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

Evidence-Based Complementary and Alternative Medicine
Volume 2012 (2012), Article ID 803239, 8 pages
http://dx.doi.org/10.1155/2012/803239

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
Wen-Hung Kuo,1 Chien-An Yao,2 Chih Hui Lin,3 and King-Jen Chang1,4

1Department of General Surgery, National Taiwan University Hospital, Taipi, Taiwan
2Department of Family Medicine, National Taiwan University Hospital, Taipi, Taiwan
3Gerent Biotech Co., Ltd., Taichung, Taiwan
4Department of Surgery, Cheng Ching General Hospital, Taichung, Taiwan

Received 15 December 2011; Accepted 18 January 2012

Academic Editor: Wolfgang Weidenhammer

Copyright © 2012 Wen-Hung Kuo et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract

To evaluate the safety and efficacy of Tien-Hsien Liquid Practical (THL-P), a Chinese herbal mixture, in patients with refractory metastatic breast cancer, we performed a randomized, double-blind, placebo-controlled, parallel-group, phase IIa pilot trial. Patients were randomly assigned to either receive THL-P or matching placebo and followed up every 4 weeks for 24 weeks. The primary endpoint was changes in the global health status/quality of life (GHS/QOL) scale. The secondary endpoints were changes in functional and symptom scales, immunomodulating effects, and adverse events. Sixty-three patients were enrolled between June 2009 and June 2011. The intent-to-treat population included 28 patients in the THL-P group and 11 patients in the placebo group. Compared to the placebo group, the THL-P group had significant improvement from baseline to last visit in GHS/QOL (41.7 versus −33.3; ), CD3, CD4/CD8, CD19, CD16+56 positive cells ( ), and higher levels of physical, role, emotional, and cognitive functioning, as well as decreased fatigue and systemic side effects. Treatment-related adverse events were mild constipation and localized itching, and no serious adverse events were reported. THL-P appears to be a safe alternative adjuvant treatment for patients with refractory metastatic breast cancer, as it effectively improves QOL and palliates cancer-related symptoms.