Research Article

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 3

Secondary endpoints: changes in the functional and symptom scales of EORTO-QLQ-BR23, lymphocytes, and body weight in the intent-to-treat population.

THL-P Placebo P value

Change from baseline
EORTO-QLQ-BR23
Functional scales a
 Body image0 (0, 33.3)0 (0, 8.3)0.346
 Sexual function0 (0, 0)0 (0, 0)0.591
 Sexual enjoyment0 (0, 0)16.7 (0, 33.3)0.582
 Future perspective16.7 (0, 33.3)0 (0, 0)0.102
Symptom scales a
 Systemic therapy side effects−4.8 (−23.8, 0)4.8 (−4.8, 9.5)0.010*
 Breast symptoms0 (−16.7, 8.3)0 (−8.3, 0)0.450
 Arm symptoms−5.6 (−33.3, 0)0 (−11.1, 22.2)0.346
 Upset by hair loss−33.3 (−33.3, 0)0 (−16.7, 0)0.316
Lymphocytes (%)
 CD36.0 (1.0, 9.5)−2.5 (−6.0, −1.0)0.001*
 CD40.0 (−2.0, 8.0)−1.5 (−4.0, 1)0.157
 CD8−1.5 (−3.0, 1.5)0.5 (−2.0, 2.0)0.387
 CD4/CD80.2 (−0.1, 0.5)−0.1 (−0.2, 0.0)0.043*
 CD193.0 (0.0, 7.5)−2.0 (−3.0, 3.0)0.021*
 CD16+568.0 (3.0, 11.0)−4.0 (−6.0, −3.0)<0.001*
Body weight (%)b0.2 ± 3.40.3 ± 4.00.964

THL-P: Tien Hsien liquid practical; EORTO-QLQ-BR23: European Organization for Research and Treatment of Breast Cancer-Specific Quality of Life Questionnaire.
* versus placebo (Mann-Whitney U testa or independent, two-sample testb).
versus baseline (Wilcoxon signed ranks testa or paired Student’s t-testb). Values are presented as median (interquartile)a and mean ± standard deviationb.