Effective of Fuzheng Yiliu Formula in combination with hormone therapy for delaying the progression of metastatic hormone-sensitive prostate cancer
GAN Shu,PAN Yi-wen,WEI Bo-an
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou510120, China
Abstract:
Objective To evaluate the clinical efficacy and potential mechanisms of Fuzheng Yiliu Formula (FZYLF) combined with hormone therapy in delaying the progression of metastatic hormone-sensitive prostate cancer (mHSPC). Methods A prospective randomized controlled trial was conducted, enrolling 50 mHSPC patients from Guangdong Provincial Hospital of Traditional Chinese Medicine. Participants were randomly assigned in 1∶1 ratio to the experimental group (FZYLF+hormone therapy, n=25) or the control group (herbal placebo+hormone therapy, n=25). Primary outcomes included serum total prostate-specific antigen (tPSA), testosterone, alkaline phosphatase (ALP), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and lymphocyte-to-monocyte ratio (LMR) at at 1 month and 3 months. Results Final follow-up included 13 patients in the FZYLF group (12 lost to follow-up) and 25 in the control group. Baseline characteristics showed no significant differences between groups (P >0.05). Post-treatment, the levels of tPSA and testosterone in both groups decreased significantly compared to before treatment, exceeding 90%, but the difference between the two groups was not statistically significant (P >0.05), the FZYLF group exhibited a median reduction of approximately 30% in ALP levels from baseline, while the control group showed no improvement. At 3 months, the FZYLF group demonstrated significantly higher LMR compared to the control group (P =0.029). No significant between-group differences were observed in tPSA, testosterone, NLR, or PLR (P >0.05). Conclusion FZYLF may delay mHSPC progression by modulating bone metabolism, suppressing inflammation, and enhancing immune response. However, the small sample size and high dropout rate limit the reliability of conclusions. Further large-scale studies with extended follow-up are warranted to validate these findings.
