Dataset Information

Shenfu injection as treatment for critical illness: a narrative review of clinical trials.

ABSTRACT:

Background and objective

Shenfu injection (SFI) is a traditional herbal medicine derived from components of ginseng and aconite and is commonly used in China to treat a variety of conditions. Shenfu has been suggested to have beneficial effects in various critical illnesses, including heart failure, cardiac arrest, and septic shock. In recent years, there have been a number of studies reporting that SFI improves patient outcomes when used concurrently with other treatments, but its use has not been adopted outside of China. This narrative review explored the results of clinical trials that have tested SFI's efficacy in various critical illnesses.

Methods

PubMed was searched for clinical trials, systematic reviews and meta-analyses published between 1990 and July 2022 relating to clinical trials using SFI in various critical illnesses. Systematic reviews and meta-analyses were included to enable inclusion of data from trials originally not published in English. The selected articles were then summarized in the following disease categories: heart failure, cardiac arrest, sepsis, and severe pulmonary disease.

Key content and findings

Clinical trials testing SFI in heart failure, cardiac arrest, sepsis, and pulmonary disease were reviewed. The design, methodology, and key findings of each trial or meta-analysis are summarized and discussed. Key limitations were also highlighted and discussed. Overall, several clinical trials suggest SFI may hold therapeutic potential for the treatment of critical illness, however, additional research is likely still needed.

Conclusions

Based on the current body of literature, further research-especially multi-center randomized, double-blind trials with detailed reporting of all methods and results according to international guidelines-is needed to evaluate whether SFI is a useful addition to existing treatments for these conditions.

SUBMITTER: Berlin N

PROVIDER: S-EPMC10894405 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature

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Publications

Shenfu injection as treatment for critical illness: a narrative review of clinical trials.

Berlin Noa N Shekhar Aditya C AC Berg Katherine M KM

Journal of thoracic disease 20240129 1

<h4>Background and objective</h4>Shenfu injection (SFI) is a traditional herbal medicine derived from components of ginseng and aconite and is commonly used in China to treat a variety of conditions. Shenfu has been suggested to have beneficial effects in various critical illnesses, including heart failure, cardiac arrest, and septic shock. In recent years, there have been a number of studies reporting that SFI improves patient outcomes when used concurrently with other treatments, but its use h ...[more]

PMID: 38410595

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Project description:Background and objectiveSince the outbreak of the 2019 novel coronavirus disease (COVID-19), acute respiratory distress syndrome (ARDS) and sepsis resulting from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection have surged in intensive care units around the world. The heterogeneity of ARDS and sepsis has long been observed, and multiple subphenotypes and endotypes correlated with different outcomes and treatment response have been identified in the search for treatable traits. Despite their similarity to typical ARDS and sepsis, COVID-19-associated ARDS and sepsis harbor distinct features, raising the question as to whether they could be considered as subphenotypes or endotypes of the historical syndromes and, accordingly, benefit from specific therapeutic strategies. This review aimed to summarize and discuss the current knowledge of COVID-19-associated critical illness and the intrinsic subphenotypes or endotypes.MethodsLiterature on the pathogenesis of COVID-19 and the subphenotyping of COVID-19-associated critical illness was derived from the PubMed database and reviewed.Key content and findingsAccumulating evidence, varying from clinical observation to basic research, has contributed to revealing the fundamental pathophysiological features of severe COVID-19 and has advanced our knowledge of the disease. COVID-19-associated ARDS and sepsis exhibit some distinctive features compared to the classic syndromes, including remarkable vascular abnormality and coagulopathy, and distinct respiratory mechanics and immune response. Some conventional subphenotypes derived from classic ARDS and sepsis have been validated in COVID-19, while novel subphenotypes and endotypes have also been identified in patients with this disease, who experience variable clinical outcomes and treatment responses.ConclusionsSubphenotyping of COVID-19-associated ARDS and sepsis can provide new insights into the development and management of these illnesses.

Project description:Background: Idiopathic pulmonary fibrosis (IPF) is disease with high mortality, and its effective treatment is limited. Shenfu injection is a traditional Chinese medicine which can improve circulation and protect cells. In this study, we aimed to investigate the feasibility and mechanism of Shenfu injection in the treatment of IPF. Methods: The components and targets of Shenfu injection were mainly retrieved from the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP) database. The targets of Shenfu injection were standardized by UniProt database. The Genecards and OMIM databases was used to search for IPF-related genes. The Venn diagram of gene intersection was drawn using the OmicStudio tools, and the protein-protein interaction network was visualized using the Cytoscape 3.7.2 software. Moreover, the metascape online software was applied to explore the enriched Gene Ontology (GO) terms and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways, and the Cytoscape 3.7.2 software was used to construct the target-pathway network. Molecular docking was used to visualize the interactions between the main active compounds and targeted proteins. Animal experiments were performed to validate the effects and mechanisms of Shenfu injection. Results: We obtained 46 co-targets of Shenfu injection and IPF. Among the hub target genes, several genes with important functions were enriched, including TNF, IL-6, IL-1B, TP53, JUN, CASP3 and CASP8. The pathway enrichment analysis for the hub target genes identified pathways in infection/inflammation, apoptosis and cancer. Molecular docking results showed that the main active compound Ginsenoside Re had high affinity to the core target proteins. These results suggested that Shenfu injection may have a positive effect in the treatment of IPF. Consistent with this finding, animal experiments showed that Shenfu injection significantly reduced pulmonary fibrosis in a mouse model with inhibition of apoptosis and inflammation by downregulating IL-1β, caspase-3 and phosphorylated NF-κB. Conclusion: Our results demonstrated that Shenfu injection efficiently alleviate bleomycin-induced pulmonary fibrosis through multi-targets in inflammation-, apoptosis- and cancer-related pathways, which provided first evidence and reference to the feasibility of Shenfu injection in the treatment of IPF.

Project description:ObjectivesRecurring issues in clinical trial design may bias results toward the null, yielding findings inconclusive for treatment effects. This study evaluated for powering bias among high-impact critical care trials and the associated risk of masking clinically important treatment effects.Design, setting, and patientsSecondary analysis of multicenter randomized trials of critically ill adults in which mortality was the main endpoint. Trials were eligible for inclusion if published between 2008 and 2018 in leading journals. Analyses evaluated for accuracy of estimated control group mortality, adaptive sample size strategy, plausibility of predicted treatment effect, and results relative to the minimal clinically important difference. The main outcome was the mortality risk difference at the study-specific follow-up interval.InterventionsNone.Measurements and main resultsOf 101 included trials, 12 met statistical significance for their main endpoint, five for increased intervention-associated mortality. Most trials (77.3%) overestimated control group mortality in power calculations (observed minus predicted difference, -6.7% ± 9.8%; p < 0.01). Due to this misestimation of control group mortality, in 14 trials, the intervention would have had to prevent at least half of all deaths to achieve the hypothesized treatment effect. Seven trials prespecified adaptive sample size strategies that might have mitigated this issue. The observed risk difference for mortality fell within 5% of predicted in 20 trials, of which 16 did not reach statistical significance. Half of trials (47.0%) were powered for an absolute risk reduction greater than or equal to 10%, but this effect size was observed in only three trials with a statistically significant treatment benefit. Most trials (67.3%) could not exclude clinically important treatment benefit or harm.ConclusionsThe design of most high-impact critical care trials biased results toward the null by overestimating control group mortality and powering for unrealistic treatment effects. Clinically important treatment effects often cannot be excluded.

Dataset Information

Shenfu injection as treatment for critical illness: a narrative review of clinical trials.

Background and objective

Methods

Key content and findings

Conclusions

Publications

Shenfu injection as treatment for critical illness: a narrative review of clinical trials.

Similar Datasets

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