Chung Lyul Lee, Hyeun-Kyoo Shin, Ji Yong Lee, Ojin Kwon, Chang-Seob Seo, Ae-Ran Kim, Bok-Nam Seo, Seung Woo Yang, Ki Hak Song, Jae Sung Lim, Jong Mok Park, Yong Gil Na, Ju Hyun Shin
Journal: International journal of urology : official journal of the Japanese Urological Association 2022;29(6):503-509
PMID: 35297106
Benign prostatic hyperplasia (BPH) is a common diagnosis of progressive enlargement of the prostate in older men and the prevalence increases with an aging population. BPH is one of the leading causes of lower urinary tract symptoms (LUTS), causing significant morbidity and decreasing the quality of life of older men. The aim of this study was to describe the efficacy and safety of combination therapy with tamsulosin, and two traditional herbal medicines - Hachimijiogan (HJG) and Ryutanshakanto (RST) in patients with LUTS due to BHP. This study is a double-blind randomised controlled trial. Participants (n= 44) were randomly assigned to one of the three groups: control (tamsulosin and placebo), RST (tamsulosin and RST) or HJG (tamsulosin and HJG) group. Results show that: - in all three groups, prostate volume increased after treatment compared to that before treatment. The HJG and RST combination do not exhibit inferior efficacy to alpha‐blocker monotherapy. - patients in all three groups showed significant improvement in international prostate symptom score (IPSS) and quality of life index without significant differences among the groups. - there weren’t significant differences in the laboratory tests results among the groups before and after treatment. Authors conclude that HJG and RST in conjunction to tamsulosin can be safe supplements for patients with adverse events on taking other medications or high operation risk.
OBJECTIVES
To evaluate the efficacy and safety of tamsulosin and Hachimijiogan or Ryutanshakanto in patients with lower urinary tract symptoms due to benign prostatic hyperplasia.
METHODS
A prospective, randomized, double-blind method was used to determine the efficacy and safety of the combination or placebo at baseline and 4, 8, and 12 weeks of study. The International Prostate Symptom Score, quality of life index, complete voiding diary, and National Institutes of Health-Chronic Prostatitis Symptom Index were studied. Uroflowmetery and postvoid residual urine volume were measured and compared. Laboratory tests including prostate-specific antigen were performed.
RESULTS
In all groups, International Prostate Symptom Score and quality of life showed improvement, but no significant differences were shown among the groups. Prostate volume increased after treatment, and uroflowmetric parameters showed improvements after treatment without significance among the three groups. The total score of the National Institutes of Health-Chronic Prostatitis Symptom Index showed a significant improvement in all groups, without significant differences among the groups. Only the pain sub-score of the National Institutes of Health-Chronic Prostatitis Symptom Index showed a significant decrease in the tamsulosin with Ryutanshakanto group compared to the control group. A total of 11 adverse reactions occurred, but they were mild and not related to the study drugs.
CONCLUSION
Ryutanshakanto can provide pain relief in patients with chronic prostatitis and chronic pelvic pain syndrome. If more research is conducted, Hachimijiogan and Ryutanshakanto may be applied as add-on treatments in patients with storage symptoms with alpha-blocker monotherapy.
© 2022 The Authors. International Journal of Urology published by John Wiley & Sons Australia, Ltd on behalf of the Japanese Urological Association.
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