Effectiveness of Homoeopathic Therapeutics in The Management of Childhood Autism Disorder
Effectiveness of Homoeopathic Therapeutics in The Management of Childhood Autism Disorder
Effectiveness of Homoeopathic Therapeutics in The Management of Childhood Autism Disorder
200]
I J R H
ORIGINAL ARTICLE
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disorder
Praful M. Barvalia, Piyush M. Oza, Amit H. Daftary, Vijaya S. Patil,
Vinita S. Agarwal1, Ashish R. Mehta2
The proposal was submitted to the institutional Children presenting with very severe autism as
ethics committee along with comprehensive safety diagnosed by CARS with history of severe and
measures. Their approval was received and the frequent violent exacerbations, which required
committee was updated from time to time during continuous allopathic medications and/or
the study. hospitalization
This study was a non‑randomized, self‑controlled, pre • Children undertaking pharmacological treatment
and post‑intervention study wherein six months was or any recent history of such treatment to treat
a self‑control period and one year was the treatment autism within 30 days of participation into the
period. Children were initially kept on observation study.
for six months without homoeopathic treatment Sample size
and their scores were recorded. This was followed A total of 60 children fulfilling above criteria were
by intervention with an observation period of one selected for the study.
year and at the end of one year, the children were
A sample size of 60 was selected on the following
evaluated. The initial six months of observation was
considerations:
used as the control period (self‑controlled) and the
1. Type I error α was taken as 0.05 giving us 95%
same patients were treated and compared with the
confidence interval
one‑year treatment period post‑intervention. They
2. Power of the study was taken as 80%. As there was not
did not receive any other pharmacological treatment
much data with similar studies available, this study
during the entire period of study.
is a first of its kind and also considering a minimal
Study population and recruitment required sample size based on the availability of
The cases were enrolled from general OPD of M.B. such patients in the population, considering the
Barvalia Foundation’s Spandan Holistic Institute confidence interval of 95% and alpha as 0.05, Power
of Applied Homoeopathy and from the institute’s was conservatively taken as 80%
mobile clinic. Regular awareness and screening 3. 10% change in ATEC score was considered as
camp were conducted in the community to screen clinically significant. Autism research institute has
and spot the cases. A series of workshops were provided ATEC range from mild to severe with
held for parents to educate them. The seminars percentile and corresponding ATEC percentage
were conducted for teachers of mainstream school change in scale and subscale. When we study this
of urban areas to sensitize them about role of range, we get some idea about changes in score
homoeopathy in autism. Similar seminars were range 10% change from previous level before
held for teachers from Anganwadis and Balwadis intervention has been seen and clinically verified
conducted by Central Government in the urban slum as significant.
areas of M and N wards of BMC (Greater Mumbai
Municipal Corporation).
Clinical diagnosis of childhood autism disorder
The diagnosis of childhood autism disorder was
Potential cases identified from the above sources made conjointly by homoeopathic physicians
were screened by the attending physicians for (PMB, PO), clinical psychologist, neurologist and
prominent symptoms of autism. Voluntary informed psychiatrist.
written consent was taken from their parents/
guardians prior to their enrollment into the study, Diagnostic parameters were essentially DSM‑IV;
i.e. before the observation period. an autistic child presents with varying degree of
cognitive ability. This was assessed by SQ (Social
Eligibility criteria Quotient) through Vineland Social Maturity Scale.
Inclusion criteria
Additionally, EEG, BERA (Brainstem‑Evoked Response
• Children from both sexes up to the age of 12 years
Audiometry), audiometry, serum serotonin, and
• Children diagnosed as suffering from childhood
genetic karyotyping were carried out at the time of
autism as per DSM‑IV (Diagnostic and Statistical
enrollment. Serum serotonin was repeated at the
Manual).
end of the study. According to previous reports,
Exclusion criteria serum serotonin levels were often but not always
• Children suffering simultaneously from other elevated in autistic children. Therefore, we examined
chronic infections like tuberculosis or HIV disease. any possible linkage.[6]
Indian Journal of Research in Homoeopathy / Vol. 8 / Issue 3 / Jul-Sep 2014 149
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Table 1: Baseline distribution of children Four children had elevated serum serotonin levels
Variables Sub‑groups Number Percentage before treatment. All of the four showed decrease in
of levels after the homoeopathic treatment. There was
children corresponding clinical improvement in these cases.
Age ≤6 years 24 40
>6 years 36 60 Four other cases had normal serum serotonin levels
Sex Male 44 73 before treatment, which increased above normal
Female 16 27 after homoeopathic treatment. These cases also
Degree of Autism Mild 24 40 showed significant clinical improvement.
Mod 27 45
In severe autism cases, out of nine cases, only one
Severe 9 15
showed high serotonin level before treatment.
Cognitive ability Dull normal 13 22
(high functioning) ATEC scores
Mild 30 50 The mean ATEC score obtained six months prior
Mod 11 18 to the treatment (ATECprev) was 72.70. The
Severe 6 10 children were observed for six months without any
Total 60 100
treatment. An ATEC was recorded at the time of
Number of children 6 10
with abnormal EEG
commencement of treatment; pre‑treatment (ATEC1)
Karyotype Fragile X 2 3.33
and post‑treatment (ATEC5) were 79.45 and 64.33,
distribution of cases respectively.
Y chromosome 1 1.6
inversion
Comparison of ATEC scores with six months
Translocation of 1 1.6 prior to the start of treatment
X chromosome When we examined the profile of cases in six
Total 4 6.6 months prior to homoeopathic treatment, where
Serotonin levels Normal 56 93.33 some children were receiving regular traditional
High 4 6.6 therapies but none of them received homoeopathic
Low 0 0 medicines, we could see that there were a number
BERA Abnormal 0 0 of children who were not doing well. When we
Audiometry Abnormal 0 0 analyzed these data, the following pattern emerged.
BERA: Brainstem-evoked response audiometry; EEG: Electroencephalogram
Ascending pattern of ATEC scores during the
A consort flow chart showing the number of self‑control period indicated deterioration of autism
participants at each stage of the study is provided and post‑intervention descending pattern of ATEC
in Figure 1. scores indicated improvement.
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implies ATEC mean percent change was 19.03. A statistically significant difference (P = 0.0001) was
Post‑intervention highest change observed was 44% observed in ATEC score at one year (ATEC5) compared
and there were 16 cases where ≥30% change was with baseline (ATEC1), which also justifies clinically
noted. significant improvement in autistic features of the
At the end of the observation period of six months children. Also, a statistically significant difference
before homoeopathic treatment, out of 60 cases, was observed in all the ATEC scores (ATEC2, ATEC3,
52 cases showed deterioration in ATEC scores, five and ATEC4) recorded at different quarters compared
cases showed status quo and three cases improved. with baseline (ATEC1) [Tables 2 and 3].
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Table 2: Repeated measures ANOVA for ATEC Table 3: Post‑hoc test for repeated measure
and AHS ANOVA
Mean SD N 95% F P Pair‑wise comparisons
confidence Measure: ATEC
interval
(I) (J) Mean Std. P valueb 95%
Lower Upper factor factor difference error confidence
bound bound 1 1 (I‑J) interval for
ATEC1 79.45 20.929 60 74.044 84.856 135.952 0.0001 differenceb
ATEC2 74.28 20.348 60 69.027 79.540 Lower Upper
ATEC3 70.42 20.138 60 65.214 75.619 bound bound
ATEC4 67.35 20.224 60 62.126 72.574 ATEC1 ATEC2 5.167* 0.654 0.0001 3.858 6.475
ATEC5 64.33 20.130 60 59.133 69.533 ATEC3 9.033* 0.867 0.0001 7.298 10.769
AHS1 36.60 11.537 60 33.620 39.580 210.599 0.0001 ATEC4 12.100* 1.082 0.0001 9.935 14.265
AHS2 28.53 9.661 60 26.038 31.029 ATEC5 15.117* 1.074 0.0001 12.968 17.265
AHS3 22.47 7.901 60 20.426 24.508 ATEC2 ATEC1 −5.167* 0.654 0.0001 −6.475 −3.858
AHS4 17.93 7.201 60 16.073 19.794 ATEC3 3.867* 0.433 0.0001 2.999 4.734
AHS5 14.30 6.667 60 12.578 16.022 ATEC4 6.933* 0.686 0.0001 5.561 8.306
SD: Standard deviation; ANOVA: Analysis of variance; ATEC: Autism treatment ATEC5 9.950* 0.738 0.0001 8.473 11.427
evaluation checklist; AHS: Autistic hyperactivity scale
ATEC3 ATEC1 −9.033* 0.867 0.0001 −10.769 −7.298
ATEC2 −3.867* 0.433 0.0001 −4.734 −2.999
ATEC sub‑scores reflecting on changes in ATEC4 3.067* 0.367 0.0001 2.333 3.800
autistic features ATEC5 6.083* 0.467 0.0001 5.149 7.018
ATEC assesses change in impairment in specific ATEC4 ATEC1 −12.100* 1.082 0.0001 −14.265 −9.935
aspects of autistic features like communication, ATEC2 −6.933* 0.686 0.0001 −8.306 −5.561
socialization, sensory awareness, and health and ATEC3 −3.067* 0.367 0.0001 −3.800 −2.333
behavior. A statistically significant difference was ATEC5 3.017* 0.308 0.0001 2.401 3.632
observed in all the autistic features recorded at ATEC5 ATEC1 −15.117* 1.074 0.0001 −17.265 −12.968
different quarters compared with baseline, which ATEC2 −9.950* 0.738 0.0001 −11.427 −8.473
ATEC3 −6.083* 0.467 0.0001 −7.018 −5.149
also justifies clinical improvement in all the autistic
ATEC4 −3.017* 0.308 0.0001 −3.632 −2.401
features of the children [Table 4].
Based on estimated marginal means. *The mean difference is significant
at the 0.05 level. b. Adjustment for multiple comparisons: Least significant
Maximum improvement observed is in behavioral difference (equivalent to no adjustments). ATEC: Autism treatment evaluation
component followed by sensory aspects [Figure 4]. checklist; ANOVA: Analysis of variance
[Figure 3]. 1'
48$57(5
Degree of behavioral dysfunction (AHS)
Of 60 children, a total of 9 children, who had mild different categories of cognitive ability
autism, had CARS score as <30 at post treatment A statistically significant difference in the mean
which indicates becoming non‑autistic after scores was also observed in autistic children
intervention (P value 0.0001), while 10 cases with belonging to different categories of cognitive ability,
moderate autism became mild [Table 9]. i.e. dull normal, mild MR, moderate MR, and severe
Improvement in autistic features with respect MR (17.46, 15.23, 14.64, and 10.33, respectively
to degree of autism with P < 0.05) [Table 6].
A statistically significant difference in the mean Changes in cognitive ability (mental retardation)
scores was observed in children belonging to all A statistically significant difference was observed in
the categories based on degree of autism, i.e. mild, SQ score at one year (SQ2) compared with baseline
moderate, and severe (14.45, 16.81 and 11.78 (SQ1) [Table 5]. It was observed that 43 children
respectively with P < 0.005) [Table 6]. belonging to dull normal and mild MR category
Improvement in autistic children belonging to have shown significant change in cognitive ability;
however, very less significant change in SQ was
observed in children with moderate and severe
retardation.
Parents, teachers and therapist reported positive
improvement in behavior and activities of daily living.
High‑functioning children reported improvement in
scholastic performance.
Overall outcome assessment
Autism research institute has provided ATEC range
from mild to severe with percentile and corresponding
ATEC scores. Based on changes in category, outcome
measures in ATEC were defined. CARS gives range of
Figure 4: Percentage change in ATEC sub‑scores pre and post‑treatment
mild, moderate and severe Autism, based on that %
of improvement was taken up.
Table 5: Mean values comparison for CARS
scores and SQ scores pre and post‑treatment At one year post‑treatment, a mild (16), moderate
with paired T‑test (21), and marked (16) improvement was observed in
Mean N SD T P majority of the children. However, a total of seven
CARS1 33.925 60 3.6311 9.496 0.0001 children were observed with either worsening or
CARS2 31.433 60 3.1856 status quo scores [Table 7 and Figure 5].
SQ2 61.083 60 18.1316 3.864 0.0001
SQ1 57.917 60 16.0231
A multivariate analysis of variance performed on CARS,
P value is calculated for the comparison of CARS and comparison of SQ using
ATEC, AHS, and SQ scores showed significant results.
paired t‑test. SQ: Social quotient A statistically significant difference in almost all the
Table 6: Improvement in autistic features with respect to degree of autism and with respect to
different categories of cognitive ability
No of cases Mean ATEC1 Mean ATEC5 Difference of means T P
Autism degree
Mild 24 64.33 49.88 14.45 11.08 0.0001
Moderate 27 85.74 68.93 16.81 8.69 0.0001
Severe 9 100.89 89.11 11.78 5.56 0.001
Cognitive ability
Dull normal (high functioning) 13 61.69 44.23 17.46 7.968 0.0001
Mild MR 30 78.07 62.83 15.23 8.995 0.0001
Mod MR 11 91.64 77 14.64 6.715 0.0001
Severe MR 6 102.5 92.17 10.33 5.622 0.002
ATEC: Autism treatment evaluation checklist; MR: Mental retardation
scores at one year post‑treatment compared with Remedy response and posology observed
baseline indicates the significant change in all the during the study
dependent variables of improvement grade [Table 8]. Centesimal scale potencies were utilized
A trend in improvement of degree of autism commencing with 200C potency. Symptomatology
and different categories of cognitive ability was was reviewed periodically. When there was no
observed with regards to number of cases assessed further improvement, potency was raised to 1 M and
pre‑treatment and post‑treatment. It was noted that later 10 M. Changes in symptomatology necessitated
a total of nine children became non‑autistic after the second prescription.
treatment [Table 9]. A total of 23 cases demanded infrequent doses
List of remedies that came during management (where remedy is repeated at an interval of two or
of cases [Table 10] greater than two weeks), while 28 cases demanded
First prescription means, first remedy which was moderately frequent repetition (where remedy is
prescribed at the time of commencement of treatment. repeated one in a week or for three consecutive
In 22 cases, symptomatology changed, which demanded days of the week), while nine cases required very
second prescription. Similarly four cases demanded frequent repetition (where remedy is repeated once
further change leading to a third prescription. At a every day of more than once in a day) to the extent
given time, only one indicated remedy was prescribed of being repeated even twice or thrice in a day.
irrespective of the severity of the autism. Acute exacerbations of intense autistic features
From above Table 10, Carcinosinum has come up in during the course of treatment
maximum number of cases (18 + 1 + 1) and it has Eight cases presented with acute exacerbations
also come maximum times as first prescription (18). of symptoms like intense agitation, restlessness,
Hyoscyamus came up in maximum cases as the unmanageable aggression, oversensitivity especially
second prescription. to sound and sometimes marked self‑injurious
behavior and incontinence of urine and stool.
Stramonium and Hyoscyamus came up to control these
6WDWXVTXR
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even every four hours. Acuteness reduced in 4‑5 days
while the indicated medicine was required to be
continued for two weeks. None of the cases required
to be hospitalized or transferred to other experts.
But of course it needed close supervision.
DISCUSSION
Challenges in the treatment of autism have been of autism viz. repetitive and stereotyped patterns of
phenomenal. Allopathic medications like Risperidone behavior, interests, and activities as well as social and
therapy addresses hyperactivity and aggressive communicative impairment of autism.[9] Homoeopathic
behaviors and is more suited to conditions like ADHD medicinal treatment of autism by Gupta et al.[10] found
60% (n = 6) improvement in autistic symptoms by
as it does not help in addressing to the core features
classical method of homeopathic treatment, whereas
non‑classical showed 38% (n = 3) improvement.
Table 8: Multivariate analysis This showed positive role of Homoeopathy in the
Source Dependent variable F value P value
management of autism. Patient compliance and small
Improvement grade CARS1 6.898 0.0001
sample size were the limitations of this study.
CARS2
ATEC1 8.802 0.0001 Current study was extensive enough to cover up children
ATEC5 from both the sexes as well as evenly distributed in age
AHS1 4.208 0.005 groups. It covered up the entire range of autism; mild,
AHS5 moderate and severe, while from the standpoint of
SQ1 10.616 0.0001 cognitive ability, children were from high functioning to
SQ2 mild, moderate, and severe mental retardation.
P value is calculated for the comparison of all dependent variable using
multivariate analysis of variance Children who were gradually regressing and showing
trend toward deterioration showed improvement
Table 9: Distribution of cases pre and in the autistic features. Across this range, changes
post‑treatment with respect to degree of autism achieved in the scores were statistically significant
and different categories of cognitive ability and intervention helped to bring down the autistic
No. of cases load. When we study the pattern of response in
Pre‑treatment Post‑treatment behavioral disturbances as well as core autistic
Degree of autism features, following points emerge.
Non‑autistic 0 9
A statistically significant difference (P = 0.0001)
Mild 24 34
was observed in ATEC score at one year (ATEC5)
Moderate 27 13
Severe 9 4
compared with baseline (ATEC1), also a statistically
Total 60 60
significant difference was observed in all the ATEC
Cognitive ability
scores (ATEC2, ATEC3, and ATEC4) recorded at
Dull normal 13 21 different quarters compared with baseline (ATEC1),
Mild MR 30 23 which justifies the clinically significant improvement
Moderate MR 11 10 in autistic features of the children reflected not only
Severe MR 6 6 in behavior like hyperactivity and impulsivity, but
Total 60 60 also in all the core autistic features, such as sensory
MR: Mental retardation impairment, socialization, communication etc.
This is further validated by statistically significant about significant change in child’s adaptive skills. To
difference (P = 0.0001) in ATEC components mean, that extent, we can see improvement occurring in
viz. communication, socialization, cognitive and retardation as reflected in SQ as well as in special
sensory awareness, and health and behavior. Analysis educator's observation about child’s improved
of the components also indicates that Homoeopathy ability.
brought about improvement in the area of behavior By effectively reducing core autistic features
and sensory impairment quite early during the consistently over a one‑year period, the study
course of treatment. These changes facilitated demonstrated a good improvement in these
psychosocial adaptation of autistic children. children’s psychosocial adaptation, activities of daily
Pace of improvement after homoeopathic intervention living, and even scholastic performance.
is worth studying. There was reduction in the ATEC Carcinosinum came up in maximum number of
score within the first quarter after intervention. instances as first prescription (n = 18), which was
This implies the positive role of intervention. This is followed by Stramonium. What is significant is to
consistent with what Dr Rimland has written about observe second prescription coming up in the
ATEC. If improvement occurs due to maturation, then management. Changes in the set of characteristic
gradual improvement is seen over a period of time. indications demanded the second prescription. We
However, if there is a perceivable improvement after observed this phenomenon in 22 instances. Thus, out
the intervention is started then treatment is helping of 60 cases, in 22 cases, 2 remedies were required
(Autism Research Institute).[11] in sequence, for e.g. Opium followed by Causticum,
Rate of change as well as quantum of change in Stramonium followed by Hyoscyamus. While in four
the autistic features is not directly proportional to cases, three remedies were required in sequence.
degree of autism but partially dependent on it. For e.g. Nux Vomica – Stramonium – Carcinosin and
Medorrhinum‑Lycopodium‑Lachesis, while in 34 cases,
There is a statistically significant difference
only one remedy was required. The study allowed
(P ≤0.005) in the mean scores of all the types of
us to obtain the profile of characteristic symptoms
autism, i.e. mild, moderate, and severe. This implies of prescribed medicines and has also given us a
that Homoeopathy can bring about significant number of clinical indications. These aspects have
improvement in all the types of cases of autism. not been discussed here.
However, mild and moderate autism indicate
superior change in comparison to severe autism. Autism is a serious chronic disorder hence
homoeopathic treatment will demand careful
Treatment had impact on all the categories of autistic observation and analysis of the changes in
children classified from the standpoint of cognitive symptomatology, which will be reflected in
ability (P = 0.0001). However, children with dull identification of second prescription.
normal intelligence showed the highest improvement
followed by children with mild retardation. This The number of children suffering from mild,
implies that cognitive ability is an imoportant variable, moderate, and severe autism is not uniform, nor
which has an impact on the outcome of treatment. large enough to study comprehensively differential
impact on different types of autism. Multi‑centric,
Overall mean SQ has shown improvement post double‑blind, placebo‑controlled, randomized study
treatment. Study demonstrated significant change in will be further helpful.
SQ in children with dull normal and mild retardation
while those with moderate and severe retardation Change in cognitive ability with regards to mental
have not shown significant change in SQ, while their retardation is a complex phenomenon and would
autistic features have improved. take into account number of variables. To analyze all
these is beyond the scope of the current study.
Children who were diagnosed to have mental
retardation demonstrate significant adaptive living CONCLUSION
skills deficits. Measured intellect deficit could be
reflection of current behavioral, communicative, The study has demonstrated the usefulness of
and social difficulties in autistic children.[12] Overall homoeopathic treatment in the management of
improvement in core autistic features can bring neuropsychological dysfunction in childhood autism
158 Indian Journal of Research in Homoeopathy / Vol. 8 / Issue 3 / Jul-Sep 2014
[Downloaded free from http://www.ijrh.org on Monday, January 27, 2020, IP: 47.31.163.200]
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parameters in infantile autism. A controlled study of 22 autistic
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