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.

Keywords:

• sodium cantharidinate and vitamin B6
• conventional medical treatment
• digestive system neoplasms
• meta-analysis

Supplementary materials

Figure S1 Forest plot of the comparison of complete response rates (A), partial response rates (B), stable disease rates (C), and progressive disease rates (D) between the experimental and control groups. Control group, CMT alone group; Experimental group, sodium cantharidinate and vitamin B6 injection (SC/B6) + CMT. The fixed-effects meta-analysis model (M–H method) was used.

Abbreviations: CMT, conventional medical treatment; M–H, Mantel–Haenszel.

Figure S2 Forest plot of the comparison of adverse effects including leukopenia (A), nausea and vomiting (B), gastrointestinal side effects (C), hepatotoxicity (D), nephrotoxicity (E), diarrhea (F), thrombocytopenia (G), transaminase disorder (H), myelosuppression (I), hand foot syndrome (J), oral mucositis (K), anorexia (L), and anemia (M) between the experimental and control groups. Control group, CMT-alone group; Experimental group, sodium cantharidinate and vitamin B6 injection (SC/B6) + CMT.

Abbreviation: CMT, conventional medical treatment.

Figure S3 Funnel plot of percentage of complete response rates (A), partial response rates (B), stable disease rates (C), and progressive disease rates (D).

References

• ChenYZhuWMZhouDXShanYFClinical study on disodium cantharidinate and vitamin B6 combined with raltitrexed and oxaliplatin in treatment of advanced colorectal cancerDrugs Clinic2016311117841787
   Google Scholar
• FanLJEfficacy of sodium cantharidinate and vitamin B6 combined with 5-fluorouracil and calcium folinate in treatment of advanced colorectal cancerMod Med J China200911106465
   Google Scholar
• FanQLWangYZhaoKXKaoJClinical observation on effects of sodium cantharidate vitamin B6 injection combined with S-1 treatment of advanced gastrointestinal tract tumor patientsGuangming J Chin Med2013284786788
   Google Scholar
• FangXHXuJCantharidin sodium vitamin B6 injection as assistant therapy for treating liver cancer in 37 casesChina Pharm20162512527
   Google Scholar
• GuanLYMaJYuanSFQuJDisodium cantharidinate and vitamin B6 combined with tegafur, gimeracil and oteracil porassium for treating stage IV pancreatic cancer in 27 casesTradit Med20152420124125
   Google Scholar
• JiaJMZhLEfficacy of sodium cantharidinate and vitamin B6 comwith intravenous chemotherapy for advanced esophageal cancerMed Inf2013269188189
   Google Scholar
• LiuGWRenWDCantharis acid sodium vitamin B6 injection comwith maintain capecitabine synchronization for the treatment of advanced colorectal cancerWorld Latest Med Inf201717261214
   Google Scholar
• LiuSHFengWZhuRXFengZCComparative study of disodium cantharidinate and vitamin B6 injection combined with oxaliplatin and tegafur in the treatment of advanced gastric cancerPract Clin J Integr Tradit Chinese West Med20088434
   Google Scholar
• MaoWDClinical study of sodium cantharidinate and vitamin B6 combined with capecitabine in the treatment of advanced gastric cancerJ Clin Med201634590349036
   Google Scholar
• ShaoHHongGLuoXEvaluation of sodium cantharidinate/vitamin B6 in the treatment of primary liver cancerJ Cancer Res Ther201410Suppl 1757825207897
   PubMed Web of Science ®Google Scholar
• ShiXYZhangJMengWMaFLiZLZhaoJFClinical observation of sodium cantharidinate and vitamin B6 injection combined with XELOX protocol in treatment of patients with advanced colorectal carcinomaMed & Pharm J Chin PLA20172963639
   Google Scholar
• TianXLYangPClinical efficacy of treatment of liver cancer with combined sodium cantharidate vitamin B6 injection and TACE therapyChin J Clin Oncol Rehabil2006134351353
   Google Scholar
• WangJHLiGPWuJHApplication of sodium cantharidinate and vitamin B6 injection in patients with advanced colorectal cancerJ Mod Med Health2010266844845
   Google Scholar
• WangYWYangRLThe effect observation of sodium cantharivitamin B6 combined with capecitabine in the treatment of advanced stomach and colorectal carcinomaMed Innov China201714362326
   Web of Science ®Google Scholar
• WeiYFWuJSHuoZGJiaZYQiSSWangXXEfficacy evaluation of sodium cantharidinate and vitamin B6 injection combined with TACE in the treatment of 48 patients with intermediate and advanced primary liver cancerChina Pharm20152457274
   Google Scholar
• WuZMLiuQShiSMYuSYClinical study of ai yishu combined with FOLFIRI regimen in the treatment of recurrent gastric cancerMed Inf2013266256
   Google Scholar
• XieZXWangJSLiuYBShort-term efficacy and adverse effects of sodium cantharidinate and vitamin B6 injection combined with chein the treatment of advanced gastric cancerHebei Med J2016381015541559
   Google Scholar
• YouZYLiuYShuXHLiuBNLiuXFMalignant ascites of gas-tumor treated with sodium cantharidinate and vitamin B6 injection and hyperthermic intraperitoneal chemotherapyWorld J Integr Tradit West Med201510912491255
   Google Scholar
• ZengLLiuYLLiuXTYangZFClinical observation of sodium cantharidinate and vitamin B6 injection in the treatment of liver cancerJ Hebei Med Univ2009306596597
   Google Scholar
• ZhangMJZuoCFClinical efficacy of sodium cantharidate vitamin B6 injection combined with chemotherapy in treatment of liver cancerJ Pract Oncol20112615052
   Google Scholar
• ZhangWYangJZhongCSEfficacy of sodium cantharidinate vitamin B6 combined with xeloda in the treatment of advanced gastric cancerJ Huaihai Med2012305446447
   Google Scholar
• ZhangWLaoWWEfficacy of sodium cantharidinate vitamin B6 combined with CapeOX in the treatment of advanced gastric cancerMed Front2015516108110
   Google Scholar
• ZhuWQSodium cantharindinate and vitamin B6 injection in combinawith TACE for primary liver cancerInt Med Health Guid News2014201421302132
   Google Scholar
• LiGPLiXRWangJHClinical observation on sodium cantharidate vitamin B6 injection combined with postoperative chemotherapy in treatment of gastric cancerPract Prev Med2010171105106
   Google Scholar

Author contributions

All authors contributed to data analysis, drafting or revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

Disclosure

The authors report no conflicts of interest in this work.