Clinical Effectiveness and Safety of Chinese Herbal Medicine Compound Kushen Injection as an Add-On Treatment for Breast Cancer: A Systematic Review and Meta-Analysis

Table 1

Characteristics of included RCTs on compound Kushen injection for breast cancer.

Study ID	Sample (T/C)	Age (y)	Course of disease (months)	Stage	Control/chemotherapies	Intervention (CKI)	Duration	Tumor responses criteria	Outcome measures
Adlt YS 2016 [25]	T:56	T:34–68	NR	I∼II	AC1	CT + CKI 20 mL, qd,21d	6 cycles	Unclear	PFS, OS, CEA/CA153 level
	C:62	C:30–65
Cao W 2012 [26]	T:52	T:42–70	NR	II∼III	C1AF	CT + CKI 20 mL, qd,10d	6 cycles	Unclear	ADRs
	C:52	C:45–68
Chen LJ 2010 [27]	T:35	T: 39–71	NR	II∼III	TC1A	CT + CKI 20 mL, qd,14d	6 cycles	WHO	ORR, DCR, HRQoL-KPS, ADRs
	C:32	C: 35–68
Dai YN 2019 [28]	T:44	T:30–67	NR	II∼III	TC1A	CT + CKI 20 mL, qd,6d	8 cycles	Unclear	ORR, DCR, HRQoL-KPS, ADRs, CEA/CA153 level
	C:44	C:30–67
Dai YN 2020 [29]	T:50	T:31–67	NR	II∼III	TC1A	CT + CKI 20 mL, qd,6d	8 cycles	Unclear	ORR, DCR
	C:50	C:30–66
Huang YH 2012 [30]	T:20	T:33–75	NR	III∼IV	TA	CT + CKI 20 mL, qd,14d	2 cycles	WHO	ORR, DCR, HRQoL-KPS, ADRs
	C:20	C:33–75
Li LY 2016 [31]	T:34	T:45.6 ± 4.2	T:5.2 ± 2.1 y	III∼IV	TA	CT + CKI 20 mL, qd,14d	2 cycles	WHO	ORR, DCR, HRQoL-KPS, ADRs
	C:34	C:46.5 ± 3.1	C:6.2 ± 3.1 y
Li YX 2012 [32]	T:30	T:49.3 ± 0.9	NR	II∼IV	C1EF	CT + CKI 15 mL, qd,14d	2 cycles	WHO	ORR, DCR, HRQoL-KPS, ADRs
	C:30	C:49.3 ± 0.9
Ma YQ 2011 [33]	T:32	T:28–63	T:10m	III∼IV	TC1A	CT + CKI 20 mL, qd,21d	3 cycles	Unclear	HRQoL-KPS, ADRs
	C:31	C:30–62	C:11m
Mao WJ 2018 [34]	T:39	T:40–70	NR	NR	TC1A	CT + CKI 15 mL, qd,12d	8 cycles	RECIST	ORR, DCR, ADRs, CEA/CA153 level
	C:39	C:40–70
Niu YL 2017 [35]	T:40	T:50.02 ± 12.11	NR	NR	GP	CT + CKI 20 mL, qd,14d	3 cycles	Unclear	HRQoL-KPS
	C:40	C:48.35 ± 12.23
Qi JH 2012 [36]	T:57	T:35–75	NR	IV	TP	CT + CKI 20 mL, qd,14d	2 cycles	WHO	ORR, DCR, HRQoL-KPS, ADRs
	C:52	C:35–75
Qian XY 2017 [37]	T:23	T:46.6 ± 5.2	NR	IV	GP	CT + CKI 20 mL, qd,10d	2 cycles	RECIST	ORR, DCR, HRQoL-KPS, ADRs
	C:23	C:47.3 ± 5.9
Ren JH 2010 [38]	T:62	T:39–65	NR	II∼III	C1AF	CT + CKI 30 mL, qd,15d	6 cycles	Unclear	HRQoL-KPS, ADRs, CEA/CA153 level
	C:60	C:39–65
Ren MY 2016 [39]	T:50	T:50.34 ± 5.13	NR	IV	TE	CT + CKI 20 mL, qd,10d	2 cycles	WHO	ORR, DCR, ADRs
	C:50	C:50.19 ± 5.24
Song RF 2009 [40]	T:64	T:22–65	NR	IV	NG	CT + CKI 20 mL, qd,20d	2 cycles	WHO	ORR, DCR, HRQoL-KPS
	C:54	C:24–63
Sun X 2008 [41]	T:38	T:28–69	NR	IV	TA	CT + CKI 20 mL, qd,10d	2 cycles	Unclear	ORR, DCR, HRQoL-KPS, ADRs
	C:32	C:28–69
Sun XH 2019 [42]	T:41	T:49.05 ± 7.29	NR	II∼III	TEC1	CT + CKI 20 mL, qd,7d	3 cycles	WHO	ORR, DCR, ADRs, CEA/CA153 level
	C:39	C:49.69 ± 6.11
Wang J 2019 [43]	T:47	T:47.2 ± 5.3	NR	II∼III	TE	CT + CKI 20 mL, qd,10d	2 cycles	UICC	ORR, DCR, HRQoL-BREF, PFS, OS, ADRs, CEA/CA153 level
	C:47	C:45.3 ± 4.9
Wang L 2007 [44]	T:30	T:28–65	NR	NR	C1EF	CT + CKI 20 mL, qd,10d	2–3 cycles	WHO	ORR, DCR, ADRs
	C:30	C:28–65
Wei YH 2010 [45]	T:12	T:35–65	NR	NR	C1AF	CT + CKI 20 mL, qd,15d	2 cycles	Unclear	HRQoL-KPS, ADRs
	C:12	C:35–65
Xu N 2017 [46]	T:52	T:42.4 ± 4.5	NR	II∼III	C1AF	CT + CKI 20 mL, qd,21d	6 cycles	RECIST	ORR, DCR, ADRs
	C:52	C:43.7 ± 5.3
Xu HJ 2017 [47]	T:49	T:28–75	NR	II∼III	TC1A	CT + CKI 12 mL, qd,10d	4 cycles	Unclear	HRQoL-KPS, ADRs
	C:49	C:26–76
Yan J 2015 [48]	T:40	T:52.3 ± 4.6	NR	II∼III	TE	CT + CKI 12 mL, qd,14d	2 cycles	WHO	ORR, DCR, HRQoL-KPS, ADRs
	C:40	C:52.5 ± 4.5
Yang X 2013 [49]	T:30	T:41.5 ± 10.29	NR	III∼IV	TE	CT + CKI 20 mL, qd,21d	NR	RECIST	ORR, DCR, HRQoL-KPS, ADRs
	C:30	C:41.5 ± 10.29
Yang H 2019 [50]	T:55	T:44.1 ± 4.5	NR	II∼III	TA	CT + CKI 20 mL, qd,7d	6 cycles	WHO	ORR, DCR, ADRs
	C:55	C:43.5 ± 4.7
Zhai XJ 2014 [51]	T:61	T:42.7 ± 10.5	NR	I∼III	C1AF	CT + CKI 20 mL, qd,21d	6 cycles	Unclear	ADRs
	C:62	C:43.5 ± 11.2
Zhang ZJ 2015 [52]	T:65	T:43.2 ± 17.9	NR	I∼II	AC1	CT + CKI 12 mL,21d	6 cycles	Unclear	HRQoL-KPS, ADRs
	C:65	C:43.2 ± 17.9
Zhang GY 2014 [53]	T:36	T:46.25 ± 5.29	T:8.25 ± 2.28	NR	TC1A	CT + CKI 30 mL, qd,14d	6 cycles	RECIST	ORR, DCR, HRQoL-KPS, ADRs
	C:36	C:46.36 ± 5.41	C:8.16 ± 2.3
Zhang JZN 2018 [54]	T:45	T:34–72	NR	IV	GC2	CT + CKI 20 mL, qd,10d	4 cycles	RECIST	ORR, DCR, HRQoL-KPS, ADRs, CEA/CA153 level
	C:45	C:33–71

Note. T: compound KuShen injection group; C: control group; d: day; y: year; NR: not reported. ∗: chemotherapy regimens: A: ADM (doxorubicin); F: 5-fluorouracil; C1: CTX (cyclophasphamide); T: docetaxel; E: EPI (epirupicin); G: GEM (gemcitabline); P: paclitaxel; N: NVB (vinorelbine); C2: CBP (carboplatin). HRQoL-KPS: health-related quality of life measured by Karnofsky Performance scale; HRQoL-BREF: health-related quality of life measured by QoL-BREF scale.