acupuncture for postherpetic neuralgia

Acupuncture for postherpetic neuralgia (Protocol)

Wang P, Zhao J, Wu T

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 postherpetic neuralgia (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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iAcupuncture for postherpetic neuralgia (Protocol)


[Intervention Protocol]

Acupuncture for postherpetic neuralgia

Peng Wang2 , Jiping Zhao1, Taixiang Wu3

1Acupuncture and Moxibustion Department, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing

, China. 2Acupuncture and Moxibustion Department, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine,

Beijing, China. 3Chinese Cochrane Centre, Chinese EBM Centre, West China Hospital, Sichuan University, Chengdu, China

Contact address: Jiping Zhao, Acupuncture and Moxibustion Department, Dongzhimen Hospital affiliated to Beijing University of

Chinese Medicine, 5 Haiyuncang , Beijing , 1007000, China. [email protected]. (Editorial group: Cochrane Neuromuscular Disease

Group.)

Cochrane Database of Systematic Reviews, Issue 2, 2009 (Status in this issue: New)


DOI: 10.1002/14651858.CD007793

This version first published online: 15 April 2009 in Issue 2, 2009. (Help document - Dates and Statuses explained)

This record should be cited as: Wang P, Zhao J, Wu T. Acupuncture for postherpetic neuralgia. Cochrane Database of Systematic

Reviews 2009, Issue 2. Art. No.: CD007793. DOI: 10.1002/14651858.CD007793.

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:

The objective of this systematic review is to assess whether acupuncture is more efficacious than no treatment, placebo or sham

acupuncture, and whether acupuncture is more efficacious than routine Western drugs for PHN.

1Acupuncture for postherpetic neuralgia (Protocol)


B A C K G R O U N D

Definition

Postherpetic neuralgia (PHN), the most common complication

of herpes zoster, is classified as pain persisting longer than three

months after the onset of the rash (Baron 2004). The rash itself is

due to activation of latent varicella-zoster virus (VZV). Pain some-

times starts before the onset of the herpetic rash. For some people,

it is the only symptom. It may persist for months or years after the

disappearance of the rash (Volmink 1996). PHN is caused by per-

sistent nerve damage which outlasts the skin lesions (Oaklander

2008).

Postherpetic neuralgia occurs especially in those with more se-

vere acute pain and rash (Johnson 2007). Approximately 20% of

people older than 50 years of age continue to report pain for six

months (Tenser 2005). The symptoms are continuous or inter-

mittent spontaneous pain and stimulus-evoked pain (Schmader

1998). The pain causes considerable physical and psychosocial

morbidity (Tenser 2005) producing insomnia, fatigue, anorexia,

depression, anxiety, social withdrawal and interference with daily

activities (Schmader 1998; Schmader 2002; Sra 2004).

Burden of disease

Despite antiviral therapy being used during the acute period, a

substantial number of people still suffer PHN (Tenser 2005). The

incidence of PHN varies from 8 to 24% in all patients with recov-

ery after the acute attack of herpes zoster (van Seventer 2006). The

number increases to 25 to 50% of people older than 50 (Schmader

2002) and to 27 to 68% of those older than 60 (Schmader 1998).

The incidence of herpes zoster varies from 0.8 (van Seventer 2006)

to 4.8 cases per 1000 people per year (Antonelli 1991; Chidiac

2001). Thus, 800,000 people suffer fromherpes zoster each year in

the US (Schmader 2002). The incidence rises to more than 1% of

individuals older than 80 (Volpi 2005) and about 50% of people

older than 90 years (Johnson 2004). Among inpatients older than

50 years, the incidence is 78% (Gil 2004). A second attack may

occur in approximately 6% of those reaching 90 years (Johnson

2004).

The annual cost of therapy for herpes zoster is EUR 7 million in

Spain (Gil 2004), 47.6 million in England andWales (Edmunds

2001), and US$ 80 million (US$ 280 per herpes zoster case) in

the US (Goldman 2005). In east London, the average overall cost

of herpes zoster is 524 per patient in the first six months. The

medical costs are highest in people over 65 and the societal costs

are highest in those under 65 years (Scott 2006).

Management

Drug therapy

Postherpetic neuralgia is difficult to treat because a uniformly ef-

fective therapy is not available although various treatments have

been tried (Schmader 1998; Matsumoto 2002).

Antiviral drugs, such as acyclovir, brivudine, valaciclovir (He 2007;

Wassilew 2003) and famciclovir (Sandy 2005) are available for

acute herpes zoster (Sra 2004). There is no evidence that corticos-

teroids reduce the incidence of PHN (He 2008).

Tricyclic antidepressants (TCAs) are considered as first line therapy

for PHN (Johnson 2004; Saarto 2007). A low-dose of the drugs

used for acute herpes zoster may prevent PHN (Mounsey 2005).

Some antiepileptics are used as second line therapy (Johnson 2004;

Wiffen 2005 (a); Wiffen 2005 (b)) including pregabalin (Zareba

2005; Sabatowski 2004), gabapentin (Curran 2003; Stacey 2003;

Wiffen 2005 (c)) and oxcarbazepine (Criscuolo 2004).

There are some other drugs used for people with PHN, in-

cluding topical anaesthetics such as the lidocaine patch 5% (

Davies 2004; Khaliq 2007), local administrations including pep-

permint oil (containing 10% menthol) (Davies 2002), capsaicin

cream ( Mounsey 2005), clonidine hydrochloride ointment (

Meno 2001), aspirin dissolved in chloroform (Kochar 1998) and

prostaglandin E1 dissolved in Vaseline (Tamakawa 1999), epidu-

ral or intrathecal sympathetic blocks with various injections (

Kumar 2004), intrathecal corticosteroids (Santee 2002), tramadol

(Boureau 2003), oxycodone (Watson 1998), divalproex sodium

(valproic acid and sodium valproate in molar ratio 1:1) (Kochar

2005), dextromethorphan, a non-selective NMDA receptor an-

tagonist (Suzuki 1996;Mizuno 2001), and the Chinese herb Gan-

oderma lucidum (Hijikata 1998).

Zoster vaccine has been approved for adults over 60 years by the

United States Food and Drug Administration. Live zoster vaccine

decreases the frequency of PHN by 66.5% (Kockler 2007).

Physical therapy

Transcutaneous electrical nerve stimulation (Johnson 2004), elec-

trical spinal cord stimulation (SCS) (Harke 2002), endoscopic

transthoracic sympathicotomy (ETS) (Matsumoto 2002) and ion-

tophoresis therapy (Ozawa 1999) have all been tried with variable

results (Matsumoto 2002).

Acupuncture for the treatment of PHN

Acupuncture is less expensive and has fewer side effects than drug

therapy (Coghlan 1992). Various acupuncture techniques are used

for PHN as follows:

1. Filiform needle or body acupuncture. This is used most

widely in acupuncture therapy and is usually now made

of stainless steel. For PHN, needling methods mean in-

serting the needles into the local points known as Ashi

acupoints around the region of pain and supplementary

acupoints usually in the limbs. The selection of sup-

plementary acupoints is based on symptoms, examina-

tion of the tongue and pulse according to the theory of

Chinese Traditional Medicine. The angle and depth of

insertion are different for different people.



2. Fire needle. The diameter of the fire needle is bigger

than that of the filiform needle. It is pricked quickly

into the skin surface about one to two millimetres deep

after burning to red in the flame and then withdrawn

quickly.

3. Three-edged needle or plum blossom needle and blood-

letting. The three-edged needle is shaped with a thick

and round handle, a triangular body and a sharp tip.

The plum blossom needle, also named dermal needle or

Qixingzhen, is a combination with seven short small

three-edged needles. Both of the needles are used for

superficial blood vessel pricking to cause bleeding.

4. Cupping.This is a therapy inwhich a glass jar is attached

to the skin surface to cause local congestion through

the removal of the air in the jar created by introducing

heat in the form of an ignited material. The therapy is

usually used after pricking with the fire needle or plum

blossom needle to assist the bloodletting.

5. Point injection. This therapy uses the syringe to inject

liquid medicine into the acupoints or the positive sen-

sitive spot to cure the disease. The medicine includes

both Western and Chinese Traditional Medicine.

6. Auricular acupuncture. The ear is considered as a holo-

gram of the body in Traditional Chinese Medicine. It is

divided into approximately 100 regions that correspond

with different parts of the body. Stimulating certain sen-

sitive points with needles or other tools is thought to

heal many diseases.

7. Electro-acupuncture. This combines needles and elec-

trical stimulation by sending a small amount of electric

current to the needle after insertion of the needles and

arrival of qi to treat diseases.

A more detailed introduction to acupuncture and pictures can be

obtained from: http://en.acutimes.com.

Rationale for undertaking this review

Acupuncture is most widely and successfully used in Western

medicine to treat chronic and intractable pain syndromes (Reilly

2000). All of the acupuncture methods above are used to treat

PHN, alone or alongside each other. There have been many tri-

als of acupuncture for treating PHN. However, the evidence for

the efficacy of acupuncture is not strong due to limitations in

the design of acupuncture trials. Most of the present trials have

been conducted with known sources of bias: for example they have

been open, single blind, with no treatment controls, and a small

sample size. The designs of the outcome measurement are often

not rigorous. Therefore, people may be confused as single trials of

acupuncture produce contradictory conclusions.

For example, the conclusion of a single blind randomised con-

trolled study was that there is no difference between the auricular

and body acupuncture group and the placebo group in pain re-

lief for people with PHN (Lewith 1983). Whereas, another ran-

domised control trial concluded that filiform needle therapy was

more effective than the oral painkiller novoltan (Zhu 2004).

To date, there have been no systematic reviews on acupuncture

therapy for PHN.

O B J E C T I V E S

The objective of this systematic review is to assess whether

acupuncture is more efficacious than no treatment, placebo or

sham acupuncture, and whether acupuncture is more efficacious

than routine Western drugs for PHN.

M E T H O D S

Criteria for considering studies for this review

Types of studies

Double-blind randomised controlled trials (RCTs) will be in-

cluded in this systematic review with no language or publication

type restriction.

Types of participants

Inclusion criteria:

1. People with PHN, regardless of age, gender and race

2. PHN is diagnosed by characteristic pain, occurring at

the sites of rashes, along the innervations region of a

cranial or spinal nerve;

3. Pain persisting at least three months after the onset of

acute shingles;

4. Pain with or without local hyperpigmentation.

Exclusion criteria:

1. People with herpes zoster ophthalmicus or herpes zoster

oticus;

2. Pregnant females;

3. People with a serious condition of the cardiovascular,

liver, renal, endocrine , immune system or haematolog-

ical systems;

4. People with a malignancy.

Types of interventions

Weconsider using simultaneously one ormore thanonemodalities

of acupuncture as acupuncture as a whole. The different types of

acupuncture include:

1. Filiform needle

2. Fire needle

3. Three-edged needle

4. Plum blossom needle

5. Auricular acupuncture

6. Electro-acupuncture



7. Point injection

8. Laser acupuncture

9. Moxibustion

10. Cupping (only the cupping used immediately after

acupuncture such as fire needle, three-edged needle,

plum blossom needle, especially on the pricked area for

bloodletting will be included).

Trials with the following comparisons will be included:

1. Acupuncture versus no treatment;

2. Acupuncture versus placebo or sham acupuncture;

3. Acupuncture versus Western medicine, of which effi-

ciency is supported by evidence or recommended by

guidelines, such as gabapentin and TCAs;

4. Acupuncture plus Chinese herbs (or physical therapy)

versus the same Chinese herbs (or physical therapy).

Types of outcome measures

Primary outcomes

1. Pain relief by 50% or more on a visual analogue scale

(VAS) or Liekert scale after one month.

Secondary outcomes

1. Pain relief by at least 50% on VAS or Liekert scale after

three months.

2. Change in quality of life measured with the physical

and mental summary scores of the Short Form 36 or

other validated quality of life scales after three months.

3. Weekly healthcare costs from randomisation to three

months after entry into the trial.

4. Adverse events including serious adverse events which

are those which require hospitalisation, are life-threat-

ening or are fatal, adverse events which lead to cessation

of treatment and all adverse events.

Search methods for identification of studies

Electronic searches

We will search the Cochrane Neuromuscular Disease Group Tri-

als Register for randomised trials using the following search terms

postherpetic neuralgia, PHN, herpes zoster, shingles, and

acupuncture, electroacupuncture, meridians, moxibustion,

acupoint, plum blossom needle, wrist ankle needle, three-

edged needle, fire needle, cupping, bloodletting. We will adapt

this strategy to search MEDLINE (from 1966 to the present),

EMBASE (from 1980 to the present), the Cochrane Central Reg-

ister of Controlled Trials (CENTRAL) (The Cochrane Library,

most recent issue), Chinese Biomedical Database (from 1979 to

the present) and www.Clinicaltrials.gov. The search strategies for

MEDLINE and EMBASE can be found in Appendix 1 and

Appendix 2.

Searching other resources

We will handsearch the Chinese Journals in which we think we

might findRCTsor controlled clinical trials (CCTs) relevant to our

study. Then we will ask stringent questions about randomisation,

concealment of allocation, observer and participant blinding and

completeness of follow up through telephone or email.

We will review the bibliographies of the randomised trials identi-

fied, contact the authors and known experts in the field and ap-

proach pharmaceutical companies to identify additional published

or unpublished data.

Data collection and analysis

Selection of studies

Two review authors will independently scrutinise titles and ab-

stracts of references retrieved from the databases. The same two

review authors will obtain the full text of all potentially relevant

studies, and then independently select eligible trials according to

the inclusion criteria. Review authors will not be blinded to the

names of the authors, institutions or journal of publication. We

will resolve disagreements by discussion between the two review

authors.

Data extraction and management

Two review authors will extract data independently on study char-

acteristics including inclusion and exclusion criteria of partici-

pants, baseline characteristics of participants, interventions and

outcomes using a self-developed data extraction form.We will ob-

tain missing and insufficient data from the study authors when-

ever possible. One review author will enter the data into Review

Manager (RevMan) 5 and a second review author will check the

data entry.

Assessment of risk of bias

Two review authors will independently assess the methodological

quality as follows:

An assessment of risk of bias will be made on all included studies

and a risk of bias table will be completed according to guidelines in

the Cochrane Handbook of Systematic Reviews of Interventions

(Higgins 2008). If randomised controlled trials are identified we

will assess randomisation sequence generation, allocation conceal-

ment, blinding (participants, personnel and outcome assessors),

incomplete outcome data, selective outcome reporting and other

sources of bias. We will then make a judgement on each of these

criteria relating to the risk of bias using Yes indicating low risk of

bias, No high risk of bias and Unclear unclear or unknown risk

of bias.

We will resolve disagreement by discussion with reference to a

third review author if necessary.

Data analysis

We will analyse data with the Cochrane statistical software pack-

age RevMan. We will express results as risk ratios (RR) with 95%

confidence intervals (CI) or risk differences (RD) with 95%CI for



dichotomous outcomes and weighted mean differences (WMD)

with 95% CI or standard mean difference (SMD) with 95% CIs

for continuous outcomes. We will use SMD when different mea-

sures are used to quantify the same clinical outcome.

Assessment of heterogeneity

If there is significant clinical heterogeneity among studies, we will

perform analysis of subsets of trials. We will use the Chi2 test and

the I2 statistic to quantify heterogeneity across trials in the same

subgroup. If there is no evidence of heterogeneity we will pool the

studies using a fixed-effect model. If significant heterogeneity is

found, we will attempt to explore possible reasons for it and solve

the problem by allocating the studies with clinical or methodolog-

ical heterogeneity which may have been ignored at the beginning

to different subsets. If the heterogeneity is still present, we will use

a random-effects model. If there are not sufficient studies (i.e. less

than two studies in every subset), we will give the results of all

studies one by one instead of performing meta-analysis.

Sensitivity analysis

Wewill undertake a sensitivity analysis by repeating the calculation

after omitting the studies that have low scores on individual quality

items.

Assessment of reporting biases

We will use a funnel plot to investigate the possibility of publica-

tion bias. Effect size will be plotted against study size in a graphi-

cal display, which will give some indication whether or not some

studies with particular study size and effect size combination have

not been published or located.

Subgroup analysis

For this review, the subgroups will be as follows:

1. People less than 60 years old versus those 60 years or

older.

2. People with a duration of post-herpetic neuralgia less

than one year versus those with a duration more than

one year

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

We thank Professor Wu Taixiang, the Chinese Cochrane Centre,

the Co-ordinator and Cochrane Neuromuscular Disease Group,

for advice in writing this protocol.

R E F E R E N C E S

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A P P E N D I C E S

Appendix 1. OVID MEDLINE search strategy

1 randomized controlled trial.pt.

2 controlled clinical trial.pt.

3 randomized.ab.

4 placebo.ab.

5 drug therapy.fs.

6 randomly.ab.

7 trial.ab.

8 groups.ab.

9 or/1-8

10 (animals not (animals and humans)).sh.

11 9 not 10

12 Acupuncture/



13 exp Acupuncture Therapy/

14 acupuncture.mp.

15 (acupoint$ or electroacupuncture or electro-acupuncture).mp.

16 (fire needl$ or warming needl$).tw.

17 plum blossom needl$.tw.

18 three edged needl$.tw.

19 wrist ankle needl$.tw.

20 elongated needl$.mp.

21 pricking blood.mp.

22 percussopunctator.mp.

23 acupressure.mp.

24 cupping.mp.

25 meridians.tw.

26 moxibustion.tw.

27 bloodletting.tw.

28 or/12-27

29 exp herpes zoster/

30 shingles.mp.

31 neuralgia, postherpetic/

32 PHN.tw.

33 herpes zoster.tw.

34 (postherpetic neuralgia or post-herpetic neuralgia).tw.

35 or/29-34

36 11 and 28 and 35

Appendix 2. OVID EMBASE search strategy

1 Randomized Controlled Trial/

2 Clinical Trial/

3 Multicenter Study/

4 Controlled Study/

5 Crossover Procedure/

6 Double Blind Procedure/

7 Single Blind Procedure/

8 exp RANDOMIZATION/

9 Major Clinical Study/

10 PLACEBO/

11 Meta Analysis/

12 phase 2 clinical trial/ or phase 3 clinical trial/ or phase 4 clinical trial/

13 (clin$ adj25 trial$).tw.

14 ((singl$ or doubl$ or tripl$ or trebl$) adj25 (blind$ or mask$)).tw.

15 placebo$.tw.

16 random$.tw.

17 control$.tw.

18 (meta?analys$ or systematic review$).tw.

19 (cross?over or factorial or sham? or dummy).tw.

20 ABAB design$.tw.

21 or/1-20

22 human/

23 nonhuman/

24 22 or 23

25 21 not 24



26 21 and 22

27 25 or 26

28 exp acupuncture/

29 (electroacupuncture or electro-acupuncture).ti,ab.

30 (acupuncture$ or acupoint or acupressure).mp.

31 plum blossom needl$.ti,ab.

32 three edged needl$.ti,ab.

33 wrist ankle needl$.ti,ab.

34 (fire needl$ or warming needl$).ti,ab.

35 meridians.ti,ab.

36 moxibustion.ti,ab.

37 cupping.ti,ab.

38 bloodletting.ti,ab.

39 or/28-38

40 exp herpes zoster/

41 shingles.mp.

42 postherpetic neuralgia/

43 herpes zoster.ti,ab.

44 (postherpetic neuralgia or post-herpetic neuralgia).ti,ab.

45 phn.tw.

46 or/40-45

47 27 and 39 and 46

H I S T O R Y

Protocol first published: Issue 2, 2009

C O N T R I B U T I O N S O F A U T H O R S

Peng Wang designed the study and wrote the protocol from the first to the final version.

Jiping Zhao commented on and revised the protocol from the aspect of acupuncture treatment.

Taixiang Wu offered guidance and suggestions about the technology through the whole writing process of the protocol. He also revised

the protocol drafts.

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

Peng Wang and Jiping Zhao are acupuncture doctors based in hospital. Taixiang Wu who has not been trained in acupuncture, is an

expert in evidence-based medicine in university. We have no potential conflicts of interest.



acupuncture for postherpetic neuralgia

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