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Clinics (Sao Paulo, Brazil) 2023Lipolytic substance injections to reduce localized fat have been extensively used because it is a low-invasive method. This review aimed to evaluate the efficacy and... (Meta-Analysis)
Meta-Analysis Review
Efficacy, safety, and potential industry bias in using deoxycholic acid for submental fat reduction ‒ A systematic review and meta-analysis of randomized clinical trials.
Lipolytic substance injections to reduce localized fat have been extensively used because it is a low-invasive method. This review aimed to evaluate the efficacy and safety of deoxycholic acid in submental fat reduction compared to a placebo and investigate the potential industry sponsorship bias in the results of randomized clinical trials on this topic. Ten electronic databases were extensively searched for randomized clinical trials without restriction on language and year of publication. Two reviewers extracted the data and assessed the individual risk of bias in the studies with the RoB 2.0 tool. The industry sponsorship bias was evaluated according to citations in the articles regarding industry funding/sponsorship throughout the texts. Fixed and random effects meta-analyses were performed, and the results were reported in Risk Ratio (RR) at a 95% Confidence Interval (95% CI). The initial search provided 5756 results, of which only five were included. Only two studies had a low risk of bias. All studies showed a potential industry bias. The meta-analysis showed that patients treated with deoxycholic acid had significant positive results for all efficacy outcomes and a higher risk of fibrosis, pain, erythema, numbness, swelling, edema, pruritus, nodules, headache, and paresthesia. The low to moderate certainty of evidence found allows concluding that deoxycholic acid is effective in submental fat reduction, causing well-tolerated adverse effects. However, all eligible studies showed a potential industry bias.
Topics: Humans; Randomized Controlled Trials as Topic; Pain; Deoxycholic Acid; Bias
PubMed: 37806137
DOI: 10.1016/j.clinsp.2023.100220 -
PloS One 2016Recombinant tissue plasminogen activator (rtPA) is the only effective drug approved by US FDA to treat ischemic stroke, and it contains pleiotropic effects besides... (Meta-Analysis)
Meta-Analysis Review
Recombinant Tissue Plasminogen Activator Induces Neurological Side Effects Independent on Thrombolysis in Mechanical Animal Models of Focal Cerebral Infarction: A Systematic Review and Meta-Analysis.
BACKGROUND AND PURPOSE
Recombinant tissue plasminogen activator (rtPA) is the only effective drug approved by US FDA to treat ischemic stroke, and it contains pleiotropic effects besides thrombolysis. We performed a meta-analysis to clarify effect of tissue plasminogen activator (tPA) on cerebral infarction besides its thrombolysis property in mechanical animal stroke.
METHODS
Relevant studies were identified by two reviewers after searching online databases, including Pubmed, Embase, and ScienceDirect, from 1979 to 2016. We identified 6, 65, 17, 12, 16, 12 and 13 comparisons reporting effect of endogenous tPA on infarction volume and effects of rtPA on infarction volume, blood-brain barrier, brain edema, intracerebral hemorrhage, neurological function and mortality rate in all 47 included studies. Standardized mean differences for continuous measures and risk ratio for dichotomous measures were calculated to assess the effects of endogenous tPA and rtPA on cerebral infarction in animals. The quality of included studies was assessed using the Stroke Therapy Academic Industry Roundtable score. Subgroup analysis, meta-regression and sensitivity analysis were performed to explore sources of heterogeneity. Funnel plot, Trim and Fill method and Egger's test were obtained to detect publication bias.
RESULTS
We found that both endogenous tPA and rtPA had not enlarged infarction volume, or deteriorated neurological function. However, rtPA would disrupt blood-brain barrier, aggravate brain edema, induce intracerebral hemorrhage and increase mortality rate.
CONCLUSIONS
This meta-analysis reveals rtPA can lead to neurological side effects besides thrombolysis in mechanical animal stroke, which may account for clinical exacerbation for stroke patients that do not achieve vascular recanalization with rtPA.
Topics: Animals; Animals, Genetically Modified; Blood-Brain Barrier; Brain Edema; Cerebral Infarction; Data Interpretation, Statistical; Disease Models, Animal; Male; Rats; Recombinant Proteins; Sensitivity and Specificity; Stroke; Thrombolytic Therapy; Tissue Plasminogen Activator
PubMed: 27387385
DOI: 10.1371/journal.pone.0158848 -
Indian Journal of Orthopaedics Sep 2022The purpose of this paper was to review the MRI features and treatment for idiopathic chondrolysis of the hip (ICH) in patients aged 18 years or less. (Review)
Review
BACKGROUND
The purpose of this paper was to review the MRI features and treatment for idiopathic chondrolysis of the hip (ICH) in patients aged 18 years or less.
METHODS
We included studies published in English up to August 2021. We accessed major electronic bibliographic databases on ICH that described MRI features, treatment, or both. We used the Joanna Briggs Institute (JBI) Critical appraisal checklist for case reports for Risk of bias assessment.
RESULTS
We pooled 136 hips (125 participants) from 35 studies with 11.6 ± 3.4 years mean age. We had 46, 8, and 106 hips to assess ICH's MRI, pharmacological, and operative interventions. Geometric marrow edema (GME) ( < 0.01), diffuse marrow edema (DME) ( < 0.05), diffuse cartilage loss (DCL) ( < 0.05), and joint effusion ( < 0.05), were significantly associated with time in first MRI reviews. GME ( < 0.01) and focal cartilage loss (FCL) ( < 0.01) decreased significantly between two MRI reviews at median time of 1.75 (IQR 0.93-4.25) and 12.5 (IQR 3.75-19.5) months. Diffuse cartilage loss ( < 0.01) and degenerative changes ( < 0.01) increased significantly between the two MRI reviews. Etanercept, Methotrexate, and Botulinum Neurotoxin A drugs were used by 3, 3, and 1 report to treat ICH. Capsulectomies, total hip arthroplasty, arthrodiastasis, arthrodesis, arthroscopy operations treated 45, 18, 5, 5, and 2 hips.
DISCUSSION
GME may be the most specific and early MRI feature in diagnosing ICH. GME and DME show an inverse relationship over time. So, it is with FCL and DCL. Despite reports on the efficacy of biologics, immunomodulators, and operations, early and late ICH management remains controversial due to poor quality studies.
SUPPLEMENTARY INFORMATION
The online version contains supplementary material available at 10.1007/s43465-022-00684-7.
PubMed: 36052391
DOI: 10.1007/s43465-022-00684-7 -
Journal of Vascular Surgery. Venous and... Jan 2024Lymphedema is a chronic condition caused by impaired lymphatic fluid drainage, resulting in progressive edema. The current mainstay of lymphedema therapy consists of... (Review)
Review
OBJECTIVE
Lymphedema is a chronic condition caused by impaired lymphatic fluid drainage, resulting in progressive edema. The current mainstay of lymphedema therapy consists of conservative therapy and surgical therapy. In this systematic review, we investigated the novel role of biomaterials in clinical lymphedema therapy and assessed their objective outcomes and the complication rate associated with their use.
METHODS
Studies were identified through systematic review using the Embase and PubMed/MEDLINE databases. Only original articles reporting the use of biomaterials for clinical lymphedema therapy were included. The primary outcome measure was the objective reduction in limb volume after biomaterial use. The secondary outcome measure was the assessment of biomaterial safety.
RESULTS
A total of 354 articles were identified in the first search, of which 10 met our inclusion criteria. These articles described the use of two biomaterials, nanofibrillar collagen scaffolds (NCSs) and silicone tubes (STs), for the treatment of lymphedema. NCS implantation showed an average excess limb volume reduction of 1% to 10.7% and clear evidence of lymphangiogenesis on imaging. No complications were 7documented after NCS implantation. ST implantation showed an average limb volume reduction of 700 to 887 mL and limb circumference reduction of 3.1 to 8 cm in patients with advanced stage lymphedema. Of 177 patients treated with ST implantation, only 11 (6.2%) developed local inflammation.
CONCLUSIONS
Both NCS and ST implantation showed promising limb volume reduction; however, with the scarce literature available, additional research is needed to determine their effectiveness. Both demonstrated good safety profiles, with no complications after NCS implantation and a complication rate equivalent to other similar implants for ST implantation.
Topics: Humans; Biocompatible Materials; Lymphedema; Edema; Extremities; Prostheses and Implants
PubMed: 37696416
DOI: 10.1016/j.jvsv.2023.08.015 -
The Cochrane Database of Systematic... Oct 2019Neurocysticercosis is the most common parasitic infection of the brain. Epilepsy is the most common clinical presentation, though it may also present with headache,... (Review)
Review
BACKGROUND
Neurocysticercosis is the most common parasitic infection of the brain. Epilepsy is the most common clinical presentation, though it may also present with headache, symptoms of raised intracranial pressure, hydrocephalus and ocular symptoms depending upon the localisation of the parasitic cysts. Anthelmintic drugs, anti-oedema drugs, such as steroids, and antiepileptic drugs (AEDs) form the mainstay of treatment.This is an updated version of the original Cochrane Review published in 2015, Issue 10.
OBJECTIVES
To assess the effects (benefits and harms) of AEDs for the primary and secondary prevention of seizures in people with neurocysticercosis.For the question of primary prevention, we examined whether AEDs reduce the likelihood of seizures in patients who have neurocysticercosis but have not had a seizure.For the question of secondary prevention, we examined whether AEDs reduce the likelihood of further seizures in patients who have had at least one seizure due to neurocysticercosis.As part of primary prevention studies, we also aimed to examine which AED has been found to be beneficial in people with neurocysticercosis in terms of duration, dose and side-effect profile.
SEARCH METHODS
For the latest update of this review, we searched the following databases on 8 July 2019: Cochrane Register of Studies (CRS Web), MEDLINE (Ovid, 1946 to July 05, 2019) and LILACS (1982- ). CRS Web includes the Cochrane Epilepsy Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), and randomised or quasi-randomised, controlled trials from Embase, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform (ICTRP). We also checked the references lists of identified studies, and contacted experts in the field and colleagues to search for additional studies and for information about ongoing studies.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials.Single-blind, double-blind or unblinded studies were eligible for inclusion.
DATA COLLECTION AND ANALYSIS
Two review authors screened all citations for eligibility (MS screened the initially identified 180 citations, MF and BDM screened the 48 citations identified for the purpose of this update).Two review authors independently extracted data and evaluated each study for risk of bias.
MAIN RESULTS
We did not find any trials that investigated the role of AEDs in preventing seizures among people with neurocysticercosis, presenting with symptoms other than seizures.We did not find any trials that evaluated evaluating individual AEDs in people with neurocysticercosis.We found one trial, comparing two AEDs in people with solitary neurocysticercosis with seizures. However, we excluded this study from the review as it was of poor quality.We found four trials that compared the efficacy of short term versus longer term AED treatment for people with solitary neurocysticercosis (identified on computed tomography (CT) scan) presenting with seizures. In total, 466 people were enrolled. These studies compared various AED treatment durations, six, 12 and 24 months. The risk of seizure recurrence with six months treatment compared with 12 to 24 months treatment was not statistically significant (odds ratio (OR) 1.34 (95% confidence interval (CI) 0.73 to 2.47; three studies, 360 participants; low-certainty evidence)). The risk of seizure recurrence with six to 12 months compared with 24 months treatment was not statistically significant (OR 1.36 (95% CI 0.72 to 2.57; three studies, 385 participants; low-certainty evidence)).Two studies co-related seizure recurrence with CT findings and suggested that persistent and calcified lesions had a higher recurrence risk and suggest longer duration of treatment with AEDs. One study reported no side effects, while the rest did not comment on side effects of drugs. None of the studies addressed the quality of life of the participants.These studies had certain methodological deficiencies such as a small sample size and a possibility of bias due to lack of blinding, which affect the results of this review.
AUTHORS' CONCLUSIONS
Despite neurocysticercosis being the most common cause of epilepsy worldwide, there is currently no evidence available regarding the use of AEDs as seizure prophylaxis among people presenting with symptoms other than seizures. For those presenting with seizures, there is no reliable evidence regarding the duration of treatment required. There is therefore a need for large scale randomised controlled trials to address these questions.
PubMed: 31608991
DOI: 10.1002/14651858.CD009027.pub3 -
The Cochrane Database of Systematic... Oct 2014Diabetic macular oedema (DMO) is a common complication of diabetic retinopathy. Although grid or focal laser photocoagulation has been shown to reduce the risk of visual... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Diabetic macular oedema (DMO) is a common complication of diabetic retinopathy. Although grid or focal laser photocoagulation has been shown to reduce the risk of visual loss in DMO, or clinically significant macular oedema (CSMO), vision is rarely improved. Antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF) modalities is used to try to improve vision in people with DMO.
OBJECTIVES
To investigate the effects in preserving and improving vision and acceptability, including the safety, compliance with therapy and quality of life, of antiangiogenic therapy with anti-VEGF modalities for the treatment of DMO.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 3), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to April 2014), EMBASE (January 1980 to April 2014), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to April 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 28 April 2014.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing any antiangiogenic drugs with an anti-VEGF mechanism of action versus another treatment, sham treatment or no treatment in people with DMO.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by The Cochrane Collaboration. The risk ratios (RR) for visual loss and visual gain of three or more lines of logMAR visual acuity were estimated at one year of follow-up (plus or minus six months) after treatment initiation.
MAIN RESULTS
Eighteen studies provided data on four comparisons of interest in this review. Participants in the trials had central DMO and moderate vision loss.Compared with grid laser photocoagulation, people treated with antiangiogenic therapy were more likely to gain 3 or more lines of vision at one year (RR 3.6, 95% confidence interval (CI) 2.7 to 4.8, 10 studies, 1333 cases, high quality evidence) and less likely to lose 3 or more lines of vision (RR 0.11, 95% CI 0.05 to 0.24, 7 studies, 1086 cases, high quality evidence). In meta-analyses, no significant subgroup difference was demonstrated between bevacizumab, ranibizumab and aflibercept for the two primary outcomes, but there was little power to detect a difference. The quality of the evidence was judged to be high, because the effect was large, precisely measured and did not vary across studies, although some studies were at high or unclear risk of bias for one or more domains. Regarding absolute benefit, we estimated that 8 out of 100 participants with DMO may gain 3 or more lines of visual acuity using photocoagulation whereas 28 would do so with antiangiogenic therapy, meaning that 100 participants need to be treated with antiangiogenic therapy to allow 20 more people (95% CI 13 to 29) to markedly improve their vision after one year. People treated with anti-VEGF on average had 1.6 lines better vision (95% CI 1.4 to 1.8) after one year compared to laser photocoagulation (9 studies, 1292 cases, high quality evidence). To achieve this result, seven to nine injections were delivered in the first year and three or four in the second, in larger studies adopting either as needed regimens with monthly monitoring or fixed regimens.In other analyses antiangiogenic therapy was more effective than sham (3 studies on 497 analysed participants, high quality evidence) and ranibizumab associated with laser was more effective than laser alone (4 studies on 919 participants, high quality evidence).Ocular severe adverse events, such as endophthalmitis, were rare in the included studies. Meta-analyses conducted for all antiangiogenic drugs compared with either sham or photocoagulation did not show a significant difference regarding serious systemic adverse events (15 studies, 441 events in 2985 participants, RR 0.98, 95% CI 0.83 to 1.17), arterial thromboembolic events (14 studies, 129 events in 3034 participants, RR 0.89, 95% CI 0.63 to 1.25) and overall mortality (63 events in 3562 participants, RR 0.88, 95% CI 0.52 to 1.47). We judged the quality of the evidence on adverse effects as moderate due to partial reporting of safety data and the exclusion of participants with previous cardiovascular events in some studies.
AUTHORS' CONCLUSIONS
There is high quality evidence that antiangiogenic drugs provide a benefit compared to current therapeutic options for DMO, that is grid laser photocoagulation, in clinical trial populations at one or two years. Future research should investigate differences between drugs, effectiveness under real-world monitoring and treatment conditions, and safety in high-risk populations, particularly regarding cardiovascular risk.
Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Aptamers, Nucleotide; Bevacizumab; Diabetic Retinopathy; Humans; Laser Coagulation; Macular Edema; Randomized Controlled Trials as Topic; Ranibizumab; Receptors, Vascular Endothelial Growth Factor; Recombinant Fusion Proteins; Triamcinolone; Vascular Endothelial Growth Factor A
PubMed: 25342124
DOI: 10.1002/14651858.CD007419.pub4 -
Medicina Oral, Patologia Oral Y Cirugia... Sep 2022Third molar surgery is frequently associated with postoperative discomfort such as pain, edema and trismus. We aimed to evaluate the current evidence on the efficacy of...
BACKGROUND
Third molar surgery is frequently associated with postoperative discomfort such as pain, edema and trismus. We aimed to evaluate the current evidence on the efficacy of adjunctive corticosteroid therapy in improving patient-centered outcomes following third molar surgery.
MATERIAL AND METHODS
This systematic review assessed and searched PubMed, Google scholar, Scopus, web of science, clinicaltrials.gov and Cochrane central for controlled trials, up to May 2021. The primary outcome measures were patient-centered outcomes such as quality of life following the use of adjunctive corticosteroid therapy in third molar removal. Only randomized controlled trials published in English language were included.
RESULTS
A total of 355 studies were initially identified, and 12 studies were finally included. The results showed that both methylprednisolone and dexamethasone decreased postoperative side effects such as pain, trismus, and edema and consequently were improving patient reported outcomes. In this regard, none of the included papers reported any significant statistical difference between these two drugs (p > 0.05). The analysis regarding the route of administration for the corticosteroids showed that local and intravenous injection of dexamethasone had equivalent effects, and both methods showed better results as compared to simple oral administration.
CONCLUSIONS
Adjunctive use of corticosteroid drugs may improve patient-centered outcomes following third molar surgery. However, there is no significant difference between drugs and routs of administration. Comparing various administration routs, local submucosal injection of dexamethasone seems to be a straightforward, painless and cost-effective adjunctive therapy.
Topics: Adrenal Cortex Hormones; Dexamethasone; Edema; Humans; Molar, Third; Outcome Assessment, Health Care; Pain; Pain, Postoperative; Patient-Centered Care; Quality of Life; Tooth Extraction; Tooth, Impacted; Trismus
PubMed: 35975802
DOI: 10.4317/medoral.25177 -
The Journal of Rheumatology Sep 2017Magnetic resonance imaging (MRI) has been increasingly recognized as a critical tool for the assessment of patients with rheumatoid arthritis (RA) and is able to... (Review)
Review
OBJECTIVE
Magnetic resonance imaging (MRI) has been increasingly recognized as a critical tool for the assessment of patients with rheumatoid arthritis (RA) and is able to reliably identify synovitis, bone marrow edema, bone erosion, and joint space narrowing (JSN)/cartilage loss. Understanding the exact relationship between each MRI feature and local synovial pathobiology is critical to dissect disease pathogenesis as well as develop future predictive models.
METHODS
A systematic review was performed of the current published literature examining the relationship between MRI abnormalities and synovial pathobiology in patients with RA.
RESULTS
Eighteen studies were identified; most focused on validation of MRI as a tool to detect and quantify synovitis, with a significant relationship demonstrated. Additionally, from the limited data available, a critical role seems likely for synovial pathways, at least in driving joint damage. However, there was a lack of data examining the relationship between synovial pathobiology and bone marrow abnormalities and JSN.
CONCLUSION
Although understanding the interrelationship of these disease biomarkers offers the potential to enhance the predictive validity of modern imaging with concomitant synovial pathobiological analysis, further studies integrating MRI with synovial tissue analysis in well-controlled cohorts at distinct disease stages before and after therapeutic intervention are required to achieve this.
Topics: Arthritis, Rheumatoid; Humans; Magnetic Resonance Imaging; Synovial Membrane; Synovitis
PubMed: 28711880
DOI: 10.3899/jrheum.161314 -
Health Technology Assessment... Dec 2009To determine the diagnostic performance and cost-effectiveness of colour vision testing (CVT) to identify and monitor the progression of diabetic retinopathy (DR). (Review)
Review
OBJECTIVE
To determine the diagnostic performance and cost-effectiveness of colour vision testing (CVT) to identify and monitor the progression of diabetic retinopathy (DR).
DATA SOURCES
Major electronic databases including MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, and Cochrane Database of Systematic Reviews were searched from inception to September 2008.
REVIEW METHODS
A systematic review of the evidence was carried out according to standard methods. An online survey of National Screening Programme for Diabetic Retinopathy (NSPDR) clinical leads and programme managers assessed the diagnostic tools used routinely by local centres and their views on future research priorities. A decision tree and Markov model was developed to estimate the incremental costs and effects of adding CVT to the current NSPDR.
RESULTS
In total, 25 studies on CVT met the inclusion criteria for the review, including 18 presenting 2 x 2 diagnostic accuracy data. The quality of studies and reporting was generally poor. Automated or computerised CVTs reported variable sensitivities (63-97%) and specificities (71-95%). One study reported good diagnostic accuracy estimates for computerised CVT plus retinal photography for detection of sight-threatening DR, but it included few cases of retinopathy in total. Results for pseudoisochromatic plates, anomaloscopes and colour arrangement tests were largely inadequate for DR screening, with Youden indices (sensitivity + specificity - 100%) close to zero. No studies were located that addressed patient preferences relating to CVT for DR. Retinal photography is universally employed as the primary method for retinal screening by centres responding to the online survey; none used CVT. The review of the economic evaluation literature found no previous studies describing the cost and effects of any type of CVT. Our economic evaluation suggested that adding CVT to the current national screening programme could be cost-effective if it adequately increases sensitivity and is relatively inexpensive. The deterministic base-case analysis indicated that the cost per quality-adjusted life-year gained may be 6364 pounds and 12,432 pounds for type 1 and type 2 diabetes respectively. However, probabilistic sensitivity analysis highlighted the substantial probability that CVT is not diagnostically accurate enough to be either an effective or a cost-effective addition to current screening methods. The results of the economic model should be treated with caution as the model is based on only one small study.
CONCLUSIONS
There is insufficient evidence to support the use of CVT alone, or in combination with retinal photography, as a method for screening for retinopathy in patients with diabetes. Better quality diagnostic accuracy studies directly comparing the incremental value of CVT in addition to retinal photography are needed before drawing conclusions on cost-effectiveness. The most frequently cited preference for future research was the use of optical coherence tomography for the detection of clinically significant macular oedema.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Color Vision Defects; Diabetic Retinopathy; Diagnostic Tests, Routine; Female; Humans; Male; Middle Aged; Reproducibility of Results; Young Adult
PubMed: 20003824
DOI: 10.3310/hta13600