Our view on
"Mega-vitamin"
therapies
Ben Sacks
and Sue Buckley
Abstract
- We have been asked for
our advice on mega vitamin
therapies (now often referred
to as Targeted Nutritional
Interventions, or TNI
more often than any other
single issue. Here we
explain why, at the present
time, we do not support
the use of any high-dosage
nutritional supplements,
nor use of the drug Piracetam.
Keywords
- Down Syndrome,
Nutrition, Vitamins, Piracetam
Introduction
Over
the last year in particular,
we have been asked for
our advice on mega vitamin
therapies (using this
term to include mega vitamin
supplements plus minerals,
hormones, piracetam etc
- now often referred to
as Targeted Nutritional
Interventions, or TNI1)
more often than any other
single issue.
The
history of medicine has
very many examples of
treatments that were (and
are) extremely fashionable
but later turn out to
be ineffective or even
harmful. Those of us who
are involved in the care
of people who have problems
that are difficult to
treat are confronted with
many treatments, some
of which promise amazing
benefits. Unfortunately,
the market has large numbers
of people who wish to
sell treatments which,
at best, are useless,
and that may even be harmful.
It is therefore important
for us to have evidence
of the real effects of
these treatments.
Those
of us whose profession
it is to advise those
who care for people with
Down syndrome have a special
responsibility to examine
the evidence carefully
and unemotionally so that
we can suggest treatments
which have shown to be
useful and not harmful.
After all, if a particular
treatment were effective
we would all recommend
it. It is against this
background that we offer
the following conclusions
and some of the reasons
for them:
* We do not support the
use of mega vitamin therapies
at the present time because
there is no credible scientific
evidence of effectiveness
and they could be harmful.
* We are concerned that
the current unsubstantiated
claims for their benefits
distract parents from
giving their children
the social and educational
experiences that we know
do improve the development
of children with Down syndrome.
* We feel that the proponents
do not understand the
dynamic nature of brain
development and the importance
of input, i.e. the child’s
everyday activities and
experience, in stimulating
brain growth and development.
Not
a New Idea
The
current proponents of
megavitamins and mineral
supplements are recommending
a type of intervention
that has been proposed
and evaluated a number
of times. An authoritative
and concise review of
the story and the evidence
since 1963 can be found
in an Editorial entitled
‘Vitamins and Down syndrome’ by Mary
Coleman, an American paediatrician
and world acknowledged
expert on Down syndrome,
in Down syndrome Quarterly,
Vol.2 no 2, June 1997.
Mary
has devoted much of her
career to improving the
health and development
of children with Down syndrome. She was the
author of the first medical
check lists to guide doctors
on their health care needs,
has published many articles
and books, and was the
founding editor of the
journal ‘Down syndrome:
Abstracts for Professionals’
(now Down syndrome Quarterly)
in the USA.
In
her article, Mary points
out that claims for the
benefits of megavitamins
often combined with minerals,
enzymes and hormones,
have been around for some
35 years. It is not a
new idea – just
being promoted again at
present.
No Evidence for Effectiveness
Mary
lists 9 studies published
between 1963 and 1989
and states ‘The
controlled studies were
uniformly negative, finding
no difference between
the treated and the untreated
children, except for the
complex Bidder study (Bidder
et. al. 1989) which documented
an actual decrease in
developmental progress
and various side effects
of the multivitamins and
minerals. No study that
adhered to even minimal
scientific methods documented
any definite improvement
or even suggestive trends
in intelligence, speech
or language, neuromotor
function, height or health’
Mary
also cites the article
published by Pruess, Fewell
and Bennet in 1989, in
which they review the
published literature on
the subject and stated
that the indiscriminate
use of multivitamin therapy
was not useful in Down syndrome. These authors
are also people who have
spent their professional
careers developing early
intervention programmes
and working to improve
the development and life
experiences of children
with Down syndrome. Like
us, I am sure they would
have been thrilled to
find that something as
easy to offer as a food
supplement improved children’s
progress, but all the
current credible evidence
says that it does not.
What is Credible Evidence?
Double-blind trials are
needed.
Any
claims that megavitamin
therapies improve aspects
of children’s health
and development need to
be subjected to double-blind
studies using a placebo
or at least comparing
children to untreated
controls. For a rigorous
and convincing study,
those assessing the children’s
progress at the start
and at the end of the
study must not know which
are the treated and untreated
children. Many studies
illustrate that unintentional
bias will contaminate
the outcome data if assessors
do know which group the
children are in. The double
blind placebo study is
the ideal design as in
this design all children
will be receiving ‘
a treatment’ and
any effects coming from
simply expectation of
improvement by either
child or family should
be similar.
Controlling other variables.
In
the ideal study, the children
in the two groups, treated
and placebo should be
identical in all respects
at the start of the study.
That is matched for sex
(same number of boys and
girls in each group);
matched for age, position
in family, developmental
and health status at start
of study; matched for
parental education and
social class of family
(as we know these factors
influence the development
of all children). During
the period of the ideal
study, both groups of
children must have exactly
the same diet, lifestyle
at home, educational and
social experiences –
as we know these may all
influence development
and health. If we were
studying typically developing
children, we could probably
recruit enough children
to the study to be able
to control for the effects
of all these other significant
variables by statistical
analysis techniques. However,
it is difficult to study
sufficiently large samples
of children with Down syndrome to allow such
analyses, so careful matching
to control these variables
is essential.
Confounding variables.
In
studies that are not double
blind we do not consider
parent observations as
reliable data on the effects
of megavitamin therapies
for the following reasons.
a) once a parent has made
the decision to embark
on a course of treatment,
they are biased in the
direction of wanting to
see that their judgement
in choosing the treatment
was correct (particularly
when they are paying for
the treatment). b) in
our experience, the parents
who do embark on such
treatments are often providing
their children with good
educational and social
opportunities as well,
so how can they decide
whether it’s the
learning opportunities
or the megavitamins that
are leading to their children
progressing well?
Current outcome claims.
The
recent claims that we
have seen from individuals
and organisations promoting
such therapies fail all
these tests. The descriptions
we have seen of the progress
of children are not convincing
evidence. As we have already
pointed out many things
influence a child’s
development. We know many
children with Down syndrome
who are developing just
as well as the children
described in the propaganda
being circulated as evidence.
These are children who
have never been on such
therapies but who do receive
good parenting in loving
homes and who have access
to good education and
health care in their communities.
Parent vulnerability
We
all have to recognise
how vulnerable we are
as parents of a child
with a disability for
which there is no cure.
We always want to do the
best for our children
and it is difficult to
decide when to accept
or reject a treatment,
even if it is not supported
by definitive evidence
of effectiveness at this
time. Maybe the evidence
will be positive in a
few years time, then our
child will have missed
out. Here there are several
points we would ask you
to consider if definitive
evidence for any therapy,
medical or educational,
that has not yet been
demonstrated to be effective.
Is the treatment safe,
even if it turns out to
be ineffective?
There
is substantial evidence
to demonstrate that megadoses
of vitamins and/or minerals
can actually be harmful.
(see MRC News, Winter
1994, Autumn 1995). The
absorption of minerals
can be reduced by unbalanced
intake because they can
interfere with each other
in this process. Even
measuring the levels of
minerals in the blood
can be misleading because
they exist in different
'pools' such as the extracellular
fluid, intracellular compartments
and the serum, each of
which have different concentrations.
Too much of both vitamins
A and D can be poisonous
as well as some of the
B vitamins. It is not
a question of 'the more
the better' but of providing
balance of vitamins and
minerals such as is found
in a normal mixed diet.
Mary
Coleman specifically considers
the evidence for the use
of water-soluble vitamins,
fat-soluble vitamins and
minerals in Down syndrome
her article. She advises
that no child should be
treated with the shotgun
approach being advocated
so vigorously at present.
Each child should be treated
as an individual and only
given any substance if
medical evidence for that
individual child suggests
that therapy is appropriate.
She concludes ‘There
is a great deal we do
not know about Down syndrome
in spite of many advances
in recent decades. Everyone
who cares about the special
needs of these children
welcomes advances in the
field if they are based
on solid evidence. Indeed,
there may be malabsorption
of vitamins or minerals
in some children; there
may be co-enzyme methods
of curbing the elevations
of so many biochemical
products measured in these
children. There may be
a way to protect these
children by altering their
immune systems in a positive
way. We look forward to
future scientific research.
Until
then, we must be careful
not to interfere with
the metabolism of children
with Down syndrome until
we understand what we
are doing. Properly handled
from birth with knowledgeable
educational and medical
care, the overwhelming
majority of children with
Down syndrome now have
great potential for a
good life and it is important
not to experiment on them
for the sake of an elusive
"medical cure".’(Coleman,
1997)
If vitamins do not make
a difference, what does?
Normal life opportunities
and experiences.
One
of us has a daughter with
Down syndrome who is now
28 years old. Both of
us have worked in the
field of learning difficulty
for more than 30 years
(as a doctor and a psychologist
respectively). In that
time we have seen vast
improvements in the development
and life opportunities
for children with Down syndrome, mostly due to
better health care and
to better access to normal
social and educational
opportunities. Many more
people with Down syndrome
are now working, leading
more ordinary and independent
lives in the community,
finding partners and speaking
out for themselves on
a national and international
level. The next generation
of children following
behind them are likely
to do even better in many
countries as more children
attend mainstream schools,
more learn to read and
write and more are welcomed
and supported as full
members of their communities.
Until the last few years,
most children born with
Down syndrome experienced
educational and social
deprivation. If a child
with no disabilities at
birth and the potential
for normal development
had only been offered
the social and educational
opportunities offered
to children with Down syndrome until the last
ten years in this country,
then we would argue that
the development of the
child would have been
retarded. Data from very
large studies in the USA
(50,000 children) support
this view, illustrating
that it is the social,
educational and family
environment that have
the most influence on
the development of intelligence
in all children (e.g.Broman
et.al. 1975, Willerman
et al. 1970)
Addressing the learning
difficulties that have
been identified.
We
know that the development
of children with Down syndrome is affected by
a number of impairments,
including slow motor development,
risk of hearing impairments,
delayed acquisition of
speech and language, and
of working memory skills.
All these will have an
impact on mental development,
with the latter three
probably being inter-related
and the most significant
for mental development.
Words are the building
blocks for mental abilities;
we learn about our world
as we learn vocabulary
as an infant, each new
word being a new piece
of information about that
world and the people in
it. Words are tools for
thinking, reasoning and
remembering – all
central to the development
of mental abilities or
‘intelligence’.
We have increasing evidence
that we can improve the
speech and language progress
of children with early
interventions and educational
programmes that include
signing and reading activities.
These and other activities
would appear to also influence
working memory development,
as they do in the development
of non-disabled children.
(Laws et al 1995, Laws,
1995, Buckley, 1995, Buckley
et al 1996,)
Understanding brain development
Advocates
of megavitamin therapies
hope that they will have
an effect on some of the
reported abnormalities
in brain development in
Down syndrome. There is
no evidence that they
do and, furthermore, the
reports on brain development
are frequently misunderstood.
Studies report less density
of brain cells in some
areas of the brain, or
less complex connections
between them. These abnormalities
could be due to genetic
and biochemical abnormalities.
They could also be the
result of understimulation
as a result of impoverished
environmental input and
abnormal rates of development.
In conclusion
We
hope that this article
has given our readers
some food for thought.
It is clear that at present
our understanding of influences
of brain development in
children is rudimentary.
We do know that input
influences the organisation
of brain systems in animals
and in man and we also
know that, however good
a child’s potential,
he or she needs the opportunity
to learn. Even if we knew
how to improve the potential
for learning in the brains
of children with Down syndrome, the most important
effect on outcome would
still be the quality of
daily interactions and
the opportunities to learn
that are provided by family,
teachers and friends.
Notes
1. Included in this definition
are products such as "Nutrivene
D", "MSB+"
(with or without Piracetam)
and "HAP CAPS."
References
Bidder,
R.T., Gray, P., Newconbe,
R.G., Evans, B.K., &
Hughes, M. (1989). The
effects of multivitamins
and minerals on children
with Down syndrome Developmental
Mediacine and Child Neurology.
31. 532-537.
Broman,
S.H., Nichols, P.L., &
Kennedy, W.A. (1975).
Preschool IQ: Prenatal
and early developmental
correlates. Hillsdale,
NJ: Lawrence Earlbaum
Associates.
Buckley,
S.J., (1995) Teaching
reading to teach talking,
Portsmouth Down syndrome
Trust Newsletter
Buckley,
S.J., Bird, G., Byrne,
A. (1996) Reading acquisition
by young children. In
New Approaches to Down syndrome Brian Stratford
& Pat Gunn (editors)
London, UK: Cassell.
Coleman,
M.(1997) Vitamins and
Down syndrome. Down syndrome
Quarterly 2,2 p 11-13.
Laws,
G. MacDonald, J. Broadley,
I. (1995) The effect of
reading on other cognitive
skills, Down syndrome:
Research and Practice
Laws,
G. (1995) Memory skills,
Portsmouth Down syndrome
Trust Newsletter
Pruess,
J.B., Fewell, R.R., &
Bennet, F.C. (1989) Vitamin
therapy and children with
Down syndrome: a review
of research. Exceptional
Children, 55, 336-341.
Willerman,
L., Broman, S.H., &
Fielder, M. (1970) Infant
development, preschool
IQ, and social class.
Child Development, 41,
69-77.