Efficacy and safety of AiDi injection in treating primary liver cancer: a systematic review on 70 randomized controlled trials.

AiDi injection (ADI) has been widely used for primary liver cancer (PLC), and numerous clinical trials in China have been conducted to compare the efficacy of ADI with other treatments for PLC. This study aimed to conduct a systematic review and meta-analysis to comprehensively evaluate ADI for PLC. PubMed, Web of Science, the Cochrane Library, CNKI, and WanFang Database were searched to select randomized controlled trials (RCTs) that evaluated ADI for PLC, with outcomes including disease control rate (DCR), objective response rate (ORR), quality of life (QoL), and serious adverse events (SAEs). The RoB2 tool was used to assess RCTs. Meta-analysis based on a random-effects model computed the overall effect sizes using odds ratio (OR) with 95% confidence intervals (CIs). Subgroup and sensitivity analyses, meta-regression, and publication bias were also conducted. The strength of evidence was assessed using the GRADE method. This study included 70 RCTs involving 5283 PLC patients. The overall RoB of RCTs was assessed as having some concerns. The effect size of OR was 2.86 (95% CI [2.41, 3.40]) with statistical significance (P < 0.00001) for DCR. The OR demonstrated statistically significant effect sizes of 2.12 (95% CI [1.84, 2.45]; P < 0.00001), 3.89 (95% CI [3.08, 4.90]; P < 0.00001), and 0.21 (95% CI [0.12, 0.36]; P < 0.00001) for ORR, QoL, and SAEs, respectively. Moreover, subgroup and sensitivity analyses, and meta-regression analyses found consistent results. Most publication bias analyses showed insignificant differences. The strength of evidence was rated as moderate. ADI combination therapy demonstrated significant efficacy and safety in PLC patients. Nevertheless, further strong evidence through more high-quality RCTs is warranted to support these findings.