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A systematic review of possible serious adverse health effects of nicotine replacement therapy.

ABSTRACT: We conducted a systematic literature review to identify and critically evaluate studies of serious adverse health effects (SAHEs) in humans using nicotine replacement therapy (NRT) products. Serious adverse health effects refer to adverse events, leading to substantial disruption of the ability to conduct normal life functions. Strength of evidence evaluations and conclusions were also determined for the identified SAHEs. We evaluated 34 epidemiological studies and clinical trials, relating NRT use to cancer, reproduction/development, CVD, stroke and/or other SAHEs in patients, and four meta-analyses on effects in healthy populations. The overall evidence suffers from many limitations, the most significant being the short-term exposure (?12 weeks) and follow-up to NRT product use in most of the studies, the common failure to account for changes in smoking behaviour following NRT use, and the sparse information on SAHEs by type of NRT product used. The only SAHE from NRT exposure we identified was an increase in respiratory congenital abnormalities reported in one study. Limited evidence indicated a lack of effect between NRT exposure and SAHEs for CVD and various reproduction/developmental endpoints. For cancer, stroke and other SAHEs, the evidence was inadequate to demonstrate any association with NRT use. Our conclusions agree with recent statements from authoritative bodies.

SUBMITTER: Lee PN

PROVIDER: S-EPMC5364244 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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A systematic review of possible serious adverse health effects of nicotine replacement therapy.

Lee Peter N PN Fariss Marc W MW

Archives of toxicology 20161003 4

We conducted a systematic literature review to identify and critically evaluate studies of serious adverse health effects (SAHEs) in humans using nicotine replacement therapy (NRT) products. Serious adverse health effects refer to adverse events, leading to substantial disruption of the ability to conduct normal life functions. Strength of evidence evaluations and conclusions were also determined for the identified SAHEs. We evaluated 34 epidemiological studies and clinical trials, relating NRT ...[more]

PMID: 27699443

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Project description:Background and aimsSmoking during pregnancy is strongly associated with negative pregnancy and perinatal outcomes. Some guidelines recommend nicotine replacement therapy (NRT) for smoking cessation during pregnancy, but adherence with NRT is generally poor and could be partially explained by nicotine-related safety concerns. We compared pregnant women's cotinine and nicotine exposures from smoking with those when they were abstinent from smoking and using NRT.DesignSystematic review with meta-analysis and narrative reporting. Twelve studies were included: in most, only one type of NRT was used. Seven were quality-assessed and judge of variable quality.SettingStudies from any setting that reported nicotine or cotinine levels when smoking and later when abstinent and using NRT.ParticipantsPregnant women who smoked and became abstinent but used NRT either in a cessation study or in a study investigating other impacts of NRT.MeasurementsWe quality-assessed longitudinal cohort studies using a modified version of the Newcastle-Ottawa scale. For meta-analysis, we used mean within-person differences in cotinine or nicotine levels when smoking and at later follow-up when abstinent and using NRT. Where such data were not available, we calculated differences in group mean levels and reported these narratively, indicating where data were not completely longitudinal.FindingsOf the 12 included studies, four cotinine-measuring studies (n = 83) were combined in a random effects meta-analysis; the pooled estimate for the mean difference (95% confidence intervals) in cotinine levels between when women were smoking and abstinent but using NRT was 75.3 (57.1 to 93.4) ng/ml (I2 = 42.1%, P = 0.11). Of eight narratively-described studies, six reported lower cotinine and/or nicotine levels when abstinent and using NRT; two had mixed findings, with higher levels when abstinent but using NRT reported from at least one assay time-point.ConclusionsPregnant women who use nicotine replacement therapy instead of smoking reduce their nicotine exposure.

Project description:BackgroundNicotine replacement therapy (NRT) is the most common form of smoking cessation pharmacotherapy and has proven efficacy for the treatment of tobacco dependence. Although expectations of mild adverse effects have been observed to be independent predictors of reduced motivation to use NRT, adverse effects associated with NRT have not been precisely quantified.ObjectiveA systematic review and meta-analysis aimed to identify all randomized clinical trials (RCTs) of NRT versus inert controls and all observational studies to determine the magnitude of reported adverse effects with NRT.MethodsSearches of 10 electronic databases from inception to November 2009 were conducted. Study selection and data extraction were carried out independently in duplicate. RCTs were pooled using a random effects method with Odds Ratio [OR] as the effect measure, while proportions were pooled from observational studies. A meta-regression analysis was applied to examine whether the nicotine patch is associated with different adverse effects from those common to orally administered NRT.ResultsNinety-two RCTs involving 32,185 participants and 28 observational studies involving 145, 205 participants were identified. Pooled RCT evidence of varying NRT formulations found an increased risk of heart palpitations and chest pains (OR 2.06, 95% Confidence Interval [CI] 1.51-2.82, P < 0.001); nausea and vomiting (OR 1.67, 95% CI 1.37-2.04, P < 0.001); gastrointestinal complaints (OR 1.54, 95% CI, 1.25-1.89, P < 0.001); and insomnia (OR 1.42, 95% CI, 1.21-1.66, P < 0.001). Pooled evidence specific to the NRT patch found an increase in skin irritations (OR 2.80, 95% CO, 2.28-3.24, P < 0.001). Orally administered NRT was associated with mouth and throat soreness (OR 1.87, 95% CI, 1.36-2.57, P < 0.001); mouth ulcers (OR 1.49, 95% CI, 1.05-2.20, P < 0.001); hiccoughs (OR 7.68, 95% CI, 4.59-12.85, P < 0.001) and coughing (OR 2.89, 95% CI, 1.92-4.33, P < 0.001). There was no statistically significant increase in anxiety or depressive symptoms associated with NRT use. Non-comparative observational studies demonstrated the prevalence of these events in a broad population.ConclusionThe use of NRT is associated with a variety of side effects. In addition to counseling and medical monitoring, clinicians should inform patients of potential side effects which are associated with the use of NRT for the treatment of tobacco dependence.

Project description:BACKGROUND:There is a worldwide shortage of health workers, and this issue requires innovative education solutions. Serious gaming and gamification education have the potential to provide a quality, cost-effective, novel approach that is flexible, portable, and enjoyable and allow interaction with tutors and peers. OBJECTIVE:The aim of this systematic review was to evaluate the effectiveness of serious gaming/gamification for health professions education compared with traditional learning, other types of digital education, or other serious gaming/gamification interventions in terms of patient outcomes, knowledge, skills, professional attitudes, and satisfaction (primary outcomes) as well as economic outcomes of education and adverse events (secondary outcomes). METHODS:A comprehensive search of MEDLINE, EMBASE, Web of Knowledge, Educational Resources Information Centre, Cochrane Central Register of Controlled Trials, PsycINFO, and Cumulative Index to Nursing and Allied Health Literature was conducted from 1990 to August 2017. Randomized controlled trials (RCTs) and cluster RCTs were eligible for inclusion. Two reviewers independently searched, screened, and assessed the study quality and extracted data. A meta-analysis was not deemed appropriate due to the heterogeneity of populations, interventions, comparisons, and outcomes. Therefore, a narrative synthesis is presented. RESULTS:A total of 27 RCTs and 3 cluster RCTs with 3634 participants were included. Two studies evaluated gamification interventions, and the remaining evaluated serious gaming interventions. One study reported a small statistically significant difference between serious gaming and digital education of primary care physicians in the time to control blood pressure in a subgroup of their patients already taking antihypertensive medications. There was evidence of a moderate-to-large magnitude of effect from five studies evaluating individually delivered interventions for objectively measured knowledge compared with traditional learning. There was also evidence of a small-to-large magnitude of effect from 10 studies for improved skills compared with traditional learning. Two and four studies suggested equivalence between interventions and controls for knowledge and skills, respectively. Evidence suggested that serious gaming was at least as effective as other digital education modalities for these outcomes. There was insufficient evidence to conclude whether one type of serious gaming/gamification intervention is more effective than any other. There was limited evidence for the effects of serious gaming/gamification on professional attitudes. Serious gaming/gamification may improve satisfaction, but the evidence was limited. Evidence was of low or very low quality for all outcomes. Quality of evidence was downgraded due to the imprecision, inconsistency, and limitations of the study. CONCLUSIONS:Serious gaming/gamification appears to be at least as effective as controls, and in many studies, more effective for improving knowledge, skills, and satisfaction. However, the available evidence is mostly of low quality and calls for further rigorous, theory-driven research.

Project description:BackgroundNicotine replacement therapy (NRT) has proven effect in assisting smoking cessation. However, its effectiveness varies across studies and population groups. This may be due to differences in the rate of adherence. Hence, this review aims to examine the level of adherence to NRT and to assess if the level of adherence to NRT affects success of smoking cessation.MethodsA systematic review and meta-analysis was conducted using studies retrieved from five electronic databases (MEDLINE, Scopus, EMBASE, Web of science, and PsycINFO) and grey literature. Pooled analysis was conducted using Stata version 16 software. Methodological quality and risk of bias were assessed using the NIH Quality Assessment Tool. Analyses were done among those studies that used similar measurements to assess level of adherence and successful smoking cessation. Heterogeneity of studies was assessed using the Higgins' I2 statistical test. Funnel plots and Egger's regression asymmetry test were used to affirm presence of significant publication bias.ResultsA total of 7521 adult participants of 18 years old and above from 16 studies were included in the analysis. Level of adherence to NRT among participants of randomised controlled trials were found to be 61% (95% CI, 54-68%), p-value of < 0.001 and I2 = 85.5%. Whereas 26% of participants were adherent among participants of population-based studies with 95% CI, 20-32%, p-value of < 0.001 and I2 = 94.5%. Level of adherence was the lowest among pregnant women (22%) with 95% CI, 18-25%, p-value of 0.31 and I2 = 15.8%. Being adherent to NRT doubles the rate of successful quitting (OR = 2.17, 95% CI, 1.34-3.51), p-value of < 0.001 and I2 = 77.6%.ConclusionsThis review highlights a low level of adherence to NRT among participants of population-based studies and pregnant women as compared to clinical trials. Moreover, the review illustrated a strong association between adherence and successful smoking cessation. Hence, it is recommended to implement and assess large scale interventions to improve adherence. Health programs and policies are recommended to integrate the issue of adherence to NRT as a core component of smoking cessation interventions.Trial registrationPROSPERO registration number: CRD42020176749 . Registered on 28 April 2020.

Project description:There is substantial evidence that mortality increases in low temperatures. Less is known about the role of prolonged cold periods denoted as cold spells.We conducted the first systematic review and meta-analysis to summarize the evidence on the adverse health effects of cold spells in varying climates.Four databases (Ovid Medline, PubMed, Scopus, Web of Science) were searched for all years and languages available. "Cold spell" was defined as an event below a temperature threshold lasting for a minimum duration of 2 days. Of 1,527 identified articles, 26 satisfied our eligibility criteria for the systematic review, and 9 were eligible for meta-analyses. The articles were grouped by the three main study questions into Overall-effect Group, Added-effect Group, and Temperature-change-effect Group.Based on random-effects models in the meta-analyses, cold spells were associated with increased mortality from all or all nonaccidental causes (summary rate ratio = 1.10; 95% CI: 1.04, 1.17 based on 9 estimates from five studies), cardiovascular diseases (1.11; 95% CI: 1.03, 1.19; 12 estimates from eight studies), and respiratory diseases (1.21; 95% CI: 0.97, 1.51; 8 estimates from four studies). Estimated associations were stronger for people ? 65 years of age (1.06; 95% CI: 1.00, 1.12) than for people 0-64 years of age (1.01; 95% CI: 1.00, 1.03). Study-specific effect estimates from a limited number of studies suggested an increased morbidity related to cold spells, but it was not possible to quantitatively summarize the evidence.Cold spells are associated with increased mortality rates in populations around the world. The body of evidence suggests that cold spells also have other adverse health effects. There was substantial heterogeneity among the studies, which should be taken into account in the interpretation of the results.Ryti NR, Guo Y, Jaakkola JJ. 2016. Global association of cold spells and adverse health effects: a systematic review and meta-analysis. Environ Health Perspect 124:12-22; http://dx.doi.org/10.1289/ehp.1408104.

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A systematic review of possible serious adverse health effects of nicotine replacement therapy.

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A systematic review of possible serious adverse health effects of nicotine replacement therapy.

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