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Mymensingh Medical Journal : MMJ Jan 2024Biosimilars are known to be pharmaceutical products which are very similar to a biologic drug. FKB327 is one such biosimilar of the drug Adalimumab which is prescribed...
Biosimilars are known to be pharmaceutical products which are very similar to a biologic drug. FKB327 is one such biosimilar of the drug Adalimumab which is prescribed in treating autoimmune diseases like Rheumatoid Arthritis. The aim of this review is to evaluate the efficacy, immunogenicity and safety of the drug FKB327 in treating patients with mild to moderate Rheumatoid Arthritis and compare the same with that of the drug Adalimumab. Two databases (PubMed and Cochrane Library) were used to screen relevant publications using pre-determined inclusion and exclusion criteria. Of the 12 studies found to be relevant, 3 were found to be eligible for the review. The data were extracted for the study characteristics, outcome measures, complications, and safety. The quality of the papers was assessed through Jadad scoring. Three (3) papers were reviewed in the study although there were limitations in reviewing efficacy as one of the papers lacked required data for efficacy. Efficacy was observed through ACR20 response and DAS28 score in the 24th week of all the three studies and immunogenicity was reviewed through the presence of Anti-drug antibody in patients after administration of both the drugs in same dosage. Safety was assessed through the development of complications after the administration of the drugs. The review concludes that there are similarities in efficacy, immunogenicity and safety between FKB327 but could not adequately prove the superiority of FKB327 over Adalimumab.
Topics: Humans; Adalimumab; Antirheumatic Agents; Arthritis, Rheumatoid; Biosimilar Pharmaceuticals; Double-Blind Method; Treatment Outcome
PubMed: 38163811
DOI: No ID Found -
Frontiers in Medicine 2023Pudendal nerve block (PNB) is a commonly used anesthesia method that has been widely used in postoperative analgesia for hemorrhoids in recent years. Therefore, we...
BACKGROUND
Pudendal nerve block (PNB) is a commonly used anesthesia method that has been widely used in postoperative analgesia for hemorrhoids in recent years. Therefore, we conducted a systematic review and meta-analysis of double-blind randomized controlled trials (RCTs) to analyze the effectiveness of PNB in postoperative analgesia for hemorrhoids.
METHODS
Relevant data and studies published from inception until August 14, 2023, were retrieved from PubMed, Embase, and Web of Science to evaluate the beneficial effects of PNB for analgesia following hemorrhoidectomy.
RESULTS
This meta-analysis included 6 double-blind RCTs comprising 501 patients. We evaluated the function of PNB in improving outcomes of postoperative analgesia of hemorrhoids. Visual analogue scale (VAS) scores on postoperative within 6 h (MD, -3.04; 95% CI, -4.13 to -1.95; < 0.0001), 12 h (MD, -3.14; 95% CI, -3.87 to -2.40; < 0.0001), and 24 h (MD, -2.25; 95% CI, -2.95 to -1.55; < 0.0001) were enhanced by the application of PNB, but not in 48 h (MD, -2.54; 95% CI, -5.29 to 0.20; = 0.07).
CONCLUSION
Pudendal nerve block (PNB) could effectively relieve postoperative pain of hemorrhoids. However, our results still need to be confirmed by multi-center clinical studies.
PubMed: 38152300
DOI: 10.3389/fmed.2023.1283512 -
European Journal of Clinical... Feb 2024To systematically assess the evidence of efficacy and safety of the use of ketamine and esketamine for patients with treatment-resistant depression (TRD) with suicidal... (Meta-Analysis)
Meta-Analysis
PURPOSE
To systematically assess the evidence of efficacy and safety of the use of ketamine and esketamine for patients with treatment-resistant depression (TRD) with suicidal ideation (SI).
METHODS
We independently searched for clinical trials from inception to January 2023 using electronic databases, e.g., PubMed and EMBASE. A systematic review and meta-analysis were performed to assess SI scores of depression rating scales, which were regarded as the outcomes.
RESULTS
A total of five independent double-blind, placebo controlled randomized clinical trials (RCTs) are eligible for inclusion. Four of the studies used ketamine as an intervention and one used esketamine as an intervention. Three hundred ninety-one patients with TRD were included (the intervention group with ketamine or esketamine is 246, and the control group is 145). No statistically significant interaction between the subscales of suicide ideation (SMD = - 0.66, 95% CI (- 1.61, 0.29); Z = 1.36, P = 0.17) and antidepressant effects (SMD = - 0.99, 95% CI (- 2.33, 0.34); Z = 1.46, P = 0.15) based on the results of ketamine and esketamine, compared with placebo groups.
CONCLUSION
This meta-analysis suggested that esketamine and ketamine have failed to reduce suicidal ideation in patients with TRD. Further studies are desirable to confirm the effects of ketamine and esketamine in TRD patients.
Topics: Humans; Ketamine; Suicidal Ideation; Depression; Administration, Intranasal; Double-Blind Method; Randomized Controlled Trials as Topic
PubMed: 38117332
DOI: 10.1007/s00228-023-03605-1 -
Journal of Attention Disorders Feb 2024The present study aimed to meta-analytically estimate the dose-response relationship of atomoxetine for treating children with ADHD. (Meta-Analysis)
Meta-Analysis
The Dose-Response Relationship of Atomoxetine for the Treatment of Children With ADHD: A Systematic Review and Dose-Response Meta-Analysis of Double-Blind Randomized Placebo-Controlled Trials.
OBJECTIVES
The present study aimed to meta-analytically estimate the dose-response relationship of atomoxetine for treating children with ADHD.
METHODS
We systematically searched double-blind randomized placebo-controlled trials that evaluated the effectiveness of atomoxetine for treating ADHD in children. The search was carried out in PubMed, Cochrane Library, CINHAL, and ClinicalTrials.gov databases, covering articles from their inception until January 20, 2023. In addition, a dose-response meta-analysis was conducted.
RESULTS
In this dose-response meta-analysis, 12 double-blind randomized placebo-controlled trials involving 2,250 patients were included. The efficacy of atomoxetine increased up to a dosage of 1.4 mg/kg, after which it reached a plateau.
CONCLUSIONS
The first dose-response meta-analysis of atomoxetine dosing for children with ADHD conducted here enhances the robustness of the Food and Drug Administration and the European Medicines Agency dose recommendations.
Topics: Child; Humans; Atomoxetine Hydrochloride; Attention Deficit Disorder with Hyperactivity; Propylamines; Double-Blind Method; Adrenergic Uptake Inhibitors; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 38069471
DOI: 10.1177/10870547231214988 -
The Journal of Headache and Pain Dec 2023Chronic migraine can be a profoundly disabling disorder that may be treated with preventive medications. However, uncertainty remains as to which preventive medication... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Chronic migraine can be a profoundly disabling disorder that may be treated with preventive medications. However, uncertainty remains as to which preventive medication is the most effective. We present a network meta-analysis to determine the effectiveness and rank of preventive drugs for chronic migraine in adults.
METHODS
We identified, reviewed, and extracted data from randomised controlled trials (RCTs) of preventive drugs for chronic migraine with at least 200 participants. Data were analysed using network meta-analysis.
FINDINGS
We included 12 RCTs of six medications (Eptinezumab, Erenumab, Fremanezumab, Galcanezumab, Onabotulinumtoxin A, and Topiramate) compared to placebo or each other. All drugs effectively reduced monthly headache and migraine days compared with placebo. The most effective drug for monthly headache days was Eptinezumab 300mg, with a mean difference of -2.46 days, 95% Credible Interval (CrI): -3.23 to -1.69. On the Surface Under the Cumulative Ranking Area (SUCRA) analysis, the probability that Eptinezumab 300mg was ranked highest was 0.82. For monthly migraine days, the most effective medication was Fremanezumab-monthly, with a mean difference: -2.77 days, 95% CrI: -3.36 to -2.17, and 0.98 probability of being ranked the highest. All included drugs, except Topiramate, improved headache-related quality of life. No eligible studies were identified for the other common preventive oral medications such as Amitriptyline, Candesartan, and Propranolol. The main reasons were that the studies did not define chronic migraine, were undertaken before the definition of chronic migraine, or were too small.
INTERPRETATION
All six medications were more effective than the placebo on monthly headache and migraine days. The absolute differences in the number of headache/migraine days are, at best, modest. No evidence was found to determine the relative effectiveness of the six included drugs with other oral preventive medications.
REGISTRATION
PROSPERO (number CRD42021265990).
Topics: Adult; Humans; Topiramate; Network Meta-Analysis; Migraine Disorders; Treatment Outcome; Headache; Double-Blind Method
PubMed: 38057728
DOI: 10.1186/s10194-023-01696-w -
Psychiatry Research Jan 2024Addiction is a substantial health concern; craving-the core symptom of addiction-is strongly associated with relapse. Transcranial direct current stimulation (tDCS) is a... (Meta-Analysis)
Meta-Analysis
Addiction is a substantial health concern; craving-the core symptom of addiction-is strongly associated with relapse. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that reduces cravings by altering cortical excitability and connectivity in brain regions. This systematic review and meta-analysis was conducted (following the PRISMA guidelines) to evaluate the efficacy of tDCS in reducing cravings for substances. Our analysis included 43 randomized, sham-controlled trials involving 1,095 and 913 participants receiving tDCS and sham stimulation, respectively. We analyzed the changes in craving scores and found that tDCS led to a moderate reduction in cravings compared with the sham effects. This effect was particularly pronounced when bilateral stimulation was used, the anodal electrode was placed on the right dorsolateral prefrontal cortex, current intensities ranged from 1.5 to 2 mA, stimulation sessions lasted 20 minutes, and the electrodes size was ≥35 cm². Notably, tDCS effectively reduced cravings for opioids, methamphetamine, cocaine, and tobacco but not for alcohol or cannabis. Our findings indicate tDCS as a promising, noninvasive, and low-risk intervention for reducing cravings for opioids, methamphetamine, cocaine, and tobacco. Additional studies are warranted to refine stimulation parameters and evaluate the long-term efficacy of tDCS in managing substance cravings.
Topics: Humans; Transcranial Direct Current Stimulation; Craving; Prefrontal Cortex; Substance-Related Disorders; Methamphetamine; Cocaine; Double-Blind Method
PubMed: 38043411
DOI: 10.1016/j.psychres.2023.115621 -
Psychiatry Research Jan 2024Major depressive disorder (MDD) and postpartum depression (PPD) are common and burdensome conditions. This study aims to evaluate the efficacy and safety of zuranolone,... (Meta-Analysis)
Meta-Analysis Review
Major depressive disorder (MDD) and postpartum depression (PPD) are common and burdensome conditions. This study aims to evaluate the efficacy and safety of zuranolone, a neuroactive steroid γ-aminobutyric acid type A receptors-positive allosteric modulator, in treating MDD and PPD. A comprehensive literature search was conducted until September 2023, identifying seven randomized controlled trials (RCTs). The results demonstrated that zuranolone significantly decreased Hamilton Rating Scale for Depression (HAM-D) scores in patients with PPD or MDD at day 15 (concluding the 14-day course) and day 42-45 (4 weeks after treatment cessation) compared with the placebo, albeit exhibiting a diminishing trend. Moreover, a higher percentage of patients with PPD or MDD achieved HAM-D response and remission with zuranolone treatment compared with placebo at day 15. However, zuranolone did not significantly increase the proportion of MDD patients achieving HAM-D remission at 42/43 days. Adverse events (AEs) such as somnolence, dizziness, and sedation were linked to zuranolone, with a higher but not statistically significant rate of discontinuation due to AEs in the zuranolone group. Overall, our findings support the rapid antidepressant effects of zuranolone in MDD and PPD, along with a relatively favorable safety and tolerability. Large-scale longitudinal RCTs are needed to evaluate the long-term efficacy of zuranolone.
Topics: Female; Humans; Depression; Antidepressive Agents; Pregnanolone; Depressive Disorder, Major; Treatment Outcome; Double-Blind Method
PubMed: 38029628
DOI: 10.1016/j.psychres.2023.115640 -
Pediatric Dermatology 2024Itch is one of the hallmarks of atopic dermatitis (AD), which has a significant impact on the quality of life of pediatric patients with AD and their caregivers. We... (Meta-Analysis)
Meta-Analysis
BACKGROUND/OBJECTIVES
Itch is one of the hallmarks of atopic dermatitis (AD), which has a significant impact on the quality of life of pediatric patients with AD and their caregivers. We aimed to conduct a systematic review and meta-analysis to evaluate the antipruritic effects of systemic AD treatments in pediatric patients with AD.
METHODS
PubMed, EMBASE, Cochrane, and Web of Science databases were searched, including studies providing original data on the effects of systemic treatment on pruritus in pediatric patients (<18 years) with AD. Placebo-controlled trials reporting a Peak Pruritus Numerical Rating Scale 4 (PP-NRS4) response were included in a meta-analysis.
RESULTS
A total of 30 studies were included, with most evidence available for dupilumab. Overall, marked improvements of pruritus (50% or greater reduction in pruritus outcome measurements) were found for treatment with cyclosporin A (2-16 years), dupilumab (6 months-17 years), abrocitinib, and upadacitinib (both 12 and 17 years). Nemolizumab (12-17 years) may be promising in reducing pruritus in pediatric patients; however, data are limited. Only five randomized controlled trials could be included in our meta-analysis, in which dupilumab, abrocitinib, and upadacitinib showed a significantly higher probability of achieving a PP-NRS4 response compared with placebo. Our study was limited by a lack of homogeneity of included studies.
CONCLUSIONS
Cyclosporin A, dupilumab, abrocitinib, and upadacitinib are all effective in decreasing pruritus and, therefore, in improving the quality of life in children with AD. As more systemic treatments for AD become available, it will be imperative to incorporate patient-oriented treatment goals such as reduction of pruritus into therapeutic decision-making.
Topics: Humans; Child; Dermatitis, Atopic; Cyclosporine; Quality of Life; Treatment Outcome; Pruritus; Severity of Illness Index; Double-Blind Method; Pyrimidines; Sulfonamides
PubMed: 38018272
DOI: 10.1111/pde.15468 -
The Journal of Clinical Pediatric... Nov 2023Over the last few years, numerous reports have lauded the efficacy of articaine hydrochloride as a local anesthetic (LA) in dental procedures. Numerous studies have... (Meta-Analysis)
Meta-Analysis
Over the last few years, numerous reports have lauded the efficacy of articaine hydrochloride as a local anesthetic (LA) in dental procedures. Numerous studies have shown that articaine outperforms lidocaine in various aspects of dental treatment, leading to its widespread adoption in both adults and children. Despite the publications of comparative studies, there remains a dearth of systematic reviews examining the adverse effects of articaine versus lidocaine in randomized controlled trials. The aim was to assess the available research on the adverse effects of articaine and lidocaine in pediatric dentistry. A comprehensive search was conducted on Cochrane Library, Pubmed, Chinese Biomedical Literature Database (CBM), Embase, Web of Science and China National Knowledge Infrastructure (CNKI). Randomized controlled trials (RCT) that compared articaine with lidocaine in pediatric dentistry were included. Methodological quality assessment and risk of bias were determined for each of the included studies. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach was used to assess the strength of evidence for every research. A total of 333 studies were identified through electronic searches. After conducting primary and secondary assessments, eight studies were included for the final qualitative analysis. We found no difference in the probability of adverse reactions between articaine and lidocaine after treatment in pediatric patients (risk ratio (RR) = 1.08, 95% confidence interval (CI) (0.54-2.15), = 0.83). However, a high heterogeneity was reported among the outcomes in the investigated studies (I = 57%), and the strength of the evidence was classified as "moderate" based on the GRADE approach. Besides, we found no significant difference in the probability of postoperative pain, postoperative soft tissue injury and edema between articaine and lidocaine in pediatric patients following treatment. There was moderate quality evidence suggesting no difference in the occurrence of adverse events between articaine and lidocaine when used for pediatric dental procedures.
Topics: Adult; Humans; Child; Lidocaine; Carticaine; Pediatric Dentistry; Anesthesia, Dental; Systematic Reviews as Topic; Anesthetics, Local; Double-Blind Method; Mandibular Nerve
PubMed: 37997231
DOI: 10.22514/jocpd.2023.078 -
Clinical NeuropharmacologyAcute traumatic brain injury is one of the most common causes of death and disability. Reduction in the level of consciousness is a significant complication that can...
OBJECTIVES
Acute traumatic brain injury is one of the most common causes of death and disability. Reduction in the level of consciousness is a significant complication that can impact morbidity. Glasgow Coma Scale (GCS) is the most widely used method of assessing the level of consciousness. Neurostimulants such as amantadine and modafinil are common pharmacologic agents that increase GCS in patients with brain trauma. This study aimed to compare the effectiveness of these 2 drugs.
METHODS
This systematic review obtained articles from Google Scholar, PubMed, Scopus, Embase, and MEDLINE databases. Extensive searches were conducted separately by 4 individuals in 3 stages. Ultimately, 16 clinical trials, cohort studies, case reports, and case series articles were obtained after reading the title, abstract, and full text and considering the exclusion criteria. The data of the final article were entered into the analysis table. This study was registered with PROSPERO (registration number CRD42022334409) and conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
RESULTS
Amantadine seems to be associated with a higher overall response rate. In contrast, modafinil is associated with the most remarkable change in GCS score during treatment. However, the number of clinical trials with high quality and sample size has not been satisfactory to compare the effectiveness of these 2 drugs and their potential side effects.
CONCLUSIONS
The authors recommend additional double-blind clinical trials are needed to be conducted with a larger sample size, comparing amantadine with modafinil to delineate the efficacy and adverse effects, both short and long term.
Topics: Humans; Modafinil; Consciousness; Brain Injuries, Traumatic; Amantadine; Brain Injuries; Randomized Controlled Trials as Topic
PubMed: 37962310
DOI: 10.1097/WNF.0000000000000577