-
Medicine Dec 2023A systematic review and meta-analysis were conducted to evaluate the efficacy and the overall safety of Faricimab compared with other anti-vascular endothelial growth... (Meta-Analysis)
Meta-Analysis
Comparative efficacy and safety of Faricimab and other anti-VEGF therapy for age-related macular degeneration and diabetic macular edema: A systematic review and meta-analysis of randomized clinical trials.
INTRODUCTION
A systematic review and meta-analysis were conducted to evaluate the efficacy and the overall safety of Faricimab compared with other anti-vascular endothelial growth factors (VEGF) therapy for neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME).
MATERIALS AND METHODS
A systematic literature search of a comprehensive electronic database was performed to identify randomized clinical trials published from January 2013 to January 2023 for Faricimab in AMD and DME. Weighted mean differences and risk ratios were used to integrate the different studies.
RESULTS
A total of 4 randomized controlled trials (RCTs) with 1678 AMD patients and 3 RCTs with 20 DME patients were included in the meta-analysis.In patients with AMD, a significant difference was found in the number of injections between Faricimab and other anti-VEGF therapy (MD = -2.42, 95% CI [-3.93 to -0.90], P = .002).No significant difference was found for the change in best corrected visual acuity (BVCA), central subfoveal thickness (CST), and gaining 15 or more letters. Similarly, no significant difference was found for adverse events.In patients with DME, a significant difference was observed for CST (MD = -22.41, 95% CI [-29.95 to -14.86], P < .00001) and the number of injections(MD = -0.93, 95% CI [-1.33 to -0.54], P < .00001). No significant difference was found for BVCA and gaining 15 or more letters, and no significant difference was found for adverse events.
CONCLUSIONS
Comprehensive evidence confirms that Faricimab achieves non-inferior or even better CST improvement than other anti-VEGF therapies with extended dosing intervals, but more long-term follow-up studies are needed to support our conclusions.
Topics: Antibodies, Bispecific; Vascular Endothelial Growth Factor A; Macular Degeneration; Humans; Randomized Controlled Trials as Topic; Macular Edema; Diabetes Complications; Treatment Outcome
PubMed: 38115358
DOI: 10.1097/MD.0000000000036370 -
Obesity Reviews : An Official Journal... Jan 2024Diagnosing lipedema remains a challenge due to its heterogeneous presentation, co-existing diseases, and the lack of objective diagnostic imaging. (Review)
Review
BACKGROUND
Diagnosing lipedema remains a challenge due to its heterogeneous presentation, co-existing diseases, and the lack of objective diagnostic imaging.
OBJECTIVE
This systematic review aims to outline the currently available diagnostic imaging methods to characterize lipedema in the legs along with their diagnostic performance.
METHODS
PubMed, Embase, Google Scholar, Scopus, and Web of Science were searched. The quality assessment of diagnostic accuracy studies (QUADAS) tool was used for quality assessment.
RESULTS
Thirty-two studies describing a total of 1154 patients with lipedema were included for final analysis. Features for lipedema have been defined using ultrasound (increased subcutaneous adipose tissue), lymphoscintigraphy (slowing of the lymphatic flow and a frequent asymmetry between the lower extremities), computed tomography (symmetrical bilateral soft tissue enlargement without either skin thickening or subcutaneous edema), magnetic resonance imaging (increased subcutaneous adipose tissue), MR lymphangiography (enlarged lymphatic vessels up to a diameter of 2 mm), and dual-energy X-ray absorptiometry (fat mass in the legs adjusted for body mass index (BMI) ≥ 0.46 or fat mass in the legs adjusted for total fat mass ≥ 0.384).
CONCLUSION
The diagnostic performance of currently available imaging modalities for assessing lipedema is limited. Prospective studies are needed to evaluate and compare the diagnostic performance of each imaging modality. Imaging techniques focusing on the pathogenesis of the disease are needed.
Topics: Humans; Lipedema; Subcutaneous Fat; Lower Extremity; Lymphatic Vessels; Hypertrophy; Diagnostic Imaging
PubMed: 37789512
DOI: 10.1111/obr.13648 -
Journal of Vascular Surgery. Venous and... Nov 2023The aim of this study was to investigate the technical feasibility, operative techniques, safety, and efficacy outcomes of procedures aimed at correcting deep venous... (Review)
Review
OBJECTIVE
The aim of this study was to investigate the technical feasibility, operative techniques, safety, and efficacy outcomes of procedures aimed at correcting deep venous reflux, in patients with chronic venous insufficiency.
METHODS
We performed systematic literature searches in PubMed, Embase, and Web of Science from databases' inception to February 2022. We included systematic reviews, randomized controlled trials, and observational studies describing surgical procedures to treat patients with deep reflux due to primary and secondary incompetence, post-thrombotic syndrome (PTS). Proportion meta-analyses were performed for all the efficacy and safety outcomes.
RESULTS
We included 57 studies in the quantitative synthesis: three randomized controlled trials including 252 patients and 54 case series including 4004 patients. Studies included a median of 38 patients, with a mean age of 51 years; 52% of them were males. Forty percent of studies included 2291 patients with primary incompetence, 29% of studies included 595 patients with PTS, and 31% of studies included 1118 patients with both diseases. As for primary incompetence, pooled estimates for all procedures showed an 89% (95% confidence interval [CI], 82%-94%) of ulcer healing, 10% (95% CI, 4%-18%) ulcer recurrence, 98% (95% CI, 93%-100%) valve patency, 84% (95% CI, 78%-90%) valve competence, 0.05% (1/1904 patients) pulmonary embolism, 1% (95% CI, 0%-3%) wound infections, 5% (95% CI, 1%-9%) hematoma, 2% (95% CI, 0%-6%) lymphocele, 2% (95% CI, 1%-4%) thrombosis, 85% (95% CI, 74%-94%) pain improvement, 89% (95% CI, 65%-100%) edema improvement, and 85% (95% CI, 73%-93%) lipodermatosclerosis improvement. Patients with PTS showed less favorable outcomes: 82% (95% CI, 71%-91%) of ulcer healing, 18% (95% CI, 5%-36%) ulcer recurrence, 88% (95% CI, 78%-96%) valve patency, 78% (95% CI, 66%-88%) valve competence, no pulmonary embolism, 6% (95% CI, 0%-22%) wound infections, 6% (95% CI, 3%-10%) hematoma, 5% (95% CI, 1%-12%) lymphocele, 7% (95% CI, 1%-16%) thrombosis, 79% (95% CI, 59%-94%) pain improvement, 75% (95% CI, 61%-88%) edema improvement, and 64% (95% CI, 9%-100%) lipodermatosclerosis improvement.
CONCLUSIONS
The number of studies included in each meta-analysis are limited, and knowing how this element can affect the statistical power, as well as the absence of comparative control groups, it is not possible to draw definitive conclusions. Nevertheless, deep venous reconstructive surgery for reflux may increase the probability of clinical improvement in patients affected by chronic venous insufficiency. Outcomes appear to be satisfactory even if possible adjunctive procedures may be required over the course of the patient's lifetime. Consequently, a strict follow-up protocol is required to maintain outcomes. Further studies are required to evaluate deep venous reconstructive surgery for reflux particularly as to how it compares with the more recently introduced endovenous approaches.
PubMed: 37453548
DOI: 10.1016/j.jvsv.2023.07.003 -
Journal of General Internal Medicine Aug 2023Cellulitis is a clinical diagnosis with several mimics and no gold standard diagnostic criteria. Misdiagnosis is common. This review aims to quantify the proportion of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Cellulitis is a clinical diagnosis with several mimics and no gold standard diagnostic criteria. Misdiagnosis is common. This review aims to quantify the proportion of cellulitis misdiagnosis in primary or unscheduled care settings based on a second clinical assessment and describe the proportion and types of alternative diagnoses.
METHODS
Electronic searches of Medline, Embase and Cochrane library (including CENTRAL) using MeSH and other subject terms identified 887 randomised and non-randomised clinical trials, and cohort studies. Included articles assessed the proportion of cellulitis misdiagnosis in primary or unscheduled care settings through a second clinical assessment up to 14 days post initial diagnosis of uncomplicated cellulitis. Studies on infants and patients with (peri-)orbital, purulent and severe or complex cellulitis were excluded. Screening and data extraction was conducted independently in pairs. Risk of bias was assessed using a modified risk of bias tool from Hoy et al. Meta-analyses were undertaken where ≥ 3 studies reported the same outcome.
RESULTS
Nine studies conducted in the USA, UK and Canada, including a total of 1600 participants, were eligible for inclusion. Six studies were conducted in the inpatient setting; three were in outpatient clinics. All nine included studies provided estimates of the proportion cellulitis misdiagnosis, with a range from 19 to 83%. The mean proportion misdiagnosed was 41% (95% CI 28 to 56% for random effects model). Heterogeneity between studies was very high both statistically (I 96%, p-value for heterogeneity < 0.001) and clinically. Of the misdiagnoses, 54% were attributed to three conditions (stasis dermatitis, eczematous dermatitis and edema/lymphedema).
DISCUSSION
The proportion of cellulitis misdiagnosis when reviewed within 14 days was substantial though highly variable, with the majority attributable to three diagnoses. This highlights the need for timely clinical reassessment and system initiatives to improve diagnostic accuracy of cellulitis and its most common mimics.
TRIAL REGISTRATION
Open Science Framework ( https://osf.io/9zt72 ).
Topics: Humans; Cellulitis; Diagnostic Errors; Canada
PubMed: 37231210
DOI: 10.1007/s11606-023-08229-w -
Asian Pacific Journal of Cancer... Dec 2023Allogeneic hematopoietic cell transplantation (allo-HCT) serves as a potentially curative intervention for various hematologic disorders. However, its utility can be...
INTRODUCTION
Allogeneic hematopoietic cell transplantation (allo-HCT) serves as a potentially curative intervention for various hematologic disorders. However, its utility can be limited by the emergence of chronic graft-versus-host disease (cGVHD). The clinical manifestations of cGVHD result from a complex immune response characterized by the involvement of both B and T cells. Ibrutinib, a pharmacological agent, acts as an inhibitor of Bruton's tyrosine kinase (BTK) pathway, which becomes activated through the B-cell receptor and regulates B-cell survival. By exerting inhibitory effects on both BTK and inhibitor of interleukin-2 inducible T-cell kinase (ITK), ibrutinib exhibits promise as a therapeutic approach for managing cGVHD. Ibrutinib may be considered as a viable treatment option for active cGVHD in cases where patients exhibit an inadequate response to corticosteroid-based therapies. This systematic review seeks to assess the efficacy and safety of ibrutinib in the context of cGVHD patient management.
METHOD
We incorporated search engines from PubMed, Embase, Cochrane Library, Scopus, Web of Science, and ClinicalTrials.gov. The study was performed following the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 and Assessing The Methodological Quality of Systematic Review (AMSTAR). We used Risk of Bias- 2 (RoB-2) tool for assess the risk of bias in randomized controlled studies (RCTs) and Newcastle Ottawa Scale (NOS) for observational and open-label studies.
RESULTS
A total of 7 studies were included in this study consisted of four open-label studies, two retrospective cohort studies, and one RCT study. These studies compared Ibrutinitib with standard therapies. Two studies investigated the pediatric population, and five studies investigated the adult population. Overall, these studies reported the overall response rate (ORR) of ibrutinib for cGVHD were 54%-78%. The results showed that in pediatric patients, the ORR were 54-78%. The results also showed that in adult patients, the ORR were 67%-76%. The most common adverse effects observed across the seven studies included pyrexia, diarrhea, abdominal pain, cough, nausea, stomatitis, vomiting, headache, bleeding and bruising, infection, muscle aches, fatigue, oral bleeding, elevated transaminases, lower gastrointestinal bleeding, persistent dizziness, sepsis, pneumonia, reduced platelet count, exhaustion, sleeplessness, peripheral edema, and fatigue.
CONCLUSION
The majority of studies have indicated that ibrutinib exhibits a high ORR and provides long-lasting responses, while also having manageable side effects.
Topics: Adult; Humans; Child; Bronchiolitis Obliterans Syndrome; Graft vs Host Disease; B-Lymphocytes; Fatigue
PubMed: 38156834
DOI: 10.31557/APJCP.2023.24.12.4025 -
British Medical Bulletin Sep 2023Transient bone osteoporosis (TBO) is characterized by persistent pain, loss of function, no history of trauma and magnetic resonance image (MRI) findings of bone marrow...
INTRODUCTION
Transient bone osteoporosis (TBO) is characterized by persistent pain, loss of function, no history of trauma and magnetic resonance image (MRI) findings of bone marrow edema.
SOURCE OF DATA
PubMed, Google scholar, EMABSE and Web of Science were accessed in February 2023. No time constrains were used for the search.
AREAS OF AGREEMENT
TBO is rare and misunderstood, typically affecting women during the third trimester of pregnancy or middle-aged men, leading to functional disability for 4-8 weeks followed by self-resolution of the symptoms.
AREAS OF CONTROVERSY
Given the limited evidence in the current literature, consensus on optimal management is lacking.
GROWING POINTS
This systematic review investigates current management of TBO.
AREAS TIMELY FOR DEVELOPING RESEARCH
A conservative approach leads to the resolution of symptoms and MRI findings at midterm follow-up. Administration of bisphosphonates might alleviate pain and accelerate both clinical and imaging recovery.
Topics: Male; Middle Aged; Pregnancy; Humans; Female; Osteoporosis; Magnetic Resonance Imaging; Diphosphonates; Bone Marrow Diseases; Edema
PubMed: 37328938
DOI: 10.1093/bmb/ldad012 -
Archives of Dermatological Research Oct 2023Morbihan disease (MD) is considered a rare complication of rosacea, which is difficult to diagnose and challenging to treat. Here, we performed a systematic review of...
Morbihan disease (MD) is considered a rare complication of rosacea, which is difficult to diagnose and challenging to treat. Here, we performed a systematic review of available case reports and case series to summarize key clinical and pathologic features of and successful treatment regimens for MD. We conducted a search of the PubMed/MEDLINE, EMBASE, and Cochrane electronic databases from their inception to the date of search on March 6, 2023. We found that MD affects patients in the fifth decade of life on average, more commonly reported in male than female (69% vs 31%). Clinically, MD affects the eyelids, cheeks, and forehead most commonly, presenting as non-pitting, erythematous edema or an edematous plaque. On biopsy, the pathologic features, such as dermal edema, sebaceous hyperplasia, perivascular and periadnexal inflammatory infiltrate, and granulomatous reaction, are frequently reported. Out of 55 patients who were able to achieve complete response without recurrence, 35% of patients were treated with isotretinoin and 22% were treated with tetracycline antibiotics with a daily dosage range of 20-80 mg and 40-200 mg, respectively. Out of those 55 patients, 22% and 7% were treated successfully with surgical intervention and intralesional injection of steroids, respectively. Additionally, lymphatic drainage has been shown to be an effective adjunctive therapeutic tool. More studies are necessary to understand the disease mechanism to improve the diagnosis of and develop evidence-based therapies for MD.
Topics: Humans; Male; Female; Rosacea; Erythema; Isotretinoin; Edema; Treatment Outcome
PubMed: 37062777
DOI: 10.1007/s00403-023-02621-6 -
BMC Musculoskeletal Disorders Oct 2023Lateral ankle sprains are highly prevalent and result in tissue damage, impairments of muscle strength, instability, and muscle activation. Up to 74% will experience... (Meta-Analysis)
Meta-Analysis
The effect of movement representation techniques on ankle function and performance in persons with or without a lateral ankle sprain: a systematic review and meta-analysis.
BACKGROUND
Lateral ankle sprains are highly prevalent and result in tissue damage, impairments of muscle strength, instability, and muscle activation. Up to 74% will experience ongoing symptoms after a lateral ankle sprain. In healthy subjects, motor imagery might induce neural changes in the somatosensory and motor areas of the brain, yielding favourable enhancements in muscular force. However, during motor imagery, difficulties in building a motor image, no somatosensory feedback, and the absence of structural changes at the level of the muscle might explain the differences found between motor imagery and physical practice. In rehabilitation, motor imagery might be supportive in rebuilding motor networks or creating new networks to restore impairments in muscle activation and movement patterns. This systematic review was undertaken to summarize the current body of evidence about the effect on motor imagery, or action observation, on lower leg strength, muscle performance, ankle range of motion, balance, and edema in persons with, and without, a lateral ankle sprain compared to usual care, a placebo intervention, or no intervention.
METHODS
A systematic review with meta-analysis of randomized controlled trials was conducted in healthy participants and participants with a lateral ankle sprain. Motor imagery or action observation in isolation, or in combination with usual care were compared to a placebo intervention, or no intervention. An electronic search of MEDLINE, EMBASE, Cinahl, Psychinfo, Sportdiscus, Web of Science, Cochrane and Google Scholar was conducted, and articles published up to 7 June 2023 were included. Two reviewers individually screened titles and abstracts for relevancy using the inclusion criteria. Variables related to muscle strength, muscle function, range of motion, balance, return to sports tests, or questionnaires on self-reported function or activities were extracted. A risk of bias assessment was done using the Cochrane Risk-of-Bias tool II by two reviewers. Meta-analysis using a random effects model was performed when two or more studies reported the same outcome measures. The Standardized Mean Difference (SMD) was calculated over the change from baseline scores. Review manager 5.4 was used to perform analysis of subgroup differences and test for statistically significant differences. Confidence intervals were visually checked for overlap between subgroups.
RESULTS
Nine studies, six examining healthy participants and three examining participants with an acute lateral ankle sprain, were included. All studies were rated with moderate to high risk of bias overall. Quality of the motor imagery interventions differed largely between studies. Meta-analysis showed a large and significant effect of motor imagery on lower leg strength (SMD 1.47, 95% CI 0.44 to 2.50); however, the evidence was downgraded to very low certainty due to substantial heterogeneity (I = 73%), limitations in the studies (some concerns in risk of bias in all studies), and imprecision (n = < 300). Evidence showed no association with ankle range of motion (SMD 0.25, 95% CI -0.43 to 0.93), edema (SMD -1.11, 95% CI -1.60 to 3.81), the anterior reach direction of the Star Excursion Balance Test (SEBT) (SMD 0.73, 95% CI -0.62 to 2.08), the posterolateral direction (SMD 0.32, 95% CI -0.94 to 1.57), and the posteromedial direction (SMD 0.52, 95% CI -0.07 to 1.10). The certainty of evidence for the different comparisons was very low.
CONCLUSIONS
There is a low certainty, significant, positive effect for motor imagery being able to improve lower leg muscle strength in healthy participants. The effect on balance, range of motion and edema was uncertain and of very low certainty.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42021243258.
Topics: Humans; Ankle; Lower Extremity; Ankle Joint; Ankle Injuries; Edema
PubMed: 37794344
DOI: 10.1186/s12891-023-06906-9 -
BioDrugs : Clinical Immunotherapeutics,... Nov 2023Several observational studies have reported acute kidney injury from intravitreal anti-vascular endothelial growth factor (anti-VEGF) drugs for retinal diseases.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Several observational studies have reported acute kidney injury from intravitreal anti-vascular endothelial growth factor (anti-VEGF) drugs for retinal diseases. However, systematic reviews and meta-analyses of randomized controlled trials on this critical topic are scant.
OBJECTIVE
To evaluate acute kidney injury risk associated with intravitreal anti-VEGF drugs in patients with retinal diseases.
METHODS
We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials on 12 July, 2023, and included randomized controlled trials reporting acute kidney injury between anti-VEGF drugs (e.g., aflibercept, bevacizumab, brolucizumab, and ranibizumab) and controls for retinal diseases (e.g., age-related macular degeneration, polypoidal choroidal vasculopathy, diabetic retinopathy/diabetic macular edema, retinal vein occlusion, and myopic choroidal neovascularization). Data were synthesized by a fixed-effects model for pooling odds ratios (ORs) using the Peto method.
RESULTS
We included 13 randomized controlled trials (four and nine trials for aflibercept and ranibizumab, respectively) with a total of 4282 participants. The meta-analysis indicated intravitreal anti-VEGF drugs did not increase the acute kidney injury risk, compared with controls (odds ratio [OR]: 1.00, 95% confidence interval [CI] 0.49-2.04, I: 0%), and no differences in the acute kidney injury risk were observed between different anti-VEGF drugs (OR: 1.10, 95% CI 0.27-4.43, I: 0% for aflibercept; OR: 0.97, 95% CI 0.42-2.22, I: 0% for ranibizumab) and between different retinal diseases (OR: 4.61, 95% CI 0.07-284.13, I: not applicable for age-related macular degeneration; OR: 0.90, 95% CI 0.42-1.93, I: 0% for diabetic retinopathy/diabetic macular edema; OR: 1.57, 95% CI 0.16-15.88, I: 0% for retinal vein occlusion).
CONCLUSIONS
Intravitreal anti-VEGF drugs were not associated with an acute kidney injury risk, regardless of which anti-VEGF drugs (aflibercept or ranibizumab) or retinal diseases (age-related macular degeneration, diabetic retinopathy/diabetic macular edema, or retinal vein occlusion) were involved.
SYSTEMATIC REVIEW PROTOCOL REGISTRATION
PROSPERO CRD42021267854.
Topics: Humans; Acute Kidney Injury; Angiogenesis Inhibitors; Bevacizumab; Diabetic Retinopathy; Endothelial Growth Factors; Intravitreal Injections; Macular Degeneration; Macular Edema; Randomized Controlled Trials as Topic; Ranibizumab; Recombinant Fusion Proteins; Retinal Diseases; Retinal Vein Occlusion; Systematic Reviews as Topic; Vascular Endothelial Growth Factor A; Vascular Endothelial Growth Factors
PubMed: 37676536
DOI: 10.1007/s40259-023-00621-6 -
Journal of Oral and Maxillofacial... Sep 2023Third molar extraction can cause surgical trauma, which is associated with pain, edema, trismus, and functional limitations. The aim of the present systematic review was... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Third molar extraction can cause surgical trauma, which is associated with pain, edema, trismus, and functional limitations. The aim of the present systematic review was to investigate the effects of photobiomodulation (PBM) following the extraction of impacted mandibular third molars.
METHODS
An electronic search was conducted in 10 databases from inception up to October 2021 and the grey literature, with no restrictions regarding language or year of publication. Randomized controlled clinical trials (RCT) were included. Studies that were not RCTs were excluded. Reviewers independently analyzed titles and abstracts, followed by full-text analysis. This systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The exposure variable was the use of PBM and the outcomes were pain, edema, and trismus. Meta-analysis was performed using a random-effects model. The estimate was calculated considering standardized mean differences (SMD) and respective 95% confidence intervals (CI) obtained for each outcome on the first, second, third and seventh postoperative days. The level of evidence was assessed using the GRADE approach.
RESULTS
The search resulted in the 3,324 records. Thirty-three RCTs were included in the systematic review and 23 of these were included in the meta-analyses. The studies involved a total of 1,347 participants (56.6% female and 43.4% male) between 16 and 44 years of age. A greater reduction in pain was found in the PBM group compared to the control group on the third postoperative day (SMD: -1.09; 95% CI: -1.63; -0.55; P < .001; low certainty). Edema was discretely lower in the PBM group on the second postoperative day (SMD: -0.61; 95% CI: -1.09; -0.13; P < .001; low certainty) and trismus was discretely lower in the PBM group on the seventh postoperative day (SMD: 0.48; 95% CI: 0.00; 0.96; P < .001; very low certainty).
CONCLUSION
The evidence of the effect of PBM regarding the control of pain, edema, and trismus following third molar extractions is low or very low.
Topics: Male; Female; Humans; Molar, Third; Trismus; Pain, Postoperative; Tooth Extraction; Tooth, Impacted; Edema
PubMed: 37290483
DOI: 10.1016/j.joms.2023.05.007