A clinical trial of creatine in ALS
Shefner JM, Cudkowicz ME, Schoenfeld D, Conrad T, Taft J, Chilton M, Urbinelli L, Qureshi M, Zhang H, Pestronk A, Caress J, Donofrio P, Sorenson E, Bradley W, Lomen-Hoerth C, Pioro E, Rezania K, Ross M, Pascuzzi R, Heiman-Patterson T, Tandan R, Mitsumoto H, Rothstein J, Smith-Palmer T, MacDonald D, Burke D, NEALS Consortium
Neurology · 217 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2004-11-09 · Neurology · vol. 63 · número 9 · págs. 1656–1661
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 293 citas · más que el 99% de estudios similares · 12.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 38 trabajos
- Acceso
- De pago
- Áreas de investigación
- Amyotrophic Lateral Sclerosis Research · Muscle Physiology and Disorders · Mitochondrial Function and Pathology
- Palabras clave
- amyotrophic lateral sclerosis, creatine supplementation, mitochondrial dysfunction, motor unit number estimation, muscle strength, grip strength, motor neuron survival, clinical trial outcome measures
- MeSH
- humans, amyotrophic lateral sclerosis, creatine, treatment outcome, double-blind method, isometric contraction, adolescent, adult, aged, middle aged, female, male
26 autores
- Jeremy M. Shefner🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Merit Cudkowicz🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- David Schoenfeld🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Thomas M. Conrad🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- J. Taft🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Mark Chilton🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Leo Urbinelli🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Muddasir Qureshi🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Haohan Zhang🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Alan Pestronk🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- James B. Caress🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- P. D. Donofrio🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Eric J. Sorenson🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Walter G. Bradley🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Catherine Lomen‐Hoerth🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Erik P. Pioro🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Kourosh Rezania🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Mark A. Ross🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Robert M. Pascuzzi🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Terry D Heiman-Patterson🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Rup Tandan🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Hiroshi Mitsumoto🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- J. D. Rothstein🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Truis Smith‐Palmer🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- Daniel J. MacDonald🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
- D. Burke🇺🇸SUNY Upstate Medical University; Washington University in St. Louis; Massachusetts General Hospital; Wake Forest University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Mitochondrial dysfunction occurs early in the course of ALS, and the mitochondria may be an important site for therapeutic intervention. Creatine stabilizes the mitochondrial transition pore, and is important in mitochondrial ATP production. In a transgenic mouse model of ALS, administration of creatine prolongs survival and preserves motor function and motor neurons.
Methods
The authors conducted a randomized double-blind, placebo controlled trial on 104 patients with ALS from 14 sites to evaluate the efficacy of creatine supplementation in ALS. The primary outcome measure was maximum voluntary isometric contraction of eight upper extremity muscles, with secondary outcomes including grip strength, ALS Functional Rating Scale-Revised, and motor unit number estimates. Patients were treated for 6 months, and evaluated monthly.
Results
Creatine was tolerated well, but no benefit of creatine could be demonstrated in any outcome measure. CI analysis showed that the study, although powered to detect a 50% or greater change in rate of decline of muscle strength, actually made an effect size of greater than 23% unlikely. It was also demonstrated that motor unit number estimation was performed with acceptable reproducibility and tolerability, and may be a useful outcome measure in future clinical trials.
Conclusion
Any beneficial effect of creatine at 5 g per day in ALS must be small. Other agents should be considered in future studies of therapeutic agents to address mitochondrial dysfunction in ALS. In addition, motor unit number estimation may be a useful outcome measure for future clinical trials in ALS.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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