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

NCT01218243 | Completed Phase 2 Results DMC

• 1 other identifier: 2009S208
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia (BPH)

Keywords

Acupuncture; Mild and moderate BPH

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

acupoint

EXPERIMENTAL

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

non-acupoint

SHAM COMPARATOR

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

Interventions

needle 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.

Also known as: acupuncture, electroacupuncture

acupoint; non-acupoint

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Beijing, 100053, China

Location

Related Publications (2)

• 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.

  PMID: 23593139 DERIVED

• 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.

  PMID: 21943105 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia; Lymphoma, Follicular

Interventions

Needles; Acupuncture Therapy; Electroacupuncture

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Complementary Therapies; Therapeutics; Combined Modality Therapy; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Results Point of Contact

• Title: Zhishun Liu, Director of the study
• Organization: Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

liuzhishun@yahoo.com.cn

8610-010-88001124

Study Officials

• Zhishun Liu

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Acupuncture Department of Guangan'men Hospital

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 11, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 27, 2013
• Results First Posted: August 23, 2012

Record last verified: 2013-05

Locations

CN (1)