Modulatory Effects of XIAOPI Formula on CXCL1 and Selected Outcomes in Triple-Negative Breast Cancer: A Randomized Controlled Clinical Trial

Figures & data

Table 1 Demographic and Clinical Characteristics of Enrolled Participants

Characteristic	Total	Control group	XIAOPI group	P value
Age, Mean (SD), year	47.1(10.4)	48.6 (9.6)	45.5 (11.1)	0.25
Age				0.18
<50 years	37(61.7%)	16	21
≥50 years	23(38.3%)	14	9
BMI				0.52
<25	48(80%)	23	25
≥25	12(20%)	7	5
Menopausal status				0.55
Pre-menopausal	32(53.3%)	18	14
Post-menopausal	26(43.3%)	11	15
Not known	2(3.3%)	1	1
Menarche age				0.44
≤13	33(55.0%)	15	18
>13	27(45.0%)	15	12
Pregnancy times				0.89
0	3(5%)	2	1
1–2	32(53.3%)	15	17
≥3	25(41.7%)	13	12
Delivery times				0.37
0	4(6.7%)	3	1
1–2	52(86.7%)	26	26
≥3	4(6.7%)	1	3
Age at first reproduction				0.72
20–24 years	17(28.3%)	7	10
25 −30 years	35(58.3%)	19	16
>30 years	5(8.3%)	2	3
Not known	3(5.0%)	2	1
Duration of lactation				0.72
0–6 months	28(46.7%)	13	15
7–12 months	21(35.0%)	10	11
>12 months	7(11.7%)	4	3
Not known	4(6.7%)	3	1
Histological grade				0.60
1	1(1.7%)	0	1
2	22(36.7%)	11	11
3	37(61.7%)	19	18
Location of tumor				0.61
Left breast	30 (50.0%)	16	14
Right breast	30 (50.0%)	14	16
Cancer stage				0.72
I	24(40.0%)	13	11
II	31(51.7%)	14	17
III	5(8.3%)	3	2
Tumor size				0.79
<2 cm	23(38.3%)	11	12
≥2 cm	37(61.7%)	19	18
Number of metastatic lymph nodes				0.78
0	46 (76.7%)	22	24
1–3	10 (16.7%)	6	4
≥4	4 (6.7%)	2	2

Figure 1 Study flowchart.

Table 2 Prevalence of Anxiety, Depression, and Sleep Quality in TNBC Patients

Characteristic	Total	Control group	XIAOPI group	p value
SAS				0.74
<50	49(81.7%)	25 (83.3%)	24 (80.0%)
≥50	11(18.3%)	5 (16.7%)	6 (20.0%)
SDS				0.44
<50	33(55.0%)	15 (50.0%)	18 (60.0%)
≥50	27(54.0%)	15 (50.0%)	12 (40.0%)
PSQI				0.60
≤7	24(40.0%)	13 (43.3%)	11 (36.7%)
>7	36(60.0%)	17 (56.7%)	19 (63.3%)

Table 3 Comparison of CXCL1 Expression of the Breast Patients Before and After XIAOPI Formula Intervention (`x±s, Pg/Ml)

Variable	Group	Baseline	Postintervention	Mean differences	Statistics (p)
CXCL1	Control group	64.23±31.98	57.92±27.43	−0.73±14.04	0.046
	XIAOPI group	67.01±27.32	55.73±19.69	−11.28±22.62

Table 4 Comparison of the SAS, SDS, PSQI and FACT-B Scores of the Breast Patients Before and After XIAOPI Formula Intervention (`x±s, Scores)

Variable	Group	Baseline	Postintervention	Mean differences	Statistics (p)
SAS	Control group	43.57±6.65	45.32±6.56	1.54±3.98	0.020
	XIAOPI group	43.83±8.62	39.48±9.69	−3.78±10.54
SDS	Control group	48.67±9.80	49.23±8.87	0.57±8.76	0.031
	XIAOPI group	49.53±10.40	43.25±13.29	−6.89±15.50
PSQI	Control group	9.93±4.71	9.42±4.78	−0.039±2.71	0.019
	XIAOPI group	9.40±4.17	7.37±3.51	−2.04±3.25
Subjective sleep quality	Control group	1.47±0.82	1.54±0.83	0.15±0.83	0.027
	XIAOPI group	1.60±0.77	1.26±0.81	−0.37±0.84
Sleep latency	Control group	2.30±0.79	2.15±0.78	−0.039±0.72	0.15
	XIAOPI group	2.10±0.80	1.78±0.64	−0.33±0.73
Sleep duration	Control group	1.33±1.12	1.19±1.13	−0.039±0.66	0.45
	XIAOPI group	1.20±0.92	1.07±0.92	−0.19±0.74
Sleep efficiency	Control group	1.40±1.25	1.35±1.32	0.039±0.72	0.18
	XIAOPI group	1.23±1.19	0.93±1.11	−0.26±0.86
Sleep disturbances	Control group	1.37±0.56	1.23±0.51	−0.077±0.48	0.10
	XIAOPI group	1.50±0.57	1.15±0.53	−0.33±0.62
Sleep medication usage	Control group	0.43±0.94	0.46±1.03	0.077±0.74	0.27
	XIAOPI group	0.20±0.76	0.074±0.27	−0.15±0.72
Daytime dysfunction	Control group	1.63±0.89	1.57±1.01	−0.15±0.92	0.34
	XIAOPI group	1.50±0.91	1.11±0.85	−0.41±0.97
Total FACT-B scores	Control group	109.20±17.91	107.63±19.49	−2.00±10.28	0.005
	XIAOPI group	109.54±16.51	115.07±20.19	8.48±15.07
Physical status	Control group	23.67±3.57	24.15±3.31	0.31±2.31	0.078
	XIAOPI group	22.47±4.33	24.33±3.56	1.89±3.89
Social/family status	Control group	20.30±6.43	19.12±6.42	−1.92±5.22	0.19
	XIAOPI group	22.33±3.79	21.89±4.70	−0.33±3.37
Emotional status	Control group	18.43±3.49	19.35±2.70	0.54±2.25	0.54
	XIAOPI group	18.80±4.16	19.63±4.41	1.00±3.14
Functional status	Control group	20.43±5.32	19.88±5.84	−1.31±4.76	0.11
	XIAOPI group	19.93±6.64	20.67±5.25	1.15±6.24
Additional attention	Control group	27.67±4.59	27.04±4.78	−2.96±4.78	0.27
	XIAOPI group	25.17±5.90	28.56±5.13	−1.44±5.13

Figure 2 Correlation analysis between SAS, SDS, PSQI, FACT-B, and CXCL1 in patients before and after intervention. The number in the box indicates the Pearson’s correlation coefficient, and the color indicates the degree of correlation. **P < 0.01, *P < 0.05.

Figure 3 Comparison of DFS between the XIAOPI formula group and the placebo group.

Data Sharing Statement

The datasets used and analysed during the current study are available from the corresponding author on reasonable request.