Safety and Efficacy of Tien-Hsien Liquid Practical in Patients with Refractory Metastatic Breast Cancer: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase IIa Trial

Table 1

Demographic and clinical characteristics of patients with refractory metastatic breast cancer at baseline.

	THL-P (𝑛=30)	Placebo (𝑛=14)	𝑃 value
Demographics
Age (years)^a	60.7±9.5	58.7±7.6	0.507
Height (cm)^a	155.3±5.9	156.5±5.4	0.512
Weight (kg)^a	57.6±8.1	59.3±10.5	0.554
T stage, 𝑛 (%)^b
T1	4 (13.4)	1 (7.2)	0.968
T2	12 (40.0)	7 (50.0)
T3	7 (23.3)	3 (21.4)
T4	7 (23.3)	3 (21.4)
Lymph nodes, 𝑛 (%)^b
N0	10 (33.3)	3 (12.4)	0.306
N1	6 (20.0)	2 (14.3)
N2	4 (13.4)	2 (14.3)
N3	10 (33.3)	7 (50.0)
Metastasis, 𝑛 (%)^b
M1	30 (100)	14 (100)	N/A
Duration of onset (years)^c	3.5 (2.0, 7.0)	4.1 (2.7, 5.4)	0.970
EORTO-QLQ-C30
GHS/QOL ^c	37.5 (16.7, 50.0)	50.0 (25.0, 66.7)	0.082
Functional scales
Physical^c	60.0 (46.7, 73.3)	70.0 (46.7, 86.7)	0.336
Role^c	66.7 (33.3, 83.3)	66.7 (33.3, 100.0)	0.643
Emotional^c	66.7 (50.0, 83.3)	75. 0 (58.3, 91.7)	0.469
Cognitive^c	66.7 (50.0, 83.3)	83.3 (66.7, 83.3)	0.118
Social^c	66.7 (33.3, 100.0)	66.7 (66.7, 100.0)	0.711
Symptom scales
Fatigue^c	55.6 (33.3, 66.7)	38.9 (22.2, 55.6)	0.273
Nausea and vomiting^c	0 (0, 16.7)	0 (0, 0)	0.362
Pain^c	33.3 (0, 66.7)	8.3 (0, 50.0)	0.382
Single items
Dyspnoea^c	33.3 (0, 66.7)	0 (0, 33.3)	0.069
Insomnia^c	33.3 (0, 33.3)	33.3 (0, 66.7)	0.608
Appetite loss^c	33.3 (0, 66.7)	0 (0, 33.3)	0.367
Constipation^c	0 (0, 33.3)	0 (0, 33.3)	0.403
Diarrhoea^c	0 (0, 0)	0 (0, 33.3)	0.523
Financial difficulties^c	33.3 (0, 33.3)	33.3 (0, 33.3)	0.746

THL-P: Tien-Hsien liquid practical: EORTO-QLQ-C30: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; GHS: global health status; QOL: quality of life.
𝑃 values were determined via the independent, two sample t-test^a, Fisher’s exact test^b, and Mann-Whitney U test^c. Values are presented as mean ± standard deviation^a, number (percentage)^b, and median (interquartile)^c.