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

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Device: needle

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100053
    • Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: 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.; Other Names: acupuncture; electroacupuncture
SHAM_COMPARATOR: 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.	Device: 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.; Other Names: acupuncture; electroacupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	baseline and the 6th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	baseline and the 18th week

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: October 8, 2010
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (ESTIMATE): October 11, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 27, 2013
• Last Update Submitted That Met QC Criteria: May 18, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Acupuncture; Mild and moderate BPH
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 2009S208