Nicotine replacement therapy: evidence from observational studies versus clinical trials

IntroductionNicotine replacement therapy (NRT) has proven effective for smoking cessation in clinical trials, however it was found less effective in population-based studies, potentially due to inconsistent or incorrect use of NRT. The aim of this paper is to describe a systematic review protocol to evaluate level of adherence to NRT; the discrepancy of adherence to NRT in clinical and population-based studies and degree of association between level of adherence and success of smoking cessation.Methods and analysisLiterature search will use five databases (Medline, Scopus, Embase, CINAHL and PsycINFO). Studies will be appraised for methodological quality using National Institutes of Health Quality Assessment Tool. To reduce heterogeneity, we will analyse clinical trials and population-based studies separately; pooled analyses will be done among studies that used similar measurements. Heterogeneity of studies will be assessed by Higgins’ I2 statistical test. When studies are adequately homogeneous, results will be pooled using random-effects model with proportion and ORs with 95% CIs and p values for each outcome. We will explain sources of heterogeneity by subgroup analysis or sensitivity analysis. Funnel plots and Egger’s regression asymmetry test with p<0.05 will be used as a cut-off point to affirm presence of statistically significant publication bias. Statistical analyses will be carried out using Stata V.16 software. Only studies reporting a valid strategy to control for reverse causality will be included.DiscussionThis review will provide evidence to support the importance of adherence on rate of smoking cessation and level of adherence to NRT. The findings will be used to inform smoking cessation interventions, researchers and policymakers.Ethics and disseminationAs a systematic literature review, this protocol does not require ethics approval. Research outcomes will be presented at relevant conferences and findings will be published in a relevant peer-reviewed journal.PROSPERO registration numberCRD42020176749.

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The blind spot in the nicotine replacement therapy literature: Assessment of the double-blind in clinical trials

Addictive Behaviors ◽

10.1016/j.addbeh.2004.02.010 ◽

2004 ◽

Vol 29 (4) ◽

pp. 673-684 ◽

Cited By ~ 23

Author(s):

Marc Mooney ◽

Thom White ◽

Dorothy Hatsukami

Keyword(s):

Clinical Trials ◽

Replacement Therapy ◽

Nicotine Replacement Therapy ◽

Blind Spot ◽

Double Blind ◽

Nicotine Replacement

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RESPONSE TO GREENE ET AL.: INDUSTRY FUNDING AND PLACEBO QUIT RATE IN CLINICAL TRIALS OF NICOTINE REPLACEMENT THERAPY: A COMMENTARY ON ETTER ET AL. (2007)

Addiction ◽

10.1111/j.1360-0443.2010.03182.x ◽

2010 ◽

Vol 105 (12) ◽

pp. 2219-2219

Author(s):

JEAN-FRANÇOIS ETTER ◽

JOHN STAPLETON

Keyword(s):

Clinical Trials ◽

Replacement Therapy ◽

Nicotine Replacement Therapy ◽

Industry Funding ◽

Nicotine Replacement ◽

Quit Rate

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Effect of Nicotine Replacement Therapy on Mortality, Delirium, and Duration of Therapy in Critically Ill Smokers: A Systematic Review and Meta-Analysis

Anaesthesia and Intensive Care ◽

10.1177/0310057x1704500505 ◽

2017 ◽

Vol 45 (5) ◽

pp. 556-561 ◽

Cited By ~ 2

Author(s):

K. T. Ng ◽

M. Gillies ◽

D. M. Griffith

Keyword(s):

Systematic Review ◽

Replacement Therapy ◽

Nicotine Replacement Therapy ◽

Critically Ill ◽

Systematic Reviews ◽

Odds Ratio ◽

Observational Studies ◽

Meta Analysis ◽

Icu Mortality ◽

Nicotine Replacement

Nicotine replacement therapy is widely used in critically ill smokers and its effect on delirium, mortality and duration of intensive care unit (ICU) admission is unknown. The aims of this review were to determine whether the management of nicotine withdrawal with nicotine replacement therapy reduces delirium, mortality or length of stay in critically ill smokers in ICU. The primary outcome was incidence of author-defined ICU delirium. Secondary outcomes were ICU or hospital mortality, ICU-free days at day 28, and ICU or hospital length of stay. We conducted a systematic review and meta-analysis of the data sources MEDLINE, EMBASE, CINAHL, and the Cochrane Database of Systematic Reviews for randomised controlled trials and observational studies. Clinical trials, observational studies and systematic reviews comparing nicotine replacement therapy with placebo or no treatment were included. Case reports, case series, non-systematic reviews and studies that involved children were excluded. Eight studies were eligible (n=2,636) for inclusion in the data synthesis. In a meta-analysis of observational studies, nicotine replacement therapy was associated with increased delirium (three studies; n=908; I2=0%; finite element method: odds ratio 4.03 [95% confidence interval 2.64, 6.15]; P <0.001). There was no difference in ICU mortality (three studies; n=1,309; P=0.10, I2=44%; finite element method: odds ratio 0.58; 95% confidence intervals 0.31– 1.10) and hospital mortality or 28-day ICU-free days. In the absence of high-quality data, nicotine replacement therapy cannot currently be recommended for routine use to prevent delirium or to reduce hospital or ICU mortality in critically ill smokers.

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