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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
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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[Intervention Protocol]
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,
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.
BACKGROUND
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).
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-
4. acupoint injection.
Types of outcome measures
Primary 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
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
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.
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
ACKNOWLEDGEMENTS
We thank Professor Taixiang Wu, Chinese Cochrane Centre, West
China Hospital, Sichuan University, for advice on writing the protocol.
REFERENCES
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.
WHATS NEW
29 September 2008
Amended
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