Objective: To assess methodological quality of clinical studies using Aidi Injection as an adjunct therapy for non-small cell lung cancer (NSCLC) and to evaluate the effects of Aidi Injection.
Methods: PubMed (1980-2008), Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2008), EMBASE (1984-2008), CancerLit (1996-2003), CBMdisc (1980-2008), CNKI database (1980-2008), Wanfang database (1980-2008), and Chongqing VIP database (1980-2008) were searched. The authors also hand-searched Chinese periodicals potentially related to the question. All randomized controlled trials comparing Aidi Injection with other treatment methods of NSCLC were included. Two reviewers selected studies, assessed the quality of studies, and extracted the data independently. The included studies were appraised and analyzed by Cochrane Collaboration Review Manager 5.0.
Results: Fourteen randomized controlled trials were included in the meta-analysis, but the quality of reports of the 14 included studies was poor. Aidi Injection combined with cobalt-60 or navelbine and platinol (NP) showed statistically significant differences in improving the response rate as compared with single use of cobalt-60 (P=0.000 2) or NP (P=0.04), and the relative risk (RR) and 95% confidence interval (CI) were 1.93 [1.36, 2.72] and 1.18 [1.00, 1.38], respectively. However, Aidi Injection combined with etoposide and platinol (EP), taxinol and platinol (TP) or gamma knife showed no significant differences as compared with single use of EP (P=0.60), TP (P=0.16) or gamma knife (P=0.34), respectively. The RR and 95% CI of EP, TP and gamma knife were 1.17 [0.65, 2.09], 1.27 [0.91, 1.78] and 1.08 [0.92, 1.26] respectively. Six studies indicated that Aidi Injection combined with NP or gamma knife could improve the quality of life.Six studies showed that Aidi Injection combined with NP or TP could improve the bone marrow hematopoietic function.Three studies indicated that Aidi Injection combined with NP could improve the immune function. Three studies showed that the combined therapy could not improve 1-, 2-, and 3-year survival rates.
Conclusion: The results of meta-analysis indicate that Aidi Injection may have adjuvant therapeutic effects in treatment of NSCLC patients, but the sample size is too small and with poor quality, and the existence of publication bias is found.The effects of Aidi Injection need to be confirmed by large multicenter randomized controlled trials.