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Clinical Oral Investigations Sep 2023This systematic review and meta-analysis examined the effects of electronic cigarettes on periodontal health compared to conventional cigarette smoke and a non-smoking... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
This systematic review and meta-analysis examined the effects of electronic cigarettes on periodontal health compared to conventional cigarette smoke and a non-smoking population.
MATERIALS AND METHODS
MEDLINE, Embase, Web of Science, CENTRAL, and ClinicalTrials.gov were screened for literature. Eligibility criteria included clinical studies published between 2006 and 2022 that compare e-cigarettes and conventional cigarettes on periodontal health (bleeding on probing (BoP), plaque index (PI), probing depth (PD), attachment loss (AL), marginal bone loss (MBL), tooth loss, molecular inflammation markers, salivary flow rate). Meta-regression analysis was used to examine the influence of moderator variables.
RESULTS
Sixteen studies were found to be eligible for qualitative synthesis. Individual analyses showed that cigarette smokers had significantly higher PI, PD, AL, and MBL and increased concentrations of proinflammatory mediators than e-cigarette users and non-smokers. Meta-analysis revealed a 0.33-fold lower chance for BoP in e-cigarette users compared to smokers (p = 0.03), whereby meta-regression failed to detect any effects regarding the age of users and frequency of smoking. A 0.01-fold decreased chance for positive BoP in e-cigarette users compared with non-smokers was seen (p < 0.01).
CONCLUSIONS
The current findings suggest that that e-cigarette use might be considered a healthier alternative to cigarette smoking concerning periodontal health. Even so, harmful effects of electronic nicotine delivery system (ENDS) usage on periodontal health were seen as well. However, a definitive decision on this research question remains elusive due to the absence of randomized controlled trials.
CLINICAL RELEVANCE
Electronic cigarettes, marketed as a safer alternative to traditional cigarettes, are becoming increasingly popular. Evidence on the use of electronic cigarettes as a cessation aid and its beneficial impact compared to cigarette smoke remains inconclusive, so the analysis conducted in this review addresses a recent question of high clinical relevance.
Topics: Humans; Electronic Nicotine Delivery Systems; Cigarette Smoking; Tobacco Products; Smokers; Electronics
PubMed: 37526741
DOI: 10.1007/s00784-023-05162-4 -
American Journal of Public Health Feb 2021To determine the association between e-cigarette use and smoking cessation. We searched PubMed, Web of Science Core Collection, and EMBASE and computed the association... (Meta-Analysis)
Meta-Analysis
To determine the association between e-cigarette use and smoking cessation. We searched PubMed, Web of Science Core Collection, and EMBASE and computed the association of e-cigarette use with quitting cigarettes using random effects meta-analyses. We identified 64 papers (55 observational studies and 9 randomized clinical trials [RCTs]). In observational studies of all adult smokers (odds ratio [OR] = 0.947; 95% confidence interval [CI] = 0.772, 1.160) and smokers motivated to quit smoking (OR = 0.851; 95% CI = 0.684, 1.057), e-cigarette consumer product use was not associated with quitting. Daily e-cigarette use was associated with more quitting (OR = 1.529; 95% CI = 1.158, 2.019) and less-than-daily use was associated with less quitting (OR = 0.514; 95% CI = 0.402, 0.665). The RCTs that compared quitting among smokers who were provided e-cigarettes to smokers with conventional therapy found e-cigarette use was associated with more quitting (relative risk = 1.555; 95% CI = 1.173, 2.061). As consumer products, in observational studies, e-cigarettes were not associated with increased smoking cessation in the adult population. In RCTs, provision of free e-cigarettes as a therapeutic intervention was associated with increased smoking cessation. E-cigarettes should not be approved as consumer products but may warrant consideration as a prescription therapy.
Topics: Adult; Cigarette Smoking; Electronic Nicotine Delivery Systems; Humans; Observational Studies as Topic; Publication Bias; Randomized Controlled Trials as Topic; Smoking Cessation; Vaping
PubMed: 33351653
DOI: 10.2105/AJPH.2020.305999 -
The American Journal of Cardiology Dec 2021Atrial fibrillation (AF) is the most common clinically significant arrhythmia, and it increases stroke risk. A preventive approach to AF is needed because virtually all...
Atrial fibrillation (AF) is the most common clinically significant arrhythmia, and it increases stroke risk. A preventive approach to AF is needed because virtually all treatments such as cardioversion, antiarrhythmic drugs, ablation, and anticoagulation are associated with high cost and carry significant risk. A systematic review was performed to identify effective lifestyle-based strategies for reducing primary and secondary AF. A PubMed search was performed using articles up to March 1, 2021. Search terms included atrial fibrillation, atrial flutter, exercise, diet, metabolic syndrome, type 2 diabetes mellitus, obesity, hypertension, stress, tobacco smoking, alcohol, Mediterranean diet, sodium, and omega-3 fatty acids. Additional articles were identified from the bibliographies of retrieved articles. The control of hypertension, ideally with a renin-angiotensin-aldosterone system inhibitor, is effective for preventing primary AF and recurrence. Obstructive sleep apnea is a common cause of AF, and treating it effectively reduces AF episodes. Alcohol increases the risk of AF in a dose-dependent manner, and abstinence reduces risk of recurrence. Sedentary behavior and chronic high-intensity endurance exercise are both risk factors for AF; however, moderate physical activity is associated with lower risk of AF. Recently, sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 agonists have been associated with reduced risk of AF. Among overweight/obese patients, weight loss of ≥10% is associated with reduced AF risk. Lifestyle changes and risk factor modification are highly effective for preventing AF.
Topics: Alcohol Drinking; Atrial Fibrillation; Bariatric Surgery; Diabetes Mellitus, Type 2; Diet Therapy; Diet, Mediterranean; Dietary Fats, Unsaturated; Endurance Training; Exercise; Fatty Acids, Omega-3; Glucagon-Like Peptide 1; Humans; Metabolic Syndrome; Obesity; Overweight; Risk Reduction Behavior; Sedentary Behavior; Sleep Apnea, Obstructive; Smoking; Smoking Cessation; Sodium-Glucose Transporter 2 Inhibitors; Weight Loss
PubMed: 34583808
DOI: 10.1016/j.amjcard.2021.08.042 -
Harm Reduction Journal Dec 2021The objective was to systematically review studies on health outcomes from smokeless tobacco (SLT) products. (Review)
Review
INTRODUCTION
The objective was to systematically review studies on health outcomes from smokeless tobacco (SLT) products.
METHODS
We analysed published literature on the health outcomes from SLT use between 01/01/2015 to 01/02/2020, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol using PubMed, Embase, Scopus, and Google Scholar.
RESULTS
Of 53 studies included, six were global, 32 from Asia, Middle East and Africa (AMEA), nine from USA and six from Europe. 'Poor'-rated studies predominated (23;43%), in particular, for global (4;66%) and AMEA (16;50%). Health outcomes differed between SLT-products and regions; those in AMEA were associated with higher mortality (overall, cancer, Coronary heart disease (CHD), respiratory but not cardiovascular disease (CVD)), and morbidity (CVD, oral and head and neck cancers), with odds ratios up to 38.7. European studies showed no excess mortality (overall, CVD, from cancers) or morbidity (ischemic heart disease (IHD), stroke, oral, head and neck, pancreatic or colon cancers) from several meta-analyses; single studies reported elevated risk of rectal cancer and respiratory disorders. Pooled study data showed protection against developing Parkinson's disease. US studies showed mixed results for mortality (raised overall, CHD, cancer and smoking-related cancer mortality; no excess risk of respiratory or CVD mortality). Morbidity outcomes were also mixed, with some evidence of increased IHD, stroke and cancer risk (oral, head and neck). No studies reported on switching from cigarettes to SLT-products.
CONCLUSION
Our review demonstrates stark differences between different SLT-products in different regions, ranging from zero harm from European snus to greatly increased health risks in AMEA. The literature on the safety profile for SLT-products for harm reduction is incomplete and potentially misinforming policy and regulation.
Topics: Head and Neck Neoplasms; Humans; Smoking; Tobacco Products; Tobacco Use; Tobacco, Smokeless
PubMed: 34863207
DOI: 10.1186/s12954-021-00557-6 -
Critical Reviews in Toxicology Feb 2020Electronic cigarette (e-cigarette) use is becoming more prevalent and is particularly popular among adolescents and conventional smokers. While the oral health sequelae...
Electronic cigarette (e-cigarette) use is becoming more prevalent and is particularly popular among adolescents and conventional smokers. While the oral health sequelae of conventional smoking are well-established, the impact of e-cigarettes on oral health is still unknown. This study aims to systematically review the available research evidence on the oral health impact of e-cigarette use. This systematic review was conducted according to PRISMA guidelines and used the Effective Public Health Practice Project Quality Assessment Tool to evaluate the evidence. Three electronic databases (PubMed, Web of Science, and Embase) were systematically searched for studies including case reports. Two independent reviewers extracted data and synthesized the findings. Ninety-nine articles were included in this systematic review. Analyses of the articles yielded seven categories based on symptom similarity and/or focus: mouth effects, throat effects, periodontal effects, dental effects, cytotoxic/genotoxic/oncologic effects, oral microbiome effects, and traumatic/accidental injury. The majority of mouth and throat symptoms experienced by e-cigarette users were relatively minor and temporary, with some evidence that conventional smokers who switched to e-cigarettes experienced mitigation of these symptoms. E-cigarette exposure increased the risk for deteriorating periodontal, dental and gingival health as well as changes to the oral microbiome. Extensive dental damage as a result of e-cigarette explosions were described in case reports. Components of e-cigarette vapor have known cytotoxic, genotoxic, and carcinogenic properties. Although switching to e-cigarettes may mitigate oral symptomatology for conventional smokers, findings from this review suggest that a wide range of oral health sequelae may be associated with e-cigarette use. Well-designed studies to investigate oral health outcomes of e-cigarette use are needed.
Topics: Electronic Nicotine Delivery Systems; Humans; Oral Health; Smokers; Smoking; Vaping
PubMed: 32043402
DOI: 10.1080/10408444.2020.1713726 -
Indian Journal of Public Health 2021Smoking is a significant risk factor for morbidity and mortality. Health education by health promotion is such a gauge to control tobacco epidemic at both national and...
BACKGROUND
Smoking is a significant risk factor for morbidity and mortality. Health education by health promotion is such a gauge to control tobacco epidemic at both national and multinational levels.
OBJECTIVES
The objectives of the study were to systematically review the literature to identify models for health behavior change and evaluate evidence for their effectiveness in smoking cessation.
METHODS
A systematic review of the literature identified four peer-reviewed studies describing two smoking cessation behavioral interventional models (transtheoretical model [TTM] and health belief model [HBM]) between 2008 and 2018. Electronic databases MEDLINE (PubMed) and Google Scholar and Trip database were carried out. There were two randomized controlled trials and two nonrandomized controlled interventional studies. There was a high degree of homogeneity of design, definition of smoking and smoking abstinence, and implementation, followed by comparison of studies. All included studies have evaluated outcome by stage of changes (component of TTM model) and therefore show the reduction of smoking rate. All studies did not have blinding of study participants, leading to a higher risk of bias in the outcome.
RESULTS
There was a statistically significant difference between TTM-based interventional group and control group in smoking cessation rate. While comparing HBM- and TTM-based behavioral counseling, there was no statistically significant difference in smoking cessation rate.
CONCLUSION
Both HBM- and TTM-based trainings were found to have positive effects on both smoking cessation and progression between the stages.
Topics: Counseling; Humans; India; Smoking; Smoking Cessation; Tobacco Use
PubMed: 34135176
DOI: 10.4103/ijph.IJPH_1351_20 -
The Cochrane Database of Systematic... Sep 2021Primary care is an important setting in which to treat tobacco addiction. However, the rates at which providers address smoking cessation and the success of that support... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Primary care is an important setting in which to treat tobacco addiction. However, the rates at which providers address smoking cessation and the success of that support vary. Strategies can be implemented to improve and increase the delivery of smoking cessation support (e.g. through provider training), and to increase the amount and breadth of support given to people who smoke (e.g. through additional counseling or tailored printed materials).
OBJECTIVES
To assess the effectiveness of strategies intended to increase the success of smoking cessation interventions in primary care settings. To assess whether any effect that these interventions have on smoking cessation may be due to increased implementation by healthcare providers.
SEARCH METHODS
We searched the Cochrane Tobacco Addiction Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and trial registries to 10 September 2020.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and cluster-RCTs (cRCTs) carried out in primary care, including non-pregnant adults. Studies investigated a strategy or strategies to improve the implementation or success of smoking cessation treatment in primary care. These strategies could include interventions designed to increase or enhance the quality of existing support, or smoking cessation interventions offered in addition to standard care (adjunctive interventions). Intervention strategies had to be tested in addition to and in comparison with standard care, or in addition to other active intervention strategies if the effect of an individual strategy could be isolated. Standard care typically incorporates physician-delivered brief behavioral support, and an offer of smoking cessation medication, but differs across studies. Studies had to measure smoking abstinence at six months' follow-up or longer.
DATA COLLECTION AND ANALYSIS
We followed standard Cochrane methods. Our primary outcome - smoking abstinence - was measured using the most rigorous intention-to-treat definition available. We also extracted outcome data for quit attempts, and the following markers of healthcare provider performance: asking about smoking status; advising on cessation; assessment of participant readiness to quit; assisting with cessation; arranging follow-up for smoking participants. Where more than one study investigated the same strategy or set of strategies, and measured the same outcome, we conducted meta-analyses using Mantel-Haenszel random-effects methods to generate pooled risk ratios (RRs) and 95% confidence intervals (CIs).
MAIN RESULTS
We included 81 RCTs and cRCTs, involving 112,159 participants. Fourteen were rated at low risk of bias, 44 at high risk, and the remainder at unclear risk. We identified moderate-certainty evidence, limited by inconsistency, that the provision of adjunctive counseling by a health professional other than the physician (RR 1.31, 95% CI 1.10 to 1.55; I = 44%; 22 studies, 18,150 participants), and provision of cost-free medications (RR 1.36, 95% CI 1.05 to 1.76; I = 63%; 10 studies,7560 participants) increased smoking quit rates in primary care. There was also moderate-certainty evidence, limited by risk of bias, that the addition of tailored print materials to standard smoking cessation treatment increased the number of people who had successfully stopped smoking at six months' follow-up or more (RR 1.29, 95% CI 1.04 to 1.59; I = 37%; 6 studies, 15,978 participants). There was no clear evidence that providing participants who smoked with biomedical risk feedback increased their likelihood of quitting (RR 1.07, 95% CI 0.81 to 1.41; I = 40%; 7 studies, 3491 participants), or that provider smoking cessation training (RR 1.10, 95% CI 0.85 to 1.41; I = 66%; 7 studies, 13,685 participants) or provider incentives (RR 1.14, 95% CI 0.97 to 1.34; I = 0%; 2 studies, 2454 participants) increased smoking abstinence rates. However, in assessing the former two strategies we judged the evidence to be of low certainty and in assessing the latter strategies it was of very low certainty. We downgraded the evidence due to imprecision, inconsistency and risk of bias across these comparisons. There was some indication that provider training increased the delivery of smoking cessation support, along with the provision of adjunctive counseling and cost-free medications. However, our secondary outcomes were not measured consistently, and in many cases analyses were subject to substantial statistical heterogeneity, imprecision, or both, making it difficult to draw conclusions. Thirty-four studies investigated multicomponent interventions to improve smoking cessation rates. There was substantial variation in the combinations of strategies tested, and the resulting individual study effect estimates, precluding meta-analyses in most cases. Meta-analyses provided some evidence that adjunctive counseling combined with either cost-free medications or provider training enhanced quit rates when compared with standard care alone. However, analyses were limited by small numbers of events, high statistical heterogeneity, and studies at high risk of bias. Analyses looking at the effects of combining provider training with flow sheets to aid physician decision-making, and with outreach facilitation, found no clear evidence that these combinations increased quit rates; however, analyses were limited by imprecision, and there was some indication that these approaches did improve some forms of provider implementation.
AUTHORS' CONCLUSIONS
There is moderate-certainty evidence that providing adjunctive counseling by an allied health professional, cost-free smoking cessation medications, and tailored printed materials as part of smoking cessation support in primary care can increase the number of people who achieve smoking cessation. There is no clear evidence that providing participants with biomedical risk feedback, or primary care providers with training or incentives to provide smoking cessation support enhance quit rates. However, we rated this evidence as of low or very low certainty, and so conclusions are likely to change as further evidence becomes available. Most of the studies in this review evaluated smoking cessation interventions that had already been extensively tested in the general population. Further studies should assess strategies designed to optimize the delivery of those interventions already known to be effective within the primary care setting. Such studies should be cluster-randomized to account for the implications of implementation in this particular setting. Due to substantial variation between studies in this review, identifying optimal characteristics of multicomponent interventions to improve the delivery of smoking cessation treatment was challenging. Future research could use component network meta-analysis to investigate this further.
Topics: Adult; Humans; Primary Health Care; Randomized Controlled Trials as Topic; Smoking; Smoking Cessation; Smoking Prevention; Tobacco Use Cessation Devices
PubMed: 34693994
DOI: 10.1002/14651858.CD011556.pub2 -
The Cochrane Database of Systematic... Mar 2021There is a common perception that smoking generally helps people to manage stress, and may be a form of 'self-medication' in people with mental health... (Meta-Analysis)
Meta-Analysis
BACKGROUND
There is a common perception that smoking generally helps people to manage stress, and may be a form of 'self-medication' in people with mental health conditions. However, there are biologically plausible reasons why smoking may worsen mental health through neuroadaptations arising from chronic smoking, leading to frequent nicotine withdrawal symptoms (e.g. anxiety, depression, irritability), in which case smoking cessation may help to improve rather than worsen mental health.
OBJECTIVES
To examine the association between tobacco smoking cessation and change in mental health.
SEARCH METHODS
We searched the Cochrane Tobacco Addiction Group's Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, PsycINFO, and the trial registries clinicaltrials.gov and the International Clinical Trials Registry Platform, from 14 April 2012 to 07 January 2020. These were updated searches of a previously-conducted non-Cochrane review where searches were conducted from database inception to 13 April 2012. SELECTION CRITERIA: We included controlled before-after studies, including randomised controlled trials (RCTs) analysed by smoking status at follow-up, and longitudinal cohort studies. In order to be eligible for inclusion studies had to recruit adults who smoked tobacco, and assess whether they quit or continued smoking during the study. They also had to measure a mental health outcome at baseline and at least six weeks later.
DATA COLLECTION AND ANALYSIS
We followed standard Cochrane methods for screening and data extraction. Our primary outcomes were change in depression symptoms, anxiety symptoms or mixed anxiety and depression symptoms between baseline and follow-up. Secondary outcomes included change in symptoms of stress, psychological quality of life, positive affect, and social impact or social quality of life, as well as new incidence of depression, anxiety, or mixed anxiety and depression disorders. We assessed the risk of bias for the primary outcomes using a modified ROBINS-I tool. For change in mental health outcomes, we calculated the pooled standardised mean difference (SMD) and 95% confidence interval (95% CI) for the difference in change in mental health from baseline to follow-up between those who had quit smoking and those who had continued to smoke. For the incidence of psychological disorders, we calculated odds ratios (ORs) and 95% CIs. For all meta-analyses we used a generic inverse variance random-effects model and quantified statistical heterogeneity using I. We conducted subgroup analyses to investigate any differences in associations between sub-populations, i.e. unselected people with mental illness, people with physical chronic diseases. We assessed the certainty of evidence for our primary outcomes (depression, anxiety, and mixed depression and anxiety) and our secondary social impact outcome using the eight GRADE considerations relevant to non-randomised studies (risk of bias, inconsistency, imprecision, indirectness, publication bias, magnitude of the effect, the influence of all plausible residual confounding, the presence of a dose-response gradient).
MAIN RESULTS
We included 102 studies representing over 169,500 participants. Sixty-two of these were identified in the updated search for this review and 40 were included in the original version of the review. Sixty-three studies provided data on change in mental health, 10 were included in meta-analyses of incidence of mental health disorders, and 31 were synthesised narratively. For all primary outcomes, smoking cessation was associated with an improvement in mental health symptoms compared with continuing to smoke: anxiety symptoms (SMD -0.28, 95% CI -0.43 to -0.13; 15 studies, 3141 participants; I = 69%; low-certainty evidence); depression symptoms: (SMD -0.30, 95% CI -0.39 to -0.21; 34 studies, 7156 participants; I = 69%' very low-certainty evidence); mixed anxiety and depression symptoms (SMD -0.31, 95% CI -0.40 to -0.22; 8 studies, 2829 participants; I = 0%; moderate certainty evidence). These findings were robust to preplanned sensitivity analyses, and subgroup analysis generally did not produce evidence of differences in the effect size among subpopulations or based on methodological characteristics. All studies were deemed to be at serious risk of bias due to possible time-varying confounding, and three studies measuring depression symptoms were judged to be at critical risk of bias overall. There was also some evidence of funnel plot asymmetry. For these reasons, we rated our certainty in the estimates for anxiety as low, for depression as very low, and for mixed anxiety and depression as moderate. For the secondary outcomes, smoking cessation was associated with an improvement in symptoms of stress (SMD -0.19, 95% CI -0.34 to -0.04; 4 studies, 1792 participants; I = 50%), positive affect (SMD 0.22, 95% CI 0.11 to 0.33; 13 studies, 4880 participants; I = 75%), and psychological quality of life (SMD 0.11, 95% CI 0.06 to 0.16; 19 studies, 18,034 participants; I = 42%). There was also evidence that smoking cessation was not associated with a reduction in social quality of life, with the confidence interval incorporating the possibility of a small improvement (SMD 0.03, 95% CI 0.00 to 0.06; 9 studies, 14,673 participants; I = 0%). The incidence of new mixed anxiety and depression was lower in people who stopped smoking compared with those who continued (OR 0.76, 95% CI 0.66 to 0.86; 3 studies, 8685 participants; I = 57%), as was the incidence of anxiety disorder (OR 0.61, 95% CI 0.34 to 1.12; 2 studies, 2293 participants; I = 46%). We deemed it inappropriate to present a pooled estimate for the incidence of new cases of clinical depression, as there was high statistical heterogeneity (I = 87%).
AUTHORS' CONCLUSIONS
Taken together, these data provide evidence that mental health does not worsen as a result of quitting smoking, and very low- to moderate-certainty evidence that smoking cessation is associated with small to moderate improvements in mental health. These improvements are seen in both unselected samples and in subpopulations, including people diagnosed with mental health conditions. Additional studies that use more advanced methods to overcome time-varying confounding would strengthen the evidence in this area.
Topics: Affect; Anxiety; Confidence Intervals; Controlled Before-After Studies; Depression; Humans; Incidence; Mental Disorders; Mental Health; Middle Aged; Quality of Life; Smoking; Smoking Cessation; Social Interaction; Stress, Psychological; Tobacco Use Cessation
PubMed: 33687070
DOI: 10.1002/14651858.CD013522.pub2 -
The Cochrane Database of Systematic... Apr 2021Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol formed by heating an e-liquid. Some people who smoke use ECs to stop or... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol formed by heating an e-liquid. Some people who smoke use ECs to stop or reduce smoking, but some organizations, advocacy groups and policymakers have discouraged this, citing lack of evidence of efficacy and safety. People who smoke, healthcare providers and regulators want to know if ECs can help people quit and if they are safe to use for this purpose. This is an update of a review first published in 2014.
OBJECTIVES
To examine the effectiveness, tolerability, and safety of using electronic cigarettes (ECs) to help people who smoke achieve long-term smoking abstinence.
SEARCH METHODS
We searched the Cochrane Tobacco Addiction Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO to 1 February 2021, together with reference-checking and contact with study authors.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and randomized cross-over trials in which people who smoke were randomized to an EC or control condition. We also included uncontrolled intervention studies in which all participants received an EC intervention. To be included, studies had to report abstinence from cigarettes at six months or longer and/or data on adverse events (AEs) or other markers of safety at one week or longer.
DATA COLLECTION AND ANALYSIS
We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking after at least six months follow-up, adverse events (AEs), and serious adverse events (SAEs). Secondary outcomes included changes in carbon monoxide, blood pressure, heart rate, blood oxygen saturation, lung function, and levels of known carcinogens/toxicants. We used a fixed-effect Mantel-Haenszel model to calculate the risk ratio (RR) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data from these studies in meta-analyses.
MAIN RESULTS
We included 56 completed studies, representing 12,804 participants, of which 29 were RCTs. Six of the 56 included studies were new to this review update. Of the included studies, we rated five (all contributing to our main comparisons) at low risk of bias overall, 41 at high risk overall (including the 25 non-randomized studies), and the remainder at unclear risk. There was moderate-certainty evidence, limited by imprecision, that quit rates were higher in people randomized to nicotine EC than in those randomized to nicotine replacement therapy (NRT) (risk ratio (RR) 1.69, 95% confidence interval (CI) 1.25 to 2.27; I = 0%; 3 studies, 1498 participants). In absolute terms, this might translate to an additional four successful quitters per 100 (95% CI 2 to 8). There was low-certainty evidence (limited by very serious imprecision) that the rate of occurrence of AEs was similar) (RR 0.98, 95% CI 0.80 to 1.19; I = 0%; 2 studies, 485 participants). SAEs occurred rarely, with no evidence that their frequency differed between nicotine EC and NRT, but very serious imprecision led to low certainty in this finding (RR 1.37, 95% CI 0.77 to 2.41: I = n/a; 2 studies, 727 participants). There was moderate-certainty evidence, again limited by imprecision, that quit rates were higher in people randomized to nicotine EC than to non-nicotine EC (RR 1.70, 95% CI 1.03 to 2.81; I = 0%; 4 studies, 1057 participants). In absolute terms, this might again lead to an additional four successful quitters per 100 (95% CI 0 to 11). These trials mainly used older EC with relatively low nicotine delivery. There was moderate-certainty evidence of no difference in the rate of AEs between these groups (RR 1.01, 95% CI 0.91 to 1.11; I = 0%; 3 studies, 601 participants). There was insufficient evidence to determine whether rates of SAEs differed between groups, due to very serious imprecision (RR 0.60, 95% CI 0.15 to 2.44; I = n/a; 4 studies, 494 participants). Compared to behavioral support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.70, 95% CI 1.39 to 5.26; I = 0%; 5 studies, 2561 participants). In absolute terms this represents an increase of seven per 100 (95% CI 2 to 17). However, this finding was of very low certainty, due to issues with imprecision and risk of bias. There was no evidence that the rate of SAEs differed, but some evidence that non-serious AEs were more common in people randomized to nicotine EC (AEs: RR 1.22, 95% CI 1.12 to 1.32; I = 41%, low certainty; 4 studies, 765 participants; SAEs: RR 1.17, 95% CI 0.33 to 4.09; I = 5%; 6 studies, 1011 participants, very low certainty). Data from non-randomized studies were consistent with RCT data. The most commonly reported AEs were throat/mouth irritation, headache, cough, and nausea, which tended to dissipate with continued use. Very few studies reported data on other outcomes or comparisons and hence evidence for these is limited, with confidence intervals often encompassing clinically significant harm and benefit.
AUTHORS' CONCLUSIONS
There is moderate-certainty evidence that ECs with nicotine increase quit rates compared to ECs without nicotine and compared to NRT. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain. More studies are needed to confirm the size of effect, particularly when using modern EC products. Confidence intervals were for the most part wide for data on AEs, SAEs and other safety markers, though evidence indicated no difference in AEs between nicotine and non-nicotine ECs. Overall incidence of SAEs was low across all study arms. We did not detect any clear evidence of harm from nicotine EC, but longest follow-up was two years and the overall number of studies was small. The evidence is limited mainly by imprecision due to the small number of RCTs, often with low event rates. Further RCTs are underway. To ensure the review continues to provide up-to-date information, this review is now a living systematic review. We run searches monthly, with the review updated when relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.
Topics: Bias; Carbon Monoxide; Cohort Studies; Electronic Nicotine Delivery Systems; Humans; Middle Aged; Nicotine; Nicotinic Agonists; Outcome Assessment, Health Care; Publication Bias; Randomized Controlled Trials as Topic; Smoking; Smoking Cessation; Smoking Prevention; Tobacco Use Cessation Devices; Vaping
PubMed: 33913154
DOI: 10.1002/14651858.CD010216.pub5 -
Endocrinology, Diabetes & Metabolism Jan 2021With increasing numbers of patients with type 2 diabetes mellitus (T2DM) worldwide, the number of associated diabetic foot complications might also increase. This...
AIMS
With increasing numbers of patients with type 2 diabetes mellitus (T2DM) worldwide, the number of associated diabetic foot complications might also increase. This systematic review was performed to summarize published data about risk factors for the diabetic foot (DF) syndrome in order to improve the identification of high-risk patients.
MATERIALS AND METHODS
Six electronic databases were searched for publications up to August 2019 using predefined stringent inclusion and exclusion criteria.
RESULTS
Of 9,476 identified articles, 31 articles from 28 different study populations fulfilled the criteria for our evaluation. The overall quality of the studies was good, and the risk of bias was low. There was large heterogeneity among the studies concerning study protocols and patient populations analysed. A total of 79 risk factors were analysed within this review. The majority of studies described a consistently positive association with different outcomes of interest related to DF for gender, peripheral neuropathy, retinopathy, nephropathy, poor glycaemic control, insulin use, duration of diabetes, smoking and height. For age, hypertension, dyslipidaemia and body mass index, the results remain inconsistent.
CONCLUSION
A most up-to-date literature review resulted in glycaemic control and smoking as the only amenable risk factors with a consistently positive association for DF. Due to the high personal and financial burden associated with DF and the large heterogeneity among included studies, additional longitudinal studies in large patient populations are necessary to identify more modifiable risk factors that can be used in the prediction and prevention of DF complications.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Diabetes Mellitus, Type 2; Diabetic Foot; Female; Glycemic Control; Humans; Male; Middle Aged; Risk Factors; Sex Factors; Smoking; Young Adult
PubMed: 33532615
DOI: 10.1002/edm2.175