Financiado en parte por Pfizer, Teva Pharmaceutical Industries, Voyager Therapeutics, Novartis Institutes for BioMedical Research
The CREST-E study of creatine for Huntington disease: A randomized controlled trial
Hersch SM, Schifitto G, Oakes D, Bredlau AL, Meyers CM, Nahin R, Rosas HD, Huntington Study Group CREST-E Investigators and Coordinators
Neurology · 73 citas
Etiquetas de revisión
Vínculos de autores con la industriaFinanciado por la industriaDatos 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
- Financiado por la industria
- Gobierno
- U.S. Department of Defense
- Gobierno
- Office of Dietary Supplements
- Gobierno
- California Institute for Regenerative Medicine
- Empresa
- Pfizer
- Empresa
- Teva Pharmaceutical Industries
- Empresa
- Voyager Therapeutics
- Gobierno
- National Institutes of Health
- Empresa
- Novartis Institutes for BioMedical Research
- Gobierno
- National Institute of Neurological Disorders and Stroke
- Gobierno
- National Center for Advancing Translational Sciences
- Gobierno
- National Center for Complementary and Integrative Health
- Gobierno
- NINDS NIH HHS
- Gobierno
- NCCIH NIH HHS
- Autores
- Al menos un autor declara un vínculo económico con la industria
- Subvenciones
- National Center for Complementary and Integrative Health (U01 AT008197); National Institute of Neurological Disorders and Stroke (U01 NS071789); National Institute of Neurological Disorders and Stroke (P01NS058793); National Center for Complementary and Integrative Health (U01AT000613)
Según 13 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2017-07-13 · Neurology · vol. 89 · número 6 · págs. 594–601
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 97 citas · más que el 96% de estudios similares · 4.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 28 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY-NC-ND
- Áreas de investigación
- Genetic Neurodegenerative Diseases · Fibromyalgia and Chronic Fatigue Syndrome Research · Muscle metabolism and nutrition
- Palabras clave
- Creatine, Placebo, Tolerability, Adverse effect, Creatine Monohydrate, Medicine, Internal medicine, Interim analysis, Randomized controlled trial, Physical therapy, Pathology
- MeSH
- humans, huntington disease, disease progression, creatine, neuroprotective agents, treatment outcome, follow-up studies, double-blind method, quality of life, middle aged, north america, australia, new zealand, female, male
8 autores
- Steven M. Hersch🇺🇸Medical University of South Carolina; University of Rochester Medicine; National Center for Complementary and Integrative Health; Massachusetts General Hospital
- Giovanni Schifitto🇺🇸Medical University of South Carolina; University of Rochester Medicine; National Center for Complementary and Integrative Health; Massachusetts General Hospital
- David Oakes🇺🇸Medical University of South Carolina; University of Rochester Medicine; National Center for Complementary and Integrative Health; Massachusetts General Hospital
- Amy‐Lee Bredlau🇺🇸Medical University of South Carolina; University of Rochester Medicine; National Center for Complementary and Integrative Health; Massachusetts General Hospital
- Catherine M. Meyers🇺🇸Medical University of South Carolina; University of Rochester Medicine; National Center for Complementary and Integrative Health; Massachusetts General Hospital
- Richard L. Nahin🇺🇸Medical University of South Carolina; University of Rochester Medicine; National Center for Complementary and Integrative Health; Massachusetts General Hospital
- Herminia Diana Rosas🇺🇸Medical University of South Carolina; University of Rochester Medicine; National Center for Complementary and Integrative Health; Massachusetts General Hospital
- For the Huntington Study Group CREST-E Investigators and Coordinators🇺🇸Massachusetts General Hospital
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objective
To investigate whether creatine administration could slow progressive functional decline in adults with early symptoms of Huntington disease.
Methods
We conducted a multicenter, randomized, double-blind, placebo-controlled study of up to 40 g daily of creatine monohydrate in participants with stage I and II HD treated for up to 48 months. The primary outcome measure was the rate of change in total functional capacity (TFC) between baseline and end of follow-up. Secondary outcome measures included changes in additional clinical scores, tolerability, and quality of life. Safety was assessed by adverse events and laboratory studies.
Results
At 46 sites in North America, Australia, and New Zealand, 553 participants were randomized to creatine (275) or placebo (278). The trial was designed to enroll 650 patients, but was halted for futility after the first interim analysis. The estimated rates of decline in the primary outcome measure (TFC) were 0.82 points per year for participants on creatine, 0.70 points per year for participants on placebo, favoring placebo (nominal 95% confidence limits -0.11 to 0.35). Adverse events, mainly gastrointestinal, were significantly more common in participants on creatine. Serious adverse events, including deaths, were more frequent in the placebo group. Subgroup analysis suggested that men and women may respond differently to creatine treatment.
Conclusions
Our data do not support the use of creatine treatment for delaying functional decline in early manifest HD.
Clinicaltrialsgov identifier
NCT00712426.
Classification of evidence
This study provides Class II evidence that for patients with early symptomatic HD, creatine monohydrate is not beneficial for slowing functional decline.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC-ND).
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