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

NCT ID: NCT01218243

Last Updated: 2013-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-05-31

Brief Summary

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.

Detailed Description

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

Conditions

Benign Prostatic Hyperplasia (BPH)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

needle

Intervention Type: DEVICE

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.

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.

Group Type: SHAM_COMPARATOR

needle

Intervention Type: DEVICE

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.

Interventions

needle

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.

Intervention Type: DEVICE

Other Intervention Names

acupuncture; electroacupuncture

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Liu Zhishun

Dean of Acupuncture Department of Guangan'men Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhishun Liu

Role: STUDY_DIRECTOR

Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Locations

Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Beijing, , China

Countries

China

References

Wang Y, Liu B, Yu J, Wu J, Wang J, Liu Z. Electroacupuncture for moderate and severe benign prostatic hyperplasia: a randomized controlled trial. PLoS One. 2013 Apr 12;8(4):e59449. doi: 10.1371/journal.pone.0059449. Print 2013.

Reference Type: DERIVED

PMID: 23593139 (View on PubMed)

Wang Y, Liu Z, Yu J, Ding Y, Liu X. Efficacy of electroacupuncture at Zhongliao point (BL33) for mild and moderate benign prostatic hyperplasia: study protocol for a randomized controlled trial. Trials. 2011 Sep 26;12:211. doi: 10.1186/1745-6215-12-211.

Reference Type: DERIVED

PMID: 21943105 (View on PubMed)

Other Identifiers

2009S208

Identifier Type: -

Identifier Source: org_study_id