Dataset Information

Efficacy and safety of sodium cantharidinate and vitamin B6 injection for the treatment of digestive system neoplasms: a meta-analysis of randomized controlled trials.

ABSTRACT:

Objective

To systematically evaluate the efficacy and safety of sodium cantharidinate and vitamin B6 (SC/B6) combined with conventional medical treatment (CMT) for the treatment of patients with advanced digestive system neoplasms (DSNs).

Methods

The Cochrane Library, Embase, PubMed, Web of Science, Chinese Scientific Journal Database (VIP), China National Knowledge Infrastructure, and Wanfang databases were searched for clinical trials using SC/B6 for DSNs. Outcome measures, including therapeutic efficacy, quality of life (QoL), and adverse events, were extracted and systematically evaluated.

Results

Data from 24 trials including 1,825 advanced DSN patients were included. Compared with CMT alone, its combination with SC/B6 significantly improved the patients' overall response rate (OR =2.25, 95% CI =1.83-2.76, P<0.00001), disease control rate (OR =2.41, 95% CI =1.85-3.15, P<0.00001), and QoL improvement rate (OR =2.75, 95% CI =2.13-3.55, P<0.00001). Moreover, adverse events caused by chemotherapy, including leukopenia, nausea and vomiting, gastrointestinal side effects, hepatotoxicity, diarrhea, transaminase disorder, myelosuppression, anorexia, and anemia, were significantly alleviated (P<0.05) when SC/B6 was applied to DSN patients. Nephrotoxicity, thrombocytopenia, hand-foot syndrome, and oral mucositis were not significantly alleviated in patients receiving combination therapy (P>0.05).

Conclusion

The combination of SC/B6 and CMT is more effective in treating DSNs than CMT alone. This combination alleviates the adverse effects associated with chemotherapy and improves the QoL of DSN patients, and its application in the clinic is worth promoting.

SUBMITTER: Liu M

PROVIDER: S-EPMC6312696 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of sodium cantharidinate and vitamin B6 injection for the treatment of digestive system neoplasms: a meta-analysis of randomized controlled trials.

Liu Meirong M Xu Chunhong C Sun Yingying Y

Drug design, development and therapy 20181228

<h4>Objective</h4>To systematically evaluate the efficacy and safety of sodium cantharidinate and vitamin B6 (SC/B6) combined with conventional medical treatment (CMT) for the treatment of patients with advanced digestive system neoplasms (DSNs).<h4>Methods</h4>The Cochrane Library, Embase, PubMed, Web of Science, Chinese Scientific Journal Database (VIP), China National Knowledge Infrastructure, and Wanfang databases were searched for clinical trials using SC/B6 for DSNs. Outcome measures, incl ...[more]

PMID: 30643386

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Project description:Background:Shengmai injection (SMI) is made from purified ginseng, Radix Ophiopogonis, and Schisandra chinensis. It has cardiotonic effects and is clinically used for the adjuvant treatment of chronic heart failure (CHF). However, its efficacy and safety are uncertain. The purpose of this study was to systematically evaluate the existing efficacy and safety evidence in randomized controlled trials (RCTs) that studied SMI for the treatment of CHF. Methods:PubMed, Embase, Cochrane Library, clinicaltrials.gov, CNKI, Wanfang, VIP, and CBM databases were searched up to September 10, 2019. RCTs that compared basic Western medicine treatment with SMI?+?basic Western medicine were included. The Cochrane Collaboration Risk of Bias Tool was used to assess the risk of bias in the RCTs. The meta-analysis used the random effects model; the mean difference (MD) and 95% confidence intervals (CIs) were combined using the inverse variance method, and the Mantel-Haenszel method was used to combine the relative risk (RR) and 95% CIs. Heterogeneity was assessed using I2 and Q tests, and the source of heterogeneity was explored by analyzing three preset subgroup hypotheses. Results:A total of 20 RCTs were included (n?=?1562), with a moderate-to-high risk of bias. The meta-analysis showed that, compared with Western medicine alone, SMI adjuvant therapy significantly improved cardiac function indicators, including left ventricular ejection fraction (MD 6.8%, 95% CI 4.68 to 8.91), stroke volume (MD 9.81?ml, 95% CI 5.67 to 13.96), cardiac output (MD 0.96?L/min, 95% CI 0.66 to 1.25), and cardiac index (MD 0.53?L/min, 95% CI 0.36 to 0.70); heterogeneity was generally high among these outcomes. Compared with the controls, patients receiving SMI adjuvant therapy also had a higher response to treatment (RR 2.89, 95% CI 2.10 to 3.99; I2?=?0%), a greater decrease in brain natriuretic peptide levels (MD -284.66?ng/l, 95% CI -353.73 to -215.59, I2?=?0%), and a greater increase in six-minute walk test performance (MD 70.67?m, 95% CI 22.92 to 118.42; I2?=?84%). Nine studies reported mild adverse events, such as gastrointestinal reactions, and no serious adverse events were reported. Conclusion:Currently, available evidence indicates that SMI, as an adjuvant for basic Western medicine treatment, can improve the cardiac function of patients with CHF with good safety outcomes. Because of the high risk of bias among the included RCTs and the large heterogeneity of partial outcomes, the findings of this study must be verified by high-quality studies with large sample sizes.

Dataset Information

Efficacy and safety of sodium cantharidinate and vitamin B6 injection for the treatment of digestive system neoplasms: a meta-analysis of randomized controlled trials.

Objective

Methods

Results

Conclusion

Publications

Efficacy and safety of sodium cantharidinate and vitamin B6 injection for the treatment of digestive system neoplasms: a meta-analysis of randomized controlled trials.

Similar Datasets

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