Effect of yunnan baiyao therapy on non-specific elevated PSA and prostate biopsy

Abstract

Objective To evaluate whether a six months course of Yunnan Baiyao therapy would lower serum prostate specific antigen (PSA) and affect outcome of prostate biopsy. Methods In this randomized, prospective and non-blinded clinical trial, we recruited eligible 96 asymptomatic patients who were older than 50 years old and with PSA of 4~20 ng/mL in our center. All patients were treated with Yunnan Baiyao for 6 months. PSA tests, digital rectal examination (DRE) and ultrasonography(US) were conducted in the following 1, 2, 3, 6 months. Six months later, patients were divided into two groups according to their treatment response: group 1 with reduced PSA level (defined as a decrease in PSA by at least 20%) and group 2 with no response. Twenty-one and 29 patients from group 1 and group 2 were randomly assigned respectively and underwent transrectal ultrasound-guided prostate biopsy. Results The average PSA decreased significantly compared with baseline value after a course of 6 months treatment, with a change of 2.05 ng/mL, about a reduction rate of 22.2%(P<0.05). Of those who received biopsy, 1 case in group 1 and 6 cases in group 2 were diagnosed with prostate cancer (4.76% vs. 20.7%, P<0.05). The sensibility and specificity of PSA reduction of ≥20% was 85.71% and 46.51% respectively. Conclusions Yunnan Baiyao may contribute to decline of elevated PSA caused by non-malignant lesions and improve positive prostate biopsy ratio, thereby avoiding unnecessary prostate biopsy. However, the outcome should be further validated by multicenter, large sample and long-term follow-up clinical trial. Key words: Prostatic Neoplasms; Prostate-Specific Antigen; YUNNAN BAI YAO