Evaluation of efficacy and safety of a herbal formulation Cystone in the management of urolithiasis: Meta-analysis of 50 clinical studies

10.5580/15ea ◽  
2010 ◽  
Vol 8 (1) ◽  
Keyword(s):  
Clinical Studies ◽  
Meta Analysis ◽  
Efficacy And Safety ◽  
Herbal Formulation

scholarly journals The Effects of a Fixed Combination of Berberis aristata and Silybum marianum on Dyslipidaemia – A Meta-analysis and Systematic Review

Planta Medica ◽  
2019 ◽  
Vol 86 (02) ◽  
pp. 132-143
Author(s):  
Barbara Tóth ◽  
Dávid Németh ◽  
Alexandra Soós ◽  
Péter Hegyi ◽  
Gréta Pham-Dobor ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Clinical Studies ◽  
Fixed Combination ◽  
Meta Analysis ◽  
Density Lipoprotein ◽  
Optimum Dose ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Silybum Marianum ◽  
Lipoprotein Level

AbstractA fixed combination of Berberis aristata and Silybum marianum (Berberol) has been used by patients with dyslipidaemia. The aim of the present meta-analysis was to systematically evaluate the efficacy and safety of a fixed combination of B. aristata and S. marianum (Berberol) on serum lipid levels compared to placebo in a meta-analysis based on randomised, controlled trials. The meta-analysis was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, using the PICO (patients, intervention, comparison, outcome) format, and it was registered in the International Prospective Register of Systematic Reviews. The Cochrane Central Register of Controlled Trials, PubMed, Embase, and Web of Science databases were searched for relevant studies. Placebo-controlled clinical studies involving adult patients with a condition of dyslipidaemia and receiving a fixed combination of B. aristata and S. marianum were included. Four randomised trials, including a total of 491 patients, were pooled in statistical analysis. According to the present meta-analysis, Berberol significantly lowered the low-density lipoprotein level, total cholesterol, fasting plasma glucose levels, and the Homeostatic Model Assessment index compared to placebo; however, its effects on the high-density lipoprotein level, triglyceride level, and body mass index were not statistically significant by the end of a 3-month treatment period. Berberol appeared to be safe, and it did not increase the levels of alanine transaminase, aspartate transaminase, and creatine kinase enzymes. Berberol is an effective and presumably safe complementary therapy for the treatment of dyslipidaemia; however, the evidence supporting its use is very limited. The optimum dose and duration of treatment are unclear. A comprehensive evaluation of efficacy and safety is required in further high-quality clinical studies involving larger patient populations.

scholarly journals Current Evidence of Mesenchymal Stem Cells Use in the Treatment of Tendon Disorders: A Systematic Review, Meta-analysis, and Meta-regression of Prospective Clinical Studies

2020 ◽  
Author(s):  
Woo Sup Cho ◽  
Sun Gun Chung ◽  
Won Kim ◽  
Chris H. Jo ◽  
Shi-Uk Lee ◽  
...  
Keyword(s):  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Clinical Studies ◽  
Meta Analysis ◽  
Mean Difference ◽  
Efficacy And Safety ◽  
Cell Dose ◽  
Human Tendon ◽  
Meta Regression ◽  
Standardized Mean Difference

Abstract Purpose: Although several studies with animals have reported the effects of mesenchymal stem cells (MSCs) for tendon regeneration, little is known about the efficacy and safety of MSCs in human tendon disorders. We performed this meta-analysis to evaluate the efficacy and safety of MSC therapy in patients with tendon disorders enrolled in prospective clinical studies.Methods: We systematically searched prospective clinical studies investigating the effects of MSCs administration on human tendon disorders with at least a 6-month follow-up period on PubMed-Medline, Embase, and Cochrane Library databases. The primary outcome of interest was the change in pain on motion related to tendon disorders. We performed a pairwise meta-analysis using the fixed-effects model to assess treatment response, which was calculated by the standardized mean difference. Meta-regression analyses were performed to assess the relationship between MSCs dose and pooled effect sizes in each cell dose.Results: Four prospective clinical trials investigating the effect of MSCs on tendon disorders were retrieved. MSCs showed significant pooled effect size (overall Hedge’s g pooled standardized mean difference (SMD) = 1.868; 95% confidence interval [CI], 1.274–2.462; P < 0.001). The treatment with MSCs improved all the aspects analyzed, i.e. pain, functional scores, radiologic parameters (magnetic resonance image or ultrasonography), and arthroscopic findings. In the meta-regression analysis, there was a significant cell dose-dependent response in pain relief (Q = 9.06, P = 0.029). While three studies reported mild adverse events after MSCs injection, these were not severe and relieved spontaneously.Conclusions: Our meta-analysis revealed that MSC therapy may improve pain, function, radiologic, and arthroscopic parameters in patients with tendon disorders. Due to the small number of studies in this meta-analysis and considering the increasing MSCs applications, there is a strong need for large-scale randomized controlled trials to confirm the long-term functional improvement as well as the adverse effects of MSC therapies in tendon disorders.

scholarly journals Efficacy and Safety of Ayush-64 as standalone or adjunct to standard care in COVID-19: A Structured Summary of Protocol for a Systematic Review

2021 ◽  
Author(s):  
Amit Kumar Rai ◽  
Azeem Ahmad ◽  
Pallavi Suresh Mundada ◽  
Krishna Kumar ◽  
Babita Yadav ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Studies ◽  
Standard Care ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Therapeutic Interventions ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Early Recovery

Abstract Background: Apart from vaccines, significant efforts have been made to develop prophylactic and therapeutic interventions against COVID-19. Lack of standard therapeutic options for the management of COVID-19 contributes to seriousness of this novel disease. The current strategy for exploring therapeutic interventions to manage this pandemic is broadly based on repurposing and repositioning of existing medications and recommending them for symptomatic support. In the early stage of COVID-19, the interventions that limit the progression of the disease and facilitate early recovery may play a significant role. AYUSH‑64 is a polyherbal Ayurveda formulation developed by the CCRAS, Ministry of Ayush, Government of India. It has been found effective and safe in various infective febrile conditions like malaria, microfilaremia, chikungunya, and influenza [1-5]. AYUSH‑64, was repurposed for the management of asymptomatic and mild to moderate COVID-19 based on the experimental and clinical outcomes indicating its potential benefits and safety in disease conditions like influenza‑like illness. Government of India recommended the use of AYUSH-64 to manage the asymptomatic and mild COVID-19 cases on the basis of outcomes of clinical studies on AYUSH-64 in COVID-19 [6,7]. In this context, this systematic review is planned to synthesize evidence related to the safety and efficacy of AYUSH-64 as standalone or adjunct to standard care in managing asymptomatic and mild to moderate COVID-19. Methods: The PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-analyses- Protocol statement) guidelines have been followed for drafting this protocol. All Randomized Controlled trials that assess the efficacy and safety of AYUSH-64 for the management of COVID-19 as standalone or adjunct to conventional standard care will be considered for this systematic review. Comprehensive search will be done for the published studies as per the pre-designed search strategy in the electronic databases such as AYUSH Research Portal’s “National Repository on AYUSH COVID-19 Clinical and Other R&D Initiatives”, PubMed, Cochrane Central Register of Controlled Trials, DHARA, IndMED, COVID-19 Evidence Alerts from McMaster PLUSTM, Epistemonikos, TRIP database, Google Scholar, National Collaborating Centre for Methods and Tools database of COVID-19 studies, Clinical Trial Registry of India and WHO dashboard for clinical trials related to COVID-19 from inception till October 2021. Data selection and extraction for each study will be performed independently by two review authors, with disagreements resolved by discussion with third review author/consensus. Risk of bias assessment will be performed using the revised tool to assess the risk of bias in randomized trials (RoB 2). The results will be quantitatively synthesized (meta-analysis) using Review Manager 5.4. If meta-analysis will not be conducive due to substantial heterogeneity, we will summarize and explain the results of the included studies as the systematic qualitative synthesis.Discussion: To date, this will be the first systematic review on the Ayurveda intervention, AYUSH-64 that will synthesize the evidence on its efficacy and safety in the management of COVID-19. The pilot search undertaken before planning this systematic review resulted in 07 clinical studies on AYUSH-64 that evaluate its efficacy and safety in the management of COVID-19. These search results justify the initiation of this systematic review. This systematic review will help the policy makers for its wider implementation in the management of asymptomatic and mild to moderate COVID-19. The results of this systematic review will be published in an indexed open-access journal to ensure wider dissemination.

scholarly journals Current Evidence of Mesenchymal Stem Cells Use in the Treatment of Tendon Disorders: A Systematic Review, Meta-analysis, and Meta-regression of Prospective Clinical Studies

2020 ◽  
Author(s):  
Woo Sup Cho ◽  
Sun Gun Chung ◽  
Won Kim ◽  
Chris H. Jo ◽  
Shi-Uk Lee ◽  
...  
Keyword(s):  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Clinical Studies ◽  
Meta Analysis ◽  
Mean Difference ◽  
Efficacy And Safety ◽  
Cell Dose ◽  
Human Tendon ◽  
Meta Regression ◽  
Standardized Mean Difference

Abstract Purpose Although several studies with animals have reported the effects of mesenchymal stem cells (MSCs) for tendon regeneration, little is known about the efficacy and safety of MSCs in human tendon disorders. We performed this meta-analysis to evaluate the efficacy and safety of MSC therapy in patients with tendon disorders enrolled in prospective clinical studies. Methods We systematically searched prospective clinical studies investigating the effects of MSCs administration on human tendon disorders with at least a 6-month follow-up period on PubMed-Medline, Embase, and Cochrane Library databases. The primary outcome of interest was the change in pain on motion related to tendon disorders. We performed a pairwise meta-analysis using the fixed-effects model to assess treatment response, which was calculated by the standardized mean difference. Meta-regression analyses were performed to assess the relationship between MSCs dose and pooled effect sizes in each cell dose. Results Four prospective clinical trials investigating the effect of MSCs on tendon disorders were retrieved. MSCs showed significant pooled effect size (overall Hedge’s g pooled standardized mean difference (SMD) = 1.868; 95% confidence interval [CI], 1.274–2.462; P < 0.001). The treatment with MSCs improved all the aspects analyzed, i.e. pain, functional scores, radiologic parameters (magnetic resonance image or ultrasonography), and arthroscopic findings. In the meta-regression analysis, there was a significant cell dose-dependent response in pain relief (Q = 9.06, P = 0.029). While three studies reported mild adverse events after MSCs injection, these were not severe and relieved spontaneously. Conclusions Our meta-analysis revealed that MSC therapy may improve pain, function, radiologic, and arthroscopic parameters in patients with tendon disorders. Due to the small number of studies in this meta-analysis and considering the increasing MSCs applications, there is a strong need for large-scale randomized controlled trials to confirm the long-term functional improvement as well as the adverse effects of MSC therapies in tendon disorders.

Safety and efficacy of direct acting oral anticoagulants and vitamin K antagonists in nonvalvular atrial fibrillation – a network meta-analysis of real-world data

VASA ◽  
2019 ◽  
Vol 48 (2) ◽  
pp. 134-147 ◽  
Author(s):  
Mirko Hirschl ◽  
Michael Kundi
Keyword(s):  
Real World ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Efficacy And Safety ◽  
Nonvalvular Atrial Fibrillation ◽  
Real World Data ◽  
Hazard Ratios ◽  
Direct Acting ◽  
Event Rates

Abstract. Background: In randomized controlled trials (RCTs) direct acting oral anticoagulants (DOACs) showed a superior risk-benefit profile in comparison to vitamin K antagonists (VKAs) for patients with nonvalvular atrial fibrillation. Patients enrolled in such studies do not necessarily reflect the whole target population treated in real-world practice. Materials and methods: By a systematic literature search, 88 studies including 3,351,628 patients providing over 2.9 million patient-years of follow-up were identified. Hazard ratios and event-rates for the main efficacy and safety outcomes were extracted and the results for DOACs and VKAs combined by network meta-analysis. In addition, meta-regression was performed to identify factors responsible for heterogeneity across studies. Results: For stroke and systemic embolism as well as for major bleeding and intracranial bleeding real-world studies gave virtually the same result as RCTs with higher efficacy and lower major bleeding risk (for dabigatran and apixaban) and lower risk of intracranial bleeding (all DOACs) compared to VKAs. Results for gastrointestinal bleeding were consistently better for DOACs and hazard ratios of myocardial infarction were significantly lower in real-world for dabigatran and apixaban compared to RCTs. By a ranking analysis we found that apixaban is the safest anticoagulant drug, while rivaroxaban closely followed by dabigatran are the most efficacious. Risk of bias and heterogeneity was assessed and had little impact on the overall results. Analysis of effect modification could guide the clinical decision as no single DOAC was superior/inferior to the others under all conditions. Conclusions: DOACs were at least as efficacious as VKAs. In terms of safety endpoints, DOACs performed better under real-world conditions than in RCTs. The current real-world data showed that differences in efficacy and safety, despite generally low event rates, exist between DOACs. Knowledge about these differences in performance can contribute to a more personalized medicine.

Sign in / Sign up

Export Citation Format

Share Document