Department of Joint Surgery, Guanghua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200052, China.
Department of Vascular Surgery, Shanghai Traditional Chinese Medicine Integrated Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200082, China.
Chin J Integr Med. 2021 Mar;27(3):170-176. doi: 10.1007/s11655-020-3258-5. Epub 2020 Apr 1.
To evaluate the effectiveness and safety of Chinese herbal external umbilicus treatment with Modified Dinggui Powder (, MDGP) in patients with chronic nonbacterial prostatitis (CNP).
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 groupl (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 outcomes 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.
The NIH-CPSI scores regarding pain or discomfort scores showed greater improvement in the MDGP group than placebo control group at weeks 2 (P0.001) and week 4 (P0.004), respectively. NIH-CPSI scores of symptom severity, total scores, the amount of leukocytes number in the prostatic fifluid 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.
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).
评价中药肚脐敷贴丁桂儿脐贴（MDGP）治疗慢性非细菌性前列腺炎（CNP）的有效性和安全性。
采用随机、双盲、安慰剂对照临床试验，将 72 例 CNP 患者采用计算机软件按 1：1 比例随机分为治疗组和安慰剂组，分别给予 MDGP 肚脐敷贴（MDGP 组，36 例）和安慰剂对照组（36 例），每周 2 次，共 4 周。同时，两组患者均每日接受中药治疗 2 次，共 4 周。主要结局指标为第 2、4 周时采用美国国立卫生研究院慢性前列腺炎症状评分指数（NIH-CPSI）问卷调查评估。次要结局指标包括前列腺液检查（白细胞和卵磷脂小体）、临床疗效评价及整个试验期间的不良事件。
第 2、4 周时，MDGP 组疼痛或不适评分的 NIH-CPSI 评分均明显优于安慰剂对照组（P<0.001）。MDGP 组 NIH-CPSI 症状严重程度、总分、前列腺液白细胞数评分均显著改善（P<0.05）。两组在尿症状、生活质量、卵磷脂等评分方面无统计学差异（P>0.05）。MDGP 组临床有效率为 73.53%（25/34），明显高于安慰剂对照组的 48.39%（25/31，P<0.05）。患者均成功设盲，试验过程中未发现严重不良事件。
丁桂儿脐贴治疗 4 周可有效缓解 CNP 患者的疼痛和症状严重程度，并增加白细胞数量（临床试验注册号：ChiCTR1800014687）。
