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Lung Cancer (Amsterdam, Netherlands) Feb 2023Thymic carcinoma (TC) is a rare cancer and patients failing initial chemotherapy (relapse/refractory) face limited therapeutic options given no approved options or... (Meta-Analysis)
Meta-Analysis Review
Thymic carcinoma (TC) is a rare cancer and patients failing initial chemotherapy (relapse/refractory) face limited therapeutic options given no approved options or consensus standard of care. This study aimed to identify and summarize clinical outcomes of all regimens evaluated in clinical trials of relapsed or refractory patients. Interventional trials enrolling advanced TC patients who failed first-line chemotherapy and reported outcomes in this group were eligible for inclusion in our systemic literature review (SLR). Between-study heterogeneity was assessed to determine the feasibility of pooling specific studies and treatments. Objective response rate (ORR), overall survival (OS), progression-free survival (PFS), and duration of response (DOR) endpoints were of interest for meta-analysis. Nineteen trials were identified in the SLR. Three trials with one or two TC patients were removed from our assessment to reduce publication bias. Response rates among studies with at least ten TC patients varied from 9 % to 38 %. Pooled ORRs in patients receiving S-1 (46 patients), sunitinib (46 patients), or pembrolizumab (66 patients) were 28 %, 24 %, and 21 %, respectively. Prolonged duration of response with pembrolizumab was observed with a pooled median of 23.8 months (95 % confidence interval [CI]: 12, not reached). Median PFS of five months or greater was reported in patients treated with sunitinib, lenvatinib, pembrolizumab, capecitabine + gemcitabine, everolimus, or S-1. Median OS of 20 months or greater was reported in trials evaluating S-1 or pembrolizumab; this endpoint was not reached in trials evaluating lenvatinib, regorafenib, or sunitinib. Generalizability of treatment effects is challenging in the research of rare diseases and meta-analysis of clinical outcomes may help to increase precision and relevance of results to the larger TC population. Our study found limited treatment options upon relapse, demonstrating a need for further investigations into novel therapeutics and well-powered clinical trials to better inform on optimal treatments.
Topics: Humans; Sunitinib; Thymoma; Platinum; Neoplasm Recurrence, Local; Lung Neoplasms; Thymus Neoplasms; Antineoplastic Combined Chemotherapy Protocols
PubMed: 36638588
DOI: 10.1016/j.lungcan.2023.01.003 -
Journal of Global Health Dec 2022All term healthy neonates are screened for jaundice before hospital discharge as a standard clinical practice, but methods vary from clinical screening (visual... (Meta-Analysis)
Meta-Analysis
BACKGROUND
All term healthy neonates are screened for jaundice before hospital discharge as a standard clinical practice, but methods vary from clinical screening (visual inspection and/or risk factor assessment) to transcutaneous bilirubin (TcB) or total serum bilirubin (TSB) testing, depending on the setting.
METHODS
This systematic review of randomized and non-randomized studies evaluated the effectiveness of universal TcB and universal TSB screening at discharge compared to clinical screening alone for term healthy neonates. The outcomes were neonatal mortality, readmission for jaundice, severe hyperbilirubinemia (>20 mg/dL), jaundice requiring exchange transfusion, and bilirubin-induced neurological dysfunction (BIND). We searched MEDLINE via Ovid, EBM reviews, Embase, CINAHL, clinical trials databases, and reference lists of retrieved articles. Two authors separately evaluated the risk of bias, extracted data, and synthesized effect estimates using relative risk (RR) for randomized and odds ratio (OR) for non-randomized studies.
RESULTS
For universal TcB at discharge, we included one randomized trial enrolling 1858 participants and four non-randomized studies enrolling 375 956 participants. No study reported neonatal mortality. The randomized trial suggested that universal TcB at discharge may decrease readmission for jaundice (risk ratio (RR) = 0.24, 95% confidence interval (CI) = 0.13 to 0.46; low certainty evidence) and severe hyperbilirubinemia (RR = 0.27, 95% CI = 0.08 to 0.97; low certainty evidence), but the effect on jaundice requiring exchange transfusion (RR = 0.20, 95% CI = 0.01 to 41.6) and BIND (RR = 0.33, 95% CI = 0.01 to 8.17) was uncertain. Meta-analysis of non-randomized studies suggested that TcB may decrease severe hyperbilirubinemia (odds ratio (OR) = 0.25, 95% = CI 0.12 to 0.52; low certainty evidence) and jaundice requiring exchange transfusion (OR = 0.28, 95% CI = 0.19 to 0.42; low certainty evidence), but the effect on readmission for jaundice was uncertain (OR = 1.01, 95% CI = 0.38 to 2.7; very low certainty evidence). For universal TSB, we included three studies from the United States enrolling 490 426 participants. The effect on severe hyperbilirubinemia (OR = 0.37, 95% CI = 0.15 to 0.88), jaundice requiring exchange transfusion (OR = 0.53, 95% CI = 0.13 to 2.25) and readmission for jaundice (OR = 1.01, 95% CI = 0.62 to 1.67) was uncertain.
CONCLUSIONS
Universal TcB at discharge may improve clinical outcomes for term healthy neonates. Evidence for universal TSB is uncertain.
REGISTRATION
PROSPERO 2020 CRD42020187279.
Topics: Infant, Newborn; Humans; United States; Patient Discharge; Bilirubin; Hyperbilirubinemia; Jaundice
PubMed: 36579719
DOI: 10.7189/jogh.12.12007 -
Medicine Dec 2022Anorexia in children can cause malnutrition, low immunity, growth retardation, and various secondary infections, resulting in a huge burden on society. In East Asia,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Anorexia in children can cause malnutrition, low immunity, growth retardation, and various secondary infections, resulting in a huge burden on society. In East Asia, Chuna manual therapy has been widely used for the treatment of childhood anorexia. We aimed to comprehensively evaluate the effects of Chuna manual therapy for treating childhood anorexia.
METHODS
Twelve databases were comprehensively searched from their inception to September 13, 2022. Only randomized controlled trials assessing Chuna manual therapy for the treatment of childhood anorexia were included. The methodological quality of the included studies was assessed using the Cochrane risk-of-bias tool. The quality of evidence for each main outcome was evaluated using the grading of recommendations assessment, development, and evaluation approach. A meta-analysis was performed, and the pooled data were presented as risk ratios (RRs) with 95% confidence intervals (CIs) for dichotomous outcomes.
RESULTS
Twenty-five RCTs involving 2230 participants were included. The meta-analysis showed that Chuna manual therapy had a higher total effective rate (TER) based on anorexia symptoms than that of lysine inositol and vitamin B12 (RR: 1.53, 95% CI: 1.28-1.84), multi-enzyme and multi-vitamin (RR: 1.21, 95% CI: 1.11-1.33), and zinc calcium gluconate (RR: 1.22, 95% CI: 1.06-1.39). There was no significant difference in total effective rate between Chuna manual therapy and zinc gluconate plus lysine. No adverse events associated with Chuna manual therapy were reported. Overall, the included studies had an unclear risk of bias, and the quality of evidence was generally moderate to low.
CONCLUSION
Current evidence showed that Chuna manual therapy may be effective and safe for improving anorexia symptoms, especially compared with lysine inositol and vitamin B12, multi-enzyme plus multi-vitamin, and zinc calcium gluconate. However, owing to the low methodological quality of the included studies, more rigorous, high-quality RCTs are required on this topic.
Topics: Humans; Child; Anorexia; Calcium Gluconate; Lysine; Musculoskeletal Manipulations; Vitamins; Vitamin B 12
PubMed: 36550806
DOI: 10.1097/MD.0000000000031746 -
Biomedicine & Pharmacotherapy =... Feb 2023Erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) are characterized by skin photosensitivity caused by accumulation of protoporphyrin IX. We aimed to... (Review)
Review
Erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) are characterized by skin photosensitivity caused by accumulation of protoporphyrin IX. We aimed to review the clinical evidence of efficacy and safety of skin photosensitivity treatments in individuals with EPP or XLP. We systematically searched MEDLINE, Embase, the Cochrane Library, and ClinicalTrials.gov. A total of 40 studies with data on 18 treatment modalities were included. Comprehensive treatment safety data were obtained from the European Medicines Agency and the United States Food and Drug Administration. The studies used different outcome measures to evaluate the sensitivity without a generally accepted method to assess treatment effect on skin photosensitivity. Of the included studies, 13 were controlled trials. Gathered, the trials showed moderate positive effect of inorganic sunscreen application and subcutaneous implant of afamelanotide and no effect of organic sunscreen application, or oral treatment with beta-carotene, cysteine, N-acetylcysteine, vitamin C, or warfarin. Studies without control groups suggested treatment effect of foundation cream, dihydroxyacetone/lawsone cream, narrow-band ultraviolet B phototherapy, erythrocyte transfusion, extracorporeal erythrocyte photodynamic therapy, or oral treatment with zinc sulphate, terfenadine, cimetidine, or canthaxanthin, but the real effect is uncertain. Assessment of treatment effect on photosensitivity in patients with EPP or XLP carries a high risk of bias since experienced photosensitivity varies with both weather conditions, exposure pattern, and pigmentation. Controlled trials of promising treatment options are important although challenging in this small patient population.
Topics: United States; Humans; Protoporphyria, Erythropoietic; Sunscreening Agents; Photosensitivity Disorders; Genetic Diseases, X-Linked; Protoporphyrins
PubMed: 36525819
DOI: 10.1016/j.biopha.2022.114132 -
Medicine Nov 2022Proton-pump inhibitors (PPIs) and vonoprazan are recommended as first-line therapies for erosive esophagitis (EE). However, it is uncertain how the magnitude of efficacy... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Proton-pump inhibitors (PPIs) and vonoprazan are recommended as first-line therapies for erosive esophagitis (EE). However, it is uncertain how the magnitude of efficacy and safety of first-line therapy, the choice of individual PPIs or vonoprazan in the treatment of EE remains controversial. This study aimed to evaluate the efficacy and safety of vonoprazan and PPIs in healing esophageal mucosal injury in patients with EE.
METHODS
Relevant databases were searched to collect randomized controlled trials of proton pump inhibitors and vonoprazan in the treatment of reflux esophagitis up to December 2021. Studies on standard-dose PPIs or vonoprazan that were published in Chinese or English and assessed healing effects in EE were included in the analysis. Stata16.0 was used to conduct a network Meta-analysis to evaluate the efficacy and safety of the treatment.
RESULTS
A total of 41 literatures were included with 11,592 enrolled patients. For the endoscopic cure rate, all the PPIs and vonoprazan significantly improve compared to Placebo; Based on the surface under the cumulative ranking curve, Ilaprazole ranked first, followed by esomeprazole, vonoprazan, pantoprazole, lansoprazole, omeprazole, rabeprazole and placebo therapy ranked the last. For the rate of adverse events, there was no significant difference among all the PPIs, vonoprazan, and placebo.
CONCLUSIONS
Ilaprazole, esomeprazole and vonoprazan have more advantages in mucosal erosion healing, there was no significant difference in the comparative safety among all interventions.
Topics: Humans; Proton Pump Inhibitors; Esomeprazole; Network Meta-Analysis; Peptic Ulcer; Rabeprazole; Esophagitis, Peptic; Abdominal Injuries
PubMed: 36451489
DOI: 10.1097/MD.0000000000031807 -
Revista Espanola de Enfermedades... Jun 2023vonoprazan, a novel potassium-competitive acid blocking agent, has better clinical outcomes in the treatment of acid-related diseases. However, some adverse events have... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND AIMS
vonoprazan, a novel potassium-competitive acid blocking agent, has better clinical outcomes in the treatment of acid-related diseases. However, some adverse events have been associated with vonoprazan for the treatment of acid-associated diseases. Therefore, this systematic review and meta-analysis aimed to explore the safety and tolerability of vonoprazan for acid-associated diseases.
METHODS
electronic databases were retrieved to determine randomized controlled trials (RCTs) of vonoprazan for acid-associated diseases with any adverse effects and discontinuation.
RESULTS
this systematic review and meta-analysis conforming to the selection criteria included 18 RCTs with a total of 7,932 participants. Compared with proton pump inhibitors, oral vonoprazan treatment showed no significant increase in the incidence of adverse effects (95 % CI = 0.987-1.095, p = 0.141). Diarrhea or loose stools analysis showed that there was a statistically significant difference between vonoprazan and proton pump inhibitors (PPIs) treatment (95 % CI = 0.661-0.966, p = 0.021). However, there was no significant difference in constipation, rash or eruption, nausea or vomiting, bloating or abdominal pain, dysgeusia, nasopharyngitis, neurological disorders, upper respiratory tract infection and abnormal investigations between vonoprazan and PPIs treatment.
CONCLUSION
vonoprazan, which has better tolerability and safety, may significantly decrease diarrhea and loose stools in acid-related patients compared with PPIs. Our meta-analysis led to safer strategies for treating acid-related diseases. More high-quality studies with larger sample sizes are needed to further elucidate its efficacy and safety.
Topics: Humans; Proton Pump Inhibitors; Constipation; Sulfonamides; Pyrroles; Diarrhea
PubMed: 36353962
DOI: 10.17235/reed.2022.9228/2022 -
Journal of Global Health Oct 2022Infant massage is commonly practiced in many parts of the world. However, the effectiveness of this intervention has not been reviewed for term, healthy newborns.
BACKGROUND
Infant massage is commonly practiced in many parts of the world. However, the effectiveness of this intervention has not been reviewed for term, healthy newborns.
METHODS
This systematic review of randomized and quasi-randomized controlled trials assessed the effect of whole-body massage with or without oil, compared to no massage in term healthy newborns. Key outcomes were neonatal mortality, systemic infections, growth, behaviour (crying or fussing time, sleep duration), and neurodevelopment. We searched MEDLINE via PubMed, Cochrane CENTRAL, EMBASE, and CINAHL (updated till November 2021), and clinical trials databases and reference lists of retrieved articles. Two authors separately evaluated the risk of bias, extracted data, and synthesized effect estimates using mean difference (MD) and standardized mean difference (SMD). The GRADE approach was used to assess the certainty of evidence.
RESULTS
We included 31 randomized and quasi-randomized trials involving 3860 participants. Infant massage was performed by different care providers starting in the neonatal period and continuing for 1-2 months in most studies. Thirteen studies reported the use of oil with body massage. No study reported neonatal mortality or systemic infections. Meta-analyses suggested that whole-body massage may increase infant length at the end of the intervention period (median assessment age 6 weeks; mean difference (MD) = 1.6 cm, 95% confidence interval (CI) = 1.4 to 1.7 cm; low certainty evidence), but the effect on weight (MD = 340 g, 95% CI = 240 to 441 g), head circumference (MD = 0.8 cm, 95% CI = 0.6 to 1.1 cm), sleep duration (MD = 0.62 hours/d, 95% CI = 0.12 to 1.12 hours/d) and bilirubin levels (MD = -31.8 mmol/L or -1.8 mg/dL, 95% CI = -23.5 to -40.0 mmol/L) was uncertain. The effect on crying/fussing time at median 3 months of age, sleep duration at 6 months of age, weight, length, and head circumference at 6-12 months follow-up, and neurodevelopment outcomes, both at the end of the intervention period and follow-up was uncertain.
CONCLUSIONS
Whole-body massage may improve the infant length at the end of the intervention period (median age 6 weeks, range 1-6 months) but the effect on other short- or long-term outcomes is uncertain. There is a need for further well-designed trials in future.
REGISTRATION
Priyadarshi M, Balachander B, Rao S, Gupta S, Sankar MJ. Effect of body massage on growth and neurodevelopment in term healthy newborns: a systematic review. PROSPERO 2020 CRD42020177442.
Topics: Bias; Bilirubin; Humans; Infant; Infant Mortality; Infant, Newborn
PubMed: 36254378
DOI: 10.7189/jogh.12.12005 -
Italian Journal of Pediatrics Oct 2022Neonatal jaundice is a transitional phenomenon affecting three out of five full-term newborns globally. Ursodeoxycholic acid could be beneficial in neonatal jaundice... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Neonatal jaundice is a transitional phenomenon affecting three out of five full-term newborns globally. Ursodeoxycholic acid could be beneficial in neonatal jaundice needing phototherapy. METHODS: We searched PubMed, EBSCO, ProQuest, and Cochrane Library up to August 21, 2021, for articles to be reviewed. Meta-analysis using random-effects model was performed.
RESULTS
Eight studies involving 1116 neonates were chosen in this review; however, only five studies were included for meta-analysis. Phototherapy duration was significantly lower in the interventional group with high heterogeneities. Subgroup analysis of the phototherapy duration based on the risk of bias resulted in a shorter duration (mean difference (MD) = -17.82; 95% CI = -20.17 to -15.47; p = < 0.001) with low heterogeneity in the treatment group. Secondary outcome focusing on mean total serum bilirubin showed a lower mean total serum bilirubin in 48 h post-treatment (MD = -0.43; 95% CI = -0.64 to -0.22; p = < 0.0001) with low heterogeneities in Asian countries."
CONCLUSIONS
Ursodeoxycholic acid might be considered as a novel adjuvant therapy in neonatal indirect hyperbilirubinemia to shorten the phototherapy duration and lower the mean total serum bilirubin.
Topics: Bilirubin; Humans; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Infant, Newborn; Jaundice, Neonatal; Phototherapy; Randomized Controlled Trials as Topic; Ursodeoxycholic Acid
PubMed: 36253867
DOI: 10.1186/s13052-022-01372-w -
Diabetes & Metabolic Syndrome Oct 2022Metformin-treated type 2 diabetes mellitus (T2DM) patients are at higher risk of vitamin B deficiency and more severe neuropathy symptoms. There is still no guideline... (Review)
Review
The efficacy of vitamin B supplementation for treating vitamin B deficiency and peripheral neuropathy in metformin-treated type 2 diabetes mellitus patients: A systematic review.
BACKGROUND AND AIMS
Metformin-treated type 2 diabetes mellitus (T2DM) patients are at higher risk of vitamin B deficiency and more severe neuropathy symptoms. There is still no guideline suggesting vitamin B supplementation for this population. This study aimed to analyze the efficacy of vitamin B supplementation in this population.
METHOD
Studies reporting the efficacy of vitamin B supplementation in metformin-treated T2DM patients were systematically searched in PubMed, Cochrane, EBSCOHost, and Scopus following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline. Additional relevant studies were searched manually through citations. Study quality and risk of bias were assessed using suitable tools.
RESULTS
Seven clinical trials with a total of 506 participants were included. Using the Cochrane's Risk of Bias 2 tools for clinical trials, 4 studies were assessed to have high risk of bias and 3 studies had low risk of bias. There were 5 studies that measured changes in serum vitamin B level, all of which reported a statistically significant increase after supplementation. Significant reductions in homocysteine after supplementation were found in 2 studies. Its effect on neuropathy symptoms was still unclear, with 2 studies reporting a significant improvement and 1 study reporting no significant effect.
CONCLUSIONS
The results of this systematic review support the implementation of vitamin B supplementation for metformin-treated T2DM to prevent or treat vitamin B deficiency and neuropathy. More high-quality clinical studies are required to generate quantitative analysis and to encourage supplementation in available guidelines.
Topics: Humans; Metformin; Diabetes Mellitus, Type 2; Vitamin B 12; Hypoglycemic Agents; Vitamin B 12 Deficiency; Peripheral Nervous System Diseases; Homocysteine; Dietary Supplements; Vitamins
PubMed: 36240684
DOI: 10.1016/j.dsx.2022.102634 -
Cells Oct 2022Major depressive disorder (MDD) and bipolar disorder (BD) with melancholia and psychotic features and suicidal behaviors are accompanied by activated immune-inflammatory... (Meta-Analysis)
Meta-Analysis Review
The Tryptophan Catabolite or Kynurenine Pathway in a Major Depressive Episode with Melancholia, Psychotic Features and Suicidal Behaviors: A Systematic Review and Meta-Analysis.
Major depressive disorder (MDD) and bipolar disorder (BD) with melancholia and psychotic features and suicidal behaviors are accompanied by activated immune-inflammatory and oxidative pathways, which may stimulate indoleamine 2,3-dioxygenase (IDO), the first and rate-limiting enzyme of the tryptophan catabolite (TRYCAT) pathway resulting in increased tryptophan degradation and elevated tryptophan catabolites (TRYCTAs). The purpose of the current study is to systematically review and meta-analyze levels of TRP, its competing amino acids (CAAs) and TRYCATs in patients with severe affective disorders. Methods: PubMed, Google Scholar and SciFinder were searched in the present study and we recruited 35 studies to examine 4647 participants including 2332 unipolar (MDD) and bipolar (BD) depressed patients and 2315 healthy controls. Severe patients showed significant lower ( < 0.0001) TRP (standardized mean difference, SMD = -0.517, 95% confidence interval, CI: -0.735; -0.299) and TRP/CAAs (SMD = -0.617, CI: -0.957; -0.277) levels with moderate effect sizes, while no significant difference in CAAs were found. Kynurenine (KYN) levels were unaltered in severe MDD/BD phenotypes, while the KYN/TRP ratio showed a significant increase only in patients with psychotic features (SMD = 0.224, CI: 0.012; 0.436). Quinolinic acid (QA) was significantly increased (SMD = 0.358, CI: 0.015; 0.701) and kynurenic acid (KA) significantly decreased (SMD = -0.260, CI: -0.487; -0.034) in severe MDD/BD. Patients with affective disorders with melancholic and psychotic features and suicidal behaviors showed normal IDO enzyme activity but a lowered availability of plasma/serum TRP to the brain, which is probably due to other processes such as low albumin levels.
Topics: Albumins; Amino Acids; Depressive Disorder, Major; Humans; Indoleamine-Pyrrole 2,3,-Dioxygenase; Kynurenic Acid; Kynurenine; Quinolinic Acids; Suicidal Ideation; Tryptophan
PubMed: 36231075
DOI: 10.3390/cells11193112