a "cocktail". JR
The use of Ginkgo, Prozac and Focalin as a "treatment" for Down syndrome
A combination of drugs recommended for depression and attention deficit and hyperactivity disorder is being widely promoted as a "treatment" for Down syndrome. There is no scientific support for the routine use of this protocol by people who have Down syndrome. It is important that families and healthcare professionals are aware of the lack of evidence for safety and benefits from use of this protocol.
Introduction
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We are a group of healthcare professionals, scientists and support organizations who care for and about people with Down syndrome. We wish to provide families with information about a proposed "treatment" for Down syndrome. We recognize that all parents wish to improve the lives of their children with Down syndrome and are interested in treatments, therapies and interventions that can help. We respect these wishes. At the same time, we are concerned that these "treatments" are potentially dangerous.
We are all aware of the advances that have been made in the basic science of memory and cognition in animal models of Down syndrome and are hopeful that these studies may lead to new ways to improve the lives of people who live with the condition.
Physicians and biomedical scientists evaluate potential interventions on the basis of safety and benefits to patients. As we describe below, the "treatments" that the Changing Minds Foundation recommends have not passed either test: there is no information whether these compounds are safe for children, especially young children. Furthermore, there is no evidence to support the claims for benefits that have been made.
Because we care about your children, we strongly urge families to consider this information when considering the claims for this "treatment".
The protocol
An organization called the Changing Minds Foundation is promoting a "new treatment for Down syndrome" that leads to "life changing" results. The "treatment" includes regular doses of Fluoxetine (Prozac), Dexmethylphenidate (Focalin XR) and Ginkgo biloba, Phosphatidylcholine, ‘Body Bio Balanced Oil’ and folinic acid. Some of these substances are associated with potential harmful side-effects. Some of these side-effects are of particular concern for people with Down syndrome and younger children.
Fluoxetine (Prozac) is used to treat depression, obsessive-compulsive disorder, bulimia nervosa and panic disorder. Dexmethylphenidate (Focalin XR) is used for the treatment of attention deficit and hyperactivity disorder (ADHD). Their use should be initiated and monitored by an appropriately qualified physician and should be limited to applications and treatments formally reviewed and approved by appropriate governmental and medical drug regulatory agencies.
Evidence of effects and safety
There is no scientific evidence to support the use of any of this protocol with people with Down syndrome of any age in order to improve memory or any other aspect of cognition. Nor is there any evidence that this protocol is safe for routine use with people who have Down syndrome.
The few studies referenced in support of this protocol are studies of mice. These mice have been engineered to carry extra copies of some genes similar to genes found on human chromosome 21. (People who have Down syndrome have an additional copy of this chromosome). These studies may or may not be good indicators of aspects of memory and learning for people who have Down syndrome. Studies in mice alone are not sufficient to support use of this (or any) protocol in children or adults with Down syndrome.
The Changing Minds Foundation promotional videos do not prove the claims of benefit from the protocol. While the people shown are clearly doing well, none of the individuals shown are functioning beyond the wide range seen in others with the syndrome. Claimed changes following ‘treatment’ could be the result of many factors. Only a controlled trial can give clear evidence of treatment effects.
Scientific progress
Scientific research has improved our understanding of Down syndrome considerably over the past 30 years. This has led to the better healthcare and education received by many people with Down syndrome today. Many scientists and organizations continue to work to improve our knowledge and understanding of effective ways to improve quality of life for people who live with Down syndrome.
Although the pace of further progress is often slow and this can be frustrating, only careful research and rigorous controlled trials can provide the evidence necessary to demonstrate that a therapy is useful and safe.
Further information
Ginkgo
Although bilobalide, a component of Ginkgo Biloba, has been shown to be a GABA antagonist, the activity has been tested only in isolated cells and in only one subtype of GABA receptors. No controlled studies have been done in animals or humans to establish safe doses, or to prove the claimed benefits.
Fluoxetine (Prozac)
The action of fluoxetine on the growth of new nerve cells seen in one part of the brain of Ts65Dn mice has not been replicated in humans. Published case reports suggest that medications like Prozac used in pregnancy can harm the fetus. The potential impact on developing minds of babies and young children is unknown. A general, or uncontrolled, increase in nerve cell growth is not necessarily a good thing, especially over long periods of time.
Dexmethylphenidate (Focalin XR)
The use of stimulant medication should be carefully considered for children with unusual heart structures, which includes about half of children with Down syndrome. Again, use is not recommended for babies or very young children.
Folinic acid
Folinic acid supplementation has been shown to have no significant effects for infants and children with Down syndrome on a range of developmental measures.
- http://www.nlm.nih.gov/medlineplus/druginfo/natural/patient-folate.html
- http://www.bmj.com/cgi/content/full/336/7644/594
‘Off label’ use
Families and healthcare professionals should understand that use of the protocol at this time is essentially experimental, with none of the benefits of a controlled trial. Monitoring for adverse effects would be the responsibility of the prescribing physician, with no one collecting that information to determine real risks. Similarly, positive effects would not be collected in a credible way that could be used by healthcare professionals to gauge the value of the treatments.
While there is no current evidence of the treatment's effectiveness for people with Down syndrome, there are significant risks of harm.
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