bmj openacupuncture for alopecia areata (aa). this review aimed to systematically evaluate the...

For peer review only

Acupuncture for treating alopecia areata: a protocol of systematic review of randomised clinical trials

Journal: BMJ Open

Manuscript ID: bmjopen-2015-008841

Article Type: Protocol

Date Submitted by the Author: 20-May-2015

Complete List of Authors: Lee, Hye Won; Korea Institute of Oriental Medicine, Jun, Ji Hee; Korea Institute of Oriental Medicine, Lee, Ju Ah; Korea Institute of Oriental Medicine, Lim, Hyun-Ja; Chodang University, Lim, Hyun-Suk; Howon University, Lee, Myeong Soo; Korea Institute of Oriental Medicine,

<b>Primary Subject Heading</b>:

Complementary medicine

Secondary Subject Heading: Complementary medicine

Keywords: COMPLEMENTARY MEDICINE, DERMATOLOGY, Clinical trials < THERAPEUTICS

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

BMJ Open on A

ugust 13, 2020 by guest. Protected by copyright.

http://bmjopen.bm

j.com/

BM

J Open: first published as 10.1136/bm

jopen-2015-008841 on 26 October 2015. D

ownloaded from

http://bmjopen.bmj.com/


1

Acupuncture for treating alopecia areata: a protocol of

systematic review of randomised clinical trials

Hye Won Lee,1 Ji Hee Jun,

2 Ju Ah Lee,

3 Hyun-Ja Lim,

4 Hyun-Suk Lim,

5 Myeong Soo Lee

2,*

1 KM Convergence Research Division, Korea Institute of Oriental Medicine, Daejeon, South

Korea

2 Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea

3KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, South

Korea

4Department of Nursing, Chodang University, Muan, South Korea

5Department of Nursing, Howon University, Kunsan, South Korea

Running title: Acupuncture for treating alopecia areata

*Correspondence to;

Myeong Soo Lee, PhD

Clinical Research Division,

Korea Institute of Oriental Medicine,

Daejeon, 305-811, South Korea

Tel: 82-(0)42-868-9266; Fax: 82-(0)42-863-9299

E-mail: [email protected]; [email protected]

Page 1 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960

on August 13, 2020 by guest. P

rotected by copyright.http://bm

jopen.bmj.com

/B

MJ O

pen: first published as 10.1136/bmjopen-2015-008841 on 26 O

ctober 2015. Dow

nloaded from



2

License statement

The Corresponding Author has the right to grant on behalf of all authors and does grant on

behalf of all authors, an exclusive licence (or non-exclusive for government employees) on a

worldwide basis to the BMJ Publishing Group Ltd and its Licensees to permit this article (if

accepted) to be published in BMJ Open and any other BMJPGL products to exploit all

subsidiary rights, as set out in our licence (http://group.bmj.com/products/journals/

instructions-for-authors/licence-forms).

Page 2 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



3

Article focus

� The aim of the proposed systematic review is to analyse randomised trial of

acupuncture for treating alopecia areata (AA).

Key messages

� This systematic review will be performed using a comprehensive search strategy and

will establish the current status of the evidence using unbiased methods.

Strengths and limitations of this study

� The strength of this systematic review is its extensive, unbiased search of various

databases without a language restriction.

� The trial screening, data extraction and assessing risk of bias will be conducted

independently by two of the authors.

� Our systematic review may pertain to the potential incompleteness of the evidence

reviewed including publication and location bias, poor quality of the primary data

and poor reporting of results.

Page 3 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



4

Abstract

Introduction: Acupuncture is frequently used in dermatology for treating a number of skin

disorders. There is no critically appraised evidence of the potential benefits and harm of

acupuncture for alopecia areata (AA). This review aimed to systematically evaluate the

efficacy of acupuncture for the management of AA in randomised clinical trials (RCTs).

Methods and analysis: Thirteen databases will be searched from their inception. These

include PubMed, AMED, EMBASE, the Cochrane Library, six Korean medical databases

(Korean Studies Information, DBPIA, the Korean Institute of Science and Technology

Information, the Research Information Centre for Health Database, KoreaMed, and the

Korean National Assembly Library), three Chinese Databases (China National Knowledge

Infrastructure Database (CNKI), the Chongqing VIP Chinese Science and Technology

Periodical Database (VIP), and the Wanfang Database). Only randomised clinical trials

(RCTs) using any type of acupuncture for AA will be considered. The selection of the

studies, data abstraction, and validation will be performed independently by two researchers.

Methodological quality will be assessed with Cochrane risk of bias.

Dissemination: The systematic review will be published in a peer-reviewed journal. The

review will also be disseminated electronically and in print. Updates of the review will be

conducted to inform and guide the healthcare practice and policy.

Trial registration number: PROSPERO 2015: CRD42015020397

Keywords: Acupuncture; alopecia areata; hair loss; systematic review

Page 4 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



5

Introduction

Description of the condition

Alopecia areata (AA) is a type of alopecia characterised by no scarring hair loss. The

condition is found in 0.1 to 0.2 % of the general population.1-3

The cause of AA appears to

be related to the disturbance of autoimmune functioning, physical stress, genetic factors and

microcirculation. 1 2 AA could cause significant psychological problems, result in reduced

self-esteem and negatively affect the quality of life.1 2

The first line treatments are topical

immunotherapy for extensive disease and intralesional corticosteroids for localised hair loss

in patches.1 2

Description of the intervention

Acupuncture is one of the most frequently used forms of complementary and alternative

medicine.4 Acupuncture involves the insertion of needles into the skin and underlying tissues

at acupuncture points for a therapeutic purpose. Acupuncture points (body, ear, head or

tongue) could be stimulated with several types of acupuncture needles, electricity, laser,

pressure, or heat. The procedure is frequently used in dermatology for treating a number of

skin disorders.5 6

The most frequently used acupuncture technique is plum-blossom

acupuncture (PBA), in which the skin should appear flushed, with bleeding.7 8

How the intervention might work

Acupuncture might help to reduce hair loss by reducing T1 attacks on the hair bulb.

Additionally, it might stimulate the hair follicles, warm the local collaterals and activate

blood circulation.8 A recent study shows that electroacupuncture reduces degranulation of the

Page 5 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



6

mast cells in the dermis,9 which is reported to be a possible cause of pathological changes in

AA. The reliable evidence is unclear.

Why it is important to this review

Acupuncture is frequently used in dermatology for treating a number of skin disorders

including AA.5 6

There is no critically appraised evidence, such as a systematic review or

meta-analysis, of the potential benefits and harm of acupuncture for AA.

Objectives

This review aimed to systematically evaluate the efficacy of acupuncture for the management

of AA reported in randomised clinical trials (RCTs).

Page 6 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



7

Methods

Study registration

The protocol of this systematic review has been registered on PROSPERO 2015 (registration

number: CRD42015020397). This systematic review protocol was conducted and reported

using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)

statement guidelines. We will document the important protocol amendments in full review.

Criteria for considering studies for this review

Type of studies

RCTs and quasi-RCTs were included. Cluster RCTs, non-randomised clinical studies,

observational studies, and case studies were excluded. Dissertations and abstracts were

included, and no restriction on publications was imposed. For duplicate publications with

different outcome measures originating from one trial published as separate papers, the

original publication was given priority, and the other publications were excluded.

Type of participants

Trials involving subjects with AA regardless of sex, age and cause were included.

Type of interventions and controls

Trials in which any type of acupuncture was used as an adjunct to conventional treatment,

usual care, or standard or other types of complementary therapies will also be included if

the control group received the same concomitant treatments as the acupuncture group. The

studies that compared two types of acupuncture were excluded.

Page 7 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



8

Type of outcome measures

Primary outcomes

- Hair regrowth

- Response rate

- Rate of hair loss

Secondary outcomes

- Quality of life

- Satisfaction with the appearance of hair

- Adverse events (AEs)

Search methods for identifying the studies

Electronic searches

The following electronic databases were searched from inception through August 2014:

Pubmed, AMED, EMBASE, the Cochrane Central Register of Controlled Trials and the

Cochrane Database of Systematic Review, DARE, five Korean Medical Databases (Korean

Studies Information Service System, DBPIA, Korea Institute of Science and Technology

Information, Research Information Service System, and KoreaMed), and 3 Chinese Medical

Databases (CNKI, Wangfang, VIP).

Searches of other resources

Additionally, we manually searched our departmental files and relevant journals (Focus on

Alternative and Complementary Therapies and Forschende Komplementärmedizin und

Klassische Naturheilkunde to June 2015. The references in all the located articles were

manually searched for further relevant articles. Dissertations and abstracts were included.

Page 8 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



9

Study strategies

Our search strategy will include main keywords ‘acupuncture’ and ‘alopecia areata’

(Supplement 1).

Data collection and analysis

Study selection

Two of the authors (Lee HW and Jun JH) of the review independently screened the titles and

abstracts of the searched studies, perform the study selection and record their decisions on a

standard eligibility form. The arbitrator (Lee MS) will decide upon the study selection when a

consensus cannot be reached. The details of the selection process will be shown in the

PRISMA flow diagram (Figure 1).

Data extraction and management

All of the included articles were read in full. Two independent reviewers (Lee HW, Jun JH

and Lee JA) extracted the data including the methods (e.g., design, blinding, duration of

follow-up), sample (e.g., population size, conditions, age, duration of disease), intervention

and control treatment, and outcome measures, according to the predetermined criteria. The

extracted data will be tabulated for further analysis. Details regarding the acupuncture and

control interventions will be extracted on the basis of the revised Standards for Reporting

Interventions in Clinical Trials of Acupuncture (STRICTA). Any disagreement among the

authors was resolved by discussion with all of the authors. When the reported data are

insufficient or ambiguous, one author (Lee MS) contacted the corresponding authors of the

included studies by e-mail or telephone to request additional information or clarification.

Page 9 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



10

Assessment of risk of bias in included studies

According to the guidelines of the Cochrane Handbook of Systematic Reviews of

Interventions, the risk of bias will be assessed to evaluate the methodological quality of the

included studies.10 The following domains will be evaluated for methodological quality:

sequence generation, allocation concealment, blinding of participants and outcome assessors,

incomplete outcome data and selective outcome reporting. The evaluated domains will be

judged as "Low", "High" or "Uncertain" according to the criteria of the Cochrane guidelines.

Measures of treatment effect

Dichotomous data will be presented as a risk ratio (RR) with 95% confidence intervals (CIs).

For continuous data, the mean difference (MD) will be used with 95% CIs. In cases of

outcome variables with different scales, the standard mean difference (SMD) will be used

instead of the weighted MD (WMD).

Unit of analysis issues

The meta-analysis will include data from parallel-group design studies. In the case of cross-

over trials, we will use the first phase of the data. If there are multiple time-point

observations, the data will be analysed as either short-term (within 4 weeks) or long-term

(over 4 weeks) follow-up.

Dealing with missing data

If missing data are detected, we will request any missing or incomplete information from the

original study investigators.

Page 10 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



11

Assessment of heterogeneity

A fixed-effects model and a random-effects model will be simultaneously used for the meta-

analysis. Heterogeneity will be tested with the Higgins I2 test. We will calculate the I

2

statistic, which will provide a measure of the inconsistencies among the included studies. We

will use a 50% cut-off point for meaningful heterogeneity among the included studies. If

heterogeneity is observed, subgroup analysis will be conducted.11

Assessment of reporting biases

Funnel plots will be used to detect reporting biases and small-study effects. If more than 10

studies are included in the meta-analysis, the test for funnel plot asymmetry will be

conducted using Egger's method. 12 13

Data synthesis

If a significant number of studies are identified, a meta-analysis will be conducted with

simultaneous use of fixed-effect and random-effect models. All statistical analyses will be

performed using RevMan 5.2.7 (the Cochrane Collaboration) software. To summarise the

effects of acupuncture on outcomes (response rate), we will abstract the risk estimates

(relative risk, RR), and 95% confidence intervals (CI). For studies with insufficient

information, we will contact the primary authors to acquire and verify data where possible. If

appropriate, we will then pool the data across studies using random effect models. The

strength of the body of evidence will be assessed with GRADE.

Subgroup analysis and investigation of heterogeneity

Page 11 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



12

To explore differences in effect sizes, subgroup analyses will be conducted on the following

topics: the severity of depression, sex, the type of acupuncture, the design of the trial (e.g.,

crossover group or parallel group), the dose of acupuncture, and treatment frequency. We will

also summarise the standardisation and characteristics of acupuncture from all included

studies.

Sensitivity analysis

Sensitivity analysis will be conducted according to the following criteria:

1. Methodological qualities (sequence generation, allocation concealment, or blinding)

2. Sample size (small sample studies, e.g., less than 40 subjects in each group, or large

sample studies, e.g., more than 40 subjects in each group)

Page 12 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



13

Ethics and dissemination

Ethical approval is not required, given that this protocol is for a systematic review. The

findings of this review will be disseminated widely through peer-reviewed publications and

conference presentations.

Discussion

This systematic review will provide a detailed summary of the current state of evidence on

the effectiveness of the acupuncture in treating AA. The review will benefit patients and

practitioners in the field of traditional and complementary medicine.

Page 13 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



14

Contribution of authors

Lee HW and MSL conceived the study. The protocol was drafted by Lee HW, Lee JA, Jun

JH, Lim HJ, Lim HS and Lee MS. The search strategy was developed and will be run by Lee

HW and Jun JH. Copies of studies will be obtained by Jun JH and Lim HJ. Selection of the

studies to include will be done by Lee HW and Jun JH. Lee MS will act as an arbiter in the

study selection stage. Extraction of data from studies will be conducted by Lee HW, Jun JH,

and Lee JA. Entering data into RevMan will be conducted by Lim HJ and Lim HS. Carrying

out the analysis will be done by Lee HW, Jun JH, and Lee MS. Interpretation of the analysis

will be done by Lee HW, Jun JH, Lee JA, Lim HJ, Lim HS and Lee MS. The final review

will be drafted Lee HW, Jun JH, Lee JA, Lim HJ, Lim HS and Lee MS. The review will be

updated by Lee HW, Jun JH and Lee MS.

Competing interests

None declared

Funding

No external funding was received. HW Lee was supported by Korea Institute of Oriental

Medicine (K15303 and K152901).

Page 14 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



15

Reference

1. Gilhar A, Etzioni A, Paus R. Alopecia areata. N Engl J Med 2012;366(16):1515-25.

2. Harries MJ, Sun J, Paus R, King LE, Jr. Management of alopecia areata. BMJ

2010;341:c3671.

3. Sperling LC, Sinclair RD, Shabrawi-Caelen LE. Alopecias. In: Bolognia JL, Jorizzo JL,

Schaffer JV, editors. Dermatology. London: Saunders, 2012:1093-114.

4. Ernst E. Acupuncture--a critical analysis. J Intern Med 2006;259(2):125-37.

5. Nelson JL, Badreshia-Bansal S. An overview of complementary and alternative medicine.

In: Taylor SC, Gathers RC, Callender VD, Rodriguez DA, Badreshia-Bansal S,

editors. Treatments for skin of color. NY: Saunders, 2011:351-74.

6. van den Biggelaar FJ, Smolders J, Jansen JF. Complementary and alternative medicine in

alopecia areata. Am J Clin Dermatol 2010;11(1):11-20.

7. Dou W. Research progress of acupuncture for treatment of alopecia areata in recent ten

years. World J Acupunct Moxibustion 2009;19(1):55-59.

8. Jiang W, Liu W. The treatment of alopecia with acupuncture and related techniques. J

Chin Med 2006;82(NA):32-5.

9. Maeda T, Taniguchi M, Matsuzaki S, Shingaki K, Kanazawa S, Miyata S. Anti-

inflammatory effect of electroacupuncture in the C3H/HeJ mouse model of alopecia

areata. Acupunct Med 2013;31(1):117-9.

10. Higgins JPT, Altman DG, Sterne JAC. Chapter 8: Assessing risk of bias in included

studies. In: Higgins JPT, Green S, editors. Cochrane Handbook for Systematic

Reviews of Interventions Version 5.1.0 (updated March 2011). : The Cochrane

Collaboration. Available from www.cochrane-handbook.org, 2011.

Page 15 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



16

11. Deeks JJ, Higgins JPT, Altman DG. Chapter 9: Analysing data and undertaking meta-

analyses. In: Higgins JPT, Green S, editors. Cochrane Handbook for Systematic



12. Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a

simple, graphical test. BMJ 1997;315(7109):629-34.

13. Sterne JAC, Egger M, Moher D. Chapter 10: Addressing reporting biases. In: Higgins

JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions

Version 5.1.0 (updated March 2011). : The Cochrane Collaboration. Available from

www.cochrane-handbook.org, 2011.

Page 16 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



Records identified through database

searching

Pubmed (n = ); EMBASE (n= ); AMED

(n= ); Cochrane Library (n= ); KoreaMed

(n= ); DBpia (n= ); RISS (n= ); KISS (n= );

CNKI (n= ); Wangfang (n= ); VIP (n= )

Scr

ee

nin

g

Incl

ud

ed

E

lig

ibil

ity

Id

en

tifi

cati

on

Additional records identified through other

sources

Hand search from books (n = )

Google (n = )

Trials from previous reviews (n= )

Records after duplicates removed

(n = )

Records screened

(n = )

Records excluded

Not related to AA (n = )

Not related to AT (n= )

Not related to human (n= )

Not clinical trials (n= )

Full-text articles assessed for

eligibility

(n = )

Studies included in qualitative

synthesis

(n = )

Studies included in quantitative

synthesis (meta-analysis)

(n = )

Full-text articles excluded, with

reasons

NRS (n = )

Not decoction (n= )

Case studies (n= )

Page 17 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



Supplement 1. Search strategies

Medline (OvidSP)

1. alopecia/

2. alopecia areata/

3. baldness/

4. or/1-3

5. exp Acupuncture Therapy/

6. Acupuncture/

7. acupoint*

8. electroacupuncture

9. ear acupuncture

10. auricular acupuncture

11. Scalp acupuncture

12. or/5-11

13. 4 and 12

Korean DB

1. 탈모

2. 탈모증

3. 초기탈모

4. 유풍

5. 원형탈모

6. 부분 탈모

7. 원형탈모증

8. 중증 원형탈모증

Page 18 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



9. 남성형 탈모

10. 남성 탈모

11. 압박성 탈모증

12. 안드로겐성 탈모증

13. 여성 탈모

14. 여성형 탈모

15. 출산후 탈모

16. 휴지기 탈모

17. 전신형탈모

18. 전두탈모증

19. 후두부 탈모

20. 온머리 탈모증

21. 성인 탈모

22. 성인 탈모증

23. 성인 원형 탈모

24. 성인 원형 탈모증

25. 성인 전두 탈모

26. 성인 전두 탈모증

27. 소아 탈모

28. 소아 원형 탈모

29. 소아 원형 탈모증

30. 소아 전두 탈모

Page 19 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



31. 소아 전두 탈모증

32. 열성 탈모

33. alopecia

34. alopecia areata

35. androgenetic alopecia

36. male pattern alopecia

37. Male pattern baldness

38. Light alopecia areata

39. Spot hair loss

40. 1-39/or

41. 자침

42. 침치료

43. 침

44. 약침

45. 온침

46. 전침

47. 이침

48. 호침

49. 두침

50. 망침

51. 침구

52. 매선

53. 매선 요법

54. Acupuncture

55. Herbal acupuncture

Page 20 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



56. pharmacoacupuncture

57. Auricular acupuncture

58. ear-acupuncture

59. Warming acupuncture

60. Warming needing

61. Warm needing


63. needle-embedding therapy


65. 41-64/or

66. 40 and 65

Page 21 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



Chinese DBs

1. 油风脱发

2. 鬼舔头

3. 斑脱发

4. 鬼剃头

5. 斑脱

6. 脱毛

7. 斑秃

8. 圓形脫毛症

9. 产后脱毛

10. 儿童斑秃

11. 男性型脱发

12. 雄激素源性脱发

13. 脂溢性脱发

14. 重型斑秃

15. 轻型斑秃

16. Severe Alopecia Areata

17. Spot hair loss

18. Alopecia

19. Alopecia Areata

20. Pelada

21. Androgenetic Alopecia

22. Male-pattern Alopecia


24. 1-23/or

25. Acupuncture

26. 针灸

27. 电针

28. 针刺

Page 22 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



29. 针

30. 刺法

31. 头针

32. 皮内针

33. 头体针

34. 芒针

35. 温针


37. ear-acupuncture

38. 耳针

39. 梅花针

39. plum-blossom needle

40. percussopunctator

41. pyonex

42. 25-41/or

43. 随机

44. 对照

45. 43-44/or

46. 24 and 42 and 45

Page 23 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



PRISMA-P (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols) 2015 checklist: recommended items to

address in a systematic review protocol*

Section and topic Item

No

Checklist item

ADMINISTRATIVE INFORMATION Page

Title:

Identification 1a Identify the report as a protocol of a systematic review 1

Update 1b If the protocol is for an update of a previous systematic review, identify as such N/A

Registration 2 If registered, provide the name of the registry (such as PROSPERO) and registration number 4

Authors:

Contact 3a Provide name, institutional affiliation, e-mail address of all protocol authors; provide physical mailing address of corresponding author 1

Contributions 3b Describe contributions of protocol authors and identify the guarantor of the review 14

Amendments 4 If the protocol represents an amendment of a previously completed or published protocol, identify as such and list changes; otherwise,

state plan for documenting important protocol amendments

7

Support:

Sources 5a Indicate sources of financial or other support for the review 14

Sponsor 5b Provide name for the review funder and/or sponsor N/A

Role of sponsor

or funder

5c Describe roles of funder(s), sponsor(s), and/or institution(s), if any, in developing the protocol N/A

INTRODUCTION

Rationale 6 Describe the rationale for the review in the context of what is already known 6

Objectives 7 Provide an explicit statement of the question(s) the review will address with reference to participants, interventions, comparators, and

outcomes (PICO)

6

METHODS

Eligibility criteria 8 Specify the study characteristics (such as PICO, study design, setting, time frame) and report characteristics (such as years considered,

language, publication status) to be used as criteria for eligibility for the review

7-8

Information sources 9 Describe all intended information sources (such as electronic databases, contact with study authors, trial registers or other grey literature

sources) with planned dates of coverage

8

Search strategy 10 Present draft of search strategy to be used for at least one electronic database, including planned limits, such that it could be repeated 8

Study records:

Data 11a Describe the mechanism(s) that will be used to manage records and data throughout the review 9

Page 24 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960

on August 13, 2020 by guest. Protected by copyright. http://bmjopen.bmj.com/ BMJ Open: first published as 10.1136/bmjopen-2015-008841 on 26 October 2015. Downloaded from



management

Selection

process

11b State the process that will be used for selecting studies (such as two independent reviewers) through each phase of the review (that is,

screening, eligibility and inclusion in meta-analysis)

9

Data collection

process

11c Describe planned method of extracting data from reports (such as piloting forms, done independently, in duplicate), any processes for

obtaining and confirming data from investigators

9

Data items 12 List and define all variables for which data will be sought (such as PICO items, funding sources), any pre-planned data assumptions and

simplifications

9

Outcomes and

prioritization

13 List and define all outcomes for which data will be sought, including prioritization of main and additional outcomes, with rationale 7-8

Risk of bias in

individual studies

14 Describe anticipated methods for assessing risk of bias of individual studies, including whether this will be done at the outcome or study

level, or both; state how this information will be used in data synthesis

10

Data synthesis 15a Describe criteria under which study data will be quantitatively synthesised 10

15b If data are appropriate for quantitative synthesis, describe planned summary measures, methods of handling data and methods of

combining data from studies, including any planned exploration of consistency (such as I2, Kendall’s τ)

11

15c Describe any proposed additional analyses (such as sensitivity or subgroup analyses, meta-regression) 11-12

15d If quantitative synthesis is not appropriate, describe the type of summary planned 11

Meta-bias(es) 16 Specify any planned assessment of meta-bias(es) (such as publication bias across studies, selective reporting within studies) 11

Confidence in

cumulative evidence

17 Describe how the strength of the body of evidence will be assessed (such as GRADE) 11

* It is strongly recommended that this checklist be read in conjunction with the PRISMA-P Explanation and Elaboration (cite when available) for important

clarification on the items. Amendments to a review protocol should be tracked and dated. The copyright for PRISMA-P (including checklist) is held by the

PRISMA-P Group and is distributed under a Creative Commons Attribution Licence 4.0.

From: Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart L, PRISMA-P Group. Preferred reporting items for systematic review and

meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015 Jan 2;349(jan02 1):g7647.

Page 25 of 25


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960




Acupuncture for treating alopecia areata: a protocol of systematic review of randomised clinical trials

Journal: BMJ Open

Manuscript ID bmjopen-2015-008841.R1

Article Type: Protocol

Date Submitted by the Author: 26-Aug-2015

Complete List of Authors: Lee, Hye Won; Korea Institute of Oriental Medicine, Jun, Ji Hee; Korea Institute of Oriental Medicine, Lee, Ju Ah; Korea Institute of Oriental Medicine, Lim, Hyun-Ja; Chodang University, Lim, Hyun-Suk; Howon University, Lee, Myeong Soo; Korea Institute of Oriental Medicine,

<b>Primary Subject Heading</b>:

Complementary medicine

Secondary Subject Heading: Complementary medicine

Keywords: COMPLEMENTARY MEDICINE, DERMATOLOGY, Clinical trials < THERAPEUTICS


BMJ Open on A

ugust 13, 2020 by guest. Protected by copyright.

http://bmjopen.bm

j.com/

BM

J Open: first published as 10.1136/bm

jopen-2015-008841 on 26 October 2015. D

ownloaded from



1

Acupuncture for treating alopecia areata: a protocol of

systematic review of randomised clinical trials

Hye Won Lee,1 Ji Hee Jun,

2 Ju Ah Lee,

3 Hyun-Ja Lim,

4 Hyun-Suk Lim,

5 Myeong Soo Lee

2,*

1 KM Convergence Research Division, Korea Institute of Oriental Medicine, Daejeon, South

Korea

2 Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea

3KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, South

Korea

4Department of Nursing, Chodang University, Muan, South Korea

5Department of Nursing, Howon University, Kunsan, South Korea

Running title: Acupuncture for treating alopecia areata

*Correspondence to;

Myeong Soo Lee, PhD

Clinical Research Division,

Korea Institute of Oriental Medicine,

Daejeon, 305-811, South Korea

Tel: 82-(0)42-868-9266; Fax: 82-(0)42-863-9299

E-mail: [email protected]; [email protected]

Page 1 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



2

License statement

The Corresponding Author has the right to grant on behalf of all authors and does grant on

behalf of all authors, an exclusive licence (or non-exclusive for government employees) on a

worldwide basis to the BMJ Publishing Group Ltd and its Licensees to permit this article (if

accepted) to be published in BMJ Open and any other BMJPGL products to exploit all

subsidiary rights, as set out in our licence (http://group.bmj.com/products/journals/

instructions-for-authors/licence-forms).

Page 2 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



3

Article focus

� The aim of the proposed systematic review is to analyse randomised trial of

acupuncture for treating alopecia areata (AA).

Key messages

� This systematic review will be performed using a comprehensive search strategy and

will establish the current status of the evidence using unbiased methods.

Strengths and limitations of this study

� The strength of this systematic review is its extensive, unbiased search of various

databases without a language restriction.

� The trial screening, data extraction and assessing risk of bias will be conducted

independently by two of the authors.

� Our systematic review may pertain to the potential incompleteness of the evidence

reviewed including publication and location bias, poor quality of the primary data

and poor reporting of results.

Page 3 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



4

Abstract

Introduction: Acupuncture is frequently used in dermatology for treating a number of skin

disorders. There is no critically appraised evidence of the potential benefits and harm of

acupuncture for alopecia areata (AA). This review aimed to systematically evaluate the

efficacy of acupuncture for the management of AA in randomised clinical trials (RCTs).

Methods and analysis: Thirteen databases will be searched from their inception. These

include PubMed, AMED, EMBASE, the Cochrane Library, six Korean medical databases

(Korean Studies Information, DBPIA, the Korean Institute of Science and Technology

Information, the Research Information Centre for Health Database, KoreaMed, and the

Korean National Assembly Library), three Chinese Databases [(China National Knowledge

Infrastructure Database (CNKI), the Chongqing VIP Chinese Science and Technology

Periodical Database (VIP), and the Wanfang Database)]. Only randomised clinical trials

(RCTs) using any type of acupuncture for AA will be considered. The selection of the

studies, data abstraction, and validation will be performed independently by two researchers.

Methodological quality will be assessed with Cochrane risk of bias.

Dissemination: The systematic review will be published in a peer-reviewed journal. The

review will also be disseminated electronically and in print. Updates of the review will be

conducted to inform and guide the healthcare practice and policy.

Trial registration number: PROSPERO 2015: CRD42015020397

Keywords: Acupuncture; alopecia areata; hair loss; systematic review

Page 4 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



5

Introduction

Description of the condition

Alopecia areata (AA) is a type of alopecia characterised by no scarring hair loss. The

condition is found in 0.1 to 0.2 % of the general population.1-3

The cause of AA appears to

be related to the disturbance of autoimmune functioning, physical stress, genetic factors and

microcirculation. 1 2 AA could cause significant psychological problems, result in reduced

self-esteem and negatively affect the quality of life.1 2 The first line treatments are topical

immunotherapy for extensive disease and intralesional corticosteroids for localised hair loss

in patches.1 2

Description of the intervention

Acupuncture is one of the most frequently used forms of complementary and alternative

medicine.4 Acupuncture involves the insertion of needles into the skin and underlying tissues

at acupuncture points for a therapeutic purpose. Acupuncture points (body, ear, head or

tongue) could be stimulated with several types of acupuncture needles, electricity, laser,

pressure, or heat. The procedure is frequently used in dermatology for treating a number of

skin disorders.5 6 The most frequently used acupuncture technique is plum-blossom

acupuncture (PBA), in which the skin should appear flushed, with bleeding.7 8

How the intervention might work

Acupuncture might help to reduce hair loss by reducing T1 attacks on the hair bulb.

Additionally, it might stimulate the hair follicles, warm the local collaterals and activate

blood circulation.8 A recent study shows that electroacupuncture reduces degranulation of the

Page 5 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



6

mast cells in the dermis,9 which is reported to be a possible cause of pathological changes in

AA. The reliable evidence is unclear.

Why it is important to this review

Acupuncture is frequently used in dermatology for treating a number of skin disorders

including AA.5 6 There is no critically appraised evidence, such as a systematic review or

meta-analysis, of the potential benefits and harm of acupuncture for AA.

Objectives

This review aimed to systematically evaluate the efficacy of acupuncture for the management

of AA reported in randomised clinical trials (RCTs).

Page 6 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



7

Methods

Study registration

The protocol of this systematic review has been registered on PROSPERO 2015 (registration

number: CRD42015020397). This systematic review protocol was conducted and reported

using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)

statement guidelines. We will document the important protocol amendments in full review.

Criteria for considering studies for this review

Type of studies

RCTs and quasi-RCTs were included. Cluster RCTs, non-randomised clinical studies,

observational studies, and case studies were excluded. Dissertations and abstracts were

included, and no restriction on publications was imposed. For duplicate publications with

different outcome measures originating from one trial published as separate papers, the

original publication was given priority, and the other publications were excluded.

Type of participants

Trials involving subjects with AA regardless of sex, age and cause were included.

Type of interventions and controls

Trials in which any type of acupuncture was used as an adjunct to conventional treatment,

usual care, or standard or other types of complementary therapies will also be included if the

control group received the same concomitant treatments as the acupuncture group. The

studies that compared two types of acupuncture were excluded.

Page 7 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



8

Type of outcome measures

Primary outcomes

- Hair regrowth

- Response rate

- Rate of hair loss

Secondary outcomes

- Quality of life

- Satisfaction with the appearance of hair

- Adverse events (AEs)

Search methods for identifying the studies

Electronic searches

The following electronic databases were searched from inception through August 2014:

Pubmed, AMED, EMBASE, the Cochrane Central Register of Controlled Trials and the

Cochrane Database of Systematic Review, DARE, five Korean Medical Databases (Korean

Studies Information Service System, DBPIA, Korea Institute of Science and Technology

Information, Research Information Service System, KoreaMed, and the Korean National

Assembly Library), and 3 Chinese Medical Databases (CNKI, VIP, andWangfang).

Searches of other resources

Additionally, we manually searched our departmental files and relevant journals (Focus on

Alternative and Complementary Therapies and Forschende Komplementärmedizin und

Klassische Naturheilkunde to June 2015. The references in all the located articles were

manually searched for further relevant articles. Dissertations and abstracts were included.

Page 8 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



9

Study strategies

Our search strategy will include main keywords ‘acupuncture’ and ‘alopecia areata’

(Supplement 1).

Data collection and analysis

Study selection

Two of the authors (Lee HW and Jun JH) of the review independently screened the titles and

abstracts of the searched studies, perform the study selection and record their decisions on a

standard eligibility form. The arbitrator (Lee MS) will decide upon the study selection when a

consensus cannot be reached. The details of the selection process will be shown in the

PRISMA flow diagram (Figure 1).

Data extraction and management

All of the included articles were read in full. Three independent reviewers (Lee HW, Jun JH

and Lee JA) extracted the data including the methods (e.g., design, blinding, duration of

follow-up), sample (e.g., population size, conditions, age, duration of disease), intervention

and control treatment, and outcome measures, according to the predetermined criteria. The

extracted data will be tabulated for further analysis. Details regarding the acupuncture and

control interventions will be extracted on the basis of the revised Standards for Reporting

Interventions in Clinical Trials of Acupuncture (STRICTA). Any disagreement among the

authors was resolved by discussion with all of the authors. When the reported data are

insufficient or ambiguous, one author (Lee MS) contacted the corresponding authors of the

included studies by e-mail or telephone to request additional information or clarification.

Page 9 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



10

Assessment of risk of bias in included studies

According to the guidelines of the Cochrane Handbook of Systematic Reviews of

Interventions, the risk of bias will be assessed to evaluate the methodological quality of the

included studies.10 The following domains will be evaluated for methodological quality:

sequence generation, allocation concealment, blinding of participants and outcome assessors,

incomplete outcome data and selective outcome reporting. Blinding of practitioner is not

possible because of nature of acupuncture and only the blinding of participants and outcome

assessors will be evaluated. The evaluated domains will be judged as "Low", "High" or

"Uncertain" according to the criteria of the Cochrane guidelines.

Assessment of the quality of acupuncture

Acupuncture is a complex intervention with many possible variations in its delivery. We will

assess the quality of acupuncture by reviewer (JAL and JHJ) as described previously

reported;11 answering the questions, ‘how would you treat the patients included in the

study?’, on five categories including ‘exactly or almost exactly the same way’, ‘similarly’,

‘differently’, ‘complete differently’, or ‘could not assess’ due insufficient information (on

acupuncture or on the patient). The degree of confidence that acupuncture will be applied

appropriately was assessed on the 100mm visual analog scale (with 0%=complete absence of

evidence that acupuncture was appropriate, and 100%=total certainty that acupuncture was

appropriate). Discrepancies will be resolved through discussions between two reviewers.

Measures of treatment effect

Page 10 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



11

Dichotomous data will be presented as a risk ratio (RR) with 95% confidence intervals (CIs).

For continuous data, the mean difference (MD) will be used with 95% CIs. In cases of

outcome variables with different scales, the standard mean difference (SMD) will be used

instead of the weighted MD (WMD).

Unit of analysis issues

The meta-analysis will include data from parallel-group design studies. In the case of cross-

over trials, we will use the first phase of the data. If there are multiple time-point

observations, the data will be analysed as either short-term (within 4 weeks) or long-term

(over 4 weeks) follow-up.

Dealing with missing data

If missing data are detected, we will request any missing or incomplete information from the

original study investigators.

Assessment of heterogeneity

A fixed-effects model and a random-effects model will be simultaneously used for the meta-

analysis. Heterogeneity will be tested with the Higgins I2 test. We will calculate the I

2

statistic, which will provide a measure of the inconsistencies among the included studies. We

will use a 50% cut-off point for meaningful heterogeneity among the included studies. If

heterogeneity is observed, subgroup analysis will be conducted.12

Assessment of reporting biases

Page 11 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



12

Funnel plots will be used to detect reporting biases and small-study effects. If more than 10

studies are included in the meta-analysis, the test for funnel plot asymmetry will be

conducted using Egger's method. 13 14

Data synthesis

If a significant number of studies are identified, a meta-analysis will be conducted with

simultaneous use of fixed-effect and random-effect models. All statistical analyses will be

performed using RevMan 5.2.7 (the Cochrane Collaboration) software. To summarise the

effects of acupuncture on outcomes (response rate), we will abstract the risk estimates

(relative risk, RR), and 95% confidence intervals (CI). For studies with insufficient

information, we will contact the primary authors to acquire and verify data where possible. If

appropriate, we will then pool the data across studies using random effect models. The

strength of the body of evidence will be assessed with GRADE.

Subgroup analysis and investigation of heterogeneity

To explore differences in effect sizes, subgroup analyses will be conducted on the following

topics: the severity of depression, sex, the type of acupuncture, the design of the trial (e.g.,

crossover group or parallel group), the dose of acupuncture, and treatment frequency. We will

also summarise the standardisation and characteristics of acupuncture from all included

studies. In the case of sham controlled trials, we will analysis the results according to the 3

types of sham acupuncture including acupuncture without penetration at the acupuncture

points, acupuncture with penetration at the acupuncture points in shallow or no stimulation,

acupuncture penetration at non- acupuncture points.

Page 12 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



13

Sensitivity analysis

Sensitivity analysis will be conducted according to the following criteria:

1. Methodological qualities (sequence generation, allocation concealment, or blinding)

2. Sample size (small sample studies, e.g., less than 40 subjects in each group, or large

sample studies, e.g., more than 40 subjects in each group)

Page 13 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



14

Ethics and dissemination

Ethical approval is not required, given that this protocol is for a systematic review. The

findings of this review will be disseminated widely through peer-reviewed publications and

conference presentations.

Discussion

This systematic review will provide a detailed summary of the current state of evidence on

the effectiveness of the acupuncture in treating AA. There are several issues which we will be

discussed in the full review including acupuncture as a complex intervention, not inertness of

sham acupuncture and practitioner blinding. The review will benefit patients and practitioners

in the field of traditional and complementary medicine.

Page 14 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



15

Contribution of authors

Lee HW and MSL conceived the study. The protocol was drafted by Lee HW, Lee JA, Jun

JH, Lim HJ, Lim HS and Lee MS. The search strategy was developed and will be run by Lee

HW and Jun JH. Copies of studies will be obtained by Jun JH and Lim HJ. Selection of the

studies to include will be done by Lee HW and Jun JH. Lee MS will act as an arbiter in the

study selection stage. Extraction of data from studies will be conducted by Lee HW, Jun JH,

and Lee JA. Entering data into RevMan will be conducted by Lim HJ and Lim HS. Carrying

out the analysis will be done by Lee HW, Jun JH, and Lee MS. Interpretation of the analysis

will be done by Lee HW, Jun JH, Lee JA, Lim HJ, Lim HS and Lee MS. The final review

will be drafted Lee HW, Jun JH, Lee JA, Lim HJ, Lim HS and Lee MS. The review will be

updated by Lee HW, Jun JH and Lee MS.

Competing interests

No, there are no competing interests.

Funding

No external funding was received. HW Lee was supported by Korea Institute of Oriental

Medicine (K15303 and K152901).

Page 15 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



16

Reference

1. Gilhar A, Etzioni A, Paus R. Alopecia areata. N Engl J Med 2012;366(16):1515-25.

2. Harries MJ, Sun J, Paus R, King LE, Jr. Management of alopecia areata. BMJ

2010;341:c3671.

3. Sperling LC, Sinclair RD, Shabrawi-Caelen LE. Alopecias. In: Bolognia JL, Jorizzo JL,

Schaffer JV, editors. Dermatology. London: Saunders, 2012:1093-114.

4. Ernst E. Acupuncture--a critical analysis. J Intern Med 2006;259(2):125-37.

5. Nelson JL, Badreshia-Bansal S. An overview of complementary and alternative medicine.

In: Taylor SC, Gathers RC, Callender VD, Rodriguez DA, Badreshia-Bansal S,

editors. Treatments for skin of color. NY: Saunders, 2011:351-74.

6. van den Biggelaar FJ, Smolders J, Jansen JF. Complementary and alternative medicine in

alopecia areata. Am J Clin Dermatol 2010;11(1):11-20.

7. Dou W. Research progress of acupuncture for treatment of alopecia areata in recent ten

years. World J Acupunct Moxibustion 2009;19(1):55-59.

8. Jiang W, Liu W. The treatment of alopecia with acupuncture and related techniques. J

Chin Med 2006;82(NA):32-5.

9. Maeda T, Taniguchi M, Matsuzaki S, Shingaki K, Kanazawa S, Miyata S. Anti-

inflammatory effect of electroacupuncture in the C3H/HeJ mouse model of alopecia

areata. Acupunct Med 2013;31(1):117-9.

10. Higgins JPT, Altman DG, Sterne JAC. Chapter 8: Assessing risk of bias in included

studies. In: Higgins JPT, Green S, editors. Cochrane Handbook for Systematic



Page 16 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



17

11. Melchart D, Linde K, Fischer P, Berman B, White A, Vickers A, et al. Acupuncture for

idiopathic headache. Cochrane Database Syst Rev 2001(1):CD001218.

12. Deeks JJ, Higgins JPT, Altman DG. Chapter 9: Analysing data and undertaking meta-

analyses. In: Higgins JPT, Green S, editors. Cochrane Handbook for Systematic



13. Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a

simple, graphical test. BMJ 1997;315(7109):629-34.

14. Sterne JAC, Egger M, Moher D. Chapter 10: Addressing reporting biases. In: Higgins

JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions

Version 5.1.0 (updated March 2011). : The Cochrane Collaboration. Available from

www.cochrane-handbook.org, 2011.

Page 17 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



18

Figure legends

Figure 1. Flow diagram of the trial selection process. AA: alopecia areata; AT: acupuncture;

NRS: non randomized studies

Page 18 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



172x169mm (300 x 300 DPI)

Page 19 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



Supplement 1. Search strategies

Medline (OvidSP)

1. alopecia/

2. alopecia areata/

3. baldness/

4. or/1-3

5. exp Acupuncture Therapy/

6. Acupuncture/

7. acupoint*


9. ear acupuncture



12. or/5-11

13. 4 and 12

Korean DB

1. 탈모

2. 탈모증

3. 초기탈모

4. 유풍

5. 원형탈모

6. 부분 탈모

7. 원형탈모증

8. 중증 원형탈모증

Page 20 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



9. 남성형 탈모

10. 남성 탈모

11. 압박성 탈모증

12. 안드로겐성 탈모증

13. 여성 탈모

14. 여성형 탈모

15. 출산후 탈모

16. 휴지기 탈모

17. 전신형탈모

18. 전두탈모증

19. 후두부 탈모

20. 온머리 탈모증

21. 성인 탈모

22. 성인 탈모증

23. 성인 원형 탈모

24. 성인 원형 탈모증

25. 성인 전두 탈모

26. 성인 전두 탈모증

27. 소아 탈모

28. 소아 원형 탈모

29. 소아 원형 탈모증

30. 소아 전두 탈모

Page 21 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



31. 소아 전두 탈모증

32. 열성 탈모

33. alopecia

34. alopecia areata

35. androgenetic alopecia

36. male pattern alopecia

37. Male pattern baldness


39. Spot hair loss

40. 1-39/or

41. 자침

42. 침치료

43. 침

44. 약침

45. 온침

46. 전침

47. 이침

48. 호침

49. 두침

50. 망침

51. 침구

52. 매선

53. 매선 요법

54. Acupuncture

55. Herbal acupuncture

Page 22 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



56. pharmacoacupuncture

57. Auricular acupuncture

58. ear-acupuncture

59. Warming acupuncture

60. Warming needing

61. Warm needing


63. needle-embedding therapy


65. 41-64/or

66. 40 and 65

Page 23 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



Chinese DBs

1. 油风脱发

2. 鬼舔头

3. 斑脱发

4. 鬼剃头

5. 斑脱

6. 脱毛

7. 斑秃

8. 圓形脫毛症

9. 产后脱毛

10. 儿童斑秃

11. 男性型脱发

12. 雄激素源性脱发

13. 脂溢性脱发

14. 重型斑秃

15. 轻型斑秃

16. Severe Alopecia Areata

17. Spot hair loss

18. Alopecia

19. Alopecia Areata

20. Pelada

21. Androgenetic Alopecia

22. Male-pattern Alopecia


24. 1-23/or

25. Acupuncture

26. 针灸

27. 电针

28. 针刺

Page 24 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



29. 针

30. 刺法

31. 头针

32. 皮内针

33. 头体针

34. 芒针

35. 温针


37. ear-acupuncture

38. 耳针

39. 梅花针

39. plum-blossom needle

40. percussopunctator

41. pyonex

42. 25-41/or

43. 随机

44. 对照

45. 43-44/or

46. 24 and 42 and 45

Page 25 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



jopen.bmj.com

/B

MJ O


ctober 2015. Dow

nloaded from



PRISMA-P (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols) 2015 checklist: recommended items to

address in a systematic review protocol*

Section and topic Item

No

Checklist item

ADMINISTRATIVE INFORMATION Page

Title:

Identification 1a Identify the report as a protocol of a systematic review 1

Update 1b If the protocol is for an update of a previous systematic review, identify as such N/A

Registration 2 If registered, provide the name of the registry (such as PROSPERO) and registration number 4

Authors:

Contact 3a Provide name, institutional affiliation, e-mail address of all protocol authors; provide physical mailing address of corresponding author 1

Contributions 3b Describe contributions of protocol authors and identify the guarantor of the review 14

Amendments 4 If the protocol represents an amendment of a previously completed or published protocol, identify as such and list changes; otherwise,

state plan for documenting important protocol amendments

7

Support:

Sources 5a Indicate sources of financial or other support for the review 14

Sponsor 5b Provide name for the review funder and/or sponsor N/A

Role of sponsor

or funder

5c Describe roles of funder(s), sponsor(s), and/or institution(s), if any, in developing the protocol N/A

INTRODUCTION

Rationale 6 Describe the rationale for the review in the context of what is already known 6

Objectives 7 Provide an explicit statement of the question(s) the review will address with reference to participants, interventions, comparators, and

outcomes (PICO)

6

METHODS

Eligibility criteria 8 Specify the study characteristics (such as PICO, study design, setting, time frame) and report characteristics (such as years considered,

language, publication status) to be used as criteria for eligibility for the review

7-8

Information sources 9 Describe all intended information sources (such as electronic databases, contact with study authors, trial registers or other grey literature

sources) with planned dates of coverage

8

Search strategy 10 Present draft of search strategy to be used for at least one electronic database, including planned limits, such that it could be repeated 8

Study records:

Data 11a Describe the mechanism(s) that will be used to manage records and data throughout the review 9

Page 26 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960




management

Selection

process

11b State the process that will be used for selecting studies (such as two independent reviewers) through each phase of the review (that is,

screening, eligibility and inclusion in meta-analysis)

9

Data collection

process

11c Describe planned method of extracting data from reports (such as piloting forms, done independently, in duplicate), any processes for

obtaining and confirming data from investigators

9

Data items 12 List and define all variables for which data will be sought (such as PICO items, funding sources), any pre-planned data assumptions and

simplifications

9

Outcomes and

prioritization

13 List and define all outcomes for which data will be sought, including prioritization of main and additional outcomes, with rationale 7-8

Risk of bias in

individual studies

14 Describe anticipated methods for assessing risk of bias of individual studies, including whether this will be done at the outcome or study

level, or both; state how this information will be used in data synthesis

10

Data synthesis 15a Describe criteria under which study data will be quantitatively synthesised 10

15b If data are appropriate for quantitative synthesis, describe planned summary measures, methods of handling data and methods of

combining data from studies, including any planned exploration of consistency (such as I2, Kendall’s τ)

11

15c Describe any proposed additional analyses (such as sensitivity or subgroup analyses, meta-regression) 11-12

15d If quantitative synthesis is not appropriate, describe the type of summary planned 11

Meta-bias(es) 16 Specify any planned assessment of meta-bias(es) (such as publication bias across studies, selective reporting within studies) 11

Confidence in

cumulative evidence

17 Describe how the strength of the body of evidence will be assessed (such as GRADE) 11

* It is strongly recommended that this checklist be read in conjunction with the PRISMA-P Explanation and Elaboration (cite when available) for important

clarification on the items. Amendments to a review protocol should be tracked and dated. The copyright for PRISMA-P (including checklist) is held by the

PRISMA-P Group and is distributed under a Creative Commons Attribution Licence 4.0.

From: Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart L, PRISMA-P Group. Preferred reporting items for systematic review and

meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015 Jan 2;349(jan02 1):g7647.

Page 27 of 27


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960



bmj openacupuncture for alopecia areata (aa). this review aimed to systematically evaluate the...

Documents