Financial incentives for smoking cessation in pregnancy: multicentre randomised controlled trial

ObjectiveTo evaluate the efficacy of financial incentives dependent on continuous smoking abstinence on smoking cessation and birth outcomes among pregnant smokers.DesignSingle blind, randomised controlled trial.SettingFinancial Incentive for Smoking Cessation in Pregnancy (FISCP) trial in 18 maternity wards in France.Participants460 pregnant smokers aged at least 18 years who smoked ≤5 cigarettes/day or ≤3 roll-your-own cigarettes/day and had a pregnancy gestation of <18 weeks were randomised to a financial incentives group (n=231) or a control group (n=229).InterventionsParticipants in the financial incentives group received a voucher equivalent to €20 (£17; $23), and further progressively increasing vouchers at each study visit if they remained abstinent. Participants in the control group received no financial incentive for abstinence. All participants received a €20 show-up fee at each of six visits.Main outcome measuresThe main outcome measure was continuous smoking abstinence from the first post-quit date visit to visit 6, before delivery. Secondary outcomes in the mothers were point prevalence abstinence, time to smoking relapse, withdrawal symptoms, blood pressure, and alcohol and cannabis use in past 30 days. Secondary outcomes in the babies were gestational age at birth, birth characteristics (birth weight, length, head circumference, Apgar score), and a poor neonatal outcome—a composite measure of transfer to the neonatal unit, congenital malformation, convulsions, or perinatal death.ResultsMean age was 29 years. In the financial incentives and control groups, respectively, 137 (59%) and 148 (65%) were employed, 163 (71%) and 171 (75%) were in a relationship, and 41 (18%) and 31 (13%) were married. The participants had smoked a median of 60 cigarettes in the past seven days. The continuous abstinence rate was significantly higher in the financial incentives group (16%, 38/231) than control group (7%, 17/229): odds ratio 2.45 (95% confidence interval 1.34 to 4.49), P=0.004). The point prevalence abstinence rate was higher (4.61, 1.41 to 15.01, P=0.011), the median time to relapse was longer (visit 5 (interquartile range 3-6) and visit 4 (3-6), P<0.001)), and craving for tobacco was lower (β=−1.81, 95% confidence interval −3.55 to −0.08, P=0.04) in the financial incentives group than control group. Financial incentives were associated with a 7% reduction in the risk of a poor neonatal outcome: 4 babies (2%) in the financial incentives group and 18 babies (9%) in the control group: mean difference 14 (95% confidence interval 5 to 23), P=0.003. Post hoc analyses suggested that more babies in the financial incentives group had birth weights ≥2500 g than in the control group: unadjusted odds ratio 1.95 (95% confidence interval 0.99 to 3.85), P=0.055; sex adjusted odds ratio 2.05 (1.03 to 4.10), P=0.041; and sex and prematurity adjusted odds ratio 2.06 (0.90 to 4.71), P=0.086. As these are post hoc analyses, the results should be interpreted with caution.ConclusionsFinancial incentives to reward smoking abstinence compared with no financial incentives were associated with an increased abstinence rate in pregnant smokers. Financial incentives dependent on smoking abstinence could be implemented as a safe and effective intervention to help pregnant smokers quit smoking.Trial registrationClinicalTrials.gov NCT02606227.

Non-traditional Acupuncture Therapies for Smoking Cessation: A Systematic Review of Randomized Controlled Trials

BackgroundNon-traditional acupuncture (NTA) therapies widely used for smoking cessation include acupressure, transcutaneous electrical acupoint stimulation (TEAS), laser acupuncture, intradermal needle, and acupoint catgut embedding (ACE). Our aim was to evaluate their therapeutic effects and safety for smoking cessation. MethodsRandomized controlled trials (RCTs) comparing NTA therapies with sham NTA or conventional therapy for smoking cessation were included. Ten databases were searched from their inception to February 2021. Two review authors independently screened studies, extracted data, and assessed the risk of bias. Meta-analysis was conducted with RevMan 5.4 software. Grading of Recommendations Assessment, Development and Evaluation (GRADE) was applied to assess the quality of evidence. The primary outcome was abstinence rate at short-term (1-3months), mid-term (3-6months), and long-term (≥6months). ResultsTwenty-five RCTs involving 2600 smokers were identified. Acupressure was found more effective than sham acupressure or conventional therapy in improving short-term (RR 1.41, 95% CI [1.04 to1.91]; low certainty; 8 trials, n=637) and mid-term abstinence rate (RR 1.63, 95% CI [1.27 to 2.09]; low certainty; 8 trials, n=749). Intradermal needle was not superior to sham control or counseling for short-term (RR 1.62, 95% CI [0.85 to 3.08]; low certainty; 5 trials, n=346) and mid-term abstinence rate (RR 1.49, 95% CI [0.68 to 3.27]; low certainty; 3 trials, n=187).TEAS failed to show a better effect than sham TEAS or counseling for short-term abstinence rate (RR 1.27, 95% CI [0.96 to 1.67];moderate certainty;5 trials, n=485), TEAS appeared more beneficial for mid-term abstinence (RR 1.58, 95% CI [1.10 to 2.27]; moderate certainty; 3 trials, n=325). Laser acupuncture was superior to sham control for long-term abstinence rate (RR 2.25, 95% CI [1.23 to 4.11]; moderate certainty; 2 trials, n=160). ACE was comparable to Bupropion for mid-term abstinence rate (RR 0.99, 95% CI [0.70 to 1.40]; low certainty; 2 trials, n=177). No serious adverse events were reported in the included trials. ConclusionsLow to moderate certainty evidence suggests that acupressure, TEAS, laser acupuncture and ACE maybe effective in achieving short-term, middle-term or long-term smoking cessation. Further large, long-term follow-up RCTs are warranted to verify their benefits and safety.Systematic review registration: INPLASY 202120054.

The Effectiveness Analysis of ‘Quit-Calendar’ Related to Current Smokers under ‘Quit-For-King’ Project (Phase II)

ackground: Quit-Calendar has been developed and initially tested in Phase I for the Quit-For-King project. The effectiveness and satisfaction of its properties were later investigated among village health volunteers. Objective: To investigate the Quit-Calendar effectiveness, factors related to quit success, and its satisfaction under the ‘Quit-For-King’ Project. Materials and Methods: One hundred eleven current smokers underwent the program. Each participant needed to go ‘cold turkey’ technique, which mean to stop smoking at once, then received 5A counseling and a Quit-Calendar. The measuring parameters included continuous abstinence rate (CAR) and point prevalence abstinence rate (PAR), investigated at 2-weeks, 1-, 3-, and 6- month periods via statistical analysis. Results: Most of the participants were males (96.4%), smoked 10 cigarettes per day (53%), heavy smokers. They were mostly in ‘preparation stage’ of change (49%). CAR was 26.11% and PAR values increased by the end of the 6-month. There were statistically significant differences between the numbers of quitters using Quit-Calendar (p<0.001). Only three factors, including numbers of cigarettes, minor illness, and levels of readiness to quit significantly affected quit success (p<0.001). The smokers stated that the Quit-Calendar could possibly help them to quit smoking. Nonetheless, some limitations need to be resolved. Conclusion: Quit-For-King project has been successful over a 3-year period. The Quit-Calendar is one of the cessation aids that promote quit success and help quitters to overcome nicotine withdrawal. Keywords: Quit-For-King, Quit-Calendar, Continuous abstinence rate (CAR), Point prevalence abstinence rate (PAR), Village health volunteers

Effectiveness of Varenicline versus Combination Nicotine Replacement Therapy for Smoking Cessation: One Year Outcomes in a Smoking Cessation Clinic in Taiwan

Introduction Varenicline and combination nicotine replacement treatment (cNRT) have been recommended as the most effective pharmacotherapies, with equal abstinence rate for smoking cessation in a network meta-analysis of randomized trials, but data from real-world long-term follow-up studies are rare. This study aimed to compare the 12-month sustained abstinence rates of smokers using varenicline versus cNRT in their quit attempt. Methods A total of 3,569 smokers were recruited via the Department of Family Medicine outpatient department at Kaohsiung Veteran General Hospital between June 2013 and March 2019. Participants received counseling from a physician and chose either varenicline (N=2,870) or cNRT (N=699) for smoking cessation. Both varenicline and cNRT users could receive a free 8-week supply and 8 clinic visits over 90 days. Participants were followed-up by telephone at 12, 24, and 52 weeks from first visit. The primary outcome measure of the study was self-reported sustained abstinence up to 52 weeks. Results Varenicline users had a significantly higher sustained abstinence rate weeks 12-52, adjusted for baseline variables (15.2% vs. 10.3%, p=0.001; aOR= 1.47, 95%CI: 1.05–2.05). Other significant predictors of 52 weeks sustained abstinence were being male, having a higher income, attending more clinical visits and have lower nicotine dependence. Conclusion Varenicline appears to have higher sustained abstinence rates to 52 weeks compared with cNRT, in a smoking cessation clinic where smokers can choose their medication option.

Efficacy of Electronic Cigarettes for Smoking Cessation: A Systematic Review and Meta-Analysis

Background: Smoking is a major public health problem and widely recognized as one cause of premature morbidity and mortality. No updated evidence to conclude about the certainty of evidence for adopting E-Cigarettes as smoking cessation intervention despite enough debate. We aim to synthesize available evidence to assess the efficacy as well as safety of E-Cigarettes versus different forms of NRT and placebo to quit smoking. Methods: We comprehensively searched of clinical trials in Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via PubMed), PsycINFO, Science Direct, Center for reviews and dissemination and HTA database and Trip database. We also searched clinicalTrial.gov and WHO International Clinical Trials Registry Platform (ICTRP) portal. We searched grey literature including Dissertations (ProQuest Dissertations and Theses), Web of Science Thomson Reuters: Conference Proceedings Citation Index, and unpublished manuscripts, examined the references of relevant articles, hand searched topic-specific journals and contacted authors for incomplete data. After data extraction, we assessed the risk of bias using the Cochrane RoB 2 tool. We synthesized data by random-effects model through the Mantel-Haenszel method and R software. We conducted subgroup analysis by length of follow-up and sensitivity analysis by restricting to only studies with low risk of bias. We created a summary of findings table based on GRADE approach. Results: We retrieved 12 clinical trials involving 9863 participants. Four studies were judged as low risk of bias across five domains of RoB 2 tool and the rest were judged as unclear risk of bias. CO- validated one-month continuous abstinence rate was significantly higher in E-cigarettes group than control (5 studies, 32.6 vs 23.1%, N = 1970, RR 1.335, 95 % CI 1.068; 1.667, moderate evidence). However, Three-month and six- month abstinence rate didn’t differ significantly between E-cigarettes and control groups (3 Studies, 12.1 vs 12.8%, N=1099, RR 1.52, 95% CI 0.348; 6.701) and (7studies, N = 5435,10.2 vs 6.6%, RR 1.347, 95%CI 0.953; 1.903, very low evidence) respectively. There is very low certainty evidence of effect of E-cigarettes compared to control whether NRT or placebo on sustained reduction of 50% or greater in baseline cigarette consumption at different follow-up periods (1 month, 3 studies, 50.9 vs 33.2%, N = 955, RR 1.29, 95 % CI 0.59; 2.82), (3 Month , 3 studies, 43.2 vs 25.3%, N = 1067, RR 1.36, 95 % CI 0.66; 2.79), (6 month , 5 studies, 27.1 vs 13.4%, N = 1981, RR 1.38, 95 % CI 0.90; 2.11) and at 12 month (1 study, 14.5 vs 12%, N = 300, RR 1.21, 95 % CI 0.64; 2.27). Only one study of 884 participants displayed improved point abstinence by 46% (improvement range 17-82%) in E-cigarettes group relative to control at 12 months (1study, 32.7 vs 22.3%, N = 884, RR 1.46, 95 % CI 1.17; 1.82, moderate evidence). E-cigarettes may increase the proportion of serious adverse effect at 6 month-follow up (1 study, 9.3 vs 5.1%, N = 657, RR 1.81, 95 % CI 1.03; 3.19, low evidence) Conclusion: We are uncertain if E-cigarettes improve continuous abstinence rate at short term (1 month). There is very low certainty evidence of the effect of E-cigarettes compared to control whether NRT or placebo on the sustained reduction of 50% or greater in baseline cigarette consumption as well as 7-day point prevalence abstinence rate at 1-,3-, and 6-month follow-up periods. Long term efficacy of E-cigarettes is unknown, and E-cigarettes may increase or have no effects on the proportion of serious adverse effect at 6 months follow up. The information presented are indeed useful for policy makers , public health practitioners, and to encourage further research. Further clinical trials are needed to assess the long-term efficacy and safety of E-cigarettes and ongoing trials are urgently needed to help concluding about the efficacy of E-cigarettes for smoking cessation. Objective: to synthesize evidence about the efficacy of electronic cigarettes versus Nicotine Replacement Therapy and placebo to quit smoking. Data sources: We searched for clinical trials with no publication date restriction until December 2019. The search included CENTRAL, MEDLINE, PsycINFO, Science Direct, Center for reviews and dissemination and HTA database and Trip database, clinical trials registries, gray literature and examined the references of relevant articles. Inclusion and exclusion criteria: Two review authors independently checked the titles and abstracts then the full text of initial hits. Main outcomes were sustained continuous abstinence rate, 7-day point prevalence abstinence rate, sustained reduction of 50% or greater in baseline cigarette consumption and adverse effects. Data extraction and synthesis: Two review authors independently extracted data and assessed risk of bias using the Cochrane RoB 2 tool. We conducted a random-effects model through the Mantel-Haenszel method. Results: We retrieved 12 trials involving 9863 participants. CO- validated 1-month continuous abstinence rate improved by 33% in the e-cigarettes group (range 6-66%, moderate evidence). We are uncertain if e-cigarettess influence continuous abstinence rate at 3-, 6- and 12 months as well as sustained reduction of 50% or greater in baseline cigarette consumption at different follow-up periods. One study of 884 participants displayed improved 12-month 7-day point abstinence by 46% (range 17%-82%). E-cigarettes may increase or do not affect the proportion of serious adverse effect at 6 and 12 months follow up. Conclusion: Very low certainty evidence supported e-cigarettess to help quit smoking in the short term. There is not enough evidence to determine if e-cigarettess are a safe and efficacious means of smoking cessation in the long term (12+ months).

Efficacy of smoking cessation in spirometry results of COPD smokers: a randomized controlled clinical trial

BackgroundNicotine replacement therapy (NRT) may be more effective if it is combined with short cognitive-behavioral interventions for smoking cessation in chronic obstructive pulmonary diseasesmokers.Material and methodsTo examine the effectiveness of guided self-change (GSC), in a randomized controlled clinical trial, 57 men ranging from 45 to 77 years old were randomly assigned to three 19-member groups (GSC, NRT, and combined GSC-NRT).The primary data on smoking cessation and pulmonary functions were examined during 29 weeks using General Linear (GEE) Model status, intention-to-treat analysis, and repeated measures ANOVA test.ResultsA total of 9 (47.4%) of the participants in the GSC and combined groups and 4 (21.1%) participants in the NRT group reported total abstinence rate from smoking by the end of 29 weeks. Daily cigarette number was changed from 24 to 4 in GSC group, 26 to 11 in NRT group, and 20 to 6 in combined group. The GEE model revealed that this variable decreased in GSC group more than two other groups significantly (P=0.003). Moreover, the FVC level of the NRT group was lower than the GSC group (P=0.04), and the FEV in the NRT group was lower than GSC group (P=0.02). Furthermore, the level of FEV1/FVC act/pred in the NRT group was lower than GSC group (−6, 95% CI: -10.4-(−1.5), P=0.008) and it was also lower in the combined group than the GSC group (−6, 95% CI: -11.3-(−0.5), PV=0.03).ConclusionGSC and combined GSC-NRT treatments were equally effective in abstinence rate. Moreover Daily cigarette and the FEV1/FVC act/pred in GSC group was more than two other groups, indicating the health professionals can apply GSC alone in smoking cessation and improve lung function of COPD smokers.

Determining the effects of exercise after smoking cessation therapy completion on continuous abstinence from smoking: Japanese study protocol

Background Despite a steady world-wide decline over recent decades, rates of smoking remain high in developed countries. In Japan, 30% of men and 10% of women are smokers. Based on these rates, 18.8 million (14.06 million men and 4.74 million women) in Japan are smokers. The rate of success for smoking cessation has recently improved due to the widespread availability of drug therapy; however, the success rate for quitting smoking one year after beginning therapy is only around 50%. Previous studies have demonstrated that exercise can relieve mental stress during continuous abstinence from smoking and curb smoking resumption. To date, no large-scale, randomized controlled trials have examined the effects of exercise on smoking cessation. The present study aims to determine the effects of exercise instruction on continuous abstinence from smoking after completion of smoking cessation therapy. Methods This is a multicenter, prospective, parallel-group, randomized controlled trial in Japan. We will enroll 300 individuals visiting a smoking cessation clinic (over 3 months) who have abstained from smoking in the second month after their initial visit as potential participants. Participants will not habitually exercise and will need to consent to participate. Participants will be randomly assigned to the exercise intervention group or control group. The intervention group will receive instruction on exercises that can be incorporated into their daily lives. The control group will be followed during the standard smoking cessation support program. The primary endpoint will be the continuous abstinence rate, and secondary endpoints will be weight, blood pressure, exhaled carbon monoxide concentration, psychological state, and blood test results. These indices will be compared between the intervention and control groups, with follow-up periods of 9 months in both groups. Discussion By examining the effects of exercise instruction after completion of 12-week smoking cessation therapy, this study should yield quality information that can be used to develop protocols to improve the continuous abstinence rate and inhibit weight gain after smoking cessation therapy. Trial registration UMIN Clinical Trials Registry, UMIN000014615. Registered on 1 October 2014.

Determining the effects of exercise after smoking cessation therapy completion on continuous abstinence from smoking: Japanese study protocol

Background: Despite a steady world-wide decline over recent decades, the smoking rates remain high in developed countries. In Japan, the smoking rate is 30% for men and 10% for women. Based on these rates, Japan's smoking population is estimated to be 18.8 million (14.06 million for men and 4.74 million for women). The rate of success for smoking cessation has recently improved due to the widespread availability of drug therapy; however, the success rate for quitting smoking one year after beginning therapy is only around 50%. Previous studies have demonstrated that exercise can relieve mental stress during continuous abstinence from smoking and curb smoking resumption. To date, no large-scale randomized controlled trials have examined the effects of exercise on smoking cessation. The present study aims to determine the effects of implementing an intervention in the form of exercise instruction after smoking cessation therapy completion on continuous abstinence from smoking. Methods: This is a multicenter, prospective, parallel-group, randomized controlled trial in Japan.We will enroll 300 individuals visiting a smoking cessation clinic (over three months) who have abstained from smoking in the second month after their initial visit as potential participants. Participants will not habitually exercise and will consent to participate. Participants will be randomly assigned to the exercise intervention group or control group. The intervention group will receive instruction on exercises that can be incorporated into their daily lives. The control group will be followed during the standard smoking cessation support program. The primary endpoint will be the continuous abstinence rate, and secondary endpoints will be weight, blood pressure, exhaled carbon monoxide concentration, psychological state, and blood test results. These indices will be compared between the intervention and control groups, with follow-up periods of nine months for both groups. Discussion: By examining the effects of exercise instruction after completion of a 12-week smoking cessation therapy, this study should yield quality information that can be used to develop protocols to improve the continuous abstinence rate and inhibit weight gain after smoking cessation therapy.

Combined nicotine patch with gum versus nicotine patch alone in smoking cessation in Hong Kong primary care clinics: a randomised controlled trial

Background The prevalence of daily cigarette smoking has dropped to 10% in Hong Kong (HK) in 2017, however, smoking still kills 5700 persons per year. Studies suggest that abstinence rates are higher with combined NRT than single NRT, although local data on safety and benefits of combined NRT are lacking. The aim of this study is to compare the effectiveness of combined NRT with single NRT among HK Chinese. Methods This is a one-year, two-arm, parallel randomised trial. Five hundred sixty smokers, who smoked ≥10 cigarettes/day for ≥1 year, were randomized to combined and single NRT. Combined NRT group received counseling and nicotine patch & gum. Single NRT group received counselling and nicotine patch. Primary outcome was abstinence rate measured as self-reported 7-day point prevalence with CO validated at 52 weeks. Secondary outcomes included smoking abstinence rates at 4, 12, & 26 weeks. Crude odds ratio and p-value were reported from logistic regression without adjustment; for trend analysis, adjusted odds ratio (AOR) and p-value were reported from Generalized Estimating Equation (GEE) (controlling for time). All AORs were adjusted for age, sex, baseline CO and clusters. Results Abstinence rates at 4, 12, 26 and 52 weeks were all higher in the combined NRT group (35.8, 21.9, 16.8, 20.1%) compared with the single NRT group (28, 16.8, 11.2, 14.3%). At 4 weeks, combined NRT group was more likely to quit smoking (OR 1.43, 95% CI, 1.00 to 2.05) than the single NRT group. From GEE analysis, combined NRT group had a significantly higher abstinence rate (23.6%) than the single NRT group (17.6%) across repeated measures at all-time points. Combined NRT group was more likely to quit smoking (OR 1.43, 95% CI, 1.15 to 1.77). No significant difference in the side effect profile was detected between groups. Conclusions Smokers given 8 weeks of combined NRT were more likely to quit smoking at 4, 12, 26 and 52 weeks compared with single NRT. Combined NRT was as well tolerated as single NRT and it should be further promoted in our community. Trial registration NCT03836560 from ClinicalTrial.gov, 9 Feb 2019.