (0.02 mm Hg per day vs no increase in the placebo group).

The authors conclude, "The current study shows that even a relatively high daily dose of nicotine, adjusted for baseline saliva cotinine levels and administered with a relatively high self reported compliance rate for a median of 105 days during the second and third trimester did not increase abstinence rates.... In the absence of evidence based drug interventions, behavioural support remains the core intervention to help pregnant smokers to quit."

In her editorial, Dr. Brose concurs that good evidence supports the efficacy of psychosocial smoking cessation interventions to help pregnant smokers quit, including strategies such as "individual counselling, financial incentives, peer support, and feedback on fetal health." She notes that the first few weeks after the target quit date are the critical period for psychosocial support and that this was when study participants did not receive such counseling.

"Given the limitations of the new trial and the potential benefit of combination therapy, it may be too early to abandon the option of [nicotine replacement therapy] entirely," Dr. Brose concludes.

The study was funded by the Ministry of Health, France, and cosponsored by Assistance Publique-Hôpitaux de Paris. Dr. Berlin has received consulting fees from Pfizer, Novartis, and Ethypharm. The other authors and Dr. Brose have disclosed no relevant financial relationships.

BMJ. Published online March 11, 2014. Article full text, Editorial extract


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