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 The Effect of Berberine on Metabolic Profiles in Type 2 Diabetic Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 2021 ◽  
pp. 1-22
Author(s):  
Jing Guo ◽  
Hongdong Chen ◽  
Xueqin Zhang ◽  
Wenjiao Lou ◽  
Pingna Zhang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Insulin Resistance ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Density Lipoprotein ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Rhizoma Coptidis ◽  
Randomized Controlled

Objective. Rhizoma Coptidis is an herb that has been frequently used in many traditional formulas for the treatment of diabetic mellitus (DM) over thousands of years. Berberine, the main active component of Rhizoma Coptidis, has been demonstrated to have the potential effect of hypoglycemia. To determine the potential advantages of berberine for diabetic care, we conducted this systematic review and meta-analysis to examine the efficacy and safety of berberine in the treatment of patients with type 2 DM. Methods. Eight databases including PubMed, Embase, Web of Science, the Cochrane library, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Database (SinoMed), Wanfang Database, and Chinese VIP Information was searched for randomized controlled trials (RCTs) reporting clinical data regarding the use of berberine for the treatment of DM. Publication qualities were also considered to augment the credibility of the evidence. Glycemic metabolisms were the main factors studied, including glycosylated hemoglobin (HbA1c), fasting plasm glucose (FPG), and 2-hour postprandial blood glucose (2hPG). Insulin resistance was estimated by fasting blood insulin (FINS), homeostasis model assessment-insulin resistance (HOMA-IR), and body mass index (BMI). Lipid profiles were also assessed, including triglyceride (TG), total cholesterol (TC), low-density lipoprotein (LDL), and high-density lipoprotein (HDL), along with inflammation factors such as C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α). Serum creatinine (Scr), blood urea nitrogen (BUN), and adverse events were applied to evaluate the safety of berberine. Results. Forty-six trials were assessed. Analysis of berberine applied alone or with standard diabetic therapies versus the control group revealed significant reductions in HbA1c ( MD = − 0.73 ; 95% CI (−0.97, −0.51)), FPG ( MD = − 0.86 , 95% CI (−1.10, −0.62)), and 2hPG ( MD = − 1.26 , 95% CI (−1.64, −0.89)). Improved insulin resistance was assessed by lowering FINS ( MD = − 2.05 , 95% CI (−2.62, −1.48)), HOMA-IR ( MD = − 0.71 , 95% CI (−1.03, −0.39)), and BMI ( MD = − 1.07 , 95% CI (−1.76, −0.37)). Lipid metabolisms were also ameliorated via the reduction of TG ( MD = − 0.5 , 95% CI (−0.61, −0.39)), TC ( MD = 0.64 , 95% CI (−0.78, −0.49)), and LDL ( MD = 0.86 , 95% CI (−1.06, −0.65)) and the upregulation of HDL ( MD = 0.17 , 95% CI (0.09, 0.25)). Additionally, berberine improved the inflammation factor. Conclusion. There is strong evidence supporting the clinical efficacy and safety of berberine in the treatment of DM, especially as an adjunctive therapy. In the future, this may be used to guide targeted clinical use of berberine and the development of medications seeking to treat patients with T2DM and dyslipidemia.

scholarly journals Efficacy and safety of bempedoic acid alone or combining with other lipid-lowering therapies in hypercholesterolemic patients: a meta-analysis of randomized controlled trials

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Xiang Zhao ◽  
Xubiao Ma ◽  
Xing Luo ◽  
Zhihua Shi ◽  
Ziwen Deng ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Density Lipoprotein ◽  
Lipid Lowering ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Atp Citrate Lyase ◽  
Randomized Controlled

Abstract Background Bempedoic acid is a new drug that reduces cholesterol synthesis via inhibiting ATP citrate lyase. It remains unclear whether the combination of bempedoic acid and other lipid-lowering drugs is better than these drugs alone. This study systematically reviewed the efficacy and safety of bempedoic acid monotherapy or combination togethers in hypercholesterolemic patients. Methods Randomized controlled trials were searched across Medline, Embase, Cochrane library, web of science, etc. The net change scores [least squares mean (LSM) percentage change] in LDL-C level were meta-analyzed using weighted mean difference. The reductions in other lipids including total cholesterol (TC), non-high-density lipoprotein cholesterol (non-HDL-C) and apolipoprotein (ApoB) and high sensitivity C reactive protein (hsCRP) were also assessed. Odds ratio (OR) of the incidence of adverse events (AEs) were calculated to evaluate the safety of bempedoic acid. Results A total of 13 trials (4858 participates) were included. Pooled data showed that the combination togethers resulted in greater reductions in LDL-C level than monotherapies (bempedoic acid + statin vs. statin: LSM difference (%), − 18.37, 95% CI, − 20.16 to − 16.57, I2 = 0; bempedoic acid + ezetimibe vs. ezetimibe: LSM difference (%), − 18.89, 95% CI, − 29.66 to − 8.13, I2 = 87%). But the difference in efficacy between bempedoic acid and ezetimibe was not obvious. Meta-regression analysis showed the treatment duration was a source of heterogeneity (adj R2 = 16.92, 95% CI, 0.04 to 0.72). Furthermore, the background therapy of statin before screening decreased the efficacy of bempedoic acid. In addition, bempedoic acid also resulted in a significant reduction in TC, non-HDL-C, ApoB and hsCRP level. The OR of muscle-related AEs by the combination of bempedoic acid and statin was 1.29 (95% CI, 1.00 to 1.67, I2 = 0) when compared with statin alone. Conclusion This study showed the efficacy of combination togethers were similar but stronger than these drugs alone. Of note, a trend of high risk of muscle-related AEs by the combination of bempedoic acid and statin was observed, though it is not statistically significant, such risk is needed to be confirmed by more trials, because it is important for us to determine which is the better combinative administration for statin-intolerant patients.

scholarly journals Effectiveness of acupuncture for cancer pain: protocol for an umbrella review and meta-analyses of controlled trials

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e018494 ◽  
Author(s):  
Yihan He ◽  
Yihong Liu ◽  
Brian H May ◽  
Anthony Lin Zhang ◽  
Haibo Zhang ◽  
...  
Keyword(s):  
Cancer Pain ◽  
Systematic Reviews ◽  
Clinical Studies ◽  
Meta Analysis ◽  
Grey Literature ◽  
Sensitivity Analyses ◽  
Controlled Trials ◽  
Statistical Heterogeneity ◽  
Meta Analyses

IntroductionThe National Comprehensive Cancer Network guidelines for adult cancer pain indicate that acupuncture and related therapies may be valuable additions to pharmacological interventions for pain management. Of the systematic reviews related to this topic, some concluded that acupuncture was promising for alleviating cancer pain, while others argued that the evidence was insufficient to support its effectiveness.Methods and analysisThis review will consist of three components: (1) synthesis of findings from existing systematic reviews; (2) updated meta-analyses of randomised clinical trials and (3) analyses of results of other types of clinical studies. We will search six English and four Chinese biomedical databases, dissertations and grey literature to identify systematic reviews and primary clinical studies. Two reviewers will screen results of the literature searches independently to identify included reviews and studies. Data from included articles will be abstracted for assessment, analysis and summary. Two assessors will appraise the quality of systematic reviews using Assessment of Multiple Systematic Reviews; assess the randomised controlled trials using the Cochrane Collaboration’s risk of bias tool and other types of studies according to the Newcastle-Ottawa Scale. We will use ‘summary of evidence’ tables to present evidence from existing systematic reviews and meta-analyses. Using the primary clinical studies, we will conduct meta-analysis for each outcome, by grouping studies based on the type of acupuncture, the comparator and the specific type of pain. Sensitivity analyses are planned according to clinical factors, acupuncture method, methodological characteristics and presence of statistical heterogeneity as applicable. For the non-randomised studies, we will tabulate the characteristics, outcome measures and the reported results of each study. Consistencies and inconsistencies in evidence will be investigated and discussed. Finally, we will use the Grading of Recommendations Assessment, Development and Evaluation approach to evaluate the quality of the overall evidence.Ethics and disseminationThere are no ethical considerations associated with this review. The findings will be disseminated in peer-reviewed journals or conference presentations.PROSPERO registration numberCRD42017064113.

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 Differences in the Effects of Anthocyanin Supplementation on Glucose and Lipid Metabolism According to the Structure of the Main Anthocyanin: A Meta-Analysis of Randomized Controlled Trials

Nutrients ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 2003
Author(s):  
Risa Araki ◽  
Akira Yada ◽  
Hirotsugu Ueda ◽  
Kenichi Tominaga ◽  
Hiroko Isoda
Keyword(s):  
Lipid Metabolism ◽  
Meta Analysis ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Resistance Index ◽  
Lipoprotein Cholesterol ◽  
Controlled Trials ◽  
Oh Groups ◽  
Chemical Structures ◽  
Glucose And Lipid Metabolism

The effectiveness of anthocyanins may differ according to their chemical structures; however, randomized clinical controlled trials (RCTs) or meta-analyses that examine the consequences of these structural differences have not been reported yet. In this meta-analysis, anthocyanins in test foods of 18 selected RCTs were categorized into three types: cyanidin-, delphinidin-, and malvidin-based. Delphinidin-based anthocyanins demonstrated significant effects on triglycerides (mean difference (MD): −0.24, p < 0.01), low-density lipoprotein cholesterol (LDL-C) (MD: −0.28, p < 0.001), and high-density lipoprotein cholesterol (HDL-C) (MD: 0.11, p < 0.01), whereas no significant effects were observed for cyanidin- and malvidin-based anthocyanins. Although non-significant, favorable effects on total cholesterol (TC) and HDL-C were observed for cyanidin- and malvidin-based anthocyanins, respectively (both p < 0.1). The ascending order of effectiveness on TC and LDL-C was delphinidin-, cyanidin-, and malvidin-based anthocyanins, and the differences among the three groups were significant (both p < 0.05). We could not confirm the significant effects of each main anthocyanin on glucose metabolism; however, insulin resistance index changed positively and negatively with cyanidin- and delphinidin-based anthocyanins, respectively. Therefore, foods containing mainly unmethylated anthocyanins, especially with large numbers of OH groups, may improve glucose and lipid metabolism more effectively than those containing methylated anthocyanins.

scholarly journals Comparative efficacy and safety of different regimens of ranibizumab for neovascular age-related macular degeneration: a network meta-analysis of randomised controlled trials

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e040906
Author(s):  
Xinyu Zhao ◽  
Lihui Meng ◽  
Youxin Chen
Keyword(s):  
Adverse Events ◽  
Macular Degeneration ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Age Related Macular Degeneration ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Age Related ◽  
Randomised Controlled

ObjectiveTo give a comprehensive efficacy and safety ranking of different therapeutic regimens of ranibizumab for neovascular age-related macular degeneration (nAMD).DesignA systematic review and network meta-analysis.MethodsThe PubMed, Embase, Cochrane Central Register of Controlled Trials, and other clinical trial registries were searched up to 1 October 2019 to identify related randomised controlled trials (RCT) of different regimens of ranibizumab for nAMD. The primary efficacy outcome was the changes of best-corrected visual acuity (BCVA) at 1 year, the primary safety outcome was the incidence of severe ocular adverse events. Secondary outcomes such as changes of central retinal thickness (CRT) were evaluated. We estimated the standardised mean difference (SMD), ORs, 95% CIs, the surface under the cumulative ranking curves and the mean ranks for each outcome using network meta-analyses with random effects by Stata 14.0.ResultsWe identified 26 RCTs involving 10 821 patients with nAMD randomly assigned to 21 different therapeutic regimens of ranibizumab or sham treatment. Ranibizumab 0.5 mg (treat and extend, T&E) is most effective in terms of changes of BCVA (letters, SMD=21.41, 95% CI 19.86 to 22.95) and three or more lines of BCVA improvement (OR=2.83, 95% CI 1.27 to 4.38). However, it could not significantly reduce retreatment times compared with monthly injection (SMD=−0.94, 95% CI −2.26 to 0.39). Ranibizumab 0.5 mg (3+pro re nata)+non-steroidal anti-inflammatory drugs (NSAIDs) is most effective in reducing CRT and port delivery system of ranibizumab (100 mg/mL) could reduce the number of retreatment most significantly. All regimes have no more risk of severe ocular complications (including vitreous haemorrhage, rhegmatogenous retinal detachment, endophthalmitis, retinal tear and retinal pigment epithelium tear) or cardiocerebral vascular complications.ConclusionsRanibizumab 0.5 mg (T&E) is most effective in improving the visual outcome. The administration of topical NSAIDs could achieve additional efficacy in CRT reduction and visual improvement. Both interventions had acceptable risks of adverse events.

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