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Therapeutic Apheresis and Dialysis :... Oct 2023The effects of tenapanor in reducing serum phosphorus in hemodialysis patients with hyperphosphatemia are uncertain and no relevant meta-analysis has been conducted. We... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The effects of tenapanor in reducing serum phosphorus in hemodialysis patients with hyperphosphatemia are uncertain and no relevant meta-analysis has been conducted. We performed a meta-analysis of randomized placebo-controlled trials to evaluate the efficacy and safety of tenapanor.
METHODS
All randomized controlled trials of tenapanor were searched up to 1 August 2022. The primary endpoint was the change in serum phosphorus level from baseline with tenapanor and placebo. Data on drug-related adverse events (AEs), gastrointestinal AEs and diarrhea were collected to determine the safety of tenapanor.
RESULTS
There were 533 patients throughout five trials that were eligible. Tenapanor significantly lowered blood phosphorus level by 1.79 mg/dl in the mean difference than the placebo. Diarrhea, gastrointestinal AEs, and drug-related AEs were more severe than placebo.
CONCLUSIONS
This meta-analysis showed that although drug side effects were common, tenapanor significantly reduced serum phosphorus level in hemodialysis patients.
Topics: Humans; Hyperphosphatemia; Double-Blind Method; Renal Dialysis; Diarrhea; Phosphorus; Randomized Controlled Trials as Topic
PubMed: 37349983
DOI: 10.1111/1744-9987.14028 -
European Archives of Psychiatry and... Oct 2023The application of transcranial direct current stimulation (tDCS) at home for the treatment of major depressive disorder (MDD) is the subject of current clinical trials....
UNLABELLED
The application of transcranial direct current stimulation (tDCS) at home for the treatment of major depressive disorder (MDD) is the subject of current clinical trials. This is due to its positive safety profile, cost-effectiveness, and potential scalability for a wide outreach in clinical practice. Here, we provide a systematic review of the available studies and also a report on the results of a randomized controlled trial (RCT) on tDCS at home for the treatment of MDD. This trial had to be prematurely terminated due to safety concerns. The HomeDC trial is a double-blinded, placebo-controlled, parallel-group study. Patients with MDD (DSM-5) were randomized to active or sham tDCS. Patients conducted tDCS at home for 6 weeks with 5 sessions/week (30 min at 2 mA) anode over F3, cathode over F4. Sham tDCS resembled active tDCS, with ramp-in and ramp-out periods, but without intermittent stimulation. The study was prematurely terminated due to an accumulation of adverse events (AEs, skin lesions), so that only 11 patients were included. Feasibility was good. Safety monitoring was not sufficient enough to detect or prevent AEs within an appropriate timeframe. Regarding antidepressant effects, the reduction in depression scales over time was significant. However, active tDCS was not superior to sham tDCS in this regard. Both the conclusions from this review and the HomeDC trial show that there are several critical issues with the use of tDCS at home that need to be addressed. Nevertheless the array of transcranial electric simulation (TES) methods that this mode of application offers, including tDCS, is highly interesting and warrants further investigation in high quality RCTs.
TRIAL REGISTRATION
www.
CLINICALTRIALS
gov .
TRIAL REGISTRATION NUMBER
NCT05172505. Registration date: 12/13/2021, https://clinicaltrials.gov/ct2/show/NCT05172505 . *Consider, if feasible to do so, reporting the number of records identified from each database or register searched (rather than the total number across all databases/registers) **If automation tools were used, indicate how many records were excluded by a human and how many were excluded by automation tools From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. https://doi.org/10.1136/bmj.n71 . For more information, visit: http://www.prisma-statement.org/.
Topics: Humans; Transcranial Direct Current Stimulation; Pilot Projects; Treatment Outcome; Depressive Disorder, Major; Double-Blind Method; Randomized Controlled Trials as Topic
PubMed: 37191697
DOI: 10.1007/s00406-023-01620-y -
International Urogynecology Journal Sep 2023The goal of this meta-analysis was to determine the efficacy and safety of medication for treating overactive bladder (OAB) in patients with Parkinson's disease (PD). (Meta-Analysis)
Meta-Analysis
The efficacy and safety of medication for treating overactive bladder in patients with Parkinson's disease: a meta-analysis and systematic review of randomized double-blind placebo-controlled trials.
INTRODUCTION AND HYPOTHESIS
The goal of this meta-analysis was to determine the efficacy and safety of medication for treating overactive bladder (OAB) in patients with Parkinson's disease (PD).
METHODS
Papers containing predefined key terms were searched in the PubMed, Embase, Web of Science, and Cochrane Library databases up to December 2021 to collect randomized double-blind placebo-controlled trials (RCTs). The review process followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statements. Two reviewers independently assessed the risk of bias using the modified Jadad scale and Cochrane risk-of-bias tool. The GRADEpro GDT was employed to evaluate the strength of evidence based on the findings of this meta-analysis.
RESULTS
We eventually included four RCTs involving 313 patients (163 patients in the medication group and 150 patients in the placebo group). Of these, the therapeutic agent in two RCTs was mirabegron (121 and 106 patients and controls, respectively, representing 3/4 -2/3 of the patients). The results showed that the number of micturition episodes per 24 h (MD -1.33; 95% CI -2.30 to -0.36; p = 0.007), the number of nocturia episodes per 24 h (MD -0.33; 95% CI -0.58 to -0.08; p = 0.009) and the number of urinary incontinence episodes per 24 h (MD -0.72; 95% CI -1.32 to -0.12; p = 0.02) were significantly lower in the medication group than in the placebo group. The OAB symptom score (MD -2.84; 95% CI -4.67 to -1.00; p = 0.002) and quality of life score (MD 15.15; 95% CI 12.33 to 17.96; p < 0.0001) of the medication group were significantly improved compared with those of the placebo group. However, no significant difference in the daily frequency of urinary urgency episodes was identified between the medication group and the placebo group (MD -0.79; 95% CI -1.71 to 0.14; p = 0.09). There were no significant differences between the two groups in terms of drug-related adverse events (OR 1.69; 95% CI 0.41 to 6.99; p = 0.47), especially in PD patients receiving mirabegron therapy.
CONCLUSIONS
Medication was effective for OAB symptoms in patients with PD, and patients tolerated adverse events well.
Topics: Humans; Urinary Bladder, Overactive; Parkinson Disease; Quality of Life; Acetanilides; Double-Blind Method; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 37052644
DOI: 10.1007/s00192-023-05528-y -
Neuromodulation : Journal of the... Dec 2023Transcranial alternating current stimulation (tACS) has been one of numerous investigation methods used for their potential to modulate brain oscillations; however, such... (Review)
Review
BACKGROUND
Transcranial alternating current stimulation (tACS) has been one of numerous investigation methods used for their potential to modulate brain oscillations; however, such investigations have given contradictory results and a lack of standardization.
OBJECTIVES
In this systematic review, we aimed to assess the potential of tACS to modulate alpha spectral power. The secondary outcome was the identification of tACS methodologic key parameters, adverse effects, and sensations.
MATERIALS AND METHODS
Studies in healthy adults who were receiving active and sham tACS intervention or any differential condition were included. The main outcome assessed was the increase/decrease of alpha spectral power through either electroencephalography or magnetoencephalography. Secondary outcomes were methodologic parameters, sensation reporting, and adverse effects. Risks of bias and the study quality were assessed with the Cochrane assessment tool.
RESULTS
We obtained 1429 references, and 20 met the selection criteria. A statistically significant alpha-power increase was observed in nine studies using continuous tACS stimulation and two using intermittent tACS stimulation set at a frequency within the alpha range. A statistically significant alpha-power increase was observed in three more studies using a stimulation frequency outside the alpha range. Heterogeneity among stimulation parameters was recognized. Reported adverse effects were mild. The implementation of double blind was identified as challenging using tACS, in part owing to electrical artifacts generated by stimulation on the recorded signal.
CONCLUSIONS
Most assessed studies reported that tACS has the potential to modulate brain alpha power. The optimization of this noninvasive brain stimulation method is of interest mostly for its potential clinical applications with neurological conditions associated with perturbations in alpha brain activity. However, more research efforts are needed to standardize optimal parameters to achieve lasting modulation effects, develop methodologic alternatives to reduce experimental bias, and improve the quality of studies using tACS to modulate brain activity.
Topics: Adult; Humans; Transcranial Direct Current Stimulation; Alpha Rhythm; Electroencephalography; Brain; Sensation; Randomized Controlled Trials as Topic
PubMed: 36725385
DOI: 10.1016/j.neurom.2022.12.007 -
Cardiovascular Drugs and Therapy Jun 2024The benefits of statins for ischemic cardio-cerebrovascular diseases are well known. However, concerns around muscle adverse events still exist. We therefore aimed to... (Meta-Analysis)
Meta-Analysis Comparative Study
PURPOSE
The benefits of statins for ischemic cardio-cerebrovascular diseases are well known. However, concerns around muscle adverse events still exist. We therefore aimed to compare the muscle safety of individual statins in adults.
METHODS
PubMed, Embase, Cochrane Central Register of Controlled Trials and Web of Science were searched to include double-blind randomized controlled trials (RCTs) comparing one statin with another or with control treatment. Pairwise meta-analyses and network meta-analyses were undertaken with Stata 14.0 software. Relative risk (RR) with 95% confidence intervals (CIs) was adopted for each outcome.
RESULTS
A total of 83 RCTs were included. In the pairwise meta-analysis, statins were significantly associated with only a slight increase in muscle symptoms compared with control (RR=1.05; 95% CI=1.01-1.09). In the drug-level network meta-analyses, no statistically significant difference was found between individual statins in the incidence of muscle symptoms, myalgia, myopathy, rhabdomyolysis, creatine kinase (CK) >10 times the upper limit of normal (ULN) or discontinuation due to muscle adverse events. In the dose-level network meta-analyses, there were no statistically significant dose-dependent effects on any outcomes except that moderate-intensity statins had a higher incidence of muscle symptoms than control (RR=1.13; 95% CI=1.01-1.27). Moderate simvastatin (RR=6.57; 95% CI=1.26-34.41) and moderate pravastatin (RR=5.96; 95% CI=1.00-35.44) had a statistically significantly higher incidence of CK >10×ULN compared with moderate atorvastatin. Lipophilic statins and statins metabolized by liver cytochrome P450 3A4 were not associated with an increased risk of muscle adverse events.
CONCLUSION
Statins may be generally safe on muscle. Moderate atorvastatin may be superior to equivalent simvastatin and pravastatin in muscle tolerability.
Topics: Hydroxymethylglutaryl-CoA Reductase Inhibitors; Humans; Randomized Controlled Trials as Topic; Muscular Diseases; Network Meta-Analysis; Double-Blind Method; Atorvastatin; Muscle, Skeletal; Myalgia; Rhabdomyolysis
PubMed: 36447018
DOI: 10.1007/s10557-022-07405-0 -
Trends in Cardiovascular Medicine Feb 2024Treatment strategies that modulate autonomic tone through interventional and device-based therapies have been studied as an adjunct to pharmacological treatment of heart... (Meta-Analysis)
Meta-Analysis Review
Treatment strategies that modulate autonomic tone through interventional and device-based therapies have been studied as an adjunct to pharmacological treatment of heart failure with reduced ejection fraction (HFrEF). The main objective of this study was to perform a meta-analysis of randomized controlled trials which evaluated the efficacy of device-based autonomic modulation for treatment of HFrEF. All randomized-controlled trials testing autonomic neuromodulation device therapy in HFrEF were included in this trial-level analysis. Autonomic neuromodulation techniques included vagal nerve stimulation (VNS), baroreflex activation (BRA), spinal cord stimulator (SCS), and renal denervation (RD). The prespecified primary endpoints included mean change and 95% confidence intervals (CI) of left ventricular ejection fraction (LVEF), NT pro-B-type natriuretic peptide (NT-proBNP), and quality of life (QOL) measures including 6-minute hall walk distance (6-MHWD), and Minnesota Living with Heart Failure Questionnaire (MLHFQ). New York Heart Association (NYHA) functional class improvement was reported as odds ratios and 95% CI of improvement by at least 1 functional class. Eight studies were identified that included 1037 participants (2 VNS, 2 BRA, 1 SCS, and 3 RD trials). This included 6 open-label, 1 single-blind, and 1 sham-controlled, double-blind study. The mean age (±SD) was 61 (±9.3) years. The mean follow-up time was 7.9 months. Twenty percent of the total patients were female, and the mean BMI (±SD) was 29.86 (±4.12). Autonomic neuromodulation device therapy showed a statistically significant improvement in LVEF (4.02%; 95% CI 0.24,7.79), NT-proBNP (-219.80 pg/ml; 95% CI -386.56, -53.03), NYHA functional class (OR 2.32; 95% CI 1.76, 3.07), 6-MHWD (48.39 m; 95% CI 35.49, 61.30), and MLHFQ (-12.20; 95% CI -19.24, -5.16) compared to control. In patients with HFrEF, the use of autonomic neuromodulation device therapy is associated with improvement in LVEF, reduction in NT-proBNP, and improvement in patient-centered QOL outcomes in mostly small open-label trials. Large, double-blind, sham-controlled trials designed to detect differences in hard cardiovascular outcomes are needed before widespread use and adoption of autonomic neuromodulation device therapies in HFrEF.
Topics: Humans; Female; Middle Aged; Aged; Male; Heart Failure; Stroke Volume; Ventricular Function, Left; Quality of Life; Single-Blind Method; Randomized Controlled Trials as Topic
PubMed: 36202286
DOI: 10.1016/j.tcm.2022.09.007 -
The International Journal of... Dec 2023The optimal dose of galcanezumab for patients with migraine remains uncertain. Therefore, we conducted a network meta-analysis to assess the comparative effectiveness of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The optimal dose of galcanezumab for patients with migraine remains uncertain. Therefore, we conducted a network meta-analysis to assess the comparative effectiveness of various doses of galcanezumab for this group of patients.
METHODS
A systematically search was implemented in several databases including the PubMed, Ovid MEDILNE, Ovid EMBASE and Cochrane Library from inception of the databases until 31 August 2020. Only randomized clinical trials of adults with migraine that assessed galcanezumab therapy and reported clinical outcomes were included. The primary efficacy outcome was monthly change in migraine headache days (MHDs). The primary safety outcome was treatment-emergent adverse events (TEAEs).
RESULTS
Overall, eight randomized clinical trials included 4,720 patients, were assessed in our systematic review. In terms of efficacy, galcanezumab 120 and 240 mg significantly reduced monthly MHDs (MD -2.02, 95% CrI -2.62 to -1.42; MD -2.06, 95% CrI -2.74 to -1.36, respectively) compared to the placebo. In terms of safety, galcanezumab 120, 150 mg and 240 mg significantly increased incidences of adverse events (RR 1.11, 95% CrI 1.03-1.20; RR 1.85, 95% CrI 1.27-2.81; RR 1.15, 95% CrI 1.06-1.24, respectively).
CONCLUSIONS
Galcanezumab 240 mg offers the first level in terms of efficacy outcomes and galcanezumab 150 mg ranks the first level in terms of increasing treatment-emergent adverse events among adult patients with migraine. Attention should be devoted to the potential risk of adverse events, especially for injection site pain when the drug is administered subcutaneously.
Topics: Adult; Humans; Treatment Outcome; Double-Blind Method; Antibodies, Monoclonal, Humanized; Migraine Disorders
PubMed: 35815440
DOI: 10.1080/00207454.2022.2098732