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
Journal
Evidence-based Complementary and Alternative Medicine
Journal Volume
2012
Pages
803239
Date Issued
2012
Author(s)
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; P < 0.05), CD3, CD4/CD8, CD19, CD16+56 positive cells (P < 0.05), 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. Copyright ? 2012 Wen-Hung Kuo et al.
SDGs
Other Subjects
CD16 antigen; CD19 antigen; CD3 antigen; CD4 antigen; CD8 antigen; herbaceous agent; tien hsien liquid practical; unclassified drug; adult; aged; article; breast metastasis; Chinese medicine; cognition; constipation; controlled study; double blind procedure; drug efficacy; drug safety; emotion; fatigue; female; follow up; health status; human; immunomodulation; intention to treat analysis; major clinical study; phase 2 clinical trial; physical activity; priority journal; pruritus; quality of life; refractory metastatic breast cancer
Type
journal article