Nicotine Patches Fail Most Pregnant WomenNovember 14th, 2014
By Kara Bobka, PharmD Student
In 2011, 10% of pregnant women reported smoking during the last trimester.1 Smoking during pregnancy can lead to miscarriages, premature births, placenta problems, birth defects, and infant death.1 The standard treatment for smoking cessation is behavioral therapy, like staying active or chewing gum, and support groups. Nicotine replacement therapy (NRT), such as over-the-counter nicotine patches, provides a way to help pregnant women achieve smoking cessation or stop smoking.2 Nicotine patches are applied directly to the skin, where they release a nicotine source that is then absorbed through the skin to decrease withdrawal symptoms for up to twenty-four hours.2,3 Yet, most recommend wearing the patch for sixteen-hours to give the body a break from nicotine and to decrease the potential for skin irritation.3
Patches fight symptoms of anxiety, cravings, irritability, restlessness, increased appetite, low mood, and poor concentration that are associated with smoking withdrawal. 3 However, two recent meta-analyses4,5 and one well-powered study6 showed that standard NRT doses (15 mg a day) are ineffective with pregnant women smokers when used for eight months or less. To address the effectiveness of NRT in pregnant smokers, a randomized, double blind, multicentre trial in the British Medical Journal (BMJ) confirms nicotine patches are no more effective than placebo at increasing either smoking cessation rates or birth weights even when nicotine doses are adjusted to individuals and given at higher doses. 7
What They Did
Berlin et al. randomized 402 pregnant women smokers (≥5 cigarettes per day) from 23 French maternity wards to receive either nicotine or placebo patches.7 All were ≥18 years of age and between 9 and 20 weeks gestation.7 All had to have health insurance. 7 More so, participants were motivated to stop smoking.7
Participants were given a two-week grace period between their initial and first follow-up visit for a chance to either stop smoking or to reduce cigarette consumption (<5 per day) on their own.7 This was necessary because people must be asked to quit smoking before using NRTs.7 Pregnant women can only be prescribed NRTs if they are unable to stop alone.7 Failing to either quit or reduce cigarette use, patients were eligible to continue, where they set a quit date and began the study.7 Smoking cessation was monitored via monthly measurements of saliva nicotine levels.7
Therapy lasted from quit date to the end of pregnancy, where women were either given 16-hour delivery nicotine patches (10-15 mg), similar to those produced in the US, or an identical placebo manufactured specifically for the study.7 For those who received active patches, daily doses ranged between 10-30 mg and were adjusted based on initial saliva nicotine levels.7 Behavioral support was provided at each visit.7
Primary outcomes were complete smoking cessation (self reported and confirmed via spirometry-confirmed carbon monoxide levels ≤8ppm) and birth weight.7 Secondary outcomes were self-reported smoking abstinence and birth characteristics.7
What They Found
Results demonstrated that 11 of 96 (5.5%) and 10 of 76 (5.1%) women in the nicotine patch and placebo patch groups, respectively, achieved complete smoking cessation (P=0.87).7 42% in the nicotine patch group and 37% in the placebo patch group decreased their consumption of cigarettes by half.7 After two weeks, 62% had smoked again.7 More so, the nicotine patch did not decrease tobacco cravings or withdrawal symptoms or the number of cigarettes smoked.7 Average birth weights of groups did not differ significantly.7 Yet, newborns of mothers who were able to quit had a notably higher birth weight than those who were unable to stop smoking.7
Study limitations included that the subjects were women who smoked at least five cigarettes a day. So, results are hard to generalize to other expecting smokers. More so, the treatment began after the first trimester. It may be more effective to begin treatment earlier since smoking abstinence before 15 weeks gestation has yielded comparable birth outcomes to those of non-smokers.8 Another study conducted in England showed NRT combinations to be effective versus single or no NRT use.9 Despite other findings and its limitations, this study shows a lack of effectiveness of NRTs in pregnant women smokers and thereby a lack of birth characteristics’ improvements.
What To Tell Patients
Although NRT has been shown to help others quit smoking, its effects on pregnant women remain unclear. Earlier treatment with NRT during pregnancy may be more beneficial, although no evidence is to suggest that at this point. So, the best way to achieve smoking cessation is via behavioral therapy and support.7
To stop smoking, the Center for Disease Control and Prevention (CDC) recommends five great behavioral therapies. These include: asking family and friends for support; developing a quit plan or joining a quit program; staying busy (Get active. Chew gum. Drink water.); avoiding smoking triggers (Toss cigarettes, lighters, and ashtrays. Avoid caffeine.); and staying positive, yet vigilant.10 To successfully stop smoking, it takes time, but you can! So, reward yourself after the first 24 hours. You deserve it! Your baby will thank you!
If you smoked and wanted to quit, what actions would you take? Would you try a nicotine patch?
Bibliography and References Cited
- Tobacco use and pregnancy. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/reproductivehealth/tobaccousepregnancy/. Published August 5, 2014. Updated 2014. Accessed October 26, 2014.
- American Society of Health-System Pharmacists, Inc. Nicotine Transdermal Patch. MedlinePlus: Trusted Health Information for You. http://www.nlm.nih.gov/medlineplus/druginfo/meds/a601084.html. Published June 13, 2013. Updated September 24, 2014. Accessed October 26, 2014.
- Nicorette® 16hr Invisipatch. Nicorette. http://www.nicorette.com.au/products/16hr-patch. Updated September 29, 2014. Accessed October 26, 2014.
- Coleman T, Chamberlain C, Cooper S, Leonardi-Bee J. Efficacy and safety of nicotine replacement therapy for smoking cessation in pregnancy: systemic review and meta-analysis. 2011;106(1): 52-61.
- Coleman T, Chamberlain C, Davey MA, Cooper SE, Leonardi-Bee J. Pharmacological Interventions for promoting smoking cessation during pregnancy. Cochrane Database Syst Rev. 2012;9:CD010078.
- Coleman T, Cooper S, Thornton JG, Grainge MJ, Watts K, Britton J, Lewis S. A Randomized Trial of Nicotine-Replacement Therapy Patches in Pregnancy. N Engl J Med. 2012;336:808-18.
- Berlin I, Grangé G, Jacob, N, Tanguy ML. Nicotine patches in pregnant smokers: randomized, placebo controlled, multicentre trial of efficacy. BMJ. 2014;348(1622):1-16.
- McCowan LM, Dekker GA, Chan E, Stewart A, Chappell LC, Hunter M, et al; SCOPE consortium. Spontaneous preterm birth and small for gestational age infants in women who stop smoking early in pregnancy: prospective cohort study. 2009;338:b1081.
- Brose LS, McEwen A, West R. Association between nicotine replacement therapy use in pregnancy and smoking cessation. Drug Alcohol Depend. 2013;132:660-664.
- Tips From Former Smokers. Centers for Disease Control and Prevention. http://www.cdc.gov/tobacco/campaign/tips/quit-smoking/guide/steps-on-quit-day.html. Updated March 24, 2014. Accessed October 26, 2014.