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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
Joint Authors
Kuo, Wen-Hung
Yao, Chien-An
Lin, Chih Hui
Chang, King-Jen
Source
Evidence-Based Complementary and Alternative Medicine
Issue
Vol. 2012, Issue 2012 (31 Dec. 2012), pp.1-8, 8 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2012-04-01
Country of Publication
Egypt
No. of Pages
8
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Kuo, Wen-Hung& Yao, Chien-An& Lin, Chih Hui& Chang, King-Jen. 2012. 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،Vol. 2012, no. 2012, pp.1-8.
https://search.emarefa.net/detail/BIM-992658
Modern Language Association (MLA)
Kuo, Wen-Hung…[et al.]. 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 No. 2012 (2012), pp.1-8.
https://search.emarefa.net/detail/BIM-992658
American Medical Association (AMA)
Kuo, Wen-Hung& Yao, Chien-An& Lin, Chih Hui& Chang, King-Jen. 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. 2012. Vol. 2012, no. 2012, pp.1-8.
https://search.emarefa.net/detail/BIM-992658
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-992658