Objective: To evaluate the effectiveness and safety of β-elemene Injection as an adjunctive treatment for lung cancer by systematic review.
Methods: We retrieved randomized controlled clinical trials related to the use of β-elemene Injection as an adjunctive treatment for lung cancer from Chinese Biomedical (CBMweb), Chinese Medical Current Content (CMCC), China National Knowledge Infrastructure (CNKI), ChinaInfo, Cochrane Central Register of Controlled Trials; MEDLINE, EMBASE, OVID and TCMLARS. We also referred to an unpublished conference proceeding titled Clinical Use and Basic: Elemene Injection. We then divided the studies into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) subgroups by RevMan 5.1 software.
Results: A total of 21 source documents (1,467 patients) matched pre-specified criteria for determining the effectiveness and safety of β-elemene Injection as an adjunctive treatment for lung cancer. Five studies involving 285 NSCLC patients reported a higher 24-month survival rate (39.09%) with the adjunctive treatment than with chemotherapy alone (26.17%; RR, 1.51; 95% CI, 1.03 to 2.21). Four studies involving 445 patients reported that the increased probability for improved performance status for patients treated with elemene-based combinations was higher than that of patients treated with chemotherapy alone (RR, 1.82; 95% CI, 1.45 to 2.29). The results from a subgroup analysis on 12 studies involving 974 NSCLC patients and 9 studies involving 593 patients with both SCLC and NSCLC showed that the tumor control rate for NSCLC improved more in the elemene-based combinations treatment group (78.70%) than in the chemotherapy alone control group (71.31%; RR, 1.06; 95% CI, 1.00 to 1.12). The tumor response rate for NSCLC also improved more among patients treated with elemenebased combinations (50.71%) than among patients treated with chemotherapy alone (38.04%; RR, 1.34; 95%CI, 1.17 to 1.54). In addition, the main adverse reaction to β-elemene Injection was phlebitis, but usually only to a mild degree. An Egger's test showed no publication bias in our study (P=0.7030).
Conclusions: The effectiveness of chemotherapy for the treatment of lung cancer may improve when combined with β-elemene injection as an adjunctive treatment. The combined treatment can result in an improved quality of life and prolonged survival. However, these results require confirmation by rigorously controlled trials.