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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhishun Liu | Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences | Beijing | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23593139 | Derived | 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. | |
| 21943105 | 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. |
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Diagnosis and assessment were made by an independent urologist who was uninvolved in the treatment process.Baseline assessments included international prostate symptom score (IPSS), postvoid residual urine (PVR) and maximum urinary flow rate (Qmax).
We recruited patients from BPH clinic by newspaper advertisements and notices at clinic site.192 participants entered the study and 92 of them were excluded.It is supposed that patients with IPSS less than 20 would be included.But few mild BPH patients came for the study.The including criteria were changed and patients with IPSS≥8 were included.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupoint | Needle on 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.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. BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated. |
| FG001 | 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. BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acupoint | Needle on 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.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. BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The data analysis of the primary outcome was based on the ITT population(data of all participants who are randomized will be analyzed). | Posted | Mean | Standard Deviation | units on a scale | baseline and the 6th week |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupoint | Needle on 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.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. BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ecchymoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhishun Liu, Director of the study | Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences | 8610-010-88001124 | liuzhishun@yahoo.com.cn |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D009339 | Needles |
| D015670 | Acupuncture Therapy |
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D003131 | Combined Modality Therapy |
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|
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 |
| Protocol Violation |
|
| BG001 | 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. BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| International Prostate Symptom Score (IPSS) | Score range:0-35(0 is best，35 is worst, ordinal) | Mean | Standard Deviation | units on a scale |
|
| bladder residual urine | Median | Full Range | ml |
|
| maximum urinary flow rate (Qmax) | Mean | Standard Deviation | ml/s |
|
| OG001 | 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. BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated. |
|
|
|
| Secondary | 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 | The data analysis of the secondary outcome was based on the ITT population. | Posted | Median | Full Range | ml | baseline and the 6th week |
|
|
|
|
| Secondary | 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 | The data analysis of the secondary outcome was based on the ITT population. | Posted | Mean | Standard Deviation | ml/second | baseline and the 6th week |
|
|
|
|
| Secondary | 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. | The data analysis of the secondary outcome was based on the ITT population. | Posted | Mean | Standard Deviation | units on a scale | baseline and the 18th week |
|
|
|
|
| Primary | 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. | The data analysis of the primary outcome is also based on per-protocol (PP) population as a supportive analysis. | Posted | Mean | Standard Deviation | units on a scale | baseline and the 6th week |
|
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 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. BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated. | 0 | 50 | 2 | 50 |
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| D052801 |
| Male Urogenital Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |