Effectiveness and Safety of Umbilicus Treatment with Modified Dinggui Powder (加味丁桂散) in Patients with Chronic Nonbacterial Prostatitis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Hai HUANG; Min-jie ZHOU; Ke-xie WANG; Chao YU; Yu-hang WANG; Jun JI; Wen PAN; Jian YING; Ling ZHAO

doi:10.1007/s11655-020-3258-5

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Effectiveness and Safety of Umbilicus Treatment with Modified Dinggui Powder (加味丁桂散) in Patients with Chronic Nonbacterial Prostatitis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Original Article | Updated：2021-08-16

- Effectiveness and Safety of Umbilicus Treatment with Modified Dinggui Powder (加味丁桂散) in Patients with Chronic Nonbacterial Prostatitis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- Effectiveness and Safety of Umbilicus Treatment with Modified Dinggui Powder (加味丁桂散) in Patients with Chronic Nonbacterial Prostatitis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- Chinese Journal of Integrative Medicine 2021年27卷第3期页码：170-176
- Affiliations：
  
  1.Department of Joint Surgery, Guanghua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai (200052), China
  2.Department of Vascular Surgery, Shanghai Traditional Chinese Medicine Integrated Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai (200082), China
  3.Department of Urology and Andrology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai(200032), China
  4.Shanghai Qigong Research Institute, Shanghai University of Traditional Chinese Medicine, Shanghai(200030), China
  5.School of Acupuncture-Moxbustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai (201203), China
- Author bio：
  
  Correspondence to: Prof. YING Jian, E-mail: yingjian03@sina.com
- Funds：
  
  the Shanghai Three-Year Development Plan Project for Traditional Chinese Medicine
- DOI：10.1007/s11655-020-3258-5
  中图分类号：
- 纸质出版日期：2021-03-01，
  
  网络出版日期：2020-04-20，
  
  录用日期：2019-02-27
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Hai HUANG, Min-jie ZHOU, Ke-xie WANG, 等. Effectiveness and Safety of Umbilicus Treatment with Modified Dinggui Powder (加味丁桂散) in Patients with Chronic Nonbacterial Prostatitis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2021,27(3):170-176.

Hai HUANG, Min-jie ZHOU, Ke-xie WANG, et al. Effectiveness and Safety of Umbilicus Treatment with Modified Dinggui Powder (加味丁桂散) in Patients with Chronic Nonbacterial Prostatitis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2021,27(3):170-176.
Hai HUANG, Min-jie ZHOU, Ke-xie WANG, 等. Effectiveness and Safety of Umbilicus Treatment with Modified Dinggui Powder (加味丁桂散) in Patients with Chronic Nonbacterial Prostatitis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2021,27(3):170-176. DOI： 10.1007/s11655-020-3258-5.

Hai HUANG, Min-jie ZHOU, Ke-xie WANG, et al. Effectiveness and Safety of Umbilicus Treatment with Modified Dinggui Powder (加味丁桂散) in Patients with Chronic Nonbacterial Prostatitis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2021,27(3):170-176. DOI： 10.1007/s11655-020-3258-5.

摘要

Abstract

Objective:

To evaluate the effectiveness and safety of Chinese herbal external umbilicus treatment with Modified Dinggui Powder (加味丁桂散

MDGP) in patients with chronic nonbacterial prostatitis (CNP).

Methods:

A randomized

double-blind

placebo-controlled clinical trial was conducted among 72 patients with CNP. Participants were randomly allocated to a treatment group and a placebo group using computer software in a 1:1 ratio

and received either MDGP external umbilicus treatment (MDGP group

36 cases) or placebo (control group

36 cases) at acupoints Shenque (CV 8)

twice a week for 4 weeks. In addtion

patients all received herbal medicine treatment twice a day for 4 weeks. The primary outcome was the US National Institutes of Health Chronic Prostatitis Symptom Scores Index (NIH-CPSI) with a questionnaire at weeks 2 and 4. The secondary outcomes including prostatic fluid examination (white blood cells and lecithin bodies)

the clinical efficacy evaluation

and the adverse events were also assessed during the entire trial.

Results:

The NIH-CPSI scores regarding pain or discomfort scores showed greater improvement in the MDGP group than placebo control group at weeks 2 (

=0.001) and week 4 (

=0.004)

respectively. NIH-CPSI scores of symptom severity

total scores and leukocytes number in the prostatic fluid in the MDGP group were significantly improved (

0.05). There was no statistical difference in the urinary symptoms

quality of life

lecithin and other scores between two groups (

0.05). The clinical effective rate was 73.53% (25/34) in the MDGP group

which was significally higher than the placebo control group with 48.39% (25/31

0.05). Patients were blinded successfully

and no serious adverse effects were found during the trial.

Conclusion:

A 4-week course of umbilicus treatment with modified Dinggui Powder seems to relieve pain and symptom severity effectively and increase the amount of leukocytes number in patients with CNP (Trial registration No. ChiCTR1800014687).

关键词

Keywords

Modified Dinggui Powderumbilicus treatmentchronic nonbacterial prostatitisrandomizedplacebo-controlled trial

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