Effectiveness and safety of Pingxiao capsule (平消胶囊) as adjuvant therapy in treatment of breast cancer: a systematic review and Meta-analysis

doi:10.19852/j.cnki.jtcm.20230713.001

Abstract

Abstract:

OBJECTIVE: To systematically review the effectiveness and safety of Pingxiao capsule (平消胶囊) adjuvant chemotherapy in the treatment of breast cancer.
METHODS: A total of 8 databases including the Cochrane Library, PubMed, EMBASE, Engineering Index, Chinese Biomedical Literature Database, Wanfang database, China National Knowledge Infrastructure Database, and China Science and Technology Journal Database were searched for the Randomized Controlled Trials (RCTs) of Pingxiao capsule combined with chemotherapy in the treatment of breast cancer published before June 2022. Two researchers independently screened the literature, extracted data, and evaluated the risk of bias. R language was used for estimating risks of bias of included studies, data analysis, and plotting.
RESULTS: A total of 15 RCTs involving 1272 patients were included in this study. Meta-analysis results indicated that compared with chemotherapy alone, Pingxiao capsule combined with chemotherapy could significantly improve breast cancer patients’ objective response rate of breast cancer patients [rate ratio (RR) = 1.35, 95% confidence interval (CI) (1.12, 1.63), P = 0.0017], the disease control rate [RR=1.16, 95% CI (1.08, 1.25), P < 0.0001], the quality of life [RR =1.42, 95% CI (1.16, 1.74), P = 0.007], and the level of the immune cells [CD3+: standardized mean difference (SMD) =1.42, 95% CI (0.76, 2.09), P < 0.001; CD4+: SMD =1.18, 95% CI (0.70, 1.66), P < 0.001]. In addition, Pingxiao capsule combined with chemotherapy can also significantly reduce CD8+ level (P < 0.0001) and reduce the symptoms of decreased white blood cell count [SMD = 0.62, 95% CI (0.39, 0.85), P < 0.0001], and the occurrence of adverse reactions such as gastrointestinal adverse reactions and limb pain (P < 0.05).
CONCLUSIONS: Pingxiao capsule can significantly improve the efficacy of chemotherapy, the quality of life and immune function of patients, and reduce the clinical side effects caused by chemotherapy. However, high-quality randomized clinical trials with large samples are required for further verification of these results.

Key words: breast neoplasms, Meta-analysis, randomized controlled trial, Pingxiao capsule

YANG Yuqing, CHEN Yuhuan, LI Chunxiao, LING Xiao, WANG Panpan, GUO Jing, ZHANG Yingying. Effectiveness and safety of Pingxiao capsule (平消胶囊) as adjuvant therapy in treatment of breast cancer: a systematic review and Meta-analysis[J]. Journal of Traditional Chinese Medicine, 2023, 43(5): 851-859.

Figures/Tables 7

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Study	Sample size (E/C)	Age (years, E/C)	Intervention		Duration (weeks)	Outcome
Study	Sample size (E/C)	Age (years, E/C)	E	C	Duration (weeks)	Outcome
Li YX 2021¹⁴	40/40	50.81/50.72	Pingxiao+capecitabine	Capecitabine	6	①②⑥
Xiang L et al 2020¹⁵	36/40	54.5/53.6	Pingxiao+capecitabine	Capecitabine	6	①②⑥
Kong Y et al 2020¹⁶	59/59	52.7/51.9	Pingxiao+CAF	CAF	12-18	①②④⑥
Li HJ et al 2019¹⁷	49/49	51.08/52.13	Pingxiao+capecitabine	Capecitabine	-	①②④
Yang QH 2017¹⁸	42/42	54.87/55.42	Pingxiao+FEC/CAF	FEC/CAF	12-18	⑤
Gao GJ et al 2016¹⁹	73/73	54.71/52.46	Pingxiao+FEC	FEC	-	④⑥
Feng D et al 2013²⁰	33/33	45.6/45.6	Pingxiao+tamoxifen	Tamoxifen		①②⑥
Jin ZN 2012²¹	31/29	56/56	Pingxiao+FEC/CAF	FEC/CAF	12-18	④⑤
Zhang XM et al 2010²²	44/41	67.2/66.8	Pingxiao+letrozol	Letrozol	-	①②③⑥
Liu ZY et al 2009²³	28/26	54/54	Pingxiao+FEC	FEC	-	①③⑥
Zhang M 2008²⁴	54/54	46.5/46.5	Pingxiao+tamoxifen	Tamoxifen	24	①②
Gao F et al 2007²⁵	50/46	48/43	Pingxiao+CAF	CAF	12	⑤⑥
Zhang QY et al 2005²⁶	27/27	50/52	Pingxiao+FEC+TE+P	FEC+TE+ P	18	①②③⑥
Li YJ et al 2005²⁷	30/30	43/43	Pingxiao+CAF	CAF	8	①②⑥
Zheng SN 2004²⁸	45/42	47.8/47.5	Pingxiao+CAF	CAF	15	⑤⑥

Study	Sample size (E/C)	Age (years, E/C)	Intervention		Duration (weeks)	Outcome
Study	Sample size (E/C)	Age (years, E/C)	E	C	Duration (weeks)	Outcome
Li YX 2021¹⁴	40/40	50.81/50.72	Pingxiao+capecitabine	Capecitabine	6	①②⑥
Xiang L et al 2020¹⁵	36/40	54.5/53.6	Pingxiao+capecitabine	Capecitabine	6	①②⑥
Kong Y et al 2020¹⁶	59/59	52.7/51.9	Pingxiao+CAF	CAF	12-18	①②④⑥
Li HJ et al 2019¹⁷	49/49	51.08/52.13	Pingxiao+capecitabine	Capecitabine	-	①②④
Yang QH 2017¹⁸	42/42	54.87/55.42	Pingxiao+FEC/CAF	FEC/CAF	12-18	⑤
Gao GJ et al 2016¹⁹	73/73	54.71/52.46	Pingxiao+FEC	FEC	-	④⑥
Feng D et al 2013²⁰	33/33	45.6/45.6	Pingxiao+tamoxifen	Tamoxifen		①②⑥
Jin ZN 2012²¹	31/29	56/56	Pingxiao+FEC/CAF	FEC/CAF	12-18	④⑤
Zhang XM et al 2010²²	44/41	67.2/66.8	Pingxiao+letrozol	Letrozol	-	①②③⑥
Liu ZY et al 2009²³	28/26	54/54	Pingxiao+FEC	FEC	-	①③⑥
Zhang M 2008²⁴	54/54	46.5/46.5	Pingxiao+tamoxifen	Tamoxifen	24	①②
Gao F et al 2007²⁵	50/46	48/43	Pingxiao+CAF	CAF	12	⑤⑥
Zhang QY et al 2005²⁶	27/27	50/52	Pingxiao+FEC+TE+P	FEC+TE+ P	18	①②③⑥
Li YJ et al 2005²⁷	30/30	43/43	Pingxiao+CAF	CAF	8	①②⑥
Zheng SN 2004²⁸	45/42	47.8/47.5	Pingxiao+CAF	CAF	15	⑤⑥

Outcome	Number of studies	Sample size		SMD	95% CI	I ² value (%)	P value
Outcome	Number of studies	E	C	SMD	95% CI	I ² value (%)	P value
CD3+	3	139	137	1.42	0.76, 2.09	83%	< 0.001
CD4+	4	212	210	1.18	0.70, 1.66	80%	< 0.001

Outcome	Number of studies	Sample size		SMD	95% CI	I ² value (%)	P value
Outcome	Number of studies	E	C	SMD	95% CI	I ² value (%)	P value
CD3+	3	139	137	1.42	0.76, 2.09	83%	< 0.001
CD4+	4	212	210	1.18	0.70, 1.66	80%	< 0.001

Study	CD8+			CD4+/CD8+
Study	SMD	95% CI	P value	SMD	95% CI	P value
Kong Y et al 2020¹⁶	－1.69	－2.11, －1.27	< 0.000	0.65	0.28, 1.02	0.0006
Gao GJ et al 2016¹⁹	2.22	1.80, 2.63	0.000	2.14	1.64, 2.64	< 0.000
Jin ZN 2012²¹	－1.68	－2.27, －1.10	< 0.000	0.82	0.29, 1.35	0.002

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