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
Figure 1
Flow diagram of the randomized, double-blind, placebo-controlled, parallel-group phase IIa clinical trial comparing Tien Hsien liquid practical (THL-P) to placebo for safety and efficacy. A total of 63 patients entered our trial between June 2009 and June 2011. Nineteen patients were excluded due to lack of confidence in the treatment (), hospital transfer (), and treatment refusal (). Forty-four patients were randomly assigned in a 2 : 1 ratio to either the THL-P group () or the placebo group (). Thirteen patients in the THL-P group and none in the placebo group had completed the study.
