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A prospective double-blind, randomized clinical trial of levocarnitine to treat autism spectrum disorders.

Geier DA, Kern JK, Davis G, King PG, Adams JB, Young JL, Geier MR - Med. Sci. Monit. (2011)

Bottom Line: Significant correlations between changes in serum free-carnitine levels and positive clinical changes were observed for hand muscle strength (R2=0.23, P=0.046), cognitive scores (R2=0.27, P=0.019), and CARS scores (R2=0.20, P=0.047).Study subjects were protocol-compliant (average adherence was >85%) and generally well-tolerated the L-carnitine therapy given.L-carnitine therapy (50 mg/kilogram-bodyweight/day) administered for 3-months significantly improved several clinical measurements of ASD severity, but subsequent studies are recommended.

View Article: PubMed Central - PubMed

Affiliation: The Institute of Chronic Illnesses, Inc., Silver Spring, MD, USA. mgeier@comcast.net

ABSTRACT

Background: L-carnitine was proposed as a potential treatment for patients diagnosed with an autism spectrum disorder to improve mitochondrial dysfunction, but no prior randomized controlled trials have been conducted.

Material/methods: Thirty subjects diagnosed with an ASD were randomly assigned to receive a standardized regimen (50 mg L-carnitine/kg bodyweight/day) of liquid L-carnitine (n=19) or placebo (n=11) for 3-months. Measures included changes in professionally completed Childhood Autism Rating Scale (CARS), hand muscle testing, and modified clinical global impression (CGI) forms; parent completed Autism Treatment Evaluation Checklist (ATEC), treatment adherence measurement (TAM), frequency and intensity of side effect rating (FISER)/global rating of side effect burden (GRSEB)/patient report of incidence of side effects (PRISE) forms; and lab testing.

Results: Significant improvements were observed in CARS (-2.03, 95% CI=-3.7 to -0.31), CGI (-0.69, 95% CI=-1.1 to -0.06), and ATEC scores. Significant correlations between changes in serum free-carnitine levels and positive clinical changes were observed for hand muscle strength (R2=0.23, P=0.046), cognitive scores (R2=0.27, P=0.019), and CARS scores (R2=0.20, P=0.047). Study subjects were protocol-compliant (average adherence was >85%) and generally well-tolerated the L-carnitine therapy given.

Conclusions: L-carnitine therapy (50 mg/kilogram-bodyweight/day) administered for 3-months significantly improved several clinical measurements of ASD severity, but subsequent studies are recommended.

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Related in: MedlinePlus

The correlation* between the change in serum free-carnitine and the change in CARS score (n=20)**. * simple linear-regression statistic; ** L-carnitine group (n=12) and placebo group (n=8); ____ – linear regression estimate; - - - - – 95% confidence interval for linear regression estimate; Δ CARS Score =−0.047 Δ Serum Free Carnitine (μmol/L) − 0.81; R2=0.20, P=0.047.
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f5-medscimonit-17-6-pi15: The correlation* between the change in serum free-carnitine and the change in CARS score (n=20)**. * simple linear-regression statistic; ** L-carnitine group (n=12) and placebo group (n=8); ____ – linear regression estimate; - - - - – 95% confidence interval for linear regression estimate; Δ CARS Score =−0.047 Δ Serum Free Carnitine (μmol/L) − 0.81; R2=0.20, P=0.047.

Mentions: Figures 3–5 evaluate the correlation between changes at the end of 3-months therapy in serum free carnitine and specific clinical outcomes measurements regardless of the treatment status of the study subjects. There was a significant positive correlation between increasing hand muscle strength and increasing serum free-carnitine levels. There were also significant correlations between increasing serum free-carnitine levels and decreasing cognitive scores (from ATEC testing) and CARS scores (decreasing scores on the ATEC and CARS indicate improvement).


A prospective double-blind, randomized clinical trial of levocarnitine to treat autism spectrum disorders.

Geier DA, Kern JK, Davis G, King PG, Adams JB, Young JL, Geier MR - Med. Sci. Monit. (2011)

The correlation* between the change in serum free-carnitine and the change in CARS score (n=20)**. * simple linear-regression statistic; ** L-carnitine group (n=12) and placebo group (n=8); ____ – linear regression estimate; - - - - – 95% confidence interval for linear regression estimate; Δ CARS Score =−0.047 Δ Serum Free Carnitine (μmol/L) − 0.81; R2=0.20, P=0.047.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3539542&req=5

f5-medscimonit-17-6-pi15: The correlation* between the change in serum free-carnitine and the change in CARS score (n=20)**. * simple linear-regression statistic; ** L-carnitine group (n=12) and placebo group (n=8); ____ – linear regression estimate; - - - - – 95% confidence interval for linear regression estimate; Δ CARS Score =−0.047 Δ Serum Free Carnitine (μmol/L) − 0.81; R2=0.20, P=0.047.
Mentions: Figures 3–5 evaluate the correlation between changes at the end of 3-months therapy in serum free carnitine and specific clinical outcomes measurements regardless of the treatment status of the study subjects. There was a significant positive correlation between increasing hand muscle strength and increasing serum free-carnitine levels. There were also significant correlations between increasing serum free-carnitine levels and decreasing cognitive scores (from ATEC testing) and CARS scores (decreasing scores on the ATEC and CARS indicate improvement).

Bottom Line: Significant correlations between changes in serum free-carnitine levels and positive clinical changes were observed for hand muscle strength (R2=0.23, P=0.046), cognitive scores (R2=0.27, P=0.019), and CARS scores (R2=0.20, P=0.047).Study subjects were protocol-compliant (average adherence was >85%) and generally well-tolerated the L-carnitine therapy given.L-carnitine therapy (50 mg/kilogram-bodyweight/day) administered for 3-months significantly improved several clinical measurements of ASD severity, but subsequent studies are recommended.

View Article: PubMed Central - PubMed

Affiliation: The Institute of Chronic Illnesses, Inc., Silver Spring, MD, USA. mgeier@comcast.net

ABSTRACT

Background: L-carnitine was proposed as a potential treatment for patients diagnosed with an autism spectrum disorder to improve mitochondrial dysfunction, but no prior randomized controlled trials have been conducted.

Material/methods: Thirty subjects diagnosed with an ASD were randomly assigned to receive a standardized regimen (50 mg L-carnitine/kg bodyweight/day) of liquid L-carnitine (n=19) or placebo (n=11) for 3-months. Measures included changes in professionally completed Childhood Autism Rating Scale (CARS), hand muscle testing, and modified clinical global impression (CGI) forms; parent completed Autism Treatment Evaluation Checklist (ATEC), treatment adherence measurement (TAM), frequency and intensity of side effect rating (FISER)/global rating of side effect burden (GRSEB)/patient report of incidence of side effects (PRISE) forms; and lab testing.

Results: Significant improvements were observed in CARS (-2.03, 95% CI=-3.7 to -0.31), CGI (-0.69, 95% CI=-1.1 to -0.06), and ATEC scores. Significant correlations between changes in serum free-carnitine levels and positive clinical changes were observed for hand muscle strength (R2=0.23, P=0.046), cognitive scores (R2=0.27, P=0.019), and CARS scores (R2=0.20, P=0.047). Study subjects were protocol-compliant (average adherence was >85%) and generally well-tolerated the L-carnitine therapy given.

Conclusions: L-carnitine therapy (50 mg/kilogram-bodyweight/day) administered for 3-months significantly improved several clinical measurements of ASD severity, but subsequent studies are recommended.

Show MeSH
Related in: MedlinePlus