Prospective Controlled Trials Research Articles

Effectiveness of traditional herbal Kampo medicine Goreisan on chronic subdural hematoma recurrence: a meta-analysis.

Objectives: Our objective was to compare the effectiveness of Traditional Chinese herbal Kampo medicine Goreisan in improving recurrence in patients with chronic subdural hematoma (CSDH). Methods: Eligible randomized controlled trials prospective trials, and retrospective cohort studies were systematically identified through searches of PubMed, Cochrane Library, and CNKI from inception to March 2024. Following the application of predetermined inclusion and exclusion criteria to screen the available studies, main outcome measures were rigorously extracted. RevMan v5.4 software was utilized to evaluate the overall recurrence rate, employing a random-effects model to calculate pooled odds ratios with the Mantel-Haenszel estimation method. Inter-study heterogeneity was assessed using the Cochran Q (Chi-square) test and I2 statistics. Funnel plots were used to evaluate publication bias. Results: Among the 48 articles initially screened for citation, eight were ultimately selected for inclusion in the study. The results of our network meta-analysis indicate that patients with newly diagnosed Chronic subdural hematoma experienced a significantly reduced recurrence rate when treated with Goreisan compared to standard neurosurgical treatment (OR: 0.72; 95% CI 0.61-0.86; p = 0.00003). There was no statistically significant difference in the incidence rates of complications, including general fatigue, allergic reactions, hepatic dysfunction, and interstitial pneumonia (OR: 7.21; 95% CI 0.37-141.29; p = 0.19). Conclusion: Traditional medicine Goreisan was effective in reducing CDSH recurrence rates. For clinical treatment, it provides a high level of evidence-based medicine. It is also necessary to conduct multicenter randomized controlled trials with dose adjustments to determine whether Goreisan interventions improve neurological function or prognosis.

Extracorporeal removal of pathogens using abiomimetic adsorber-Anew treatment strategy for the intensive care unit : Seraph® 100 Microbind® Affinity Blood Filter and its fields of application

In 2019 the World Health Organization (WHO) listed antimicrobial resistance among the top 10threats to global health. The Seraph® 100 Microbind® Affinity blood filter (Seraph® 100) has been in use since 2019 to eliminate pathogens from the bloodstream in addition to anti-infective pharmacotherapy. It is the first device used to rapidly and efficiently reduce the number of circulating bacteria and viruses. After abackground on the concept of extracorporeal pathogen removal in general, this review summarizes the preclinical and clinical data on the Seraph® 100 Affinity Blood Filter. The clinical effect of this treatment and potential therapeutic options are described. Structured PubMed review including references published up to February 2024. Case reports, uncontrolled observational studies and data from registries show widespread clinical use of the Seraph® 100 ranging from difficult to treat bacterial (super) infections to viral infections. The treatment can be done as stand-alone hemoperfusion or in combination with all forms of kidney replacement therapy as well as in extracorporeal membrane oxygenation. The use of the Seraph® 100 varies in terms of duration, concomitant therapy and clinical settings. Due to the absence of prospective controlled trials the clinical effect cannot be properly evaluated.

Extracorporeal removal of pathogens using abiomimetic adsorber-Anew treatment strategy for the intensive care unit : Seraph® 100 Microbind® Affinity Blood Filter and its fields of application

In 2019 the World Health Organization (WHO) listed antimicrobial resistance among the top 10threats to global health. The Seraph® 100 Microbind® Affinity blood filter (Seraph® 100) has been in use since 2019 to eliminate pathogens from the bloodstream in addition to anti-infective pharmacotherapy. It is the first device used to rapidly and efficiently reduce the number of circulating bacteria and viruses. After abackground on the concept of extracorporeal pathogen removal in general, this review summarizes the preclinical and clinical data on the Seraph® 100 Affinity Blood Filter. The clinical effect of this treatment and potential therapeutic options are described. Structured PubMed review including references published up to February 2024. Case reports, uncontrolled observational studies and data from registries show widespread clinical use of the Seraph® 100 ranging from difficult to treat bacterial (super) infections to viral infections. The treatment can be done as stand-alone hemoperfusion or in combination with all forms of kidney replacement therapy as well as in extracorporeal membrane oxygenation. The use of the Seraph® 100 varies in terms of duration, concomitant therapy and clinical settings. Due to the absence of prospective controlled trials the clinical effect cannot be properly evaluated.

Role of Adjuvant Mitomycin C in The Endoscopic Treatment of Laryngotracheal Stenosis (Meta-Analytic Study)

Abstract Background Laryngotracheal stenosis is a life-threatening restriction in pulmonary ventilation. It is an umbrella term, including luminal compromise at the level of the larynx, subglottis, or trachea. Etiology of laryngotracheal stenosis is multifactorial. In adults and adolescents it is mostly acquired, where in children it may be acquired or congenital. Acquired laryngotracheal stenosis can result from previous intubation or tracheostomy, systemic disease, trauma, infection, or idiopathic causes. Historically, infectious etiology was common. Currently, laryngotracheal stenosis most frequently results from prolonged intubation or trauma from intubation itself. Objective To evaluate the effectiveness of topical Mitomycin C as an adjuvant treatment with the endoscopic management of laryngotreacheal stenosis. Patients and Methods The total number of patients in all the included studies was 454, 379 patients in MMC group and 75 patients in non-MMC group. Results This meta-analysis study showed that resolution (success) rate in MMC group was (68.7%) and there was a significant increase in resolution (success) rate in MMC compared to non- MMC group (p = 0.011) with the odds of being 5 times higher in MMC group (OR = 5.04). The Complications rate in MMC using patients was (4%). The result of this meta-analysis study showed that Mitomycin C is an effective and safe adjuvant in the endoscopic treatment of laryngotracheal stenosis. However, this study included limitations. We recommend the need of more high quality prospective randomized controlled trials, two armed studies and further studies in the future to achieve stronger results. Conclusion We suggest that that Mitomycin C is an effective and safe adjuvant in the endoscopic treatment of laryngotracheal stenosis. However, this study included limitations. We recommend the need of more high quality prospective randomized controlled trials, two armed studies and further studies in the future to achieve stronger results.

A Test Method for Identifying Selection Bias Risk in Prospective Controlled Clinical Therapy Trials Using the I2 Point Estimate.

A test method is proposed for identifying potential selection bias risk in single prospective controlled clinical therapy trials that can be applied by trial reviewers. The method is described in detail and was tested on eight randomised controlled trials (RCTs) with reported negative Berger-Exner test results as negative and on eight prospective, controlled cohort studies as positive controls. All 16 studies were identified by systematic literature search. The test method yielded negative results for all RCTs and positive results for six out of the eight cohortstudies. All test results remained within the expected limits for both study types, suggesting a reasonably high accuracy for correctly identifying selection bias risk. However, the method does not provide the possibility to establish whether such bias risk has actually altered trial outcomes. Instead, a positive test result may provide an empirical basis for rating a trial as of high selection bias risk during trial appraisal.

Clinical Implications of Remote Dielectric Sensing-Guided Management.

Background: Remote dielectric sensing (ReDS) systems can quantify the degree of pulmonary congestion rapidly and non-invasively. However, the clinical implications of ReDS-guided medication adjustment remain uncertain. Methods: Patients hospitalized to treat cardiovascular diseases, including heart failure, valvular disease, and coronary artery disease, and underwent ReDS measurement before index discharge between 2021 and 2022 were included. According to our institutional protocol, ReDS values were blinded to the attending clinicians until February 2022 (blind period). After the period, ReDS values were timely opened to the attending clinicians, and medications such as diuretics were adjusted according to the ReDS values (target value between 20% and 35%) before index discharge (open period). A composite primary outcome of all-cause death and heart failure readmissions was compared between the two groups. Results: A total of 183 patients were included (median 79 years old, 101 men), consisting of 138 patients in the blind period and 45 patients in the open period. During a median of 646 (401, 818) days after the index discharge, 33 patients experienced the primary outcome of interest. Management during the open period, where medications were adjusted according to ReDS values, was independently associated with a lower incidence of the primary outcome with an adjusted hazard ratio of 0.22 (95% confidence interval 0.05-0.94, p = 0.041), as compared with those of the blind period. Conclusions: According to the findings of the present retrospective study, ReDS-guided management may have the potential to reduce the risk of mortality and heart failure admission in individuals hospitalized for cardiovascular diagnoses. Further prospective randomized control trials involving those with a variety of background etiologies and clinical scenarios are warranted to validate our findings and establish optimal ReDS-guided management.

A Systematic Review of Loco-Sedative Anesthesia for Urologic Surgery

ObjectiveTo perform a systematic review of the characteristics and outcomes of conscious sedation and local anesthesia for various urologic procedures. Urologic care has much to gain from the routine integration of ambulatory surgery via loco-sedative anesthetic techniques for both surgeon and patient. MethodsA comprehensive systematic literature search was conducted on PubMed, and Scopus databases following PRISMA criteria from June to August 2021. Articles were included if they were English, prospective, randomized, or non-randomized controlled trials that used local anesthetic or conscious sedation for urologic interventions in adult patients. Additionally, included studies provided primary data on the use loco-sedative anesthesia and the efficacy and complications. All studies included were further reviewed to assess the biases and conflicts of interests. Results32 studies with 6897 patients were included in the review. Mean patient age was 46.4 years. The most common anesthetic and analgesic relief was the use of local anesthetic with 1% lidocaine. The majority used lidocaine as an injection, whereas the second most common route of administration was a topical cream. However, there was significant heterogeneity in the type of local or conscious sedation method and whether a combination was used. 44.4% of the studies used the visual analog scale as their primary endpoint. All the studies reported an 83% to 100% successful procedure rate without note of significant sedation-related complications. ConclusionsGiven the high efficacy rates, loco-sedative anesthesia is a promising technique for urologic interventions and should be further investigated to determine whether it may become be the standard of care.

Pain catastrophizing in rheumatic diseases: prevalence, origin, and implications.

Pain is a crucial factor in rheumatic disorders, and reducing it is a primary goal of successful treatment. Adaptive pain-coping strategies can enhance this improvement, but maladaptive approaches such as pain catastrophizing may worsen overall patient well-being. This narrative review aims to provide a concise overview of the existing knowledge on pain catastrophizing in the most prevalent specific rheumatic disorders. The objective of this study was to improve understanding of this phenomenon and its implications, as well as to pinpoint potential directions for future research. We conducted searches in the MEDLINE/PubMed, SCOPUS, and DOAJ bibliography databases to identify articles related to pain catastrophizing in rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, systemic sclerosis, systemic lupus erythematosus, Sjögren's syndrome, juvenile idiopathic arthritis, and osteoarthritis (non-surgical treatment). Data extraction was performed on November 1, 2023. The investigators screened the identified articles to determine their relevance and whether they met the inclusion criteria. Following a bibliography search, which was further expanded by screening of citations and references, we included 156 records in the current review. The full-text analysis centred on pain catastrophizing, encompassing its prevalence, pathogenesis, and impact. The review established the role of catastrophizing in amplifying pain and diminishing various aspects of general well-being. Also, potential treatment approaches were discussed and summarised across the examined disorders. Pain catastrophizing is as a significant factor in rheumatic disorders. Its impact warrants further exploration through prospective controlled trials to enhance global patient outcomes.

Dietary Supplementation of Myo-Inositol, Cocoa Polyphenols, and Soy Isoflavones Improves Vasomotor Symptoms and Metabolic Profile in Menopausal Women with Metabolic Syndrome: A Retrospective Clinical Study.

Background and Objectives: Hormonal changes physiologically occurring in menopausal women may increase the risk of developing metabolic and vasomotor disturbances, which contribute to increase the risk of developing other concomitant pathologies, such as metabolic syndrome (MetS). Materials and Methods: Retrospective data from 200 menopausal women with MetS and vasomotor symptoms taking one sachet per day of the dietary supplement INOFOLIC® NRT (Farmares srl, Rome, Italy) were collected. Each sachet consisted of myo-Inositol (2000 mg), cocoa polyphenols (30 mg), and soy isoflavones (80 mg, of which 50 mg is genistin). Patients recorded their symptoms through a medical questionnaire at the beginning of the administration (T0) and after 6 months (T1). Results: We observed an improvement in both the frequency and the severity of hot flushes: increased percentage of 2-3 hot flushes (28 at T0 vs. 65% at T1, p value < 0.001) and decreased percentage of 4-9 hot flushes (54% at T0 vs. 18% at T1, p value < 0.001). Moreover, symptoms of depression improved after supplementation (87% at T0 vs. 56% at T1 of patients reported moderate depression symptoms, p value < 0.001). Regarding metabolic profile, women improved body mass index and waist circumference with a reduction in the percentage of overweight and obesity women (88% at T0 vs. 51% at T1, p value = 0.01; 14% at T0 vs. 9% at T1, p value = 0.04). In addition, the number of women suffering from non-insulin dependent diabetes reduced (26% at T0 vs. 16% at T1, p value = 0.04). Conclusions: These data corroborate previously observed beneficial effects of the oral administration of myo-Inositol, cocoa polyphenols, and soy isoflavones against menopausal symptoms in the study population. Considering the promising results of the present study, further prospective controlled clinical trials are needed to deeply understand and support the efficacy of these natural compounds for the management of menopausal symptoms.

Periarticular Injections with Liposomal Bupivacaine in Comparison with Traditional (Bupivacaine/Ropivacaine) Periarticular Injections in Total Hip Arthroplasty: A Systematic Review

Objectives This systematic review aims to comprehensively evaluate the current literature to determine whether local infiltration liposomal bupivacaine (LB) used in total hip arthroplasty (THA) results in reduced pain scores and opioid consumption compared to traditional local anesthetics. Methods A systematic review was conducted using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines using Ovid Medline, PubMed, Scopus, and ScienceDirect databases. Articles were screened independently by two investigators based on inclusion criteria of 1) prospective randomized control trials or retrospective cohort studies, 2) conducted after the 2015 Food and Drug Administration (FDA) expansion of LB indication to local surgical infiltration, 3) compared LB as a periarticular injection to other local anesthetics used as a periarticular injection, and 4) available in English. Primary outcomes of pain scores and opioid consumption were reported. Secondary outcomes of interest included mobility, length of stay, costs, incidence of adverse events, and readmission rates. Bupivacaine costs $3 per dose, while LB costs $334 per dose. Results A total of seven articles were identified with the inclusion criteria. Four studies concluded that LB improves patient outcomes of pain scores and opioid consumption in patients receiving THA. Three studies found no benefit to using LB compared to their controls. Four studies found no significant reduction in the length of stay between the groups. There were no reported differences in the incidence of adverse events or total costs between the two groups. Conclusion There are minimal benefits of reduced pain scores or opioid consumption when using LB opioid-sparing protocols compared to current protocols for patients undergoing THA. Level of Evidence III

Monocyte-to-high-density lipoprotein ratio and systemic immune-inflammation index: Potential parameters for the evaluation of disease activity and severity in Graves' ophthalmopathy?

To assess changes in monocyte-to-high-density lipoprotein (HDL) ratio (MHR), neutrophil-to-lymphocyte ratio (NLR), and systemic immune-inflammation index (SII) with Graves' ophthalmopathy (GO) and their possible relation with GO disease activity and severity. A total of 20 patients with GO and 24 healthy controls were involved in the study. The thyroid status, MHR (monocyte count/HDL cholesterol level), NLR (neutrophil count/lymphocyte count) and SII [(neutrophil count × platelet count)/lymphocyte count] were compared between the groups. The relation of systemic inflammation parameters with disease activity and severity was evaluated. The mean Clinical Activity Score (CAS) was 0.75 ± 0.78 in the GO group. None of the patients were active. The severity was mild for 14 (70.0%) patients and moderate-to-severe for 6 (30.0%) patients. MHR (17.28 ± 5.56 vs. 13.28 ± 5.08), NLR (2.51 ± 1.09 vs. 1.69 ± 0.53) and SII [600.42 (391.79-837.16) vs. 413.69 (344.26-603.82)] values were significantly increased in GO patients than in the controls (p = 0.017, p = 0.005 and p = 0.036, respectively). CAS was significantly correlated with MHR (r = 0.815, p < 0.001), NLR (r = 0.768, p = 0.017) and SII (r = 0.837, p < 0.001). The severity of GO was associated with increased MHR, NLR and SII (p = 0.019, p = 0.036 and p = 0.008, respectively). ROC analysis demonstrated that MHR, NLR and SII have a good ability to differentiate GO patients from healthy individuals. GO patients have higher MHR and SII levels than healthy controls. Higher MHR, NLR and SII values were associated with increasing disease severity and activity, supporting the efficacy of these non-invasive, low-cost markers in determining the course of GO. Future prospective controlled trials are needed to elucidate the relation between inflammatory markers and GO.

Effects of task shifting from primary care physicians to nurses: a protocol for an overview of systematic reviews

IntroductionTask-shifting from primary care physicians (PCPs) to nurses is one option to better and more efficiently meet the needs of the population in primary care and to overcome PCP shortages....

A comparison of intra-articular hyaluronic acid and platelet-rich plasma for knee osteoarthritis: a systematic review.

Knee osteoarthritis (KOA), the most common chronic degenerative condition in an older population, accounts for many disabilities around the world. One of the most popular treatments is intra-articular injection of hyaluronic acid (HA) and platelet-rich plasma (PRP). Prior studies have found that both HA and PRP had a therapeutic effect on KOA. This study aims to perform a systematic review regarding whether PRP is superior to HA for KOA. We conducted a comprehensive literature search using Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines for prospective randomized control trials (pRCTs) in three international databases PubMed, Google Scholar, and ScienceDirect from 2019-2022. Two researchers independently searched the reviews, extracted, and cross-checked the data. The disparity when choosing the literature was resolved by discussion. The modified Jadad was scale used to assess the quality of the included studies. Cochrane risk of bias 2 tool (RoB-2) was used for determininzg risk of bias. Twenty three studies were eligible for inclusion. Four pRCT with the highest Jadad score were selected as best evidence. Risk of bias assesment concluded two studies having a low risk of bias, one is high risk of bias, and the other possesses some concerns.. Three studies found no difference in patient-reported outcomes between PRP and HA group and one study concluded that PRP is more effective than HA in treating KOA. Intra-articular injections of PRP and HA are effective interventions for KOA. However, there is not enough evidence of PRP superiority over HA.

Fetal Long QT Syndrome - Challenges in Perinatal Management: A Review and Case Report. Induction of Labor and Vaginal Birth Under Continuous Magnesium Therapy.

Congenital LQTS is an often undetected inherited cardiac channel dysfunction and can be a reason for intrauterine fetal demise. It can present in utero as CTG and ultrasound abnormalities, i. e., bradycardia, ventricular tachycardia, or fetal hydrops. Diagnosis is made by CTG, echocardiography, or fMCG. Intrauterine therapy with a ß blocker and i. v. magnesium should be started. Our objective was to examine the current knowledge about diagnosis and treatment of LQTS and in particular to highlight the opportunity of vaginal birth under continuous intravenous magnesium therapy. Therefore, a thorough MEDLINE and Google Scholar search was conducted. Randomized controlled trials, meta-analyses, prospective and retrospective cohort trials, and case reports were considered. We showed the possibility of vaginal delivery under continuous magnesium therapy in a case of suspected fetal LQTS. A stepwise concept for diagnosis, monitoring, and peripartum management in low, intermediate, and high risk cases of fetal LQTS is presented. If risk is low or intermediate, a vaginal delivery under continuous monitoring is reasonable. Induction of labor at term should be evaluated.

Effect of Hydroxyapatite on Alveolar Bone Regeneration in Various Dental Procedure: Systematic Review and Meta-Analysis

Background. The effect of hydroxyapatite (HA) bone substitute on alveolar bone regeneration has been analyzed in various dental procedures including ridge preservation, sinus augmentation, and periodontal bone defect treatment. The objective on this study was to determine and analyze the structural effect of the HA bone substitute in these dental applications. Methods. The systematic review was conducted using electronic databases from PUBMED, EMBASE, and COCHRANE. The search covered articles published from 1998 up to November 2023. The primary outcome measures were radiographic (intraoral periapical, CT long cone-paralleling technique, computer-assisted densitometry image analysis), histologic/histomorphometry, and other radiographic methods. The secondary outcome measures related to bone regeneration were assessed, including clinical, radiographic/histologic, and histological evaluations. Conclusion. The present systematic review focused on randomized controlled trials (RCTs) and prospective controlled clinical trials (CCTs). The results showed that HA and ß-TCP were found to be safe and clinically acceptable compared to other treatments.

Effect of Prophylactic Placement of Percutaneous Endoscopic Gastrostomy on the Surgical Prognosis in Patients With Oral Cancer: A Pilot Study.

This study assessed the application of prophylactic percutaneous endoscopic gastrostomy (pPEG) in patients with newly diagnosed oral cancer (OC) who underwent surgery and were ready for subsequential chemoradiation. In total, 113 patients who underwent OC surgical treatment were divided into pPEG (n = 26), nasogastric tube (n = 54), and oral feeding (n = 33) groups. Their baseline characteristics, surgery-related outcomes, and nutritional data were analyzed using the Wilcoxon rank-sum test and χ2 test. No statistical significance was shown among the 3 groups using different flaps for reconstructing OC-related defects (P > 0.05). Patients of the pPEG group had the lowest incidence of surgical site infection (SSI; 23.1%, P = 0.006), but the longest hospital stay (24.1 ± 7.9d, P < 0.001). Prophylactic percutaneous endoscopic gastrostomy may decrease the frequency of SSI but increase the length of hospitalization in SSI OC. However, multicentric prospective clinical controlled trials with large sample sizes are needed to further validate our findings.

Clinical Trials of High-Intensity Focused Ultrasound for Cancer: Concerns Arising from Low Post-Hoc Power.

Prospective controlled trials of high-intensity focused ultrasound for cancers were evaluated. Post-hoc power was <0.80 in 30/47 trials and in 22/39 trials with positive results, indicating low quality in most trials. Unscientific endpoints, small sample sizes, and high dropout rates led to low post-hoc power that caused inter-trial heterogeneity and overestimated the therapeutic effect. The objective response rate was not a substitute for survival time for estimating the sample size and assessing the efficacy. The present data can interpret a paradox: HIFU is considered to have slighter cytotoxicity to non-cancer tissues and no radiation but is frequently combined with chemotherapy and/or radiotherapy in practice.

Effect of prone positioning on survival in adult patients receiving venovenous extracorporeal membrane oxygenation for acute respiratory distress syndrome: a prospective multicenter randomized controlled study.

Current data supporting the use of prone positioning (PP) during venovenous extracorporeal membrane oxygenation (VV-ECMO) in patients with acute respiratory distress syndrome (ARDS) are limited. This prospective randomized controlled study aimed to determine whether PP implemented within 24 hours of ECMO can improve survival in these patients. From June 2021 to July 2023, 97 adult patients receiving VV-ECMO for ARDS in three centers were enrolled and 1:1 randomized into PP (n=49) and control groups (n=48). Patients in the PP group receiving prone positioning, while the control group were maintained in the supine position. The primary outcome was 30-day survival, and secondary outcomes included in-hospital survival and other clinical outcomes. All 97 patients were included for analysis. Patient characteristics did not significantly differ between the two groups. The median duration of PP was 81 hours, and the median number of PP sessions was 5 times. PP improved oxygenation and ventilator parameters. The incidence of complications during PP was low, with pressure sores being the most frequent (10.2%). The 30-day survival was significantly higher in the PP group (67.3% vs. 45.8%; P=0.033), as was in-hospital survival (61.2% vs. 39.6%; P=0.033). In the PP group, the successful ECMO weaning rate was significantly higher (77.5% vs. 50.0%; P=0.005), and the duration of ECMO support was significantly shorter {10 [8-11] vs. 10 [8-14] days; P=0.038}. However, in subgroup analysis of COVID patients the 30-day survival, in-hospital survival, successful ECMO weaning rate and the duration of ECMO support did not differ between the groups. The duration of mechanical ventilation, length of intensive care unit stay, and length of hospital stay did not significantly differ between the groups. When initiated within 24 hours of ECMO, PP can improve 30-day survival in patients with ARDS receiving VV-ECMO. In addition, it may improve the successful ECMO weaning rate and reduce the duration of ECMO support. However, considering the limitations, more strictly designed, large sample prospective randomized controlled trials are proposed. Chinese Clinical Trial Registry ChiCTR2300075326.

Prognostic Impact of Bone Marrow Fibrosis and Effects of Tyrosine Kinase Inhibitors on Bone Marrow Fibrosis in Chronic Myeloid Leukemia

BackgroundMyelofibrosis is reported in around 40% of newly diagnosed chronic myeloid leukemia (CML) patients and have an important role in the pathobiology and prognosis of CML. This retrospective study aimed to evaluate the effects of bone marrow (BM) fibrosis on disease prognosis and the effects of specific tyrosine-kinase inhibitors (TKIs) on BM fibrosis in CML patients. MethodsThe study included 96 patients (>18 years) diagnosed with chronic phase (CP) CML. The clinical and demographic information were collected from the medical files. Post-treatment BM aspirate and core biopsy samples were analyzed for the presence of fibrosis and dysplasia. ResultsThe mean age of the study patients was 52.69 years; 47.9% of the patients were female. At the onset, 53 (63.1%) patients had BM fibrosis. The difference in the overall survival of the patients with respect to BM fibrosis grades was significant (p = .001). Within the BM fibrosis grade groups, there were significant differences between grade 0 vs. grade 2, grade 0 vs. grade 3, and grade 1 vs. grade 3 (p = .005, p = .002, and p = .003 respectively) There was no significant association between the presence of BM fibrosis at the onset and not responding to first-line therapy (p = .724). Moreover, no significant association was found between the presence of BM fibrosis at the onset and molecular (p = .623) or cytogenetic response (p = .535) to first-line therapy. Additionally, the association between the type of second-line and third-line therapy and molecular response (p = .773 and p = .424, respectively) or cytogenetic response (p = .298 and p = .641) was not significant. ConclusionAlthough BM fibrosis seems to be a crucial complication of CML with a poor prognosis, it can be reversed via TKI treatment which may result in improved survival. It might be considered to check the BM for this complication on a regular basis during therapies to test its prognostic influence in CML patients in prospective controlled trials. Further studies focused on this issue are required to utilize BM fibrosis as a candidate prognostic factor.

Choroidal thickness after anti‐vascular endothelial growth factor in treatment‐naïve typical neovascular age‐related macular degeneration patients: A systematic review and meta‐analysis

Aims/Purpose: To evaluate the effect of anti‐vascular endothelial growth factor (anti‐VEGF) on choroidal thickness (CT) in treatment‐naïve typical neovascular age‐related macular degeneration (AMD) patients during the loading phase.Methods: A systematic literature search was conducted in CENTRAL, MEDLINE, EMBASE, Scopus, Web of Science, Clinical Trials, ICTRP and ISRCTN from inception to October 19, 2022. The protocol was registered with PROSPERO (CRD42022371192). We included both retrospective and prospective randomized controlled trials, cohort studies, case control and case series of typical neovascular AMD patients. Studies with polypoidal choroidal vasculopathy or unclear diagnoses and reports in other languages than English were excluded. Risk of bias was assessed using critical appraisal tools provided by Joanna Briggs Institute.Results: 43 studies were included in the review. Meta‐analysis of all studies reporting sufficient data and simultaneously disregarding measurement technique, macular neovascularization (MNV) type and anti‐VEGF type, yielded a significant decrease of CT with anti‐VEGF treatment. To decrease bias, sub‐analyses for Type 1 and 2 MNV sorted by anti‐VEGF type found a significant effect for both aflibercept and ranibizumab, and the effect appears greater in the aflibercept group. For Type 3 MNV, the baseline CT was generally thinner and the decrease more modest.Conclusions: Anti‐VEGF drugs decrease CT in typical neovascular AMD. There is a greater effect of aflibercept compared to ranibizumab. For bevacizumab and brolucizumab there are few studies, but available data show a tendency of greater effect in the latter. There are low numbers of randomized trials on the topic and publication bias might affect the results. More studies randomized to treatment of patients with a thin baseline choroid should be conducted.