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Multiple Sclerosis and Related Disorders Apr 2019Ocrelizumab was approved for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) by the US Food and Drug Administration...
BACKGROUND
Ocrelizumab was approved for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) by the US Food and Drug Administration in March 2017 and by the European Medicines Agency in January 2018. These approvals were based on two pivotal randomized controlled trials (RCTs), OPERA I and OPERA II, comparing ocrelizumab 600 mg with an active comparator, interferon β-1a 44 μg (Rebif), and the first trial with positive results in patients with PPMS, which compared ocrelizumab with placebo. However, direct evidence of the efficacy and safety of ocrelizumab in RMS compared with other disease-modifying therapies (DMTs) approved for RMS is not available from RCTs. In the absence of such RCTs, network meta-analyses (NMAs) were conducted to compare indirectly the relative efficacy and safety of ocrelizumab with all other approved DMTs for the treatment of RMS.
METHODS
Systematic literature searches were conducted in MEDLINE, Embase, the Cochrane Library, trial registers, relevant conference websites and health technology assessment agency websites. Eligible RCTs evaluated approved treatments for multiple sclerosis (MS) in which more than 75% of patients had a relapsing form of MS. NMAs were conducted for four efficacy and three safety outcomes, and treatment hierarchies were generated for each outcome using surface under the cumulative ranking curve (SUCRA) values.
RESULTS
Results suggest that ocrelizumab has superior efficacy to 10 of the 17 treatments in the 12-week confirmed disability progression network and 12 of the 17 treatments in the annualized relapse rate network (both including placebo). The efficacy of ocrelizumab was comparable with the other treatments in both networks. In the serious adverse events and discontinuation due to adverse events networks, ocrelizumab demonstrated a safety profile comparable with all other treatments (including placebo). SUCRA values consistently ranked ocrelizumab among the most effective or tolerable treatments across all outcomes.
CONCLUSIONS
Results suggest that ocrelizumab has an efficacy superior to or comparable with all other currently approved DMTs across all endpoints analyzed, and a similar safety profile, indicating it offers a valuable package for the treatment of patients with RMS.
Topics: Antibodies, Monoclonal, Humanized; Humans; Immunologic Factors; Multiple Sclerosis, Relapsing-Remitting; Network Meta-Analysis
PubMed: 30677733
DOI: 10.1016/j.msard.2018.12.040 -
Frontiers in Surgery 2022The purpose of this study is to compare fusion rate, clinical outcomes, complications among transforaminal lumbar interbody fusion (TLIF), and other techniques for...
OBJECTIVE
The purpose of this study is to compare fusion rate, clinical outcomes, complications among transforaminal lumbar interbody fusion (TLIF), and other techniques for lumbar spine diseases.
DESIGN
This is a systematic review and meta-analysis.
DATA SOURCES
PubMed, EMBASE, Scopus, Web of Science, and CENTRAL databases were searched from January 2013 through December 2019.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES
Randomized controlled trials (RCTs) that compare lumbar interbody fusion with posterolateral fusion (PLF) and/or other lumbar interbody fusion were included for the review.
DATA EXTRACTION AND SYNTHESIS
Two independent reviewers extracted relevant data and assessed the risk of bias. Meta-analysis was performed using a random-effects model. Pooled risk ratio (RR) or mean difference (MD) with a 95% confidence interval of fusion rate, clinical outcomes, and complications in TLIF and other techniques for lumbar spinal diseases.
RESULTS
Of 3,682 potential studies, 15 RCTs (915 patients) were included in the meta-analysis. Compared to other surgical techniques, TLIF had slightly lower fusion rate [RR = 0.84 (95% CI = 0.72-0.97), = 0.02, = 0.0%] at 1-year follow-up whereas there was no difference on fusion rate at 2-year follow-up [RR = 1.06 (95% CI = 0.96-1.18), = 0.27, = 69.0%]. The estimated RR of total adverse events [RR = 0.90 (95% CI = 0.59-1.38), = 0.63, = 0.0%] was similar to no fusion, PLF, PLIF, and XLIF groups, and revision rate [RR = 0.78 (95% CI = 0.34-1.79), = 0.56, = 39.0%] was similar to PLF and XLIF groups. TLIF had approximately half an hour more operative time than other techniques (no fusion, ALIF, PLF, PLIF, XLIF) [MD = 31.88 (95% CI = 5.33-58.44), = 0.02, = 92.0%]. There was no significant difference between TLIF and other techniques in terms of blood loss (no fusion, PLIF, PLF) and clinical outcomes (PLF).
CONCLUSIONS
Besides fusion rate at 1-year follow-up and operative time, TLIF has a similar fusion rate, clinical outcomes, parameters concerning operation and complications to no fusion, PLF, and other interbody fusion (PLIF, ALIF, XLIF).
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/, identifier: CRD42020186858.
PubMed: 35360425
DOI: 10.3389/fsurg.2022.829469 -
Indian Journal of Dermatology 2023Atopic dermatitis (AD), also known as atopic eczema, is a chronic inflammatory skin condition that recurs frequently and has diverse clinical features. The main... (Review)
Review
The Efficacy of Moisturisers Containing Ceramide Compared with Other Moisturisers in the Management of Atopic Dermatitis: A Systematic Literature Review and Meta-Analysis.
Atopic dermatitis (AD), also known as atopic eczema, is a chronic inflammatory skin condition that recurs frequently and has diverse clinical features. The main mechanism of AD is the dysfunction of the skin-epidermal barrier. One of the causes of stratum corneum (SC) structural integrity disruption is the decreased production of ceramide, an important lipid component in SC. The latest generation of moisturisers contain ceramide to help replace this lipid deficit. This study aimed to compare the efficacy of moisturisers containing ceramide with other moisturisers for AD management. Searches were conducted systematically on PubMed, the Cochrane Library, ScienceDirect, Clinicaltrials.gov, and Google Scholar for studies published from January 2012 to July 2022. Interventions and outcomes were compared in this study. Statistical analysis was performed with ReviewManager 5.4 software. Five articles met the eligibility and inclusion criteria. Three articles were meta-analyses on trans-epidermal water loss (TEWL) outcomes and two articles were meta-analyses on SCORing Atopic Dermatitis (SCORAD) outcomes. A meta-analysis of TEWL results found that TEWL values were not significantly different in subjects treated with ceramide-containing moisturisers (mean difference: -3.56, 95% CI [-8.63, 1.52], = 0.17) with high heterogeneity (I = 92%) compared to other treatments. The change in SCORAD was significantly higher in moisturisers containing ceramide (mean difference: -0.98, 95% CI [-1.63, -0.33], = 0.003) with low heterogeneity (I = 0%). Moisturisers containing ceramide improve SCORAD and TEWL; however only the changes in SCORAD in moisturisers containing ceramide is superior to other moisturisers.
PubMed: 37151263
DOI: 10.4103/ijd.ijd_991_22 -
Journal of Thyroid Research 2016Diseases associated with the thyroid gland are one of the most frequently seen endocrine disorders across the globe. Total thyroidectomy is currently the preferred... (Review)
Review
Diseases associated with the thyroid gland are one of the most frequently seen endocrine disorders across the globe. Total thyroidectomy is currently the preferred treatment for many thyroid diseases. Controversies exist among surgeons regarding safety of total thyroidectomy due to the risk associated with it like postoperative hypoparathyroidism or recurrent laryngeal nerve damage. Since, in the recent years, the incidence of thyroidectomy is in increasing trend in south Indian population, this review aims to study the available data regarding the appropriateness and safety of total thyroidectomy and compares it with subtotal thyroidectomy and other thyroid surgeries. This is a retrospective comprehensive review of various articles and publications regarding total and partial thyroidectomy performed across the world. Many retrospective studies and few prospective studies suggest that the incidence of transient hypocalcemia is higher after total thyroidectomy than after subtotal thyroidectomy, but the incidence of other complications including recurrent laryngeal nerve palsy and postoperative hematoma is not significantly different between the two procedures. Hence in our review we found that total thyroidectomy is safe and cost effective with low complication rates and provides little significant advantage of being safer procedure compared to subtotal thyroidectomy.
PubMed: 27006857
DOI: 10.1155/2016/7594615 -
Medicine Jul 2016This study aimed to compare 6 months to 5 years stent thrombosis (ST) and adverse cardiovascular outcomes associated with sirolimus-eluting stents (SES) and other... (Meta-Analysis)
Meta-Analysis Review
Stent thrombosis and adverse cardiovascular outcomes observed between six months and five years with sirolimus-eluting stents and other drug-eluting stents in patients with Type 2 diabetes mellitus complicated by coronary artery disease: A systematic review and meta-analysis.
This study aimed to compare 6 months to 5 years stent thrombosis (ST) and adverse cardiovascular outcomes associated with sirolimus-eluting stents (SES) and other drug-eluting stents (DES) in patients with type 2 diabetes mellitus (T2DM).Electronic databases were searched for studies comparing SES with other DES in patients with T2DM. Total ST, definite ST, probable ST, and other adverse cardiovascular outcomes reported between 6 months and 5 years were considered as the clinical end points in this study. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated for categorical variables and the pooled analyses were performed with RevMan 5.3 software.Twenty-nine studies involving a total number of 25,729 patients with diabetes were included in this meta-analysis. SES were not associated with significantly higher total, definite, and probable STs with OR: 0.95, 95% CI: 0.77-1.17, P = 0.62; OR: 0.94, 95% CI: 0.65-1.37, P = 0.76; and OR: 1.05, 95% CI: 0.77-1.45, P = 0.74, respectively. SES were also noninferior to the other non-sirolimus eluting drug eluting stents (non-SE DES) in terms of all-cause mortality, cardiac death, myocardial infarction, and stroke with OR: 0.92, 95% CI: 0.82-1.03, P = 0.16; OR: 1.09, 95% CI: 0.88-1.35, P = 0.44; OR: 0.92, 95% CI: 0.80-1.06, P = 0.26; and OR: 0.79, 95% CI: 0.49-1.28, P = 0.43, respectively. Target vessel revascularization, target lesion revascularization, and major adverse cardiac events were also similarly reported between SES and non-SE DES with OR: 1.04, 95% CI: 0.83-1.31, P = 0.72; OR: 1.25, 95% CI: 0.95-1.64, P = 0.11; and OR: 1.06, 95% CI: 0.90-1.25, P = 0.49, respectively.During this particular follow-up period, SES were not associated with any increase in ST among these patients with T2DM. Mortality and other adverse cardiovascular outcomes were also not significantly different between these 2 groups. Hence, SES should be considered neither superior nor inferior to other DES. They are expected to be equally effective and safe to use in patients with T2DM.
Topics: Cardiovascular Diseases; Coronary Artery Disease; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Drug-Eluting Stents; Humans; Sirolimus; Thrombosis; Time Factors; Treatment Outcome
PubMed: 27399125
DOI: 10.1097/MD.0000000000004130 -
PloS One 2016In the era of somatostatin analogues and targeted therapies, the role of chemotherapy in NET remains largely undefined. This systematic review aimed to assess the effect... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND/OBJECTIVES
In the era of somatostatin analogues and targeted therapies, the role of chemotherapy in NET remains largely undefined. This systematic review aimed to assess the effect of chemotherapy on response rates (RR), progression-free survival (PFS), overall survival (OS) and toxicity compared to other chemotherapies/systemic therapies or best supportive care in patients with advanced or metastatic NET.
METHODS
Randomised controlled trials (RCTs) from 1946 to 2015 were identified from MEDLINE, EMBASE, other databases and conference proceedings. Review of abstracts, quality assessment and data abstraction were performed independently by two investigators. Meta-analyses were conducted using Mantel-Haenszel analysis with random-effects modelling.
RESULTS
Six RCTs comparing standard streptozotocin plus 5-fluorouacil (STZ/5FU) chemotherapy to other chemotherapy regimens, and 2 comparing this to interferon (IFN) were included. Only 1 study was considered at low risk of bias. STZ/5-FU was no different to other chemotherapies in response rate [RR 0.96; 95% confidence interval (CI) 0.72-1.27], PFS (RR 0.95; CI 0.81-1.13), or OS (RR 1.03; CI 0.77-1.39). IFN may produce higher response than STZ/5FU (RR 0.20; CI 0.04-1.13), but event rates were small and survival was no different. Interferon was associated with higher overall haematological (RR 0.47; CI 0.27-0.82) and lower overall renal toxicity (RR 3.61; CI 1.24-10.51).
CONCLUSION
Strong evidence is lacking in the area of chemotherapy in neuroendocrine tumors. There is currently no evidence that one chemotherapeutic regimen is significantly better than the other, nor is interferon better than chemotherapy. There is an urgent need to design RCTs comparing modern chemotherapy to other agents in NET.
Topics: Antineoplastic Combined Chemotherapy Protocols; Disease-Free Survival; Fluorouracil; Humans; Interferons; Neoplasm Metastasis; Neuroendocrine Tumors; Randomized Controlled Trials as Topic; Somatostatin; Streptozocin; Treatment Outcome
PubMed: 27362760
DOI: 10.1371/journal.pone.0158140 -
Environmental Health Perspectives Sep 2013Results from animal toxicology studies are critical to evaluating the potential harm from exposure to environmental chemicals or the safety of drugs prior to human... (Review)
Review
BACKGROUND
Results from animal toxicology studies are critical to evaluating the potential harm from exposure to environmental chemicals or the safety of drugs prior to human testing. However, there is significant debate about how to evaluate the methodology and potential biases of the animal studies. There is no agreed-upon approach, and a systematic evaluation of current best practices is lacking.
OBJECTIVE
We performed a systematic review to identify and evaluate instruments for assessing the risk of bias and/or other methodological criteria of animal studies.
METHOD
We searched Medline (January 1966-November 2011) to identify all relevant articles. We extracted data on risk of bias criteria (e.g., randomization, blinding, allocation concealment) and other study design features included in each assessment instrument.
DISCUSSION
Thirty distinct instruments were identified, with the total number of assessed risk of bias, methodological, and/or reporting criteria ranging from 2 to 25. The most common criteria assessed were randomization (25/30, 83%), investigator blinding (23/30, 77%), and sample size calculation (18/30, 60%). In general, authors failed to empirically justify why these or other criteria were included. Nearly all (28/30, 93%) of the instruments have not been rigorously tested for validity or reliability.
CONCLUSION
Our review highlights a number of risk of bias assessment criteria that have been empirically tested for animal research, including randomization, concealment of allocation, blinding, and accounting for all animals. In addition, there is a need for empirically testing additional methodological criteria and assessing the validity and reliability of a standard risk of bias assessment instrument.
Topics: Animals; Bias; Double-Blind Method; MEDLINE; Random Allocation; Research Design; Risk Assessment; Sample Size; Toxicity Tests
PubMed: 23771496
DOI: 10.1289/ehp.1206389 -
The Cochrane Database of Systematic... Jun 2023Neonates might be exposed to numerous painful procedures due to diagnostic reasons, therapeutic interventions, or surgical procedures. Options for pain management... (Review)
Review
BACKGROUND
Neonates might be exposed to numerous painful procedures due to diagnostic reasons, therapeutic interventions, or surgical procedures. Options for pain management include opioids, non-pharmacological interventions, and other drugs. Morphine, fentanyl, and remifentanil are the opioids most often used in neonates. However, negative impact of opioids on the structure and function of the developing brain has been reported.
OBJECTIVES
To evaluate the benefits and harms of opioids in term or preterm neonates exposed to procedural pain, compared to placebo or no drug, non-pharmacological intervention, other analgesics or sedatives, other opioids, or the same opioid administered by a different route.
SEARCH METHODS
We used standard, extensive Cochrane search methods. The latest search date was December 2021.
SELECTION CRITERIA
We included randomized controlled trials conducted in preterm and term infants of a postmenstrual age (PMA) up to 46 weeks and 0 days exposed to procedural pain where opioids were compared to 1) placebo or no drug; 2) non-pharmacological intervention; 3) other analgesics or sedatives; 4) other opioids; or 5) the same opioid administered by a different route.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were pain assessed with validated methods and any harms. We used a fixed-effect model with risk ratio (RR) for dichotomous data and mean difference (MD) for continuous data, and their confidence intervals (CI). We used GRADE to assess the certainty of the evidence for each outcome.
MAIN RESULTS
We included 13 independent studies (enrolling 823 newborn infants): seven studies compared opioids to no treatment or placebo (the main comparison in this review), two studies to oral sweet solution or non-pharmacological intervention, and five studies (of which two were part of the same study) to other analgesics and sedatives. All studies were performed in a hospital setting. Opioids compared to placebo or no drug Compared to placebo, opioids probably reduce pain score assessed with the Premature Infant Pain Profile (PIPP)/PIPP-Revised (PIPP-R) scale during the procedure (MD -2.58, 95% CI -3.12 to -2.03; 199 participants, 3 studies; moderate-certainty evidence); may reduce Neonatal Infant Pain Scale (NIPS) during the procedure (MD -1.97, 95% CI -2.46 to -1.48; 102 participants, 2 studies; low-certainty evidence); and may result in little to no difference in pain score assessed with the Douleur Aiguë du Nouveau-né (DAN) scale one to two hours after the procedure (MD -0.20, 95% CI -2.21 to 1.81; 42 participants, 1 study; low-certainty evidence). The evidence is very uncertain about the effect of opioids on pain score assessed with the PIPP/PIPP-R scale up to 30 minutes after the procedure (MD 0.14, 95% CI -0.17 to 0.45; 123 participants, 2 studies; very low-certainty evidence) or one to two hours after the procedure (MD -0.83, 95% CI -2.42 to 0.75; 54 participants, 2 studies; very low-certainty evidence). The evidence is very uncertain about the effect of opioids on episodes of bradycardia (RR 3.19, 95% CI 0.14 to 72.69; 172 participants, 3 studies; very low-certainty evidence). Opioids may result in an increase in episodes of apnea compared to placebo (RR 3.15, 95% CI 1.08 to 9.16; 199 participants, 3 studies; low-certainty evidence): with one study reporting a concerning increase in severe apnea (RR 7.44, 95% CI 0.42 to 132.95; 31 participants, 1 study; very low-certainty). The evidence is very uncertain about the effect of opioids on episodes of hypotension (RR not estimable, risk difference 0.00, 95% CI -0.06 to 0.06; 88 participants, 2 studies; very low-certainty evidence). No studies reported parent satisfaction with care provided in the neonatal intensive care unit (NICU). Opioids compared to non-pharmacological intervention The evidence is very uncertain about the effect of opioids on pain score assessed with the Crying Requires oxygen Increased vital signs Expression Sleep (CRIES) scale during the procedure when compared to facilitated tucking (MD -4.62, 95% CI -6.38 to -2.86; 100 participants, 1 study; very low-certainty evidence) or sensorial stimulation (MD 0.32, 95% CI -1.13 to 1.77; 100 participants, 1 study; very low-certainty evidence). The other main outcomes were not reported. Opioids compared to other analgesics or sedatives The evidence is very uncertain about the effect of opioids on pain score assessed with the PIPP/PIPP-R during the procedure (MD -0.29, 95% CI -1.58 to 1.01; 124 participants, 2 studies; very low-certainty evidence); up to 30 minutes after the procedure (MD -1.10, 95% CI -2.82 to 0.62; 12 participants, 1 study; very low-certainty evidence); and one to two hours after the procedure (MD -0.17, 95% CI -2.22 to 1.88; 12 participants, 1 study; very low-certainty evidence). No studies reported any harms. The evidence is very uncertain about the effect of opioids on episodes of apnea during (RR 3.27, 95% CI 0.85 to 12.58; 124 participants, 2 studies; very low-certainty evidence) and after the procedure (RR 2.71, 95% CI 0.11 to 64.96; 124 participants, 2 studies; very low-certainty evidence) and on hypotension (RR 1.34, 95% CI 0.32 to 5.59; 204 participants, 3 studies; very low-certainty evidence). The other main outcomes were not reported. We identified no studies comparing different opioids (e.g. morphine versus fentanyl) or different routes for administration of the same opioid (e.g. morphine enterally versus morphine intravenously).
AUTHORS' CONCLUSIONS
Compared to placebo, opioids probably reduce pain score assessed with PIPP/PIPP-R scale during the procedure; may reduce NIPS during the procedure; and may result in little to no difference in DAN one to two hours after the procedure. The evidence is very uncertain about the effect of opioids on pain assessed with other pain scores or at different time points. The evidence is very uncertain about the effect of opioids on episodes of bradycardia, hypotension or severe apnea. Opioids may result in an increase in episodes of apnea. No studies reported parent satisfaction with care provided in the NICU. The evidence is very uncertain about the effect of opioids on any outcome when compared to non-pharmacological interventions or to other analgesics. We identified no studies comparing opioids to other opioids or comparing different routes of administration of the same opioid.
Topics: Humans; Infant, Newborn; Analgesics; Analgesics, Opioid; Apnea; Bradycardia; Fentanyl; Hypotension; Morphine; Pain; Pain, Procedural
PubMed: 37350685
DOI: 10.1002/14651858.CD015056.pub3 -
Sports Medicine (Auckland, N.Z.) May 2024Physical activity is known to improve psychological and cognitive outcomes. Learning dance sequences may challenge cognition, partnered or group dance may benefit social... (Meta-Analysis)
Meta-Analysis
The Effectiveness of Dance Interventions on Psychological and Cognitive Health Outcomes Compared with Other Forms of Physical Activity: A Systematic Review with Meta-analysis.
BACKGROUND
Physical activity is known to improve psychological and cognitive outcomes. Learning dance sequences may challenge cognition, partnered or group dance may benefit social interactions, and the artistic aspect may improve psychological wellbeing. Dance is an equally effective form of physical activity compared with other structured physical activities to improve physical health, but it is unclear how effective dance could be for psychological and cognitive outcome measures.
OBJECTIVE
To systematically review the literature on the effectiveness of structured dance interventions, compared with structured exercise programmes, on psychological and cognitive outcomes across the lifespan.
METHODS
Eight databases were searched from earliest records to July 2022. Studies investigating a dance intervention lasting ≥ 4 weeks, including psychological and/or cognitive health outcomes, and having a structured exercise comparison group were included. Screening and data extraction were performed by two independent reviewers at all stages. All reviewer disagreements were resolved by the primary author. Where appropriate, meta-analysis was performed, or an effect size estimate generated.
RESULTS
Of 21,737 records identified, 27 studies met the inclusion criteria. Total sample size of included studies was 1392 (944 females, 418 males, 30 unreported). Dance was equally as effective as other physical activity interventions in improving quality of life for people with Parkinson's disease [mean difference 3.09; 95% confidence interval (CI) - 2.13 to 8.30; p = 0.25], reducing anxiety (standardised mean difference 2.26; 95% CI - 2.37 to 6.90; p = 0.34), and improving depressive symptoms (standardised mean difference 0.78; 95% CI - 0.92 to 2.48; p = 0.37). Preliminary evidence found dance to be superior to other physical activity interventions to improve motivation, aspects of memory, and social cognition and to reduce distress. Preliminary evidence found dance to be inferior to other physical activity interventions to improve stress, self-efficacy and language fluency.
CONCLUSION
Undertaking structured dance of any genre is generally equally and occasionally more effective than other types of structured exercise for improving a range of psychological and cognitive outcomes.
TRIAL REGISTRATION
PROSPERO: CRD42018099637.
Topics: Humans; Dancing; Cognition; Exercise; Quality of Life; Parkinson Disease; Dance Therapy; Mental Health; Depression
PubMed: 38270792
DOI: 10.1007/s40279-023-01990-2