Abstract

Introduction. Brucea javanica oil emulsion injection (BJOEI) is an antitumor drug extracted from the traditional Chinese medicinal plant Brucea javanica, which has broad prospects as an adjuvant treatment for gastric cancer (GC); however, its efficacy and safety are still controversial. We plan to conduct a systematic review and meta-analysis to summarise the clinical efficacy and safety of BJOEI in the treatment of GC and provide credible evidence for the clinical application and subsequent studies of BJOEI. Methods and Analysis. This systematic review will include articles identified by electronically searching the following databases: PubMed, EMBASE, CENTRAL, Web of Science, the Chinese Biomedical Literature Database (CBM), the China National Knowledge Infrastructure (CNKI), Wanfang Database, and Chinese Scientific Journals Database (VIP Database) from inception to 31 July 2021. The primary outcomes of this research will be the clinical total effective rate, performance status, and adverse drug reactions (ADRs). The systematic review will be performed using RevMan 5 software. Finally, we will use the Grading of Recommendations Assessment, Development and Evaluation System (GRADE) to assess the quality of evidence. Ethics and Dissemination. Ethical approval is not required for literature-based studies. The results of this systematic review will be published in a peer-reviewed journal. PROSPERO registration number: CRD42021265646.

Highlights

  • Brucea javanica oil emulsion injection (BJOEI) is an antitumor drug extracted from the traditional Chinese medicinal plant Brucea javanica, which has broad prospects as an adjuvant treatment for gastric cancer (GC); its efficacy and safety are still controversial

  • Several systematic reviews have been conducted to evaluate the clinical efficacy of BJOEI on GC, none have assessed the quality of the synthesised evidence and arrived at definitive conclusions

  • Traditional Chinese medicine (TCM) has been in practice for thousands of years and has an irreplaceable role in complementary and adjuvant therapy

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Summary

Introduction

With the fifth and fourth highest incidence and mortality rates of cancer worldwide, gastric cancer (GC) has become a major threat to human life. Chemotherapy, radiotherapy, and molecular targeting are effective methods in the treatment of GC. Several systematic reviews have been conducted to evaluate the clinical efficacy of BJOEI on GC, none have assessed the quality of the synthesised evidence and arrived at definitive conclusions. We plan to conduct a systematic review to objectively evaluate the efficacy and safety of BJOEI in the treatment of GC and assess the quality of the synthesised evidence, considering the latest findings. Studies that administered BJOEI to the control group as an adjunctive therapy will not be included. We will include studies in which the control group adopted standard treatment (e.g., chemotherapy and radiotherapy). (1) Primary outcomes: the primary outcomes of this study were clinical total effective rate, performance status, and ADRs (2) Secondary outcomes: safety of the BJOEI therapies, including adverse events and withdrawals for any reason

Search Methods for Identification of Studies
Data Collection and Analysis
Discussion
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