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A comparative consecutive case series of 20 children with a diagnosis of ADHD receiving homeopathic treatment, compared with 10 children receiving usual care

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  • Northern College of Acupuncture

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Unlabelled: 20 consecutively enrolled children age 5-16 with Attention Deficit Hyperactivity Disorder (ADHD) received treatment by a homeopath (8 consultations and individualized remedies) for one year. Ten subsequently enrolled children received similar time and attention for 4 months. The study explored optimum treatment protocols; the effectiveness, deliverability and acceptability of treatment; and the feasibility of outcome measurement and recruitment. Parents completed Conners' Parent Rating Scale, Revised Long Version ( Cprs-r: L) every 4 months, from which DSMIV total scores were extracted; and Measure Your Own Medical Outcome Profile (MYMOP) every consultation. An interaction between time (baseline/4 months) and group (treatment/non-treatment) was found .756 F (1,28)=9.06, p=0.005. The intervention was associated with statistically significant improvements in treated children over the year: Cprs-r: L (t (18)=4.529, p≤0.000); MYMOP (t (18)=6.938, p≤0.000). Mean DSMIV total t scores decreased at each time point: baseline: 85 (SD 5.1); 4 months 76.2 (SD 10.9); and 12 months 71.5 (SD 12.77). Recruitment of control participants was problematic. Recruitment to treatment was feasible via ADHD support groups, charities, police support agencies and social services, not schools or NHS services. Attending appointments was problematic for some participants, but home visits did not improve uptake. The best venue was a familiar clinic. Some participants took medicines inappropriately, but generally taking homeopathic remedies was acceptable and well implemented. Cprs-r: L (80 items) was problematic for some parents. MYMOP was preferred by parents but not acceptable to stakeholders. In this small consecutive sample the intervention was associated with improvements in criminality, anger and children with a concomitant diagnosis of Autism Spectrum Disorder ASD. Treatment by a homeopath was associated with sustained, increasing improvements and the intervention was acceptable to participants. More methodically rigorous research is warranted. "We recommend that future research in this area uses comparative effectiveness randomised controlled trial designs. We also recommend that these trials measure outcomes of relevance to stakeholder needs - the people and services who care for those with ADHD - parents, teachers and social workers and the criminal justice system".
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ORIGINAL PAPER
A comparative consecutive case series
of 20 children with a diagnosis of ADHD
receiving homeopathic treatment,
compared with 10 children receiving
usual care
Philippa Fibert
1,2,
*, Clare Relton
2
, Morag Heirs
3
and Deborah Bowden
1
1
Goldsmiths, University of London, New Cross, London SE14 6NW, UK
2
School of Health and Related Research, University of Sheffield, 30 Regent Court, Sheffield S1 4DA, UK
3
Northern College of Acupuncture, 61 Micklegate, York YO1 6LJ, UK
20 consecutively enrolled children age 5e16 with Attention Deficit Hyperactivity Disor-
der (ADHD) received treatment by a homeopath (8 consultations and individualized rem-
edies) for one year. Ten subsequently enrolled children received similar time and
attention for 4 months. The study explored optimum treatment protocols; the effective-
ness, deliverability and acceptability of treatment; and the feasibility of outcome mea-
surement and recruitment.
Parents completed Conners’ Parent Rating Scale, Revised Long Version (CPRS-R:L) every
4 months, from which DSMIV total scores were extracted; and Measure Your Own Med-
ical Outcome Profile (MYMOP) every consultation.
An interaction between time (baseline/4 months) and group (treatment/non-treatment)
was found .756 F (1,28) = 9.06, p = 0.005. The intervention was associated with statisti-
cally significant improvements in treated children over the year: CPRS-R:L (t (18)
= 4.529, p £0.000); MYMOP (t (18) = 6.938, p £0.000). Mean DSMIV total t scores
decreased at each time point: baseline: 85 (SD 5.1); 4 months 76.2 (SD 10.9); and 12
months 71.5 (SD 12.77).
Recruitment of control participants was problematic. Recruitment to treatment was
feasible via ADHD support groups, charities, police support agencies and social services,
not schools or NHS services. Attending appointments was problematic for some partic-
ipants, but home visits did not improve uptake. The best venue was a familiar clinic.
Some participants took medicines inappropriately, but generally taking homeopathic
remedies was acceptable and well implemented. CPRS-R:L (80 items) was problematic
for some parents. MYMOP was preferred by parents but not acceptable to stakeholders.
In this small consecutive sample the intervention was associated with improvements in
criminality, anger and children with a concomitant diagnosis of Autism Spectrum Disor-
der ASD.
Treatment by a homeopath was associated with sustained, increasing improvements
and the intervention was acceptable to participants. More methodically rigorous
research is warranted. “We recommend that future research in this area uses compara-
*Correspondence: Philippa Fibert, Present address: School of Health and Related Research, University of Sheffield, 30 Regent Court,
Sheffield S1 4DA, UK.
E-mail: p.fibert@sheffield.ac.uk
Received 24 March 2015; revised 13 August 2015; accepted 25 September 2015
Homeopathy (2015) -,1e8
Ó2015 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.homp.2015.09.008, available online at http://www.sciencedirect.com
Please cite this article in press as: Fibert P, et al., A comparative consecutive case series of 20 children with a diagnosis of ADHD receiving homeopathic
treatment, compared with 10 children receiving usual care, Homeopathy (2015), http://dx.doi.org/10.1016/j.homp.2015.09.008
tive effectiveness randomised controlled trial designs. We also recommend that these
trials measure outcomes of relevance to stakeholder needs ethe people and services
who care for those with ADHD eparents, teachers and social workers and the criminal
justice system”. Homeopathy (2015) -,1e8.
Keywords: Attention Deficit Hyperactivity Disorder; ADHD; Autism Spectrum
Disorder; ASD; Homeopathy; Treatment by a homeopath
Introduction
There is a need to explore novel, cost effective, safe
treatments for children with developmental disorders
such as Attention Deficit Hyperactivity Disorder
(ADHD) in order to improve outcomes.
ADHD is a significant strain on stakeholder services and
at high risk of negative outcomes such as criminality
(where it has been found to be the most important predictor
of violent offending
1
), school disruption and exclusion (Of
526 UK families with an ADHD child, 11% were found to
be permanently excluded (www.addiss.co.uk)). Children
with ADHD and their siblings report being substantially
less happy with their family, with life overall (levels of
wellbeing 6% less than matched peers), and to experience
elevated levels of intra-family bullying.
2
Evidence suggests that currently recommended inter-
ventions (behavioural and pharmaceutical) are effective
whilst implemented but not associated with long term im-
provements. Side effects of pharmaceutical medication
include poor sleep, decreased appetite, dizziness and stom-
ach pain.
3,4
A recent review found average treatment
persistence with stimulants to be 136 days
5
with adverse ef-
fects the most commonly cited reason for discontinuation.
Many discontinue medication in adolescence.
6
Two-thirds of those with a child with ADHD report us-
ing Complementary and Alternative Medicine (CAM)
treatments of some kind
7
with homeopathy one of the
preferred options.
8
Reasons include minimizing symp-
toms, additional benefits when combined with conven-
tional treatment and potentially avoiding side effects of
prescribed medication.
7
However there is currently mini-
mal high quality evidence regarding the clinical effective-
ness of complementary and alternative therapies.
9
The peer reviewed evidence base for homeopathy for
ADHD to date consists of: six placebo controlled rando-
mised controlled trials (RCTs) testing the efficacy of ho-
meopathic remedies (of which two tested non-
individualized remedies
10,11
and four tested
individualized remedies
12e15
); two observational studies
of treatment by homeopaths
16,17
; and one within subjects
trial of treatment by homeopaths measuring ADHD
symptoms in ASD.
18
The majority of RCTs of individual-
ized remedies (3/4) showed statistically significant effects,
as did the within subjects trial of treatment by homeopaths
and the two observational studies; whilst neither RCT of
non-individualized remedies showed any effects.
A 2007 systematic review assessing “the safety and
effectiveness of homeopathy for ADHD” concluded that
there is at present insufficient evidence” and advised
that there is a need for .good quality observational
studies documenting how homeopaths in the country of
an intended trial actually practice, including [sufficient]
time to see benefit”.
19
This advice was mirrored by one
of homeopathy’s detractors who has also suggested that
studies of clinical effectiveness, describing the therapy
as it is practiced in the real world may be a better means
of informing stakeholders of the potential of homeopathic
treatment”.
20
This case series addresses these recommen-
dations.
Such pragmatic studies of the effectiveness of complex
interventions are also recommended by the Medical
Research Council,
21
which suggests that only once the
effectiveness of interventions has been established, should
the efficacy of the separate components be explored. “The
interacting components of the therapeutic system of home-
opathy include: the remedy, the therapeutic consultation
and the application of the principles of homeopathy (indi-
vidualisation, the simillimum) (Relton et al. 2008). Despite
MRC recommendations for testing complex interventions,
99% of current homeopathy trials test the efficacy of ho-
meopathic remedies (mirroring drug trials), and not the
clinical effectiveness of the whole intervention as it is usu-
ally practised (Relton et al 2008). It likely that such trials
are underestimates (due to only testing one component
(the remedy), and constriction of the complex interaction
between components).”
Therefore this observational study documents the effec-
tiveness of receiving treatment by a homeopath in the UK.
It describes the progression of twenty children with a diag-
nosis of ADHD over the course of one year’s homeopathic
treatment. Ten children were subsequently enrolled to
receive similar time and attention for 4 months to control
for any non-specific effects of spending time with an empa-
thetic practitioner which have been suggested as an expla-
nation for the positive effects of homeopathic
treatment.
22e24
“Since the purpose of this study was to
document the potential of treatment by a homeopath as
experienced in clinical practice, not the specific effects of
homeopathic remedies, no placebo remedies were
compared.”
This study explores optimum treatment protocols; the
effectiveness, deliverability and acceptability of treatment;
the feasibility of outcome measurement; and the feasibility
of recruiting a broad representative sample, particularly of
those engaging with support services. Children’s treatment
was paid for by Turner’s Court Youth Trust (an ex-borstal
charitable foundation dedicated to prevention of crimi-
nality) and the Homeopathic Research Institute. It was
ADHD case series
P Fibert et al
2
Homeopathy
Please cite this article in press as: Fibert P, et al., A comparative consecutive case series of 20 children with a diagnosis of ADHD receiving homeopathic
treatment, compared with 10 children receiving usual care, Homeopathy (2015), http://dx.doi.org/10.1016/j.homp.2015.09.008
submitted as a component of studies at Goldsmiths, Uni-
versity of London (Research Methodology in Psychology)
and info rms an ongoing pragmatic RCT at the University of
Sheffield.
Methods
Inclusion criteria and recruitment strategy (see
Figure 1)
Children aged 5e16 with a prior clinical diagnosis of
ADHD reported by parents, were recruited by advertising
at schools, youth clubs, police services, social services
and ADHD support groups in the south east region of the
UK. No restriction was put upon the length of time since
diagnosis or co-morbidities. Children could be taking con-
ventional medication or undertaking other adjunctive treat-
ments. Exclusion criteria were children where English was
not spoken, or families not attending two consecutive ap-
pointments in the first 4 months. If this occurred new fam-
ilies were recruited.
Parents expressing interest were sent information about
the project, what to expect from a homeopathic consulta-
tion and a consent form to be completed by both parents
and children. After informed consent was received, the first
20 applicants were enrolled to receive homeopathic treat-
ment, then the next 10 applicants were enrolled to receive
similar time and attention. These participants were offered
homeopathic treatment after 4 months. Figure 1 demon-
strates the recruitment pathway.
Intervention
Children received a course of homeopathic treatment
from the lead researcher (PF), a qualified homeopath for
5 years; criminal records bureau (CRB) and police
checked; a member of the Society of Homeopaths, bound
by its code of ethics within which child protection policy
is embedded. Ethical approval for the study was obtained
from the Society of Homeopaths and Goldsmiths, Univer-
sity of London. Consultations took place in a variety of set-
tings: patient’s home, Red Cross Centre, or Alternative
Therapies Clinic. Venue choice depended on the family’s
location.
Treatment consisted of an initial consultation of
1½ hours between parent, child and homeopath; seven
follow up appointments at 4e6 week intervals; and individ-
ualized homeopathic remedies prescribed following each
consultation and taken, usually on a daily basis. Where
necessary, consultation without child or parent was ar-
ranged to discuss familial discord or negative behaviour.
Parents were free to contact the practitioner between ap-
pointments with any queries.
Follow ups lasted for 40 min. The homeopath was at lib-
erty at each consultation to continue with the prescribed
remedy, change to a different one, change potency, pre-
scribe additional remedies, and use different prescribing
methodologies. Homeopathic remedies were prescribed
in pill or liquid form, sourced from homeopathic pharma-
cies ‘Helios’ or ‘Vital Homeopathics’, packaged and sent
to participants by Marlow Homeopathic Clinic.
Comparison group
Parents and children received 4 visits at 6 week intervals
from the same practitioner, with a similar amount of con-
tact time to the treatment group. No remedies or placebo
remedies were prescribed or lifestyle advice given and
the practitioner did not ask the kind of questions expected
in a homeopathic interview, but engaged in friendly, sym-
pathetic conversation.
Outcome measurement
Two outcome measures were completed by parents. The
Conners’ Parent Rating Scale erevised long version
(CPRS:R-L)
25
is a well-known validated outcome scale de-
signed for assessing ADHD symptoms, and consists of an
80 item measure measuring six different subscales and
seven different global ratings including the Diagnostic
and Statistical Manual of Mental Disorders 4th edition
(DSMIV) total score, which was selected for analysis pur-
poses.
The Measure Your Own Medical Outcome Profile (MY-
MOP)
26,27
is a patient generated outcome measure
consisting of self-chosen items measured using a Likert
scale (0 (as good as it could be) to 6 (as bad as it could
be)) which allows parents to select their key concerns
(two symptoms considered most bothersome, an activity
the condition limits participation in, and wellbeing) and
document how they change over time. Although validated
for use by adults, it has not previously been used by a
parent reporting on behalf of a child. Total scores are
computed by averaging the four items, with diminution
of scores representing improvement. Teenagers completed
their own MYMOP forms in addition to their parents.
MYMOP was completed at the end of each consultation,
CPRS:R-L at the end of consultation 1 (baseline), 4 (4
months) and 8 (one year). Measures were completed
without input from the researcher unless the parent was
Figure 1 Recruitment and treatment progression.
ADHD case series
P Fibert et al
3
Homeopathy
Please cite this article in press as: Fibert P, et al., A comparative consecutive case series of 20 children with a diagnosis of ADHD receiving homeopathic
treatment, compared with 10 children receiving usual care, Homeopathy (2015), http://dx.doi.org/10.1016/j.homp.2015.09.008
unable to fill in the form due to reading or writing diffi-
culties, in which case the practitioner read the form to
the parent and filled in their verbal responses.
If participants were found to have missed out any items
of CPRS:R-L the previous score for that item was
substituted; substituted scores were therefore ‘no change’
scores. MYMOP total scores were mean calculations,
therefore if items were missing, the mean was calculated
based on the number of answers given.
Statistical tests
Statistical analysis addressed two questions: did homeo-
pathic treatment provide adjunctive benefits compared to
similar time and attention? And were the effects of homeo-
pathic treatment cumulative?
The first question (primary analysis) compared usual
treatment + homeopathic treatment with usual treat-
ment + similar time and attention, at baseline and 4 months
using 2 2 mixed analysis of variance (ANOVA) where
the independent variable was treatment status with two cat-
egories: treatment and non-treatment. The dependent vari-
ables were either standardized DSM1V total scores or
average MYMOP scores measured at two time points
(baseline and 4 months) to examine whether improvement
over time depended on group.
To explore the long term effects of homeopathic treat-
ment (secondary analysis), repeated measures t-tests
were applied to the treated population at baseline, 4 months
and one year, measuring change in DSMIV total scores and
average MYMOP scores.
Feasibility
A range of recruitment methods, intervention venues,
and homeopathic methodologies were explored to develop
optimum protocols.
Results
Participant characteristics
Children came from the following recruitment venues:
ADHD support groups (N = 13); word of mouth (N = 8);
local schools and youth clubs (N = 4); police family inter-
vention project (buckscc.gov.uk) (N = 3); and an early
intervention and prevention local government project
(buckscc.gov.uk) (N = 2). They came from three counties
in England: Buckinghamshire, Oxfordshire and Northamp-
tonshire.
One child was found not to have a medically confirmed
diagnosis of ADHD at the initial consultation. Three chil-
dren from two families failed to attend two consecutive
follow ups. Two children did not complete a full year of
treatment due to family issues (marital abuse and ill health
of a sibling) (Figure 1).
All children had received a diagnosis of ADHD from
their consulting physician as reported by parents. All chil-
dren met the threshold for an ADHD diagnosis according
to parent completed baseline Conners’ DSMIV scores
(mean 84.7, SD 5.33) (Table 1).
Children were between 5 and 16 years old (average
age = 11, SD 2.9). Five participants were female. Half the
children attended primary schools and half secondary
schools. Thirteen children attended special schools, whilst
the remainder attended local schools with additional sup-
port. Two children had criminal records. Children had di-
agnoses additional to ADHD: autism spectrum disorders
(N = 4), oppositional defiant disorders (N = 4), dyslexia
(N = 4), dyspraxia (N = 2), global developmental delay
and speech delay (N = 1).
Twelve children (4 female and 8 male) were already on
stable doses of conventional medication for at least four
months when they enrolled on the study. The remaining 8
were not taking medication either because they had
stopped due to adverse symptoms (N = 6), or due to ethical
concerns (N = 2). All participants were under the care of a
paediatrician. None of the children were engaged in behav-
ioural interventions during the study although five reported
having participated in them in the past. Families were
involved in a variety of services to manage their children:
police, social services, educational interventions, ADHD
support groups, behavioural management tools, play ther-
apy and counselling.
A similar number of control and treatment group chil-
dren took pharmaceutical medication and all girls were
on medication. Children in the treatment group were
younger than the control group but this difference was
non-significant (p = 0.583). The control group had a
smaller percentage of females (10% compared to 20%).
Data management
One parent was unable to complete the outcome mea-
surements due to dyslexia. Outcomes were therefore read
out and filled in by the researcher.
Twenty items out of 6400 were missing from CPRS:R-L.
These were substituted with previous scores. Missing data
in MYMOP occurred in three cases where one item was
missed out. The average was calculated for three instead
of four scores in each case.
Statistical results
SPSS statistical software was used. An alpha level of .05
was used for all statistical tests. Tests were corrected for
multiple comparisons using the Bonferroni correction pro-
cedure. Visual examination of histograms and skew and
kurtosis values showed data to be normally distributed
and Mauchley’s test of sphericity was non-significant
(.199, DSMIV; .162 MYMOP).
Table 1 Comparison of Treatment and Control group
characteristics
Treatment group Control group
Pharmaceutical
Medication status
12/20 take
meds (60%)
(4 female)
6/10 take
meds (60%)
(1 female)
Sex 20% female 10% female
Age mean = 10.15
(SD 2.7)
mean = 11.8
(SD 2.8)
ADHD case series
P Fibert et al
4
Homeopathy
Please cite this article in press as: Fibert P, et al., A comparative consecutive case series of 20 children with a diagnosis of ADHD receiving homeopathic
treatment, compared with 10 children receiving usual care, Homeopathy (2015), http://dx.doi.org/10.1016/j.homp.2015.09.008
Homogeneity of variance assumptions were not met for
DSMIV time 2 and were not improved by data transforma-
tion.
Primary analysis:Data examination of the two groups
found similar means, variances and ranges at baseline. At
4 months, treatment group mean scores decreased whilst
control group means remained similar, indicating the direc-
tion of subsequent statistical tests. The range and variance
amongst the treated group changed at 4 months, whilst re-
maining similar for the control group (see Table 2).
A significant interaction between time (baseline and 4
months) and group (treatment and non-treatment) was
found using Multivariate test Wilks Lambda (see Figure 2):
Secondary analysis:The intervention was associated
with statistically significant improvements in the treated
group compared to itself between baseline and one year
CPRS-R:L (t (18) = 4.529, p = 0.000) and MYMOP (t
(18) = 6.938, p = 0.000) (see Table 3). The largest mean
score change occurred in the first 4 months.
The increase in standard deviation over time can be un-
derstood by looking at individual change scores of treated
children: five scores remained similar over 1 year, and five
experienced large improvements (over 20 percentiles) (see
Figure 3).
Feasibility
Recruitment of control participants only yielded half the
participants required for the equally sized groups initially
proposed. Recruitment to the treatment group was feasible.
Participants were recruited via ADHD support groups and
charities where a positive and personal relationship was es-
tablished. Recruitment of a broad representative sample,
for example including children engaged with support ser-
vices was effective. Recruitment via schools and NHS ser-
vices was ineffective.
Attending appointments was problematic for some partic-
ipants, particularly those engaged with support services but
visiting patients in their own home did not improve uptake.
Best venue was a clinic known to the patient such as an
agency clinic. Worst venue was patient’s home where partic-
ipants were frequently distracted or absent, or had the TVon,
was more costly and less time efficient to the homeopath.
Although some participants took medicines inappropri-
ately, lost them, or stopped taking them, generally taking
homeopathic medicines was acceptable and well imple-
mented. Regular consultations allowed for adjustment
and correction and appeared to be important for this popu-
lation particularly. Four months was sufficient to show
change between groups. However results after one year
showed further improvement. It was a surprise observation
that children involved with the criminal justice system at
the start of treatment reduced their involvement.
Table 2 Descriptive statistics control v treatment at baseline and 4 months
Treatment (N = 20) Control (N = 10) Treatment (N = 20) Control (N = 10)
Base-line Mean
(SD)
DSMIV 85 (5.1) 84.1 (5.9) 4 months 76.2 (10.9) 83.4 (6.7)
MYMOP 4.53 (.63) 4.73 (.85) 2.84 (1.33) 4.76 (.73)
Variance DSMIV 26.1 35.88 119.6 44.5
MYMOP 0.4 0.73 1.77 0.53
Range DSMIV 16 16 33 21
MYMOP 2.00 2.50 5.75 1.75
Figure 2 Time treatment over 4 months.
Table 3 Descriptive statistics of the treated group at 3 time points
Baseline 4 months 1 year
DSMIV (SD) 85 (5.1) 76.2 (10.9) 71.5 (12.77)
MYMOP (SD) 4.53 (.63) 2.84 (1.33) 2.17 (1.24)
0.756 F (1,28) = 9.06, p = 0.005 (DSMIV)
0.721 F (1,28) = 10.85, p = 0.003 (MYMOP)
ADHD case series
P Fibert et al
5
Homeopathy
Please cite this article in press as: Fibert P, et al., A comparative consecutive case series of 20 children with a diagnosis of ADHD receiving homeopathic
treatment, compared with 10 children receiving usual care, Homeopathy (2015), http://dx.doi.org/10.1016/j.homp.2015.09.008
A novel methodology based on isopathic prescriptions
of parent reported environmental stressors
28
was found to
be particularly effective.
The outcome measure CPRS-R:L was found to be too
long and in too small print for some parents, several of
whom also had ADHD or other learning difficulties. MY-
MOP was acceptable to parents. They measured similar
levels of statistical significance.
Homeopathic treatment
Homeopathic remedies required daily administration to
retain their effectiveness and when stopped, symptoms
tended to return. No potency was observed to be more effi-
cacious overall.
Eleven different remedies were used, namely: stramo-
nium (4), tuberculinum (3), Calcarea carbonica (3), medor-
rhinum (2), carcinosin (2) aranea ixobola (1), baryta carb
(1), lac delphinum (1), sulphur (1), syphilinum (1), lycopo-
dium (1).
Additional to their individualized remedies, 4 children
were treated using a novel homeopathic methodology
whereby an environmental substance suggested by the
parent to be causative or aggravating was given.
28
These
children received 30c, 200c, 1 M and 10 M potencies of
cannabis, launderette chemicals, anti-psychotic drugs or
anti-biotics.
Five children (25%) did not measure any benefit
from homeopathic treatment. Issues such as difficult,
on-going stressful family situations, dietary sensitivities,
and inability to find an appropriate remedy may explain
this.
Five children (25%) measured large changes. Three had
additional diagnoses of autism spectrum disorders and four
described environmental insults and were treated using
CEASE methodology.
28
Adverse effects
Homeopathic aggravations (transient adverse symp-
toms) were noted in four children after receiving isopathic
potencies of environmental substances. The adverse
symptoms were bruising, increased hyperactivity (2),
a nervous tic. In two cases these prescriptions were dis-
continued according to the wishes of parents and child,
and symptoms resolved within 24 h. In two cases the pre-
scription was continued according to the wishes of
parents and child, and symptoms resolved within two
weeks.
Concomitant pathology
Improvements in other symptoms were described by
parents and recorded by the homeopath: warts, allergies
(animals, dust, pollens etc), chronic lung infection,
eczema, hay fever, nocturnal enuresis, incontinence and
soiling, nightmares, sleep and anger.
Discussion
Study design
Treatment by this homeopath was associated with posi-
tive outcomes, but the study has a number of design weak-
nesses limiting conclusions: a small participant sample,
especially in the control group; participants were selected
consecutively and may not be a true random sample of
the population; outcome measurement was from a single
source eparents aware of their child’s status, in the pres-
ence of the homeopath who was also the researcher, leaving
measurement open to bias (conscious or otherwise).
ADHD diagnosis and change scores were not indepen-
dently verified.
The study was not designed to explore the specific ef-
fects of a component of the homeopathic intervention as
previous trials do. Whilst it is not possible to determine
which components might have been more effective, for
example the remedy or the consultation, the control group
employed suggests that parents felt receiving homeopathic
treatment was more beneficial than a sympathetic chat.
Because there was only one practitioner, results strictly
relate to the ability of that practitioner. Other ADHD home-
opathy studies also have single homeopaths.
A strength of the study was the freedom to prescribe
individualized homeopathic remedies mirroring usual
practice as recommended by the Cochrane systematic re-
view.
19
Suggestions for a future pragmatic clinical trial
design emerge which continue to test the effectiveness of
the intervention as experienced in real life, thus retaining
external and ecological validity, but improving internal val-
idity and generalisability: random group allocation;
blinded outcome measurement by teachers or physicians;
measurement of objective outcomes of interest to stake-
holders such as cost effectiveness, criminality and school
exclusion; treatment in several sites by several homeo-
paths; and a larger sample size.
Figure 3 Changes in individual DSMIV scores of treated children
over one year.
ADHD case series
P Fibert et al
6
Homeopathy
Please cite this article in press as: Fibert P, et al., A comparative consecutive case series of 20 children with a diagnosis of ADHD receiving homeopathic
treatment, compared with 10 children receiving usual care, Homeopathy (2015), http://dx.doi.org/10.1016/j.homp.2015.09.008
Homeopathic prescribing
The study explored a variety of methodologies over the
course of one year. ADHD trials to date have tended to test
unusual remedies (selenium and potassium phosphate
complex
10
; valeriana officinalis
11
) or remedies prescribed
using unusual homeopathic methodologies (Boenninghau-
sen
13
; Sensation
14
).
Some children received several different remedies dur-
ing the course of the year according to the progression of
their ADHD symptoms, whilst some received only one.
Because parents described environmental substances they
thought might have influenced their child’s condition, the
practitioner implemented a novel methodology,
28
prescrib-
ing the perceived toxins in homeopathic potency, addi-
tional to their individualized prescription (see
29
for an
individual Case Study). The apparent effectiveness of this
methodology was a surprise finding of this study, although
management of initial adverse effects (or homeopathic ag-
gravations) was also a feature.
The necessity of daily prescriptions has also been re-
ported by other researchers.
12,13
Participants
Recruitment of control participants was problematic and
only recruited half the participants required. Even this was
only achieved via the incentive of subsequent homeopathic
treatment. However, recruitment to the treatment group
was feasible. Children with a wide spectrum of ADHD,
including children already in trouble with the law and
involved with social services, were recruited from agencies
dealing with children in trouble (police support agencies
and social services).
Three of the five children who experienced large
changes (<18 percentiles) had a diagnosis of autism spec-
trum disorder (ASD) in addition to ADHD, suggesting
that further research into ADHD in this sub-group may
be useful. One study
18
has also demonstrated improve-
ments in ADHD in ASDs. Four of the five perceived their
symptoms to be associated with environmental toxicity and
were treated using CEASE methodology.
Measurement tools
MYMOP has not been validated to be completed by the
parent on the child’s behalf, however results were similar to
DSMIV, suggesting that it can be employed in this way.
DSMIV homogeneity of variance assumptions were not
met at time 2. ANOVA is considered to be robust to viola-
tion of the assumption of homogeneity of variance when
sample sizes are equal, but not when they are unequal.
When the larger sample has larger variance, as in this
case, the tendency is for the F ratio to be a conservative es-
timate.
30
Both measures appeared to be similarly sensitive to
change, were acceptable to most parents, well responded
to and understood. Both parents and teenagers found MY-
MOP easy to use, but some parents struggled with
CPRS:R-L, finding there were too many questions too
closely spaced. MYMOP is not a specific measure of
ADHD, and when reporting this study, was found to be un-
acceptable to ADHD researchers and public policy stake-
holders.
Conclusion
The personal, social and financial costs of ADHD are
significant and currently recommended treatments provide
narrow clinical benefits and may have side effects. The ma-
jority of children in this study were on prescribed medica-
tion, however all presented with considerable remaining
problems as represented by their high DSMIV scores at
baseline. The improvements shown by
3
/
4
of the children
suggest that homoeopathy may offer safe, effective adjunc-
tive treatment which improves wider outcomes without
side effects; or alternative treatment for children who do
not respond, or respond adversely, to conventional medica-
tions. Further, more methodologically rigorous research is
warranted to explore this systematically.
It is of note that improvement was cumulative with
continuing homeopathic treatment. One other long term
study has looked at 10 year effects of ongoing homeopathic
treatment
31
and also observes this. Evidence suggests
converse effects with pharmacological and behavioural
treatments.
32e34
Homeopathy trials for ADHD conducted to date have
not represented homeopathy as practiced in the real
world, and may underestimate effects: remedies are
potentially inappropriately applied; the effects of the ho-
meopathic consultation are not measured; the effects of
interactions are not measured. Pragmatic studies of treat-
ment by homeopaths in real world settings will give better
estimates of the clinical effectiveness of homeopathic
treatment and provide more useful information to stake-
holders than the results of trials comparing placebo to ve-
rum homeopathic remedies. Only once the effectiveness
of real world clinical treatment has been established,
should future research attempt to unpick any of the inter-
acting specific effects of components of treatment by a
homeopath (the remedy, the consultation and the applica-
tion of the principles of homeopathy) (Relton et al 2008).
While the current study had design limitations, these pre-
liminary results suggest that treatment by a homeopath
may be useful as practiced in the real world and further
study is warranted.
Conflictsofinterest
None.
Acknowledgements
Children’s homeopathic treatment was paid for by Tur-
ner’s Court Youth Trust and The Homeopathic Research
Institute.
ADHD case series
P Fibert et al
7
Homeopathy
Please cite this article in press as: Fibert P, et al., A comparative consecutive case series of 20 children with a diagnosis of ADHD receiving homeopathic
treatment, compared with 10 children receiving usual care, Homeopathy (2015), http://dx.doi.org/10.1016/j.homp.2015.09.008
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ADHD case series
P Fibert et al
8
Homeopathy
Please cite this article in press as: Fibert P, et al., A comparative consecutive case series of 20 children with a diagnosis of ADHD receiving homeopathic
treatment, compared with 10 children receiving usual care, Homeopathy (2015), http://dx.doi.org/10.1016/j.homp.2015.09.008
... Three of these were excluded, because they did not use individualized homeopathy, leaving seven potential studies. 24,25,[40][41][42][43][44] One of the placebo-controlled studies 44 was excluded from the analysis, because it was poorly documented, did not use a validated score, and had a non-randomized pilot-study design. Thus, we included six studies, four double-blind placebo-controlled studies and two active-controlled open-label studies, one of which was nonrandomized. ...
... Excluding Filbert et al. 41 as a sensitivity analysis, because this study used a slightly different outcome (DSM-IV rating) does not homogenize the sample and reduces the effect size slightly to g = 0.534 (95% CI 0.11-0.96; z = 2.46, p = 0.014). ...
... Our data show it might be worthwhile: an effect size of 0.6 standard deviations is clinically relevant and in our analysis also statistically robust. 41 Oberai et al. 25 Jones 43 Frei et al. 24 Jacobs et al. 42 Oberai et al. 25 Jones 43 Frei et al. 24 Jacobs et al. 42 1 Fig. 3 Forest plot of placebo-controlled studies of homeopathy in attention deficit and hyperactivity disorder. ...
Article
Full-text available
Background Attention deficit and hyperactivity disorder (ADHD) prevalence is increasing, compliance to treatment is often poor, and additional treatment options are warranted. We aim to investigate whether individualized homeopathic treatment is effective in children with ADHD when compared to placebo or usual care alone. Methods Thirty-seven online sources were searched with a last update in March 2021. Studies investigating the effects of individualized homeopathy against any control in ADHD (ICD-10 category F90.0) were eligible. Data were extracted to a predefined excel sheet independently by two reviewers. Results Six studies were analyzed. All but one were randomized and showed low-to-moderate risk of bias; two were controlled against standard treatment and four were placebo-controlled and double-blinded. The meta-analysis revealed a significant effect size across studies of Hedges’ g = 0.542 (95% CI 0.311–0.772; z = 4,61; p < 0.001) against any control and of g = 0.605 (95% CI 0.05–1.16; z = 2.16, p = 0.03) against placebo ( n = 4). The effect estimations are based on studies with an average sample size of 52 participants. Conclusions Individualized homeopathy showed a clinically relevant and statistically robust effect in the treatment of ADHD. Impact This paper summarizes the current evidence of individualized homeopathy in attention deficit and hyperactivity disorder (ADHD), and the results show a clinical improvement for patients receiving this additional treatment. Individualized homeopathy has shown evidence of effectiveness in the treatment of ADHD in several small trials, this is the first systematic review and meta-analysis. This data may encourage caregivers to consider co-treatment or referral to individualized homeopathy when treating childhood ADHD.
... This case report documents the treatment by this author, (a qualified homeopath) of two siblings with multi-morbidities including Attention Deficit Hyperactivity Disorder (ADHD) during 1 year. The siblings took part in a comparative consecutive case series of 30 children with diagnoses of ADHD receiving homeopathic treatment or usual care carried out between 2010 and 2013, [1]. Additional permission to publish these case reports was received from the family. ...
... The medicine was prescribed in descending potencies (10 M, 1 M, 200c, 30c, 12c, 6c)a different potency to be taken each day of the week, and repeated weekly. 1 Both children were also given an isopathic prescription consisting of homeopathic potencies of substances they were allergic to in 6 c potency 2 and instructed to take them twice daily, and before exposure to any known allergens. Both were also given a clinical, complex prescription of several homeopathic medicines considered to aid sleep (Narayani calming pills [21]) 3 and instructed to dissolve a pill in water every evening, and take a sip every 5 min. ...
... From the mother's responses and from questioning and observing the child, the homeopathic medicine carcinocin was prescribed in descending potencies. 1 This medicine is indicated for individuals who are sympathetic, affectionate and anxious about others, don't like being reprimanded, find concentrating difficult, tend to excessive weariness, tend to have aching, rheumatic pains in the limbs, asthma, eczema, and insomnia [20]. ...
Article
Introduction Homeopathy is a system of therapeutics based on the Law of Similars where ‘like cures like’, using highly diluted substances that cause, in healthy persons, symptoms like those to be treated. Patients are prescribed for on an individual rather than diagnosis specific basis. This case report describes the progress of two siblings with multiple diagnoses (including ADHD), on multiple medications, receiving homeopathic treatment during one year. Multi-morbidity is a growing problem. Separate medicines are prescribed for each complaint resulting in polypharmacy, which is associated with increased incidence of adverse drug reactions. Methods The siblings received a variety of individualised homeopathic medicines, prescribed according to classical, clinical and isopathic methodologies. DSMIV ADHD total scores were measured every 4 months; and self-selected symptoms were measured using ‘Measure Your Own Medical Outcome Profile’ (MYMOP) during the 6 weekly consultations. Results Before treatment Sibling 1’s DSMIV total T score was 90+ (highest possible), MYMOP score was 5.25. Sibling 2’s DMSM total T score was 86, MYMOP score was 5.25. The siblings were on 8 medications each. After one year Sibling 1’s DSMIV total T score was 50 (normal range), MYMOP score 0.25. Sibling 2’s DSMIV total T score was 53, MYMOP score 0.00. Sibling 1 was not taking any conventional medications and sibling 2 was taking one medication. Conclusion Treatment by a homeopath employing a variety of homeopathic methodologies and medicines over 1 year was associated with improvements in ADHD status, patient generated outcomes, parent reported pathology and reduction in conventional medication. No causal conclusions on treatment efficacy can be derived, nor the effects of homeopathic medicines separated out from the reduction in conventional medicines. More systematic research is warranted to tease out these effects, and should document treatment by homeopaths as experienced in clinical practice to explore therapeutic potential.
... This case report documents the treatment by this author, (a qualified homeopath) of two siblings with multi-morbidities including Attention Deficit Hyperactivity Disorder (ADHD) during 1 year. The siblings took part in a comparative consecutive case series of 30 children with diagnoses of ADHD receiving homeopathic treatment or usual care carried out between 2010 and 2013, [1]. Additional permission to publish these case reports was received from the family. ...
... The medicine was prescribed in descending potencies (10 M , 1 M, 200c, 30c, 12c, 6c) a different potency to be taken each day of the week, and repeated weekly. 1 Both children were also given an isopathic prescription consisting of homeopathic potencies of substances they were allergic to in 6 c potency 2 and instructed to take them twice daily, and before exposure to any known allergens. Both were also given a clinical, complex prescription of several homeopathic medicines considered to aid sleep (Narayani calming pills [21]) 3 and instructed to dissolve a pill in water every evening, and take a sip every 5 min. ...
... [12] Despite over a century of scientific endeavour, effective conventional treatment options for dementia are still lacking in conventional medicine. Homeopathic treatment has been reported to be useful in some psychiatric disorders such as Schizophrenia [13] , Depression [14] , attention deficit hyperactivity disorder [15] , Autism [16] , and obsessive compulsive disorder, [17] but there is a dearth of the literature in homoeopathy that shows usefulness in neurocognitive disorders such as dementia except for a series of three cases of elderly, institutionalized patients with problems relating to dementia which reported a good response to homeopathic medicines. [18] There are different approaches to homeopathic prescribing. ...
... 26 Patient and public involvement The STAR project was preceded by a case series. 27 Families with children with ADHD participating in this preceding study expressed frustration at the lack of helpful treatment options and a desire to support research testing new treatments which might help their children. These families contributed to the design of the STAR project including: the design and piloting of the study questionnaire where an extra open-ended question 'use this space for anything else you would like to tell us' was added (see online supplemental appendix 1); and the generation of an interactive hip-hop rap performance called Lost Voices based on participating family's stories, which was widely shared on Facebook and helped increase recruitment. ...
... 26 Patient and public involvement The STAR project was preceded by a case series. 27 Families with children with ADHD participating in this preceding study expressed frustration at the lack of helpful treatment options and a desire to support research testing new treatments which might help their children. These families contributed to the design of the STAR project including: the design and piloting of the study questionnaire where an extra open-ended question 'use this space for anything else you would like to tell us' was added (see online supplemental appendix 1); and the generation of an interactive hip-hop rap performance called Lost Voices based on participating family's stories, which was widely shared on Facebook and helped increase recruitment. ...
Article
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Objective To identify interventions being used to manage attention-deficit/hyperactivity disorder (ADHD) in the UK. Design A survey within the Sheffield Treatments for ADHD Research project. A convenience sample of participants in the UK who consented to join an observational cohort were asked closed questions about medication, behavioural change programmes and service use, and an open-ended question about what else they used. Setting A broad variety of non-National Health Service, non-treatment seeking settings throughout the UK, including local authority organisations, schools, ADHD and autism spectrum condition support groups and social media. Participants Families of children aged 5–18 with carer reported ADHD and Conners Global Index (CGI) T scores of 55+. Results Responses from 175 families were analysed. The mean age of the children was 10.21 (2.44), and two-thirds (n=114) had additional diagnoses. The majority used medications to manage ADHD (n=120) and had participated in a parenting class (n=130). Just over a quarter (28%, n=49) did not use ADHD medications, and used sleep medications. Just under half had consulted psychologists (n=83), and 32 had participated in other talking therapies such as psychotherapy, counselling and cognitive–behavioural therapy. A few used aids such as reward charts or fiddle toys (n=17) and participated in activities (mostly physical) (n=14). A substantial minority (78/175) had used non-mainstream treatments, the most popular being homoeopathy (n=32), nutritional interventions (n=21) and bodywork such as massage or cranial osteopathy (n=9). Conclusions Families reported use of a wide variety of treatments to help with management of their children with ADHD in addition to their use of mainstream treatments.
... Sample size for the pilot trial is calculated to recruit at least 30 participants in each arm in order to estimate the pooled standard deviation of the outcome with a reasonable degree of precision for the full trial [48,49]. We have estimated that attrition will be 20% based on a preliminary feasibility-controlled case series [50] and that a further 20% joining the STAR cohort will either not meet the first trial inclusion criteria or not accept the offer of treatment. ...
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Background Attention deficit hyperactivity disorder (ADHD) is a common and growing problem and a leading cause of child referrals to Child and Adult Mental Health Services (CAMHS). It is a drain on resources across nationally funded support agencies and associated with negative outcomes such as early criminality, school disruption and antisocial behaviour. Mainstream interventions (pharmacological and behavioural) demonstrate effectiveness whilst implemented, but are costly, often have unwanted side effects and do not appear to be affecting long-term outcomes. Development of a robust evidence base for the effectiveness of current and novel interventions and their impact over the long term is required. The aim of the Sheffield Treatments for ADHD Research (STAR) project is to facilitate a rigorous evidence base in order to provide information about the comparative (cost) effectiveness and acceptability of multiple interventions to key stakeholders. Methods The Trials within Cohorts (TwiCs) design was used to build a cohort of children with a diagnosis of ADHD and conduct a three-armed pilot trial of the clinical and cost effectiveness of two novel interventions: (a) treatment by nutritional therapists and (b) treatment by homoeopaths, compared to (c) treatment as usual. Participants are recruited to the STAR long-term observational cohort, and their outcomes of interest (ADHD symptoms, health-related quality of life, school disruption, resource use and criminality) are measured every 6 months by carers and (blinded) teachers. Two promising interventions were identified for the first randomised controlled trial embedded in the cohort. A random selection of eligible participants is offered treatments (a) and (b). The outcomes of those offered treatment are compared to those not offered treatment using intention to treat (ITT) analysis. The feasibility of recruiting to the cohort and the trial, delivering the interventions, the effectiveness of the interventions and the appropriateness, sensitivity and collectability of outcomes is trialled. Discussion The results of this trial will provide information on the feasibility of the TwiCs design to facilitate multiple trials of potential interventions for children with ADHD, and the acceptability, clinical and cost effectiveness of two potential interventions for ADHD to ADHD stakeholders including service providers. Future stages of the STAR project will test other treatments informed by the results in stage 1. Trial registration ISRCTN number 17723526. 10.1186/ISRCTN17723526. Date assigned 27/4/15.
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An open-label pilot study of individualized homeopathy for attention deficit hyperactivity disorder (ADHD) was conducted to assess the potential for future studies with a focus on the feasibility of the recruitment plan and outcome measure schedules; identification of any group characteristics of participants who respond significantly to the therapy; and establishing the length of time required for an improvement in ADHD symptoms. Participants (aged 6-16) were recruited through community advertisement and outreach. Participants completed 1 screening and 9 individualized homeopathic follow-up consultations. ADHD symptoms were assessed using the Conners 3 - Parent Questionnaire administered at each consultation. The pre- and post-study difference in Conners Global Index - Parent (CGI-P) T-score was evaluated for each participant. Baseline data of those who showed a statistically significant improvement (responders) were compared to those who did not (non-responders). 35 participants were enrolled over 11 months. 80% completed all 10 consultations in a median of 12.1 months. 63% had a statistically significant improvement in the primary outcome, first occurring after a mean of 4.5 visits. Overall scores for participants completing at least 2 data points decreased from a baseline median of 85.5 to 74.0 (p < 0.001, CI 95%). There were no significant baseline differences between responders and non-responders. No serious adverse events related to the therapy were reported. The change in the median CGI-P T-score from baseline to the end of this open-label pilot study was statistically significant. The research methods are feasible. Future studies are warranted. NCT01141634. © 2014 S. Karger GmbH, Freiburg.
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Attention deficit hyperactivity disorder (ADHD) is an increasingly prevalent behavioural disorder characterised by inattention, impulsivity and hyperactivity. Valeriana officinalis is a botanical medicine that has been found to be beneficial in the treatment of disorders characterised by restlessness. To date, no research has been conducted on homeopathic preparations of Valeriana officinalis for this condition. The aim of this three-week, double-blind, placebo-controlled pilot study was to determine the efficacy of homeopathic Valeriana officinalis mother tincture (MT) and 3X potency on ADHD. Thirty children between the ages of five and 11 years, pre-diagnosed with ADHD, were recruited. Valeriana officinalis MT (n = 10), 3X (n = 10) or placebo (n = 10) were administered orally three times a day for two weeks. Efficacy was assessed by the Barkley and DuPaul teacher rating scale, the children's checking task and the parent symptom questionnaire scores on day 1 (prior to treatment), at the end of weeks two and three (with treatment), and then after the third week following no treatment. A statistically significant improvement was found in the participants' behaviour in the MT and 3X groups, with particular reference to sustained attention, anxiety and impulsivity and/or hyperactivity. Preliminary findings suggested that Valeriana officinalis MT and 3X may have applications in the management of ADHD.
Article
Introduction: ADHD is a common and growing problem which manifests and is diagnosed via a cluster of behaviours such as inability to regulate emotions or manage motivational delay and problems with executive functioning. It frequently accompanies autism spectrum disorders and dyslexia. Homoeopathy is a system of therapeutics based on the Law of Similars where 'like cures like'. Conditions are treated by highly diluted substances that cause, in healthy persons, symptoms like those of the condition to be treated. The aim of this case report is to describe the homoeopathic treatment and progress of one 16 year old youth with diagnoses of ADHD, Asperger's syndrome and dyslexia subjected to in-utero cannabis exposure. Methods: The youth received individualised homoeopathic medicines and additional ultra-molecular dilutions of cannabis. Outcome was measured using the parent completed Conner's Parent Rating Scale-Revised-Long version (CPRS:R-L) every 4 months, with DSMIV total score selected for analysis; and Measure Your Own Medical Outcome Measure (MYMOP) every 6 weeks, completed by parent and patient. Results: At start of treatment the patient's DSMIV total T score was 90+ (highest possible); after 18 months it was 59 (within normal range). MYMOP score at start of treatment was 4.5 and 1.75 after 18 months. Conclusion: Treatment by a homoeopath over 1 1/2 years was associated with improvements in ADHD status and patient generated outcomes. Ultra molecular dilutions of a recreational drug the patient was subjected to in-utero appear to have contributed to improvements. Systematic research with larger numbers would be required to confirm or refute this single case observation.