Acupuncture Department, China Academy of Chinese Medical Sciences, Beijing, China.
Trials. 2011 Sep 26;12:211. doi: 10.1186/1745-6215-12-211.
BACKGROUND: Acu-point specificity is a key issue in acupuncture. To date there has not been any satisfactory trial which can ratify the specific effect of acupuncture. This trial will evaluate the specific effect of BL33 for mild and moderate benign prostatic hyperplasia (BPH) on the basis of its effectiveness. The non-specific effect will be excluded and the therapeutic effect will be evaluated. METHOD: This is a double-blinded randomized controlled trial. 100 Patients will be randomly allocated into the treatment group (n = 50) and the control group (n = 50). The treatment group receives needling at BL33 and the control group receives needling at non-point. The needling depth, angle, direction, achievement of De Qi and parameters of electroacupuncture are exactly the same in both groups. The primary outcome measure is reduction of international prostate symptom score (IPSS) at the 6th week and the secondary outcome measures are reduction of bladder residual urine, increase in maximum urinary flow rate at the 6th week and reduction of IPSS at the 18th week. DISCUSSION: This trial will assess the specific therapeutic effect of electroacupuncture at BL33 for mild and moderate BPH. TRIAL REGISTRATION: Protocol Registration System of Clinical Trials.gov NCT01218243.
背景:穴位特异性是针灸的关键问题。迄今为止,尚无任何令人满意的试验可以证实针刺的特殊疗效。本试验将在其有效性的基础上,评价 BL33 穴针刺治疗轻、中度良性前列腺增生(BPH)的特异性效应。排除非特异性效应,评价疗效。
方法:这是一项双盲随机对照试验。将 100 例患者随机分为治疗组(n = 50)和对照组(n = 50)。治疗组接受 BL33 针刺,对照组接受非穴位针刺。两组针刺深度、角度、方向、得气及电针参数完全相同。主要结局指标为第 6 周国际前列腺症状评分(IPSS)的降低,次要结局指标为第 6 周膀胱残余尿量减少、最大尿流率增加及第 18 周 IPSS 降低。
讨论:本试验将评估 BL33 穴电针对轻、中度 BPH 的特异性治疗作用。
试验注册:ClinicalTrials.gov 临床试验方案注册系统 NCT01218243。
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