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Homeopathy for attention deficit/hyperactivity disorder or

hyperkinetic disorder (Review)

Heirs M, Dean ME

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2007, Issue 4
http://www.thecochranelibrary.com

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review)


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Analysis 1.1. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 1 Conners Global Index Scores
(Parent) CGI-P. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Analysis 1.2. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 2 ADHD Index (Parent). . . 24
Analysis 1.3. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 3 Hyperactivity (Parent). . . . 25
Analysis 1.4. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 4 Inattention (Parent). . . . 26
Analysis 1.5. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 5 Restless/Impulsive (Parent). . 26
Analysis 1.6. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 6 Oppositional/Conduct (Parent). 27
Analysis 1.7. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 7 Emotional Lability (Parent). . 27
Analysis 1.8. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 8 Anxiety (Parent). . . . . . 28
Analysis 1.9. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 9 Global Index Scores (Parent). 29
Analysis 2.1. Comparison 2 Homeopathy versus Placebo (Teacher Ratings), Outcome 1 Global Index Total. . . . 29
Analysis 2.2. Comparison 2 Homeopathy versus Placebo (Teacher Ratings), Outcome 2 Restless/Impulsive. . . . 30
Analysis 2.3. Comparison 2 Homeopathy versus Placebo (Teacher Ratings), Outcome 3 Emotional Lability. . . . 30
Analysis 3.1. Comparison 3 Homeopathy versus Placebo (Child completed tests), Outcome 1 Inattention. . . . . 31
Analysis 3.2. Comparison 3 Homeopathy versus Placebo (Child completed tests), Outcome 2 Impulsivity. . . . . 32
WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . . 33
INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) i


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Review]

Homeopathy for attention deficit/hyperactivity disorder or


hyperkinetic disorder

Morag Heirs1 , Mike Emmans Dean2


1 Centre for Reviews and Dissemination, University of York, York, UK. 2 Department of Health Sciences, University of York, York, UK

Contact address: Morag Heirs, Centre for Reviews and Dissemination, University of York, York, YO10 5DD, UK. mkc500@york.ac.uk.

Editorial group: Cochrane Developmental, Psychosocial and Learning Problems Group.


Publication status and date: Edited (no change to conclusions), published in Issue 1, 2009.
Review content assessed as up-to-date: 28 February 2006.

Citation: Heirs M, Dean ME. Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder. Cochrane Database
of Systematic Reviews 2007, Issue 4. Art. No.: CD005648. DOI: 10.1002/14651858.CD005648.pub2.

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

ABSTRACT
Background
Homeopathy is one form of complementary/alternative medicine which is promoted as being a safe and effective form of treatment for
children and adults. Within the UK homeopathy use is estimated at 1.9% of the adult population (Thomas 2004), and around 11%
for children under 16 years (Simpson 2001). There has been increased interest in homeopathy’s potential as a non-pharmacological
intervention for attention deficit/hyperactivity disorder as an alternative to the use of stimulant medications such as Ritalin. Homeopathy
is a system of medicine based on the principle of treating “like with like” using various dilutions of natural or man-made substances.
Homeopathy focuses on the unique characteristics of each patient’s experience and symptomatology and uses this information to
determine the appropriate prescription for each patient.
Objectives
To assess the safety and effectiveness of homeopathy as a treatment for attention deficit/hyperactivity disorder.
Search methods
We searched a wide set of databases from their inception to March 2006 including: CENTRAL, MEDLINE, AMED, BIOSIS, CIS-
COM, CINAHL, Dissertation Abstracts, ECH (European Committee for Homeopathy thesis database), EMBASE, ERIC, HomIn-
form (Glasgow Homeopathic Hospital Library), LILACS, PsycINFO, Science Citation Index, SIGLE, GIRI - International congress
on ultra-low doses, Liga Medicorum Homeopathica Internationalis.
We contacted experts in the field about ongoing or current research.
Selection criteria
All studies where individualised, clinical or formula homeopathy had been used to treat participants with ADHD or HKD who were
randomly or quasi-randomly allocated to either true treatment or a control were selected. Control groups could include wait-list, no
treatment, medication, placebo homeopathy, educational or behavioural interventions.
Data collection and analysis
Data from four eligible studies (total n = 168) were extracted and entered into RevMan. Results were synthesised and estimates of the
effect sizes were calculated and presented as appropriate (using standardised mean differences) in both graphical and narrative form
(narrative only was used where no effect size calculation was possible).
Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 1
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Main results

The forms of homeopathy evaluated to date do not suggest significant treatment effects for the global symptoms, core symptoms of
inattention, hyperactivity or impulsivity, or related outcomes such as anxiety in Attention Deficit/Hyperactivity Disorder.

Authors’ conclusions

There is currently little evidence for the efficacy of homeopathy for the treatment of ADHD. Development of optimal treatment
protocols is recommended prior to further randomised controlled trials being undertaken.

PLAIN LANGUAGE SUMMARY

Homeopathy for ADHD

This review aimed to assess the evidence for homeopathy as an intervention for attention deficit/hyperactivity disorder. Four trials were
retrieved and assessed with mixed results. Overall the results of this review found no evidence of effectiveness for homeopathy for the
global symptoms, core symptoms or related outcomes of attention deficit/hyperactivity disorder.

BACKGROUND Diagnosis is usually determined by child/adolescent psychiatrists


or paediatricians according to either the DSM-IV or the ICD-10.
Both sets of diagnostic criteria state that for a diagnosis of ADHD/
HKD symptoms must have been present for at least six months,
Description of the condition causing distress and in conflict with the child’s developmental level,
Attention-deficit/hyperactivity disorder (ADHD) has only existed and impairment should present and be apparent in two or more
as a diagnostic category since 1980, with the publication of the settings. The symptoms should have been present before the age
Diagnostic and Statistical Manual (DSM) Version III (Barkley of 7 years, and should not be better explained by an alternative
1990). Hyperactivity syndrome began to be distinguished from diagnosis.
brain damage syndromes in the 1960s. Since the 1970s hyperac- Using ICD-10 criteria, prevalence has been estimated at around
tivity syndrome has been closely associated with attention deficits, 1% of school-aged children in the UK, increasing to 5% if DSM-
leading to wide acceptance in some circles that ADHD is a com- IV criteria are used. This translates to around 366,000 children
plex disorder with both developmental and biological underpin- in England and Wales (Lord 2000). A US population-based birth
nings. There is an ongoing debate around the social construction cohort study of 5,781 children estimated a prevalence of 7.5% at
of ADHD as a disease category (Brady 2004 Cooper 1999) and age 19 years using DSM-IV criteria (Barbaresi 2004). Lower UK
there is as yet no clear consensus on the underlying aetiology. prevalence may be due to the use of the narrower ICD-10 criteria,
Brain imaging and genetic research are current areas of interest, and to diagnosing the condition only after referral to secondary
but observation of behaviour remains the basis of diagnosis in the care, among other factors. ADHD can affect both males (more
absence of reliable tests for biological markers. commonly) and females, of any ethnicity. The affected population
DSM-IV diagnostic criteria for ADHD include the ’core’ signs has generally been defined as children and adolescents to age 18
of inattention, hyperactivity and impulsiveness. They also recog- years. After this point the patient is usually referred to adult services
nize three subgroups of ADHD: i) predominantly hyperactive- although in some areas this occurs at age 16 (ADDISS 2003).
impulsive type (not showing significant inattention); ii) predom- ADHD persists in 30% to 70% of adults having had the disorder
inantly inattentive type (not showing significant hyperactive-im- in childhood, and a self-report screening scale for detection of
pulsive behaviour); and iii) combined type (displaying inattentive ADHD in general adult populations without a previous diagnosis
and hyperactive-impulsive symptoms) (APA 2000). Hyperkinetic is under development and has shown reasonable concordance with
disorder (HKD) is the term used in ICD-10 (WHO 1992), and blind clinical diagnoses in a US community sample (Kessler 2005).
refers to a more seriously affected subgroup, similar to patients Currently available treatments for ADHD include behavioural
diagnosed as having DSM-IV ’combined type’. training for teachers and parents, and parenting skills classes. Drug

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 2


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
therapy began in the 1930s (Bradley 1937), and started to attract on their symptom picture and unique characteristics which are
attention in the 1950s (Laufer 1957). Since the 1970s, stimulant then matched with a suitable medicine. Homeopathic pharmacy
medications such as dexamfetamine, and methylphenidate have involves a unique process in which the source material is serially
increasingly been used as the treatment of choice (Coghill 2004), diluted, with violent succussion at each stage. Called ’dynamiza-
but remain controversial (Timini 2003). More recently, the first tion’ or ’potentization’, the process may be repeated many times
licensed drug treatment claimed by the manufacturer to be a non- until no molecules of the starting substance theoretically remain.
stimulant was atomoxetine. During treatment, medicines, dilution, dosage and repetition may
be changed in response to changes in the patient’s condition.
Different homeopathic approaches have been tested in clinical
Description of the intervention trials, and categorized as ’classical’, ’clinical’, ’complex’ and ’iso-
pathic’ subtypes (Linde 1997). Classical homeopathy is the com-
Survey research has demonstrated that a significant proportion of
plex intervention described above, involving an in-depth consulta-
children diagnosed with ADHD will receive some form of non-
tion and individualized analysis (Chapman 1999). Clinical home-
standard treatment or intervention; for example data from Canada
opathy is not holistic treatment, but provides a standardized pre-
indicated that although the majority of a sample questioned were
scription for a predefined condition, based either on traditional
using medication for ADHD symptoms, around 50% were also
recommendations, or new analysis of symptoms (Clark 2000).
using a non-standard treatment (Johnston 2005). Australian sur-
Complex homeopathy combines several clinical medicines into a
veys have reported between 66-68% of children with ADHD
single formula (Weiser 1998). Isopathic medicines are prepared
have also been given non-standard therapy (Sinha 2005). Rea-
from known or presumed aetiological agents (Taylor 2000). Clas-
sons for seeking alternative treatments include minimising symp-
sical homeopathy can potentially include the other modalities, as
toms of ADHD, additional benefit when combined with conven-
part of an individualized course of treatment.
tional treatment and potentially avoiding side effects of prescribed
medication (Sinha 2005). Non-standard therapy or intervention
covers a wide range of alternatives from dietary changes, physical
Why it is important to do this review
therapies such as chiropractic, herbal medication and homeopathy
(Brue 2002). Data on the current use of homeopathy for ADHD Several global systematic reviews and meta-analyses have exam-
are limited. A survey from Florida, USA, found that around 3% of ined trials of homeopathy meeting specific criteria, and have found
children diagnosed with ADHD in a school-sample were using or evidence of superiority to placebo (Linde 1997; Cucherat 2000;
had used homeopathy (Bussing 2002) while a study in Australia Dean 2004; Kleijnen 1991). A recent meta-regression of placebo-
reported that of 67.6% of diagnosed children using non-standard controlled homeopathy trials and randomly selected orthodox tri-
therapy, 6% had tried homeopathy (Sinha 2005). als has claimed that specific effects of homeopathic medicines
Homeopathy could be attributed to placebo (Shang 2005) although there has
In recent years, homeopathy has gained general prominence as an been considerable debate around the methods of this paper (see
alternative form of treatment. The therapeutic system originated Homeopathy 2006). A systematic review of adverse effects of
200 years ago with the German physician and pharmacologist homeopathy has reported that it appears to be generally safe, but
Samuel Hahnemann (1755-1843). As systematised by him, it has that adverse effects might be under-reported (Dantas 2000).
numerous features to distinguish it from botanical and conven- To our knowledge no systematic review on the safety and effective-
tional approaches to diagnosis and treatment (Hahnemann 1913). ness of homeopathy for ADHD has been carried out (Brue 2002),
Its fundamental principle is treatment of ’like with like’: any nat- and in view of the increasing numbers of children diagnosed with
ural or man-made substance capable of causing specific disease ADHD receiving non-standard treatments, this review is both rel-
states and symptoms in healthy individuals may be used to treat evant and timely.
the same symptoms when they occur as part of sickness. During
homeopathic diagnosis, the symptoms of each patient are con-
sidered primarily as an expression of a unique personal illness, as
well as evidence that the patient can be assigned to a conventional OBJECTIVES
disease category. Qualitative aspects of the patient’s experience of 1. To assess the efficacy and effectiveness of homeopathy as a treat-
illness (for instance, emotions such as ’feeling forsaken’ or symp- ment for ADHD/HKD.
tom modalities such as ’restlessness increased after 1800 hours’)
are of particular relevance in determining treatment. Concomi- 2. To evaluate the safety of homeopathy as a treatment for ADHD/
tant symptoms and co-morbid conditions are also included in the HKD.
analysis as part of a ’symptom complex’. In homeopathic treat-
ment therefore, there are no uniform medicines to be given for par-
ticular conditions; the medicine for each patient is chosen based METHODS

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 3


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Criteria for considering studies for this review • Overall incidence/severity of the problem behaviours
measured using a rating scale completed by parent, clinician or
child
Types of studies • Incidence/severity of the core symptoms (e.g. hyperactivity,
Efficacy and effectiveness: Randomised and quasi-randomised tri- inattention and impulsivity)
als (e.g. by day of the week, alternate numbers, case number or • School/academic performance measured via grades or
alphabetical order) comparing homeopathy with no treatment, teacher reports
placebo, medication, behavioural or educational interventions, or • Depression/anxiety-related outcomes using a rating scale
other usual care. Quasi-randomised trials have been included in completed by parent, clinician or child
the review but not in the meta-analysis. • Conduct/oppositional disorder outcomes using a rating
Safety: Any design including non-randomised controlled studies, scale completed by parent, clinician or child
cohort studies, case-controlled-studies, and case series. • Adverse effects, preferably measured with a validated scale
(based on parent or child responses) such as the Barkley
Stimulant Drugs Side Effects Rating Scale (Barkley 1990)
Types of participants • Quality of Life as assessed by parent, child or clinician or
Participants diagnosed with ADHD or HKD according to recog- proxied by a measure such as the Clinical Global Impression
nised criteria: DSM-IV (APA 2000) or ICD-10 (WHO 1992). score changes (NIMH 1985)
This review found studies only with children however if trials with Outcomes should preferably have been measured using validated
adults are located in future they will be included, but analysed and published scales such as those reviewed by Collett 2003.
separately. Studies that report ADHD symptom improvement as a secondary
Co-morbidity: classical homeopathy treats ’whole patients’, in ad- rather than a primary outcome will be considered for inclusion if
dition to their conventional disease labels. Participants who, how- located in any updates.
ever, have a separate diagnosis of autistic spectrum disorder, learn-
ing disability, etc., will be analysed separately if such papers are
located in future updates. Search methods for identification of studies

Types of interventions
Electronic searches
Homeopathic medicines prepared according to national pharma-
Databases were searched without language restrictions for any pa-
copeias, or other explicit protocols. Eligible comparisons for this
per mentioning homeopathy and its synonyms (homeop$ OR ho-
review were compiled by consulting the relevant literature (Lord
moeop$ OR homöop$ OR omeop$).
2000; MTA 1999; King 2006) and include the following:
The records from each search were compiled into a single EndNote
• Wait-list or no treatment
library and de-duplicated. The library was then searched, using
• Pharmacological treatment (e.g. methylphenidate etc)
the following disease-specific terms:
• Usual care (if patient has not been referred to a secondary
1. Attention Deficit Disorder with Hyperactivity/
centre for assessment this will cover any intervention being
2. adhd
offered by the GP, primary mental health worker or educational
3. addh
psychologist if involved)
4. adhs
• Multidisciplinary packages (secondary care: school-based
5. hyperactiv$
interventions, behavioural training, parenting skills)
6. hyperkin$
• Placebo (usually this consists of the patient participating in
7. attention deficit$
a normal homeopathic consultation but receiving identical
8. brain dysfunction
placebo instead of the homeopathic medication).
9. or/1-8
Studies attempting to estimate the ’added value’ of homeopathy An RCT filter was not used as a broad range of study designs will
(in, for example, trials of medication plus homeopathic treatment be evaluated (see Types of Studies above).
versus medication alone) will be considered if located in the future. The results were then searched for population-specific terms to
divide studies into those dealing with children or young people
and those concerned with adult patients.
Types of outcome measures 1. Child/
Trials reporting at least one of the following outcomes were in- 2. Adolescent/
cluded: 3. (child$ or boy$ or girl$ or schoolchild$ or adolescen$ or teen$
or young pe$ or youth$)

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 4


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
4. or/1-3 independently with no disagreement on inclusion/exclusion de-
Published trials cisions. The reference lists of retrieved articles were scanned to
The following databases were searched from inception: identify further trials.
Cochrane Central Register of Controlled Trials (CENTRAL),
published in The Cochrane Library searched 2006 (Issue 1)
MEDLINE searched 1966 to March 2006 Data extraction and management
PreMedline searched March 2006 A data extraction form was developed by both authors (MH and
AMED searched 1985 to March 2006 MED). Data on settings, populations, method of diagnosis, in-
BIOSIS searched 1985 to March 2006 terventions, outcomes, and analysis were extracted by one author
Centre for Complementary Medicine Research (University of Mu- (MH) and independently checked for accuracy by the second au-
nich, Germany) Database: searched to March 2006 thor (MED). Attempts were made to contact authors for missing
CISCOM (Research Council for Complementary Medicine) data, and all such correspondence was logged with some additional
searched to end of 2005 (as no longer available thereafter) data being entered.
CINAHL searched 1982 to March 2006 Homeopathic treatments were categorized as:
Dissertation Abstracts International searched late 1960’s to March 1. Individualised (’classical’, ’constitutional’)
2006 2. Formula (single constituent ’clinical’ or multi-constituent ’com-
ECH (European Committee for Homeopathy plex’)
thesis database) PDF of theses searched to March 2006 [http:// 3. Isopathy
www.homeopathyeurope.org/) This taxonomy was based on published guidelines for reporting
EMBASE searched 1980 to March 2006 homeopathic treatments (Dean 2006) and clarified to ensure that
ERIC searched 1966 to March 2006 each category was mutually exclusive. Each trial was independently
HomInform (Glasgow Homeopathic Hospital Library) searched assigned to one of these groups by MH and MED with no dis-
March 2006 agreements arising.
LILACS (Latin American database) searched 1982 to March 2006 These data have been summarised in the table “Characteristics of
PsycINFO searched 1872 to March 2006 included studies”.
Science Citation Index searched 1945 to March 2006
SIGLE (Grey Literature in Europe) searched 1980 to 2005
Ongoing research: Assessment of risk of bias in included studies
Clinical Trials (USA) searched March 2006 Two authors (MH and MED) independently assessed the risk of
Current Controlled Trials (UK) searched March 2006 bias in the individual trials according to the following areas (as
National Research Register (UK) searched 2006 (Issue 1) specified in the revised Cochrane Handbook)
Conference proceedings etc: • sequence generation
ISI Proceedings searched 1990 to March 2006 • concealment of allocation of treatment group
GIRI - International congress on ultra-low doses • blinding
Liga Medicorum Homeopathica Internationalis • incomplete outcome data
SIGLE searched 1980 to 2005
Each item was judged to be met (low risk of bias), not met (high
risk of bias) or unclear (uncertain risk of bias).
Searching other resources Authors involved in the included studies were contacted (Frei
2006a; Frei 2006b; Frei 2006c; Hsu Schmitz 2006; Strauss 2006a;
We requested information on unpublished trials from authors of
Strauss 2006b; Strauss 2007) to supply missing information from
published studies, and experts and information groups in the areas
three studies (Frei 2005; Jacobs 2005; Strauss 2000). Attempts to
of ADHD and homeopathy.
contact the author of a fourth study have been unsuccessful.

Data collection and analysis Measures of treatment effect


Dichotomous outcomes were not presented in any of the included
studies, however if they are included in future updates the treat-
Selection of studies ment effects will be presented as relative risks (RR).
MH and MED independently screened the titles, abstracts and Continuous outcomes were analysed using means and standard
keywords of all records using disease- and population-specific deviations where available or as calculated from the published
terms, and noted their decisions on potential study acceptability. data. Where continuous outcomes were measured with similar,
Relevant articles were obtained and screened by MH and MED but not identical, instruments across studies, standardised mean

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 5


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
differences were calculated. Where some scales increased to show Sensitivity analysis
benefit and others decreased one set of values was multiplied by -1 A sensitivity analysis allows for a measurement of the robustness
to ensure that for this review, a decrease in mean value represented of results in terms of a priori assumptions made at the outset of
an improvement in symptoms. Confidence intervals of 95% were the review.
used for treatment effect estimates. Random and fixed effect mod- If sufficient data are available in future updates of the review sen-
els were examined and where possible the fixed effect model was sitivity analysis will be conducted for publication bias (published
used. versus not published), trial quality (overall effects on trial quality),
Studies were grouped according to the comparator used and anal- and treatment analyses (intention-to-treat versus non-intention-
ysis carried out for core symptoms (hyperactivity, inattention, im- to-treat).
pulsivity), overall behaviour and by assessor (parent, teacher, self
or clinician).

RESULTS
Assessment of heterogeneity
Heterogeneity between the included studies was assessed by con-
sidering differences in (a) the study population, (b) intervention, Description of studies
(c) outcome measures, and (d) study quality. In addition, where See: Characteristics of included studies; Characteristics of excluded
pooling was appropriate, heterogeneity was assessed using the Chi- studies.
square test and I2 which describes the variation of effects that
may be due to heterogeneity rather than sampling error (Higgins
2002). Results of the search
Searches were carried out from inception of the databases to March
2006. After downloading the initial results to EndNote and search-
ing with disease-specific terms a total of 112 potential papers were
Assessment of reporting biases
identified.
Where feasible in future updates, the possibility of publication bias
will be investigated with funnel plots (trial effect versus standard
error) if sufficient studies are found, or Galbraith plots if not. Efficacy
Asymmetry could be due to publication bias, but could also be Titles and abstracts were assessed and 106 papers excluded from
due to a relationship between trial size and effect size. In the event the review. The six remaining studies were retrieved, of which four
that a relationship is found, clinical diversity of the studies will met the eligibility criteria. One of these exclusions was a collection
also be examined (Egger 1997). of case studies and the second was a duplicate. All studies were
carried out by different research teams between 1997-2005 and
are published journal articles.
Data synthesis
Where sufficient data were available and statistical combination Safety
was appropriate based on the population and intervention de- Titles and abstracts were assessed and papers excluded from the
tails, a meta-analysis was undertaken, using RevMan 4.2 software review.
(RevMan 2003). Further pooling may be possible in future up- All authors of eligible papers from the efficacy section were con-
dates. tacted to ascertain if they held any unpublished safety data from
current or previous research. Only one paper was included in this
section, a published journal article that was also included in the
efficacy review (Jacobs 2005).
Subgroup analysis and investigation of heterogeneity
Where sufficient data are available in future updates, subgroup
analyses will be used to investigate whether homeopathy has dif- Included studies
ferent effects in different populations. We are aware that reliance
on subgroup analyses can lead to misleading conclusions (Oxman
1992; Yusuf 1991) and will conservatively look only for effects Setting
related to gender and age (patients), and homeopathic treatment Two of the four studies included in this review were carried out in
type (interventions). the USA - one delivered the homeopathy in a private clinic based

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 6


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
in Seattle (Jacobs 2005), the second conducted the consultation Three trials reported using child-performance tests to assess atten-
following psychological testing - both performed in the child’s tion and impulsivity. Jacobs used the Conners’ Continuous Per-
foster home or facility (Lamont 1997). The third study was located formance test (Conners 1995), Strauss used a checking task that
in South Africa (Strauss 2000) with the final study conducted in assessed sustained attention (CCT 1983) and Frei used the Test
Switzerland using a private homeopathic practitioner’s office (Frei battery for Attention Performance (TAP 1992) to measure atten-
2005). tion and impulsivity.
None of the papers reported the time of year of the study - so
it is unclear if participants were in school or on holiday/vacation
during the trials. Design
Of the three papers which described their studies as ’randomised’
[Strauss 2000, Frei 2005, Jacobs 2005], two gave details of the
Participants
randomisation procedure while one included no description of
All of the participants in these studies were children with ages randomisation in the published paper but details were later ob-
ranging between 7-15 years. All four papers reported that they tained (Strauss 2007). The fourth study (Lamont 1997) allocated
used children with a diagnosis of ADHD and in two of the studies participants by alternation (quasi-randomisation) which is a less
this diagnosis was re-confirmed either by a psychiatrist or with reliable method for minimising variation than true randomisation
a battery of diagnostic questionnaires before entry into the trial (Kunz 1998).
(Jacobs 2005; Frei 2005). Jacobs 2005, Lamont 1997 and Strauss 2000 used parallel group
comparison designs with pre-post measurement and Frei 2005
used an initial screening period followed by a placebo controlled
Interventions cross-over design. Follow-up periods ranged from 2 to 4.5 months.
Each of the included studies is summarised below and further
All four studies compared active homeopathy with identical
details are provided in the table “Characteristics of Studies”:
placebo homeopathy (a matching sugar pill or solution); three
Homeopathic treatment of children with attention deficit hy-
papers used individualised homeopathy (Frei 2005; Jacobs 2005;
peractivity disorder: a randomised double blind placebo con-
Lamont 1997) and one used a standardised formula containing
trolled crossover trial (Frei 2005)
various potencies of two medicines (Strauss 2000). The individ-
This Swiss study included children aged 6-16 years diagnosed with
ualised homeopathy was distinctly different in each of the three
DSM-IV ADHD (mean age of 10 years) recruited from surgeries
studies and is detailed in the summaries.
and support groups. The diagnosis was re-confirmed for entry. The
Homeopaths prescribing in these studies had varying degrees of
initial consultation took place with parent(s) and child but the 4-
post-qualification experience ranging from 20 years (Jacobs 2005)
weekly follow-ups were carried out with the parents only to min-
to 4 years (Lamont 1997).
imise psychological support to the children. An initial screening
All studies reported data on at least one of the core aspects of
period was used to identify a subset of children which responded
ADHD/HKD as evaluated by the parent or primary carer.
to homeopathy. An indefinite number of follow-ups were allowed
at this stage and medicines could be prescribed or changed until
a successful response was obtained. Participants who successfully
Outcome Measures
responded to homeopathy (50% amelioration of symptoms on
Three of the trials used a well-known validated outcome scale Conners’ Global Index) were then entered into the randomised
designed for assessing ADHD symptoms - the Conners’ Ratings cross-over trial. Allocation was based on stratified computer gener-
Scales. Strauss used an older version (Conners 1973) while Jacobs ated randomisation tables. Participants received either: their nor-
and Frei both used the revised forms (CRS-R Conners 2001). mal homeopathic medication or a placebo for six weeks in each
Frei used the full parent-rating scale in assessment and unblinded phase with no further consultations. 83 participants took part in
follow-up, with the primary outcome measure being the Conners’ the screening phase and 62 in the trial itself with 31 in each group.
Global Index-Parent form (CGI-P) which is a ten item summary The medicines were given in LM liquid potencies as daily drops
scale. Jacobs used both the CGI-P and the CRS-R parent forms and prescribing was based on work done previously by the research
throughout their study yielding more detailed outcome data. team including methods from Bönninghausen and a specially de-
The fourth study (Lamont 1997) used an unpublished 5-point veloped questionnaire (described in Frei 2006). This trial was in-
rating scale of change in hyperactivity. A study reviewing the terested in comparing the extent of maintenance or deterioration
impact of using unpublished rating scales to assess outcomes in of symptoms as assessed by the primary outcome measure: Con-
schizophrenia concluded that use of these measures significantly ners’ Global Index - Parent form at entry to the trial, end of cross-
increases the likelihood of treatment superiority, suggesting that as over period 1, end of period 2 and after 14 weeks. An extensive
reviewers we should be cautious about the results (Marshall 2000). battery of neuropsychological tests was also carried out at baseline

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 7


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
and following an open-label follow-up period. 30 days and 60 days: an earlier version of the Conners’ Rating
Homeopathic treatment of attention deficit hyperactivity dis- Scales (Conners 1973) was used to assess improvements as rated
order: a controlled study (Lamont 1997) by the parents and a ’cancellation task’ (CCT 1983) was used to
This was a quasi-randomised, controlled single-site trial compar- evaluate sustained attention during the study. Participants took
ing individualised homeopathic medicines with identical placebo the homeopathic medicine throughout the 60 day trial period and
pills in children diagnosed with DSM-IV ADHD in California, were followed up to termination of the medication.
USA. All participants were recruited when children were referred Homeopathy for attention deficit/hyperactivity disorder: a pilot
for psychological testing. All of the children were either in care, randomised-controlled trial (Jacobs 2005)
foster homes or under the supervision of a social worker. There This study was a randomised placebo controlled trial of individ-
was a high level of ethnic diversity (35% Black, 47% Hispanic and ualised homeopathy for children diagnosed with ADHD using
18% Caucasian). Following diagnosis by the researcher, a homeo- the DSM-IV. Participants were recruited through advertising and
pathic consultation was carried out to identify an appropriate in- direct mailings to healthcare professionals and psychologists. The
dividual medicine using classical homeopathic prescribing and the computerized Diagnostic Interview Schedule for Children was
RADAR repertory software (no further details reported). Children used to ensure children met the DSM-IV criteria for ADHD. An
were then alternately assigned to verum (n=23) or placebo (n= in-depth homeopathic consultation was carried out by one of two
20) conditions and received their medication by post. Medicines privately practicing homeopaths based in Boston, USA, for each
were given as 6 x 200c pills taken daily in both placebo and verum child followed by the prescription of a homeopathic medicine. At
homeopathy arms for up to 5 days. During the trial up to three the point where the prescription was sent to the pharmacy each
medicine changes were possible in the verum arm. A partial cross- participant was randomised to receive verum or placebo homeopa-
over design was used where those children initially assigned to thy according to a computer generated blocked, stratified num-
placebo were later given verum medicines. The author reports that ber generation algorithm. The prescribing method used in this
none of the participants were aware of the use of placebos during study is one of the newer approaches and termed the ’Bombay’ or
the trial as there had been significant problems with compliance ’Sankaran’ method (Jacobs 2006). The medicines were prescribed
in an unpublished pilot study. Follow-up lasted approximately 2 without restrictions and with the freedom to vary the potency and
months with 43 children of an average age of 10 years taking part. frequency at the follow-up visits on 6 and 12 weeks. The placebo
Symptoms of hyperactivity were measured by an unpublished five- homeopathy followed the same structure and neither homeopath
point scale of change in hyperactivity. This scale was administered nor patient was aware of the treatment allocation. 43 children with
by telephone 10 days after each homeopathic prescription. a mean age of 9 years took part in the study, 21 in the verum
The efficacy of a homeopathic preparation in the management group and 22 in the placebo group. ADHD symptoms at 18 weeks
of attention deficit hyperactivity disorder (Strauss 2000) were measured by validated rating scales completed by parents
This South African study compared the effects of a commer- and teachers (Conners’ Revised Rating Scales Conners 2001) and
cially available combination homeopathic medicine with identical computer tasks that assessed attention and impulsivity (Conners
placebo in children aged 7-10 years reported as having ADHD. 1995).
Children were classified as medicated (n=10) or not medicated (n=
10) on entry to the trial. Participants were recruited via posters at
support groups and in doctor’s surgeries (Strauss 2007). All the Risk of bias in included studies
children were aged between 7 and 10 years and had previously
received a diagnosis of ADHD from a registered psychiatrist ac- Methodological quality was assessed independently by two authors
cording to legislation in South Africa (Strauss 2006b). The narrow (MH and MED) using criteria outlined in the Methods section
age group included was justified as being the time frame problems within the data extraction form. Results from the quality assess-
were most likely to be presenting to health professionals. There ment are summarised below with full details available in the ’Risk
was no clinical consultation as a standard medicine was used, and of bias’ tables.
children were randomly allocated to four groups of five as follows:
Arm A (n=5) verum homeopathy + Ritalin, Arm B (n=5) placebo Allocation
homeopathy + Ritalin, Arm C (n=5) verum homeopathy + no Ri-
Sequence generation and allocation concealment
talin, Arm D (n=5) placebo homeopathy + no Ritalin. The study
Of the four studies included in this review, two of the randomised
was described only as randomised, personal communication with
controlled trials reported details of both the sequence generation
the author reported that a fellow researcher carried out the ran-
(computer generated stratified randomisation) and concealment
domisation using a computer and then made up the medication
of randomisation in sufficient depth in the published papers to
(Strauss 2007). The formula containing various potencies of two
merit a positive judgement for these categories (Jacobs 2005; Frei
medicines was taken as daily drops in both placebo and verum
2005). This substantially reduces the likelihood of bias or subver-
conditions for two months. Outcomes were measured at baseline,
sion in these trials. The third randomised controlled trial (Strauss

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 8


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
2000) merely described the allocation process as random with no out (Strauss 2007). No data have been presented on these patients,
further details in the published paper but following correspon- and they were excluded from all analyses.
dence was judged to be sufficient because the computerised ran- Lamont 1997 presented mean scores but it was possible to esti-
dom allocation was performed by a colleague (Strauss 2007). The mate the standard deviations based on the t-values reported us-
final study (Lamont 1997) was quasi-randomised, alternation be- ing methods from the Cochrane Handbook. Three children were
ing performed by the clinician who was also the researcher and withdrawn from the active intervention arm after changes to their
performed the analysis, making the study potentially more sus- stimulant medication and these were not included in the final
ceptible to bias. analysis, so no ITT was carried out.

Effects of interventions
Blinding
Section A: reports the individual results of the studies grouped
Jacobs 2005 and Frei 2005 both reported blinding of patients, by rater (parent 01, teacher 02, child 03) under the following
care providers and outcome assessors and described procedures for headings; global ratings, core symptoms, related outcomes. All
ensuring this was maintained throughout the trial. Frei did not studies used homeopathy versus placebo therefore no grouping by
assess if the blinding was successful or not and Jacobs checked comparator intervention was necessary.
with the prescribing homeopaths but not the parents or children Section B: details the meta-analysis of data for global scores and
in their study. Strauss 2000 reported the study as double-blind but core outcomes as rated by parents and evaluated by child-com-
did not provide any further information in the published paper. pleted tasks where there were sufficient data reported.
Based on correspondence, it seems likely that the participants and Section C: reports the safety data.
author (also the assessor and researcher) were blinded to allocation
although there were no checks of blinding success. Lamont 1997
chose not to reveal to the carers/parents or children that they were Section A: Study Results
taking part in a placebo controlled trial meaning both were blind This section reports the results for each of the outcomes of interest
to allocation. Lamont was not blind to allocation and was the identified in the Methods section. Effect sizes and 95% confidence
outcome assessor for the study. intervals have been calculated where possible and unless otherwise
noted a minus sign favours the active homeopathic intervention
rather than the placebo control. Final post-intervention values
were used in preference to change scores as advised by the CDPLP
Incomplete outcome data
Group. Fixed and random effects models were both checked but
Reporting of the analysis and results was variable between the four fixed effects models were sufficient for most analyses given the lack
studies. Jacobs 2005 reported point estimates and variability in a of heterogeneity. Effect sizes were calculated as standardised mean
variety of forms, performed an intention to treat (ITT) analysis differences (SMD) since not all trials had used the same outcome
and reported loss to follow-up (one in placebo group) and missing measure or version of a particular ratings scale. SMD’s allow for
values due to drop-outs (two in intervention, three in placebo). comparisons across different outcome measures within the same
They did not report what procedures they used to deal with missing variable of interest.
data.
Frei 2005 reported medians and ranges in their published paper
although the data were not skewed and means/SD’s were later 01 - Parent Ratings
obtained (Frei 2006a; Hsu Schmitz 2006) and not all variables
were presented with measures of variability. Withdrawals after the
first cross-over period were assumed to be missing at random by 1.1 Global ratings
the authors. There were no losses or drop-outs but four patients Two studies (Frei 2005; Jacobs 2005) measured overall symp-
were withdrawn due to medical conditions. An ITT analysis was toms using the Conners’ Global Index rated by parents (CGI-
used and reported. P) (Conners 2001). Higher scores on this ten item scale indicate
Strauss 2000 presented only mean scores and percentages in the poorer functioning and more severe symptom load.
published paper with no measures of variability given or possible to Effect size was calculated as advised by the statistician with the
be calculated. Contact with the author and receipt of the original CDPLP Group. A mean difference in final scores and 95% CI
thesis (Strauss 2006a) revealed that again only mean values or was provided by the authors and the standard error calculated
percentages were reported. 22 patients were originally randomised from this. This gave a generic inverse variance weighted average
to the study with one being withdrawn due to lack of compliance treatment effect. A significant benefit of verum homeopathy over
and a second being advised by their general practitioner to drop- placebo in the cross-over phase of the study was noted [-1.67 (CI

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 9


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
-3.32, -0.02)]. This was a cross-over study as noted previously and given verum homeopathy and a within-subject analysis carried out.
due to the design of the trial it is possible that there may have been Again it was unclear which medicine administration the verum
regression to the mean (Bland 1994) in the first phase, or a carry- improvement scores referred to, therefore these data were not con-
over effect (Elbourne 2002) in either phase one or two. Sufficient sidered for this review.
data have not yet been obtained to permit investigation of these
potential factors.
The data from Jacobs permitted an SMD calculation and showed
no evidence for effectiveness of verum homeopathy over placebo c) Inattention
homeopathy [SMD 0.13 (CI -0.47, 0.73)]. Only one study reported data on inattention, Jacobs used the
CPRS-R domain of inattention but no evidence of effectiveness
was found [SMD 0.39 (CI -0.21, 1.00)].
1.2 Core symptoms

d) Restless/Impulsivity
a) ADHD index Two studies reported restlessness/impulsivity outcome data, Ja-
Jacobs measured overall ADHD symptoms using the ADHD cobs reported scores from the CPRS-R which found no significant
Index subscale of the Conners’ Parents Rating Scales - Revised evidence of effectiveness [SMD 0.02 (CI -0.57, 0.62)]. Strauss re-
(CPRS-R) brief form and found no evidence for effectiveness of ported similar data from the CRS and again no evidence of effec-
verum homeopathy over placebo homeopathy [SMD 0.17 (CI - tiveness was found [SMD -0.14 (CI -1.02, 0.74)].
0.43, 0.77)].
Strauss used an older version of the Conners’ Rating Scales (CRS)
which included a domain termed the Hyperactivity Index but has 1.3 Related outcomes
been renamed the ADHD Index in later revisions to better reflect
the item content (Conners 2001). The results showed no evidence
of effectiveness of homeopathy on ADHD Index score as rated by
parents [SMD -0.17 (CI -1.05, 0.71)]. a) Anxiety
One study reported Anxiety as an outcome based on a domain
within the older CRS. Strauss’ data showed a non-significant dif-
ference in levels of anxiety [SMD -0.55 (CI -1.45, 0.34)].
b) Hyperactivity
Jacobs reported data on the Hyperactivity subscale from CPRS-R
scored by the parents which showed no evidence of effectiveness
of homeopathy on hyperactivity symptoms [SMD 0.21 (CI -0.39, b) Conduct/Oppositional
0.81)]. Jacobs and Strauss both reported data on conduct/oppositional
Lamont used a five point rating scale completed by parents or car- behaviour outcome variable with neither finding evidence of ef-
ers that evaluated any observed change in hyperactivity in the past fectiveness: Jacobs [SMD 0.10 (CI -0.50, 0.70)], Strauss [SMD -
10 days. This produces a change score without a reference baseline. 0.26 (CI -1.14, 0.63)].
This scale is reported to have been used in a previous pilot study
but no information was available on its development or valida-
tion. Lamont’s study reported results from the first medicine pre-
scription and using these data evidence of effectiveness was found c) Emotional Lability
[SMD -0.65 (CI -1.27, -0.03)]. The study design also involved This is a domain only included in the newer revised Conners’
varying the medicine if the original prescription was judged to be scales, therefore only Jacobs reported these data and it did not in-
ineffective in the verum group. These results were reported as fol- dicate any evidence of effectiveness [SMD 0.21 (CI -0.39, 0.81)].
lows: “when more than one homeopathic medicine was given, the im-
provement score from the best one only was used”(Lamont 1997). Full
change scores were not presented for all prescriptions therefore it 02 - Teacher Ratings
was unclear which medicine administration the verum improve- Jacobs was the only study to use teacher based ratings of symptoms
ment scores referred to, therefore these data were not considered and behaviour. All data were collected using the Conners’ Global
for this review. Index-Teacher form (CGI-T) which provides a global total [SMD
A final set of results were also reported based on the partial cross- 0.41 (CI -0.20, 1.01)] and two further sub-domains covering Core
over design; where those participants receiving placebo were then Symptoms and Related Outcomes respectively. Restless/Impulsive

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 10


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[SMD 0.39 (CI -0.21, 1.00)] and Emotional Lability [SMD 0.41 Strauss (formula approach) and Jacobs (individualised homeopa-
(CI -0.19, 1.02)]. No significant differences were recorded in any thy). While we acknowledge the substantial differences in treat-
of these three teacher-rated variables. ment approach (as detailed in the description of included studies
section) it was felt by the reviewers that pooling was still appro-
priate since overall all of the included studies could be interpreted
03 - Child Ratings as addressing the ongoing controversy of whether homeopathic
dilutions have any efficacy over a placebo dose.

a) Inattention 01 - Parent Ratings


Frei assessed inattention using the Test battery for Attention Per-
formance (TAP 1992) but did not provide sufficient data to allow
the calculation of an effect size. 1.1 Global ratings
Jacobs and Strauss both used child-completed tasks to assess levels
A generic inverse-variance analysis was carried out to pool the re-
of attention in the participants. Jacobs used the Conners’ Contin-
sults from two trials of individualised homeopathy versus placebo
uous Performance Test (Conners 1995). The CPT is a computer
(Jacobs 2005 and Frei 2005) based on the data available from the
program that flashes up successive letter stimuli, respondents are
studies. Both studies used the same outcome measure - parent
required to press the space bar or click the mouse whenever any
rated Conners’ Global Index scores - providing data from a total of
letter except the letter ’X’ appears on the computer screen. The
105 participants. In the analysis Frei 2005 was given substantially
number of omission errors (missed targets) were then taken as a
more weighting than Jacobs 2005 as a result of having a larger
measure of inattention. No significant difference was recorded for
sample and less variance around the estimate. The combined data
this outcome by Jacobs [SMD -0.12 (CI -0.72, 0.48)].
show no evidence of the effectiveness of homeopathy over placebo
Strauss used a pencil and paper task described as the Childrens’
in improving CGI scores for children with ADHD [average treat-
Checking Task (CCT 1983). In the CCT, the child is presented
ment effect -1.56 (CI -3.18, 0.06)].
with a block of characters (letters/symbols/numbers) and asked to
score through a target whenever it appears in the block. The orig-
inal paper presented the results as percentage correctly identified.
1.2 Core symptoms
Using data provided by the author, MH converted the percentages
into raw scores and then multiplied these by -1 to provide a mea-
sure of inattention rather than successful attention. Having car-
ried out this conversion there was no significant difference [SMD
-0.53 (CI -1.42, 0.37)]. a) ADHD index
Core symptom scores were measured using the ADHD index com-
ponent of the CPRS and CRS by Jacobs 2005 (individualised) and
Strauss 2000 (formula) respectively as outlined. The two studies
b) Impulsivity provided data from a total of 63 participants (32 verum home-
Based on the Continuous Performance Test described above and opathy and 31 placebo homeopathy) and indicated no evidence of
used by Jacobs, the number of commission errors (false alarms) can the effectiveness of homeopathy in improving the core symptom
be used to reflect levels of impulsivity. No evidence of effectiveness scores of ADHD [SMD 0.06 (CI -0.43, 0.56)].
was found [SMD -0.07 (CI -0.67, 0.53)].
Frei assessed impulsivity using the Test battery for Attention Per-
formance (TAP) but did not provide sufficient data to allow the
calculation of an effect size. b) Hyperactivity
Jacobs 2005 was the only fully randomised study to report hy-
peractivity outcome data, however the quasi-randomised study by
Section B: Meta-analysis Lamont 1997 using an un-validated scale focused on this variable.
This section details the meta-analysis of data for global scores A sensitivity analysis of Jacobs 2005 and Lamont 1997 using final
and core outcomes as rated by parents and evaluated by child- values and first prescription data only found no evidence of the
completed tasks where there were sufficient data reported by the effectiveness of homeopathy in improving hyperactivity in chil-
included papers. dren with ADHD [SMD -0.22 (CI -1.06, 0.23)]. A random ef-
We have not analysed by type of homeopathy due to the lack fects model was used in this analysis to account for the significant
of studies available- most of the pooling possible was between statistical heterogeneity.

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 11


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
c) Restless/Impulsivity Overall this review found no evidence that homeopathy has a sig-
Jacobs 2005 and Strauss 2000 assessed restlessness/impulsivity us- nificant impact on the overall severity, core symptoms or related
ing the relevant domain of the CPRS and CRS by Jacobs (individ- outcomes of children diagnosed with Attention Deficit Hyperac-
ualised) and Strauss (formula) respectively. The two studies pro- tivity Disorder.
vided data from a total of 63 participants (32 verum homeopathy Three of these studies looked at the overall change in symptoms
and 31 placebo homeopathy) and indicated no evidence of the during homeopathic treatment while a fourth examined the main-
effectiveness of homeopathy in improving restlessness/impulsivity tenance or deterioration of previously achieved improvement.
in children with ADHD [SMD -0.03 (CI -0.52, 0.46)]. While varying forms of homeopathy were used in each trial, re-
sults were pooled where possible to address the common question
about what effects, if any, can be observed as a result of using ultra-
1.3 Related outcomes
low dosages as has been done in other reviews (e.g. Linde 1997).
Three studies used individualised homeopathy as the treatment
model although they drew on different prescribing strategies and
a) Conduct/Oppositional sources while one used a standard formula prescription.
Related behaviour issues were measured using the relevant do- Focusing on the three trials included in the meta-analysis: signifi-
main of the CPRS and CRS by Jacobs 2005 (individualised) and cant heterogeneity exists between these trials in terms of how the
Strauss 2000 (formula) respectively. The two studies provided data ’homeopathic treatment’ was operationalised and implemented, as
from a total of 63 participants (32 verum homeopathy and 31 well as the effects. Strauss 2000 used a formula of medicines given
placebo homeopathy) and indicated no evidence of the effective- without individualisation to patients over a relatively short period
ness of homeopathy in improving conduct problems/oppositional of time, and analysis of the raw data did not indicate a beneficial ef-
behaviours in children with ADHD [SMD -0.01 (CI -0.51, 0.48)]. fect over placebo. Jacobs 2005 used a form of individualised home-
opathy similar to how ’classical’ homeopathy is used in practice
with freedom to vary the medicines as well as potency (strength)
03 - Child Ratings and frequency, although critics have suggested that the treatment
period of 18 weeks was too short to show benefit from homeopa-
thy hence the negative findings. A previous observational study,
using a different treatment protocol, found that around 6 months
a) Inattention
was required to identify the correct medicine and see a change in
Jacobs 2005 and Strauss 2000 measured inattention through child symptoms (Frei 2001). Frei 2005 used a treatment protocol based
completed tasks that were either computer based or pencil-and- on that observational study (Frei 2001) where medicine identi-
paper. Data were prepared as detailed in Section A comparison 03 fication was not carried out under a time limit. The subsequent
and combined to give results from a total of 63 participants (32 cross-over placebo comparison phase showed a small but statisti-
verum homeopathy and 31 placebo homeopathy). Pooling indi- cally significant benefit from homeopathic treatment when core
cated no evidence of the effectiveness of homeopathy in improving symptoms were rated by parents. Interestingly this study differed
attention in children with ADHD [SMD -0.25 (CI -0.74, 0.25)]. from Jacobs in that children were only seen once by the home-
opath and all follow-ups carried out with the parents by telephone.
The authors stated intention was to reduce the non-specific effects
Section C: Safety Data
of homeopathy and test the impact of the medicine itself as far as
Despite extensive searching and contact with authors in the area possible.
only one source of safety data was located. Jacobs 2005 used a Stim-
ulant Side-Effects Checklist during their randomised controlled Overall therefore, a trial of formula homeopathy found no differ-
trial and reported that no significant differences were recorded be- ence between placebo and verum (Strauss 2000), a trial of classical
tween verum and placebo homeopathy groups. No adverse events individualised homeopathy that more closely mirrored usual prac-
were recorded in either group. It was not possible to calculate any tice found no significant difference between verum and placebo
summary statistics for this outcome. (Jacobs 2005) and a trial of individualised homeopathy with min-
imised non-specific effects found a significant benefit from home-
opathy (Frei 2005).
There was a lack of data collected regarding safety issues and this
DISCUSSION should be addressed in any future trials of homeopathy generally
as well as in this particular area.
Four studies were included in this review, and three in the meta-
analyses, reporting research conducted over a ten-year period. There was a lack of data collection from the children/young peo-

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 12


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ple themselves in these trials, none of which used child-centred AUTHORS’ CONCLUSIONS
outcome measures or sought their opinions on the impact of the
treatments. Given the available research on the importance of in- Implications for practice
cluding children’s perspectives and opinions within their health-
There is at present insufficient evidence to recommend the use of
care, and the ability of even young children to report on their
homeopathy for children diagnosed with ADHD.
health status and quality of life, these issues should be addressed
in any future research (e.g. Eiser 2001; Rebok 2001; Wallander
2001). Implications for research
This review has highlighted that should further research be carried
There is insufficient evidence to draw robust conclusions about
out, optimal detailed treatment protocols are required and should
the effectiveness of any particular form of homeopathy for ADHD
be developed to reflect current practice. We plan to update this
at present given that only three randomised controlled trials have
review within 24 months to incorporate any new studies and/or
been carried out, and all were relatively small in size. When pooled,
respond to comments or criticisms.
results do not indicate a significant benefit of homeopathy, but
due to the heterogeneity between homeopathic interventions be-
ing tested there may be scope for more targeted research to test
different treatment protocols.
There are a number of factors that could be taken into account in ACKNOWLEDGEMENTS
future trials. Good quality observational studies documenting how
We would like to thank Dr Leon Strauss, Dr Heiner Frei and Dr
homeopaths in the country of an intended trial actually practice,
Jennifer Jacobs for their help in clarifying details of the trials with
including time to see benefit and adverse events or side effects,
which they are associated.
are crucial for the development of good quality trials (McCarney
2004). Future trials should ideally take this information into ac- We would like to thank Jo Abbott, trial search coordinator for the
count in the design phase, while recognising that homeopathy, par- CDPLPG, for her help in running and collating the results of our
ticularly individualised homeopathy, is a package of care which po- search strategies, Dr Julian Higgins (CDPLPG) and Dr Simon
tentially contains multiple active ingredients (Thompson 2006). Gilbody (University of York) for their statistical advice and Dr
The latter point relates to an ongoing debate as to the suitability Jane Dennis, co-ordinator of the CDPLPG for her support and
of the placebo-controlled trial for testing homeopathy, which is assistance in the face of so many questions. We would also like
exacerbated when ethics committees refuse to permit a wait-list to thank Vivien Hendry (doctoral student, Health Sciences, York)
condition (e.g. Jacobs 2005) to explore the non-specific effects. for reading and commenting on drafts.

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alternative medicine in a general population in Great ∗
Indicates the major publication for the study

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 16


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
CHARACTERISTICS OF STUDIES

Characteristics of included studies [ordered by study ID]

Frei 2005

Methods Screening phase to identify responders, followed by cross-over randomised controlled


trial (computer generated stratified by age and CGI using blocks of 4)

Participants 83 children with ADHD confirmed by neuropsychological examination entered the


screening phase. All other medication or treatments for ADHD had to be stopped for the
duration of the screening and trial. 62 children aged between 7-15 years (mean 10 yrs)
entered the cross-over RCT phase when their symptoms had improved by 50% under
homeopathic treatment

Interventions Individualised homeopathic medicines were prescribed in the screening phase (n=83) as
daily liquid doses (LM potencies).
Medicines were prescribed according to Hahnemann and Bönninghausen. Children were
seen only once by the homeopathic physician with treatment progress assessed by the
parents at 4-weekly intervals and medicine adjusted as necessary.
In the trial phase participants received either the successful remedy (n=31) or an identical
placebo (n=31) to be taken daily for 6 weeks followed by cross-over. No contact with
the homeopathic physician occurred during the cross-over trial phase

Outcomes Screening stage: CRS-R Parent and Teacher forms, Kinsbourne Attention Questionnaire
Baseline of trial: Conners Global Index-Parent form, Questionnaire of Change of Be-
haviour (QCB), VLMT (auditory learning test), sub-tests of WISC (Wechsler intelli-
gence test), K-ABC Kaufman Assessment Battery for Children, TAP Test Assessment
battery for Attention Performance.
Final outcomes: CGI-Parent, VLMT, QCB, WISC

Notes This trial aimed to identify children who successfully responded to homeopathy by
demonstrating at least a 50% reduction in their ADHD symptoms. From previous
research it was assumed that this gain would only be maintained while the child continued
to take the remedy allowing a placebo-controlled comparison where the outcome of
interest was deterioration in symptoms under placebo compared to maintenance of
improvement under verum or real homeopathy

Risk of bias

Item Authors’ judgement Description

Adequate sequence generation? Yes Allocation was based on stratified computer


generated randomisation tables. Stratifying
variables: age and symptom severity mea-
sured by CGI-P

Allocation concealment? Yes The randomisation tables were generated at


the University of Berne, the treatment as-
signments were then sealed in consecutively

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 17


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Frei 2005 (Continued)

numbered envelopes before being passed to


the medication manufacturers. The man-
ufacturers were informed by writing when
a child was eligible to enter the cross-over
trial with no other contact between any of
the study personnel. Assignments are un-
likely to have been predicted

Blinding? Yes During the screening phase all medications


All outcomes were sent straight from the manufacturer.
On entering the cross-over phase the rele-
vant medicine or placebo was sent out ac-
cording to treatment assignment. Medica-
tion and placebo were indistinguishable.
Neither child/family, clinician or investi-
gators knew of the treatment allocation.
Blinding was not assessed during this study

Incomplete outcome data addressed? Yes 5 patients refused to enter the cross-
All outcomes over phase following open-label treatment.
There were no losses or drop-outs during
the cross-over trial, but four patients (out of
62) were withdrawn due to medical condi-
tions (1 increasing tics, 2 behavioural disor-
ders, 1 reactive depression). An ITT analy-
sis was used and reported. Withdrawals af-
ter the first cross-over period were assumed
to be missing at random by the authors

Jacobs 2005

Methods Randomised controlled trial (computer generated, blocked, stratified algorithm)

Participants 43 children with confirmed ADHD diagnosis (computerised Diagnostic Interview


Schedule for Children) with mean age of 9 years. 9 participants were already taking
stimulant medication but still displaying symptoms (n=5 active, n=4 placebo)

Interventions Individualised homeopathic medicines prescribed using the Bombay or Sankaran method
with option to vary prescription at 6 and 12 week follow-up.
Randomisation was implemented by the pharmacy when the first prescription was re-
ceived with neither the participants or the homeopathic physician being aware of the
allocation. 21 children received verum homeopathy and 22 children received an indis-
tinguishable placebo. Homeopathic treatment lasted for 18 weeks in total

Outcomes Baseline: Conners Parents Rating Scale (CPRS), Conners Global Index-Parent(CGI-P)
, Conners Global Index-Teacher (CGI-T), Continuous Performance Test (CPT).
Follow-up at 18 weeks: CPRS, CGI-P, CGI-T, CPT, Stimulant Side Effects Checklist,
Clinical Global Impression (Clinicians)

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 18


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Jacobs 2005 (Continued)

Notes Included for both efficacy and safety.

Risk of bias

Item Authors’ judgement Description

Adequate sequence generation? Yes Allocation sequence was based on com-


puter generated blocked, stratified number
generation algorithm. Stratifying variables:
initial symptom severity and current use of
stimulant medication

Allocation concealment? Yes The sequence was passed to the distribut-


ing pharmacy. As each child began treat-
ment, the homeopath would send in their
prescription to the pharmacy to be posted
out. The pharmacy filled the prescription
with verum or placebo according to the ran-
domisation sequence. There was no further
contact between physician and medicine
distribution or treatment allocation. As-
signments are unlikely to have been pre-
dicted

Blinding? Yes Patients, care providers and outcome as-


All outcomes sessors were all blinded to treatment allo-
cation. Care providers (homeopaths) per-
formed no better than chance when asked
to guess which treatment group patients
were assigned to

Incomplete outcome data addressed? Unclear Performed an intention to treat (ITT) anal-
All outcomes ysis and reported loss to follow-up (one
in placebo group) and missing values due
to drop-outs (two in intervention, three in
placebo). No further information available
on reason for drop-out. They did not re-
port what procedures they used to deal with
missing data

Lamont 1997

Methods Quasi-randomised controlled trial with partial cross-over (alternate allocation)

Participants 43 children with ADHD confirmed by psychological testing, mean age of 10 years. 35%
Black, 47% Hispanic, 18% Caucasian. All children were in foster homes, in care or
under the supervision of a social worker

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 19


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Lamont 1997 (Continued)

Interventions Individualised homeopathic medicines were prescribed for each child following a con-
sultation using classical homeopathic prescribing and the RADAR repertory software.
Medicines were given as 6 x 200c pills daily for up to 5 days. Progress was followed-up
10 days after the prescription with the option of changing the medicine on two further
occasions.
The placebo group received an indistinguishable placebo pill on one occasion but later
on were crossed-over to receive verum homeopathy as described above.
The only contact between child and homeopathic physician was at the first consultation.
Follow-up was carried out by phone with parents or carers

Outcomes Outcomes were reported by parent/carer to the researcher by telephone 10 days after each
prescription using an un validated five-point rating scale of “change in hyperactivity”
which spanned -2 ’much worse’ to 0 ’no change’ to +2 ’much better’. The author reports
that this scale was used because of halo effects observed in an earlier unpublished pilot
study using the Conners Rating Scales although no further information was provided

Notes Parents/carers and children were not informed about the use of placebo in this study
although they were aware of taking part in research about homeopathy for ADHD

Risk of bias

Item Authors’ judgement Description

Adequate sequence generation? No This study was quasi-randomised using al-


ternation.

Allocation concealment? No Allocation was performed by the clinician


who was also the researcher and performed
the analysis. Assignments were easily pre-
dicted

Blinding? Unclear Participants (children) and their families/


All outcomes carers were blinded to the treatment allo-
cation since they were not informed of the
use of placebos in this trial. The study in-
vestigator who also collected the outcomes
data, however, was unblinded

Incomplete outcome data addressed? No Three children (out of 43) were with-
All outcomes drawn from the active intervention arm af-
ter changes to their stimulant medication
following homeopathic treatment. These
participants were not included in any of the
analyses. No attrition or loss-to-follow-up
was reported for this study

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 20


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Strauss 2000

Methods Randomised controlled trial (no details of randomisation)

Participants 20 children with previously diagnosed ADHD (no confirmation) aged between 7-10
years. Half of the participants (n=10) were already taking Ritalin.
18 boys, 2 girls.

Interventions Formula homeopathic combination medicine was used containing selenium in 10X,
15X, 30X, 200X with potassium phosphate in 2X, 10X, 30X, 200X. This combination
is sold commercially to improve concentration, memory and altertness.
This was taken as ten drops three times daily. The placebo group received an identical
liquid solution with the same instructions. Drops were taken for two months

Outcomes Outcomes were measured at baseline, 30 days and 60 days.


The Conners’ Rating Scales were reported as being used, parent-report version of the
scales before the most recent revision.
A child performance task termed the Childrens’ Checking Task was used to assess sus-
tained attention

Notes

Risk of bias

Item Authors’ judgement Description

Adequate sequence generation? Yes The study was described only as ran-
domised in the publication, personal com-
munication with the author reported that a
fellow researcher carried out the randomi-
sation using a computer

Allocation concealment? Unclear Fellow researcher carried out the randomi-


sation and then made up the verum or
placebo medications appropriately (per-
sonal communication)

Blinding? Yes Described as double blind in publica-


All outcomes tion. Participants and families were blinded
- being given verum or indistinguish-
able placebo medications according to
treatment allocation. The investigator was
blinded to allocation during the trial
(known only to colleague). Investigator un-
blinded during analysis

Incomplete outcome data addressed? No Published paper reported 20 patients ran-


All outcomes domised to the study with no data on at-
trition or exclusion. Communication with
author: of an original 22, one was with-
drawn due to lack of compliance and a sec-

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 21


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Strauss 2000 (Continued)

ond was advised by their general practi-


tioner to drop-out (Strauss 2007). No data
have been presented on these patients, and
they were excluded from all analyses

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Frei 2001 This was an uncontrolled observational study. Participants recieved homeopathic treatment and if unsuccessful were
then progressed on to methylphenidate

Lamont 1998 This paper is a reprint of Lamont (1997) which is included in the review. No additional information was presented
in this version

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 22


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DATA AND ANALYSES

Comparison 1. Homeopathy versus Placebo (Parent Ratings)

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

1 Conners Global Index Scores 2 Mean Difference (Fixed, 95% CI) -1.56 [-3.18, 0.06]
(Parent) CGI-P
2 ADHD Index (Parent) 2 63 Std. Mean Difference (IV, Fixed, 95% CI) 0.06 [-0.43, 0.56]
3 Hyperactivity (Parent) 2 Std. Mean Difference (IV, Random, 95% CI) Subtotals only
3.1 Randomised only 1 43 Std. Mean Difference (IV, Random, 95% CI) 0.21 [-0.39, 0.81]
3.2 Quasi and fully 2 86 Std. Mean Difference (IV, Random, 95% CI) -0.22 [-1.06, 0.63]
randomised (Final values)
4 Inattention (Parent) 1 43 Std. Mean Difference (IV, Fixed, 95% CI) 0.39 [-0.21, 1.00]
5 Restless/Impulsive (Parent) 2 63 Std. Mean Difference (IV, Fixed, 95% CI) -0.03 [-0.52, 0.46]
6 Oppositional/Conduct (Parent) 2 63 Std. Mean Difference (IV, Fixed, 95% CI) -0.01 [-0.51, 0.48]
7 Emotional Lability (Parent) 1 43 Std. Mean Difference (IV, Fixed, 95% CI) 0.21 [-0.39, 0.81]
8 Anxiety (Parent) 1 20 Std. Mean Difference (IV, Fixed, 95% CI) -0.55 [-1.45, 0.34]
9 Global Index Scores (Parent) 1 43 Std. Mean Difference (IV, Fixed, 95% CI) 0.13 [-0.47, 0.73]

Comparison 2. Homeopathy versus Placebo (Teacher Ratings)

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

1 Global Index Total 1 43 Std. Mean Difference (IV, Fixed, 95% CI) 0.41 [-0.20, 1.01]
2 Restless/Impulsive 1 43 Std. Mean Difference (IV, Fixed, 95% CI) 0.39 [-0.21, 1.00]
3 Emotional Lability 1 43 Std. Mean Difference (IV, Fixed, 95% CI) 0.41 [-0.19, 1.02]

Comparison 3. Homeopathy versus Placebo (Child completed tests)

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

1 Inattention 2 Std. Mean Difference (IV, Fixed, 95% CI) Subtotals only
1.1 Original figures 2 63 Std. Mean Difference (IV, Fixed, 95% CI) -0.25 [-0.74, 0.25]
1.2 Adjusted figures 2 62 Std. Mean Difference (IV, Fixed, 95% CI) -0.21 [-0.71, 0.29]
2 Impulsivity 1 43 Std. Mean Difference (IV, Fixed, 95% CI) -0.07 [-0.67, 0.53]

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 23


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Analysis 1.1. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 1 Conners Global
Index Scores (Parent) CGI-P.

Review: Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder

Comparison: 1 Homeopathy versus Placebo (Parent Ratings)

Outcome: 1 Conners Global Index Scores (Parent) CGI-P

Mean Mean
Study or subgroup Mean Difference (SE) Difference Weight Difference
IV,Fixed,95% CI IV,Fixed,95% CI
Frei 2005 -1.67 (0.84) 96.9 % -1.67 [ -3.32, -0.02 ]

Jacobs 2005 1.77 (4.7) 3.1 % 1.77 [ -7.44, 10.98 ]

Total (95% CI) 100.0 % -1.56 [ -3.18, 0.06 ]


Heterogeneity: Chi2 = 0.52, df = 1 (P = 0.47); I2 =0.0%
Test for overall effect: Z = 1.89 (P = 0.059)
Test for subgroup differences: Not applicable

-10 -5 0 5 10
Favours treatment Favours control

Analysis 1.2. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 2 ADHD Index
(Parent).

Review: Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder

Comparison: 1 Homeopathy versus Placebo (Parent Ratings)

Outcome: 2 ADHD Index (Parent)

Std. Std.
Mean Mean
Study or subgroup Treatment Control Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

Jacobs 2005 21 63.65 (13.88) 22 61.65 (8.82) 68.3 % 0.17 [ -0.43, 0.77 ]

Strauss 2000 10 9.6 (6.15) 10 10.6 (5.19) 31.7 % -0.17 [ -1.05, 0.71 ]

Total (95% CI) 31 32 100.0 % 0.06 [ -0.43, 0.56 ]


Heterogeneity: Chi2 = 0.39, df = 1 (P = 0.53); I2 =0.0%
Test for overall effect: Z = 0.25 (P = 0.80)
Test for subgroup differences: Not applicable

-4 -2 0 2 4
Favours treatment Favours control

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 24


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Analysis 1.3. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 3 Hyperactivity
(Parent).

Review: Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder

Comparison: 1 Homeopathy versus Placebo (Parent Ratings)

Outcome: 3 Hyperactivity (Parent)

Std. Std.
Mean Mean
Study or subgroup Treatment Control Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

1 Randomised only
Jacobs 2005 21 67.4 (14.96) 22 64.35 (13.51) 100.0 % 0.21 [ -0.39, 0.81 ]

Subtotal (95% CI) 21 22 100.0 % 0.21 [ -0.39, 0.81 ]


Heterogeneity: not applicable
Test for overall effect: Z = 0.69 (P = 0.49)
2 Quasi and fully randomised (Final values)
Jacobs 2005 22 67.4 (14.96) 21 64.35 (13.51) 50.5 % 0.21 [ -0.39, 0.81 ]

Lamont 1997 20 -1 (0.98) 23 -0.35 (0.98) 49.5 % -0.65 [ -1.27, -0.03 ]

Subtotal (95% CI) 42 44 100.0 % -0.22 [ -1.06, 0.63 ]


Heterogeneity: Tau2 = 0.27; Chi2 = 3.85, df = 1 (P = 0.05); I2 =74%
Test for overall effect: Z = 0.51 (P = 0.61)

-4 -2 0 2 4
Favours treatment Favours control

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 25


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Analysis 1.4. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 4 Inattention (Parent).

Review: Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder

Comparison: 1 Homeopathy versus Placebo (Parent Ratings)

Outcome: 4 Inattention (Parent)

Std. Std.
Mean Mean
Study or subgroup Treatment Control Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

Jacobs 2005 22 64.55 (15.59) 21 59.47 (8.84) 100.0 % 0.39 [ -0.21, 1.00 ]

Total (95% CI) 22 21 100.0 % 0.39 [ -0.21, 1.00 ]


Heterogeneity: not applicable
Test for overall effect: Z = 1.27 (P = 0.20)
Test for subgroup differences: Not applicable

-4 -2 0 2 4
Favours treatment Favours control

Analysis 1.5. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 5 Restless/Impulsive
(Parent).

Review: Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder

Comparison: 1 Homeopathy versus Placebo (Parent Ratings)

Outcome: 5 Restless/Impulsive (Parent)

Std. Std.
Mean Mean
Study or subgroup Treatment Control Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

Jacobs 2005 22 63.25 (14.97) 21 62.94 (10.82) 68.3 % 0.02 [ -0.57, 0.62 ]

Strauss 2000 10 4.3 (2.41) 10 4.65 (2.29) 31.7 % -0.14 [ -1.02, 0.74 ]

Total (95% CI) 32 31 100.0 % -0.03 [ -0.52, 0.46 ]


Heterogeneity: Chi2 = 0.09, df = 1 (P = 0.76); I2 =0.0%
Test for overall effect: Z = 0.12 (P = 0.91)
Test for subgroup differences: Not applicable

-4 -2 0 2 4
Favours treatment Favours control

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 26


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Analysis 1.6. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 6
Oppositional/Conduct (Parent).

Review: Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder

Comparison: 1 Homeopathy versus Placebo (Parent Ratings)

Outcome: 6 Oppositional/Conduct (Parent)

Std. Std.
Mean Mean
Study or subgroup Treatment Control Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

Jacobs 2005 22 64.05 (13.17) 21 62.65 (14.39) 68.4 % 0.10 [ -0.50, 0.70 ]

Strauss 2000 10 7.3 (5.46) 10 9.2 (8.48) 31.6 % -0.26 [ -1.14, 0.63 ]

Total (95% CI) 32 31 100.0 % -0.01 [ -0.51, 0.48 ]


Heterogeneity: Chi2 = 0.43, df = 1 (P = 0.51); I2 =0.0%
Test for overall effect: Z = 0.05 (P = 0.96)
Test for subgroup differences: Not applicable

-4 -2 0 2 4
Favours treatment Favours control

Analysis 1.7. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 7 Emotional Lability
(Parent).

Review: Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder

Comparison: 1 Homeopathy versus Placebo (Parent Ratings)

Outcome: 7 Emotional Lability (Parent)

Std. Std.
Mean Mean
Study or subgroup Treatment Control Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

Jacobs 2005 22 58.05 (15.24) 21 55.06 (12.74) 100.0 % 0.21 [ -0.39, 0.81 ]

Total (95% CI) 22 21 100.0 % 0.21 [ -0.39, 0.81 ]


Heterogeneity: not applicable
Test for overall effect: Z = 0.68 (P = 0.50)
Test for subgroup differences: Not applicable

-4 -2 0 2 4
Favours treatment Favours control

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 27


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Analysis 1.8. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 8 Anxiety (Parent).

Review: Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder

Comparison: 1 Homeopathy versus Placebo (Parent Ratings)

Outcome: 8 Anxiety (Parent)

Std. Std.
Mean Mean
Study or subgroup Treatment Control Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

Strauss 2000 10 1.8 (2.97) 10 3.35 (2.36) 100.0 % -0.55 [ -1.45, 0.34 ]

Total (95% CI) 10 10 100.0 % -0.55 [ -1.45, 0.34 ]


Heterogeneity: not applicable
Test for overall effect: Z = 1.21 (P = 0.23)
Test for subgroup differences: Not applicable

-4 -2 0 2 4
Favours treatment Favours control

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 28


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Analysis 1.9. Comparison 1 Homeopathy versus Placebo (Parent Ratings), Outcome 9 Global Index Scores
(Parent).

Review: Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder

Comparison: 1 Homeopathy versus Placebo (Parent Ratings)

Outcome: 9 Global Index Scores (Parent)

Std. Std.
Mean Mean
Study or subgroup Treatment Control Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

Jacobs 2005 22 62.65 (14.96) 21 60.88 (12.07) 100.0 % 0.13 [ -0.47, 0.73 ]

Total (95% CI) 22 21 100.0 % 0.13 [ -0.47, 0.73 ]


Heterogeneity: not applicable
Test for overall effect: Z = 0.42 (P = 0.68)
Test for subgroup differences: Not applicable

-4 -2 0 2 4
Favours treatment Favours control

Analysis 2.1. Comparison 2 Homeopathy versus Placebo (Teacher Ratings), Outcome 1 Global Index Total.

Review: Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder

Comparison: 2 Homeopathy versus Placebo (Teacher Ratings)

Outcome: 1 Global Index Total

Std. Std.
Mean Mean
Study or subgroup Treatment Control Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

Jacobs 2005 22 63.53 (11.16) 21 58.81 (11.66) 100.0 % 0.41 [ -0.20, 1.01 ]

Total (95% CI) 22 21 100.0 % 0.41 [ -0.20, 1.01 ]


Heterogeneity: not applicable
Test for overall effect: Z = 1.32 (P = 0.19)
Test for subgroup differences: Not applicable

-4 -2 0 2 4
Favours treatment Favours control

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 29


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Analysis 2.2. Comparison 2 Homeopathy versus Placebo (Teacher Ratings), Outcome 2 Restless/Impulsive.

Review: Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder

Comparison: 2 Homeopathy versus Placebo (Teacher Ratings)

Outcome: 2 Restless/Impulsive

Std. Std.
Mean Mean
Study or subgroup Treatment Control Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

Jacobs 2005 22 67.26 (12.14) 21 62.25 (13.03) 100.0 % 0.39 [ -0.21, 1.00 ]

Total (95% CI) 22 21 100.0 % 0.39 [ -0.21, 1.00 ]


Heterogeneity: not applicable
Test for overall effect: Z = 1.27 (P = 0.20)
Test for subgroup differences: Not applicable

-4 -2 0 2 4
Favours treatment Favours control

Analysis 2.3. Comparison 2 Homeopathy versus Placebo (Teacher Ratings), Outcome 3 Emotional Lability.

Review: Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder

Comparison: 2 Homeopathy versus Placebo (Teacher Ratings)

Outcome: 3 Emotional Lability

Std. Std.
Mean Mean
Study or subgroup Treatment Control Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

Jacobs 2005 22 52.16 (8.96) 21 48.31 (9.31) 100.0 % 0.41 [ -0.19, 1.02 ]

Total (95% CI) 22 21 100.0 % 0.41 [ -0.19, 1.02 ]


Heterogeneity: not applicable
Test for overall effect: Z = 1.34 (P = 0.18)
Test for subgroup differences: Not applicable

-4 -2 0 2 4
Favours treatment Favours control

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 30


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Analysis 3.1. Comparison 3 Homeopathy versus Placebo (Child completed tests), Outcome 1 Inattention.

Review: Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder

Comparison: 3 Homeopathy versus Placebo (Child completed tests)

Outcome: 1 Inattention

Std. Std.
Mean Mean
Study or subgroup Treatment Control Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Original figures
Jacobs 2005 22 61.59 (15.97) 21 63.6 (16.51) 69.1 % -0.12 [ -0.72, 0.48 ]

Strauss 2000 10 12.3 (8.84) 10 37.8 (65.18) 30.9 % -0.53 [ -1.42, 0.37 ]

Subtotal (95% CI) 32 31 100.0 % -0.25 [ -0.74, 0.25 ]


Heterogeneity: Chi2 = 0.54, df = 1 (P = 0.46); I2 =0.0%
Test for overall effect: Z = 0.97 (P = 0.33)
2 Adjusted figures
Jacobs 2005 22 61.59 (15.97) 21 63.6 (16.51) 69.9 % -0.12 [ -0.72, 0.48 ]

Strauss 2000 10 12.3 (8.84) 9 17.78 (16.41) 30.1 % -0.40 [ -1.32, 0.51 ]

Subtotal (95% CI) 32 30 100.0 % -0.21 [ -0.71, 0.29 ]


Heterogeneity: Chi2 = 0.26, df = 1 (P = 0.61); I2 =0.0%
Test for overall effect: Z = 0.81 (P = 0.42)
Test for subgroup differences: Chi2 = 0.01, df = 1 (P = 0.91), I2 =0.0%

-4 -2 0 2 4
Favours treatment Favours control

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 31


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Analysis 3.2. Comparison 3 Homeopathy versus Placebo (Child completed tests), Outcome 2 Impulsivity.

Review: Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder

Comparison: 3 Homeopathy versus Placebo (Child completed tests)

Outcome: 2 Impulsivity

Std. Std.
Mean Mean
Study or subgroup Treatment Control Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

Jacobs 2005 22 56.38 (13.33) 21 57.42 (14.79) 100.0 % -0.07 [ -0.67, 0.53 ]

Total (95% CI) 22 21 100.0 % -0.07 [ -0.67, 0.53 ]


Heterogeneity: not applicable
Test for overall effect: Z = 0.24 (P = 0.81)
Test for subgroup differences: Not applicable

-4 -2 0 2 4
Favours treatment Favours control

WHAT’S NEW
Last assessed as up-to-date: 28 February 2006.

Date Event Description

6 November 2008 Amended Converted to new review format.

HISTORY
Protocol first published: Issue 1, 2006
Review first published: Issue 4, 2007

Date Event Description

20 August 2007 New citation required and conclusions have changed Substantive amendment

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 32


Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
CONTRIBUTIONS OF AUTHORS
MH is responsible for the overall design and co-ordination of the review.
MH and MED were jointly responsible for the development of the protocol. The literature search and screening of retrieved papers
against the inclusion criteria was undertaken by MH and MED.
MH and MED appraised the quality of the selected papers and MH extracted the data. MH carried out the analysis and interpretation
with contributions from MED and both authors contributed to the completion of the review.

DECLARATIONS OF INTEREST
None to report.

SOURCES OF SUPPORT

Internal sources
• University of York, UK.

External sources
• Department of Health, UK.

DIFFERENCES BETWEEN PROTOCOL AND REVIEW


The name of the first author of this review was Morag Coulter at first publication of this review. In 2008, the author’s name changed
to Morag Heirs.

INDEX TERMS

Medical Subject Headings (MeSH)


Attention Deficit Disorder with Hyperactivity [∗ drug therapy]; Homeopathy [∗ methods]; Hyperkinesis [∗ drug therapy]; Randomized
Controlled Trials as Topic

MeSH check words


Child; Humans

Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder (Review) 33


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

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