Risk of Gastrointestinal Bleeding on Treatment With Statin Alone or With Concomitant Administration of Warfarin: A Systematic Review and Meta-analysis of 5.3 Million Participants

2021 ◽  
pp. 106002802110497
Author(s):  
Akshaya Srikanth Bhagavathula ◽  
Kota Vidyasaga ◽  
Eyob Alemayehu Gebreyohannes ◽  
Wubshet Tesfaye
Keyword(s):  
Gastrointestinal Bleeding ◽  
Observational Studies ◽  
Data Extraction ◽  
Meta Analysis ◽  
Concomitant Administration ◽  
Pooled Analysis ◽  
Data Synthesis ◽  
Study Selection ◽  
Statin Monotherapy ◽  
Statin Use

Objective: This study aimed to comprehensively evaluate the risk of gastrointestinal bleeding (GIB) with statin monotherapy or with concomitant warfarin use. Data Sources: PubMed, Web of Science, and EMBASE (via Scopus) were searched for observational studies that reported the risk of GIB in adults on statin therapy or with concomitant warfarin use until August 28, 2021. Study Selection and Data Extraction: Observational studies evaluating the risk of GIB in adults (age >18 years) on statin medication or concomitant use with warfarin were included. Data Synthesis: In all, 14 studies with a total of 5 235 123 participants, reporting 48 677 GIB events (43 734 from statin users and 4943 from users of statin combined with warfarin), were included in the analyses. The pooled analysis revealed no difference in the risk of GIB with statin monotherapy (relative risk [RR]: 0.65; 95% CI: 0.42-1.02) or concomitant statin + warfarin use (RR: 0.97; 95% CI: 0.91-1.02). Prior use of statin was not associated with GIB risk (RR: 0.88; 95% CI: 0.63-1.22), whereas a shorter duration of statin use (<5 years) was associated with a lower risk of GIB (RR: 0.42; 95% CI: 0.18-0.97). Relevance to Patient Care and Clinical Practice: This analysis provides strong evidence on the association between statin use (with/without warfarin) and risk of GIB. Conclusion: Statin alone or combined with warfarin was not significantly associated with either an increased or decreased risk of GIB. The GIB risk was significantly lower when statins were used for a short duration (<5 years). The putative relationship between statins and GIB in warfarin users warrant further investigation.

Blinding Strategies in Dry Needling Trials: Systematic Review and Meta-Analysis

2019 ◽  
Vol 99 (11) ◽  
pp. 1461-1480 ◽  
Author(s):  
Felicity A Braithwaite ◽  
Julie L Walters ◽  
Lok Sze Katrina Li ◽  
G Lorimer Moseley ◽  
Marie T Williams ◽  
...  
Keyword(s):  
Data Extraction ◽  
Meta Analysis ◽  
Cognitive Strategies ◽  
Evidence Based ◽  
Dry Needling ◽  
Data Synthesis ◽  
Study Selection ◽  
Methodological Bias ◽  
Tactile Sensations ◽  
Effectiveness Data

Abstract Background Blinding of participants and therapists in trials of physical interventions is a significant and ongoing challenge. There is no widely accepted sham protocol for dry needling. Purpose The purpose of this review was to summarize the effectiveness and limitations of blinding strategies and types of shams that have been used in dry needling trials. Data Sources Twelve databases were searched from inception to February 2016. Study Selection Trials that compared active dry needling with a sham that simulated dry needling were included. Data Extraction The main domains of data extraction were participant/therapist details, intervention details, blinding strategies, blinding assessment outcomes, and key conclusions of authors. Reported blinding strategies and sham types were synthesized descriptively, with available blinding effectiveness data synthesized using a chance-corrected measurement of blinding (blinding index). Data Synthesis The search identified 4894 individual publications with 27 trials eligible for inclusion. In 22 trials, risk of methodological bias was high or unclear. Across trials, blinding strategies and sham types were heterogeneous. Notably, no trials attempted therapist blinding. Sham protocols have focused on participant blinding using strategies related to group standardization and simulation of tactile sensations. There has been little attention given to the other senses or cognitive strategies to enhance intervention credibility. Nonpenetrating sham types may provide effective participant blinding. Limitations Trials were clinically and methodologically diverse, which limited the comparability of blinding effectiveness across trials. Reported blinding evaluations had a high risk of chance findings with power clearly achieved in only 1 trial. Conclusions Evidence-based consensus on a sham protocol for dry needling is required. Recommendations provided in this review may be used to develop sham protocols so that future protocols are more consistent and potentially more effective.

scholarly journals A Meta-Analysis of Pregnancy Outcomes With Levothyroxine Treatment in Euthyroid Women With Thyroid Autoimmunity

2019 ◽  
Vol 105 (4) ◽  
pp. 1009-1019 ◽  
Author(s):  
Xiaodong Sun ◽  
Ningning Hou ◽  
Hongsheng Wang ◽  
Lin Ma ◽  
Jinhong Sun ◽  
...  
Keyword(s):  
Pregnancy Outcomes ◽  
Birth Rate ◽  
Data Extraction ◽  
Meta Analysis ◽  
Thyroid Autoimmunity ◽  
Data Synthesis ◽  
Definitive Evidence ◽  
Study Selection ◽  
Adverse Pregnancy ◽  
Levothyroxine Treatment

Abstract Context Thyroid autoimmunity (TAI), the most common cause of (sub)clinical hypothyroidism, is associated with adverse pregnancy outcomes. The benefits of levothyroxine (LT4) intervention in women with TAI remain controversial. Objective The purpose of this analysis is to determine the effect of LT4 on pregnancy outcomes in euthyroid women with TAI. Data sources Databases were searched up to May 2019. Study selection Randomized controlled trails (RCTs) and retrospective studies that reported effects of LT4 administration on pregnancy outcomes in euthyroid women with TAI were screened. Data extraction Quality assessment and data extraction were conducted independently by 2 researchers. Conflicts were settled by a third researcher. Data synthesis Six trials comprising 2249 women were included. Overall, no beneficial effect on pregnancy outcomes was observed with LT4 supplementation. For women with individualized initial LT4 dosages, the risk of miscarriage decreased (relative risk [RR] 0.62, 95% CI: 0.41-0.93, I2 = 28%); there was no difference among women with fixed LT4 dosages (RR 0.96, 95% CI: 0.74-1.24, I2 = 0%). Women who initiated LT4 treatment in early pregnancy had a significantly lower preterm birth rate (RR 0.54, 95% CI: 0.31-0.92, I2 = 0%) than those who received no treatment or placebo. No improvement was observed among women who initiated treatment before conception (RR 1.14, 95% CI: 0.71-1.84, I2 = 0%). Conclusion No definitive evidence showed improvement of pregnancy outcomes with LT4 supplementation in euthyroid women with TAI. However, therapeutic strategies, especially dosages and initial times of intervention, may be of great importance. Additional large RCTs are needed in the future.

scholarly journals Prevalence of Hypothyroidism in Pregnant Women in India: A Meta-Analysis of Observational Studies

2021 ◽  
Vol 2021 ◽  
pp. 1-19
Author(s):  
Vikas Yadav ◽  
Deepti Dabar ◽  
Akhil D. Goel ◽  
Mohan Bairwa ◽  
Akanksha Sood ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Observational Studies ◽  
Data Extraction ◽  
Meta Analysis ◽  
Rank Correlation ◽  
Overt Hypothyroidism ◽  
Study Selection ◽  
Pooled Prevalence ◽  
Meta Regression Analysis ◽  
Women In India

Introduction. This meta-analysis was conducted to estimate the prevalence of hypothyroidism among pregnant women in India. Methods. We searched PubMed, Web of Science, Scopus, Google Scholar, and Shodhganga (Indian thesis repository) for observational studies, providing prevalence of hypothyroidism among pregnant women in India. Systematic study selection and data extraction procedures were followed. Quality assessment of each study was done using JBI critical appraisal checklist. The random effects model was used for pooling the effect sizes. Publication bias was assessed using the funnel plot and rank correlation test. I2 statistics was used to measure heterogeneity across the studies. Heterogeneity in the pooled estimates was further explored with subgroup analyses and meta-regression analysis. Results. Sixty-one studies were found eligible and included in this review. The pooled estimate of the prevalence of hypothyroidism in pregnant women was 11.07% (95% CI: 8.79–13.84, I2 = 99%). Pooled prevalence estimates of subclinical and overt hypothyroidism are 9.51% (95% CI: 7.48–12.04, I2 = 98%) and 2.74% (95% CI: 2.08–3.58, I2 = 94%). Conclusion. We documented 11.07% pooled prevalence of hypothyroidism in pregnant women in India.

scholarly journals Associations of tobacco retailer density and proximity with adult tobacco use behaviours and health outcomes: a meta-analysis

2021 ◽  
pp. tobaccocontrol-2021-056717
Author(s):  
Joseph G L Lee ◽  
Amanda Y Kong ◽  
Kerry B Sewell ◽  
Shelley D Golden ◽  
Todd B Combs ◽  
...  
Keyword(s):  
Health Outcomes ◽  
Tobacco Use ◽  
Data Extraction ◽  
Meta Analysis ◽  
Grey Literature ◽  
Inclusion Criteria ◽  
Data Synthesis ◽  
Literature Searches ◽  
Adult Participants ◽  
Study Selection

ObjectiveWe sought to conduct a systematic review and meta-analysis of evidence to inform policies that reduce density and proximity of tobacco retailers.Data sourcesTen databases were searched on 16 October 2020: MEDLINE via PubMed, PsycINFO, Global Health, LILACS, Embase, ABI/Inform, CINAHL, Business Source Complete, Web of Science and Scopus, plus grey literature searches using Google and the RAND Publication Database.Study selectionIncluded studies used inferential statistics about adult participants to examine associations between tobacco retailer density/proximity and tobacco use behaviours and health outcomes. Of 7373 studies reviewed by independent coders, 37 (0.5%) met inclusion criteria.Data extractionEffect sizes were converted to a relative risk reduction (RRR) metric, indicating the presumed reduction in tobacco use outcomes based on reducing tobacco retailer density and decreasing proximity.Data synthesisWe conducted a random effects meta-analysis and examined heterogeneity across 27 studies through subgroup analyses and meta-regression. Tobacco retailer density (RRR=2.55, 95% CI 1.91 to 3.19, k=155) and proximity (RRR=2.38, 95% CI 1.39 to 3.37, k=100) were associated with tobacco use behaviours. Pooled results including both density and proximity found an estimated 2.48% reduction in risk of tobacco use from reductions in tobacco retailer density and proximity (RRR=2.48, 95% CI 1.95 to 3.02, k=255). Results for health outcomes came from just two studies and were not significant. Considerable heterogeneity existed.ConclusionsAcross studies, lower levels of tobacco retailer density and decreased proximity are associated with lower tobacco use. Reducing tobacco supply by limiting retailer density and proximity may lead to reductions in tobacco use. Policy evaluations are needed.

scholarly journals Is e-cigarette use in non-smoking young adults associated with later smoking? A systematic review and meta-analysis

2020 ◽  
Vol 30 (1) ◽  
pp. 8-15 ◽  
Author(s):  
Jasmine N Khouja ◽  
Steph F Suddell ◽  
Sarah E Peters ◽  
Amy E Taylor ◽  
Marcus R Munafò
Keyword(s):  
Animal Studies ◽  
Data Extraction ◽  
Meta Analysis ◽  
Self Report ◽  
Smoking History ◽  
Cochrane Library ◽  
Cigarette Use ◽  
Data Synthesis ◽  
Study Selection ◽  
Negative Controls

ObjectiveThe aim of this review was to investigate whether e-cigarette use compared with non-use in young non-smokers is associated with subsequent cigarette smoking.Data sourcesPubMed, Embase, Web of Science, Wiley Cochrane Library databases, and the 2018 Society for Research on Nicotine and Tobacco and Society for Behavioural Medicine conference abstracts.Study selectionAll studies of young people (up to age 30 years) with a measure of e-cigarette use prior to smoking and an outcome measure of smoking where an OR could be calculated were included (excluding reviews and animal studies).Data extractionIndependent extraction was completed by multiple authors using a preprepared extraction form.Data synthesisOf 9199 results, 17 studies were included in the meta-analysis. There was strong evidence for an association between e-cigarette use among non-smokers and later smoking (OR: 4.59, 95% CI: 3.60 to 5.85) when the results were meta-analysed in a random-effects model. However, there was high heterogeneity (I2=88%).ConclusionsAlthough the association between e-cigarette use among non-smokers and subsequent smoking appears strong, the available evidence is limited by the reliance on self-report measures of smoking history without biochemical verification. None of the studies included negative controls which would provide stronger evidence for whether the association may be causal. Much of the evidence also failed to consider the nicotine content of e-liquids used by non-smokers meaning it is difficult to make conclusions about whether nicotine is the mechanism driving this association.

The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis

2012 ◽  
Vol 72 (12) ◽  
pp. 1947-1955 ◽  
Author(s):  
Sandra Garcês ◽  
Jocelyne Demengeot ◽  
Elizabeth Benito-Garcia
Keyword(s):  
Drug Response ◽  
Inflammatory Diseases ◽  
Data Extraction ◽  
Meta Analysis ◽  
Random Effect ◽  
Data Synthesis ◽  
Immune Mediated ◽  
Study Selection ◽  
Bowel Diseases ◽  
Inflammatory Bowel

BackgroundImmunogenicity of aTNFs is one of the mechanisms behind treatment failure.ObjectiveTo assess the effect of anti-drug antibodies (ADA) on drug response to infliximab, adalimumab and etanercept, and the effect of immunosuppression on ADA detection, in patients with Rheumatoid Arthritis, Spondyloarthritis, Psoriasis and Inflammatory Bowel Diseases.Data sourcesPubMed, EMBASE, Cochrane databases, article reference lists (through August 19 2012).Study selectionOut of 2082 studies, 17 were used in the meta-analysis (1RCT; 16 observational studies).Data extractionTwo reviewers extracted data. Risk ratios (RR), 95% CI, using random-effect models, sensitivity analysis, meta-regressions and Egger's test were calculated.Data synthesisOf 865 patients, ADA against infliximab or adalimumab reduced drug response rate by 68% (RR=0.68, 95% CI=0.12 to 0.36), an effect attenuated by concomitant methotrexate (MTX): <74% MTX+: RR=0.23, 95% CI=0.15 to 0.36; ≥74% MTX+: RR=0.32, 95% CI=0.22 to 0.48. Anti-etanercept antibodies were not detected. Of 936 patients, concomitant MTX or azathioprine/mercaptopurine reduced ADA frequency by 47% (RR=0.53, 95% CI=0.42 to 0.67), particularly when ADA were assessed by RIA (RR=0.36, 95% CI=0.23 to 0.55) compared with ELISA (RR=0.63, 95% CI=0.53 to 0.74).ConclusionsADA reduces drug response, an effect that can be attenuated by concomitant immunosuppression, which reduces ADA frequency. Drug immunogenicity should be considered for the management of patients receiving biological therapies.

scholarly journals Is e-cigarette use in non-smoking young adults associated with later smoking? A systematic review and meta-analysis

2019 ◽  
Author(s):  
Jasmine N Khouja ◽  
Steph F Suddell ◽  
Sarah Peters ◽  
Amy E Taylor ◽  
Marcus R Munafò
Keyword(s):  
Animal Studies ◽  
Data Extraction ◽  
Meta Analysis ◽  
Self Report ◽  
Smoking History ◽  
Cochrane Library ◽  
Cigarette Use ◽  
Data Synthesis ◽  
Study Selection ◽  
Negative Controls

AbstractObjectiveThe aim of this review was to investigate whether e-cigarette use compared to non-use in young non-smokers is associated with subsequent cigarette smoking.Data sourcesPubMed, Embase, Web of Science, Wiley Cochrane Library databases, and the 2018 Society for Research on Nicotine and Tobacco and Society for Behavioural Medicine conference abstracts.Study selectionAll studies of young people (up to age 30 years) with a measure of e-cigarette use prior to smoking and an outcome measure of smoking where an odds ratio could be calculated were included (excluding reviews and animal studies).Data ExtractionIndependent extraction was completed by multiple authors using a pre-prepared extraction form.Data synthesisOf 9,199 results, 17 studies were included in the meta-analysis. There was strong evidence for an association between e-cigarette use among non-smokers and later smoking (OR 4.59, 95% CI 3.60 to 5.85) when the results were meta-analysed in a random effects model. However, there was high heterogeneity (I2 = 88%).ConclusionsWhilst the association between e-cigarette use among non-smokers and subsequent smoking appears strong, the available evidence is limited by the reliance on self-report measures of smoking history without biochemical verification. None of the studies included negative controls which would provide stronger evidence for whether the association may be causal. Much of the evidence also failed to consider the nicotine content of e-liquids used by non-smokers meaning it is difficult to make conclusions about whether nicotine is the mechanism driving this association.

scholarly journals Determinants of Frequent Attendance in Primary Care. Study Protocol for a Systematic Review of Longitudinal Studies

2020 ◽  
Vol 17 (10) ◽  
pp. 3710
Author(s):  
André Hajek ◽  
Benedikt Kretzler ◽  
Hans-Helmut König
Keyword(s):  
Systematic Review ◽  
Primary Care ◽  
Longitudinal Studies ◽  
Observational Studies ◽  
Data Extraction ◽  
Meta Analysis ◽  
Study Selection ◽  
Frequent Attendance ◽  
Longitudinal Observational Studies

Thus far, no study has systematically synthesized longitudinal studies investigating the determinants of frequent attendance in primary care. Consequently, the purpose of our systematic review is to give an overview of evidence based on longitudinal observational studies analyzing the determinants of frequent attendance. Three electronic databases (Medline, PsycINFO, CINAHL) will be searched. Moreover, the reference lists of studies included in our systematic review will be searched manually. Longitudinal observational studies examining the determinants of frequent attendance in primary care will be included. Disease-specific samples will be excluded. Data extraction focuses on methods (e.g., measurement of frequent attendance, statistical analysis), characteristics of the sample and key results. Furthermore, the quality of the studies included will be examined using an appropriate tool. Two reviewers will perform study selection, data extraction, and quality assessment. A meta-analysis will be conducted (if possible).

scholarly journals The role of corticosteroids in the management of critically ill patients with coronavirus disease 2019 (COVID-19): A meta-analysis

2020 ◽  
Author(s):  
Kalyan Kumar Gangopadhyay ◽  
Jagat J Mukherjee ◽  
Binayak Sinha ◽  
Samit Ghosal
Keyword(s):  
Critically Ill ◽  
Critically Ill Patients ◽  
Data Extraction ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Data Synthesis ◽  
Systemic Corticosteroids ◽  
Study Selection ◽  
Coronavirus Infection

AbstractObjectiveThere are no controlled studies on the role of systemic corticosteroids (CS) in patients with coronavirus disease 2019 (COVID-19). In the absence of high-quality evidence, understandably the recommendations from various organizations are cautious. Several randomized controlled trials are underway but shall take time to conclude. We therefore undertook a meta-analysis to ascertain the role of CS in the management of critically ill patients with COVID-19.Data SourcesElectronic databases, including Pubmed, Cochrane library and Embase, were searched, using the keywords of interest and the PICO search technique, from inception to 12th April 2020.Study SelectionStudies highlighting the use of CS in coronavirus infection with severe acute respiratory syndrome (SARS), Middle East Respiratory Syndrome (MERS) and COVID-19 were selected based on pre-determined inclusion criteria.Data extractionData was extracted into an excel sheet and transferred to comprehensive meta-analysis software version 3, Biostat Inc., Englewood, NJ, USA, for analysis.Data synthesisFive studies with SARS-CoV-2 infection were included in the meta-analysis. The rate ratio (RR) for mortality in patients with SARS-CoV-2 infection was 1.26 (95% CI: 0.96-1.65, I2: 74.46), indicating lack of benefit of CS therapy on mortality in critically ill patients with COVID-19. The RR for mortality on analysis of the three studies that particularly reported on patients with significant pulmonary compromise secondary to SARS-CoV-2 infection was neutral (RR: 0.91, 95% CI: 0.63-1.33, I2: 63.38).ConclusionsThe use of CS in critically ill patients with COVID-19 did not improve or worsen mortality. Pending further information from controlled studies, CS can be used in critically ill patients with COVID-19 with ‘critical illness related corticosteroid insufficiency’ and moderate to severe ARDS without the risk of increased mortality.

scholarly journals Thromboembolic Events, Recurrent Gastrointestinal Bleeding and Mortality after Resuming Anticoagulant Following Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 2799-2799
Author(s):  
Chatree Chai-Adisaksopha ◽  
Christopher M. Hillis ◽  
Mark A. Crowther
Keyword(s):  
Gastrointestinal Bleeding ◽  
Board Of Directors ◽  
Thromboembolic Event ◽  
Data Extraction ◽  
Meta Analysis ◽  
Thromboembolic Events ◽  
Gi Bleeding ◽  
Advisory Committees ◽  
Estimate Effect ◽  
Study Selection

IMPORTANCE: Gastrointestinal bleeding is one of the most common sites of bleeding complicated by anticoagulant therapy. Patients with anticoagulant-associated gastrointestinal (GI) bleeding are at risk of both thromboembolic events after anticoagulant interruption and recurrent bleeding following anticoagulant resumption. OBJECTIVE: To determine the risk of thromboembolism, recurrent GI bleeding and mortality for long-term anticoagulated patients who experienced GI bleeding. DATA SOURCES: We searched MEDLINE, EMBASE and CENTRAL from inception-July 2014, conferences abstracts (January 2006-July 2014) and www.clinicaltrials.gov up to the last week of January 2014 with no language restriction. STUDY SELECTION: Randomized controlled trials and cohort studies DATA EXTRACTION AND SYNTHESIS: Two reviewers independently performed study selection, data extraction and study quality assessment. MAIN OUTCOMES AND MEASURES: Selected outcomes were thromboembolic events, recurrent gastrointestinal bleeding and all-cause mortality. RESULTS: A total of 6 studies were included in the qualitative analysis and 2 studies in the quantitative analysis. Thromboembolic events occurred in 92 of 984 patients (9.34%) who resumed warfarin and in 147 of 895 (16.4%) patients who did not. The resumption of warfarin was associated with a significant reduction in thromboembolic event (HR 0.65 [95% CI, 0.54 to 0.78], p < 0.001, I2=90%) Recurrent GI bleeding occurred in 101 of 954 (10.59%) patients who restarted warfarin and in 40 of 895 (4.47%) patients who did not. There was no statistically significant increase in recurrent GI bleeding for patients who restarted warfarin compared to those who did not (HR 1.19 [95% CI, 0.95 to 1.48], p = 0.13, I2 = 0%). Death occurred in 203 of 984 (20.63%) patients who resumed warfarin and 316 of 896 (35.27%) patients who did not resume warfarin. Resumption of warfarin was associated with significant reduction in mortality (HR 0.64 [95% CI, 0.54 to 76], p <0.01, I2 = 75%). CONCLUSIONS AND RELEVANCE: This meta-analysis demonstrates that resumption of warfarin following interruption due to GI bleeding is associated with a reduction in thromboembolic events and mortality without a significantly increased risk of recurrent GI bleeding. Figure 1 Forrest plot of the estimate effect of thromboembolic event, recurrent gastrointestinal bleeding and mortality in patient who resumed anticoagulant versus patients who did no resume Figure 1. Forrest plot of the estimate effect of thromboembolic event, recurrent gastrointestinal bleeding and mortality in patient who resumed anticoagulant versus patients who did no resume Disclosures Crowther: Leo Pharma: Membership on an entity's Board of Directors or advisory committees, Research Funding; CSL Behring: Speakers Bureau; Boehriniger Ingelheim: Consultancy; Shire: Speakers Bureau; Celgene: Speakers Bureau; Bayer: Speakers Bureau; Asahi Kasai: Membership on an entity's Board of Directors or advisory committees; Portola: Membership on an entity's Board of Directors or advisory committees; Viropharma: Membership on an entity's Board of Directors or advisory committees.

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