Outcomes and comparisons Studies Participants Effect estimate (95%CI) REM Study ID references Compound Kushen injection plus chemotherapy versus chemotherapy alone ORR Stage II∼III 7 656 RR 1.31, [1.17, 1.46], I 2 [28 , 29 , 42 , 43 , 46 , 48 , 50 ] Stage IV 6 533 RR 1.33, [1.11, 1.60], I 2 [36 , 37 , 39 –41 , 54 ] DCR Stage II∼III 7 656 RR 1.20, [1.12, 1.28], I 2 [28 , 29 , 42 , 43 , 46 , 48 , 50 ] Stage IV 6 533 RR 1.22, [1.11, 1.35], I 2 [36 , 37 , 39 –41 , 54 ] ORR WHO criteria 10 825 RR 1.36, [1.18, 1.56], I 2 [30 –32 , 36 , 39 , 40 , 42 , 44 , 48 , 50 ] RECIST criteria 6 450 RR 1.40, [1.16, 1.68], I 2 [34 , 37 , 46 , 49 , 53 , 54 ] DCR WHO criteria 10 825 RR 1.17, [1.08, 1.28], I 2 [30 –32 , 36 , 39 , 40 , 42 , 44 , 48 , 50 ] RECIST criteria 6 450 RR 1.35, [1.21, 1.52], I 2 [34 , 37 , 46 , 49 , 53 , 54 ] KPS score improvement rate Stage II∼III 5 468 RR 2.93, [1.88, 4.56], I 2 [28 , 38 , 42 , 47 , 48 ] Stage IV 4 343 RR 2.98, [1.88, 4.72], I 2 [36 , 37 , 40 , 41 ] QoL-BREF score 1 94 MD 18.11, [16.50, 19.72] [43 ] PFS 1 94 MD 2.24, [1.26, 3.22] [43 ] OS 1 94 MD 2.24, [1.45, 3.43] [43 ] ADRs Leukocyte decrease 15 1121 RR 0.60, [0.5, 0.71], I 2 [27 , 30 –34 , 36 , 37 , 39 , 41 , 42 , 47 , 48 , 53 , 54 ] Platelet decrease 9 750 RR 0.41, [0.29, 0.58], I 2 [27 , 28 , 36 , 37 , 39 , 42 , 47 , 53 , 54 ] Liver injury 13 1215 RR 0.42, [0.31, 0.57], I 2 [26 –28 , 36 , 37 , 39 , 42 –44 , 46 , 50 –52 ] Renal injury 9 879 RR 0.63, [0.46, 0.86], I 2 [27 , 28 , 36 , 37 , 42 , 46 , 49 –51 ] Nausea and vomiting 14 1171 RR 0.68, [0.59, 0.79], I 2 [26 , 33 , 34 , 36 , 37 , 41 , 43 , 44 , 46 , 47 , 49 , 51 , 53 , 54 ] Diarrhea 3 210 RR 0.55, [0.35, 0.88], I 2 [26 , 37 , 49 ] Alopecia 8 584 RR 0.51, [0.39, 0.67], I 2 [27 , 28 , 33 , 34 , 36 , 37 , 49 , 50 , 53 ] Oral mucositis 4 441 RR 0.18, [0.07, 045], I 2 [26 , 46 , 50 , 51 ] Tumor marker Decrease rate of CEA 3 336 RR 1.19, [1.05, 1.35], I 2 [25 , 28 , 52 ] Decrease rate of CA153 2 206 RR 1.15, [1.03, 1.27], I 2 [25 , 29 ]
