Acupuncture For Benign Prostatic Hyperplasia

Acupuncture for benign prostatic hyperplasia (Protocol)
Zhang W, Weina P, Liu Z, Wu T
This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane
Library 2009, Issue 2
http://www.thecochranelibrary.com

Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . .
ABSTRACT . . . . . . . . .
BACKGROUND . . . . . . .
OBJECTIVES . . . . . . . .
METHODS . . . . . . . . .
REFERENCES . . . . . . . .
WHATS NEW . . . . . . . .
HISTORY . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS
DECLARATIONS OF INTEREST .
SOURCES OF SUPPORT . . . .
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[Intervention Protocol]
Acupuncture for benign prostatic hyperplasia

Wei Zhang1 , Peng Weina2 , Zhishun Liu1 , Taixiang Wu3
1 Department of Acupuncture and Moxibustion, Chinese Academy of Traditional Chinese Medicine, Beijing, China. 2 Acupuncture,
Guanganmen Hospital, Beijing, China. 3 Chinese Cochrane Centre, Chinese EBM Centre, West China Hospital, Sichuan University,
Chengdu, China
Contact address: Wei Zhang, Department of Acupuncture and Moxibustion, Chinese Academy of Traditional Chinese Medicine,
Guang An Men Hopital, No.5 Bei Xian Ge Street, Beijing, Xuanwu District, 100053, China. zhangwei_7108@hotmail.com. (Editorial
group: Cochrane Prostatic Diseases and Urologic Cancers Group.)
Cochrane Database of Systematic Reviews, Issue 2, 2009 (Status in this issue: Unchanged)
DOI: 10.1002/14651858.CD006016
This version first published online: 19 April 2006 in Issue 2, 2006. (Help document - Dates and Statuses explained)
This record should be cited as: Zhang W, Weina P, Liu Z, Wu T. Acupuncture for benign prostatic hyperplasia. Cochrane Database
of Systematic Reviews 2006, Issue 2. Art. No.: CD006016. DOI: 10.1002/14651858.CD006016.
ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
Our objective is to conduct a systematic review, and if possible, a quantitative meta-analysis, with evidence available from randomized
controlled trials to assess the efficacy and safety of acupuncture therapy for BPH.

BACKGROUND
Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate commonly encountered among aged men.
Histological investigations have shown that more than 40% of
men in their fifties and nearly 90% of men in their eighties suffer
from BPH (Berry 1984). Lower urinary tract symptoms (LUTS)
associated with BPH include obstructive symptoms (weak urinary stream, hesitancy, intermittency, incomplete bladder emptying, terminal urine dribbling, abdominal straining), and irritative
symptoms (urinary frequency, urgency and nocturia) (Christensen
1990, Caine 1987). In the United States treatment of BPH accounts for approximately 1.7 million physician-office visits (Guess
1992) and results in more than 300,000 prostatectomies annually
(McConnell 1994). In China, prostate specimens from 321 deceased were collected from 1989 to 1992. The frequency of BPH
was 13.2% among those 41 to 50 years old and increased until
it reached 83.3% among those 81 to 90 years old. The histologic
frequency of BPH in China was similar to that in Western countries (Gu 1994).
Treatment of BPH includes minimally invasive therapy (MIT),
surgery and medical therapy.
Acupuncture is a very important part of Traditional Chinese
Medicine (TCM). It has a literary history of more than 2000
years. Acupuncture is a therapy that inserts needles into certain
points, called Xue Wei, of the human body. Many centuries
ago acupuncture developed into a discipline, with its own theory
and practice. It is believed in TCM theory that acupuncture can
strengthen the human bodys vital essence, called Qi, and can
remove the blockage of channels. Acupuncture is also helpful with
a wide range of other diseases.
In China, BPH has been treated with acupuncture, and the procedures efficacy has been tested by some research. In an animal
model it has been reported that acupuncture can neutralize pathological changes in low levels of nitric oxide synthase (NOS), as
well as impaired kidney function, as manifested by high blood
urea nitrogen (BUN) and serum creatinine (Cr) (Xu 2002). Currently, researchers outside China are treating LUTS with acupuncture. Using the International Prostate Symptom Score, a randomized controlled trial (RCT) has assessed the effects of acupuncture on LUTS, as well as prostate specific antigen (PSA). It found
that acupuncture to the kidney-bladder meridian relieves neither
LUTS nor affects PSA (Johnstone 2003).
To date, the clinical application of acupuncture for BPH and its
reporting has been anecdotal, and its effects has not been systematically reviewed.
ized controlled trials to assess the efficacy and safety of acupuncture therapy for BPH.
METHODS
Criteria for considering studies for this review
Types of studies
Randomized controlled clinical trials
Types of participants
Men with symptomatic benign prostatic hyperplasia
Types of interventions
Acupuncture therapy with needle insertion, including body , auricular , scalp, as well as electroacupuncture, will be considered.
Also included will be acupuncture combined with other treatments
or medications, such as herbals. Excluded will be any stimulation
other than a needle, such as acupressure, seed stimulation or surface electrodes (TENS).
The control interventions will include: no intervention, placebo
acupuncture, sham acupuncture, pharmacological treatments
(herbal medicine or conventional medicine, such as 5-alpha reductase inhibitors and alpha blockers), or any other interventions.
Placebo acupuncture refers to a needle attached to the skin surface
(not penetrating the skin but at the same acupoints) (van Tulder
2000).
Sham acupuncture refers to:
(1) a needle placed in an area close to but not in an acupuncture
point (van Tulder 2000);
(2) subliminal skin electrostimulation via electrodes attached to
the skin (SCSSS 1999).
Types of outcome measures
The primary outcome measures will be change in urological symptoms as measured by validated urologic symptom scores, including Boyarsky, the American Urologic Association Symptom Score,
and the International Prostate Symptom Score (IPSS).
Secondary outcome measures will include:
1. Quality of life score (QOL);
2. Adverse events, such as intolerable pain during acupuncture,
bleeding during or after the session, breaking or winding of the
needle, injury to organs (e.g., pneumothorax), and fainting. The
number and severity of adverse events should be recorded;
3. Urodynamic measures, which are defined as change in peak
urine flow (measured in mL/sec), mean urine flow (measured in
mL/sec), residual urine volume (measured in mL), nocturia (measured in times per evening), and changes in prostate size (measured
in cc).
OBJECTIVES
Our objective is to conduct a systematic review, and if possible, a
quantitative meta-analysis, with evidence available from random-
Search methods for identification of studies

See the Cochrane Prostatic Diseases and Urologic Cancers Group

search strategy.
Electronic searches
We will search the following electronic databases irrespective of
language and publication status:
1. The Trials Registers of the Cochrane Prostatic Diseases and
Urologic Cancers Group;
2. The Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library (Issue 4, 2004);
3. MEDLINE (1966-2004);
4. EMBASE (1998-2004);
5. Chinese Biomedical Database (1979-2004).
A highly sensitive search strategy will be used for identifying randomized controlled trials, and will be provided for reviewers. We
will use MEDLINE on the Ovid web site to locate these trials.
Below is a further search strategy for MEDLINE:
#30 benign prostatic hyperplasia or bph/
#31 lower urinary tract symptoms or luts/
#32 or/30-31
#33 acupuncture/
#34 acupuncture points/
#35 (electroacupuncture or electroacupuncture).tw.
#36 electroacupuncture.tw.
#37 acupuncture$.tw.
#38 acupoints.tw.
#39 meridians/
#40 or /33-39
#41 29 and 32 and 40
The reference lists of all identified papers will be searched for further information. We will contact authors for unpublished studies.
Data collection and analysis

Eligibility:
Two reviewers, Zhang and Peng, will independently decide on
eligibility.
Data extraction
A data extraction form will be developed and study data will be
assessed and extracted independently by two reviewers, Zhang and
Peng. The following data will be extracted from each included
study: patients demographic characteristics, including maximum,
minimum and mean age; inclusion and exclusion criteria; and
type, frequency and treatment course of acupuncture therapy and
outcomes. Type, severity and number of adverse effects, as well as
number and reasons for dropouts, withdrawals, and lost of follow-
up will also be recorded. Information not available in the trials will

be sought from authors by e-mail or telephone. Extracted data will
be reviewed by the principal reviewer (Zhang) and discrepancies
will be judged by the arbitrator, Liu.
QUALITY ASSESSMENT
Quality assessment will be carried out by two independent reviewers (Zhang and Peng), and will be made according to the empirical
evidence (Schulz 1995, Jadad 1996, Juni 2001, Kjaergard 2001).
We intend to assess the methodological quality as described by
Kjaergard et al. (Kjaergard 2001) and the Cochrane Reviewers
Handbook 4.2.2.
A third party (Liu) will resolve disagreements.
Data analyses
Analyses will be implemented with the Cochrane Collaboration
Review Manager (RevMan 4.3) software. All the primary and secondary outcome measures will be combined and analyzed for evidence of homogeneity (P>0.1) using a fixed-effects model. Dichotomous results will be expressed as relative risk (RR) and ratio of risk of the treatment group versus the control group, with
95% confidence intervals (CI). For continuous variables, weighted
mean differences (WMD)--the difference between treatment and
control pooled means at endpoint--along with their 95% confidence intervals, will be calculated. A random-effects model will be
used in case heterogeneity exists.
Sensitivity Analyses
We will implement a sensitivity analyses in order to explore the
influence of the following factors on effect size:
Exclude unpublished studies (if there are any);
Analyze study quality;
Exclude any trials with long study duration or are too
large to establish how much they dominate the results;
Exclude trials using the following filters: diagnostic criteria, language of publication and race.
Subgroup Analyses
Here we will compare the effects between subgroups by
different acupuncture types
other comparisons
location.
Publication Bias
Potential biases will be investigated using the funnel plot .We will
use linear regression to measure funnel plot asymmetry on the
logarithmic scale of relative risk (RR).

REFERENCES
Additional references
acupuncture of the kidney-bladder distinct meridian for lower urinary tract symptoms.. Journal of Urology. 2003;169(3):10379.
AUA 2003
American Urological Association, Inc. The management of benign
prostatic hyperplasia.. American Urological Association, Inc 2003.
Berry 1984
Berry SL, Coffey, DS, Walsh PC, Ewing LL. The development of
human benign prostatic hyperplasia with age.. J Urol 1984;132:
4749.
Caine 1987
Caine M, Schuger L. The capsule in benign prostatic hypertrophy..
NIH Publication No. 87-2881 1987.
Christensen 1990
Christensen MM, Bruskewitz RC. Clinical manifestations of benign
prostatic hyperplasia and the indications for therapeutic intervention.. Urol Clin North Am 1990;17:50916.
Gu 1994
Gu FL, Xia TL, Kong XT. Preliminary study of the frequency of
benign prostatic hyperplasia and prostatic cancer in China.. Urology.
1994;44(5):68891.
Guess 1992
Guess HA. Benign prostatic hyperplasia antecedents and natural history.. Epidemiol Rev 1992;14:13153.
Jadad 1996
Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al.Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Controlled Clinical Trials 1996;17:
112.
Johnstone 2003
Johnstone, P. A. Bloom, T. L, Niemtzow, R. C, Crain, D, Riffenburgh, R. H, Amling. C. L. A prospective, randomized pilot trial of
Juni 2001
Juni Peter, Altman DG, Egger M. Assessing the quality of controlled
clinical trials. BMJ 2001;323(7303):426.
Kjaergard 2001
Kjaergard LL, Villumsen J, Gluud C. Reported methodologic quality
and discrepancies between large and small randomized trials in metaanalyses. Annals of Internal Medicine 2001;135(11):9829.
McConnell 1994
McConnell JD, Barry MJ, Bruskewitz RC. Benign prostatic hyperplasia: Diagnosis and treatment.. Clinical Practice Guideline. No.
8, AHCPR Publication No. 94-0582 Edition. Rockville, MD:
Agency for Health Care Policy and Research, Public Health Service,
US Department of Health and Human Services 1994.
Schulz 1995
Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of
bias: dimensions of methodological quality associated with estimates
of treatment effects in controlled trials. AMA 1995;273:40812.
SCSSS 1999
Swedish Collaberation on Sensory Stimulation in Stroke. Sensory
stimulation after stroke: a randomized controlled trial.. Cerebrovasc
Dis 1999;9(suppl 1):28.
van Tulder 2000
van Tulder MW, Cherkin DC, Berman B, Lao L, Koes BW. Acupuncture for low back pain.. Cochrane Library, 2000, Issue 4.
Xu 2002
Xu JF, Yang ZG. How acupuncture influence the NOS activity and renal function of mice with prostatic hyperplasia.. Shang Hai acupuncture Journal 2002;21(6):3637.
Indicates the major publication for the study
WHATS NEW
8 November 2008
Amended
Converted to new review format.
HISTORY
Protocol first published: Issue 2, 2006

CONTRIBUTIONS OF AUTHORS
Zhang Wei designed and wrote the protocol. Zhang will take part in the whole procedure, including data extraction, contacting with
editors, statistical analysis, quality assessment, and completing the SR. Wu Taixiang gave support and guidance on methodology and
the protocol. Liu Zhishun reviewed and commented on the protocol. Liu worked as arbitrator. Peng Weina and Zhang Wei will extract
data and assess quality.
DECLARATIONS OF INTEREST
None known.
SOURCES OF SUPPORT
Internal sources
Department of Acupuncture and Moxibustion,Guang An Men Hospital,Chinese Academy of TCM, China.
External sources
Chinese Cochrane Center,Chinese Centre of Evidence-based Medicine,West China Hospital of Sichuan University, China.


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Acupuncture for benign prostatic hyperplasia (Protocol)

Zhang W, Weina P, Liu Z, Wu T