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

Acupuncture for osteoarthritis (Protocol)

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

T A B L E O F C O N T E N T S

1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iAcupuncture for osteoarthritis (Protocol)


[Intervention Protocol]

Acupuncture for osteoarthritis

Jeanette Ezzo2, Victoria A Hadhazy3, Brian M Berman3, Marc C Hochberg1

1School of Medicine, University of Maryland, Baltimore, MD, USA. 2Research, James P. Swyers Enterprises, Baltimore, Maryland,

USA. 3Complementary 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. [email protected]. (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.

A B S T R A C T

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.

1Acupuncture for osteoarthritis (Protocol)


B A C K G R O U N D

Osteoarthritis (OA) is themost 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 con-

dition. For example, it is now believed that OA may not be a sin-

gle 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 fo-

cused managing the condition by minimizing morbidity. Current

recommendations for the management of OA, including guide-

lines published by the American College of Rheumatology, focus

on the relief of pain and stiffness and maintenance or improve-

ment in functional status as important goals of therapy (Hochberg

1995).

Many pharmacological therapies for OA can be associated with

significant adverse effects (Blackshear 1985;Herman1986; Brandt

1993, Schlegal 1986). Therefore, the need for effective, nontoxic

therapies for OA, has become evident. Non pharmacologic phys-

ical modalities include patient education, physical and occupa-

tional therapy, aerobic and resistive exercises and weight loss (Puett

and Griffin 1994).

Acupuncture, one non pharmacologic modality, is gaining popu-

larity among OA patients, especially those who have failed to re-

spond 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 muscu-

loskeletal 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 acupunc-

ture 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 re-

searched anddocumentedhypothesis, knownas 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

(2-4Hz) electro- acupuncture is believed to stimulate the release of

ACTH, stimulating the adrenal cortex and the release of cortisol,

producing anti-inflammatory effects.

O B J E C T I V E S

To review all randomized or quasi-randomized (not strictly ran-

domized 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 standardmedical treat-

ment compared to standard medical care alone for osteoarthritis

of the knee.

M E T H O D S

Criteria for considering studies for this review

Types of studies

Randomized and quasi-randomized controlled trials will be in-

cluded. 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 acupunc-

ture points by needle insertion. Both forms of needle manipula-

tion (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 ma-

nipulation, 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 in-

jections in the affected joint(s). If physiotherapy or physical ther-

apy 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 (OMER-

ACT) (Bellamy 1997). These are: 1) a validated measure for pain;

2) functional change; and 3) global assessment made by the pa-

tient. 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 French-

based acupuncture database), Dissertation Abstracts, other elec-

tronic 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 stud-

ies, 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 addi-

tional 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 stud-

ies 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 As-

sociations will be hand searched.

d. Additional Conference Abstracts and Posters for hand search-

ing:

Proceedings from the World Congresses on Pain

Pain in Osteoarthritis International Medical Conference in: Sem-

inars 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 onmethodological 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 with-

drawals and drop-outs, year(s) of the study, country of study, man-

ner 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 elec-

trical, high frequency electrical), total number of treatments, fre-

quency 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 de-

nominators across textbooks for the acceptable acupuncture treat-

ment for osteoarthritis of the knee. By this standard, the acupunc-

ture treatments in the studies will be rated as adequate or in-

adequate. 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 ma-

nipulation of acupuncture procedure (various manipulations are

known to stimulate different endorphin/monoamine cascades),

the total number of treatments received, and/or the overall ad-

equacy of the acupuncture treatment (discussed in the next sec-

tion).

All trials included in the systematic review will be entered into Re-

viewManager 4.0.4 (RevMan 4.0.4). For painmeasures, standard-

ized effects sizes will be estimated (change divided by the baseline

standard deviation of the sample). The results for each interven-

tion group will be weighted by the sample size of the group. Di-

chotomous 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 weight-

ing each individual OR by the inverse of the variance of the esti-

mate 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 robust-

ness of the meta-analysis. This analysis will examine the effects of

methodological quality on study outcomes.

A C K N OW L E D G E M E N T S

We would like to express appreciation to William Mac Beckner,

Ginny Stone and Don Frese, the information specialists who as-

sisted in identifying relevant trials. We further acknowledge the

NIH Office of Alternative Medicine (OAM) for providing fund-

ing to the Complementary Medicine Field through NIH.

WH A T S N E W

22 May 2008 Amended Converted to RM5. CMSG ID C104-P

H I S T O R Y

Protocol first published: Issue 4, 1998



D E C L A R A T I O N S O F I N T E R E S T

None known

S O U R C E S O F S U P P O R T

Internal sources

University of Maryland, Baltimore, USA.

External sources

No sources of support supplied



acupuncture for osteoarthritis

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