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Systematic Review and Meta-Analysis of Randomized Controlled Trials of Liangxue Tongyu Formula on Patients With Acute Intracerebral Hemorrhage.

ABSTRACT: Background:As a traditional Chinese medicine (TCM) prescription for acute stroke, Liangxue Tongyu formula (LXTYF) was widely used as auxiliary treatment measure in some clinical practice. This study aimed to evaluate the clinical efficacy and safety of LXTYF combined western conventional medicine (WCM) with WCM only for acute intracerebral hemorrhage (ICH). Methods:We systematically searched PubMed, Embase, Cochrane Library, CMB (Chinese biomedicine database), CNKI (China National Knowledge Infrastructure), WanFang, and VIP until August 2019 to confirm relevant randomized controlled trials (RCTs) compared the combination of LXTYF and WCM with WCM alone for the treatment of acute ICH. Two investigators independently assessed the risk of bias, and extracted and analyzed the data from the identified studies using RevMan 5.3.0 software following Cochrane's standard and PRISMA guidelines. The herbal compositions of LXTYF were also assessed. Results:15 RCTs were identified, totally recruiting 1648 patients with acute intracerebral hemorrhage. Compared with the WCM alone, the combination therapy of LXTYF with WCM could improve the clinical effective rate (RR, 1.21; 95% CI, 1.15-1.25, P < 0.05) and ADL score (MD, 18.09; 95% CI, 12.11-24.07; P < 0.05), and reduce syndrome scores of the TCM (MD, -4.11; 95% CI, -4.69 to -3.53; P < 0.05) and the Glasgow outcome score(GOS) (MD=0.43, 95%CI: 0.06 to 0.79, P=0.02) Moreover, there was no sufficient evidence to indicate the adverse effects would increase compared with WCM alone. Conclusion:Based on current evidence, we concluded that the combined therapy had some benefits in treating acute intracerebral hemorrhage. However, considering the potential biases and limitations of our study, additional large, high-quality RCTs are required in the future to confirm or refute the effects of LFTYF combined with WCM in acute stroke.

SUBMITTER: Jiang C

PROVIDER: S-EPMC7174629 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Systematic Review and Meta-Analysis of Randomized Controlled Trials of Liangxue Tongyu Formula on Patients With Acute Intracerebral Hemorrhage.

Jiang Chao C Yang Xiaojuan X Dong Ju J Li Guochun G

Frontiers in pharmacology 20200415

<h4>Background</h4>As a traditional Chinese medicine (TCM) prescription for acute stroke, Liangxue Tongyu formula (LXTYF) was widely used as auxiliary treatment measure in some clinical practice. This study aimed to evaluate the clinical efficacy and safety of LXTYF combined western conventional medicine (WCM) with WCM only for acute intracerebral hemorrhage (ICH).<h4>Methods</h4>We systematically searched PubMed, Embase, Cochrane Library, CMB (Chinese biomedicine database), CNKI (China National ...[more]

PMID: 32351387

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Project description:Background: Edaravone alleviates neurological deficits among patients with intracerebral hemorrhage; however, its effects on mortality and long-term functional outcomes remain unknown. Objective: To assess clinical outcomes associated with edaravone initiated within 7 days of symptoms onset in intracerebral hemorrhage. Methods: We systematically searched PubMed, Embase, Cochrane Library, CiNii, China National Knowledge Infrastructure, Chinese VIP information, Wanfang Data, and SinoMed for relevant randomized controlled trials from their inception to 1 May 2021 and conducted a comprehensive systematic review and meta-analysis (PROSPERO registration number: CRD42019147801). All-cause mortality and long-term functional outcomes were taken as the primary outcomes. Results: A total of 38 randomized controlled trials including 3,454 participants with acute intracerebral hemorrhage were included. The selected articles were of poor quality. Meta-analysis revealed that edaravone could not reduce all-cause mortality [relative risk (RR) = 0.51; 95% confidence interval (CI) (0.11-2.32); p = 0.38]. No studies reported on long-term functional outcomes in those trials. In addition, edaravone alleviated neurological deficits [mean difference (MD) = -5.44; 95% CI (-6.44 to -4.44); p<0.00001], improved the activities of daily living [MD = 8.44; 95% CI (7.65-9.23); p<0.00001], reduced the hematoma volume [MD = -4.71; 95% CI (-5.86 to -3.56); p<0.00001], and increased treatment response [RR = 1.26; 95% CI (1.22-1.31); p<0.00001]. In terms of safety outcome, there was no significant difference between the edaravone group and the control groups [RR = 1.67; 95% CI (0.92 to 3.06); p = 0.09]. Conclusion: Till date, edaravone does not associate with mortality reduction when initiated within 7 days of intracerebral hemorrhage onset. The effect of edaravone on long-term functional outcomes remains unknown due to lack of data. Although edaravone alleviated neurological deficits, improved activities of daily living, and reduced hematoma volume, we cautiously interpreted the results owing to the overall poor quality and high heterogeneity of the included trials. Presently, the results are insufficient to support edaravone as a routine treatment option for acute intracerebral hemorrhage.

Project description:Background: The role of tranexamic acid (TXA) in preventing hematoma expansion (HE) in patients with acute spontaneous intracerebral hemorrhage (ICH) remains unclear. We aim to investigate the efficacy and safety of TXA in acute spontaneous ICH with a particular focus on subgroups. Methods: Randomized controlled trials (RCTs) were retrieved from CENTRAL, Clinicaltrials.gov, EMBASE, PubMed, and WHO ICTRP. The primary outcome measurement was HE. The secondary outcome measurements included 3-month poor functional outcome (PFO), 3-month mortality, and major thromboembolic events (MTE). We conducted subgroup analysis according to the CT markers of HE (standard-risk population and high-risk population) and the time from onset to randomization (>4.5 and ≤4.5 h). Results: We identified seven studies (representing five RCTs) involving 2,650 participants. Compared with placebo, TXA may reduce HE on subsequent imaging (odd ratio [OR] 0.825; 95% confidence interval [CI] 0.692-0.984; p = 0.033; I2 = 0%; GRADE: moderate certainty). TXA and placebo arms did not differ in the rates of 3-month PFO, 3-month mortality, and MTE. Subgroup analysis indicated that TXA reduced the risk of HE in the high-risk population with CT markers of HE (OR 0.646; 95% CI 0.503-0.829; p = 0.001; I2 = 0 %) and in patients who were treated within 4.5 h of symptom onset (OR 0.823; 95% CI 0.690-0.980; p = 0.029; I2 = 0%), but this protective effect was not observed in the standard-risk population and patients who were treated over 4.5 h of symptom onset. Conclusions: Tranexamic acid (TXA) may decrease the risk of HE in patients with acute spontaneous ICH. Importantly, the decreased risk was observed in patients who were treatable within 4.5 h and with a high risk of HE, but not in those who were treatable over 4.5 h and in standard-risk population. However, PFO or mortality at 3 months did not significantly differ between patients who received TXA and those who received placebo. TXA is safe for acute spontaneous ICH without increasing MTE.

Project description:BackgroundPrognostic tools for intracerebral hemorrhage (ICH) patients are potentially useful for ascertaining prognosis and recommended in guidelines to facilitate streamline assessment and communication between providers. In this systematic review with meta-analysis we identified and characterized all existing prognostic tools for this population, performed a methodological evaluation of the conducting and reporting of such studies and compared different methods of prognostic tool derivation in terms of discrimination for mortality and functional outcome prediction.MethodsPubMed, ISI, Scopus and CENTRAL were searched up to 15th September 2016, with additional studies identified using reference check. Two reviewers independently extracted data regarding the population studied, process of tool derivation, included predictors and discrimination (c statistic) using a predesignated spreadsheet based in the CHARMS checklist. Disagreements were solved by consensus. C statistics were pooled using robust variance estimation and meta-regression was applied for group comparisons using random effect models.ResultsFifty nine studies were retrieved, including 48,133 patients and reporting on the derivation of 72 prognostic tools. Data on discrimination (c statistic) was available for 53 tools, 38 focusing on mortality and 15 focusing on functional outcome. Discrimination was high for both outcomes, with a pooled c statistic of 0.88 for mortality and 0.87 for functional outcome. Forty three tools were regression based and nine tools were derived using machine learning algorithms, with no differences found between the two methods in terms of discrimination (p = 0.490). Several methodological issues however were identified, relating to handling of missing data, low number of events per variable, insufficient length of follow-up, absence of blinding, infrequent use of internal validation, and underreporting of important model performance measures.ConclusionsPrognostic tools for ICH discriminated well for mortality and functional outcome in derivation studies but methodological issues require confirmation of these findings in validation studies. Logistic regression based risk scores are particularly promising given their good performance and ease of application.

Project description:Some studies have indicated the efficacy of quetiapine in the treatment of generalized anxiety disorder (GAD).The purpose of this study was to systematically review the efficacy, acceptability, and tolerability of quetiapine in adult patients with GAD.The SCOPUS, MEDLINE, CINAHL, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched in April 2015. All randomized controlled trials (RCTs) of GAD were considered to be included in this meta-analysis. All RCTs of quetiapine in GAD patients providing endpoint outcomes relevant to severity of anxiety, response rate, remission rate, overall discontinuation rate, or discontinuation rate due to adverse events were included. The version reports from suitable clinical studies were explored, and the important data were extracted. Measurement for efficacy outcomes consisted of the mean-changed scores of the rating scales for anxiety, and response rate.A total of 2,248 randomized participants in three RCTs were included. The pooled mean-changed score of the quetiapine-treated group was greater than that of the placebo-treated group and comparable to selective serotonin reuptake inhibitors (SSRIs). Unfortunately, the response and the remission rates in only 50 and 150 mg/day of quetiapine-XR (extended-release) were better than those of the placebo. Their response and remission rates were comparable to SSRIs. The rates of pooled overall discontinuation and discontinuation due to adverse events of quetiapine-XR were greater than placebo. Only the overall discontinuation rate of quetiapine-XR at 50 and 150 mg/day and the discontinuation rate due to adverse events of quetiapine-XR at 50 mg/day were comparable to SSRIs.Based on this meta-analysis, quetiapine-XR is efficacious in the treatment of GAD in adult patients. Despite its low acceptability and tolerability, the use of 50-150 mg/day quetiapine-XR for adult GAD patients may be considered as an alternative treatment. Further well-defined studies should be conducted to warrant these outcomes.

Dataset Information

Systematic Review and Meta-Analysis of Randomized Controlled Trials of Liangxue Tongyu Formula on Patients With Acute Intracerebral Hemorrhage.

Publications

Systematic Review and Meta-Analysis of Randomized Controlled Trials of Liangxue Tongyu Formula on Patients With Acute Intracerebral Hemorrhage.

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