Nicotine Replacement Therapy Group Research Articles

Evaluating the effectiveness of nicotine replacement therapy in critically ill smokers: A meta-analysis of randomized controlled trials.

The effectiveness of nicotine replacement therapy (NRT) in critically ill patients remains uncertain, as conflicting research results have been reported. Despite potential side effects and inconsistent data on safety and efficacy, NRT is still prescribed in intensive care units (ICUs) to prevent withdrawal symptoms and manage agitation in patients who are smokers. This meta-analysis aimed to assess the effectiveness of nicotine replacement therapy in critically ill smoking patients. A systematic review and meta-analysis of randomized controlled trials investigated the outcomes of smokers admitted to ICUs and were randomized either to receive or not receive nicotine replacement therapy (NRT) during their ICU stay. The MEDLINE and Embase databases were searched from inception through 13 February 2023 using OVID. The primary outcome was ICU length of stay (LOS) for this systematic review and meta-analysis. Meta-analysis was conducted using both random-effects and fixed-effect models; the latter is recommended when meta-analysis is restricted to just a few studies. The study was registered in the Prospective International Register of Systematic Reviews (PROSPERO) under reference number CRD42023407804. Of 28 studies initially identified, three, with 67 patients on NRT and 72 controls, were deemed eligible for pooled analysis. Patients who received NRT experienced a shorter LOS (mean difference, MD= -3.06; 95% CI: -5.88 - -0.25, p=0.0, I2=0%). The mechanical ventilation (MV) duration was also shorter in the NRT group, but this difference was not statistically significant (MD= -1.24; 95% CI: -3.21-0.72, p=0.22, I2=12.69%). Delirium duration was reported by two studies, from which pooled analysis revealed an MD of -0.50 (95% CI: -1.63-0.62, I2=0%). The vasopressor duration was assessed in two studies, and the overall MD for vasopressor duration was not statistically different between NRT patients and controls in the fixed-effects model (MD=0.11; 95% CI: -0.75-0.96, I2=0%). Critically ill smoker patients who received NRT experienced a significantly shorter ICU LOS but no significant differences in the durations of MV, vasopressor use, or delirium.

Switching to e-cigarettes as harm reduction among individuals with chronic disease who currently smoke: Results of a pilot randomized controlled trial.

E-cigarettes (ECs) may be an effective harm reduction strategy for individuals with conditions like chronic obstructive pulmonary disease (COPD), asthma, coronary artery disease (CAD), and peripheral arterial disease (PAD) who smoke combustible cigarettes (CCs). Our aim was to examine how individuals with chronic conditions transition from CCs to ECs and its impact on health outcomes. In a pilot randomized controlled trial (RCT), patients with COPD, asthma, CAD/PAD who currently smoke CCs and have not used nicotine replacement therapy (NRT) or ECs in the past 14 days were randomized to receive ECs or combination NRT with behavioral counselling. Disease symptoms, acceptability/satisfaction (TSQM-9) and feasibility, and cigarettes per day (CPD), and/or EC use were collected at baseline, 3-, and 6-months. Descriptive statistics and a linear regression were conducted to explore changes in CPD and chronic condition-specific assessments (CAT, SAQ-7, ACT) that assess COPD, asthma, and CAD/PAD symptom change. At 3-months, the EC group (n=63, mean CPD=9±11) reduced their CPD by 54% vs. 60% in the NRT group (n=58, mean CPD=7±6), p=0.56. At 6-months, 17.5% had switched completely to ECs while 23% quit smoking in the NRT arm. CAT scores showed a significant 6-point reduction in the EC arm (p=0.03). Participants scored an average of 69±27 for EC effectiveness, 87±23 for convenience, and 75±27 for overall satisfaction. This pilot study suggests that ECs may be a safer alternative for chronic condition patients using CCs and warrants further research on expected smoking cessation/reduction among individuals who use ECs. The findings from this pilot RCT hold significant implications with chronic conditions such as COPD, asthma, CAD and PAD who smoke CCs. The observed reduction in cigarettes per day and improvement in respiratory symptoms suggest that switching to ECs appears feasible and acceptable among those with chronic diseases. These results suggest that ECs may offer an alternative for individuals struggling to quit CC smoking through existing pharmacotherapies. This study supports further exploration of switching to ECs as a harm reduction strategy among CC users who have been unsuccessful at quitting by other means.

Effectiveness of Varenicline and Cytisine for Alcohol Use Reduction Among People With HIV and Substance Use

Cigarette smoking and risky alcohol consumption co-occur and are undertreated. Nicotine receptor partial agonists and nicotine replacement therapy (NRT) treat smoking but are unproven for alcohol, and clinical trials rarely include individuals with HIV, substance use, and mental health conditions. To compare the effects on drinking and smoking of nicotinic acetylcholine receptor partial agonists varenicline and cytisine with those of NRT. This 4-group randomized, double-blinded, placebo-controlled clinical trial was conducted from July 2017 to December 2020 in St Petersburg, Russia. Included participants were 400 individuals with HIV who engaged in risky drinking (≥5 prior-month heavy-drinking days [HDDs]) and daily smoking; they were followed up for 12 months after enrollment. Data were analyzed from May 2021 through June 2022. Participants received alcohol and tobacco counseling, 1 active medication, and 1 placebo in 1 of 4 groups: active varenicline and placebo NRT (group 1), placebo varenicline and active NRT (group 2), active cytisine and placebo NRT (group 3), or placebo cytisine and active NRT (group 4). The primary outcome was number of prior-month HDDs at 3 months. Secondary outcomes included biochemically validated abstinence from alcohol at 3 months and smoking at 6 months. Among 400 participants (263 [65.8%] men; mean [SD] age, 39 [6] years), 97 individuals (24.3%) used opioids and 156 individuals (39.1%) had depressive symptoms. These individuals had a mean (SD) CD4 count of 391 (257) cells/mm3, smoked a mean (SD) of 21 [8] cigarettes/d, and reported a mean (SD) of 9.3 (5.8) HDDs in the prior 30 days. At 3 months, the mean (SD) number of HDDs was decreased vs baseline across all groups (group 1: 2.0 [3.8] HDDs vs. 9.5 [6.1] HDDs; group 2: 2.1 [4.3] HDDs vs 9.3 [5.7] HDDs; group 3: 1.5 [3.3] HDDs vs 8.9 [5.0] HDDs; group 4: 2.4 [5.2] HDDs vs 9.6 [6.3] HDDs). There were no significant differences at 3 months between groups in mean (SD) HDDs, including group 1 vs 2 (incident rate ratio [IRR], 0.94; 95% CI, 0.49-1.79), 3 vs 4 (IRR, 0.60; 95% CI, 0.30-1.18), and 1 vs 3 (IRR, 1.29; 95% CI, 0.65-2.55). There were no significant differences at 6 months between groups in smoking abstinence, including group 1 vs 2 (15 of 100 individuals [15.0%] vs 17 of 99 individuals [17.2%]; odds ratio [OR],0.89; 95% CI, 0.38-2.08), 3 vs 4 (19 of 100 individuals [19.0%] vs 19 of 101 individuals [18.8%]; OR, 1.00; 95% CI, 0.46-2.17), and 1 vs 3 (OR, 0.79; 95% CI, 0.35-1.78). Post hoc analyses suggested lower mean (SD) HDDs (eg, at 3 months: 0.7 [1.8] HDDs vs 2.3 [4.6] HDDs) and higher alcohol abstinence (eg, at 3 months: 30 of 85 individuals [35.3%] vs 54 of 315 individuals [17.1%]) among those who quit vs continued smoking. This study found that among individuals with HIV who engaged in risky drinking and smoking, varenicline and cytisine were not more efficacious than NRT to treat risky drinking and smoking but that behavior change rates were high in all groups. ClinicalTrials.gov Identifier: NCT02797587.

The Effectiveness of E-Cigarettes for Smoking Cessation.

Our primary aim was to assess-in the German population-the effectiveness of e-cigarettes (ECs; with or without nicotine), nicotine replacement therapy (NRT), and no use of evidence-based aids in smoking cessation. Analysis of cross-sectional data from a representative survey of the population (age 14-96 years) conducted in 2016-2021. All current smokers and recent ex-smokers (< 12 months since quitting) who had made ≥ 1 attempt to quit in the past 12 months (n = 2740) were included. They were asked about use of cessation aids in their most recent quit attempt and their current smoking status. Two hundred thirty-nine respondents had used ECs, 168 NRT, and 2333 no aid. After adjustment for potential confounders, the odds of abstinence were 1.78 times higher for smokers who had used ECs in their quit attempt than in the group that had used no aids (95% confidence interval [1.09; 2.92]; p = 0.02) and 1.46 times higher than in the NRT group ([0.68; 3.13]; p = 0.34, Bayes factor = 1.26). Compared with the unaided group, the odds of abstinence were 2.34 times higher ([1.21; 4.53]; p = 0.01) in the subgroup using ECs with nicotine and 1.48 times higher ([0.68; 3.26]; p = 0.33) in the subgroup using ECs without nicotine. The unadjusted abstinence rates in people who had started their quit attempt > 6 months earlier were 15.6% [9.4; 23.8] in the ECs group and 13.8% [7.3; 22.9] in the NRT group. In Germany, use of ECs in an attempt to quit smoking is associated with a higher rate of abstinence than attempting to quit unaided.

Efficacy of nicotine-replacement therapy, bupropion, and a combination of both for treating nicotine addiction

Background Most of the studies about the efficacy of smoking-cessation medication and its side effects were conducted in developed countries on participants who differ from Arab population in sociocultural and genetic factors. Patients and methods A randomized controlled trial was conducted on a convenient sample of 100 smokers at the smoking-cessation clinic. The participants were allocated into four groups: nicotine-replacement therapy (NRT), bupropion (BPP), combination of NRT+BPP, and placebo. Counseling was offered to all participants. Outcomes: self-reported smoking status with biochemical verification (success to stop smoking, lapse, relapse, or failure to stop smoking) at 3 and 6 months from starting treatment. Results The total success rate in four studied groups was 14% at 3 months and 8% at 6 months. There was no evidence of any statistically significant difference between any of the interventional groups (NRT, BPP, or their combination) and placebo group at 3 and 6 months as regards success rate (8, 12, 8, and 28%, respectively, at 3 months and 8, 12, 0, and 12%, respectively, at 6 months). There were no serious adverse events in the studied groups. Headache was more significantly reported by placebo group compared with all other groups (P=0.01), and urgency was more significantly reported by placebo group compared with NRT group (P=0.001). Conclusion The study found no evidence of the superior effect of NRT, BPP, or their combination over placebo in helping smokers quit smoking at 3 and 6 months. However, more withdrawal symptoms were reported by the placebo group.

Effectiveness of smoking cessation intervention in opioid-dependent male subjects on buprenorphine maintenance treatment: An open-label trial.

High prevalence (more than 80%) rates of tobacco smoking have been found both in, opioid-dependent subjects and among opioid-dependent subjects on opioid substitution treatment (OST) with buprenorphine or methadone. We aimed to explore the efficacy of combined nicotine replacement therapy (NRT) and individual counseling (IC) when compared to NRT alone in subjects on OST with buprenorphine. This study was carried out in a tertiary medical care center. It was an open-label randomized clinical trial. A total of 57 buprenorphine maintained smokers were recruited and randomized into two groups. They were assigned nicotine gum for 4 weeks plus either (1) a baseline IC session, and a second IC session after 1 week, or (2) simple advice to quit. In the first group, 31 subjects received NRT with IC and in the second group, 26 subjects received NRT plus simple advice to quit. The primary outcomes of this study were seven days point prevalence abstinence, biochemically confirmed by carbon monoxide (CO) breath analyzer, and reduction in smoking (mean no. of cigarettes or bidis/day). The smoking behavior during the 4 weeks follow-up period was assessed by the timeline follow-back (TLFB) method and confirmed by the CO breath analyzer. The group of subjects who received NRT with IC showed higher rates of smoking cessation at the end of treatment (51%) as compared to the NRT and simple advice group where smoking cessation rates were around 8% (P < 0.001). A multi-component approach (pharmacotherapy and counseling) enhances treatment outcomes and enhances rates of abstinence from smoking.

Efficacy and safety of electronic cigarettes as a smoking cessation intervention: A systematic review and network meta-analysis.

INTRODUCTIONThis systematic review of randomized controlled trials (RCTs) evaluated the efficacy and safety of electronic cigarettes (e-cigarettes, ENDS) in helping people who smoke to achieve abstinence compared with electronic non-nicotine delivery systems (ENNDS, no nicotine) or any smoking cessation comparator treatment or combination of treatments at 24–26 weeks and at 52 weeks.METHODSSystematic review techniques involved searches of three databases in February 2020 with update searches run on 14 May 2021, two-person independent screening, two-person independent assessment of bias, formal extraction of data with verification by a second person, a feasibility assessment to decide if meta-analysis was appropriate, and network meta-analysis (NMA) of data at 24–26 weeks. Data at 52 weeks were narratively summarized.RESULTSTen RCTs met the inclusion criteria, eight for efficacy and ten for safety. Eight of the nine RCTs were assessed as at high risk of bias. The sample sizes of the RCTs were 30–2012. Using nicotine replacement therapy (NRT) as the reference treatment, the incidences of smoking cessation at 24–26 weeks were comparable between ENDS and NRT groups (RR=1.17; 95% CrI: 0.66–1.86). Three sensitivity analyses were carried out indicating the main findings for 24–26 weeks were robust to assumptions. The findings at 52 weeks were inconclusive.CONCLUSIONSThis systematic review and NMA indicates that there is no clear evidence of a difference in effect between nicotine containing e-cigarettes and NRT on incidences of smoking cessation at 24–26 weeks, and substantial uncertainty remains.

Feasibility and Acceptability of a Smoking Cessation Program for Individuals Released From an Urban, Pretrial Jail

Tobacco use prevalence among individuals involved in the criminal-legal system is 125% higher than that of the general population and leads to high levels of smoking-related morbidity and mortality. To examine the acceptability, feasibility, and preliminary clinical outcomes of a smoking cessation intervention for individuals who are incarcerated. This pilot randomized clinical trial was conducted from January 2019 to May 2020. Participants were recruited in a pretrial county jail in a large Midwestern US city and were followed up after release. Participants were incarcerated, smoked daily before incarceration, desired to stay quit or reduce cigarette smoking upon release, and expected to be released to the community within 90 days of enrollment. Data analysis was performed from June to October 2020. Participants randomized to the counseling plus nicotine replacement therapy (NRT) group received 1 hour of smoking cessation counseling in jail, a supply of nicotine lozenges upon release, and up to 4 telephone counseling sessions after release. Those randomized to brief health education (BHE) received 30 minutes of general health education in jail. The primary clinical outcome was biologically verified 7-day point prevalence abstinence (PPA) at 3 weeks after release. Secondary clinical outcomes included 7-day PPA at 12 weeks, changes in number of cigarettes per day, and time to smoking lapse and relapse. A total of 46 participants (42 men [91%]; mean [SD] age, 38.2 [9.1] years) were enrolled and remained eligible at release; 23 were randomized to the counseling plus NRT group and 23 were randomized to the BHE group. Recruitment, enrollment, and retention of participants was feasible and acceptable. There were no significant differences in smoking abstinence between groups as determined by 7-day PPA at 3 weeks (adjusted 7-day PPA, 11.9% for counseling plus NRT vs 10.6% for BHE; odds ratio, 1.13; 95% CI, 0.14-9.07) and at 12 weeks (adjusted 7-day PPA, 11.1% for counseling plus NRT vs 14.3% for BHE; odds ratio, 0.75; 95% CI, 0.09-6.11). Cigarettes per day for the counseling plus NRT group decreased more compared with the BHE group at both 3 weeks (difference [SE], -4.58 [1.58] cigarettes per day; 95% CI, -7.67 to -1.48 cigarettes per day; P = .007) and 12 weeks (difference [SE], -3.26 [1.58] cigarettes per day; 95% CI, -5.20 to -0.20 cigarettes per day; P = .04) after release. Initiation of counseling plus NRT during incarceration and continuing after release is feasible and acceptable to participants and may be associated with reduced cigarette use after release. However, additional supports are needed to increase engagement in telephone counseling after release. A larger clinical trial is warranted to determine the effectiveness of counseling plus NRT. ClinicalTrials.gov Identifier: NCT03799315.

Neuropsychiatric safety of varenicline in the general and COPD population with and without psychiatric disorders: a retrospective cohort study in a real-world setting

ObjectivesTo evaluate the real-world association between varenicline and neuropsychiatric adverse events (NPAEs) in general and chronic obstructive pulmonary disease (COPD) population with and without psychiatric disorders compared with nicotine replacement...

Efficacy of electronic cigarettes for tobacco smoking cessation: An adapted systematic review

Abstract Background Worldwide smoking remains the leading cause of preventable morbidity and mortality. Electronic cigarettes (ECs) are increasingly used by tobacco smokers as an aid to smoking cessation; however, their efficacy remains uncertain. Methods Electronic databases, clinical trial registries and grey literature sources were searched. The aim was to examine randomised controlled trials or prospective cohort studies, published since the 2016 Cochrane review on this topic, that assessed the efficacy of ECs in achieving smoking cessation among current smokers. Results Two RCTs and five cohort studies, including a total of 16,460 participants, were eligible for inclusion. One RCT found sustained 1-year abstinence of 18.0% in the EC group versus 9.9% in the nicotine replacement therapy group (RR: 1.83; 95% CI 1.30 to 2.58; P &amp;lt; 0.001). The second RCT did not find a statistically significant difference in abstinence rates between EC users and non-users (RR 0.71). Of the five included cohort studies, four reported statistically significant RRs. Two found a positive association (RRs of 1.45 and 1.84) between EC use and smoking cessation but two studies showed EC use was associated with reduced smoking cessation (RRs of 0.25 and 0.35). Due to significant heterogeneity between the studies the data were deemed unsuitable for pooling into a meta-analysis. All trials assessing smoking reduction reported higher rates of reduction among EC users. No serious adverse events were reported with EC use. Follow-up periods of included trials ranged from one to four years, with an average of 1.6 years. Conclusions There is limited, low-quality evidence that ECs are an effective intervention for smoking cessation and smoking reduction. The overall quality of evidence is low as it is based on a small number of studies with inconsistent and imprecise results. Due to the short follow-up periods of the included trials, the long-term safety of ECs is unclear from this review. Key messages Limited evidence that electronic cigarettes are an effective smoking cessation intervention. Further well-designed randomised controlled trials are required to investigate the efficacy of ECs for smoking cessation.

Efficacy of standard nicotine replacement therapy (NRT) versus video-assisted nurse-led NRT on tobacco cessation: A randomized controlled pilot trial

IntroductionNicotine effectiveness has been tested in multiple forms to stop tobacco use. However, the evidence remains inconclusive for the efficacy of a single nicotine intervention. This study aims to test the efficacy of a nurse-led video-assisted nicotine replacement therapy (NRT) to standard NRT on tobacco addiction and cessation among tobacco users. DesignRandomised controlled trial (RCT) comparing two study groups (41/group) with blinded follow-up at two and four weeks. A video-assisted nurse-led NRT and routine standard treatment groups are compared. A weekly call reminder was placed to the video-assisted nurse-led group to take nicotine gum/lozenge and to attend follow-up regularly. MeasuresPrimary endpoints at two and four weeks were self-reported addiction status and tobacco cessation. A standardized urine cotinine test was performed to validate self-reported addiction status at five weeks. ResultsAddiction status was significantly (p < 0.001) improved in the video-assisted nurse-led NRT group. A significant improvement was observed in importance (p < 0.001) to quit tobacco at two weeks of follow-ups. The participants in the nurse-led group enable to boost their readiness (p < 0.001) to quit tobacco at the second and fourth-week follow-ups. There was a significant reduction in urine cotinine levels at 5th week (OR: 2.79, CI 1.26–6.18) in the nurse-led NRT group. ConclusionsA video-assisted nurse-led nicotine replacement therapy found effective in reducing tobacco use. Developing culturally appropriate material and technology use can be a cost-effective means to curb the problem of tobacco and substance abuse.

Briefly Noted

Vaping and nicotine replacement therapy (NRT) were equally effective at decreasing craving and withdrawal symptoms for smokers discharged from smoke‐free residential treatment for substance use disorder, a pilot study has found. The study, a randomized controlled trial to be published in Nicotine &amp; Tobacco Research on behalf of the Society for Research on Nicotine and Tobacco in Australia, also found that retention was greater for the vaping group (96% at 12 weeks) than the NRT group (68%). For the study, 100 patients received telephone Quitline support and a 12‐week supply of either NRT or a vaping device. At 12 weeks, 14% of the vaping group and 18% of the NRT group report not smoking at all in the last seven days. The researchers concluded that their criteria for retention might have been too strict, and that “some leeway and looking at eventual success over the period people continue to engage with the aids would give a better picture of their long‐term potential.” There is a big movement to legalize vaping in Australia. A key point, however, is that patients readily engaged with smoking cessation after treatment when given the chance. “QuitNic: A pilot randomised controlled trial comparing nicotine vaping products with nicotine replacement therapy for smoking cessation following residential detoxification” by Billie Bonevski and colleagues is available open access, go to https://academic.oup.com/ntr/advance‐article/doi/10.1093/ntr/ntaa143/5889985.

Factors influencing the uptake and use of nicotine replacement therapy and e-cigarettes in pregnant women who smoke: a qualitative evidence synthesis.

Nicotine replacement therapy (NRT) delivers nicotine without the toxic chemicals present in tobacco smoke. It is an effective smoking cessation aid in non-pregnant smokers, but there is less evidence of effectiveness in pregnancy. Systematic review evidence suggests that pregnant women do not adhere to NRT as prescribed, which might undermine effectiveness. Electronic cigarettes (e-cigarettes) have grown in popularity, but effectiveness and safety in pregnancy are not yet established. The determinants of uptake and use of NRT and e-cigarettes in pregnancy are unknown. To explore factors affecting uptake and use of NRT and e-cigarettes in pregnancy. We searched MEDLINE(R), CINAHL and PsycINFO on 1 February 2019. We manually searched OpenGrey database and screened references of included studies and relevant reviews. We also conducted forward citation searches of included studies. We selected studies that used qualitative methods of data collection and analysis, included women who had smoked in pregnancy, and elicited participants' views about using NRT/e-cigarettes for smoking cessation or harm reduction (i.e. to smoke fewer cigarettes) during pregnancy. We identified determinants of uptake and use of NRT/e-cigarettes in pregnancy using a thematic synthesis approach. Two review authors assessed the quality of included studies with the Wallace tool. Two review authors used the CERQual approach to assess confidence in review findings. The contexts of studies from this review and the relevant Cochrane effectiveness review were not similar enough to fully integrate findings; however, we created a matrix to juxtapose findings from this review with the descriptions of behavioural support from trials in the effectiveness review. We included 21 studies: 15 focused on NRT, 3 on e-cigarettes, and 3 on both. Studies took place in five high-income countries. Most studies contributed few relevant data; substantially fewer data were available on determinants of e-cigarettes. Many studies focused predominantly on issues relating to smoking cessation, and determinants of NRT/e-cigarette use was often presented as one of the themes. We identified six descriptive themes and 18 findings within those themes; from these we developed three overarching analytical themes representing key determinants of uptake and adherence to NRT and/or e-cigarettes in pregnancy. The analytical themes show that women's desire to protect their unborn babies from harm is one of the main reasons they use these products. Furthermore, women consider advice from health professionals when deciding whether to use NRT or e-cigarettes; when health professionals tell women that NRT or e-cigarettes are safer than smoking and that it is okay for them to use these in pregnancy, women report feeling more confident about using them. Conversely, women who are told that NRT or e-cigarettes are as dangerous or more dangerous than smoking and that they should not use them during pregnancy feel less confident about using them. Women's past experiences with NRT can also affect their willingness to use NRT in pregnancy; women who feel that NRT had worked for them (or someone they know) in the past were more confident about using it again. However, women who had negative experiences were more reluctant to use NRT. No trials on e-cigarette use in pregnancy were included in the Cochrane effectiveness review, so we considered only NRT findings when integrating results from this review and the effectiveness review. No qualitative studies were conducted alongside trials, making full integration of the findings challenging. Women enrolled in trials would have agreed to being allocated to NRT or control group and would have received standardised information on NRT at the start of the trial. Overall, the findings of this synthesis are less relevant to women's decisions about starting NRT in trials and more likely to help explain trial participants' adherence to NRT after starting it. We considered most findings to be of moderate certainty; we assessed findings on NRT use as being of higher certainty than those on e-cigarette use. This was mainly due to the limited data from fewer studies (only in the UK and USA) that contributed to e-cigarette findings. Overall, we judged studies to be of acceptable quality with only minor methodological issues. Consistent messages from health professionals, based on high-quality evidence and clearly explaining the safety of NRT and e-cigarettes compared to smoking in pregnancy, could help women use NRT and e-cigarettes more consistently/as recommended. This may improve their attitudes towards NRT or e-cigarettes, increase their willingness to use these in their attempt to quit, and subsequently encourage them to stay smoke-free.

Pharmacological interventions for promoting smoking cessation during pregnancy.

Tobacco smoking in pregnancy causes serious health problems for the developing fetus and mother. When used by non-pregnant smokers, pharmacotherapies (nicotine replacement therapy (NRT), bupropion, and varenicline) are effective for increasing smoking cessation, however their efficacy and safety in pregnancy remains unknown. Electronic cigarettes (ECs) are becoming widely used, but their efficacy and safety when used for smoking cessation in pregnancy are also unknown.To determine the efficacy and safety of smoking cessation pharmacotherapies and ECs used during pregnancy for smoking cessation in later pregnancy and after childbirth, and to determine adherence to smoking cessation pharmacotherapies and ECs for smoking cessation during pregnancy.We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (20 May 2019), trial registers, and grey literature, and checked references of retrieved studies.Randomised controlled trials (RCTs) conducted in pregnant women, comparing smoking cessation pharmacotherapy or EC use with either placebo or no pharmacotherapy/EC control. We excluded quasi-randomised, cross-over, and within-participant designs, and RCTs with additional intervention components not matched between trial arms.We followed standard Cochrane methods. The primary efficacy outcome was smoking cessation in later pregnancy; safety was assessed by 11 outcomes (principally birth outcomes) that indicated neonatal and infant well-being. We also collated data on adherence to trial treatments. We calculated the risk ratio (RR) or mean difference (MD) and the 95% confidence intervals (CI) for each outcome for each study, where possible. We grouped eligible studies according to the type of comparison. We carried out meta-analyses where appropriate.We included 11 trials that enrolled a total of 2412 pregnant women who smoked at enrolment, nine trials of NRT and two trials of bupropion as adjuncts to behavioural support, with comparable behavioural support provided in the control arms. No trials investigated varenicline or ECs. We assessed four trials as at low risk of bias overall. The overall certainty of the evidence was low across outcomes and comparisons as assessed using GRADE, with reductions in confidence due to risk of bias, imprecision, and inconsistency. Compared to placebo and non-placebo (behavioural support only) controls, there was low-certainty evidence that NRT increased the likelihood of smoking abstinence in later pregnancy (RR 1.37, 95% CI 1.08 to 1.74; I² = 34%, 9 studies, 2336 women). However, in subgroup analysis by comparator type, there was a subgroup difference between placebo-controlled and non-placebo controlled RCTs (test for subgroup differences P = 0.008). There was unclear evidence of an effect in placebo-controlled RCTs (RR 1.21, 95% CI 0.95 to 1.55; I² = 0%, 6 studies, 2063 women), whereas non-placebo-controlled trials showed clearer evidence of a benefit (RR 8.55, 95% CI 2.05 to 35.71; I² = 0%, 3 studies, 273 women). An additional subgroup analysis in which studies were grouped by the type of NRT used found no difference in the effectiveness of NRT in those using patches or fast-acting NRT (test for subgroup differences P = 0.08). There was no evidence of a difference between NRT and control groups in rates of miscarriage, stillbirth, premature birth, birthweight, low birthweight, admissions to neonatal intensive care, caesarean section, congenital abnormalities, or neonatal death. In one study infants born to women who had been randomised to NRT had higher rates of 'survival without developmental impairment' at two years of age compared to the placebo group. Non-serious adverse effects observed with NRT included headache, nausea, and local reactions (e.g. skin irritation from patches or foul taste from gum), but data could not be pooled. Adherence to NRT treatment regimens was generally low. We identified low-certainty evidence that there was no difference in smoking abstinence rates observed in later pregnancy in women using bupropion when compared to placebo control (RR 0.74, 95% CI 0.21 to 2.64; I² = 0%, 2 studies, 76 women). Evidence investigating the safety outcomes of bupropion use was sparse, but the existing evidence showed no difference between the bupropion and control group.NRT used for smoking cessation in pregnancy may increase smoking cessation rates in late pregnancy. However, this evidence is of low certainty, as the effect was not evident when potentially biased, non-placebo-controlled RCTs were excluded from the analysis. Future studies may therefore change this conclusion. We found no evidence that NRT has either positive or negative impacts on birth outcomes; however, the evidence for some of these outcomes was also judged to be of low certainty due to imprecision and inconsistency. We found no evidence that bupropion may be an effective aid for smoking cessation during pregnancy, and there was little evidence evaluating its safety in this population. Further research evidence on the efficacy and safety of pharmacotherapy and EC use for smoking cessation in pregnancy is needed, ideally from placebo-controlled RCTs that achieve higher adherence rates and that monitor infants' outcomes into childhood. Future RCTs of NRT should investigate higher doses than those tested in the studies included in this review.

Varenicline versus nicotine replacement therapy for long-term smoking cessation: an observational study using the Clinical Practice Research Datalink.

Smoking is the leading avoidable cause of illness and premature mortality. The first-line treatments for smoking cessation are nicotine replacement therapy and varenicline. Meta-analyses of experimental studies have shown that participants allocated to the varenicline group were 1.57 times (95% confidence interval 1.29 to 1.91 times) as likely to be abstinent 6 months after treatment as those allocated to the nicotine replacement therapy group. However, there is limited evidence about the effectiveness of varenicline when prescribed in primary care. We investigated the effectiveness and rate of adverse events of these medicines in the general population. To estimate the effect of prescribing varenicline on smoking cessation rates and health outcomes. Clinical Practice Research Datalink. We conducted an observational cohort study using electronic medical records from the Clinical Practice Research Datalink. We extracted data on all patients who were prescribed varenicline or nicotine replacement therapy after 1 September 2006 who were aged ≥ 18 years. We investigated the effects of varenicline on smoking cessation, all-cause mortality and cause-specific mortality and hospitalisation for: (1) chronic lung disease, (2) lung cancer, (3) coronary heart disease, (4) pneumonia, (5) cerebrovascular disease, (6) diabetes, and (7) external causes; primary care diagnosis of myocardial infarction, chronic obstructive pulmonary disease, depression, or prescription for anxiety; weight in kg; general practitioner and hospital attendance. Our primary outcome was smoking cessation 2 years after the first prescription. We investigated the baseline differences between patients prescribed varenicline and patients prescribed nicotine replacement therapy. We report results using multivariable-adjusted, propensity score and instrumental variable regression. Finally, we developed methods to assess the relative bias of the different statistical methods we used. People prescribed varenicline were healthier at baseline than those prescribed nicotine replacement therapy in almost all characteristics, which highlighted the potential for residual confounding. Our instrumental variable analysis results found little evidence that patients prescribed varenicline had lower mortality 2 years after their first prescription (risk difference 0.67, 95% confidence interval -0.11 to 1.46) than those prescribed nicotine replacement therapy. They had similar rates of all-cause hospitalisation, incident primary care diagnoses of myocardial infarction and chronic obstructive pulmonary disease. People prescribed varenicline subsequently attended primary care less frequently. Patients prescribed varenicline were more likely (odds ratio 1.46, 95% confidence interval 1.42 to 1.50) to be abstinent 6 months after treatment than those prescribed nicotine replacement therapy when estimated using multivariable-adjusted for baseline covariates. Patients from more deprived areas were less likely to be prescribed varenicline. However, varenicline had similar effectiveness for these groups. Patients prescribed varenicline in primary care were more likely to quit smoking than those prescribed nicotine replacement therapy, but there was little evidence that they had lower rates of mortality or morbidity in the 4 years following the first prescription. There was little evidence of heterogeneity in effectiveness across the population. Future research should investigate the decline in prescribing of smoking cessation products; develop an optimal treatment algorithm for smoking cessation; use methods for using instruments with survival outcomes; and develop methods for comparing multivariable-adjusted and instrumental variable estimates. Not all of our code lists were validated, body mass index and Index of Multiple Deprivation had missing values, our results may suffer from residual confounding, and we had no information on treatment adherence. This trial is registered as NCT02681848. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 9. See the NIHR Journals Library website for further project information.

The effectiveness of individual interventions on smoking cessation of chronic obstructive pulmonary disease patients

Context: Guided self-change (GSC) is theory-driven based on cognitive-behavioral change models such as transtheoreticlal model (TTM) and can be applied with nicotine replacement therapy (NRT) for behavioral change of smoking in chronic obstructive pulmonary disease (COPD) smokers. Aims: This study aimed to investigate the individual GSC, NRT, and GSC-NRT on smoking cessation of COPD patients. Settings and Design: This randomized clinical control trial study was carried out in Imam Khomeini Hospitals in Mazandaran province in 2016–2017. Materials and Methods: Three- group block randomized controlled trial, comparing GSC (n = 20), NRT (n = 20), and GSC-NRT (n = 20) in smoking cessation and other related variables COPD smokers with follow-up to 29-week. Statistical Analysis Used: Descriptive statistics, Chi-square, and repeated measures ANOVA test were used to analyze the data. Results: The GEE model revealed that GSC reduced the odds of quitting smoking rate compared to the NRT group (odds ratio = 0.31, 95% confidence interval: 0.022–0.545, ES = 0.20). Furthermore, the TTM questionnaire, the Fagerstrom test for nicotine dependence, and spirometry variables were evaluated in the three groups. The recovery in nicotine dependency, the exhaled carbon monoxide and spirometry variables was more pronounced in the GSC and GSC-NRT groups than in the NRT over 29 weeks after the treatments. Cons (PV = 0.009, ES = 0.52), pros (PV = 0.04, ES = 0.12), experiential process (PV = 0.005, ES = 0.18), counterconditioning (PV = 0.04, ES = 0.12), stimulus control (PV = 0.004, ES = 0.19), environmental-reevaluation (PV = 0.0001, ES = 0.30), and habitual craving (PV = 0.004, ES = 0.19) were significant across the three groups. Conclusion: The interventions in the GSC and combined GSC-NRT groups were significantly more effective than in the NRT group in TTM variables, and GSC and combined GSC-NRT were equally effective in smoking cessation rate.

Effect of the different smoking cessation regimens with acupuncture on smoking withdrawal and their influence factors: a multi-center randomized controlled trial

To evaluate the clinical effect of acupuncture on smoking cessation and withdrawal symptoms and to explore the influence factors of acupuncture on smoking cessation. A total of 500 subjects with tobacco dependence were randomized into an acupuncture group, an auricular therapy group, an acupuncture plus auricular therapy group, a TENS group and a nicotine replacement therapy group (NRT group), 100 cases in each one. In the acupuncture group, acupuncture was applied at Baihui (GV 20), Lieque (LU 7), Hegu (LI 4) and Zusanli (ST 36). The treatment was given 5 times a week, once a day in the first 2 weeks. The treatment was given once every 2 days in the week 3 and 4, 3 times a week, and twice a week, once every 3 days in the week 5 to 8. In the auricular therapy group, the ear point pressure therapy was used at shenmen (TF4), neifenmi (CO18), pizhixia (AT4) and jiaogan (AH6a), 3 times a week. In the acupuncture plus auricular therapy group, acupuncture and auricular therapy were adopted with the same points and manipulation as the previous two groups. Acupuncture was given 3 times a week and the auricular therapy was given twice a week. In the TENS group, SDZ-Ⅱ B type electric acupuncture apparatus was used to stimulate Lieque (LU 7) and Zusanli (ST 36), once a day. In the NRT group, the nicotine patch was used on the chest, back and the upper arms of the subjects, once a day. The duration of treatment was 8 weeks as one course in every group. Afterwards, the 16-week follow-up was conducted. The time-point withdrawal rate was evaluated by the level of urine cotinine in 8 weeks of treatment and in the follow-up in the subjects of 5 groups. The persistent withdrawal rate was evaluated by the self-report of the subjects in 8 weeks of treatment as well as in the follow-up in the 5 groups. The withdrawal effect, the score of the fagerstrom test for nicotine dependence (FTND) and the score of the heaviness of smoking index (HSI) were compared among the groups. Twenty indexes were selected as the potential influence factors, the 72 h withdrawal rate based on the level of urine cotinine in 8 weeks of treatment and in the follow-up was taken as the dependent variable. Using the two categories of Logistic regression analysis, the influence factors of therapeutic effect of acupuncture were screened for smoking cessation. After 8 weeks of treatment, the time-point withdrawal rate in the subjects among the groups was NRT group > acupuncture plus auricular therapy group > auricular therapy group > acupuncture group > TENS group. In the follow-up, the time-point withdrawal rate was acupuncture plus auricular therapy group > NRT group > acupuncture group > TENS group > auricular therapy group, but without statistical significance in comparison (P>0.05). After 8 weeks of treatment, the persistent withdrawal rate in the subjects among the groups was auricular therapy group > TENS group > acupuncture group > acupuncture plus auricular therapy group > NRT group. In the follow-up visit, the persistent withdrawal rate was auricular therapy group > TENS group > acupuncture plus auricular therapy group > acupuncture group > NRT group. The result in the auricular therapy group was better than all of the other 4 groups (P<0.05). Except in the follow-up visit, FTND score in the acupuncture group was lower than the auricular therapy group (P<0.05), FTND score and HSI score were not different significantly in statistics among the groups either in 8 weeks of treatment or in the follow-up (P>0.05). The regression analysis showed that the factors, i.e. nationality, educational background, drinking frequency, pre-treatment FTND score, pre-treatment HSI score and smoking cessation for physical reason in family, were correlated significantly with the withdrawal result after 8-week treatment (P<0.05). The factors, i.e. education background, smoking age, pre-treatment FTND score and different therapeutic methods, were correlated significantly with the withdrawal result in the follow-up (P<0.05). Acupuncture combined with auricular therapy effectively reduce nicotine dependence and smoking intensity and relieve withdrawal symptoms. There are many factors that affect the withdrawal effect in smoking cessation. Hence, the influence factors in smoking cessation with acupuncture should be clearly determined so as to develop the individual regimen for smoking cessation and improve the clinical therapeutic effect of acupuncture on smoking cessation.

Efficacy of guided self-change for smoking cessation in chronic obstructive pulmonary disease patients: A randomized controlled clinical trial.

INTRODUCTIONThe aim of this study was to examine the efficacy of guided self-change (GSC), nicotine replacement therapy (NRT), and their combination, on smoking cessation among patients with COPD.METHODSA total of 60 participants were randomly assigned to three groups for GSC (n=20), nicotine replacement therapy (NRT) (n=20) or their combination (n=20), from December 2016 to November 2017. The quality of life (QoL) questionnaire, clinical assessment test (CAT) and exhaled carbon monoxide (CO), were measured at baseline and post-treatment.RESULTSAt 6, 12, and 29 weeks, the abstinence rate in the NRT group was 5.3%, 15.8% and 21.1%, in the GSC group 21.1%, 31.6% and 47.4%, and in the combined group 36.8%, 36.8% and 47.4%, respectively. The exhaled CO in the NRT group was greater than the GSC group, however this difference was not statistically significant (3.4; 95% CI: -0.24–7.0; p=0.067), CO levels in the combined group were less than the GSC group, while this difference was also not significant (-0.75; 95% CI : -4.2–2.7; p=0.68). CAT and QoL recovery in the GSC and combined groups were higher than in the NRT group (9.2; 95% CI: 5.0–13.4; p=0.001) and (-4.5; 95% C: -8.1– -0.6; p=0.02), respectively. However, differences between combined and GSC groups were not significant (p=0.24 and p=0.41, respectively). There was a statistically significant difference between the abstinence rate in the GSC or combined group and the NRT group (p=0.001). The GEE model showed that GSC reduced the odds of smoking compared with the NRT group (interaction group effect) (OR=0.31, 95% CI: 0.022–0.545; p=0.001).CONCLUSIONSIn our context among COPD patients, GSC was more effective in decreasing smoking than NRT alone. Moreover, the recovery of exhaled carbon monoxide, CAT and QoL in GSC was more than in the NRT group. Moreover, since GSC was as effective as GSC plus NRT, the effectiveness of the combination method for smoking cessation in COPD patients may be attributed to GSC.Clinical trial registration details: IRCT201609271457N11; www.irct.ir

Is the apparently protective effect of maternal nicotine replacement therapy (NRT) used in pregnancy on infant development explained by smoking cessation?: secondary analyses of a randomised controlled trial

ObjectiveTo investigate relationships between maternal smoking status in pregnancy and infant development. The largest randomised controlled trial of nicotine replacement therapy (NRT) for smoking cessation in pregnancy, the smoking, nicotine...

Association between post-cessation weight gain and eating behavior changes.

OBJECTIVE:Fear of post-cessation weight gain may be a barrier to cessation therapy or may lead to smoking relapse. This study aimed to evaluate the relationship between the change in eating behavior and post-cessation weight gain.METHODS:A prospective study that included 103 cigarette smokers, who visited the family medicine clinics of a training and research hospital for smoking cessation treatment between June 2018 and December 2018, was planned. A face to face survey (including Turkish version of Dutch Eating Behaviour Questionnaire-DEBQ and weight measures) was applied to all individuals at first and the final visits for the assessment of restrained, emotional, and external eating behaviors. Statistical analyses were completed using the IBM SPSS Statistics 22 program.RESULTS:Of 103 patients screened (M age=38.3 years SD=9.28), 58.3% were male, and 40.8% were in heavy nicotine dependence level (NDL) group. The mean weight increased by 4.74±2.63 kg in three months of smoking cessation. In the high NDL group, three subscales score (restrained p<0.001, emotional p=0.007, external p=0.005) of the DEBQ increased. Weight gain was significative associated with NDL (p=0.01). There was a positive correlation between Fagerstrom score and weight (kg) gain (r: 0.34; p=0.001). Weight change according to the emotional eating behavior was significantly different by gender (female p=0.005; male p=0.04). Women had a higher difference in emotional eating behavior score than men. Obese smokers had a higher initial restrained eating score than non-obese smokers (p=0.009). Weight gain of nicotine replacement therapy group had a similar result in the pharmacotherapy (varenicline) group (p=0.26). Both of treatment types concluded with a significant weight change (p=0.001).CONCLUSION:This study obtained that post-cessation weight gain is related to high nicotine dependence, and quit smoking causes increased scores of emotional, restrained, external eating behavior subscales. Post-cessation eating behavior is negatively affected by quit smoking.