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Complementary and Alternative Medicine Down Syndrome

Source: Roizen NJ. Complementary and Alternative Therapies for Down Syndrome. MRDD Research Reviews. 2005; 11: 149-155.

This review addresses both complementary and alternative medicine (CAM) therapies and conventional medical therapies (CMT) that have not been accepted as mainstream clinical practice.

Dietary Supplement Therapy

Drug Therapy

Cell Therapy

Plastic Surgery

Dietary supplement therapy

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Combination Nutritional Therapies

Supplements that generally include many ingredients, including vitamins, minerals, and thyroid compounds.

Evidence:

  • A study comparing the “U” series (48 ingredients, including thyroid globulin, organic ioidine, minerals, and bone meal) developed by Dr. Henry Turkel with a placebo in 24 children with DS (ages 3 months – 11 years old) found no significant differences in IQ, growth, hemogram, urinalysis or x-rays between the treatment and placebo groups
  • Randomized, controlled trials (total n = 161; age range 6 months to 40 years old) have attempted to determine the effects of a combination of vitamins, minerals and thyroid hormones advocated by Dr. Ruth Harrell on children with DS; none demonstrated significant effects on IQ, physical appearance or general health
  • There are no peer-reviewed studies of “Haps Caps,” a mixture of vitamins, minerals, and enzymes promoted by Dr. Jack Warner
  • There are no peer-reviewed studies of “MSB Plus” (Nutri-Chem Labs of Canada) or “NuTriVene-D” (International Nutrition, Inc. of Baltimore); these formulas were developed by Dixie Lawrence Tafoya, the adoptive mother of a girl with DS, and are based on Turkel’s mixture with additional ingredients

Antioxidants (i.e. Vitamin E)

Rationale:

Increased oxidative stress may be involved in DS pathology.

  • The gene for superoxide dismutase (SOD) is on chromosome 21
  • A gene dosage effect may account for the fact that increased SOD activity has been observed in the tissues of individuals with DS
  • SOD metabolizes oxygen-derived free radicals to hydrogen peroxide
  • Excess hydrogen peroxide can react with iron and other transition metals to form a hydroxyl radical that initiates lipid peroxidation and consequent cell membrane damage
  • Increased SOD activity can reduce immunity
    • The number of superoxide radicals is reduced due to increased metabolism to hydrogen peroxide, consequently decreasing the microbicidal activity of leukocytes
    • Increased hydrogen peroxide can damage immune cells and impair phagocyte activation

Evidence:

  • Animal studies have shown that increased SOD leads to increased lipid peroxidation in the brain
  • The neurons of fetuses with DS have increased levels of lipid peroxidation compared to individuals without DS
  • Neutrophils from individuals with DS have decreased levels of superoxide radicals compared to individuals without DS
  • Overproduction of SOD in a mouse model leads to:
    • Decreased superoxide radical concentration, increased hydrogen peroxide levels and reduced microbicidal and fungicidal activity
    • Depressed granulocyte and macrophage production in bone marrow cells
  • Increased concentrations of a biomarker of oxidative DNA damage (8-hydroxy-2-deoxyguanosine) were found in the urine of individuals with DS compared to their siblings (n=166 matched pairs)
  • Lymphocytes of individuals with DS had greater levels of chromosomal damage than individuals without DS
    • Adding the antioxidant vitamin E to the cell culture reduced chromosomal damage by 50%
  • Animal models indicate that increased SOD levels may lead to premature aging
  • When compared the cells of age-matched children without DS, the cells of children with DS have increased features of aging

Selenium

Rationale:

Selenium is part of GSHPX, an endogenous antioxidant.

Evidence:

  • 48 children with DS (1-16 years old) were treated with selenium (10 ìg/kg/day) for 6 months; close to 50% of participants lost to follow-up
    • Concentration of immunoglobulin G2 increased by 33%
    • Concentration of immunoglobulin G4 increased by 75%
    • Participants reported fewer infections during the study period
  • 7 individuals with DS (1–54 years old) given selenium (25 ìg/kg/day) for 0.3 to 1.5 years; 10 unsupplemented individuals as controls
    • 25% increase in GSHPX activity in treatment group versus controls

Zinc

Rationale:

The cytosolic copper-zinc-SOD enzyme requires zinc.

Evidence:

  • 13 of 16 studies found that individuals with DS had significantly lower serum zinc levels than individuals without DS
  • A one year randomized crossover trial of zinc (6 months treatment/6 months placebo) with 64 individuals with DS (1-19 years old) found that the zinc treated group had significantly fewer episodes of cough and that zinc treated children under 10 had significantly fewer cough days
  • In vitro studies
    • Adding zinc to the serum of individuals with DS led to increases in thymic factor to normal levels and a decrease in serum thymic inhibitory factor
    • After 4 months of supplementation with zinc (1 mg/kg/day), individuals with DS had an increase in the in vitro incorporation of thymidine into phytohaemagglutin-stimulated lymphocytes to levels similar to those of individuals without DS

Vitamin A

Evidence:

  • Some studies have documented reduced serum vitamin A concentration in individuals with DS
  • In a randomized trial, pairs of children with DS (ages 3-15 years old) and their sibling were assigned to 1000 IU/kg/day of vitamin A or placebo for 6 months; the difference in infection levels between children with DS and their siblings decreased from significant to insignificant levels for the pairs taking vitamin A but not the placebo; there were inadequacies in the methods used to assess infection frequency and the blinding procedures in this study

Vitamin B6

Rationale:

Vitamin B6 is involved in serotonin synthesis. Individuals with DS may have decreased serotonin levels.

Evidence:

  • Two randomized clinical trials (n=108 infants with DS) did not find any significant clinical improvements over the course of 3 years of treatment with vitamin B6

Thiamin

Evidence:

  • 11 children with DS (ages 8-16) were given supplemental thiamin; no improvements on the Stanford-Binet IQ scale were noted

Niacin

Evidence:

  • 12 individuals with DS (ages 6-36) were given supplemental niacin; no improvements on the Stanford-Binet IQ scale were noted

Drug Therapy

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Donepezil

Rationale:

Donepezil is a selective inhibitor of acetylcholinesterase (AchE) and can increase choline levels. It is used as a treatment in Alzhimer’s disease (AD) because the pathology of AD has been linked to degeneration of cholinergic neurons, neocortical deficits in choline acetyltransferase, reduced choline uptake, and reduced actylcholine release. Increased choline levels may also benefit individuals with DS.

Evidence:

  • 4 adults with DS (ages 27-64) were treated with donepezil for 6 months; the two younger adults without dementia improved on the Vineland Adaptive Behavior Scale
    • Side effects: short-term agitation and diarrhea; resolved during course of study
  • 9 adults with DS treated with donepezil for 83-182 days; found that dementia scores improved significantly
  • 24 adults with DS treated with donepezil for 24 weeks; found that expressive language performance improved
  • Placebo-controlled trial: 19 adults with DS randomized to treatment or placebo; treated with donepezil for 12 weeks; improved language score; no improvement on cognitive subtests, behavior scores or caregiver ratings
  • Double-blind, placebo controlled, parallel group trial in 27 adults with DS and AD; treatment group received donepezil for 24 weeks
    • The treatment group had nonstatistically significant decrease in deterioration on the Dementia Scale for Mentally Retarded Persons, the Severe Impairment Battery, and the Adaptive Behavior Scale
    • The treatment group had less improvement on Neuropsychiatric Inventory scores compared to the placebo group
    • Reported side effects: diarrhea, insomnia, fatigue and nausea

Piracetam

Rationale:

The use of this drug for children with Down Syndrome was promoted by Dixie Lawrence Tafoya, the mother who developed the MSB Plus and NuTriVene-D dietary supplements, after she noticed improvements in her adopted daughter’s concentration, awareness and speech when she was taking the dietary supplement and piracetam.

Piracetam is a psychoactive drug derived from gamma-aminobutyric acid (GABA). It may have an antioxidant mechanism of action. It has been used to treat individuals with Alzheimers disease, developmental dyslexia, and stroke.

Evidence:

  • Piracetam improves cognitive performance in animal models.
  • Treating cortical cultures from individuals with DS with GVS-111 (a piracetam analog) led to a significant reduction in degeneration and improved neuronal survival
  • A double-blind crossover study: 25 moderate to high functioning children with DS (ages 6-13) treated with piracetam; 28% of children dropped out of trial
    • There was no improvement in cognitive performance on the piracetam versus the placebo
    • Side effects: aggressiveness (n = 4), agitation or irritability (n = 2), sexual arousal (n = 2), poor sleep (n = 1), and decreased appetite (n = 1)

Vasopressin

Evidence:

  • Nine individuals with DS (age 10-42) treated with vasopressin; no positive effects on word list and visual verbal paired associated tasks

Pituitary extract

Evidence:

  • Three children with DS (age 16 months to 4 years) treated with pituitary extract; no positive effects on function measured on the Griffiths mental developmental scale

Growth hormone (GH)

Evidence:

  • Treatment leads to increased growth velocity
  • No peer-reviewed studies examining effect of GH treatment on final height

Known/potential side effects:

  • Lawson Wilkins Pediatric Endocrine Society: GH treatment may increase risk of leukemia in children with DS

Cell therapy

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Freeze-dried or lyophilized cells from fetal tissues of sheep and rabbits are administered. Sicca cell therapy involves subcutaneous injections of freeze-dried or lyophilized fetal brain cells. Sicca cell treatments are not legal in the U.S. but are available in Europe and via mail; 21 of 190 U.S. individuals with DS (11%) had received sicca cell therapy in one clinical survey.

Evidence:

  • A double-blind prospective study of cell therapy in Canada with 59 individuals with DS found no positive effects on cognitive function
  • A placebo-controlled study of cell therapy in England with 20 individuals with DS found no positive effects on cognitive function
  • Retrospective analysis comparing 21 children with DS who had received sicca cell therapy with 21 children with DS who had not received the therapy (matched on demographics and for cardiac history); no significant differences in 18 variables measuring growth, social adaptive skills, motor skills, and cognitive development

Known/potential side effects:

  • Allergic or hypersensitivity reactions due to the injection of foreign protein
  • Transmission of viruses

Plastic surgery

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Several procedures are possible, including:

  • Wedge resection of the tongue
  • Removal of epicanthal folds of eye and straightening out the oblique eyelid axis
  • Reduction of lower lip
  • Implants of silicone or cartilage at the chin, nasal bridge, and cheeks

Rationale:

Individuals with DS may face social barriers and prejudices because of the characteristic facial features associated with DS. Decreasing the size of the tongue may improve breathing, chewing, swallowing, and speech clarity and decrease drooling.

Evidence:

Studies including objective measures and uninvolved observers have not found improvements in speech

  • 18 children with DS who had tongue-reduction surgery: no significant reduction in articulation errors
  • 23 children with DS who had a partial glossectomy: no differences in pre- and postoperative acoustic speech intelligibility based on audiotape ratings by three lay people and three professionals

Most parents do not support plastic surgery for their children with DS

  • Parents of children with DS who had/did not have plastic surgery did not have significantly different perceptions of their children’s personal, physical and social function

Known/potential complications:

  • Suture dehiscence
  • Additional lengthening procedures required if the tip of the tongue is too short
  • Infection and dislocation of silicone implants

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