An Efficacy Trial of Electroacupuncture at Points of Bilateral BL33 for Mild and Moderate Benign Prostatic Hyperplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat)
研究概览
简要总结
To evaluate efficacy of BL33 for mild and moderate benign prostatic hyperplasia(BPH).There are trials showing that electroacupuncture on BL33 for mild and moderate BPH is more effective than terazosin. It could reduce the International Prostate Syndrome Score (IPSS) by 6.68±2.84(39.79%),lower urinary symptoms bother of score(BS) and bladder residual urine, and increase maximum urinary flow rate.But the efficacy of BL33 has not been studied. The objective of this study is to evaluate efficacy of BL32 for mild and moderate BPH by comparison with non-acupoint group.
详细描述
efficacy here means specific effect(or active ingredient) of the point BL33.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •50-70 years old
- •Mild to moderate BPH evaluated by I-PSS
- •Patients having urinary dysfunction more than 3 months
- •Patients with stable life signs
- •no use of α1 receptor blocker, 5α-reductase inhibitor or traditional Chinese medicine for over 1 week
- •Volunteer to join this research and sign the written informed consent prior to receiving treatment
排除标准
- •Urinary dysfunction caused by gonorrhea or urinary tract infection
- •Oliguria and anuria caused by urinary calculi, prostate cancer, bladder tumor and acute/chronic renal failure
- •Urinary dysfunction caused by neurogenic bladder, bladder neck fibrotic and urethral stricture
- •Failure of invasive therapy for prostatic obstruction
- •Injured local organs, muscle and nerve caused by pelvic operation or historical trauma
- •Upper urinary obstruction and hydrocele combined with damaged renal function due to BPH diagnosed by B-ultrasound
- •Patients who can't stick to treatment because of economic reason, far distance between home and the hospital or difficult walking etc.
研究组 & 干预措施
acupoint
Needle at bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd)is put on with Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. There are 5 sessions in the first two weeks and 3 sessions in the last two weeks, 30 min/session.
干预措施: needle (Device)
non-acupoint
Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
干预措施: needle (Device)
结局指标
主要结局
Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat)
时间窗: baseline and the 6th week
International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),6 week mean minus baseline mean.And analysis for this outcome measure is based on ITT population.
Change of International Prostate Symptom Score(IPSS) at the 6th Week Compared With Baseline(Per-protocol).
时间窗: baseline and the 6th week
International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),6 week mean minus baseline mean. And analysis for this outcome measure is based on per-protocol population.
次要结局
- Change of Bladder Residual Urine at the 6th Week(baseline and the 6th week)
- Change of Maximum Urinary Flow Rate(Qmax)at the 6th Week(baseline and the 6th week)
- Change of International Prostate Symptom Score (IPSS) at the 18th Week(baseline and the 18th week)
研究者
Liu Zhishun
Dean of Acupuncture Department of Guangan'men Hospital
Guang'anmen Hospital of China Academy of Chinese Medical Sciences