Creatine for amyotrophic lateral sclerosis/motor neuron disease
Pastula DM, Moore DH, Bedlack RS
The Cochrane database of systematic reviews · 13 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
- Metaanálisis (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2010-06-15 · Cochrane Database Syst Rev · vol. 12 · número 6 · pág. CD005225
- Editorial
- Elsevier BV
- Citado
- 55 citas
- Referencias
- 55 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Amyotrophic Lateral Sclerosis Research · Muscle Physiology and Disorders · Neurogenetic and Muscular Disorders Research
- Palabras clave
- creatine, amyotrophic lateral sclerosis, motor neuron disease, survival, disease progression, ALSFRS-R, forced vital capacity, ATP production, individual patient data, drug safety and efficacy, adverse events, creatine supplementation, individualized dosing, quality of life
- MeSH
- humans, amyotrophic lateral sclerosis, motor neuron disease, disease progression, creatine, neuroprotective agents, vital capacity, randomized controlled trials as topic
3 autores
- Daniel M. Pastula🇺🇸University of California, San Francisco; University of California San Francisco Medical Center
- Dan H. Moore🇺🇸California Pacific Medical Center
- Richard Bedlack🇺🇸Duke University; Duke Medical Center
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Creatine, a naturally-occurring nitrogenous organic acid involved in adenosine triphosphate (ATP) production, has been shown to increase survival in mouse models of amyotrophic lateral sclerosis (ALS). Results from human trials, however, have been mixed. Given conflicting results regarding creatine's efficacy, we conducted a systematic review.
Objectives
To systematically examine creatine's efficacy in prolonging ALS survival and in slowing ALS disease progression.
Search strategy
We searched the Cochrane Neuromuscular Disease Group Trials Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library issue 4, 2009), MEDLINE and EMBASE in October 2009 for any trial involving creatine in the treatment of ALS. We also contacted experts in the field for any additional studies.
Selection criteria
Randomized trials of treatment with creatine or placebo in patients diagnosed with ALS. Our primary outcome was tracheostomy-free survival time; secondary outcomes were ALS progression as measured by changes in ALS functional rating revised scores (ALSFRS-R) and percent predicted forced vital capacity (FVC) over time.
Data collection and analysis
Two authors independently selected studies, assessed risk of bias and extracted data. We obtained and analyzed individual participant data from each study.
Main results
We included three trials involving 386 participants randomized to either creatine 5 to 10 g per day or placebo. Creatine was reportedly well-tolerated in all three included studies, with no evidence of renal failure or serious adverse events specifically attributable to creatine. Using a pooled log-rank statistical test, we found no statistical difference in survival between the placebo and creatine groups across all three studies (Chi(2) = 0.09, P = 0.76). In addition, we found no statistical difference in ALSFRS-R slopes between the two groups across all three studies using a pooled linear mixed-effects model (slope difference of +0.03 ALSFRS-R/month in the creatine group; P = 0.76). Interestingly, there was a trend towards slightly worsened FVC slope in the creatine group (slope difference of -0.63 FVC/month in the creatine group) using a pooled linear mixed-effects model across the two studies which included FVC as an outcome, but this difference was not statistically significant (P = 0.054).
Authors' conclusions
In patients already diagnosed with clinically probable or definite amyotrophic lateral sclerosis (ALS), creatine at doses ranging from 5 to 10 g per day did not have a statistically significant effect on survival, ALS functional rating revised scores (ALSFRS-R) progression or percent predicted forced vital capacity (FVC) progression.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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