Trial Outcomes & Findings for An Efficacy Trial of Electroacupuncture at Points of Bilateral BL33 for Mild and Moderate Benign Prostatic Hyperplasia (NCT NCT01218243)
NCT ID: NCT01218243
Last Updated: 2013-05-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
baseline and the 6th week
Results posted on
2013-05-27
Participant Flow
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.
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
Treatment Completed
|
45
|
42
|
|
Overall Study
COMPLETED
|
41
|
36
|
|
Overall Study
NOT COMPLETED
|
9
|
14
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Protocol Violation
|
5
|
10
|
Baseline Characteristics
An Efficacy Trial of Electroacupuncture at Points of Bilateral BL33 for Mild and Moderate Benign Prostatic Hyperplasia
Baseline characteristics by cohort
| Measure |
Acupoint
n=50 Participants
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.
|
Non-acupoint
n=50 Participants
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.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age Continuous
|
64.8 years
STANDARD_DEVIATION 7.05 • n=5 Participants
|
65.9 years
STANDARD_DEVIATION 6.74 • n=7 Participants
|
65.37 years
STANDARD_DEVIATION 6.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
International Prostate Symptom Score (IPSS)
|
20.10 units on a scale
STANDARD_DEVIATION 6.52 • n=5 Participants
|
18.76 units on a scale
STANDARD_DEVIATION 6.06 • n=7 Participants
|
19.43 units on a scale
STANDARD_DEVIATION 6.30 • n=5 Participants
|
|
bladder residual urine
|
20 ml
n=5 Participants
|
16 ml
n=7 Participants
|
20 ml
n=5 Participants
|
|
maximum urinary flow rate (Qmax)
|
13.04 ml/s
STANDARD_DEVIATION 6.73 • n=5 Participants
|
15.93 ml/s
STANDARD_DEVIATION 7.33 • n=7 Participants
|
14.51 ml/s
STANDARD_DEVIATION 7.15 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and the 6th weekPopulation: The data analysis of the primary outcome was based on the ITT population(data of all participants who are randomized will be analyzed).
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.
Outcome measures
| Measure |
Acupoint
n=50 Participants
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.
|
Non-acupoint
n=50 Participants
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.
|
|---|---|---|
|
Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat)
|
7.26 units on a scale
Standard Deviation 5.12
|
2.34 units on a scale
Standard Deviation 4.85
|
PRIMARY outcome
Timeframe: baseline and the 6th weekPopulation: The data analysis of the primary outcome is also based on per-protocol (PP) population as a supportive analysis.
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.
Outcome measures
| Measure |
Acupoint
n=45 Participants
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.
|
Non-acupoint
n=42 Participants
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.
|
|---|---|---|
|
Change of International Prostate Symptom Score(IPSS) at the 6th Week Compared With Baseline(Per-protocol).
|
7.24 units on a scale
Standard Deviation 5.23
|
2.79 units on a scale
Standard Deviation 5.17
|
SECONDARY outcome
Timeframe: baseline and the 6th weekPopulation: The data analysis of the secondary outcome was based on the ITT population.
Bladder residual urine was used to assess the bladder function, 6 week mean minus baseline mean
Outcome measures
| Measure |
Acupoint
n=50 Participants
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.
|
Non-acupoint
n=50 Participants
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.
|
|---|---|---|
|
Change of Bladder Residual Urine at the 6th Week
|
0 ml
Interval -172.0 to 84.0
|
0 ml
Interval -120.0 to 80.0
|
SECONDARY outcome
Timeframe: baseline and the 6th weekPopulation: The data analysis of the secondary outcome was based on the ITT population.
Maximum urinary flow rate was used to assess the bladder function, 6 week mean minus baseline mean
Outcome measures
| Measure |
Acupoint
n=50 Participants
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.
|
Non-acupoint
n=50 Participants
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.
|
|---|---|---|
|
Change of Maximum Urinary Flow Rate(Qmax)at the 6th Week
|
0.36 ml/second
Standard Deviation 4.51
|
0.98 ml/second
Standard Deviation 4.05
|
SECONDARY outcome
Timeframe: baseline and the 18th weekPopulation: The data analysis of the secondary outcome was based on the ITT population.
International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),18 week mean minus baseline mean.
Outcome measures
| Measure |
Acupoint
n=50 Participants
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.
|
Non-acupoint
n=50 Participants
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.
|
|---|---|---|
|
Change of International Prostate Symptom Score (IPSS) at the 18th Week
|
5.48 units on a scale
Standard Deviation 5.16
|
1.8 units on a scale
Standard Deviation 5.06
|
Adverse Events
Acupoint
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-acupoint
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acupoint
n=50 participants at risk
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.
|
Non-acupoint
n=50 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
ecchymoma
|
0.00%
0/2 • 3 months
|
100.0%
2/2 • Number of events 2 • 3 months
|
Additional Information
Zhishun Liu, Director of the study
Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
Phone: 8610-010-88001124
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place