Arturo J Martí-Carvajal, Mario A Gemmato-Valecillos, Diana Monge Martín, Mark Dayer, Eduardo Alegría-Barrero, Juan Bautista De Sanctis, Juan Marcos Parise Vasco, Ricardo J Riera Lizardo, Susana Nicola, Cristina Elena Martí-Amarista, Andrea Correa-Pérez
{"title":"Interleukin-receptor antagonist and tumour necrosis factor inhibitors for the primary and secondary prevention of atherosclerotic cardiovascular diseases.","authors":"Arturo J Martí-Carvajal, Mario A Gemmato-Valecillos, Diana Monge Martín, Mark Dayer, Eduardo Alegría-Barrero, Juan Bautista De Sanctis, Juan Marcos Parise Vasco, Ricardo J Riera Lizardo, Susana Nicola, Cristina Elena Martí-Amarista, Andrea Correa-Pérez","doi":"10.1002/14651858.CD014741.pub2","DOIUrl":"10.1002/14651858.CD014741.pub2","url":null,"abstract":"<p><strong>Background: </strong>Atherosclerotic cardiovascular disease (ACVD) is worsened by chronic inflammatory diseases. Interleukin receptor antagonists (IL-RAs) and tumour necrosis factor-alpha (TNF) inhibitors have been studied to see if they can prevent cardiovascular events.</p><p><strong>Objectives: </strong>The purpose of this study was to assess the clinical benefits and harms of IL-RAs and TNF inhibitors in the primary and secondary prevention of ACVD.</p><p><strong>Search methods: </strong>The Cochrane Heart Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase, EBSCO CINAHL plus, and clinical trial registries for ongoing and unpublished studies were searched in February 2024. The reference lists of relevant studies, reviews, meta-analyses and health technology reports were searched to identify additional studies. No limitations on language, date of publication or study type were set.</p><p><strong>Selection criteria: </strong>RCTs that recruited people with and without pre-existing ACVD, comparing IL-RAs or TNF inhibitors versus placebo or usual care, were selected. The primary outcomes considered were all-cause mortality, myocardial infarction, unstable angina, and adverse events.</p><p><strong>Data collection and analysis: </strong>Two or more review authors, working independently at each step, selected studies, extracted data, assessed the risk of bias and used GRADE to judge the certainty of evidence.</p><p><strong>Main results: </strong>We included 58 RCTs (22,053 participants; 21,308 analysed), comparing medication efficacy with placebo or usual care. Thirty-four trials focused on primary prevention and 24 on secondary prevention. The interventions included IL-1 RAs (anakinra, canakinumab), IL-6 RA (tocilizumab), TNF-inhibitors (etanercept, infliximab) compared with placebo or usual care. The certainty of evidence was low to very low due to biases and imprecision; all trials had a high risk of bias. Primary prevention: IL-1 RAs The evidence is very uncertain about the effects of the intervention on all-cause mortality(RR 0.33, 95% CI 0.01 to 7.58, 1 trial), myocardial infarction (RR 0.71, 95% CI 0.04 to 12.48, I² = 39%, 2 trials), unstable angina (RR 0.24, 95% CI 0.03 to 2.11, I² = 0%, 2 trials), stroke (RR 2.42, 95% CI 0.12 to 50.15; 1 trial), adverse events (RR 0.85, 95% CI 0.59 to 1.22, I² = 54%, 3 trials), or infection (rate ratio 0.84, 95% 0.55 to 1.29, I² = 0%, 4 trials). Evidence is very uncertain about whether anakinra and cankinumab may reduce heart failure (RR 0.21, 95% CI 0.05 to 0.94, I² = 0%, 3 trials). Peripheral vascular disease (PVD) was not reported as an outcome. IL-6 RAs The evidence is very uncertain about the effects of the intervention on all-cause mortality (RR 0.68, 95% CI 0.12 to 3.74, I² = 30%, 3 trials), myocardial infarction (RR 0.27, 95% CI 0.04 to1.68, I² = 0%, 3 trials), heart failure (RR ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"9 ","pages":"CD014741"},"PeriodicalIF":8.8,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11411914/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ahmad Alhamid, Ziad Aljarad, Abdelkader Chaar, Alyssa Grimshaw, Ibrahem Hanafi
{"title":"Endoscopic therapy for gastrointestinal angiodysplasia.","authors":"Ahmad Alhamid, Ziad Aljarad, Abdelkader Chaar, Alyssa Grimshaw, Ibrahem Hanafi","doi":"10.1002/14651858.CD014582","DOIUrl":"10.1002/14651858.CD014582","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of the different endoscopic management approaches for gastrointestinal angiodysplasia in symptomatic adults.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"9 ","pages":"CD014582"},"PeriodicalIF":8.8,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11411905/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Anna Karen Haugaard, Rita Saude Conde, Ana Rita J Maria, Abhijna Vithal Yergolkar, Karsten Juhl Jørgensen, Bruno Heleno
{"title":"Immunotherapy for advanced and recurrent malignant pleural mesothelioma.","authors":"Anna Karen Haugaard, Rita Saude Conde, Ana Rita J Maria, Abhijna Vithal Yergolkar, Karsten Juhl Jørgensen, Bruno Heleno","doi":"10.1002/14651858.CD014720","DOIUrl":"10.1002/14651858.CD014720","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of immune checkpoint inhibitors (single-agent or combination therapy) in people with advanced malignant pleural mesothelioma in a first-line or salvage setting.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"9 ","pages":"CD014720"},"PeriodicalIF":8.8,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11409431/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Benjamin JR Buckley, Linda Long, Signe S Risom, Deirdre A Lane, Selina K Berg, Christian Gluud, Pernille Palm, Kirstine L Sibilitz, Jesper H Svendsen, Ann-Dorthe Zwisler, Gregory YH Lip, Lis Neubeck, Rod S Taylor
{"title":"Exercise-based cardiac rehabilitation for adults with atrial fibrillation.","authors":"Benjamin JR Buckley, Linda Long, Signe S Risom, Deirdre A Lane, Selina K Berg, Christian Gluud, Pernille Palm, Kirstine L Sibilitz, Jesper H Svendsen, Ann-Dorthe Zwisler, Gregory YH Lip, Lis Neubeck, Rod S Taylor","doi":"10.1002/14651858.CD011197.pub3","DOIUrl":"10.1002/14651858.CD011197.pub3","url":null,"abstract":"<p><strong>Background: </strong>Atrial fibrillation (AF), the most prevalent cardiac arrhythmia, disrupts the heart's rhythm through numerous small re-entry circuits in the atrial tissue, leading to irregular atrial contractions. The condition poses significant health risks, including increased stroke risk, heart failure, and reduced quality of life. Given the complexity of AF and its growing incidence globally, exercise-based cardiac rehabilitation (ExCR) may provide additional benefits for people with AF or those undergoing routine treatment for the condition.</p><p><strong>Objectives: </strong>To assess the benefits and harms of ExCR compared with non-exercise controls for people who currently have AF or who have been treated for AF.</p><p><strong>Search methods: </strong>We searched the following electronic databases: CENTRAL in the Cochrane Library, MEDLINE Ovid, Embase Ovid, PsycINFO Ovid, Web of Science Core Collection Thomson Reuters, CINAHL EBSCO, LILACS BIREME, and two clinical trial registers on 24 March 2024. We imposed no language restrictions.</p><p><strong>Selection criteria: </strong>We included randomised clinical trials (RCTs) that investigated ExCR interventions compared with any type of non-exercise control. We included adults 18 years of age or older with any subtype of AF or those who had received treatment for AF.</p><p><strong>Data collection and analysis: </strong>Five review authors independently screened and extracted data in duplicate. We assessed risk of bias using Cochrane's RoB 1 tool as outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We assessed clinical and statistical heterogeneity by visual inspection of the forest plots and by using standard Chi² and I² statistics. We performed meta-analyses using random-effects models for continuous and dichotomised outcomes. We calculated standardised mean differences where different scales were used for the same outcome. We used the GRADE approach to assess the certainty of the evidence.</p><p><strong>Main results: </strong>We included 20 RCTs involving a total of 2039 participants with AF. All trials were conducted between 2006 and 2024, with a follow-up period ranging from eight weeks to five years. We assessed the certainty of evidence as moderate to very low. Five trials assessed comprehensive ExCR programmes, which included educational or psychological interventions, or both; the remaining 15 trials compared exercise-only cardiac rehabilitation with controls. The overall risk of bias in the included studies was mixed. Details on random sequence generation, allocation concealment, and use of intention-to-treat analysis were typically poorly reported. Evidence from nine trials (n = 1173) suggested little to no difference in mortality between ExCR and non-exercise controls (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.76 to 1.49; I² = 0%; 101 deaths; low-certainty evidence). Based on evidence from 10 trials (n = 825), ExCR may have little","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"9 ","pages":"CD011197"},"PeriodicalIF":8.8,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11406592/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Balendra P Singh, Nishi Singh, Srinivasan Jayaraman, Richard Kirubakaran, Suja Joseph, M S Muthu, Hemant Jivnani, Fang Hua
{"title":"Occlusal interventions for managing temporomandibular disorders.","authors":"Balendra P Singh, Nishi Singh, Srinivasan Jayaraman, Richard Kirubakaran, Suja Joseph, M S Muthu, Hemant Jivnani, Fang Hua","doi":"10.1002/14651858.CD012850.pub2","DOIUrl":"10.1002/14651858.CD012850.pub2","url":null,"abstract":"<p><strong>Background: </strong>Temporomandibular disorders (TMD) are conditions related to the musculoskeletal structure of the temporomandibular joint, which may lead to muscle or joint pain and other health issues. TMD may present in muscles only (myogenous), joints only (arthrogenous), or both (mixed), and may affect one side or both sides of the face. Myogenous TMD may present with or without limited mouth opening. Arthrogenous TMD may present as disc displacement with or without reduction ('reduction' meaning the articular disc resumes its normal position when the jaw is moving). Occlusal interventions change the occlusal relationship of maxillary and mandibular teeth to improve the alignment of the tooth contact, with the aim of relieving pain, and improving psychosocial functioning and quality of life. Occlusal interventions include splints and adjustments. Occlusal splints are specially designed mouth guards; they are generally classified as stabilisation, reflex or repositioning splints. Occlusal adjustment is the grinding down of teeth to improve occlusion.</p><p><strong>Objectives: </strong>To assess the effects of occlusal interventions in people diagnosed with temporomandibular disorders (TMD), compared to other interventions or no treatment, on joint pain, muscle pain at rest and when chewing, quality of life, discomfort, and recurrence.</p><p><strong>Search methods: </strong>Cochrane Oral Health's Information Specialist searched following sources up to 9 August 2022: Cochrane Oral Health's Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via Ovid, Embase via Ovid, and two trials registers.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) of occlusal interventions (splints or adjustment) for managing TMD compared with no treatment, placebo, occlusal splint with a different mechanism of action, or other active treatments.</p><p><strong>Data collection and analysis: </strong>We adopted standard Cochrane methods to select studies, extract and analyse data, assess the risk of bias in the studies, and judge the certainty of the evidence. We reported outcomes as short term (three months or less) or long term (more than three months).</p><p><strong>Main results: </strong>We included 57 studies (2846 participants) that compared occlusal splints with no treatment, placebo, or another treatment. Most of the studies evaluated full hard stabilisation splint (FHSS) as the occlusal splint. We judged only one study to be at low risk of bias. Our key outcomes of interest were self-reported joint pain when chewing, muscle pain at rest and when chewing, discomfort, severity and frequency of joint noise, and recurrence rate. The duration of the studies ranged from 5 weeks to 84 months. The key results presented below were measured between 4.4 weeks and 4 months. It is important to note that we have very low certainty in the evidence for all comparisons and outcomes assessed. ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"9 ","pages":"CD012850"},"PeriodicalIF":8.8,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11403706/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sivan Schipper, Kabir Nigam, Yasmin Schmid, Vanessa Piechotta, Michael Ljuslin, Yvan Beaussant, Guido Schwarzer, Christopher Boehlke
{"title":"Psychedelic-assisted therapy for treating anxiety, depression, and existential distress in people with life-threatening diseases.","authors":"Sivan Schipper, Kabir Nigam, Yasmin Schmid, Vanessa Piechotta, Michael Ljuslin, Yvan Beaussant, Guido Schwarzer, Christopher Boehlke","doi":"10.1002/14651858.CD015383.pub2","DOIUrl":"10.1002/14651858.CD015383.pub2","url":null,"abstract":"<p><strong>Background: </strong>Psychedelic-assisted therapy refers to a group of therapeutic practices involving psychedelics taken under therapeutic supervision from physicians, psychologists, and others. It has been hypothesised that psychedelic-assisted therapy may reduce symptoms of anxiety, depression, and existential distress in patients facing life-threatening diseases (e.g. cancer). However, these substances are illegal in most countries and have been associated with potential risks.</p><p><strong>Objectives: </strong>To assess the benefits and harms of psychedelic-assisted therapy compared to placebo or active comparators (e.g. antidepressants) for treatment of anxiety, depression, and existential distress in people with life-threatening diseases.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, and two trial registers on 30 March 2024. In addition, we undertook reference checking, citation searching, and contact with study authors to identify additional studies. We used no language or date restrictions.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs), with no restrictions regarding comorbidity, sex, or ethnicity. Interventions comprised a substance-induced psychedelic experience preceded by preparatory therapeutic sessions and followed by integrative therapeutic sessions.</p><p><strong>Data collection and analysis: </strong>We used the standard methodological procedures expected by Cochrane.</p><p><strong>Main results: </strong>We included six studies in the review, which evaluated two different interventions: psychedelic-assisted therapy with classical psychedelics (psilocybin ('magic mushrooms') and lysergic acid diethylamide (LSD)), and psychedelic-assisted therapy with 3,4-methylenedioxymethamphetamine (MDMA or 'Ecstasy'). The studies randomised 149 participants with life-threatening diseases and analysed data for 140 of them. The age range of participants was 36 to 64 years. The studies lasted between 6 and 12 months, and were conducted in outpatient settings in the USA and in Switzerland. Drug companies were not involved in study funding, but funding was provided by organisations that promote psychedelic-assisted therapy. Primary outcomes (at 1 to 12 weeks) Anxiety Psychedelic-assisted therapy using classical psychedelics (psilocybin, LSD) may result in a reduction in anxiety when compared to active placebo (or low-dose psychedelic): State Trait Anxiety Inventory (STAI-Trait, scale 20 to 80) mean difference (MD) -8.41, 95% CI -12.92 to -3.89; STAI-State (scale 20 to 80) MD -9.04, 95% CI -13.87 to -4.21; 5 studies, 122 participants; low-certainty evidence. The effect of psychedelic-assisted therapy using MDMA on anxiety, compared to placebo, is very uncertain: STAI-T MD -14.70, 95% CI -29.45 to 0.05; STAI-S MD -16.10, 95% CI -33.03 to 0.83; 1 study, 18 participants; very low certainty evidence. Depression Psychedelic-assisted therapy using classical psychedelic","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"9 ","pages":"CD015383"},"PeriodicalIF":8.8,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11390284/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281481","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Automated peritoneal dialysis versus continuous ambulatory peritoneal dialysis for people with kidney failure.","authors":"Esmee Driehuis, Marga Eshuis, Alferso Abrahams, Karlien François, Robin Wm Vernooij","doi":"10.1002/14651858.CD006515.pub2","DOIUrl":"10.1002/14651858.CD006515.pub2","url":null,"abstract":"<p><strong>Background: </strong>Peritoneal dialysis (PD) is a home-based kidney replacement therapy (KRT) performed in people with kidney failure. PD can be performed by manual filling and draining of the abdominal cavity, i.e. continuous ambulatory PD (CAPD), or using a device connected to the PD catheter that is programmed to perform PD exchanges, i.e. automated PD (APD). APD is considered to have several advantages over CAPD, such as a lower incidence of peritonitis, fewer mechanical complications, and greater psychosocial acceptability. Acknowledging the increasing uptake of APD in incident and prevalent patients undergoing PD, it is important to re-evaluate the evidence on the comparative clinical and patient-reported outcomes of APD compared to CAPD. This is an update of a Cochrane review published in 2007.</p><p><strong>Objectives: </strong>To compare clinical and patient-reported outcomes of APD to CAPD in people with kidney failure.</p><p><strong>Search methods: </strong>In this update, we searched the Cochrane Kidney and Transplant Register of Studies until 29 August 2024. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal, and ClinicalTrials.gov.</p><p><strong>Selection criteria: </strong>Randomised controlled trials (RCTs) comparing APD with CAPD in adults (≥ 18 years) with kidney failure.</p><p><strong>Data collection and analysis: </strong>Two authors independently screened the search results and extracted data. Data synthesis was performed using random-effects meta-analyses, expressing effect estimates as risk ratios (RR) with 95% confidence intervals (CI) for dichotomous data and mean differences (MD) with 95% CIs for continuous data. Certainty in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.</p><p><strong>Main results: </strong>Two RCTs (131 randomised people) comparing APD with CAPD were included in this update. One RCT had a follow-up of six months, and one RCT had a follow-up of 24 months. The risk of bias in the included studies was mostly low, except for the high risk of performance bias for subjective outcomes. The evidence is very uncertain about the effect of APD compared to CAPD on death, hospitalisations, PD-related peritonitis, change of dialysis modality, residual kidney function, health-related quality of life (HRQoL), overhydration, blood pressure, exit-site infections, tunnel infections, mechanical complications, PD catheter removal, or dialysis adequacy measures. These results were largely based on low to very low certainty evidence; hence, caution is warranted when drawing conclusions.</p><p><strong>Authors' conclusions: </strong>Insufficient evidence exists to decide between APD and CAPD in kidney failure patients with regard to clinical and patient-reported outcomes. Therefore, current evidence is insuffi","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"9 ","pages":"CD006515"},"PeriodicalIF":8.8,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11388675/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281469","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ben Ridley, Silvia Minozzi, Marien Gonzalez-Lorenzo, Cinzia Del Giovane, Thomas Piggott, Graziella Filippini, Guy Peryer, Matteo Foschi, Irene Tramacere, Elisa Baldin, Francesco Nonino
{"title":"Immunomodulators and immunosuppressants for progressive multiple sclerosis: a network meta-analysis.","authors":"Ben Ridley, Silvia Minozzi, Marien Gonzalez-Lorenzo, Cinzia Del Giovane, Thomas Piggott, Graziella Filippini, Guy Peryer, Matteo Foschi, Irene Tramacere, Elisa Baldin, Francesco Nonino","doi":"10.1002/14651858.CD015443.pub2","DOIUrl":"10.1002/14651858.CD015443.pub2","url":null,"abstract":"<p><strong>Background: </strong>In recent years a broader range of immunomodulatory and immunosuppressive treatment options have emerged for people with progressive forms of multiple sclerosis (PMS). While consensus supports these options as reducing relapses, their relative benefit and safety profiles remain unclear due to a lack of direct comparison trials.</p><p><strong>Objectives: </strong>To compare through network meta-analysis the efficacy and safety of alemtuzumab, azathioprine, cladribine, cyclophosphamide, daclizumab, dimethylfumarate, diroximel fumarate, fingolimod, fludarabine, glatiramer acetate, immunoglobulins, interferon beta 1-a and beta 1-b, interferon beta-1b (Betaferon), interferon beta-1a (Avonex, Rebif), laquinimod, leflunomide, methotrexate, minocycline, mitoxantrone, mycophenolate mofetil, natalizumab, ocrelizumab, ofatumumab, ozanimod, pegylated interferon beta-1a, ponesimod, rituximab, siponimod, corticosteroids, and teriflunomide for PMS.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, and Embase up to August 2022, as well as ClinicalTrials.gov and the WHO ICTRP.</p><p><strong>Selection criteria: </strong>Randomised controlled trials (RCTs) that studied one or more treatments as monotherapy, compared to placebo or to another active agent, for use in adults with PMS.</p><p><strong>Data collection and analysis: </strong>Two review authors independently selected studies and extracted data. We performed data synthesis by pair-wise and network meta-analysis. We assessed the certainty of the body of evidence according to GRADE.</p><p><strong>Main results: </strong>We included 23 studies involving a total of 10,167 participants. The most frequent (39% of studies) reason for a rating of high risk of bias was sponsor role in study authorship and data management and analysis. Other concerns were performance, attrition, and selective reporting bias, with 8.7% of studies at high risk of bias for all three of these domains. The common comparator for network analysis was placebo. Relapses over 12 months: assessed in one study (318 participants). None of the treatments assessed showed moderate or high certainty evidence compared to placebo. Relapses over 24 months: assessed in six studies (1622 participants). The number of people with clinical relapses is probably trivially reduced with rituximab (risk ratio (RR) 0.60, 95% confidence interval (CI) 0.19 to 1.95; moderate certainty evidence). None of the remaining treatments assessed showed moderate or high certainty evidence compared to placebo. Relapses over 36 months: assessed in four studies (2095 participants). The number of people with clinical relapses is probably trivially reduced with interferon beta-1b (RR 0.82, 95% CI 0.73 to 0.93; moderate certainty evidence). None of the remaining treatments assessed showed moderate or high certainty evidence compared to placebo. Disability worsening over 24 months: assessed in 11 studies (5284 participants). None of th","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"9 ","pages":"CD015443"},"PeriodicalIF":8.8,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11384553/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Maria Quigley, Nicholas D Embleton, Nicholas Meader, William McGuire
{"title":"Donor human milk for preventing necrotising enterocolitis in very preterm or very low-birthweight infants.","authors":"Maria Quigley, Nicholas D Embleton, Nicholas Meader, William McGuire","doi":"10.1002/14651858.CD002971.pub6","DOIUrl":"10.1002/14651858.CD002971.pub6","url":null,"abstract":"<p><strong>Background: </strong>When sufficient maternal milk is not available, donor human milk or formula are the alternative forms of enteral nutrition for very preterm or very low-birthweight (VLBW) infants. Donor human milk may retain the non-nutritive benefits of maternal milk and has been proposed as a strategy to reduce the risk of necrotising enterocolitis (NEC) and associated mortality and morbidity in very preterm or VLBW infants.</p><p><strong>Objectives: </strong>To assess the effectiveness of donor human milk compared with formula for preventing NEC and associated morbidity and mortality in very preterm or VLBW infants when sufficient maternal milk is not available.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Maternity and Infant Care (MIC) database, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL), from the earliest records to February 2024. We searched clinical trials registries and examined the reference lists of included studies.</p><p><strong>Selection criteria: </strong>Randomised or quasi-randomised controlled trials comparing feeding with donor human milk versus formula in very preterm (< 32 weeks' gestation) or VLBW (< 1500 g) infants.</p><p><strong>Data collection and analysis: </strong>Two review authors evaluated the risk of bias in the trials, extracted data, and synthesised effect estimates using risk ratio, risk difference, and mean difference, with associated 95% confidence intervals. The primary outcomes were NEC, late-onset invasive infection, and all-cause mortality before hospital discharge. The secondary outcomes were growth parameters and neurodevelopment. We used the GRADE approach to assess the certainty of the evidence for our primary outcomes.</p><p><strong>Main results: </strong>Twelve trials with a total of 2296 infants fulfilled the inclusion criteria. Most trials were small (average sample size was 191 infants). All trials were performed in neonatal units in Europe or North America. Five trials were conducted more than 40 years ago; the remaining seven trials were conducted in the year 2000 or later. Some trials had methodological weaknesses, including concerns regarding masking of investigators and selective reporting. Meta-analysis showed that donor human milk reduces the risk of NEC (risk ratio (RR) 0.53, 95% confidence interval (CI) 0.37 to 0.76; I² = 4%; risk difference (RD) -0.03, 95% CI -0.05 to -0.01; 11 trials, 2261 infants; high certainty evidence). Donor human milk probably has little or no effect on late-onset invasive infection (RR 1.12, 0.95 to 1.31; I² = 27%; RD 0.03, 95% CI -0.01 to -0.07; 7 trials, 1611 infants; moderate certainty evidence) or all-cause mortality (RR 1.00, 95% CI 0.76 to 1.31; I² = 0%; RD -0.00, 95% CI -0.02 to 0.02; 9 trials, 2116 infants; moderate certainty evidence).</p><p><strong>Authors' conclusions: </strong>The evidence shows that donor human milk re","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"9 ","pages":"CD002971"},"PeriodicalIF":8.8,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11378496/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139525","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marcus Glenton Prescott, Katarzyna Wróblewska-Seniuk, Mikaela Lenells, Michelle Fiander, Roger Soll, Matteo Bruschettini
{"title":"Vestibular stimulation for promoting development and preventing morbidity in preterm infants.","authors":"Marcus Glenton Prescott, Katarzyna Wróblewska-Seniuk, Mikaela Lenells, Michelle Fiander, Roger Soll, Matteo Bruschettini","doi":"10.1002/14651858.CD016072","DOIUrl":"10.1002/14651858.CD016072","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of vestibular stimulation compared to standard care or non-vestibular stimulation for physical and neurological development in preterm infants. To assess whether the effects of vestibular stimulation differ according to gestational age at birth; the type, frequency, and duration of the intervention; and settings, such as the country where the study is conducted.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"9 ","pages":"CD016072"},"PeriodicalIF":8.8,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11392060/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142132060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}