BACKGROUND: Nicotine replacement therapy (NRT) aims to temporarily replace much of the nicotine from cigarettes to reduce motivation to smoke and nicotine withdrawal symptoms, thus easing the transition from cigarette smoking to complete abstinence.
OBJECTIVES: To determine the effectiveness and safety of nicotine replacement therapy (NRT), including gum, transdermal patch, intranasal spray and inhaled and oral preparations, for achieving long-term smoking cessation, compared to placebo or 'no NRT' interventions.
SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group trials register for papers mentioning 'NRT' or any type of nicotine replacement therapy in the title, abstract or keywords. Date of most recent search is July 2017.
SELECTION CRITERIA: Randomized trials in people motivated to quit which compared NRT to placebo or to no treatment. We excluded trials that did not report cessation rates, and those with follow-up of less than six months, except for those in pregnancy (where less than six months, these were excluded from the main analysis). We recorded adverse events from included and excluded studies that compared NRT with placebo. Studies comparing different types, durations, and doses of NRT, and studies comparing NRT to other pharmacotherapies, are covered in separate reviews.
DATA COLLECTION AND ANALYSIS: Screening, data extraction and 'Risk of bias' assessment followed standard Cochrane methods. The main outcome measure was abstinence from smoking after at least six months of follow-up. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. We calculated the risk ratio (RR) for each study. Where appropriate, we performed meta-analysis using a Mantel-Haenszel fixed-effect model.
MAIN RESULTS: We identified 136 studies; 133 with 64,640 participants contributed to the primary comparison between any type of NRT and a placebo or non-NRT control group. The majority of studies were conducted in adults and had similar numbers of men and women. People enrolled in the studies typically smoked at least 15 cigarettes a day at the start of the studies. We judged the evidence to be of high quality; we judged most studies to be at high or unclear risk of bias but restricting the analysis to only those studies at low risk of bias did not significantly alter the result. The RR of abstinence for any form of NRT relative to control was 1.55 (95% confidence interval (CI) 1.49 to 1.61). The pooled RRs for each type were 1.49 (95% CI 1.40 to 1.60, 56 trials, 22,581 participants) for nicotine gum; 1.64 (95% CI 1.53 to 1.75, 51 trials, 25,754 participants) for nicotine patch; 1.52 (95% CI 1.32 to 1.74, 8 trials, 4439 participants) for oral tablets/lozenges; 1.90 (95% CI 1.36 to 2.67, 4 trials, 976 participants) for nicotine inhalator; and 2.02 (95% CI 1.49 to 2.73, 4 trials, 887 participants) for nicotine nasal spray. The effects were largely independent of the definition of abstinence, the intensity of additional support provided or the setting in which the NRT was offered. A subset of six trials conducted in pregnant women found a statistically significant benefit of NRT on abstinence close to the time of delivery (RR 1.32, 95% CI 1.04 to 1.69; 2129 participants); in the four trials that followed up participants post-partum the result was no longer statistically significant (RR 1.29, 95% CI 0.90 to 1.86; 1675 participants). Adverse events from using NRT were related to the type of product, and include skin irritation from patches and irritation to the inside of the mouth from gum and tablets. Attempts to quantitatively synthesize the incidence of various adverse effects were hindered by extensive variation in reporting the nature, timing and duration of symptoms. The odds ratio (OR) of chest pains or palpitations for any form of NRT relative to control was 1.88 (95% CI 1.37 to 2.57, 15 included and excluded trials, 11,074 participants). However, chest pains and palpitations were rare in both groups and serious adverse events were extremely rare.
AUTHORS' CONCLUSIONS: There is high-quality evidence that all of the licensed forms of NRT (gum, transdermal patch, nasal spray, inhalator and sublingual tablets/lozenges) can help people who make a quit attempt to increase their chances of successfully stopping smoking. NRTs increase the rate of quitting by 50% to 60%, regardless of setting, and further research is very unlikely to change our confidence in the estimate of the effect. The relative effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the individual. Provision of more intense levels of support, although beneficial in facilitating the likelihood of quitting, is not essential to the success of NRT. NRT often causes minor irritation of the site through which it is administered, and in rare cases can cause non-ischaemic chest pain and palpitations.
BACKGROUND: Tobacco use is the leading preventable cause of disease, disability, and death in the United States. Interventions to help adults quit smoking might stop or reduce tobacco-related illness.
PURPOSE: To systematically review evidence for the effectiveness and safety of pharmacotherapy and behavioral tobacco cessation interventions among adults, including pregnant women and those with mental health conditions, and to conduct a de novo search for primary evidence related to electronic nicotine delivery systems for adults.
METHODS: We conducted a review of reviews and searched for existing systematic reviews published through August 1, 2014 in the following databases and organizations' websites: PubMed, PsycInfo, the Database of Abstracts of Reviews of Effects, the Cochrane Database of Systematic Reviews, the Centre for Reviews and Dissemination Health Technology Assessment, the Agency of Healthcare Research and Quality, British Medical Journal Clinical Evidence, the Canadian Agency for Drugs and Technologies in Health, Center for Disease Control and Prevention's Guide to Community Preventive Services, the Institute of Medicine, the National Institute for Health and Clinical Excellence, the National Health Service Health Technology Assessment Programme, and the Surgeon General. We included reviews that were published in the English language that systematically reported the effects of tobacco cessation interventions on health, cessation, or adverse outcomes. We excluded nonsystematic meta-analyses and narrative reviews and those that focused on harm reduction or relapse prevention. We conducted an a priori search for primary trial evidence related to the effectiveness and safety of electronic nicotine delivery systems (ENDS) (through March 1, 2015) and a search for pharmacotherapy among pregnant women (through August 15, 2014) to supplement the review of reviews methodology. Two investigators independently reviewed abstracts and full-text articles against a set of a priori inclusion and quality criteria. Discrepancies were resolved by consensus. One reviewer abstracted data into an evidence table and a second reviewer checked these data. We grouped reviews based on population (general adults, pregnant women, individuals with mental health conditions) and intervention (pharmacotherapy, behavioral, or combined interventions). We identified one or more reviews within each population and intervention subgroup that represented the most current and applicable evidence to serve as the basis for the main findings (“primary” reviews) and discussed complementary and discordant findings from other included reviews as necessary. We did not reanalyze any of the individual study evidence; we presented pooled analyses and existing point estimates from included reviews.
RESULTS: We included 54 systematic reviews, 22 of which served as the basis for the primary findings. Among adults, nine reviews addressed the efficacy and/or harms of nicotine replacement therapy (NRT), bupropion hydrochloride sustained release (bupropion SR), and/or varenicline. None of these reviews reported on health outcomes. All three medications were found to be effective in increasing smoking quit rates compared with placebo or nondrug arms at 6 or more months followup. The pooled risk ratio (RR) for abstinence for NRT was 1.60 (95% confidence interval [CI], 1.53 to 1.68); for bupropion SR, RR 1.62 (95% CI, 1.49 to 1.76); and for varenicline, 2.27 (95% CI, 2.02 to 2.55). Combined NRT versus a single form of NRT showed a statistically significantly greater cessation effect in pooled analysis (RR 1.34 [95% CI, 1.18 to 1.51]). None of the drugs were associated with major cardiovascular adverse events, although NRT produced higher rates of all cardiovascular events (driven by minor events). One review on combined pharmacotherapy and behavioral interventions reported a relative increase in quitting by 82 percent versus nonpharmacotherapy usual care (RR 1.82 [95% CI, 1.66 to 2.00]). We included an additional 33 reviews that addressed behavioral tobacco cessation treatments among adults, including those that focused on specific subpopulations such as older adults. Compared with various controls, behavioral interventions such as in-person advice and support from clinicians, self-help materials, and telephone counseling had modest, but significantly increased, relative smoking cessation at 6 or more months (18% to 96%). For example, the pooled RR of physician advice versus no advice was 1.76 (95% CI, 1.58 to 1.96) for smoking cessation at 6 or more months followup. Only two trials addressed the efficacy and harms related to the use of electronic cigarettes and these trials suggested no benefit on smoking cessation among smokers intending to quit. We included eight reviews that focused on pregnant women that found significant benefits for perinatal health, including increased birth weight and reduced preterm birth. These benefits were evident with behavioral interventions, and suggested by data from some of the NRT trials, although that evidence was limited. Cessation during late pregnancy was greater among women receiving any type of behavioral intervention, with evidence most clear for counseling. Rates of validated cessation among women allocated to NRT (5% to 24%) compared with placebo (0% to 15%) were not statistically different, although few studies contributed data. Our reviews among individuals with depression or schizophrenia provided limited trial evidence on the efficacy of pharmacotherapy or behavioral interventions. There was, however, some evidence of a benefit for bupropion among those with schizophrenia and the addition of a mood management component to behavioral interventions for smokers with depression.
CONCLUSIONS: This review of reviews suggests that behavioral interventions and pharmacotherapy, alone or in combination, are effective in helping to reduce rates of smoking among the general adult population. Behavioral interventions, in particular, can assist pregnant women to stop smoking. Data on the effectiveness and safety of electronic nicotine delivery systems are limited. Future research should focus on direct comparisons between different combinations and classes of drugs; the incidence of serious adverse events related to medications for cessation; the efficacy and safety of ENDS; and pharmacotherapies for pregnant women and those with mental health conditions including evidence on health outcomes.
Smoking during pregnancy has been linked to a variety of adverse outcomes for both maternal and child health. Decades of studies have sought to increase cessation antepartum and reduce relapse postpartum. A number of effective interventions exist to significantly reduce smoking rates during pregnancy; however, less is known about how to prevent relapse in the postpartum period. This review investigates interventions to prevent relapse in the long-term postpartum period. We focus specifically on nonspontaneous quitters (individuals who quit smoking as a result of an external intervention) to reveal differences in long-term response to interventions for this population compared to spontaneous quitters. A systematic literature search yielded 32 relevant studies of pharmacological, behavioral, and incentives-based interventions. Results were compiled, analyzed, and compared in order to evaluate success factors in maintaining cessation postpartum. Though intervention groups showed consistently higher quit rates during pregnancy than control groups, none of the intervention types were effective at preventing relapse in the longer-term postpartum period. One study maintained significantly higher abstinence in the longer-term period postpartum using a mix of behavioral and incentives strategies. Additional research in this area is needed to identify optimal intervention strategies to reduce long-term postpartum relapse, particularly for nonspontaneous quitters. (PsycInfo Database Record (c) 2021 APA, all rights reserved)
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.
Nicotine replacement therapy (NRT) aims to temporarily replace much of the nicotine from cigarettes to reduce motivation to smoke and nicotine withdrawal symptoms, thus easing the transition from cigarette smoking to complete abstinence.
OBJECTIVES:
To determine the effectiveness and safety of nicotine replacement therapy (NRT), including gum, transdermal patch, intranasal spray and inhaled and oral preparations, for achieving long-term smoking cessation, compared to placebo or 'no NRT' interventions.
SEARCH METHODS:
We searched the Cochrane Tobacco Addiction Group trials register for papers mentioning 'NRT' or any type of nicotine replacement therapy in the title, abstract or keywords. Date of most recent search is July 2017.
SELECTION CRITERIA:
Randomized trials in people motivated to quit which compared NRT to placebo or to no treatment. We excluded trials that did not report cessation rates, and those with follow-up of less than six months, except for those in pregnancy (where less than six months, these were excluded from the main analysis). We recorded adverse events from included and excluded studies that compared NRT with placebo. Studies comparing different types, durations, and doses of NRT, and studies comparing NRT to other pharmacotherapies, are covered in separate reviews.
DATA COLLECTION AND ANALYSIS:
Screening, data extraction and 'Risk of bias' assessment followed standard Cochrane methods. The main outcome measure was abstinence from smoking after at least six months of follow-up. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. We calculated the risk ratio (RR) for each study. Where appropriate, we performed meta-analysis using a Mantel-Haenszel fixed-effect model.
MAIN RESULTS:
We identified 136 studies; 133 with 64,640 participants contributed to the primary comparison between any type of NRT and a placebo or non-NRT control group. The majority of studies were conducted in adults and had similar numbers of men and women. People enrolled in the studies typically smoked at least 15 cigarettes a day at the start of the studies. We judged the evidence to be of high quality; we judged most studies to be at high or unclear risk of bias but restricting the analysis to only those studies at low risk of bias did not significantly alter the result. The RR of abstinence for any form of NRT relative to control was 1.55 (95% confidence interval (CI) 1.49 to 1.61). The pooled RRs for each type were 1.49 (95% CI 1.40 to 1.60, 56 trials, 22,581 participants) for nicotine gum; 1.64 (95% CI 1.53 to 1.75, 51 trials, 25,754 participants) for nicotine patch; 1.52 (95% CI 1.32 to 1.74, 8 trials, 4439 participants) for oral tablets/lozenges; 1.90 (95% CI 1.36 to 2.67, 4 trials, 976 participants) for nicotine inhalator; and 2.02 (95% CI 1.49 to 2.73, 4 trials, 887 participants) for nicotine nasal spray. The effects were largely independent of the definition of abstinence, the intensity of additional support provided or the setting in which the NRT was offered. A subset of six trials conducted in pregnant women found a statistically significant benefit of NRT on abstinence close to the time of delivery (RR 1.32, 95% CI 1.04 to 1.69; 2129 participants); in the four trials that followed up participants post-partum the result was no longer statistically significant (RR 1.29, 95% CI 0.90 to 1.86; 1675 participants). Adverse events from using NRT were related to the type of product, and include skin irritation from patches and irritation to the inside of the mouth from gum and tablets. Attempts to quantitatively synthesize the incidence of various adverse effects were hindered by extensive variation in reporting the nature, timing and duration of symptoms. The odds ratio (OR) of chest pains or palpitations for any form of NRT relative to control was 1.88 (95% CI 1.37 to 2.57, 15 included and excluded trials, 11,074 participants). However, chest pains and palpitations were rare in both groups and serious adverse events were extremely rare.
AUTHORS' CONCLUSIONS:
There is high-quality evidence that all of the licensed forms of NRT (gum, transdermal patch, nasal spray, inhalator and sublingual tablets/lozenges) can help people who make a quit attempt to increase their chances of successfully stopping smoking. NRTs increase the rate of quitting by 50% to 60%, regardless of setting, and further research is very unlikely to change our confidence in the estimate of the effect. The relative effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the individual. Provision of more intense levels of support, although beneficial in facilitating the likelihood of quitting, is not essential to the success of NRT. NRT often causes minor irritation of the site through which it is administered, and in rare cases can cause non-ischaemic chest pain and palpitations.
