Acupuncture For Attention-Deficit Hyperactivity Disorder

Acupuncture for attention-deficit hyperactivity disorder
(ADHD) in children and adolescents (Protocol)

Li S, Yu B, Zhou D, He C, Kang L, Wang X, Jiang S, Chen X
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 attention-deficit hyperactivity disorder (ADHD) in children and adolescents (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . .
ABSTRACT . . . . . . . . .
BACKGROUND . . . . . . .
OBJECTIVES . . . . . . . .
METHODS . . . . . . . . .
ACKNOWLEDGEMENTS
. . .
REFERENCES . . . . . . . .
HISTORY . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS
DECLARATIONS OF INTEREST .
SOURCES OF SUPPORT . . . .
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[Intervention Protocol]
Acupuncture for attention-deficit hyperactivity disorder

(ADHD) in children and adolescents
Shasha Li2 , Bo Yu1 , Dong Zhou3 , Chengqi He4 , Lin Kang5 , Xiaotong Wang6 , Songhe Jiang7 , Xiang Chen7
1 Department
of paediatrics, The Second Affiliated Hospital of Wenzhou Medical College, Wenzhou, China. 2 Department of Rehabilitation Medicine, The 2nd Affiliated Hospital, Wenzhou Medical College, Wenzhou, China. 3 Department of Neurology, West
China Hospital, Sichuan University, Chengdu, China. 4 Department of Rehabilitation Medicine, West China Hospital of Sichuan
University, Chengdu, China. 5 Department of Psychiatrics, West China Hospital of Sichuan University, Chengdu, China. 6 Department
of Neurology, The 2nd Affiliated Hospital of Wenzhou Medical College, Wenzhou, China. 7 Department of Rehabilitation Medicine
, The 2nd Affiliated Hospital, Wenzhou Medical College, Wenzhou, China
Contact address: Bo Yu, Department of paediatrics, The Second Affiliated Hospital of Wenzhou Medical College, No 109, Xue-Yuan-XiLu Street, Wenzhou, Zhejiang, 325027, China. [email protected]. (Editorial group: Cochrane Developmental, Psychosocial
and Learning Problems Group.)
Cochrane Database of Systematic Reviews, Issue 2, 2009 (Status in this issue: New)
DOI: 10.1002/14651858.CD007839
This version first published online: 15 April 2009 in Issue 2, 2009. (Help document - Dates and Statuses explained)
This record should be cited as: Li S, Yu B, Zhou D, He C, Kang L, Wang X, Jiang S, Chen X. Acupuncture for attentiondeficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database of Systematic Reviews 2009, Issue 2. Art. No.:
CD007839. DOI: 10.1002/14651858.CD007839.
ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
1.To assess the efficacy of acupuncture as a treatment for ADHD in children and adolescents.
2.To evaluate the safety of acupuncture as a treatment for ADHD in children and adolescents.
BACKGROUND
The defining features of Attention-Deficit/Hyperactivity Disorder (ADHD) are inattention, hyperactivity and impulsivity (APA
2000). In individuals with ADHD, these behaviours are present
for at least six months at levels higher than is typical for their stage
of development, are present early in life (currently defined as before age 7), and cause impairment (Pelham 2006). DSM-IV (APA
1994) divides ADHD into three subtypes according to the nature
of the symptoms: (1) predominantly inattentive type (ADHD-I);
(2) predominantly hyperactive-impulsive type (ADHD-HI); and
(3) combined type (ADHD-C). The inattentive subtype consists
of individuals who exhibit inattentive behaviours but not hyperactive/impulsive behaviours whereas the hyperactive/impulsive subtype consists of the reverse, and individuals with the combined
subtype have both (James 2008, Pelham 2006).
Description of the condition

In the 1970s, ADHD was known as hyperkinesis (Latin for superactive) or hyperactivity, and in the 1980s as Attention Deficit
Disorder (ADD). ADD could be diagnosed with or without hyperactivity. Currently, the condition is referred to as ADHD, a
term which includes various subtypes. Subtyping allows for the
fact that in different people, presentation of inattention and hyperactivity may vary. Thus, as Brassett-Harknett and Butler
conclude changes in nosology reflects the developments in research; ADHD better describes the clinical phenomena (BrassettHarknett 2007).
According to a recent review of aetiology, prevalence figures for
childhood ADHD, based on clinical populations, range from 3%
to 10%, and the maximum age risk lies somewhere between 5
and 10 years (Brassett-Harknett 2007, citing APA 1994; Costello
1989; Parr 2003). Some epidemiological studies have claimed
higher prevalence rates for ADHD, ranging from 9% to 19%(
Paule 2000; Taylor 1991), suggesting that under-diagnosis may
be common. Figures vary according by the definition or diagnostic criteria used, the nationality, size and selection of the sample;
and/or by the subtype under study.
Brassett-Harknett writes further that research into the etiology
of ADHD has revealed genetic, biochemical, environmental, and
social factors. Both Hill 2001 and Taylor 1991 maintained that
ADHD is a syndrome caused by several different pathologies,
among which a genetic susceptibility seemed to be the most common. Although environmental factors cannot be ignored, research from family, twin and adoption studies points to a substantial genetic component in the aetiology of ADHD. Heritability
estimates range from 0.50 to 0.98; in monozygotic twins, ADHD
concordance rates are in the higher range of 0.80-0.98 (Faraone
2000a; Faraone 2000b; Faraone 2000d; Gjone 1996; Pennington
1996). It has thus been proposed that hyperactive-impulsive type
ADHD tends to breed true but inattentive and combined subtypes do not (Faraone 2000c) (Brassett-Harknett 2007).
Description of the intervention

Management of ADHD
Pharmacological treatments
Pharmacotherapy (as well as a variety of behavioral techniques)

remains the mainstay of treatment options (DeNisco 2005).
The three primary types of pharmacological treatment used
in AD/HD are: psychostimulants, nonstimulant-noradrenergic
reuptake blockers, and [alpha]-agonist antihypertensive agents
(Scheres 2005). According to DeNisco et al., psychostimulants
are the most prescribed psychotropic agent for children, especially
for the treatment of AD/HD (DeNisco 2005). There are significant data to support the safety, efficacy, and reliability of stimulant
agents in improving core symptoms of AD/HD(DeNisco 2005;
Spencer 2000; AAP 2001a).
Amphetamine preparations and methylphenidate preparations
are still the first-line agents in ADHD management (AACP
1997). Over the past 30 years, the most common therapy for
ADHD has been short-acting immediate release stimulants such
as methylphenidate (Ritalin), dextroamphetamine (Adderall), and
pemoline (Cylert) (Spencer 2000). All three stimulants increase
synaptic levels of dopamine and norepinephrine, although the
specific molecular mechanisms of action differ (Spencer 2000).
Many studies have reported the short-term efficacy of these medications, especially methylphenidate, in the treatment of ADHD
with positive effects on disruptive symptoms and academic activity
(Spencer 2000); however, adverse effects may include a decrease
in appetite, headaches, abdominal discomfort, sleep difficulties,
irritability, and social withdrawal. Other adverse effects may occur
in children on too high a dosage or those who are overly sensitive
to stimulants and may appear emotionally flat or overly restricted
(DeNisco 2005; also, Pliszka 2000).
Clonidine (Catapres) and guanfacine (Tenex) are [alpha]-2 agonists that are also occasionally used for the treatment of ADHD,
especially if there are conduct issues present (Spencer 2000; Pliszka
2000; Geenhill 2002 ). Clonidine has powerful sedative properties, useful for those with sleep difficulties.
Behavioral treatments
Behavior therapy can also be useful in the treatment of ADHD. It

involves specific interventions that aim to modify the physical and
social environment to alter or change behavior. It is also important
to incorporate changes such as more structure, closer attention,
and limitations of distractions (DeNisco 2005; AAP 2001b). Behavior therapy is different from psychological interventions directed to the child and designed to change the childs emotional
status (play therapy) or thought patterns (cognitive therapy or cognitive-behavior therapy). These have little documented efficacy in
the treatment of ADHD, but parent training in behavior therapy
and classroom behavior interventions have successfully changed
the behavior of children with ADHD (DeNisco 2005).
Chan et al. have written of the difficulties both parents and clini-
cians have in choosing an acceptable therapy for the young child

with ADHD and concluded that due to increases in psychotropic
prescriptions (even for the very young) it may be important for
clinicians caring for children with ADHD to be familiar with
complementary and alternative medicine (CAM) and its role in
ADHD (Chan 2002).
Acupuncture
Acupuncture originated in ancient China approximately 2,500

years ago and is a key component of traditional Chinese medicine
(TCM). Acupuncture techniques involve insertion of needles and
the stimulation of the needles may involve manual, electrical, heat,
laser or other forms of stimulation.
2001; NIH 1998); however, existing evidence may not be rigorous

enough for acupuncture to be recommended for routine use.
There are a large number of studies of the clinical efficacy of
acupuncture in ADHD published in the world, especially in
China, but not all demonstrate a beneficial effect on ADHD (Cai
1999; Li 2004; Regina 2002; Wang 2006). To our knowledge,
systematic reviews of trials of acupuncture in ADHD have not
yet been conducted. Whether or not acupuncture is effective for
ADHD in children and adolescents is therefore still unknown.
The aim of this review was to systematically analyse all the randomised controlled trials of acupuncture for children and adolescents with ADHD to provide the best available evidence to inform
clinical practice and further research planning on ADHD management.
How the intervention might work

The theory of channels (or meridians) and collaterals has directed
the clinical practice of Chinese medicine for thousands of years
and provides the theoretical basis for acupuncture. Physiologically, the channels and collaterals are considered to be a series of
connecting passages through which qi and blood circulate to regulate the functions of the zang-fu organs, tissues, and sense organs
(TCM Basics 2008).
In the main course of a channel, there are many key points called
acupuncture points. They are not isolated points on the skin,
but are also connected with the organs. According to the location where needling is carried out acupuncture can also be classified into body acupuncture, scalp acupuncture, auricular acupuncture and ankle-wrist acupuncture (Zhang 2006). Stimulation of
acupuncture points can treat diseases by regulating organ function,
promoting the flow of Qi and blood (nutrient-blood) through
the channels and collaterals, and improving the bodys ability to
resist diseases. Qi and blood are very important concepts in Chinese medicine: the meaning of nutrient-blood within TCMs conception of Qi is related, but not identical to, the circulation of
blood as understood in Western medicine. According to the channels theory, the meaning of Qi originates from the needle induced
sensation passing through the channels during acupuncture (Jiang
2008).
A wide range of conditions (including ADHD) are thought to
benefit from treatment with acupuncture; however, the mechanism for acupunctures potential effect on ADHD is still being
researched.
OBJECTIVES
1.To assess the efficacy of acupuncture as a treatment for ADHD
in children and adolescents.
2.To evaluate the safety of acupuncture as a treatment for ADHD
in children and adolescents.
METHODS
Criteria for considering studies for this review

Types of studies
Randomised controlled trials and quasi randomised controlled trials will be used to investigate the efficacy and safety of acupuncture
for children and adolescents with ADHD or ADD.
1. Randomised controlled clinical trials (RCTs) comparing
acupuncture with at least one control group that used placebo,
sham treatment or conventional treatment in children and adolescents with ADHD.
2. Quasi-randomised controlled trials can be defined as trials in
which the allocation of patients into different groups was undertaken by means of sequential assignment (such as alternate date of
referral, alternate case record numbers, dates of birth, day of the
week or alphabetical order).
Types of participants
Why it is important to do this review

Acupuncture is reported to be a relatively simple, inexpensive and
safe treatment compared to other conventional interventions, is
acceptable to Chinese patients and has been widely used to improve severity of the core symptoms in patients with ADHD (Li
2004; Wang 2006). As a therapeutic intervention, acupuncture
is also increasingly practiced in some Western countries (Kemper
Participants (under the age of 18) diagnosed with attention deficit

hyperactivity disorder (ADHD) or hyperkinetic disorders (HKD)
according to established diagnostic criteria. ADHD or ADD as
determined by DSM-III (APA 1980; APA 1987) or DSM-IV criteria (APA 1994; APA 2000), diagnoses of Hyperkinetic Disorder
as determined by ICD-9 or ICD-10 criteria (WHO 1993). Adults
will be excluded.
Types of interventions
Studies must use acupuncture techniques involving insertion of
needles. Stimulation of the needles may involve manual, electrical,
heat, laser or other forms of stimulation.
Control interventions may be: placebo acupuncture, sham
acupuncture, or other conventional treatment . Placebo acupuncture refers to a needle attached to the skin surface (not penetrating the skin but at the same acupoints) (Van Tulder 2000). Sham
acupuncture refers to:
(1) a needle placed in an area close to but not in the acupuncture
points (Van Tulder 2000);
(2) subliminal skin electrostimulation via electrodes attached to
the skin (SCSSS 1999).
Comparisons investigated may include, if data are available:
(1) acupuncture only compared with placebo or sham treatment;
(2) acupuncture in addition to baseline medication or treatment
compared with placebo or sham treatment in addition to baseline
medication or treatment;
(3) acupuncture in addition to baseline medication or treatment
compared with baseline medication or treatment alone.
Trials that compared different forms of acupuncture only will be
excluded.
Types of outcome measures
Trials reporting at least one of the following outcome measures
will be included.
Primary outcomes
A. Symptoms of ADHD
- Incidence/severity of the core symptoms (inattention, impulsivity,
hyperactivity) measured by validated rating scales, including:
The revised Conners Parent Rating Scale (CPRS-R) (Conners
1997; Conners 1998a)
Conners Teacher Rating Scale (CTRS-R) (Conners 1998b)
ADHD Rating Scale IV (Zhang 2005 )
Attention Deficit Disorder Evaluation Scale (ADDES) (Adesman
1991)
Test of Variable of Attention (TOVA) (Greenberg 1999)
Connors Continuous Performance Test (Connors 1995)
Yale Childrens Inventory (Shaywitz 1988)
The ADHD Adolescent Self-Report Scale (Robin 1996)
The Internal Restlessness Scale (Weyandt 2003).
B. Quantitative laboratory assessment measures of ADHD
symptoms:
Continuous Performance Test (CPT)
The Gordon Diagnostic System (GDS)
The Childrens Checking Task (CCT)
Delay of Gratification Tasks
The Choice-Delay Task (C-DT)
The Stop Signal Task (SST) (Nichols 2004)
The Auditory Continuous Performance Test (Riccio 1996).
C. Overall incidence/severity of the problem behaviours
Child Behavior Checklist (CBCL) (Achenbach 2000)
The Adolescent Behavior Checklist(Adams 1997)

Behavior Assessment System for Children (BASC) (Reynolds
1992).
Secondary outcomes
A. Intelligence
Standardised measures including the intelligence scale, including:
Wechsler Intelligence Scale for Children-III (Wechsler 1991)
Stanford-Binet Intelligence Scales (Becker 2003)
Tower of London Test (Shaywitz 1988)
B. School/academic performance
Measured by scale, grades or teacher reports, including:
Wechsler Individual Achievement Test (WIAT) (Wechsler 1992)
The Peabody Individual Achievement Test (Klinge 1974)
C. Psychopathology outcomes:
Depression/anxiety-related outcomes, including for example:
The Diagnostic Inventory for Depression (Zimmerman 2004)
Multidimensional Anxiety Scale for Children(MASC) (March
1997)
Conduct/oppositional disorder outcomes, including:
The Oppositional Defiant Behavior Inventory (Harada 2004)
D. Family and social outcomes:
Validated measures may include:
Parenting Stress Index (Loyd 1985)
Parenting Scale for Parents of Children with ADHD (Harvey
2001)
Social Adjustment Inventory for Children and Adolescents(SAICA)(Biederman 1993)
E. Quality of Life:
Validated measures may include:
The ADHD Impact Module (Landgraf 2002)
Adult Attention-Deficit/Hyperactivity Disorder Quality-of-Life
Scale (AAQoL) (Brod 2006)
Clinical Global Impression score changes (NIMH 1985), Childrens Global Assessment Scale (CGAS) (Shaffer 1983)
F. Possible adverse effects (any adverse events as reported in trials):
Fainting: can be due to nervous tension, hunger, fatigue, improper
position or manipulation, such as overly forceful manipulation;
Stuck needle: local muscle spasm due to nervousness, heavy manipulations that cause muscle fibers to tighten around the needle;
Bent needle: may arise from unskillful manipulation, imbalanced
force, overly applied force, or changes in the patients posture after
insertion;
Broken needle: may result from the poor quality of the needle or
eroded base of the needle, from strong muscle spasm, or a sudden
movement of the patient when the needle is in place, or from
withdrawing a stuck needle;
Hematoma: may arise from injury of the blood vessels during
insertion, or from not pressing the point after withdrawing the
needle;
Unendurable pain: may arise from unskillful manipulation or manipulation which is too forceful.
Depending on availability of data, we will attempt to classify adverse events as serious or non-serious. Serious adverse events will
be defined as any outward medical occurrence that was life threatening, resulted in death or persistent or significant disability, or
any medical event which may have jeopardised the patient or required intervention to prevent it (ICH-GCP 1997). All other adverse events will be considered non-serious.
Search methods for identification of studies

Electronic searches
Databases will be searched without language restrictions for any
paper mentioning acupuncture and its synonyms (acupuncture,
electro-acupuncture, body acupuncture, acupuncture points, auricular acupuncture, scalp acupuncture,etc.), and ADHD, and
children and young people.
The following sources will be searched:
Cochrane Central Register of Controlled Trials (CENTRAL)
MEDLINE
PreMedline
AMED
BIOSIS
Centre for Complementary Medicine Research (University of Munich, Germany)
CISCOM (Research Council for Complementary Medicine)
CINAHL
EMBASE
ERIC
PsycINFO
The search strategy for MEDLINE is as follows.
#1.Attention Deficit Disorder with Hyperactivity/
#2.adhd
#3.addh
#4.adhs
#5.hyperactiv$
#6.hyperkin$
#7.attention deficit$
#8.brain dysfunction
#9.or/1-8
#10.Child/
#11.Adolescent/
#12.(child$ or boy$ or girl$ or schoolchild$ or adolescen$ or teen$
or young person$ or young people$ or youth$)
#13.or/10-12
#14 acupuncture therapy/ or acupuncture, ear/ or electroacupuncture/
#15 accupunct$
#16 or/14/15
#17 9 and 12 and 16
This search strategy will be modified where necessary to search
the other databases listed. No language or date restrictions will be
used. Search filters designed to find controlled trials will be used.

Searching other resources
Handsearches will be considered following the electronic
searches,particularly where abstracts from relevant neuropsychological and associated meetings are not available electronically.
The following journals that are published in Chinese will be
searched:
Chinese Acupuncture and Moxibustion (1961 to 1979),
Journal of Clinical Acupuncture and Moxibustion (1965 to 1979),
Journal of Traditional Chinese Medicine (1960 to 1979),
New Journal of Traditional Chinese Medicine (1969 to 1979),
Research of Acupuncture and Moxibustion (1976 to 1979)
Conference proceedings relevant to this topic will also be handsearched.
Additional searches
The reference lists of identified randomised clinical trials and review articles will be checked in order to find randomised trials not
identified by the electronic or hand searches. Ongoing trials will be
searched through Current Controlled Trials (www.controlled-trials.com), and grey literature through the OPENSIGLE database.
Unpublished trials
We will request information on unpublished trials from authors

of published studies, and experts and information groups in the
areas of ADHD and acupuncture.
Data collection and analysis

Selection of studies
Two reviewers (Shasha Li and Bo Yu) will independently screen
the titles and abstracts obtained by the search strategies against the
eligibility criteria stated above.
Verification of study eligibility will be done by Shasha Li and Bo
Yu before data abstraction.
For articles that appear to be eligible RCTs, the full articles will
be obtained and inspected to assess the relevance, based on the
preplanned criteria for inclusion.
At all stages, reasons for inclusion and exclusion of articles will
be noted. Disagreements will be resolved through consensus, or
referred for arbitration by the editorial base of the Cochrane Developmental, Psychosocial and Learning Problems Group (CDPLPG) if needed.
Data extraction and management
Data will be independently extracted by two reviewers (Shasha
Li and Bo Yu) using a pre designed data collection form, and
saved electronically with appropriate version control. The data
collection form will be pilot tested for clarity, relevance to the
study questions and completeness. The instruction for codings
and meanings will be placed adjacent or near to the data field that
is to be coded. The coding of the form with a revision date or
version number will be applied to ensure ease of updating. Any

unpublished information if used will be written and coded with a
specified remark. The comparison of extracted data will be done by
each author independently. Any disagreements will be discussed
with a third reviewer (Lin Kang) and the decisions documented.
Where there are missing data, and where no information is provided about adverse events, we will contact the authors using every
means available (email, formal letter, fax, telephone call).
All relevant data will be entered into RevMan 5.0 by Shasha Li
and rechecked by Bo Yu for correctness. The reliability of data
extraction and data entry will be examined throughout the process.
In case of trials using a cross over design, all data will be abstracted.
Data of the first phase of study will only be used for analysis.The
data of the second phase after crossing over will be described in the
characteristics of included study table, but not in the comparisons
and data table .
Assessment of risk of bias in included studies
For each included study, two reviewers (Shasha Li and Bo Yu)
will independently complete the Cochrane Collaborations tool
for assessing risk of bias (Higgins 2008, section 8.5.1). We will
assess the degree to which:
the allocation sequence was adequately generated (sequence
generation)
the allocation was adequately concealed (allocation concealment)
knowledge of the allocated interventions was adequately prevented during the study (blinding)
incomplete outcome data were adequately addressed
reports of the study were free of suggestion of selective outcome
reporting
the study was apparently free of other problems that could put
it at high risk of bias
Each domain was allocated one of three possible categories for
each of the included studies: Yes for low risk of bias, No for high
risk of bias, and Unclear where the risk of bias was uncertain or
unknown.
Disagreements will be resolved through consensus, or referred for
arbitration by the editorial base of the CDPLPG if needed.
Measures of treatment effect
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. The standardised mean difference (SMD) will be used
where different outcome measures of the same construct were reported. 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.
Unit of analysis issues

(a) Cluster-randomised trials
Where trials have used clustered randomization, we anticipate that
study investigators would have presented their results after appropriately controlling for clustering effects (robust standard errors or hierarchical linear models). If it is unclear whether a cluster-randomized trial has used appropriate controls for clustering,
the study investigators will be contacted for further information.
Where appropriate controls were not used, individual participant
data will be requested and re-analysed using multilevel models
which control for clustering. Following this, effect sizes and standard errors will be meta-analysed in RevMan using the generic
inverse method (Higgins 2008). If appropriate controls were not
used and individual participant data is not available, statistical
guidance will be sought from the Cochrane Method Group and
external experts as to which method to apply to the published
results in attempt to control for clustering. If there is insufficient
information to control for clustering, outcome data will be entered into RevMan using individuals as the units of analysis, and
then sensitivity analysis will be used to assess the potential biasing
effects of inadequately controlled clustered trials (Donner 2001).
(b) Crossover trials
When conducting a meta-analysis combining the results of
crossover trials, we will use the inverse variance methods recommended by Elbourne (Elbourne 2002). Where data presented from
a crossover trial is restricted (and more information was not available from the original investigators) we will use the presented data
within the first phase only, up to the point of crossover.
(c) Multi-arm trials
All eligible outcome measures for all trial arms will be included in
this review.
Dealing with missing data
Intention-to-treat analyses
For the included studies which used the intention-to-treat analysis
by filling in or imputation of data for missing cases (such as last
observation carried forward method or assumed no changes). The
authors will be contacted for available data.
Assessment of heterogeneity
Heterogeneity can occur from many sources. An important aspect
of every meta-analysis is to consider and emphasise the existence
of heterogeneity and to take account of this in the interpretation
of results. Sources of heterogeneity (clinical heterogeneity) can be
divided into two groups: biologic and methodological .
Biological:
1. Characteristic of patients: age, sex, socio-economic status, education.
2. Subtype of attention deficit/hyperactivity disorders etc.
3. Disorder severity and chronicity: mild, moderate, severe.
4.
Comorbidity
of
emotional/psychiatric
problems, speech/language problems, learning problems, psychosocial
problems conduct disorder.
Methodological:
1. Type of acupuncture therapies
(a) Techniques:
* different types of acupuncture therapies (body acupuncture, auricular acupuncture, scalp acupuncture, electroacupuncture, laser
acupuncture, acupressure);
* combination of different techniques of acupuncture therapies
(body acupuncture and scalp acupuncture etc.)
(b) Intensity and frequency of practice: duration of acupuncture
per treatment session, frequency of practice, duration of practice.
2. Different follow up period: at the end of trial, any specified
period after trial, repeated follow up measure.
3. Multi-component intervention: drugs, counselling, biofeedback, parent training, psychotherapy, family therapy etc.
Clinical heterogeneity will be assessed by noting the difference
in the distribution of important participant factors between trials
(age, gender, specific diagnosis/diagnostic subtypes, duration of
disorder, associated diseases), and methodological heterogeneity
will be assessed by noting different trial design factors (randomisation concealment, blinding, losses to follow-up, treatment type,
co-interventions). Statistical heterogeneity will be assessed by examining 2 (Higgins 2008; section 9.5.2), a quantity that describes
approximately the proportion of variation in point estimates due
to heterogeneity rather than sampling error. In addition, a chisquared test of homogeneity will be employed to determine the
strength of evidence that the heterogeneity is genuine.
Assessment of reporting biases
If possible, a funnel plot (Light 1984; Egger 1997) will be used
to determine potential publication bias, by plotting the effect size
against sample size. Publication bias may result when trials with
negative results are under-represented.
Any other types of bias of each studies (e.g. selection,measurement,
attrition bias) will be reported in the results and discussion.
with more events) are given more weight. The analyses will be
carried out using RevMan Analyses software in Review Manager
(Cochrane software).
Subgroup analysis and investigation of heterogeneity
If sufficient studies are found, the data will be analysed in subgroups according to the following categories:
- childhood (under 13 years)
- adolescence (13-18 years)
- different types of acupuncture therapies (body acupuncture, auricular acupuncture, scalp acupuncture, electroacupuncture, laser
acupuncture, acupressure);
- different control interventions;
- treatment duration (less than two weeks or more than two weeks);
- duration of disease (less than one month, 1 to 12 months, more
than one year);
- Chinese vs. non-Chinese studies.
Strategies for exploring heterogeneity:
1. Identification of the methodological differences between studies.
2. Subgroup analysis
3. Meta-regression if enough data are available (Meta-regression
should generally not be considered when there are fewer than 10
trials in a meta-analysis) (Higgins 2008).
Sensitivity analysis
If heterogeneity results from studies at high risk of bias, we will
undertake sensitivity analyses to explore the impact of studies with
poor ratings on dimensions described in the risk of bias table. A
priori sensitivity analyses are planned for:
(1) concealment of allocation
(2) blinding of outcome assessors
(3) extent of dropouts
Data synthesis
We will undertake a quantitative synthesis of the data using both
fixed and random effects models. Meta-analysis should be performed where we consider studies to be sufficiently homogeneous
in terms of participants, interventions, comparators and outcome
measures to provide a meaningful summary. In carrying out metaanalysis, the weight given to each study was the inverse of the
variance so that the more precise estimates (from larger studies
ACKNOWLEDGEMENTS
We would like to acknowledge the Cochrane Developmental, Psychosocialand Learning Problems Group (CDPLPG) for their technical support. We thank Dr. Jane Dennis (Cochrane CDPLPG)
and Professor Taixiang Wu (Chinese Cochrane Center, China) for
their kind advice and encouragement in the preparation of this
protocol.
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Indicates the major publication for the study
HISTORY
Protocol first published: Issue 2, 2009
CONTRIBUTIONS OF AUTHORS
Dr. Shasha Li and Dr. Bo Yu will perform the bibliographic searches, identify the studies, assess their methodological quality, extract
the data, and produce the first draft of the review. Dr. Chengqi He and Dr. Dong Zhou will assess the methodological quality of the
studies, check the extracted data, and comment on all the draft manuscripts. Dr. Kang Lin, Dr. xiaotong Wang, Dr. Songhe Jiang and
Dr. Xiang Chen will help to perform the bibliographic searches, identify the studies, assess their methodological quality and extract the
data.
DECLARATIONS OF INTEREST
None known for any author.
SOURCES OF SUPPORT
Internal sources
Chinese Cochrane Center, West China Hospital of Sichuan University, China.
Training Class for Cochrane system review
Cochrane Developmental, Psychosocial and Learning Problems Group (CDPLPG), UK.
Technical support
11
External sources
Research Fund of State Administration of Traditional Chinese Medicine of Zhejiang Province, China.
Construction Project of Medical Key Subject in Zhejiang Province of China (Rehabilitation Medicine), China.
12

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What is the purpose of this study protocol?

What is the purpose of this study protocol?

What conditions are being studied in this protocol?

What conditions are being studied in this protocol?

Acupuncture for attention-deficit hyperactivity disorder

(ADHD) in children and adolescents (Protocol)

Acupuncture for attention-deficit hyperactivity disorder

Description of the condition

Description of the intervention

Pharmacotherapy (as well as a variety of behavioral techniques)

Behavior therapy can also be useful in the treatment of ADHD. It

cians have in choosing an acceptable therapy for the young child

Acupuncture originated in ancient China approximately 2,500

2001; NIH 1998); however, existing evidence may not be rigorous

How the intervention might work

Criteria for considering studies for this review

Why it is important to do this review

Participants (under the age of 18) diagnosed with attention deficit

The Adolescent Behavior Checklist(Adams 1997)

Search methods for identification of studies

used. Search filters designed to find controlled trials will be used.

We will request information on unpublished trials from authors

Data collection and analysis

version number will be applied to ensure ease of updating. Any

Unit of analysis issues

monisedtripartite guideline. Guideline for good clinical practice.

Indicates the major publication for the study

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