Acupuncture For Osteoarthritis

Acupuncture for osteoarthritis (Protocol)
Ezzo J, Hadhazy VA, Berman BM, Hochberg MC
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 . . . . . . . .
ACKNOWLEDGEMENTS
. .
WHATS NEW . . . . . . .
HISTORY . . . . . . . . .
DECLARATIONS OF INTEREST
SOURCES OF SUPPORT . . .
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[Intervention Protocol]
Acupuncture for osteoarthritis

Jeanette Ezzo2 , Victoria A Hadhazy3 , Brian M Berman3 , Marc C Hochberg1
1 School
of Medicine, University of Maryland, Baltimore, MD, USA. 2 Research, James P. Swyers Enterprises, Baltimore, Maryland,
USA. 3 Complementary Medicine Program, University of Maryland School of Medicine, Baltimore, Maryland, USA
Contact address: Marc C Hochberg, School of Medicine, University of Maryland, 10 S Pine St MSTF 8-34, Baltimore, MD, 21201,
USA. mhochber@umaryland.edu. (Editorial group: Cochrane Musculoskeletal Group.)
Cochrane Database of Systematic Reviews, Issue 2, 2009 (Status in this issue: Unchanged)
DOI: 10.1002/14651858.CD001977
This version first published online: 26 October 1998 in Issue 4, 1998. (Help document - Dates and Statuses explained)
This record should be cited as: Ezzo J, Hadhazy VA, Berman BM, Hochberg MC. Acupuncture for osteoarthritis. Cochrane Database
of Systematic Reviews 1998, Issue 4. Art. No.: CD001977. DOI: 10.1002/14651858.CD001977.
ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
To review all randomized or quasi-randomized (not strictly randomized methods of allocation e.g., by date of birth, hospital record
number or alternation) controlled trials pertaining to the efficacy of acupuncture in the treatment of OA of the knee, hip or hand. The
three specific objectives of this systematic review are:
1) To assess the efficacy of acupuncture compared to standard medical treatment for osteoarthritis.
2) To assess the efficacy of true acupuncture compared to sham acupuncture for osteoarthritis of the knee.
3) To assess the efficacy of acupuncture plus standard medical treatment compared to standard medical care alone for osteoarthritis of
the knee.

BACKGROUND
Osteoarthritis (OA) is the most common form of arthritis, and is a
major cause of morbidity, physical limitation, and increased health
care utilization, including total joint arthroplasty, especially in the
elderly (Scott and Hochberg 1993; Hochberg 1997; Lawrence
1998).
Recent years have seen advances in our understanding of this condition. For example, it is now believed that OA may not be a single disorder but rather a group of overlapping distinct diseases.
Presently there is no cure for OA (Creamer and Hochberg 1997;
Creamer 1998). Therefore, the treatment of OA is primarily focused managing the condition by minimizing morbidity. Current
recommendations for the management of OA, including guidelines published by the American College of Rheumatology, focus
on the relief of pain and stiffness and maintenance or improvement in functional status as important goals of therapy (Hochberg
1995).
Many pharmacological therapies for OA can be associated with
significant adverse effects (Blackshear 1985; Herman 1986; Brandt
1993, Schlegal 1986). Therefore, the need for effective, nontoxic
therapies for OA, has become evident. Non pharmacologic physical modalities include patient education, physical and occupational therapy, aerobic and resistive exercises and weight loss (Puett
and Griffin 1994).
Acupuncture, one non pharmacologic modality, is gaining popularity among OA patients, especially those who have failed to respond to standard therapy. Approximately one million consumers
utilize acupuncture annually in the United States (Paramore 1997)
and that a large percentage of these users are patients with musculoskeletal disorders such as OA (Diehl 1996). Although the safety
of acupuncture has been well demonstrated (Lytle 1993) and the
utilization of acupuncture is increasing, the efficacy of acupuncture for OA, either as a stand alone treatment or an adjunct to
standard medical care, remains in question.
Several models explaining the possible mechanisms of action for
acupuncture analgesia have been proposed. The most widely researched and documented hypothesis, known as the neurohumoral
model of acupuncture analgesia (Han 1997; Huang 1987; Sims
1997) will be briefly described here. This model proposes that
the acupuncture needle stimulates the A delta afferents (types II
and III) of a peripheral neuron. This neuron, terminating in the
dorsal horn of the spinal cord, transfers the impulse to a second
neuron within the same spinal segment. This second neuron then
activates three levels of the nervous system. In ascending order,
these levels are: 1) the spinal cord itself, within the same segment,
2) the midbrain, where two of the three anatomical structures of
the bodys internal analgesia mechanism reside: the periaqueductal
gray matter (PAGM) and raphe magnus nucleus (RMN), and 3)
the pituitary-hypothalamus complex.
As each of these three levels are stimulated, specific endorphins and

monomines (serotonin and noradrenalin) become involved in a
chemical cascade, which inhibits pain. Additionally, low frequency
(2-4 Hz) electro- acupuncture is believed to stimulate the release of
ACTH, stimulating the adrenal cortex and the release of cortisol,
producing anti-inflammatory effects.
OBJECTIVES
To review all randomized or quasi-randomized (not strictly randomized methods of allocation e.g., by date of birth, hospital
record number or alternation) controlled trials pertaining to the
efficacy of acupuncture in the treatment of OA of the knee, hip or
hand. The three specific objectives of this systematic review are:
1) To assess the efficacy of acupuncture compared to standard
medical treatment for osteoarthritis.
2) To assess the efficacy of true acupuncture compared to sham
acupuncture for osteoarthritis of the knee.
3) To assess the efficacy of acupuncture plus standard medical treatment compared to standard medical care alone for osteoarthritis
of the knee.
METHODS
Criteria for considering studies for this review

Types of studies
Randomized and quasi-randomized controlled trials will be included. Because quasi-randomized studies will be included in the
review, a sensitivity analysis will be performed to assess whether
these studies differ qualitatively from the randomized trials.
Types of participants
Participants greater than 18 years of age, of either gender, and
having a diagnosis of osteoarthritis of the extremities (hip, knee
and small joints) will be included. Osteoarthritis of the spine will
not be included. Studies stating the participants had knee pain
or hip pain but not explicitly stating that the pain was due to
osteoarthritis will be excluded from the review.
Types of interventions
a. Acupuncture will be limited to the stimulation of acupuncture points by needle insertion. Both forms of needle manipulation (manual or electrical) will be accepted. However, methods of
stimulating acupuncture points other than needle insertion, e.g.,
digital pressure or surface electrodes (TENS or infrared) will be
excluded.

b. Sham (fake) acupuncture will be defined as the superficial

needling of non acupuncture points, usually without needle manipulation, done either proximally and/or distally to the true
acupuncture points.
c. Standard medical care will be defined as the use of non steroidal
anti-inflammatory medications (NSAIDs) or localized steroid injections in the affected joint(s). If physiotherapy or physical therapy is the comparison group intervention, this will be analyzed
separately from NSAIDs.
Types of outcome measures
The primary outcome measures will include those proposed by
Outcome Measures in Rheumatology Clinical Trials (OMERACT) (Bellamy 1997). These are: 1) a validated measure for pain;
2) functional change; and 3) global assessment made by the patient. Secondary measures, which will be included providing there
is sufficient data, are: 1) side effects of treatment; 2) quality of life
measures; and 3) medical utilization.
Search methods for identification of studies

Identification of published studies:
a. We will search the Cochrane Complementary Medicine Field
Registry of randomized clinical trials and controlled clinical trials.
This registry, contains approximately 3500 studies, which have
been retrieved from MEDLINE, EMBASE, Acubase (a Frenchbased acupuncture database), Dissertation Abstracts, other electronic complementary medicine databases and hand searches.
b. MEDLINE will be searched (1966- September 1998) using the
optimally-sensitive search strategy (Dickersin, 1997) for retrieving
all randomized trials. We will couple this search with the following
keywords:arthritis, osteoarthritis, rheumatology, knee pain,
hip pain, joint pain, oriental medicine, Traditional Chinese
Medicine, meridians, acupuncture, and osteoarthrosis
c. The CAMPAIN (Complementary and Alternative Medicine
and Pain) database which includes about 9000 citations (not
limited to RCTs or CCTs) from assorted electronic and hand
searched sources, will be searched using the keywords arthritis,
osteoarthritis, and acupuncture.
d. Aculars (an acronym for Acupuncture Literature Analysis and
Retrieval System) which contains approximately 40,000 citations
from more than 500 biomedical journals and related conferences,
published in China and other countries since 1984, will also be
searched, using the same keywords described in B.
e. The Science Citation Index will be searched for additional studies, once we have identified studies to be included in the review,
from the already described sources. We will search for articles
which have cited one or more of the included studies in order to
identify other relevant studies.
f. Bibliographies from retrieved articles will be searched for additional studies.
2. Identification of unpublished studies: In order to minimize

the impact of publication bias, we will actively seek conference
abstracts and unpublished trials. Potential publication bias will be
evaluated with inverted funnel plot techniques.
a. Acupuncture journals which are neither indexed electronically
in one of the above databases, nor presently being hand searched
by the Complementary Medicine Field, will be identified and
hand searched. Additionally, serial conference proceedings with
the word(s) arthritis, rheumatology, rheumatism, musculoskeletal,
pain or acupuncture in the conference title, will be hand searched.
Also, an inquiry will be sent to the investigators of included studies and the research directors of acupuncture schools requesting
information of additional trials.
b. Conferences from the following Rheumatology Associations
will be hand searched:
American College of Rheumatology
British Society of Rheumatology
Canadian Rheumatology Association
c. Available conference proceedings from known Acupuncture Associations will be hand searched.
d. Additional Conference Abstracts and Posters for hand searching:
Proceedings from the World Congresses on Pain
Pain in Osteoarthritis International Medical Conference in: Seminars in arthritis and rheumatism v 18(4) Suppl 2.
International Pain Symposium (Atlanta: 1992)
Advances in pain research and therapy
e. Rheumatology journals to be hand searched
Journal of Rheumatology
Arthritis and Rheumatism
British Journal of Rheumatology
Clinical and Experimental Rheumatology.
Data collection and analysis

Data Extraction
Data will be extracted independently by two trained reviewers
(MH, JE). Inter-rater agreement between reviewers will be assessed
using the kappa statistic. Disagreements on methodological quality
ratings will be discussed by the two reviewers to reach a consensus.
Further patient data to be extracted and presented in an evidence
table will include: details on the patients basic disease, duration
of disease, age and gender of patients, reason and number of withdrawals and drop-outs, year(s) of the study, country of study, manner of recruitment (e.g., media advertisements, outpatient clinic,
inpatient pain clinic) and adverse effects. Although these are not
internal validity issues, per se, they may be used to investigate
heterogeneity among studies, or serve as predictors of outcomes.
Acupuncture treatment data to be extracted will include: the type
of needle manipulation used (e.g., manual, low frequency electrical, high frequency electrical), total number of treatments, frequency of treatments, duration of treatment, whether or not de

chi was elicited (and in the case of sham acupuncture, whether

de chi was confined to the treatment group), type of acupuncture
(e.g., traditional Chinese acupuncture, five-element acupuncture,
auriculotherapy), number of points used, location of points used,
and the training and experience of the acupuncturist in treating
osteoarthritis of the knee.
Assessment of the quality of acupuncture procedure
The adequacy of the acupuncture treatment will be assessed in
two ways. First, acupuncture textbooks will be reviewed using a
method previously cited for other types of chronic pain (Birch
1997). This method ascertains whether there are common denominators across textbooks for the acceptable acupuncture treatment for osteoarthritis of the knee. By this standard, the acupuncture treatments in the studies will be rated as adequate or inadequate. Secondly, two acupuncturists with prior experience in
treating OA will be given the description of the study population
and the acupuncture procedure, and will be blinded to the results
of the study. The clinicians will be asked, Given your clinical
experience would you rate the acupuncture treatment adequate
or not adequate for this population? Kappa statistics will be
calculated between panelists.
Statistical Analysis
A fixed effects model will be used, approximate chi square tests for
heterogeneity will be used to assess outcome data for compatibility
with the assumption of a uniform risk ratio (p>0.10). In the event
that there is significant (p>0.10) heterogeneity among studies, we
will use a random effects model (der Simonian and Laird, 1986)
and perform appropriate subgroup analysis. Separate assessment
according to the type of arthritic joint i.e., hip, knee, hand (joints
of the spine are excluded) will be performed as part of the primary
analysis, and results from the separate joint assessments will be
combined if results are similar across joints. Appropriate subgroup
analyses may include length of follow up time, type of needle manipulation of acupuncture procedure (various manipulations are
known to stimulate different endorphin/monoamine cascades),
the total number of treatments received, and/or the overall adequacy of the acupuncture treatment (discussed in the next section).
All trials included in the systematic review will be entered into Review Manager 4.0.4 (RevMan 4.0.4). For pain measures, standardized effects sizes will be estimated (change divided by the baseline
standard deviation of the sample). The results for each intervention group will be weighted by the sample size of the group. Dichotomous results will include dropouts and withdrawals as non
responders (intention-to-treat analysis) and will be summarized as
odds ratios (ORs). The summary OR will be obtained by weighting each individual OR by the inverse of the variance of the estimate for each trial. Because overall effects will only be estimated
for groups of trials using the same type of reference group (e.g.,
sham acupuncture, NSAIDS, steroid injection), it is likely that
more than one meta-analysis will be performed.
A sensitivity analysis will be conducted to evaluate the robustness of the meta-analysis. This analysis will examine the effects of
methodological quality on study outcomes.
ACKNOWLEDGEMENTS
We would like to express appreciation to William Mac Beckner,
Ginny Stone and Don Frese, the information specialists who assisted in identifying relevant trials. We further acknowledge the
NIH Office of Alternative Medicine (OAM) for providing funding to the Complementary Medicine Field through NIH.
WHATS NEW
22 May 2008
Amended
Converted to RM5. CMSG ID C104-P
HISTORY
Protocol first published: Issue 4, 1998

DECLARATIONS OF INTEREST
None known
SOURCES OF SUPPORT
Internal sources
University of Maryland, Baltimore, USA.
External sources
No sources of support supplied


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Acupuncture for osteoarthritis (Protocol)

Ezzo J, Hadhazy VA, Berman BM, Hochberg MC