Combined effects of keishibukuryogan on cystitis with blood stasis in elderly women

Hitoshi O1

Research Type


Abstract Category

Female Lower Urinary Tract Symptoms (LUTS) / Voiding Dysfunction

Abstract 773
Non Discussion Abstract
Scientific Non Discussion Abstract Session 37
Female Infection, Urinary Tract Clinical Trial Prevention
1.Kobe Medical Center


Hypothesis / aims of study
Keishibukuryogan (KBG, Chinese: gui zhi fu ling wan; cinnamon twig and poria pill) is a typical Herbal medicine in Japanese traditional medicine employed for the treatment of ‘Oketsu’ (blood stasis: microcirculatory disorder) in patients with moderate physical strength who tend to experience hot flashes. It is composed of persicae semen, moutan cortex, paeoniae radix, cinnamomi cortex, and poria. The effect of improving coldness of the lower extremities in menopausal women1] and the effect of ameliorating lower extremity swelling due to deep vein thrombosis (DVT)2] have been previously reported.
In this study, we examined the clinical effects of KBG or choreitogoshimotsuto (CGS, Chinese: zhu ling tang he si wu tang; polyporus plus four agents decoction), which are often prescribed in combination with antimicrobial agents for the treatment of various urinary tract infections, in addition to the use of antimicrobial agents administered only for acute uncomplicated cystitis in elderly women with blood stasis.
Study design, materials and methods
The subjects comprised 90 women (age 55-78 years [mean: 69.4 years] from whom consent could be obtained in writing. The subjects had ‘Blood Stasis Score of Terasawa’3] of 21-42 (mean score: 30.1) and were divided into 3 groups: 1); CPDX-PR (Cefpodoxime Proxetil)  100 mg, twice daily (one in the morning and one in the evening), administered for 1 week (group A), 2); 2.5 gr. of KBG added to CPDX-PR for 3 times /day for 4 weeks (group B), 3); 2.5 gr. of CGS added to CPDX-PR for 3 times/day for 4 weeks (group C). The examination items were urine culture (at the time of initial visit) and changes in subjective symptoms (urinary frequency, urinary urgency, pain on micturition, etc.) and objective findings (urinary sediments, ‘Blood Stasis Score of Terasawa’) from treatment baseline to 1, 4, and 8 weeks after intervention.
No significant difference with respect to baseline sensitivity for all antimicrobial agents was noted. The subjective symptom improvement rates were as follows: 1 week, 66.7%, 60.0%, 76.7% (group A, group B, group C); 4 weeks, 76.7%, 73.3%, 80.0%; after 8 weeks, 63.3%, 86.7%, 73.3% (after 8 weeks, no statistical differences were observed among these 3 groups [Fisher’s exact test]). Objective improvement rates were as follows: 1 week, 73.3%, 80.0%, 76.7%; 4 weeks, 83.3%, 86.7%, 80.0%; after 8 weeks, 66.7%, 96.7%, 76.7% (after 8 weeks, group A vs. group B; p =0.018. odds; 10.0. group A vs. group C; not statistically significant, group B vs. group C; not statistically significant [Fisher’s exact test]). Patients with ‘Blood Stasis Score of Terasawa’ of 30 points or more before treatment were 43.3 %%, 53.3%, 56.7%, and after 8 weeks, 30.0%, 0%, 36.7% (group A vs. group B; p=0.005, odds; 23.2, group A vs. group C; not statistically significant, group B vs. group C; p=0.003, odds; 21.7). No adverse events were observed in this study by prescribing KBG and CGS.
Interpretation of results
‘Blood Stasis Score of Terasawa’ significantly improved in group B in comparison with other groups. With regard to subjective symptoms and objective findings, significant improvements were observed between group A and group B only for objective findings after 8 weeks. It was suggested that an antimicrobial agent and KBG combination therapy improve blood stasis and may be more effective in comparison with the antimicrobial-only administration regarding the relapse of subacute infection after 8 weeks. The results of the present study could not confirm the utility of CGS.
Concluding message
Antimicrobial agents and keishibukuryogan (KBG) combination therapy may reduce the subacute relapse rate after acute uncomplicated cystitis treatment in elderly women with blood stasis compared with antimicrobial monotherapy. Improvement of the usefulness of ‘Kampo’ combination therapy with antimicrobial agents to avoid relapse of urinary tract infections was suggested in this study.
Figure 1
  1. Ushiroyama T, Ikeda A, Sakuma K, et al. Comparing the effects of estrogen and an herbal medicine on peripheral blood flow in post-menopausal women with hot flashes: hormone replacement therapy and gui-zhi-fu-ling-wan, a Kampo medicine. Am J Chin Med. 2005;33(2):259-67.
  2. Shinobu H, Shintaro S, Tomohisa E, et al. Examination of Clinical Efficacy of Keishibukuryogan on Non-Specific Complaints Associated with Varicose Veins of the Lower Extremity. Jpn J Phlebol. 2013;24(3):303-10.
  3. Hikiami H, Goto H, Sekiya N, et al. Comparative efficacy of Keishi-bukuryo-gan and pentoxifylline on RBC deformability in patients with "oketsu" syndrome. Phytomedicine. 2003;10(6-7):459-66.
<span class="text-strong">Funding</span> none <span class="text-strong">Clinical Trial</span> Yes <span class="text-strong">Public Registry</span> No <span class="text-strong">RCT</span> No <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics Committee</span> The ethics committee of Kobe Medical Center <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes