An Efficacy Trial of Electroacupuncture at Points of Bilateral BL33 for Mild and Moderate Benign Prostatic Hyperplasia

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Benign Prostatic Hyperplasia (BPH)

Treatments: Device: needle

Study type: Interventional

Funder types: Other

Identifiers

NCT01218243

2009S208

Details and patient eligibility

About

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.

Full description

efficacy here means specific effect(or active ingredient) of the point BL33.

Enrollment: 100 patients

Sex: Male

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

acupoint

Experimental group

Description:

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.

Treatment:

Device: needle

non-acupoint

Sham Comparator group

Description:

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.

Treatment:

Device: needle