21 Predictors of recruitment in randomised controlled trials of smoking cessation: meta-regression analyses from the IC-SMOKE systematic review project. Abstract competing for the ‘doug altman scholarship’

Author(s):  
Alessio Bricca ◽  
Zoe Swithenbank ◽  
Neil Scott ◽  
Shaun Treweek ◽  
Marie Johnston ◽  
...  
BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e027389 ◽  
Author(s):  
Robert Pearsall ◽  
Daniel J Smith ◽  
John R Geddes

ObjectiveSmoking in people with serious mental illness is a major public health problem and contributes to significant levels of morbidity and mortality. The aim of the review was to systematically examine the efficacy of methods used to aid smoking cessation in people with serious mental illness.MethodA systematic review and meta-analysis of randomised controlled trials to compare the effectiveness and safety of pharmacological and behavioural programmes for smoking cessation in people with serious mental illness. Electronic databases were searched for trials to July 2018. We used the Cochrane Collaboration’s tool for assessing the risk of bias.ResultsTwenty-eight randomised controlled trials were identified. Varenicline increased the likelihood of smoking cessation at both 3 months (risk ratio (RR) 3.56, 95% CI 1.82 to 6.96, p=0.0002) and at 6 months (RR 3.69, 95% CI 1.08 to 12.60, p=0.04). Bupropion was effective at 3 months (RR 3.96, 95% CI 1.86 to 8.40, p=0.0003), especially at a dose of 300 mg/day, but there was no evidence of effect at 6 months (RR 2.22, 95% CI 0.52 to 9.47, p=0.28). In one small study, nicotine therapy proved effective at increasing smoking cessation up to a period of 3 months. Bupropion used in conjunction with nicotine replacement therapy showed more effect than single use. Behavioural and bespoke interventions showed little overall benefit. Side effects were found to be low.ConclusionThe new information of this review was the effectiveness of varenicline for smoking cessation at both 3 and 6 months and the lack of evidence to support the use of both bupropion and nicotine products for sustained abstinence longer than 3 months. Overall, the review found relatively few studies in this population.


2021 ◽  
pp. 00261-2021
Author(s):  
Stefan Andreas ◽  
Christian Röver ◽  
Judith Heinz ◽  
Christian Taube ◽  
Tim Friede

A decreasing trend in exacerbation rates has been observed in chronic obstructive pulmonary disease (COPD). Since mortality is linked to exacerbations, it is of interest to investigate whether a similar time trend is present also in mortality rates.We performed a systematic review of placebo groups in published randomised controlled trials. Mortality rate was modelled based on a Poisson distribution for the event counts. Adding information on mortality as well as on newly published studies on a previous database, we performed a meta-regression.Among the 56 included studies representing 14 166 patients, an annual decrease in mortality rates by 6.1% [−0.6%, 12.6%] (p=0.073) was observed. Consistent results were obtained in subgroups as well as when adjusting for potential confounders. The correlation between exacerbation rate and mortality rate was positive but weak as well as insignificant.In summary, analysis of randomised controlled trials in COPD patients showed a decrease in mortality in the placebo arms over the last two decades. This effect is comparable to the previously observed decrease in annual exacerbation rate. Albeit insignificant our results suggest that care is needed in the design of new trials or when comparing results from trials published many years apart.


2021 ◽  
pp. 026988112199182
Author(s):  
Danilo Arnone ◽  
Hassan Galadari ◽  
Carl J Rodgers ◽  
Linda Östlundh ◽  
Karim Abdel Aziz ◽  
...  

Background: OnabotulinumtoxinA is a novel therapeutic intervention whose mechanism of action is believed to modify the negative facial feedback, thus abating symptoms of depression. This putative new antidepressant agent offers minimal systemic side effects and negligible risk of pharmacological interactions. We set out to examine the evidence for the use of onabotulinumtoxinA in major depression. Methods: A systematic search of the literature identified double-blind randomised controlled trials (RCTs) investigating the use of onabotulinumtoxinA in the treatment of major depression versus placebo. Data, reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA), was combined in meta-analyses (PROSPERO registration ID: CRD42020183538). Results: The search identified five RCTs (four double-blind) comparing onabotulinumtoxinA to placebo. OnabotulinumtoxinA was more effective than placebo when administered within the 20–40 IU dose range in double-blind RCTs. The analysis was free of publication bias and significantly heterogeneous. Meta-regression analyses indicated that onabotulinumtoxinA was more efficacious in women and in higher doses in female patients and less effective with polypharmacy, especially when an increasing number of antidepressants were prescribed. The effectiveness of onabotulinumtoxinA was higher in more recently published double-blind RCTs. Conclusion: The meta-analysis supports the efficacy of the intervention with the results being highly heterogeneous across studies. In view of the heterogeneity of the findings and the significant moderators of benefit (sex, year of study completion and the interaction between sex and dose), more research is required to better understand the role of onabotulinumtoxinA in the treatment of depression.


BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e044222
Author(s):  
Catherine M Pound ◽  
Jennifer Zhe Zhang ◽  
Ama Tweneboa Kodua ◽  
Margaret Sampson

ObjectivesDespite the aggressive marketing of electronic nicotine device systems (ENDS) as smoking cessation tools, the evidence of their effectiveness is mixed. We conducted a systematic review of randomised controlled trials to determine the effect of ENDS on cigarette smoking cessation, as compared with other types of nicotine replacement therapies (NRT).DesignSystematic review and meta-analysis using the Grading of Recommendations Assessment, Development and Evaluation approach.Data sourcesMEDLINE, Embase, the CENTRAL Trials Registry of the Cochrane Collaboration using the Ovid interface, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform trials registries were searched through 17 June 2020.Eligibility criteria for studiesRandomised controlled trials in which any type of ENDS was compared with any type of NRT, in traditional cigarette users.Data extraction and synthesisThe primary outcome was smoking cessation, defined as abstinence from traditional cigarette smoking for any time period, as reported in each included study, regardless of whether abstinence is self-reported or biochemically validated. Secondary outcomes included smoking reduction, harms, withdrawal and acceptance of therapy. A random-effect model was used, and data were pooled in meta-analyses where appropriate.ResultsSix studies were retained from 270. Most outcomes were judged to be at high risk of bias. The overall quality of evidence was graded as ‘low’ or ‘very low’. Pooled results showed no difference in smoking cessation (rate ratio (RR) 1.42, 95% CI 0.97 to 2.09), proportion of participants reducing smoking consumption (RR 1.25, 95% CI 0.79 to 1.98), mean reduction in cigarettes smoked per day (mean difference 1.11, 95% CI −0.41 to 2.63), or harms (RR 0.96, 95% CI 0.76 to 1.20), between groups.ConclusionWe found no difference in smoking cessation, harms and smoking reduction between e-cigarette and NRT users. However, the quality of the evidence was low. Further research is needed before widespread recommendations are made with regard to the use of ENDS.PROSPERO registration numberSystematic review registration number: protocol registered with the International Prospective Register of Systematic Reviews (PROSPERO) on February 27th, 2020; CRD42020169416.


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