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Acupuncture for symptomatic treatment of diabetic

peripheral neuropathy (Protocol)


Zhao T, Zhang R, Zhao H

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 symptomatic treatment of diabetic peripheral neuropathy (Protocol)


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

TABLE OF CONTENTS
HEADER . . . . . . . . . .
ABSTRACT . . . . . . . . .
BACKGROUND . . . . . . .
OBJECTIVES . . . . . . . .
METHODS . . . . . . . . .
ACKNOWLEDGEMENTS
. . .
REFERENCES . . . . . . . .
WHATS NEW . . . . . . . .
HISTORY . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS
DECLARATIONS OF INTEREST .
SOURCES OF SUPPORT . . . .

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Acupuncture for symptomatic treatment of diabetic peripheral neuropathy (Protocol)


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

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[Intervention Protocol]

Acupuncture for symptomatic treatment of diabetic


peripheral neuropathy
Ting Zhao1 , Ruifeng Zhang1 , Hong Zhao2
1 Acupuncture

Department, Guang An Men Hospital Affiliated to China Academy of Traditional Chinese Medicine, Beijing, China.
Guang An Men Hospital, Chinese Academy of Traditional Chinese Medicine, Beijing,

2 Department of Acupuncture and Moxibustion,

China
Contact address: Ting Zhao, Acupuncture Department, Guang An Men Hospital Affiliated to China Academy of Traditional Chinese
Medicine, No 5, Beixiange, Beijing, 100053, China. dancingqueenzt@yahoo.com.cn. (Editorial group: Cochrane Neuromuscular
Disease 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.CD006280
This version first published online: 18 October 2006 in Issue 4, 2006. (Help document - Dates and Statuses explained)
This record should be cited as: Zhao T, Zhang R, Zhao H. Acupuncture for symptomatic treatment of diabetic peripheral neuropathy.
Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD006280. DOI: 10.1002/14651858.CD006280.

ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
To assess the beneficial and harmful effects of acupuncture therapy for symptomatic diabetic peripheral neuropathy compared with
placebo, no treatment or other treatments.

Acupuncture for symptomatic treatment of diabetic peripheral neuropathy (Protocol)


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

BACKGROUND

Prevalence and causes


Peripheral neuropathy is a common complication of diabetes mellitus. On average the onset of symptoms occurs 10 to 20 years after
diabetes has been diagnosed. Common symptoms of diabetic peripheral neuropathy (DPN) include numbness and/or insensitivity; prickling and/or tingling sensation; burning sensation; aching
pain and/or tightness; sharp, shooting, lancinating pain; and allodynia and/or hyperalgesia (Bastyr 2005). Abnormal sensations
and pain are features of approximately 10% of all cases of diabetic neuropathy and can cause marked diminution in quality of
life for these patients. It is a chronic progressive disease accounting for considerable morbidity. Diabetic neuropathy was observed
in 56% of patients with type 1 diabetes (Iwanicka 2000). It is
the most common peripheral neuropathy in developed countries
(Yasuda 2003). In the United States, diabetic symmetrical distal
neuropathy or diabetic polyneuropathy is the most common form
of neuropathy (Poncelet 2003).
The mechanisms of this disease include persistent hyperglycaemia,
microvascular disease, modification of proteins critical to neural
function by glycation and glycosylation, altered metabolism of
fatty acids, increased activity in the polyol pathway and decreased
neurotrophic factors.

Pathology
The pathogenesis of diabetic neuropathy has not been fully elucidated but is multifactorial. Some people with diabetes experience
painful diabetic neuropathy (PDN), while others experience an
asymptomatic, progressive loss of peripheral nerve function (Page
1997). Painful diabetic neuropathy is a major cause of morbidity
in diabetes mellitus (Emanuele 1997). Painful diabetic neuropathy tends to develop in stages. Early on, intermittent pain and
tingling is noted in the extremities, particularly the feet. In later
stages, the pain is more intense and constant. In the second type
of neuropathy, a painless neuropathy develops. This greatly increases the risk of severe tissue injury because pain no longer alerts
the person to injury. Loss of sensation predisposes the patient to
the development of diabetic foot ulcers and infection. Resulting
infections may lead to serious sequelae of cellulitis, osteomyelitis,
or gangrene, with amputation as the only possible cure in some
instances (Hemstreet 2001).

improve quality of life and prevent chronic ulcerations (Poncelet


2003). Until now, there has not been an effective therapy for this
disease.

Acupuncture for diabetic peripheral neuropathy


Acupuncture has been used for a long time in China to treat
symptoms of diabetic neuropathy. Acupuncture therapy includes
body acupuncture, scalp acupuncture, acupoint injection, electroacupuncture, laser acupuncture, moxibustion (an external
method of preventing and treating diseases by ignition of moxa to
stimulate the acupuncture points. It has the function of warming
channels, to expel cold, and to induce the smooth flow of Qi and
blood) or a combination of the above approaches. This ancient
therapy hinges on the belief that a persons state of health depends
on the balance and level of energy in the body.
It is known that acupuncture relieves pain by controlling the activities of the autonomic nervous system. It has been shown that
opioid-signaling events are involved in both neuropathic pain and
the analgesic effects of acupuncture (Ko 2002), and the analgesic
effect of acupuncture has a physiological basis. Using neurophysiological, neuropharmacological, neurobiochemical and neuromorphological methods, the neurohumoral mechanism of the analgesic effect of acupuncture was studied from the peripheral neural
pathway of acupuncture sensation De-Qi (needling sensation in
Chinese Traditional Medicine (CTM)) to the central neuromodulatory effect (Cao 2002). This study indicated that needling of
the acupuncture point could elicit De-Qi sensation. De-Qi refers
to induction of the channel Qi after the needle is inserted. During
the needling sensation, the patients have soreness, numbness, and
a feeling of distension or heaviness around the point. This means
acupuncture could activate nerve fibres ascending in the anterolateral spinothalamic tract which conduct pain and temperature
sensation and activate the anti-nociceptive system causing release
of opioid peptides which stimulate descending inhibitory pathways resulting in analgesia (Cao 2002).
Although acupuncture was traditionally not recommended in patients with diabetes due to fear of infection and subsequent gangrene, modern advances in needle manufacture and sterilization
have allowed practitioners to perform acupuncture safely on patients with diabetes.

Present status
Treatment
Glucose control has been proven to prevent or slow the progression
of diabetic neuropathy. The goals of treating diabetic neuropathy
are to prevent progression and reduce the symptoms of the disease.
Treatment options include oral medication and insulin. Supportive therapies, including pain management and podiatric care, can

Drug treatment for the symptoms of diabetic peripheral neuropathy is often inadequate. Uncontrolled studies of TENS and of
acupuncture have been reported to decrease pain in >75% of patients with diabetic neuropathy (Julka 1998). Limited evidence
from previous studies of acupuncture for pain relief suggests that
50 to 80% of patients appear to benefit from treatment and that
some pain relief may be maintained after treatment ends. One re-

Acupuncture for symptomatic treatment of diabetic peripheral neuropathy (Protocol)


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

cent study indicated that acupuncture has the action of improving


the metabolism of blood sugar and blood-lipid, lowering blood
viscosity, and restoring the functions of peripheral nerve cells,
thus giving definite therapeutic effects for diabetic peripheral neuropathy (Jiang 2006). Very few adverse effects are associated with
acupuncture.
Our preliminary searches identified about 90 trials on treatment of
diabetic peripheral neuropathy with acupuncture in the Chinese
Biomedical Database (December 2001). The role and efficacy of
acupuncture for treatment of the symptoms of diabetic peripheral neuropathy are still unclear. A systematic review of controlled
trials comparing acupuncture to placebo, no treatment or other
treatments is needed.

4. acupoint injection.
Types of outcome measures
Primary outcomes

The primary outcome measure will be change in a symptom score


after four weeks because the focus of the review is on treatment of
symptoms. Studies where scores have not been adjusted for baseline values will also be used if necessary and feasible. The Total
Symptom Score (Ametov 2003) at four weeks after randomisation
is an acceptable symptom score. Where this outcome is not available, we will use clinically significant improvement with whatever
scale was used by the authors, as the primary outcome measure. In
the event that data are only available for a period shorter than four
weeks, then the average change in score per week will be used.
Secondary outcomes

OBJECTIVES
To assess the beneficial and harmful effects of acupuncture therapy
for symptomatic diabetic peripheral neuropathy compared with
placebo, no treatment or other treatments.

METHODS

Secondary outcome measures include:


1. Change in nerve conduction attributes at least four
weeks after randomisation.
2. Change in sum score of an impairment scale, such as the
Neuropathy Impairment Score (Young 1993), at least
six months after randomisation.
3. Change in quality of life at least six months after randomisation.
4. Adverse events occurring as a result of acupuncture
treatment, for example, fainting due to acupuncture.

Criteria for considering studies for this review


Types of studies

Search methods for identification of studies

Randomised controlled trials (RCTs) or quasi-randomised trials


(ie trials in which allocation is by alternation or day of the week
or some other systematic system) of acupuncture therapy in the
treatment of diabetic peripheral neuropathy will be included regardless of language and type of publication.

We will attempt to identify all relevant studies regardless of language and publication status (published, unpublished, in press,
and in progress).
We will search the Trials Register of the Cochrane Neuromuscular
Disease Group. In addition, we will also search the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane
Library.

Types of participants
We will include participants with diabetic peripheral neuropathy.
Diabetic peripheral neuropathy will be defined according to the diagnostic criteria of the World Health Organization (WHO 1999).
Types of interventions
Any type of acupuncture therapy alone compared with placebo,
no treatment or any other treatment. Acupuncture includes:
1. body acupuncture
2. electroacupuncture
3. acupoint injection
We will include trials where acupuncture is combined with another
treatment provided the control group receives the same treatment.
We will consider four types of acupuncture separately and together.
The different types of acupuncture are:
1. acupuncture
2. electroacupuncture
3. acupuncture and moxibustion

(1) Electronic databases


We will search the following electronic databases: MEDLINE
(1966 to 2006), EMBASE (1980 to 2006), and the China National Knowledge Infrastructure database (CNKI) (1960 to 2006).
(a) Search Strategy for MEDLINE:

A.Search strategy to locate RCTs


search terms 1-30, as given in the Cochrane Handbook , appendix
5 (Higgins 2005).
B.Search strategy to locate diabetic peripheral neuropathy
31. exp diabetes mellitus/
32. diabet$.mp.
33. 31 or 21
34. neuropath$.mp.
35. exp peripheral nervous system diseases/
36. peripheral$ nervous$ system$ disease$.mp.

Acupuncture for symptomatic treatment of diabetic peripheral neuropathy (Protocol)


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

(b) We will adapt this strategy as necessary to search EMBASE.

Two authors (TZ, RZ) will independently enter data into a data
extraction form about the details of study population, intervention, and outcomes. The data extraction form will include the following items:
1. General information: title, authors, reference source,
contact address, year of publication.
2. Trial characteristics: design, method of randomisation,
allocation concealment, blinding (participants, people
administering treatment, outcome assessors).
3. Intervention(s): interventions(s) (dose, route, timing),
comparison intervention(s) (dose, route, timing).
4. Participants: total number and number in comparison
groups, age.
5. Primary and secondary outcomes described above.
We will resolve all matters emerging during data extraction by referring back to the original article and consensus. If necessary, we
will contact the authors of the primary studies to request information.
For binary outcomes, we will extract the number of events and
total number in each group. For continuous outcomes, we will
extract or impute the mean, standard deviation, and sample size
of each group.

(2) Hand searching

Assessment of risk of bias in included studies

We will hand search the following Chinese Journals: Chinese


Journal of Integrated Traditional and Western medicine; Research
of Traditional Chinese Medicine; Modern Traditional Chinese
Medicine; Modern Journal of Integrated Traditional and Western
Medicine; New Journal of Traditional Chinese Medicine; Forum
on Traditional Chinese Medicine; Chinese Acupuncture; Journal
of Tianjin University of Traditional Chinese Medicine; Journal of
Beijing University of Traditional Chinese Medicine; Clinical Research of Acupuncture; Journal of Shanghai Acupuncture-Moxibustion; Hebei Journal of Traditional Chinese Medicine; Shanxi
Traditional Chinese Medicine; Acupuncture Research; Journal of
World Acupuncture.
We will also check the citations of existing reviews and of all trials
identified by the above methods.

The quality assessment will include an evaluation of the following


components for each included study. Each component will be
categorised as Adequate, Unclear, Inadequate or Not used.

Data collection and analysis

Two authors (TZ, RZ) will independently assess each trial.

Selection of studies

Data synthesis

Two authors (TZ, RZ) will retrieve the full articles for further
assessment if the title, abstract and the keywords given suggest
that the study: (1) was for treating diabetic peripheral neuropathy,
(2) referred to a quasi-randomised or randomised controlled trial,
(3) compared acupuncture with other another active intervention,
placebo or no treatment. We will measure interrater agreement for
study selection using the kappa statistic, and reach agreement by
consensus, with reference to a third author if necessary.

If the data are dichotomous, we will report relative risks (RR) with
95% confidence intervals. If data are continuous, we will report
weighted mean difference (WMD and 95% CI) for continuous
outcomes. We will test for heterogeneity by using the Chi-square
test. If the result is P<= 0.10, we will use a random-effects model.
If not, we will use a fixed-effect model. We will assess possible
sources of heterogeneity by sensitivity and subgroup analyses as
described below. We will test for publication bias by using the
funnel plot or other corrective analytical methods depending on
the number of included trials.

37. polyneuropath$.mp.
38. or/34-37
39. 33 and 38
40. exp Diabetic Neuropathies/
41. diabetic neuropath$.mp.
42. diabetic polyneuropath$.mp.
43. or/39-42
C.Search Strategy to locate acupuncture intervention:
44. exp acupuncture/
45. exp electroacupuncture/
46. exp meridians/
47. exp acupuncture points/
48. exp acupuncture therapy/
49. acupuncture$.mp.
50. acupoint injection.mp.
51. electroacupuncture.mp.
52. acupuncture therapy.mp.
53. acupuncture points.mp.
54. or/44-53
55. 30 and 43 and 54

Data extraction and management

Randomisation (allocation generation) - adequate when


the allocation sequence protects against biased allocation to the comparison groups
Randomisation (allocation concealment) - adequate
when clinicians and participants are unaware of future
allocations
Observer blinding (masking) - adequate when the outcome assessor is unaware of the allocation.
Participant blinding - adequate when the participant is
unaware of the allocation.
Loss to follow-up - adequate when >80% of participants
are followed up.

Acupuncture for symptomatic treatment of diabetic peripheral neuropathy (Protocol)


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

We will consider adverse events and costs and cost-effectiveness of


acupuncture for diabetic peripheral neuropathy in the Discussion
section with reference to the non-randomised literature.
Sensitivity analysis
If heterogeneity results from low quality studies, we will undertake
sensitivity analyses by repeating the analysis after omitting studies
lacking specific quality attributes.

ACKNOWLEDGEMENTS
We thank Professor Taixiang Wu, Chinese Cochrane Centre, West
China Hospital, Sichuan University, for advice on writing the protocol.

REFERENCES

Acupuncture for symptomatic treatment of diabetic peripheral neuropathy (Protocol)


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

Additional references
Ametov 2003
Ametov AS, Barinov A, Dyck PJ, Hermann R, Kozlova N, Litchy WJ,
et al.The sensory symptoms of diabetic polyneuropathy are improved
with alpha-lipoic: the SYDNEY trial. Diabetes Care 2003;26(3):
7706.
Bastyr 2005
Bastyr EJ 3rd, Price KL, Bril V. The MBBQ Study Group. Development and validity testing of the neuropathy total symptom score6: questionnaire for the study of sensory symptoms of diabetic peripheral neuropathy. Clinical Therapeutics 2005;27(8):127894.
Cao 2002
Cao X. Scientific bases of acupuncture analgesia. Acupuncture and
Electro-therapeutics Research 2002;27(12):114.
Emanuele 1997
Emanuele NV, Emanuele MA. Diabetic neuropathy: therapies for
peripheral and autonomic symptoms. Geriatrics 1997;52(4):402,
45-9.
Hemstreet 2001
Hemstreet B, Lapointe M. Evidence for the use of gabapentin in the
treatment of diabetic peripheral neuropathy. Clinical Therapeutics
2001;23(4):52031.
Higgins 2005
Higgins JPT, Green S, editors. Cochrane Handbook for Systematic
Reviews of Interventions 4.2.5 [updated May 2004. 2005, Issue 3.
Iwanicka 2000
Iwanicka Z, Glab E, Bilinska M, Wasikowa R. The incidence of neuropathy in patients with diabetes type 1. Endokrynologia, diabetologia i choroby przemiany materii wieku rozwojowego : organ Polskiego
Towarzystwa Endokrynologw Dziecicych. 2000;6(2):939.
Jiang 2006
Jiang H, Shi K, Li X, Zhou W, Cao Y. Clinical study on the wrist-ankle
acupuncture treatment for 30 cases of diabetic peripheral neuritis.
Journal of Traditional Chinese Medicine 2006;26:812.

Julka 1998
Julka IS, Alvaro M, Kumar D. Beneficial effects of electrical stimulation on neuropathic symptoms in diabetes patients. Journal of Foot
and Ankle Surgery 1998;37(3):1914.
Ko 2002
Ko J, Na DS, Lee YH, Shin SY, Kim JH, Hwang BG, et al.cDNA
microarray analysis of the differential gene expression in the neuropathic pain and electroacupuncture treatment models. Journal of
Biochemistry and Molecular Biology 2002;35(4):4207.
Page 1997
Page JC, Chen EY. Management of painful diabetic neuropathy. A
treatment algorithm. Journal of the American Podiatric Medical Association 1997;87(8):3709.
Poncelet 2003
Poncelet AN. Diabetic polyneuropathy. Risk factors, patterns of
presentation, diagnosis, and treatment. Geriatrics 2003;58(6):16-8,
24-5, 30.
WHO 1999
World Health Organization. WHO Diagnosis and Classification
of Diabetes Mellitus.. WHO Department of Noncommunicable
Disease Surveillance 1999.
Yasuda 2003
Yasuda H, Terada M, Maeda K, Kogawa S, Sanada M, Haneda M,
et al.Diabetic neuropathy and nerve regeneration. Progress in Neurobiology 2003;69(2):22985.
Young 1993
Young MJ, Boulton AJ, MacLeod AF, Williams DR, Sonksen PH. A
multicentre study of the prevalence of diabetic peripheral neuropathy in the United Kingdom hospital clinic population. Diabetologia
1993;36(2):1504.

Indicates the major publication for the study

Acupuncture for symptomatic treatment of diabetic peripheral neuropathy (Protocol)


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

WHATS NEW

29 September 2008

Amended

Converted to new review format.

HISTORY
Protocol first published: Issue 4, 2006

CONTRIBUTIONS OF AUTHORS
All of the authors have contributed to developing the protocol.

DECLARATIONS OF INTEREST
None known.

SOURCES OF SUPPORT
Internal sources
Guang An Men Hospital Affiliated to China Academy of Trditional Chinese Medicine, China.

External sources
No sources of support supplied

Acupuncture for symptomatic treatment of diabetic peripheral neuropathy (Protocol)


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