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Homeopathic treatment of children with attention deficit hyperactivity disorder: A randomised, double blind, placebo controlled crossover trial

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Unlabelled: An increasing number of parents turn to homeopathy for treatment of their hyperactive child. Two publications, a randomised, partially blinded trial and a clinical observation study, conclude that homeopathy has positive effects in patients with attention deficit hyperactivity disorder (ADHD). The aim of this study was to obtain scientific evidence of the effectiveness of homeopathy in ADHD. A total of 83 children aged 6-16 years, with ADHD diagnosed using the Diagnostic and Statistical Manual of Mental Disorders-IV criteria, were recruited. Prior to the randomised, double blind, placebo controlled crossover study, they were treated with individually prescribed homeopathic medications. 62 patients, who achieved an improvement of 50% in the Conners' Global Index (CGI), participated in the trial. Thirteen patients did not fulfill this eligibility criterion (CGI). The responders were split into two groups and received either verum for 6 weeks followed by placebo for 6 weeks (arm A), or vice-versa (arm B). At the beginning of the trial and after each crossover period, parents reported the CGI and patients underwent neuropsychological testing. The CGI rating was evaluated again at the end of each crossover period and twice in long-term follow-up. At entry to the crossover trial, cognitive performance such as visual global perception, impulsivity and divided attention, had improved significantly under open label treatment (P<0.0001). During the crossover trial, CGI parent-ratings were significantly lower under verum (average 1.67 points) than under placebo (P =0.0479). Long-term CGI improvement reached 12 points (63%, P <0.0001). Conclusion: The trial suggests scientific evidence of the effectiveness of homeopathy in the treatment of attention deficit hyperactivity disorder, particularly in the areas of behavioural and cognitive functions.
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ORIGINAL PAPER
Heiner Frei Æ Regula Everts Æ Klaus von Ammon
Franz Kaufmann Æ Daniel Walther
Shu-Fang Hsu-Schmitz Æ Marco Collenberg
Katharina Fuhrer Æ Ralph Hassink Æ Maja Steinlin
Andre
´
Thurneysen
Homeopathic treatment of children with attention deficit hyperactivity
disorder: a randomised, double blind, placebo controlled crossover trial
Received: 8 March 2005 / Revised: 23 May 2005 / Accepted: 1 June 2005 / Published online: 27 July 2005
Ó Springer-Verlag 2005
Abstract An increasing number of parents turn to
homeopathy for treatment of their hyperactive child.
Two publications, a randomised, partially blinded trial
and a clinical observation study, conclude that home-
opathy has positive effects in patients with attention
deficit hyperactivity disorder (ADHD). The aim of this
study was to obtain scientific evidence of the effective-
ness of homeopathy in ADHD. A total of 83 children
aged 6–16 years, with ADHD diagnosed using the
Diagnostic and Statistical Manual of Mental Disorders-
IV criteria, were recruited. Prior to the randomise d,
double blind, placebo controlled crossover study, they
were treated with individually prescribed homeopathic
medications. 62 patients, who achieved an improvement
of 50% in the Conners’ Global Index (CGI), partici-
pated in the trial. Thirteen patients did not fulfill this
eligibility criterion (CGI). The responders were split into
two groups and received either verum for 6 weeks fol-
lowed by placebo for 6 weeks (arm A), or vice-versa
(arm B). At the beginning of the trial and after each
crossover period, parents reported the CGI and patients
underwent neuropsychological testing. The CGI rating
was evaluated again at the end of each crossover period
and twice in long-term follow-up. At entry to the
crossover trial, cognitive performance such as visual
global perception , impulsivity and divided attention,
had improved significantly under open label treatment
(P<0.0001). During the crossover trial, CGI pa rent–
ratings were significantly lower under verum (average
1.67 points) than under placebo (P=0.0479). Long-term
CGI improvement reached 12 points (63%, P<0.0001).
Conclusion: The trial suggests scientific evidence of the
effectiveness of homeopathy in the treatment of atten-
tion deficit hyperactivity disorder, particularly in the
areas of behavioural and cognitive functions.
Keywords Attention deficit hyperactivity disorder Æ
Homeopathy Æ Indiv idualised treatment Æ Randomised
double blind trial Æ Treatment effectiveness
Abbreviations ADHD: attention deficit hyperactivity
disorder Æ CGI: Conners’ global index Æ CPRS: Conners’
parent rating scale (long form) Æ CTRS: Conners teacher
rating scale Æ DSM-IV: diagnostic and statistical manual
of mental disorders Æ K-ABC: Kaufman assessment
battery for children Æ QCB: questionnaire of change of
behaviour Æ TAP: test battery for attention performance Æ
VLMT: German version of the Rey auditory verbal
learning test (RAVLT) Æ WISC-III: German version of
Wechsler intelligence scale for children
Introduction
The attention deficit hyperactivity disorder (ADHD/
ADD) is a combination of disturbed attention (visual,
H. Frei
Swiss Association of Homeopathic Physicians SAHP,
Lucerne, Switzerland
R. Everts Æ F. Kaufmann Æ D. Walther Æ K. Fuhrer
M. Steinlin (&)
Division of Paediatric Neurology, University Children’s Hospital,
Inselspital, 3010 Berne, Switzerland
E-mail: maja.steinlin@insel.ch
Tel.: +41-31-6329424
Fax: +41-31-6329500
K. von Ammon Æ A. Thurneysen
Kollegiale Instanz fu
¨
r Komplementa
¨
rmedizin
(KIKOM)/Homeopathy, Imhoof Pavillon,
Inselspital, 3010 Berne, Switzerland
E-mail: andre.thurneysen@kikom.unibe.ch
Tel.: +41-31-6329758
Fax: +41-31-6324263
S.-F. Hsu-Schmitz Æ M. Collenberg
Department of Mathematical Statistics and Actuarial Science
(IMSV), University of Berne, Berne, Switzerland
R. Hassink
Zentrum fu
¨
r Entwicklungsfo
¨
rderung und pa
¨
diatrische
Neurorehabilitation, Bienne, Switzerland
Eur J Pediatr (2005) 164: 758–767
DOI 10.1007/s00431-005-1735-7
tactile, auditory and proprioceptive) and hyperactivity/
impulsivity or passivity. Diagnostic criteria for the
disorder are six or more symptoms of either inatten-
tion, hyperactivity/impulsivity, or both [2]. ADHD is
one of the most common disorders of childhood,
occurring in 3%–5% of children, with male to female
ratios ranging from 3:1 to 9:1 [16]. Common medical
treatments are stimulants which fall under the legis-
lation for narcotics. Parents who do not want such
medication for their child increasingly seek homeo-
pathic alternatives [5,10]. Homeopathy is claimed to
influence disease using the effect of highly diluted
substances, chosen according to the characteristic
individual symptoms of the patient. The aim of the
homeopathic physician is to find the specific remedy
that corresponds accurately to the individual symp-
toms of the patient [11]. Since this process depends on
precise observations by patients or parents, the initial
phase of treatment is often char acterised by the use of
different medications until an optimal response is
reached. The effectiveness of homeopathy, in which
the active substance is no longer traceable due to its
high dilution, is controversial.
Positive effects of homeopathy on ADHD symp-
toms have been observed in a randomised, partially
blinded, placebo controlled crossover trial with 43
children by Lamont [17] who found significant treat-
ment effects. In an observation study with open label
treatment, Frei and Thurneysen [8] observed in 86 of
115 children an improvement of 55% in the Conners’
Global Index (CGI) rated by parents. Of the patients
in this study, 22% needed methylphenidate and 3%
reacted neither to homeopathy nor methylphenidate
[8]. A criticism of these trials is that, as they were not
completely blinded, there is no scientific evidence that
the improvements observed were the result of a
treatment effect. Two large meta analys es ha ve, how-
ever, concluded that the clinical effects of home opathic
treatments should not just be interpreted as a placebo
effect [15,20]. The unsatisfactory methodology of many
of the studies analysed have, however, been criticised.
The suggestion that better trials in specific clinical
diseases are necessary to establish scientific evidence
for the effectiveness of homeopathy led to the present
study.
Objectives
The primary objective was to investigate whether
homeopathy is significantly distinct from placebo in the
treatment of ADHD. Neuropsychological tests best
suited to detect differences in children’s performance
during the trial were explored. Secondary objectives
were to define the time needed for satisfactory amelio-
ration of symptoms (i.e. to reach eligibility for the
crossover trial) and to assess the effectiveness of long-
term treatment.
Methods
Design
The need for individually prescribed homeopathic
medication complicates the planning of a double blind
clinical trial, as blinding is only possible after the correct
individual medication for each patient has been found.
Since this process is particularly difficult in ADHD pa-
tients, a straightforward randomised controlled trial was
considered impossible. In our previous study [8], we
made the observation that in early phase of ADHD
treatment with Q-potencies (Liquid homeopathic medi-
cations produced by dilution steps of 1:50,000, admin-
istered daily [ 22]), the improvement attained declines
within 4 weeks after stopping the med ication and reap-
pears if treatment is restarted. The deterioration seen
when early treatment is interrupted could therefore be
used to test the difference between placebo and verum in
a crossover trial and led to the present study design. In
the first phase of this study, children received individu-
ally prescribed homeopathic treatment (screening
phase). Children who achieved a pre-defined level of
improvement then participated in a randomised, double
blind, placebo controlled crossover trial, to study dete-
rioration under placebo.
The double blind part of the study consisted of two
parallel groups of children who received verum (V) for 6
weeks followed by placebo (P) for 6 weeks (arm A: VP),
or placebo for 6 weeks followed by verum for 6 weeks
(arm B: PV). Both arms received another 6 weeks of
open label treatment (arm A: VPV, arm B: PVV) and an
additional long-term follow-up under treatment. The
length of each crossover period was determined using
the data from the previous study [8] and a pre liminary
study in four children which revealed that the carry-over
effect was longer than 4 weeks after stopping treatment.
Since a carry-over effect may be an obstacle for a
crossover trial, relativel y long crossover periods of 6
weeks were chosen. From previous experience, this
duration was thus considered long enough to diminish
this problem. No wash-out time was therefore incorpo-
rated between the two crossover periods.
Eligibility
Eligibility criteria for screenin g phase: age between 6 and
16 years, both genders, confirmed ADHD according to
criteria of the Diagnostic and Statistical Manual of
Mental Disorders (DSM)-IV [2] and known neuropsy-
chological correlates (greater difficulty in learning,
memory, non-automated language tasks, and traditional
frontal executive measures) [6,23], necessity for treat-
ment, absence of any chronic physical, neurological or
psychiatric disorders. Necessity for treatment was as-
sumed if parents or teachers imperatively demanded an
intervention in order to improve the integration and
759
performance of the patient in the family or school. A
primary selection of possible candidates was made using
the Conners’ Parent Rating Scale (CPRS), the Conners’
Teacher Rating Scale (CTRS) [7] and the Kinsbourne
Attention Questionnaire [14]. Patients complying with
the ADHD criteria in these questionnaires underwent
neuropsychological and neurological testing at the
Division of Paediatric Neurology of the University
Children’s Hospital Berne to confirm the ADHD diag-
nosis. Subjects taking methylphenidate were obliged to
stop medication before neuropsychological testing.
Candidates not conforming to rigorous ADHD criteria
in the questionnaires were excluded. Patients were re-
cruited between January 2002 and September 2003 by
referral of informed paediatricians and by information
of regional ADHD parent organisations. All parents
previously knew about their participation in a study
involving homeopathy.
Assessment for confirmation of diagnosis
A 2- to 4 h neuropsychological examination was per-
formed on patients by a paediatric psychologist and a
paediatric neurologist between January 2002 and Sep-
tember 2003. The tests were always arranged in the same
order. The organisation of the session and the time of day
for testing were identical for all subjects in order to avoid
effects of uncontrolled factors on performance. The
investigation included the following tests: Checklist
DSM-IV criteria [2], Kaufman Assessm ent Battery for
Children (K-ABC) [13] or German version of Wechsler
Intelligence Scale for Children (WISC-III) [27], Test bat-
tery for Attention Performance (TAP) [30], the Largo
motor function test [18] and general physical and neuro-
logical examination. Children conforming to all diag-
nostic ADHD criteria, including a parent-rated CGI [7]of
at least 14 points without any treatment, were referred to
the homeopathic paediatrician for individual treatment.
Eligibility criteria for crossover trial
Patients must reach an amelioration of 50% of the initial
CGI value or at least 9 poi nts during the screening
phase. Written informed consent was obtained from the
parents of each child.
Treatment and assessments
Screening phase: Patients entered homeopathic treat-
ment within 1 month after confirmation of diagnosis.
Every eligible child was seen only once at the beginning
of the screening phase by the homeopathic physician to
minimise any further psychological support influencing
ADHD symptoms. They received an individually
prescribed homeopathic treatment daily according to
the guidelines described by Hahnemann [11] and
Boenninghausen [3]. Any other ADHD treatment was
prohibited throughout the who le study perio d and had
to stop immediately or subsequently. Compliance to this
rule was checked by periodical inquiry during treatment
monitoring and neuropsychological assessments. Treat-
ment progress was clinically assessed with parents only,
at intervals of 4 weeks by the homeopathic paediatrician
including regular reporting of the CGI. No other
counselling took place during these sessions. Adjustment
of the medication was made as necessary. The duration
of the screening phase was unlimited.
Crossover trial: Participants eligible for the crossover
trial were referred to the University Children’s Hospital
between September 2002 and February 2004 and as-
signed at random to treatment sequence arm A or B.
Patients, their parents, the investigators and the treating
physician were blind to the assigned treatments and the
treating physi cian had no contact with patients and
parents during the crossov er trial. Children with acute
diseases, serious accidents and severe social changes in
their life during the crossover trial were not assessed for
all endpoints and were considered as dropouts; they
were, however, included in the primary endpoint anal-
ysis according to the intention-to-treat principle.
Open label treatment follow-up: At the end of the
second crossover period, all patients continued on open
label verum-treatment for an unlimited period of time.
Endpoints
The primary endpoint for the crossover trial was the
parents’ rating of CGI, a 10-item rating scale containing
the most important ADHD symptoms (i.e. temper
outbursts/excitable, impulsive/overactive/cries often/
inattentive/fidgeting/disturbs other children/easily frus-
trated/fails to finish things/moods change quickly.
Rating: 0= never, 1= occasionally, 2= often, 3= very
often) [7]. Baseline value for the crossover trial was the
CGI assessed after the screening phase. The CGI and the
Questionnaire of Change of Behaviour (QCB) as well as
VLMT and subtests of WISC-III, K-ABC, Verbal
Learning Test (VLMT) [12] and TAP were evaluated at
the beginning of the crossover trial, after each crossover
period and 6 weeks after the crossover trial. To minimise
learning effects, only a few of these tests were identical
with the diagnostic evaluation. The Connors’ question-
naire was completed again by parents and teachers 14
weeks after the crossover trial and a final CGI was as-
sessed by the homeopathic paediatrician between April
2004 and September 2004 independent of the child’s
current state.
Ethics
The study was conducted in accordance with the Inter-
national Conference on Harmonisation, Guidelines for
Good Clinical Practice [19], the Declaration of Helsinki
760
with all its amendments [29], and in compliance with
relevant regulations for informed consent and protection
of subject rights in Switzerland. The study protocol was
approved by the ethics committee of the Canton of
Berne and Swissmedic. The sponsors had no influence
on the design, implementation and publication of the
study.
Statistics
The samp le size was calculated for the CGI, the primary
endpoint in the crossover trial. A mean reduction of
11.25 points (SD 4.00) in CGI had been observ ed in a
previous homeopathic study [8]. Four weeks after
interruption of treatment, the CGI increased by only 5
points (unpublished observation), indicating a possible
carry-over effect of verum. If this effect were strong,
measurements obtained during the second period should
be ignored [9]. A statistical test of carry-over effect is,
however, not recommended [ 24]. To take into account
the potential carry-over effect and drop-outs, the sample
size was therefore esti mated using the conservative ap-
proach of a t -test for two parallel groups in the first
period. A reduction of 5 points from pre-treatment value
due to verum was considered clinically relevant and a
zero point reduction was assumed under placebo. Tak-
ing into account the possibly greater heterogeneity in
this trial due to a different recruitment practice when
compared with the previous study, the SD was inflated
to 5 for verum and the same value was assumed for
placebo. To have a 5% significance level and a 95%
statistical power, 27 patients were required in each
treatment arm. Hen ce, a total of approximate 50–60
patients was planned. No interim analyses were con-
sidered.
Patient stratification by age and CGI before treat-
ment start was used in the crossover trial: stratum 1: age
6–11 years, baseline CGI 14–21; stratum 2: age 6–11
years, baseline CGI 22–30; stratum 3: age 12–16 years,
baseline CGI 14–21; stratum 4: age 12–16 years, baseline
CGI 22–30. For each stratum, a randomisation list for
50 patients was computer-generated with a block size of
4 by the IMSV at the University of Berne. The random
treatment assignments were sealed in consecutively
numbered envelopes and given to the manufacturer
Spagyros, who produced the homeopathic medications
[11] and their placebos. Spagyros was informed in
writing by the treating physician when a child was eli-
gible for the double blind crossover study. The appro-
priate medication for that child was then prepared
according to the randomisation scheme. The medication
was sent by mail to the participating family at the
beginning of each crossover period. Placebos (20%
alcohol) were indistinguishable from verum in packag-
ing, labelling, colour and taste. There was no contact
between Spagyros, the investigators, the participants
and the treating physician during the crossover trial,
except when a child dropped out due to unexpected
problems.
Fig. 1 Participant flow chart.
Left side: recruitment and
selection of participants for
screening phase. Participant
flow during screening phase and
crossover trial. Right side:
dropouts at all levels
761
The assessments of each outcome variable recorded
at the end of both crossover periods within a patient
were not independent. To analyse such correlated data, a
linear mixed model, including a random patient effect, a
fixed treatment effect and a fixed period effect was ap-
plied using SAS version 8 [4,28]. With this approach,
patients who dropped out after the first crossover period
could also be included in the analysis by assuming
missing at random. For other types of analyses, patients
with missing values were excluded. For selected vari-
ables of behaviour and cognitive performance, the
within-patient differences between diagnosis and
the beginning of the crossover trial were analysed using
the Wilcoxon signed rank test. The changes in CGI from
diagnosis to later time points were analysed by paired
t-test. All significance tests were two-sided. All analyses
of secondary endpo ints were of an exploratory nature
without adjustment for multiple testing. The statistician
was blinded to the sequence of the two study arms.
Results
Recruitment, participant flow and baseline data
A total of 140 children were evaluated and 83 fulfilled
the rigorous criteria to enter the screening process. A
group of 70 children was eligible for and 62 participated
in the crossover study. Eight children dropped out due
to insufficient response to homeopathy (three no re-
sponse at all, five partial responders with a median
improvement of 7 points, range 6–8) and five patients
dropped out due to compliance problems (medi an
improvement 6 points, range 3–8). All data presented
below were collected from the 62 children who partici-
pated in the crossover trial. Figure 1 shows details of the
recruitment phase and the participant flow. Summaries
of the baseline data are presented in Table 1 and Ta-
ble 2. Patient characteristics were similar between
treatment arms (i.e. no statistically significant differences
were found in baseline data between treatment arms
with one exception, number recall (K-ABC, P=0.0284).
The median CGI before treatment was 19 (range 15–
25) on both treatment arms. As usual in groups of
ADHD subjects, cognitive functions of the patients as
a group did not deviate much from the normal popu-
lation means (exception: auditory short term memory,
Table 2).
Screening phase
The 62 children participating in the crossover trial at-
tained the eligibility criteria after a mean treatment
duration of 5.1 months (SD 3.20, range 1–18 months)
with a median CGI of 8 (range 4–15). The following
homeopathic medications were used in potencies be-
tween Q 3 and Q 42 with success (number of patients):
Calcarea-carb. (15), Sulphur (8), Chamomilla (5),
Lycopodium (5), Silica (5), Hepar-sulph. (4), Nux-vom.
(4), China (3), Ignatia (3), Mercurius (3), Capsicum (1),
Causticum (1), Hyoscyamus (1), Phosphorus (1), Phos-
phoric-ac. (1), Sepia (1), Staphysagria (1) [1 ].
The neuropsychological tests assessed at diagnosis
and at entry to the crossover trial allo w comparison of
performance throughout the screening pha se. Highly
significant improvement in visual detection of details,
impulsivity and divided attention were observed
(Table 3).
Crossover trial
Of the 62 randomised patients, 4 dropped out during the
crossover trial, three during crossover period one and
one during crossover period two (3 verum, 1 placebo).
Reasons for drop out were increasing tics, behaviou ral
problems and a reactive depression. Following the
intention-to-treat principle, all 62 patients were included
in the analysis.
Prior to the crossover trial, both treatment arms had
similar CGIs (8, range 3–16 in arm A vs. 9, range 4–20 in
Table 1 Baseline data, diagnostic criteria and CGI data. No statistically significant differences were found in baseline data between
treatment arms
Arm A (n =31) Arm B (n =31)
Baseline data
Gender (girls/boys) 4/27 3/28
Median age (range) 10 (7–15) 10 (7–15)
Social situation (intact family/single parent) 23 (74%)/8 (26%) 20 (65%)/11 (35%)
Prior stimulant treatment 7 (23%) 4 (13%)
Clinical characteristics at diagnosis
DSM-IV criteria
Inattention ( n =56) 27 (87%) 29 (94%)
Hyperactivity/impulsivity ( n =36) 19 (61%) 17 (55%)
Inattention and hyperactivity/impulsivity ( n =31) 15 (48%) 16 (52%)
CGI data
Median before treatment, cut-off <14 (range) 19 (15–25) 19 (15–25)
Median at end of screening phase (range) 8 (5–14) 8 (4–15)
Ratio of changes with respect to before treatment value 58% 58%
762
arm B, Fig. 2, point 1). Within-patient comparison of
treatment effect shows that the CGI, the primary end-
point, decreased under verum with a mean of 1.67 points
(95% CI 3.316, -0.016) compared with placebo, indi-
cating a statistically significant improvement in ADHD
symptoms with verum ( P =0.0479, Table 4). The per-
iod effect was also statistically significant, with a positive
parameter estimate of 2.19. The CGI was therefore on
average 2.19 points higher in crossover period one,
independent of treatment (12, range 3–24, verum in arm
A compared with 13, range 3–25, placebo in arm B,
Fig. 2, point 2). At the end of crossover period two,
ADHD symptoms decreased in children receiving verum
(CGI 9, range 3–19) while children on placebo still had a
high CGI (12, range 4–21) (Fig. 2, point 3). Also, at the
end of the following 6 weeks of open label treatment, the
ADHD symptoms of both treatment groups had re-
turned to around their values at beginning of the
crossover trial (8, range 2–16 in arm A vs. 8, range 2–21
in arm B Fig. 2, point 4).
Exploratory analysis of 70 neuropsychological
parameters during the crossover trial resulted in a few
within-patient differences in behavioural and cognitive
outcomes between placebo and verum, (Table 4): signif-
icantly better resistance to verbal interference in the
VLMT during the verum phase (P=0.0328) and a trend
towards amelioration of stability of mood and in reaction
to unexpected events were observed (P=0.0693 and
P=0.1001, respectively). Conversely, verum resulted in a
significant reduction in alertness to visual details (picture
completion, WISC-III, P=0.0302) and a trend towards
decreasing performance in visual-spatial organisation
(bloc design, WISC-III, P=0.0632).
Open label treatment follow-up
Comparison of the scores CPRS scores between start of
treatment an d 14 weeks after crossover trial still revealed
highly significant improvements in all subscales, in both
Table 2 Baseline data from neuropsychological tests ( BC block counting, DA divided attention, GC gestalt closure, GN go/nogo, HM
hand movements, m mistakes, MA matrix analogies, NR number recall, PS photo series, STM short-term memory, TR triangles, WO
word order)
Arm A ( n =31)
a
Arm B ( n =31)
a
Normal values Baseline values (mean ± SD)
Intelligence
General intelligence (K-ABC) 100±15 96.1±11.8 95.2±7.7
Sequential Processing Scale (K-ABC) 100±15 88.4±13.0 85.5±10.0
Simultaneous Processing Scale (K-ABC) 100±15 101.4±13.1 101.8±10.4
Memory
Sequential short-term memory (K-BC, HM) 10±3 8.5±3.2 8.7±2.5
Auditory abstract STM (K-ABC, NR) 10±3 7.6±2.0 6.3±1.8
Auditory semantic STM (K-ABC, WO) 10±3 8.3±2.9 8.1±2.5
Spatial short term memory (K-ABC, BC) 10±3 10.2±2.5 9.7±2.9
Perception
Visual global (K-ABC, GC) 10±3 10.0±2.6 10.5±2.1
Visual constructive (K-ABC, TR) 10±3 10.4±2.2 9.9±2.5
Executive functions
Inferential thinking (K-ABC, MA) 10±3 10.2±2.5 10.5±2.2
Performance sequences (K-ABC, PS) 10±3 10.1±2.4 10.4±2.5
Attention
Divided attention (TAP, DA, m) 50±10 48.4±11.7 45.2±12.4
Impulsivity (TAP, GN, m) 50±10 41.8±7.7 41.9±11.6
a
No statistically significant differences were found in neuropsychological baseline data between treatment arms (exception attributable to
coincidental: number recall (K-ABC); P =0.0284)
Table 3 Results of screening phase. Total of observed differences in cognitive performance between diagnosis and crossover period one
(Wilcoxon signed rank test). ( C median of reaction time, GCA gestalt closure, SDB standard deviation of reaction time)
Outcome variable Median of differences Difference in %
a
P
b
Effect
Visual global perception (GCA, K-ABC) -3 10.1 0.0001 Improvement
Impulsivity (Go/NoGo, SDB, TAP) -13 17.0 0.1044 Improvement
Impulsivity (Go/NoGo, median C, TAP) 17.5 16.2 0.0001 Improvement
Impulsivity (Go/NoGo, mistakes, TAP) -43 104.2 0.0001 Improvement
Divided attention (SDB, TAP) -30.5 24.1 0.0001 Improvement
Divided attention (median C, TAP) -32 44.3 0.0001 Improvement
Divided attention (missings, TAP) -29 24.6 0.0001 Improvement
Divided attention (mistakes, TAP) -30.5 27.1 0.0001 Improvement
a
Ratio of changes with respect to the before treatment values
b
If P <0.05, then the difference in performance between diagnosis and crossover period one is significantly different from zero
763
mothers’ and fathers’ ratings. Teachers ratings (CTRS)
showed a significant improvement in behaviour, and a
trend in improvement of the CGI. Impulsivity/hyper-
activity and passivity were improved, but did not reach
significance in the teachers observations (Table 5). The
median CGI of the 62 children dropped significantly
from 19 (range 15–25) at treatment start to 8 (range 2–
16) 6 weeks after the crossover trial (Fig. 3). At follow-
up 14 weeks after the crossover trial, however, a rise to
10 points (range 1–18) was observed (Fig. 3). This rise
may be attributable to lack of treatment compliance as
both children and parents were less likely to follow the
strict conditions of the crossover periods during con-
tinued open label treatment. At the final assessment
(median duration of treatment 19 months, range 10–30
months: early entry into the trial led to longer follow-up
times), 53 children reached a median CGI of 7 points
(range 2–15) (Fig. 3), corresponding to an overall
improvement of 63% ( P <0.0001).
Discussion
The necessity of individual prescriptions in homeopathy
is a severe obstacle for any double blind trial. The
present study design, including a screening phase prior
the crossover trial, and analysing deterioration instead
of improvement during crossover trial, enab led us to use
individually prescribed medication in a double blind
trial. Since it is known that homeopathic medications
may produce strong carryover effects and that these ef-
fects may compromise the results of a crossover trial,
placebo-phases had to be of a duration which was at the
limits of tolerance for a number of participating families.
Another limitation of the study design was the necessity
to exclude patients from the crossover trial who showed
an inadequate response to homeopathic treatment dur-
ing the screening phase. This means that the intention to
treat principle could not be followed through all the
way. The implications of this obstacle are discussed
Fig. 2 CGI course during
crossover trial according to
treatment arm (medians and
ranges). Arm A: unexpected rise
in CGI during verum phase,
possibly due to expectation of
receiving placebo in first phase.
Persistent high CGI with
placebo in second phase,
normalisation of CGI with
open label verum after
crossover trial. Arm B: CGI
rose with placebo in first phase
and returned to CGI values
within the normal range with
verum treatment in second
phase, as expected
Table 4 Results of crossover trial. Parameter estimates and P values of linear mixed models for outcome variables. ( BD bloc design, PC
picture completion)
Outcome variable Effect
a
Parameter estimate P Effect during verum period
CGI A (primary endpoint) Treatment -1.67 0.0479 Improvement
Period 2.19 0.0102
Verbal loss after interference B (VLMT) Treatment -11.27 0.0328 Improvement
Period -2.52 0.6294
Stability of mood C (QCB) Treatment 0.45 0.0693 Improvement
Period -1.07 <0.0001
Reaction to unexpected events D (QCB) Treatment 0.29 0.1001 Improvement
Period -0.67 0.0003
Alertness to visual details E (PC, WISC-III) Treatment -0.61 0.0302 Worsening
Period -0.92 0.0013
Visual spatial organisation F (BD, WISC-III) Treatment -0.63 0.0632 Worsening
Period 0.18 0.5843
a
Treatment effect refers to within-patient mean difference between treatments, i.e. verum-placebo. Period effect refers to within-patient
mean difference between periods, i.e. period 1-period 2. Tests A and B measure intensity of symptoms, negative treatment effect implies
improvement. Tests C, D, E and F measure capabilities, positive treatment effect implies improvement
764
below. Patients participating in the study were selected
by a rigorous diagnostic evaluation, ruling out any oth er
diagnosis but ADHD. In addition, strict inquiries at
periodical monitoring were performed to prevent the
application of any other treatment but homeopathy. The
long duration of observation of an average of 19 months
was chosen to grant that observed changes are not just
of transitory nature.
Effects of homeopathy in children with ADHD have
been demonstrated in the present randomised double
blind crossover trial. The within-patient difference in
CGI between treatment with verum or placebo was
statistically significant (P=0.0479) and supports the
positive effect of homeopathy. However, CGI decreased
by only 17% (1.67 CGI points), somewhat less than that
expected from the results of an earlier study [8]. This
may be partially due to more precisely prescribed indi-
vidual homeopathic medication in this trial, with a
consequently stronger carry-over effect. Another reason
for this small difference is the unexpected increase in
CGI during crossover period one in both treatment
groups. This increase could possibly be explained by a
psychological expectancy effect [26]. Parents and chil-
dren both may have anticipated placebo in crossover
period one rather than two, and this presumed expec-
tancy (period) effect was stronger than the treatment
Table 5 Long-term treatment effects. Differences in CPRS and CTRS between diagnosis and follow-up 14 weeks after crossover trial
(Wilcoxon signed rank test)
CPRS Median of differences Difference in % P Effect
Behaviour 3.5 42.5 0.0001 Improvement
Learning/attention 3 36.5 0.0001 Improvement
Psychosomatics 1 46.7 0.0004 Improvement
Impulsivity/hyperactivity 3 41.5 0.0001 Improvement
Shyness/anxiety 1 39.5 0.0001 Improvement
CGI 7 43.3 0.0001 Improvement
CTRS
Behaviour 3 36.4 0.0347 Improvement
Impulsivity/hyperactivity 2 28.0 0.1932 Improvement
Passivity 2 27.8 0.1184 Improvement
CGI 3 30.8 0.0561 Improvement
Fig. 3 Course of CGI between
diagnosis and follow-up
(median, quartile, range).
Alterations of CGI throughout
screening-phase, crossover trial
and long-term follow-up.
Transient rise after crossover
trial due to possible compliance
problems. The latest follow-up
during open label treatment
showed a maximum
amelioration of 12 points (63%)
765
effect. The question arises whether the parents just rated
the CGI in a way which they expected to be favourable
for the outcome of the study. While on treatment arm A
during the first crossover period this might have actually
been the case, such a bias can be ruled out for crossover
period two on arm A, in which the same parents re-
ported a persistent deterioration under placebo. After
the initial (unexpect ed) worsening under verum, they
would report an improvement in crossover period two, if
their rating would follow just their opinion about what
should be a favourable outcome. However, in crossover
period two, the phenomenon disappeared and led to a
significant decrease in the CGI of the verum group
(treatment effect) whereas the placebo group maintained
an elevated CGI. The intended treatment effect and the
unexpected period effect together resulted in the ob-
served CGI levels, especially in crossover period one.
The treatment effect became evident in crossover period
two. Following an additional 6 weeks of open label
treatment, both gro ups had CGI values similar to those
at the beginning of the crossover trial, an indirect con-
firmation of the appropriateness of the study design. The
validity of the CGI has been proven over time across
many studies and therefore won’t be doubted in the
context of this study [25].
Since at the beginning of the trial it was unknown
whether homeopathic treatment would affect cognitive
functioning and which functions might possibly be af-
fected, a large number of cognitive variables, often im-
paired in ADHD children, were selected for study. The
trial design inevitably required a repetition of these tests
within a short period of time. Consequently, learning
effects, which might mask possible treatment effects,
were to be expected. Only a few significant treatment
effects were observed (positive: improved auditory short-
term memory, a trend to increased stability of mood,
better reactions to unexpected events; negative: decrease
in alertness to visual details and the trend towards de-
creased visual spatial organisation). These significa nt
changes in neuropsychological tests during the crossover
trial may be due to chance only, as a result of the high
number of tests performed. The expected learning effects
are indica ted by significant period effects of many vari-
ables. A strong carry-over effect with a persistence of
66% of the improvements reached under homeopathy
throughout the placebo phases, however, diminished the
possibility of positive neuropsychological tests further.
Eleven outliers in crossover period one and six in
crossover period two showed CGI-values contrary to the
expected courses, and diminished the statistical results
additionally in a way that the CGI difference between
placebo and verum was considerably smaller than ex-
pected.
Comparison of some of the cognitive tests at diag-
nosis and at the beginning of the crossover trial after the
initial open label homeopathic therapy suggests, how-
ever, highly significant treatment effects. Since every
other treatment was stopped during the screening phase,
this improvement is only explicable by the homeopathic
intervention. The question arises whether the eight pa-
tients who dropped out of the screening phase due to
insufficient treatment response cause a selection bias
influencing the results considerably. Five of these
dropouts still had a partial amelioration under treat-
ment. Their influence on the high significance of the
results of the screening phase and the long-term follow
up would therefore have been minimal. Thus, it is un-
likely that they would have caused considerably different
results. Improv ements in cognitive deficits following
stimulant treatment of ADHD patients, especially spa-
tial working memory, attention-set shifting and visua l
search performance have been reported [21]. The effect s
of homeopathy observed in this study are similar. To
gain a better insight into the quantitative aspects of
cognitive improvements following medication, a com-
parison of matched patients receiving stimulants,
homeopathy or place bo would be worthwhile.
The CGI and the CPRS scores (parent ratings) de-
creased between 37% and 63% over the long-term
observation period, most probably related to treatment
induced adjustment of behaviour. The CTRS improve-
ment ratings by teachers were smaller (between 28% and
37%) than those of the parents, reflecting the higher
cognitive stress for patients in school situations. How-
ever, on the whole, the overall intensity of ADHD
symptoms appears to be lower during treatment and
results in an improv ement in the childrens’ social,
emotional and scholastic behaviour. The question whe-
ther these long-term improvements are a treatment effect
or merely due to a spontaneous change in development
of the children cannot by definitely answered by our trial
data. However, the authors have observed that stopping
treatment after prolonged medication leads to a slow
decline of previous improvements over a time period of
several months in most children. Such a course cannot
just be explained by spontaneous evolution and is highly
suggestive of a treatment effect.
The results of this tri al point to the effectiveness of
homeopathy in the treatment of ADHD. To corroborate
the findings presented here, the authors suggest a larger
and independent multicentre study. Since homeopathic
treatment of ADHD is not an easy undertaking, a
training phase for participating treating physicians in the
methodology used in this study would be essential prior
to starting the trial. Different homeopathic approaches
might lead to other observations. Factors limiting the
widespread use of homeopathy in the treatment of
ADHD are the time needed for amelioration of symp-
toms, thus excluding this treatment from use in emer-
gency situations, and the necessity of accurate
observation and recording of symptoms by the parents.
Acknowledgements We sincerely thank all patients and families
who took part in this trial for the enormous amount of time they
sacrificed for travelling, testing and treatment sessions as well as for
their patience in observing symptoms. Sincere thanks also to Jac-
queline Ryffel and her staff at Spagyros for preparing and mailing
the medications and placebos to the patients. Many thanks to
Martina Frei for her contribution in the starting phase of the study
766
and to Carol Lim for her substantial help in the preparation of the
manuscript. This study was financed by grants of the following
foundations and institutions: Gertrude von Meissner Foundation,
Basel; Software AG Foundation, Darmstadt; Hans Eggenberger
Foundation, Zu
¨
rich; SNE Foundation, Solothurn; Fondation
Home
´
opathie Pierre Schmidt Gene
`
ve; PanMedion Foundation,
Zu
¨
rich; Spagyros AG, Gu
¨
mligen; Gudjons Laboratory, Stadtber-
gen; Swiss Federal Railways (SBB), Berne.
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... When used in compliance with the basic treatment principles of homeopathy as described by Hahnemann (individualized homeopathic prescription of one single substance at a time), beneficial effects of this intervention have been shown for various kinds of medical conditions, including child diarrhea, 20 supportive care in cancer, 21,22 fibromyalgia, 23 or ADHD. 24,25 For ADHD, we set out to test, by means of meta-analysis, whether the therapeutic effects of individualized homeopathy found in single clinical studies are consistent and robust. We aim to investigate whether individualized homeopathic treatment shows clinical effects in children with ADHD when compared to placebo or usual care alone. ...
... 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. ...
... As it is only one study that uses such a long treatment duration, it is unclear whether the larger effect is truly a function of study duration or whether it is a peculiarity of this particular study. Observational follow-up data from one of the included studies 24 show equally good clinical results of homeopathic treatment when compared with MPH. 47,48 Further longterm trials are necessary to corroborate these findings. ...
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.
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Thesis
One of the most prominent criticisms levelled towards traditional & complementary medicine (T&CM) is the lack of sufficient proof of quality, safety and efficacy of most T&CM therapies. Furthermore, studies have shown that doctors are often unprepared to discuss or draw appropriate conclusions concerning T&CM. These problems are further compounded by the absence of ethical guidelines for doctors when at the interface of conventional medicine and T&CM. Setting on this background, this study sought to address a gap in local policy and literature by proposing recommendations on ethical practices when doctors are at the interface of conventional medicine and T&CM. The study employed a library-based research method to examine the current development of Malaysia’s T&CM regulatory framework, and it is followed by an analysis of the ethical dilemmas faced by doctors concerning T&CM. The ethical dilemmas analysed focused on the conflict between respect for autonomy and paternalism, issues with the doctor-patient relationship, and emerging issues relating to the promising therapeutic effect of traditional herbal medicine during a pandemic. Following the analysis, this study developed recommendations on the most appropriate ethical practices, which can be divided into three main components. Begin with ‘Pre-Care’ which was intended for relevant stakeholders to make strategic interventions in knowledge dissemination. Following that, ‘During-Care’ encompassed eight pillars of an ethical framework for doctors when at the interface of conventional medicine and T&CM. Finally, ‘Post-Care’ addressed the duty to report harmful or adverse events related to T&CM. This study aimed to assist the medical fraternity and key stakeholders to take necessary interventions by incorporating ethical practices in T&CM, in order to ensure patients receive the utmost benefit while minimising potential harms.
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U ovom radu navedeni su razlozi zašto se ljudi sve više okreću alternativnoj i komplementarnoj medicini, prednost ovih metoda u odnosu na konvencionalnu medicinu i farmaceutsko-hemijske preparate, kao i istraživanja i statistike o korištenju alternativne medicine. Da bi se bolje shvatili značaj i uloga alternativne medicine u liječenju, osim podjele opšte medicine, objašnjene su i grane alternativne medicine sa posebnim osvrtom na metode liječenja vezane za farmaceutsku struku, a to su homeopatija, fitoterapija i aromaterapija.U poglavlju o homeopatiji navedeni su oblici i primjena homeopatskih lijekova, kao i njihova prednost u odnosu na klasične lijekove. Fitoterapija kao najstariji oblik medicine koristi se ne samo u liječenju, već i u prevenciji mnogih bolesti. Biljne lijekove podržala je i Svjetska zdravstvena organizacija koja pruža pomoć nastojanjima nerazvijenih zemalja da povećaju upotrebu biljnih lijekova i time troše manje ionako ograničenih sredstava na gotove tvorničke lijekove. Aromaterapija kao sastavni dio fitoterapije polako zauzima svoje zasluženo mjesto u savremenoj medicini. Eterična ulja ostvaruju svoje dejstvo na sve ćelije organizma i tako ga vraćaju u ravnotežu. Opisani su načini primjene kao i djelovanje na organizam. Navedeni su razlozi vraćanja prirodnom liječenju i smanjenju bolničkih troškova i upotrebe sintetskih lijekova koji ponekad nanose više štete nego koristi.
Chapter
Der Begriff „Komplementärmedizin“ umfasst Verfahren, welche die Schulmedizin ergänzen. Der Begriff „alternative Medizin“ bezeichnet Verfahren, welche die Schulmedizin ersetzen. Beide Verfahren werden vor allem bei chronischen Krankheiten von einem Großteil der Bevölkerung genutzt, z. B. von 40 % der Familien mit einem neurologisch erkrankten Kind oder juvenilem Diabetes melliltus, 50 % bei Autismus. Die Verfügbarkeit von digitalen Plattformen erleichtert die Suche nach komplementären und alternativen Behandlungsformen. Die Qualität der aus Netzwerken bezogenen Informationen ist dubios. Bei kritischer Prüfung sind nur etwa 4 % der Beiträge inhaltlich und stilistisch vergleichbar mit wissenschaftlichen Arbeiten; 56 % sind substanziell ungenügend oder falsch.
Chapter
Die homöopathische Medizin ist eine von Samuel Hahnemann entwickelte Heilmethode und durch das Ähnlichkeitsprinzip „similia similibus curentur“ definiert. Die klassische Homöopathie wird unter Verwendung von potenzierten Einzelmitteln nach der Ähnlichkeitsregel mit an Gesunden geprüften Arzneimitteln durchgeführt. Diese Arzneimittel werden potenziert, d. h. verdünnt und verschüttelt. Die Anwendungsbereiche der Homöopathie ergeben sich aus ihrer Eigenschaft, eine Regulationstherapie zu sein.
Chapter
The Kaufman Assessment Battery for Children—Second Edition (KABC-II, Kaufman & Kaufman, 2004) measures the cognitive abilities and mental processing of children and adolescents between the ages of 3 years 0 months and 18 years 11 months. Administered individually, this clinical instrument consists of 16 subtests (plus a Delayed Recall scale) and provides examiners with a Nonverbal scale composed of subtests that can be administered in pantomime and responded to motorically. The Nonverbal Scale is especially useful for children who are hearing impaired or have limited English proficiency (Kaufman, Kaufman, Kaufman-Singer, & Kaufman, 2005).
Article
The Q-potencies represent the quintessence of Hahnemann's last 14 years of his active life. They are the result of his continuing effort to find a comprehensive and profound way of medication and shorten the time of treatment. The history, the development, the indications and the practical application is demonstrate.