Jean Jacques Dugoua, Ping Wu, Dugald Seely, Oghenowede Eyawo, Edward Mills

Non-small-cell lung cancer (NSCLC) is a leading cause of death. Interventions to reduce mortality in patients with NSCLC represent a patient-important field of research. Little is known about interventions used outside the Western world for NSCLC. One intervention widely used in Asia is astragalus-based herbal preparations. We conducted a comprehensive systematic review of all published randomized clinical trials (RCTs) evaluating astragalus-based herbal preparations in NSCLC patients. We searched independently, in duplicate, 6 English language electronic databases and 2 Chinese-language databases. We abstracted data independently, in duplicate on studies reporting of methods, survival outcomes, tumor responses, and performance score responses. We applied a random-effects meta-analysis and report outcomes as relative risks (RR) with 95% confidence intervals (CIs). We included 65 RCTs enrolling 4751 patients. All trials included the herbal preparations plus platinum-based chemotherapy versus chemotherapy alone. We pooled 7 studies (n = 529) reporting on survival at 6 months and found a pooled RR of 0.54 (95% CI, 0.45 to 0.65, P ≤ 0.0001). We included 20 trials (n = 1520) on survival at 12 months and found a pooled RR of 0.65 (95% CI, 0.54 to 0.79, P ≤ 0.0001). This effect was consistent at 24 and 36 months. When we applied a composite endpoint of any tumor treatment response, we pooled data from 57 trials and found a pooled RR of 1.35 in favor of herbal treatment (95% CI, 1.26 to 1.44, P ≤ 0.0001). Statistical heterogeneity was low across trials. The quality of reporting the RCTs was generally poor. There is also reason to believe that studies reported as randomized may not be. We found a large treatment effect of adding astragalus-based herbal treatment to standard chemotherapy regimens. There is a pressing need for validation of these findings in well-conducted RCTs in a Western setting.