Efficacy and safety of pharmacotherapy for smoking cessation among pregnant smokers: a meta-analysis.

BACKGROUND: The efficacy and safety of pharmacotherapy for smoking cessation among pregnant smokers has not yet been established. OBJECTIVE: To investigate the efficacy and safety of pharmacotherapy for smoking cessation among pregnant smokers. SEARCH STRATEGY: A search was made of PubMed, Embase and CENTRAL in June 2011. SELECTION CRITERIA: Randomised controlled trials (RCTs), quasi-RCTs and retrospective or prospective controlled studies were included. DATA COLLECTION AND ANALYSIS: The main analyses were designed to examine the efficacy of pharmacotherapy for smoking cessation among pregnant smokers based on the longest follow-up data available and from data obtained at the latest available time-point in pregnancy in each study. MAIN RESULTS: Of 74 articles identified from the databases, seven studies (five RCTs, one quasi-RCT and one prospective study) involving a total of 1386 pregnant smokers, 732 in the intervention groups and 654 in the control groups, were included in the final analyses. In a fixed-effects meta-analysis of all seven studies based on the longest follow-up data available, pharmacotherapy had a significant effect on smoking cessation (relative risk [RR] 1.80; 95% confidence interval [CI] 1.32-2.44). Subgroup meta-analysis by type of study design also showed similar findings for RCTs (RR 1.48; 95% CI 1.04-2.09) and other types of studies (RR 3.25; 95% CI 1.65-6.39). The abstinence rate at late pregnancy in the intervention ranged from 7 to 22.6% (mean abstinence rate 13.0%; 95% CI 10.9-15.2%). A few minor adverse effects and serious adverse effects were reported in several studies. AUTHOR'S CONCLUSIONS: This study indicates that there may be clinical evidence to support the use of pharmacotherapy for smoking cessation among pregnant smokers. Further RCTs are needed.