Our view on
"Mega-vitamin" therapies

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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.