PMID- 38113988
OWN - NLM
STAT- MEDLINE
DCOM- 20240115
LR  - 20240405
IS  - 1872-7573 (Electronic)
IS  - 0378-8741 (Linking)
VI  - 322
DP  - 2024 Mar 25
TI  - The efficacy and safety of compound kushen injection for adults with esophageal 
      cancer: A meta-analysis of randomized controlled trials.
PG  - 117604
LID - S0378-8741(23)01474-5 [pii]
LID - 10.1016/j.jep.2023.117604 [doi]
AB  - ETHNOPHARMACOLOGICAL RELEVANCE: Compound Kushen injection (CKI), derived from the 
      traditional Chinese medicine Sophora flavescens, has been widely prescribed to 
      treat a variety of cancers including esophageal cancer (ESCA) in China. AIM OF 
      THE STUDY: This study aimed to evaluate the efficacy and safety of CKI for ESCA 
      systematically. METHODS: The protocol was registered in the PROSPERO database 
      with No. CRD42022320503. PubMed, Embase, the Cochrane Library, Web of Science, 
      CNKI, Wanfang Database, Clinicaltrials, and Chi-CTR were searched to select RCTs 
      that compared CKI with other interventions for ESCA with outcome measures 
      including clinical efficacy, complete response, quality of life (QoL), adverse 
      events (AEs), and serious AEs (SAEs). The Cochrane Risk of Bias 2 (RoB2) tool was 
      used to assess the quality of RCT. The overall effect sizes were estimated with 
      odds ratios (ORs) and 95% confidence intervals (CIs) on binary outcome data. 
      Meta-analyses were conducted to estimate effect sizes. Subgroup and sensitivity 
      analyses on characteristics of RCTs were performed to test the robustness. 
      Publication bias was also detected with different methods. The evidence strength 
      was assessed with the Grading of Recommendation, Assessment, Development, and 
      Evaluation method. RESULTS: This study finally included 35 RCTs with 2491 ESCA 
      patients. The RoB of RCTs was some concern. The effect size of OR was 2.92 (95% 
      CI [2.39, 3.57]) on clinical efficacy, 2.27 (95% CI [1.84, 2.81]) on complete 
      response, 3.71 (95% CI [2.86, 4.80]) on QoL, 0.39 (95% CI [0.30, 0.50]) on AEs, 
      and 0.13 (95% CI [0.07, 0.27]) on SAEs where the statistical significances 
      (P < 0.00001) were found for all outcome measures. These overall effect sizes 
      showed that CKI was more efficacious and safety for ESCA. Moreover, subgroup and 
      sensitivity analyses found consistent results. Most publication bias analyses 
      showed insignificant differences. The evidence strengths were moderate. 
      CONCLUSION: The moderate evidence from this comprehensive PRISMA-compliant 
      meta-analysis suggested that CKI may be a valuable alternative for adult patients 
      with ESCA on its significant efficacy and safety. However, more RCTs of high 
      quality with low RoB, large sample sizes, and long follow-up periods are still 
      warranted to update the ESCA clinical guideline for physicians and policymakers 
      in further study.
CI  - Copyright (c) 2023 Elsevier B.V. All rights reserved.
FAU - Pan, Jiangpeng
AU  - Pan J
AD  - The Research and Application Center of Precision Medicine, The Second Affiliated 
      Hospital, Zhengzhou University, Zhengzhou, Henan, PR China; Academy of Medical 
      Sciences, Zhengzhou University, Zhengzhou, Henan, PR China. Electronic address: 
      jiangpengpan@126.com.
FAU - Jia, Yongliang
AU  - Jia Y
AD  - BGI College & Henan Institute of Medical and Pharmaceutical Sciences, Zhengzhou 
      University, Zhengzhou, Henan, PR China. Electronic address: jiayl@zzu.edu.cn.
FAU - Shi, Jianxiang
AU  - Shi J
AD  - BGI College & Henan Institute of Medical and Pharmaceutical Sciences, Zhengzhou 
      University, Zhengzhou, Henan, PR China. Electronic address: 
      jianxiangshi@zzu.edu.cn.
FAU - Yao, Ruinan
AU  - Yao R
AD  - Department of Neurology, The First Affiliated Hospital of Zhengzhou University, 
      Zhengzhou, Henan, PR China. Electronic address: nancy20212022@126.com.
FAU - Guo, Jiancheng
AU  - Guo J
AD  - The Research and Application Center of Precision Medicine, The Second Affiliated 
      Hospital, Zhengzhou University, Zhengzhou, Henan, PR China. Electronic address: 
      gjc@zzu.edu.cn.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20231217
PL  - Ireland
TA  - J Ethnopharmacol
JT  - Journal of ethnopharmacology
JID - 7903310
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Drugs, Chinese Herbal)
RN  - IYR6K8KQ5K (kushen)
SB  - IM
MH  - Adult
MH  - Humans
MH  - *Antineoplastic Agents
MH  - *Drugs, Chinese Herbal/adverse effects/therapeutic use
MH  - *Esophageal Neoplasms/drug therapy
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
OTO - NOTNLM
OT  - Clinical efficacy
OT  - Compound kushen injection
OT  - Esophageal cancer
OT  - Meta-analysis
OT  - Randomized controlled trials
COIS- Declaration of competing interest No authors have competing interests. And all 
      authors report no disclosures.
EDAT- 2023/12/20 06:42
MHDA- 2024/01/15 12:42
CRDT- 2023/12/19 19:16
PHST- 2023/05/08 00:00 [received]
PHST- 2023/11/03 00:00 [revised]
PHST- 2023/12/13 00:00 [accepted]
PHST- 2024/01/15 12:42 [medline]
PHST- 2023/12/20 06:42 [pubmed]
PHST- 2023/12/19 19:16 [entrez]
AID - S0378-8741(23)01474-5 [pii]
AID - 10.1016/j.jep.2023.117604 [doi]
PST - ppublish
SO  - J Ethnopharmacol. 2024 Mar 25;322:117604. doi: 10.1016/j.jep.2023.117604. Epub 
      2023 Dec 17.