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1. Procedure-Related Complications of Catheter Ablation for Atrial Fibrillation

Author

Karim Benali, Paul Khairy, Nefissa Hammache, Adrian Petzl, Antoine Da Costa, Atul Verma, Jason G. Andrade, Laurent Macle, Université de Montréal (UdeM), Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Montreal Heart Institute - Institut de Cardiologie de Montréal, McGill University Health Center [Montreal] (MUHC), Dr Benali has received grant support from the Group of Pacing and Cardiac Electrophysiology of the French Society of Cardiology. Dr Verma has received grant support, advisory board fees, and lecture fees from Bayer, Biosense Webster, and Medtronic, has received grant support from Biotronik, Bristol Myers Squibb, and Boehringer Ingelheim, has received consulting fees from Boston Scientific, MedLumics, and Thermedical, and has received lecture fees from Servier. Dr Andrade has received grant support from Baylis Medical, and and has received lecture fees from Biosense Webster. Dr Macle has received grant support and honoraria from Biosense Webster, Abbott, and Pfizer-Bristol Myers Squibb. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Subjects
meta-analysis, trend, catheter ablation, adverse event, atrial fibrillation, complication, [SDV.IB]Life Sciences [q-bio]/Bioengineering, randomized trials, Cardiology and Cardiovascular Medicine, mortality
Abstract

International audience; Background: Catheter ablation of atrial fibrillation (AF) is a commonly performed procedure. However, it is associated with potentially significant complications. Reported procedure–related complication rates are highly variable, depending in part on study design. Objectives: The purpose of this systematic review and pooled analysis was to determine the rate of procedure-related complications associated with catheter ablation of AF using data from randomized control trials and to assess temporal trends. Methods: MEDLINE and EMBASE databases were searched from January 2013 to September 2022 for randomized control trials that included patients undergoing a first ablation procedure of AF using either radiofrequency or cryoballoon (PROSPERO, CRD42022370273). Results: A total of 1,468 references were retrieved, of which 89 studies met inclusion criteria. A total of 15,701 patients were included in the current analysis. Overall and severe procedure-related complication rates were 4.51% (95% CI: 3.76%-5.32%) and 2.44% (95% CI: 1.98%-2.93%), respectively. Vascular complications were the most frequent type of complication (1.31%). The next most common complications were pericardial effusion/tamponade (0.78%) and stroke/transient ischemic attack (0.17%). The procedure-related complication rate during the most recent 5-year period of publication was significantly lower than during the earlier 5-year period (3.77% vs 5.31%; P = 0.043). The pooled mortality rate was stable over the 2 time periods (0.06% vs 0.05%; P = 0.892). There was no significant difference in complication rate according to pattern of AF, ablation modality, or ablation strategies beyond pulmonary vein isolation. Conclusions: Procedure-related complications and mortality rates associated with catheter ablation of AF are low and have declined in the past decade. © 2023 American College of Cardiology Foundation

Published
2023

2. Independent and Joint‐<scp>GWAS</scp>for growth traits inEucalyptusby assembling genome‐wide data for 3373 individuals across four breeding populations

Author

Bárbara S. F. Müller, Janeo Eustáquio de Almeida Filho, Aurélio Mendes Aguiar, Alexandre Alves Missiaggia, Orzenil B. Silva-Junior, Dario Grattapaglia, Leandro G. Neves, Elizabete Keiko Takahashi, Bruno Marco de Lima, Carla Garcia, Matias Kirst, Salvador A. Gezan, BÁRBARA S. F. MULLER, UNB, ORZENIL BONFIM DA SILVA JUNIOR, Cenargen, LEANDRO G. NEVES, RAPID GENOMICS LLC, USA, DARIO GRATTAPAGLIA, Cenargen., JANEO E. DE ALMEIDA FILHO, UENF, BRUNO M. LIMA, FIBRIA S.A. TECHNOLOGY CENTER, CARLA C. GARCIA, INTERNATIONAL PAPER OF BRAZIL, ALEXANDRE MISSIAGGIA, FIBRIA S.A. TECHNOLOGY CENTER, AURELIO M. AGUIAR, FIBRIA S.A. TECHNOLOGY CENTER, ELIZABETE TAKAHASHI, CELULOSE NIPO-BRASILEIRA (CENIBRA) S.A., MATIAS KIRST, UNIVERSITY OF FLORIDA, USA, and SALVADOR A. GEZAN, UNIVERSITY OF FLORIDA, USA

Subjects
musculoskeletal diseases, 0106 biological sciences, 0301 basic medicine, Physiology, Population, Inheritance Patterns, Single-nucleotide polymorphism, Genome-wide association study, Plant Science, Biology, Polymorphism, Single Nucleotide, 01 natural sciences, Genome, Linkage Disequilibrium, 03 medical and health sciences, Quantitative Trait, Heritable, High-throughput SNP genotyping, Joint-GWAS, Regional heritability mapping (RHM), SNP, education, Genetic association, Principal Component Analysis, Eucalyptus, education.field_of_study, Genome-wide association study (GWAS), Heritability, Plant Breeding, Meta-analysis, 030104 developmental biology, Evolutionary biology, Tree breeding, Relatedness, Genome, Plant, Genome-Wide Association Study, 010606 plant biology & botany
Abstract

Genome-wide association studies (GWAS) in plants typically suffer from limited statistical power. An alternative to the logistical and cost challenge of increasing sample sizes is to gain power by meta-analysis using information from independent studies. We carried out GWAS for growth traits with six single-marker models and regional heritability mapping (RHM) in four Eucalyptus breeding populations independently and by Joint-GWAS, using gene and segment-based models, with data for 3373 individuals genotyped with a communal EUChip60KSNP platform. While single-single nucleotide polymorphism (SNP) GWAS hardly detected significant associations at high-stringency in each population, gene-based Joint-GWAS revealed nine genes significantly associated with tree height. Associations detected using single-SNP GWAS, RHM and Joint-GWAS set-based models explained on average 3-20% of the phenotypic variance. Whole-genome regression, conversely, captured 64-89% of the pedigree-based heritability in all populations. Several associations independently detected for the same SNPs in different populations provided unprecedented GWAS validation results in forest trees. Rare and common associations were discovered in eight genes involved in cell wall biosynthesis and lignification. With the increasing adoption of genomic prediction of complex phenotypes using shared SNPs and much larger tree breeding populations, Joint-GWAS approaches should provide increasing power to pinpoint discrete associations potentially useful toward tree breeding and molecular applications.

Published
2018

3. Physical functional performance and prognosis in patients with heart failure: a systematic review and meta-analysis

Author

Antonio Cuesta-Vargas, Ricardo Gómez-Huelgas, María Rosa Bernal-López, Iván José Fuentes-Abolafio, Brendon Stubbs, Luis M. Pérez-Belmonte, [Fuentes-Abolafio,IJ, Cuesta-Vargas,AI] Department of Physiotherapy, Faculty of Health Science, University of Malaga, The Institute of Biomedical Research in Malaga (IBIMA), Clinimetric Group FE-14, Malaga, Spain. [Stubbs,B] Physiotherapy Department, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, UK. [Stubbs,B] Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK. [Stubbs,B] Positive Ageing Research Intitute (PARI), Faculty of Health Social Care and Education, Anglia Ruskin University, Chelmsford, UK. [Pérez-Belmonte,LM, Bernal-López,MR, Gómez-Huelgas,R] Internal Medicine Department, Instituto de Investigación Biomédica de Malaga (IBIMA), Regional University Hospital of Málaga, Málaga, Spain. [Pérez-Belmonte,LM] Unidad de Neurofisiología Cognitiva, Centro de Investigaciones Médico Sanitarias (CIMES), Instituto de Investigación Biomédica de Málaga (IBIMA), Universidad de Málaga (UMA), Campus de Excelencia Internacional (CEI) Andalucía Tech, Málaga, Spain. [Pérez-Belmonte,LM] Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, Madrid, Spain. [Bernal-López,MR, Gómez-Huelgas,R] CIBER Fisio-patología de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain. [Cuesta-Vargas,AI] School of Clinical Sciences, Faculty of Health at the Queensland University of Technology, Brisbane, Queensland, Australia., and Brendon Stubbs is supported by a Clinical Lectureship (ICA-CL-2017-03-001) jointly funded by Health Education England (HEE) and the National Institute for Health Research (NIHR). Brendon Stubbs is part funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust. Brendon Stubbs is also supported by the Maudsley Charity, King’s College London and the NIHR South London Collaboration for Leadership in Applied Health Research and Care (CLAHRC) funding. This paper presents independent research. The views expressed in this publication are those of the authors and not necessarily those of the acknowledged institutions. María Rosa Bernal-López was supported by 'Miguel Servet Type I' program (CP15/00028) from the ISCIII-Madrid (Spain), cofinanced by the Fondo Europeo de Desarrollo Regional-FEDER.

Subjects
Male, lcsh:Diseases of the circulatory (Cardiovascular) system, Hospitalización, Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Statistics as Topic::Probability::Risk::Risk Assessment [Medical Subject Headings], Walking, 030204 cardiovascular system & hematology, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], 0302 clinical medicine, Risk Factors, Physical functional performance, Hospitalisation, Medicine, 030212 general & internal medicine, Phenomena and Processes::Musculoskeletal and Neural Physiological Phenomena::Musculoskeletal Physiological Phenomena::Musculoskeletal Physiological Processes::Movement::Motor Activity::Exercise::Walking [Medical Subject Headings], Persons::Persons::Age Groups::Adult::Aged [Medical Subject Headings], Aged, 80 and over, Insuficiencia cardíaca, Pronóstico, Middle Aged, Prognosis, Cardiac surgery, Hospitalization, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Patient Care::Hospitalization [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Sensitivity and Specificity::Predictive Value of Tests [Medical Subject Headings], Meta-analysis, Female, Gait Analysis, Cardiology and Cardiovascular Medicine, Research Article, medicine.medical_specialty, Check Tags::Male [Medical Subject Headings], Walk Test, Functional tests, Heart failure, CINAHL, Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Statistics as Topic::Probability::Risk::Risk Factors [Medical Subject Headings], Risk Assessment, 03 medical and health sciences, Predictive Value of Tests, Humans, In patient, Mortality, Aged, Angiology, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Techniques, Cardiovascular::Heart Function Tests::Exercise Test [Medical Subject Headings], business.industry, Diseases::Cardiovascular Diseases::Heart Diseases::Heart Failure [Medical Subject Headings], Persons::Persons::Age Groups::Adult::Middle Aged [Medical Subject Headings], Evidence-based medicine, medicine.disease, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Physical Examination::Gait [Medical Subject Headings], Functional Status, Check Tags::Female [Medical Subject Headings], lcsh:RC666-701, Persons::Persons::Age Groups::Adult::Aged::Aged, 80 and over [Medical Subject Headings], Mortalidad, Physical therapy, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis [Medical Subject Headings], Observational study, business, Rendimiento físico funcional
Abstract

Background Patients with Heart Failure (HF) show impaired functional capacities which have been related to their prognosis. Moreover, physical functional performance in functional tests has also been related to the prognosis in patients with HF. Thus, it would be useful to investigate how physical functional performance in functional tests could determine the prognosis in patients with HF, because HF is the leading cause of hospital admissions for people older than 65 years old. This systematic review and meta-analysis aims to summarise and synthesise the evidence published about the relationship between physical functional performance and prognosis in patients with HF, as well as assess the risk of bias of included studies and the level of evidence per outcome. Methods Major electronic databases, such as PubMed, AMED, CINAHL, EMBASE, PEDro, Web of Science, were searched from inception to March 2020 for observational longitudinal cohort studies (prospective or retrospective) examining the relationship between physical functional performance and prognosis in patients with HF. Results 44 observational longitudinal cohort studies with a total of 22,598 patients with HF were included. 26 included studies reported a low risk of bias, and 17 included studies showed a moderate risk of bias. Patients with poor physical functional performance in the Six Minute Walking Test (6MWT), in the Short Physical Performance Battery (SPPB) and in the Gait Speed Test showed worse prognosis in terms of larger risk of hospitalisation or mortality than patients with good physical functional performance. However, there was a lack of homogeneity regarding which cut-off points should be used to stratify patients with poor physical functional performance from patients with good physical functional performance. Conclusion The review includes a large number of studies which show a strong relationship between physical functional performance and prognosis in patients with HF. Most of the included studies reported a low risk of bias, and GRADE criteria showed a low and a moderate level of evidence per outcome.

Published
2020

4. Human variability in polymorphic CYP2D6 metabolism: Implications for the risk assessment of chemicals in food and emerging designer drugs

Author

Camille Béchaux, Witold Więcek, Jean-Lou Dorne, Emanuela Testai, Kevin Darney, Billy Amzal, Leonie S. Lautz, Direction de l'Evaluation des Risques (DER), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), Certara UK Limited, Istituto Superiore di Sanita [Rome], Quinten, European Food Safety Authority (EFSA), and This work was supported by the European Food Safety Authority (EFSA) under Contract numbers: [OC/EFSA/SCER/2014/06]: Witold Wiecek and Billy Amzal, and [GP/EFSA/SCER/2015/01]: Keyvin Darney, Leonie Lautz and Emanuela Testai. Views expressed in this paper are the authors only and do not represent the views of the European Food safety Authority.

Subjects
CYP2D6, Uncertainty factors, [SDV]Life Sciences [q-bio], Cmax, Pharmacology, Biology, Risk Assessment, 030226 pharmacology & pharmacy, Designer Drugs, Human variability, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Pharmacokinetics, Humans, Toxicokinetics, GE1-350, 030304 developmental biology, General Environmental Science, 0303 health sciences, Bayes Theorem, 3. Good health, Environmental sciences, Meta-analysis, Cytochrome P-450 CYP2D6, chemistry, Toxicity, Bayesian Inference, Xenobiotic, Drug metabolism
Abstract

International audience; The major human cytochrome P450 CYP2D6 isoform enzyme plays important roles in the liver and in the brain with regards to xenobiotic metabolism. Xenobiotics as CYP2D6 substrates include a whole range of pharmaceuticals, pesticides and plant alkaloids to cite but a few. In addition, a number of endogenous compounds have been shown to be substrates of CYP2D6 including trace amines in the brain such as tyramine and 5-methoxytryptamine as well as anandamide and progesterone. Because of the polymorphic nature of CYP2D6, considerable inter-phenotypic and inter-ethnic differences in the pharmaco/toxicokinetics (PK/TK) and metabolism of CYP2D6 substrates exist with potential consequences on the pharmacology and toxicity of chemicals. Here, large extensive literature searches have been performed to collect PK data from published human studies for a wide range of pharmaceutical probe substrates and investigate human variability in CYP2D6 metabolism. The computed kinetic parameters resulted in the largest open source database, quantifying inter-phenotypic differences for the kinetics of CYP2D6 probe substrates in Caucasian and Asian populations, to date. The database is available in supplementary material (CYPD6 DB) and EFSA knowledge junction (DOI to added). Subsequently, meta-analyses using a hierarchical Bayesian model for markers of chronic oral exposure (oral clearance, area under the plasma concentration time curve) and acute oral exposure (maximum plasma concentration (Cmax) provided estimates of inter-phenotypic differences and CYP2D6-related uncertainty factors (UFs) for chemical risk assessment in Caucasian and Asian populations classified as ultra-rapid (UM), extensive (EMs), intermediate (IMs) and poor metabolisers (PMs). The model allowed the integration of inter-individual (i.e. inter-phenotypic and inter-ethnic), inter-compound and inter-study variability together with uncertainty in each PK parameter. Key findings include 1. Higher frequencies of PMs in Caucasian populations compared to Asian populations (>8% vs 1-2%) for which EM and IM were the most frequent phenotype. 2. Large inter-phenotypic differences in PK parameters for Caucasian EMs (coefficients of variation (CV) > 50%) compared with Caucasian PMs and Asian EMs and IMs (i.e CV < 40%). 3. Inter-phenotypic PK differences between EMs and PMs in Caucasian populations increase with the quantitative contribution of CYP2D6 for the metabolism (fm) for a range of substrates (fm CYP2D6 range: 20-95% of dose) (range: 1-54) to a much larger extent than those for Asian populations (range: 1-4). 4. Exponential meta-regressions between Fm CYP2D6 in EMs and inter-phenotypic differences were also shown to differ between Caucasian and Asian populations as well as CYP2D6-related UFs. Finally, implications of these results for the risk assessment of food chemicals and emerging designer drugs of public health concern, as CYP2D6 substrates, are highlighted and include the integration of in vitro metabolism data and CYP2D6 variability distributions for the development of quantitative in vitro in vivo extrapolation models.

Published
2021

5. Consumption of Fish and ω-3 Fatty Acids and Cancer Risk: An Umbrella Review of Meta-Analyses of Observational Studies

Author

Hans Oh, Mingyang Song, Jae Il Shin, Ai Koyanagi, Louis Jacob, Andreas Kronbichler, Gaeun Kim, Michael Eisenhut, Eun Kyoung Choi, Sun Jae Jung, Lin Yang, Marco Solmi, Gwang Hun Jeong, Eunyoung Jung, Brendon Stubbs, Keum Hwa Lee, Eunyoung Cho, Joaquim Radua, Edward Giovannucci, NaNa Keum, Hyo Jin Seong, Nicola Veronese, Hyunbong Park, Lee Smith, Gabriele Gamerith, Giuseppe Grosso, Trevor Thompson, Elena Dragioti, Sarah E Jackson, Leandro Fórnias Machado de Rezende, Shuji Ogino, Jong Yeob Kim, Hans van Vliet, Sung Hwi Hong, Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), South London and Maudsley NHS Foundation Trust National Institute for Health Research, NIHR NIHR Collaboration for Leadership in Applied Health Research and Care South London National Institutes of Health, NIH: R35 CA197735 Maudsley Charity King’s College London National Institutes of Health, NIH: R35 CA197735, KHL, HJS, GK, GHJ, and JYK contributed equally to this work. The authors report no funding received for this study. Author Disclosures: The authors report no conflicts of interest. BS is supported by a Clinical Lectureship (ICA-CL-2017-03-001) jointly funded by Health Education England (HEE) and the National Institute for Health Research (NIHR), is in part funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust, and is also supported by the Maudsley Charity, King’s College London, and the NIHR South London Collaboration for Leadership in Applied Health Research and Care (CLAHRC) funding. The time effort of SO was in part supported by US National Institutes of Health grant R35 CA197735. This paper presents independent research. The views expressed in this publication are those of the authors and not necessarily those of the acknowledged institutions. Address correspondence to JIS (e-mail: shinji@yuhs.ac) or EKC (e-mail: ekchoi@yuhs.ac). Supplemental Table 1 is available from the 'Supplementary data'link in the online posting of the article and from the same link in the online table of contents at https://academic.oup.com/advances. Abbreviation used: ALA, α-linolenic acid, AMSTAR2, A Measurement Tool to Assess Systematic Reviews 2, CUP, Continuous Update Project, DPA, docosapentaenoic acid, GRADE, Grading of Recommendations Assessment, Development and Evaluation, HCC, hepatocellular carcinoma, NA, not assessable, PI, prediction interval, PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses, WCRF/AICR, Word Cancer Research Fund/American Institute for Cancer Research., The time effort of SO was in part supported by US National Institutes of Health grant R35 CA197735., Lee, K.H., Seong, H.J., Kim, G., Jeong, G.H., Kim, J.Y., Park, H., Jung, E., Kronbichler, A., Eisenhut, M., Stubbs, B., Solmi, M., Koyanagi, A., Hong, S.H., Dragioti, E., De Rezende, L.F.M., Jacob, L., Keum, N., Van Der Vliet, H.J., Cho, E., Veronese, N., Grosso, G., Ogino, S., Song, M., Radua, J., Jung, S.J., Thompson, T., Jackson, S.E., Smith, L., Yang, L., Oh, H., Choi, E.K., Shin, J.I., Giovannucci, E.L., and Gamerith, G.

Subjects
Male, Risk, Oncology, medicine.medical_specialty, [SDV]Life Sciences [q-bio], BF, Medicine (miscellaneous), Review, Cohort Studies, 03 medical and health sciences, Prostate cancer, 0302 clinical medicine, Breast cancer, ω-3 fatty acid, Meta-Analysis as Topic, Neoplasms, Internal medicine, Fatty Acids, Omega-3, medicine, Animals, Humans, cancer, 030212 general & internal medicine, ω-3 fatty acid, fish, cancer, umbrella review, meta-analysis, chemistry.chemical_classification, fish, Nutrition and Dietetics, umbrella review, business.industry, Endometrial cancer, Fishes, Fatty acid, Cancer, medicine.disease, R1, 3. Good health, meta-analysis, Observational Studies as Topic, chemistry, Case-Control Studies, 030220 oncology & carcinogenesis, Meta-analysis, Female, Skin cancer, business, Liver cancer, Food Science
Abstract

Multiple studies have suggested that ω-3 fatty acid intake may have a protective effect on cancer risk; however, its true association with cancer risk remains controversial. We performed an umbrella review of meta-analyses to summarize and evaluate the evidence for the association between ω-3 fatty acid intake and cancer outcomes. We searched PubMed, Embase, and the Cochrane Database of Systematic Reviews from inception to December 1, 2018. We included meta-analyses of observational studies that examined associations between intake of fish or ω-3 fatty acid and cancer risk (gastrointestinal, liver, breast, gynecologic, prostate, brain, lung, and skin) and determined the level of evidence of associations. In addition, we appraised the quality of the evidence of significant meta-analyses by using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. We initially screened 598 articles, and 15 articles, including 57 meta-analyses, were eligible. Among 57 meta-analyses, 15 reported statistically significant results. We found that 12 meta-analyses showed weak evidence of an association between ω-3 fatty acid intake and risk of the following types of cancer: liver cancer (n = 4 of 6), breast cancer (n = 3 of 14), prostate cancer (n = 3 of 11), and brain tumor (n = 2 of 2). In the other 3 meta-analyses, studies of endometrial cancer and skin cancer, there were no assessable data for determining the evidence levels. No meta-analysis showed convincing, highly suggestive, or suggestive evidence of an association. In the sensitivity analysis of meta-analyses by study design, we found weak associations between ω-3 fatty acid intake and breast cancer risk in cohort studies, but no statistically significant association in case-control studies. However, the opposite results were found in case of brain tumor risk. Although ω-3 fatty acids have been studied in several meta-analyses with regard to a wide range of cancer outcomes, only weak associations were identified in some cancer types, with several limitations. Considering the nonsignificant or weak evidence level, clinicians and researchers should cautiously interpret reported associations between ω-3 fatty acid consumption and cancer risks. Copyright © 2020 The Author(s) on behalf of the American Society for Nutrition.

Published
2020

6. Does reductio ad absurdum have a place in evidence-based medicine?

Author

Florian Naudet, Bruno Falissard, Comportement et noyaux gris centraux = Behavior and Basal Ganglia [Rennes], CHU Pontchaillou [Rennes]-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université européenne de Bretagne - European University of Brittany (UEB)-Institut des Neurosciences Cliniques de Rennes (INCR), Troubles du comportement alimentaire de l'adolescent (UMR_S 669), Université Paris-Sud - Paris 11 (UP11)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), This paper was supported by the Institut National de la Santé et de la Recherche Médicale (INSERM). The sponsor had no role concerning preparation, review or approval of the manuscript., Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes = Institute of Clinical Neurosciences of Rennes (INCR), Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Lecoupe-Grainville, Marie, Comportement et noyaux gris centraux [Rennes], Université de Rennes 1 ( UR1 ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Université européenne de Bretagne ( UEB ) -CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Troubles du comportement alimentaire de l'adolescent ( UMR_S 669 ), and Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris-Sud - Paris 11 ( UP11 )

Subjects
Evidence-based medicine, media_common.quotation_subject, Major depressive disorder, Epistemology, Publication bias, Placebos, 03 medical and health sciences, 0302 clinical medicine, Nothing, [ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology, Rhetorical question, Reductio ad absurdum, Humans, Medicine, 030212 general & internal medicine, Meaning (existential), Set (psychology), Absurdity, Placebo, media_common, Medicine(all), [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Depression, business.industry, Comment, Statistics, Antidepressants, General Medicine, Antidepressive Agents, 3. Good health, Meta-analysis, Commentary, business, 030217 neurology & neurosurgery, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Medical literature
Abstract

In a meta-analysis published in BMC Medicine, we explored whether evidence-based medicine can actually be sure that ‘sucrose = sucrose’ in the treatment of depression. This paper, based upon a reductio ad absurdum, addressed an epistemological question using a ‘scientific’ approach, and could be disconcerting as suggested by Cipriani and Geddes’ commentary. However, most papers are based upon a mixture of observations and discussions about sense and meaning. Ultimately, there is nothing more than a story, told with words or numbers. Randomised controlled trials provide information about average patients that do not exist. These results ignores an entire segment of therapeutics that plays a crucial role, namely care. This information is usually set out using a ‘grammar’ that is ambiguous, since statistical tests of hypothesis have raised epistemological questions that are not as yet solved. Moreover, many of these stories remain untold, and unpublished. For these reasons evidence-based medicine is a vehicle for many paradoxes and controversies. Reductio ad absurdum can be useful in precisely this case, to underline how and why the medical literature can sometimes give an impression of absurdity of this sort. Even if the data analysis in our paper was rather rhetorical, we agree that it should comply with the classic standards of reporting and we provide the important extra data that Cipriani and Geddes have requested. Please see related articles: http://www.biomedcentral.com/1741-7015/11/230 and http://www.biomedcentral.com/1741-7015/12/105.

Published
2014

7. Which placebo to cure depression? A thought-provoking network meta-analysis

Author

Bruno Falissard, Florian Naudet, Jean Michel Reymann, Philippe Charlier, Bruno Millet, Anne Solène Maria, Comportement et noyaux gris centraux = Behavior and Basal Ganglia [Rennes], Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes = Institute of Clinical Neurosciences of Rennes (INCR), Service de Psychiatrie, Centre Hospitalier Guillaume Régnier, Troubles du comportement alimentaire de l'adolescent (UMR_S 669), Université Paris-Sud - Paris 11 (UP11)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Médecine légale, Anatomo-pathologie et Paléopathologie [CHU Raymond Poincaré], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Raymond Poincaré [AP-HP], Laboratoire Ethique Politique et Santé (EA 4569), Université Paris Descartes - Paris 5 (UPD5), Unité de Méthodologie des Essais Thérapeutiques, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Laboratoire de Pharmacologie Expérimentale et Clinique, Université de Rennes - Faculté de Médecine (UR Médecine), Université de Rennes (UR)-Université de Rennes (UR)-Université de Rennes - Faculté de Médecine (UR Médecine), Université de Rennes (UR), Service de Santé Publique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse, This paper was supported by the Institut National de la Santé et de la Recherche Médicale (INSERM)., Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Laboratoire de Pharmacologie Expérimentale et Clinique, Université de Rennes 1 - Faculté de Médecine (UR1 Médecine), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université de Rennes 1 - Faculté de Médecine (UR1 Médecine), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Comportement et noyaux gris centraux [Rennes], Université de Rennes 1 ( UR1 ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Université européenne de Bretagne ( UEB ) -CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Troubles du comportement alimentaire de l'adolescent ( UMR_S 669 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris-Sud - Paris 11 ( UP11 ), Médecine légale, Anatomo-pathologie et Paléopathologie, Université de Versailles Saint-Quentin-en-Yvelines ( UVSQ ) -Assistance publique - Hôpitaux de Paris (AP-HP)-AP-HP Hôpital Raymond Poincaré [Garches], Laboratoire Ethique Politique et Santé ( EA 4569 ), Université Paris Descartes - Paris 5 ( UPD5 ), Centre d'Investigation Clinique [Rennes] ( CIC ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Rennes 1 ( UR1 ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Laboratoire de Pharmacologie Expérimentale et Clinique, Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Paul Brousse, Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Université de Rennes (UR)-Université de Rennes (UR)-Université de Rennes 1 - Faculté de Médecine (UR1 Médecine), and BMC, Ed.

Subjects
medicine.medical_specialty, Psychotherapist, Alternative medicine, Major depressive disorder, Placebo, Publication bias, 03 medical and health sciences, 0302 clinical medicine, [SDV.BBM.GTP]Life Sciences [q-bio]/Biochemistry, Molecular Biology/Genomics [q-bio.GN], medicine, 030212 general & internal medicine, Psychiatry, Depression (differential diagnoses), Medicine(all), Fluoxetine, business.industry, Rank (computer programming), General Medicine, Antidepressants, medicine.disease, 3. Good health, Meta-analysis, [ SDV.BBM.GTP ] Life Sciences [q-bio]/Biochemistry, Molecular Biology/Genomics [q-bio.GN], [SDV.BBM.GTP] Life Sciences [q-bio]/Biochemistry, Molecular Biology/Genomics [q-bio.GN], business, 030217 neurology & neurosurgery, Research Article, medicine.drug
Abstract

International audience; BACKGROUND: Antidepressants are often considered to be mere placebos despite the fact that meta-analyses are able to rank them. It follows that it should also be possible to rank different placebos, which are all made of sucrose. To explore this issue, which is rather more epistemological than clinical, we designed an unusual meta-analysis to investigate whether the effects of placebo in one situation are different from the effects of placebo in another situation. METHODS: Published and unpublished studies were searched for by three reviewers on Medline, the Cochrane Library, Embase, clinicaltrials.gov, Current Controlled Trial, in bibliographies, and by mailing key organizations. The following studies in first-line treatment for major depressive disorder were considered to construct an "evidence network": 1) randomized controlled trials (RCTs) versus placebo on fluoxetine, venlafaxine and 2) fluoxetine versus venlafaxine head-to-head RCTs.Two network meta-analyses were run to indirectly compare response and remission rates among three different placebos: 1) fluoxetine placebo, 2) venlafaxine placebo, and 3) venlafaxine/fluoxetine placebo (that is, placebo compared to both venlafaxine and fluoxetine). Publication biases were assessed using funnel plots and statistically tested. RESULTS: The three placebos were not significantly different in terms of response or remission. The antidepressant agents were significantly more efficacious than the placebos, and venlafaxine was more efficacious than fluoxetine. The funnel plots, however, showed a major publication bias. CONCLUSION: The presence of significant levels of publication bias indicates that we cannot even be certain of the conclusion that sucrose equals sucrose in trials of major depressive disorder. This result should remind clinicians to step back to take a more objective view when interpreting a scientific result. It is of crucial importance for their practice, far more so than ranking antidepressant efficacy.

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