Transcript DEFINITION

CLINICAL STUDY ON THE ROLE OF AN
AYURVEDIC COMPOUND (MANAS
NIYAMAK YOGA) AND SHIRODHARA
IN THE MANAGEMENT OF
ADHD IN CHILDREN
Prof. Dr. ABHIMANYU KUMAR
M Sc (Psy) MD (Ayurveda), DCA, D.Yoga, PhD (Ayurveda)
DIRECTOR
ALL INDIA INSTITUTE OF AYURVEDA
New Delhi (India)
&
Director General
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES
e mail : [email protected]
DEFINITION
• ADHD is characterized by inattention,
including increased distractibility and
difficulty sustaining attention, poor impulse
control and decreased self inhibitory
capacity, and motor over activity and
motor restlessness –
DSM-IV (American Psychiatric Association, 1994)
PREVALENCE
– According to the 2000 edition of DSM-IV- TR,
ADHD affects 3-7% of all children in the U.S.
(APA, 2000)
– The prevalence of ADHD in the general
population of school age children is about 35% in the west.
(Anderson JC, et al., 1987;Swanson JM et al., 1998)
Male To Female Ratio
– ADHD is 4-6 times more common in boys
than in girls. (Bhatis MS et. al., 1991)
– Ratio varies between 2:1 and 4:1. (Wolraich ML et.
al., 1989)
– Male to female ratio ranges from 4:1 to 9:1
(DSM – IV; Szatmari P et. al., 1989)
– Male to female ratio was 6.4:1.
(Maya Mukhopadhyaya et al.,2003)
AIM & OBJECTS OF THE STUDY
To enhance mental performance.
To get answer of the problem without any
side effects.
To provide relief in symptoms of ADHD.
To improve school performance and to
improve overall health status of child.
MATERIAL AND METHODS
A randomized double blind placebo control study was
conducted in children with ADHD.
SELECTION OF CASES
• Source - Children for the present study were screened
out from OPD of National Institute of Ayurveda, Jaipur
and from various schools, situated in Jaipur by survey
method.
• Age group - Children between 6 to 15 years were
considered for study.
• Numbers of cases- 48 children were registered out of
which 8 children discontinued the treatment.
GROUPING OF PATIENTS
Selected children were randomly divided into four groups keeping in mind that
all the four groups had children from various grades (classes), schools &
socio economic strata.
•
Group A –
This group of 10 children were given the
Ayurvedic compound Manas Niyamak Yoga (MN1
granules).
•
Group B –
This group of 10 children were given the
Ayurvedic compound (MN1 granules) +
shirodhara(ksheerdhara)
•
Group C –
This group of 10 children were given only
placebo.
•
Group D –
This group of 10 children were given placebo
(MN2 granules) + shirodhara.
DIAGNOSTIC CRITERIA
Pre-assessment screening of ADHD children
was done according to ADHD preassessment criteria based on DSM - IV
criteria.
Inclusion Criteria
• Subjects aged 6-15 yrs of either sex
satisfying DSM- IV criteria.
• Children with average / normal IQ level.
Exclusion Criteria
• Children with physical disability.
• Children with psychiatric illness.
• Children with gross brain damage
causing mental retardation.
• Children with any genetic disorder
• Unreliable history.
Discontinuation criteria
• Any acute or severe illness.
• Parents not willing to continue the
treatment
Assessment criteria
•
•
•
•
•
DSM – IV
Coefficient of Division of Attention
Reaction Time
Finger Dexterity Test
IQ assessment
Side effect evaluation criteria
To rule out possible side effects of the
study drugs, clinical criteria were
adopted. It included the
documentation of information related
to change in appetite, sleep,
abdominal features, drowsiness,
irritability etc.
Material For diagnosis of ADHD
• A pre-assessment questionnaire was made on the
basis of DSM- IV criteria having 18 questions, which
were filled up, by the schoolteachers and parents of
the patients.
• DSM – IV -TR Criteria
• Division of Attention Board (Electrical) -for Attention
Span
• Vernier Chronoscope (electronic)-for assessment of
Reaction Time.
• Finger Dexterity Board with pins- for assessment of
Motor Ability.
• ‘Draw – A- Man’ test for Indian children for assessing
the IQ of the child.
DRUG (MANAS NIYAMAK YOGA)
Contents of Study Drug
•
•
•
•
•
•
•
•
•
•
Brahmi (Bacopa monnieri)1 Part
Mandukparni (Centella asiatica)1Part
Shankhpushpi (Convolvulous pluricaulis)1Part
Jatamansi (Nardostachys jatamansi) 1Part
Vacha (Acorus calamus)1Part
Ashwagandha (Withania somnifera) 1Part
Vidanga (Embelia ribes) 1Part
Madhuyasti (Glycyrrhiza glabra)1Part
Chitraka (Plumbago zeylanica) 1Part
Pippali (Piper longum)¼ Part
BRAHMI
(Bacopa Monnieri)
MANDUKAPARNI
(Centella asiatica)
SHANKHPUSHPI
(Convolvulous pluricaulis)
JATAMANSI
(Nardostachys jatamansi)
VACHA
(Acorus calamus)
ASHWAGANDHA
(Withania somnifera)
VIDANGA
(Embelia ribs)
MADHUYASHTI
(Glycyrrhiza glabra)
CHITRAK
(Plumbago zeylanica)
PIPPALI
(Piper longum)
SHIRODHARA (KSHEERDHARA)
In this process, the milk was poured over the
forehead of patients in the form of a
regular stream from a specific height of
about 8 cms in a fixed fashion in the form
of oscillatory movements i.e. to & fro
movement of milk stream over the
forehead of the patients for 30-45 minutes
daily for 2 weeks.
PLACEBO
The placebo for the study was also in
the form of granules with the same
color and texture as study drug
(Granules MN2) containing starch
and sugar.
CRITERIA OF ASSESSMENT
After 3 months of treatment, the tests were
re-administered. Effect of the therapy was
assessed on the basis of improvement in
obtained scores in Attention Span,
Reaction Time, Motor Ability and DSM-IV
criteria. IQ levels were also assessed after
3 months of treatment.
RESULTS
CO-EFFICIENT OF DIVISIION OF ATTENTION (CD)
Showing change in Co-efficient of Division of Attention (CD)
Groups
Mean score
N
%
SD
SE (±)
‘t’
‘p’
Value
Value
BT
AT
Diff.
Group A
0.35
0.29
0.06
10 17.14 0.0306 0.0097 05.773 <0.001
Group B
0.34
0.27
0.07
10 20.58 0.0156 0.0049 14.2857 <0.001
Group C
0.33
0.32
Group D
0.34
0.32
0.005 10 01.52 0.0139 0.0044 01.1363 >0.10
0.02
10 05.88 0.0145 0.0046 04.130
<0.01
• Statistically highly significant change in coefficient of
division of attention was observed group A and B (P<0.001)
• Significant change was observed in-group D (p<0.01)
Change in Coefficient of Division of Attention
25
20
20.58
17.14
15
%
10
5.88
5
1.52
0
Group A
Group B
Groups
Group C
Group D
Table Showing change in Reaction Time
Groups
Mean score
N
%
SD
SE (±)
‘t’
‘p’
Value
Value
BT
AT
Diff.
Group A
01.36
0.72
0.64
10 47.42 0.1715 0.0542 11.8753 <0.001
Group B
01.20
0.53
0.67
10 55.83 0.0994 0.0314 21.3375 <0.001
Group C
01.36 01.41 -0.51 10 03.75 0.0610 0.0193 02.642 >0.10
Group D
01.29
0.91
0.38
10 29.07 0.0897 0.0284 13.2394 <0.001
• Groups A, B and D showed statistically highly significant
change in Reaction Time (P<0.001).
• Group B showed maximum change (55.83%).
Change in Reaction Time (RT)
60
50
40
30
%
20
10
0
-10
55.83
47.42
29.07
-3.75
Group A
Group B
GROUPS
Group C
Group D
Table Showing change in time taken in Finger
Dexterity Test (FDT)
Mean score
Groups
N
BT
AT
Diff.
Group A
06.77
06.03
0.74
Group B
06.84
05.40
1.44
10
%
SD
SE (±)
‘t’ Value
‘p’
Value
10.96
0.1225 0.0387 19.1730
<0.001
20.98
0.1259 0.0398 36.0552
<0.001
0.61
0.0816 0.0258 01.6280
>0.10
01.85
0.1212 0.0383 03.2110
<0.02
10
Group C
06.84
06.80
0.04
10
Group D
06.62
06.51
0.12
10
• Statistically highly significant change was observed in group
A and B (P<0.001).
• Group D showed statistically significant change (P<0.02).
Change in Time taken in Finger Dexterity Test
(FDT) Right Hand
25
20.98
20
%
15
10.96
10
5
0.61
1.85
0
Group A
Group B
Groups
Group C
Group D
Overall Improvement in Core Symptoms of ADHD
50
40.67
40
34
40
30.67
30
24
29.34
27.34
22.33
%
20
17.67
6.67
10
0
12
4.33
Group A
Group B
Inattention
Group C
Hyperactivity
Impulsivity
Group D
DISCUSSION
 Maximum numbers of ADHD children
(47.50%) were between age ranges 6-9
years followed by 37.50% in age group
9-12 years. The data suggest
higher
prevalence of disease in
elementary
school years and gradual attenuation
of symptoms with the advancement of
age.
 Children from joint families were more
affected
(55%).
 Study included maximum number of
cases (70%) with vata-pitta prakriti . The
symptoms of ADHD are comparable to
that of mentioned in individuals with vata
and
pitta
prakriti.
Behaviors
of
predominantly vata prakriti individuals
are more similar to that of ADHD.
Predominance of pitta prakriti over vata is
comparable to the co morbidities &
associated problems with ADHD like ODD,
Anti-social behavior, violence, aggression,
temper tantrums etc.
 Maximum number of patients (50%) were of
Rajasika-Sattvika prakriti and 30% of patients
were
of
Rajasika-Tamas
prakriti.
Predominance of rajas part thus may cause
wide emotional swings, low tolerance to
emotional changes and exaggerated emotional
reactions that may manifest as ADHD.
 Maximum number of cases (70%) had average
or poor (20%) parent child relationship.
Studies indicate that persistent cases of
ADHD seem especially likely to occur where
parent child conflict, greater maternal
directive ness and negativity, and greater
child defiant behavior exist.
 Study included Majority of cases (55%)
having fewer friends. Children with ADHD
have
immature
interactive
skills,
egocentric selfish behavior, low frustration
tolerance,
increased
sensitivity
to
environmental stimuli. All of these may
lead to rejection by the peer group.
 Maximum number of patients (22.50%)
showed a positive family history of ADHDalike symptoms. The findings suggest the
genetic predisposition and heritability of
the disorder.
 Academic underperformance was found in
most of the ADHD children (85%). It can be
concluded that the academic performance is
the most commonly affected areas of child’s
functioning in the school years having ADHD.
 65% of cases had aggression and 57.50% had
violence associated with ADHD. Anxiety found
in 20% of cases. 15% cases presented
antisocial behaviors. Self-neglect was found in
30% of cases whereas 25% of cases had
limited social skill. Data indicate the presence
of co morbid conditions and other associated
problems with ADHD.
EFFECT ON CORE SYMPTOMS OF DSM-IV
• Group B showed maximum % of improvement among all
the four groups in all the core symptoms while group C
showed minimum improvement.
• Group B showed significant gain over group A and group
D indicating synergistic effect of study drug and
shirodhara.
EFFECT ON REACTION TIME
• Groups A, B and D showed statistically highly significant
change in Reaction Time (P<0.001).
• Statistically significant advantage was observed in group
B over group A (p<0.01).
• Moderately significant advantage of group A over group
D (p<0.02) was observed
EFFECT ON COEFFICIENT OF DIVISION OF
ATTENTION SPAN (CD)
• Statistically highly significant change in
coefficient of division of attention was observed
group A and B (P<0.001).
• Significant change was observed in-group D
(p<0.01).
• Statistical evaluation of differences of change in
CD between all the four groups showed
insignificant results.
EFFECT ON FDT
• Statistically highly significant improvement in
groups A and B (P<0.02), indicating the efficacy
of the individuals therapies in each group.
• Only group B showed highly significant
advantage over group C (p<0.001) and
significant advantage over groups A and D
(p<0.02 and p<0.01 respectively), indicating the
combined effect of drug and sirodhara in
improving the motor ability.
CONCLUSION
 Both the study drug & Shirodhara were effective in
alleviating the symptoms of ADHD, but drug
combined with Shirodhara had much greater
potential to ameliorate the symptoms of ADHD
rather than the drug or shirodhara alone.
 No adverse effects of the drug were observed
during the study which indicates the safety profile
of the study drug.