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Acupuncture for bladder dysfunction after spinal cord injury

(Protocol)
Jiaqi W, Sung L, Zhishun L, Yu J

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

Acupuncture for bladder dysfunction after spinal cord injury (Protocol)


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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Acupuncture for bladder dysfunction after spinal cord injury (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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[Intervention Protocol]

Acupuncture for bladder dysfunction after spinal cord injury


Wang Jiaqi1 , Linda Sung2 , Liu Zhishun3 , Jinna Yu4
1 Acupuncture Deparment, China Academy of Traditional Chinese Medicine, Beijing, China. 2 Department of Medicine, The Royal
Melbourne Hospital, North Melbourne, Australia. 3 Department of Acupuncture and Moxibustion, Guang An Men Hospital, Chinese
Academy of Traditional Chinese Medicine, Beijing, China. 4 Acupuncture Department, Guang An Men Hospital of China Academy
of Chinese Traditional Medicine, Beijing, China

Contact address: Wang Jiaqi, Acupuncture Deparment, China Academy of Traditional Chinese Medicine, No.5 Bei Xian Ge , Beijing,
100053, China. ae2000wangjiaqi@hotmail.com. (Editorial group: Cochrane Incontinence Group.)
Cochrane Database of Systematic Reviews, Issue 2, 2009 (Status in this issue: Unchanged)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DOI: 10.1002/14651858.CD006550
This version first published online: 18 April 2007 in Issue 2, 2007. (Help document - Dates and Statuses explained)
This record should be cited as: Jiaqi W, Sung L, Zhishun L, Yu J. Acupuncture for bladder dysfunction after spinal cord injury.
Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: CD006550. DOI: 10.1002/14651858.CD006550.

ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
The objective of this review is to assess any benefits or adverse effects of acupuncture treatment for bladder dysfunction after spinal
cord injury.
The following comparisons will be made:
1. Acupuncture intervention versus no intervention;
2. A specific acupuncture intervention versus another intervention;
3. Acupuncture with another intervention versus that intervention alone
4. Early acupuncture versus delayed, selective acupuncture.

Acupuncture for bladder dysfunction after spinal cord injury (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

BACKGROUND
Individuals with a spinal cord injury (SCI) may need lifelong
follow up by specialists due to the risk of secondary complications (Hansen 2004). Neurogenic bladder dysfunction is a major problem for spinal cord injured patients (Cheng 1998) and is
the most common complication (Cheng 1998; Dahlberg 2004).
Earlier studies indicated that renal failure and other urinary tract
complications were the leading causes of death in the first 12 years
after SCI (DeVivo 1993). Neurogenic bladder dysfunction commonly follows disruption of normal innervation such as following
injury to the spinal cord (SCI) (Chen 2005). The main neural
circuits controlling the two functions of the bladder, that is storage and voiding of urine, are trans-spinal so that intact cord connections between the pons in the brain and the sacral segments
of the spinal cord are necessary to sustain physiological control (
Fowler 1999). Neurogenic bladder dysfunction (NBD) includes
both urinary incontinence and urine retention. The underlying
reasons for the symptoms of NBD can be detrusor under activity
or overactivity, depending on the site of neurological insult. The
urinary sphincter may also be affected, resulting in sphincter under activity or overactivity and loss of coordination with bladder
function. Appropriate therapy and a successful outcome depend
on accurate diagnosis through taking a careful medical and voiding history together with a variety of clinical examinations that
include urodynamics and selective radiographic imaging studies (
Bauser 1987).
The earliest known description of neurogenic bladder was in the
Edwin Smith papyrus from ancient Egypt (Inder 2004). Therapy
for neurogenic bladder dysfunction is wide-ranging, it includes behavioural treatment, medicine, surgery and supportive treatment,
for example, intermittent catheterization, botulinum toxin type A
injection and a variety of surgical techniques such as transurethral
sphincterotomy (Inder 2004). Successful management of bladder
dysfunction not only decreases the morbidity and mortality but
also improves quality of life. It usually takes two to three months
of bladder training to reach maximum effect and only about two
thirds of people attain good bladder function with a conventional
bladder training programme. An alternative approach is medication but potential side-effects and contraindications must be
weighed against possible benefit (Baldessarini 1990; Brown 1990).
Dry mouth, constipation, blurred vision and metallic taste are
some common side-effects of some of these medications. Because
of these side-effects, only a small proportion of patients are compliant with medications after six months of treatment (Chapple
2005).
In ancient Traditional Chinese Medicine (TCM), the disease
names for neurogenic bladder dysfunction include Yini and
Longbi, which correspond to urinary incontinence and urine
retention. Hindrance of bladder emptying is called Longbi and
inability to maintain the function of the bladder to avoid leakage
is called yini. Bladder dysfunction is mainly divided into four
types in TCM according to the diagnosis made through observ-

ing the tongue, pulse and symptoms. The types are: 1. stagnation
of Liver-Qi, with mental depression or restlessness and irritability, urine retention or delay in urination, abdominal distention
and red tongue with thin and yellowish fur, wiry pulse as part of
the syndrome; 2. deficiency of Spleen-Qi, the syndrome of this
type includes straining distention of the lower abdomen, feeling
the need for urination but not passing urine, or oliguria with delayed urination, lassitude, poor appetite, shortness of breath, pale
tongue with thin fur, thready and weak pulse; 3. insufficiency of
Kidney-Qi, the syndrome of this type includes retention of urine
or dribbling and difficult urination, pale complexion, lassitude,
aversion to cold, coldness below the loins, weakness of knees, pale
tongue with whitish fur, deep and thready pulse; 4. downward flow
of dampness and heat, the syndrome of this type includes urine
retention or oliguria, scanty dark yellow urination with burning
sensation, lower abdominal distention or constipation, bitter taste
with sticky mouth, red tongue with yellowish sticky fur, and rapid
pulse (Huang 2002; Long 1999).
Acupuncture is an ancient Chinese therapy practiced for more
than 2500 years to cure disease and relieve pain (Lee 1990). It is an
invasive procedure in which thin metal needles are inserted into
specific body sites and either slowly twisted manually or stimulated
electrically. Advantages of acupuncture are a wide range of indications, many reports of curative effects, simple application, low
cost and safety. Acupuncture and the related treatment moxibustion are very popular among the people of China and have made
a great contribution to the prosperity of the Chinese nation for
thousands of years. Acupuncture therapy includes body acupuncture, auricular acupuncture, scalp acupuncture, electroacupuncture, laser acupuncture, acupressure, or a combination of the above
approaches. In 1979, the World Health Organization drew up a
provisional list of 47 diseases that could be treated with acupuncture. Neurogenic bladder dysfunction following spinal cord injury was suggested to be potentially treatable with acupuncture (
Bonnerman 1979). Many studies on the use of acupuncture to
treat this type of problem report beneficial outcomes, including improved bladder function. Treatment duration ranges from
five months to three or five years. Electroacupuncture along the
bladder meridian (paravertebral) area has been especially recommended. Additional studies published since 1979 support these
findings. Honjo and colleagues (Honjo 1998) from Japan observed
that needle stimulation of acupuncture point Bladder 33 (third
posterior sacral foramina) significantly improved urinary incontinence. These researchers conducted urodynamic studies on 11
adult males and two adult females with detrusor hyperflexia. No
side-effects were found in these patients after treatment and incontinence symptoms disappeared after acupuncture treatment.
Their bladder capacity was also reported to be improved. Cheng
from Taiwan (Cheng 1998) observed that patients receiving electroacupuncture (acupuncture points CV 3, 4 and Bladder 32)
achieved balanced voiding within fewer days than those who did
not receive acupuncture. People starting acupuncture treatment

Acupuncture for bladder dysfunction after spinal cord injury (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

within three weeks after spinal cord injury required significantly


fewer days of treatment compared to those treated with acupuncture after three weeks. Patients with complete spinal cord injury,
either with pronounced detrusor-sphincter dyssynergia with an
upper motor neuron lesion or with persistent areflexic bladder
with a lower motor neuron lesion, were reportedly not affected by
acupuncture.
These inconsistencies in results may be due to the methodological weakness of the trials, such as inadequate blinding of patients,
investigators or both, inadequate allocation concealment or insufficient duration of treatment. There is no known systematic review of acupuncture in the treatment of bladder dysfunction after
spinal cord injury. This review aims to systematically review all
randomised controlled trials (RCTs) (including crossover studies)
that examine the effectiveness of acupuncture for bladder dysfunction after spinal cord injury.

OBJECTIVES
The objective of this review is to assess any benefits or adverse effects of acupuncture treatment for bladder dysfunction after spinal
cord injury.
The following comparisons will be made:
1. Acupuncture intervention versus no intervention;
2. A specific acupuncture intervention versus another intervention;
3. Acupuncture with another intervention versus that intervention
alone
4. Early acupuncture versus delayed, selective acupuncture.

Types of interventions
All kinds of acupuncture involving needles, whether inserted into
the skin or not, used primarily for the treatment of neurogenic
bladder dysfunction after spinal cord injury compared with no
active treatment or sham treatment, medication, another kind of
acupuncture, another conservative treatment, the same kind of
acupuncture treatment at different acupoints and any other type
of intervention.
Types of outcome measures
Primary outcome

1. Urinary symptoms for participants:


subjective report of urinary incontinence (no improvement or persistent symptoms);
number of pad or clothing changes per 24 hours;
frequency of incontinence from self-report or a diary;
frequency of micturition per 24 hours;
number with urinary urgency;
degree of urinary urgency;
micturition time.
2. Objective clinical assessment:
standardised pad test (24 hour, 1 hour; grammes of
urine lost).
3. Changing urodynamics, including:

maximal cystometric bladder capacity;


residual urine;
maximal detrusor pressure;
other.

4. Patient quality of life:


incontinence-specific quality of life measures,
generic quality of life measures.

METHODS

Criteria for considering studies for this review

5. Adverse effects due to treatment:


pain;
other side-effects of treatment.
6. Other outcomes subsequently deemed appropriate.

Types of studies
All randomised and quasi-randomised trials evaluating the effects
of acupuncture interventions designed to improve the symptoms
of bladder dysfunction in people who have had a spinal cord injury.
Types of participants
Patients of any age or gender with a diagnosis of bladder dysfunction caused by spinal cord injury, in any stage, will be included.
Individuals with urinary incontinence or urine retention without
neurogenic disease will be excluded. Neurogenic bladder dysfunction caused by other disease such as diabetes mellitus, stroke, tumour, or syringomyelia will be excluded.

Search methods for identification of studies


Electronic searches
The following electronic databases will be searched for trials irrespective of language and publication status:
the Cochrane Incontinence Review Group Trials Register;
the Cochrane Complementary Medicine Field Trials
Register;

Acupuncture for bladder dysfunction after spinal cord injury (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

the Cochrane Central Register of Controlled Trials


(CENTRAL) (The Cochrane Library 2007, Issue 1);
MEDLINE (1966 to 2006);
EMBASE (1998 to 2006);
Chinese Biomedical Database (1979 to 2006);
China National Knowledge Infrastructure (CNKI)
(1979 to 2006);
Chinese Scientific Journals Database and Chinese S&T
Journal Database (both on VIP) (1994 to 2006).
The search strategy for MEDLINE is as follows.
A. Search strategy to locate spinal cord injury
#1 spinal cord injury/
#2 spinal cord trauma/
#3 spinal cord contusion/
#4 or/1-3
B. Search strategy to locate bladder dysfunction
#5 neurogenic bladder dysfunction/
#6 neurogenic bladder disorders/
#7 bladder. uninhibited neurogenic/
#8 bladder dysfunction/
#9 or/5-8
C. Search strategy to locate acupuncture interventions
#10 acupuncture/
#11 electroacupuncture /
#12 electro-acupuncture/
#13 body acupuncture/
#14 acupuncture points
#15 ear acupuncture
#16 scalp acupuncture
#17 laser acupuncture
#18 or/10-17
#19 4 and 9 and 18
Handsearches
Handsearches will be considered following the electronic searches,
particularly where abstracts from relevant urological and associated meetings are not available electronically. The following
journals that are published in Chinese will be searched: Chinese
Acupuncture and Moxibustion (1981 to 1979), Journal of Clinical Acupuncture and Moxibustion (1985 to 1979), Journal of Traditional Chinese Medicine (1960 to 1979), New Journal of Traditional Chinese Medicine (1969 to 1979), Research of Acupuncture and Moxibustion (1976 to 1979) from their first publication
date onwards to 1979. Conference proceedings relevant to this
topic will also be handsearched.
Additional searches
The reference lists of identified randomised clinical trials and review articles will be checked in order to find randomised trials
not identified by the electronic or hand searches. Ongoing trials
will be searched through the UK National Research Register and
Current Controlled Trials (www.controlled-trials.com), and grey
literature through the SIGLE database.

Data collection and analysis


Selection of studies
Potentially relevant articles will be evaluated by two review authors
to determine if they meet the prespecified criteria and to assess
their methodological quality. Any disagreement between review
authors will be resolved by consensus or through a third party.
Data extraction and management
Studies will be excluded from the review if they are not randomised
or quasi-randomised parallel group or cross-over trials, or if on
more detailed examination they do not meet the review inclusion
criteria. These studies will be listed in the Characteristics of excluded studies table.
Data analyses
Data from individual trials will be combined for meta-analysis
when the interventions are sufficiently similar (that is, individual
trials compare the same acupuncture therapy versus the same control intervention). The analyses will be carried out using RevMan
Analyses software in Review Manager (Cochrane software).
Analysis will be carried out for both continuous and categorical
dichotomous data. Data will be combined using odds ratios (OR)
or relative risks (RR) and 95% confidence intervals for dichotomous data. Continuous data will be assessed using weighted mean
difference (WMD), or standardised mean difference if different
scales have been used, and 95% confidence intervals (CI). Reason for any heterogeneity will be explored. Summary effect calculations will be done using the fixed-effect model unless there
is persistent, unexplained heterogeneity. To explore whether there
are any differences between study results due to factors for which
there is empiric or biological evidence of effect, subgroup analysis
and meta-regression will be done, if there are sufficient studies to
analyse.
Sensitivity Analyses
If the data allow, sensitivity analysis will be performed to assess
the quality of the study data. A sensitivity analysis will be carried out to determine if the findings from the primary analysis is
changed by incorporating different types of trials in the analysis.
This will be done by varying the inclusion criteria and repeating
the analysis with the new data set. In addition, the effect of including randomised controlled trials reported only in abstracts and in
languages other than English will be examined. Furthermore, if a
sufficient number of randomised trials are identified we plan to
perform sensitivity analysis to explore the influence of trial quality
on effect estimates. The quality components of methodology include adequacy of generation of allocation sequence, concealment
of allocation and the use of intention-to-treat analysis (yes or no).
Subgroup Analyses
If a sufficient number of randomised trials are identified, we will
perform the following subgroup analyses:

Acupuncture for bladder dysfunction after spinal cord injury (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

1. different types of acupuncture therapies (body acupuncture, auricular acupuncture, scalp acupuncture, electroacupuncture, laser
acupuncture, acupressure);
2. different control interventions;
3. treatment duration (less than two weeks or more than two
weeks);
4. duration of disease (less than one month, 1 to 12 months, more
than one year).

REFERENCES

Additional references
Baldessarini 1990
Baldessarini RJ. Drugs and the treatment of psychiatric disorders. In:
Gillman AG, Rall TW, Nies AS, Taylor P editor(s). Goodman and
Gilmans the Pharmacologic Basis of Therapeutics. 8th Edition. New
York: Pergamon Press, 1990:383435.
Bauser 1987
Tanagho EA, Jack W, McAninch JW. Neurogenic Bladder Dysfunction.
1987.
Bonnerman 1979
Bonnerman R. Acupuncture: the World Health Organization view.
World Health 1979.
Brown 1990
Brown JH. Atropine, scopolamine and related antimuscarinic drugs.
In: Gilman AG, Rall TW, Nies AS, Taylor P editor(s). Goodman and
Gilmans the Pharmacologic Basis of Therapeutics. 8th Edition. New
York: Pergamon Press, 1990:15065.
Chapple 2005
Chapple C, Khullar V, Gabriel Z, Dooley JA. The effects of antimuscarinic treatments in overactive bladder: a systematic review
and meta-analysis. European Urology 2005;48(1):526.
Chen 2005
Chen AA, Meng F, Morioka CA, Churchill BA, Kangarloo H. Automated generation of individually customized visualizations of diagnosis-specific medical information using novel techniques of information
extraction. Los Angeles: Medical Informatics Group, University of
California, 2005.
Cheng 1998
Cheng PT, Wong MK, Chang PL. A therapeutic trial of acupuncture
in neurogenic bladder of spinal cord injured patients: A preliminary
report. Spinal Cord 1998;36:47680.

Dahlberg 2004
Dahlberg A, et al.Bladder management of persons with spinal cord
lesion. Spinal Cord 2004;42:6948.
DeVivo 1993
DeVivo MJ, Black KJ, Stover SL. Causes of death during the first
12 years after spinal cord injury. Archives of Physical Medicine and
Rehabilitation 1993;74:248.
Fowler 1999
Fowler CJ. Neurological disorders of micturition and their treatment.
Brain 1999;122:121331.
Hansen 2004
Hansen RB, Biering-Sorensen F, Kristensen JK. Bladder emptying
over a period of 10-45 years after a traumatic spinal cord injury.
Spinal Cord 2004;42(11):6317.
Honjo 1998
Honjo H, Kitakoji H. Acupuncture for urinary incontinence in patients with chronic spinal cord injury. A preliminary report. Nippon
Hinyokika Gakkai Zasshi 1998;89(7):6659.
Huang 2002
Huang Zhigang, You Bin. Acupuncture for urinary incontinence
32 cases in patients after spinal cord injury. Journal of Shanghai
Acupuncture and Moxibustion 2002;21:31.
Inder 2004
Inder Perkash, MD. Neurogenic bladder: past, present, and future.
The Journal of Spinal Cord Medicine 2004;27:3836.
Lee 1990
Lee MHM, Liao SJ. Acupuncture in physiatry. In: Kottke FJ,
Lehmann JF editor(s). Krusens Handbook of Physical Medicine and
Rehabilitation. 4th Edition. Philadelphia, PA: WB Saunders Co Ltd,
1990.
Long 1999
Long Zhixian, Zheng Shouzeng, He Min, et al.Acupuncture and Moxibustion. Academy Press [Xue Yuan], 1999.

Indicates the major publication for the study

Acupuncture for bladder dysfunction after spinal cord injury (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

WHATS NEW

28 October 2008

Amended

Converted to new review format.

HISTORY
Protocol first published: Issue 2, 2007

CONTRIBUTIONS OF AUTHORS
Wang Jiaqi wrote the original protocol and incorporated comments from co-reviewers.

DECLARATIONS OF INTEREST
None

SOURCES OF SUPPORT
Internal sources
Guang An Men Hospital, Beijing, China.
University of Otago, New Zealand.

External sources
No sources of support supplied

Acupuncture for bladder dysfunction after spinal cord injury (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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