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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 |
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| KeyWord:Modified Dinggui Powder, umbilicus treatment, chronic nonbacterial prostatitis, randomized, placebo-controlled trial |
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| 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 (P=0.001) and week 4 (P=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 (P<0.05). There was no statistical difference in the urinary symptoms, quality of life, lecithin and other scores between two groups (P>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, P<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). |
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