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.
efficacy here means specific effect(or active ingredient) of the point BL33.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
For the acupoint group,needle on bilateral BL33 60-80mm 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.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), 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.The non-point group take the place 2 cun far from BL33 on the outside horizontally as the non-point and the manipulation methods are the same with those of the point group.
Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
Beijing, China
Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat)
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.
Time frame: baseline and the 6th week
Change of International Prostate Symptom Score(IPSS) at the 6th Week Compared With Baseline(Per-protocol).
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.
Time frame: baseline and the 6th week
Change of Bladder Residual Urine at the 6th Week
Bladder residual urine was used to assess the bladder function, 6 week mean minus baseline mean
Time frame: baseline and the 6th week
Change of Maximum Urinary Flow Rate(Qmax)at the 6th Week
Maximum urinary flow rate was used to assess the bladder function, 6 week mean minus baseline mean
Time frame: baseline and the 6th week
Change of International Prostate Symptom Score (IPSS) at the 18th Week
International Prostate Symptom Score (IPSS) Range:0-35(0 is best,35 is worst, ordinal),18 week mean minus baseline mean.
Time frame: baseline and the 18th week
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