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 2

Primary endpoints: Changes in the functional and symptom scales of EORTO-QLQ-C30 in the intent-to-treat population.

	THL-P (𝑛=28)	Placebo (𝑛=11)	𝑃-value
Change from baseline
EORTO-QLQ-C30
GHS/QOL	41.7 (29.2, 50.0)^†	−33.3 (−33.3, 0)^†	<0.001*
Functional scales
Physical	13.3 (3.3, 26.7)^†	0 (−13.3, 13.3)	0.014*
Role	0 (0, 41.7)^†	0 (−16.7, 0)	0.018*
Emotional	8.3 (0, 25.0)^†	0 (−33.3, 8.3)	0.024*
Cognitive	16.7 (0, 16.7)^†	0 (−33.3, 0)	<0.001*
Social	0 (0, 33.3)^†	0 (−33.3, 33.3)	0.379
Symptom scales
Fatigue	−22.2 (−33.3, −11.1)^†	0 (−11.1, 22.2)	<0.005*
Nausea and vomiting	0 (0, 0)	0 (0, 16.7)	0.656
Pain	0 (−25.0, 16.7)	0 (0, 16.7)	0.124
Single items
Dyspnoea	0 (−33.3, 0)	0 (0, 0)	0.528
Insomnia	0 (0, 16.7)	0 (0, 33.3)	0.569
Appetite loss	0 (0, 0)	0 (0, 0)	0.633
Constipation	0 (−16.7, 0)	0 (0, 0)	0.770
Diarrhoea	0 (0, 33.3)	0 (0, 33.3)	0.866
Financial difficulties	0 (0, 0)	0 (0, 0)	0.747

THL-P: Tien-Hsien liquid practical; EORTO-QLQ-C30: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30.
* 𝑃<0.05 versus placebo (Mann-Whitney U test). ^†𝑃<0.05 versus baseline (Wilcoxon signed ranks test). Values are presented as median (interquartile).