Funded in part by 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 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Industry funded
- Government
- U.S. Department of Defense
- Government
- Office of Dietary Supplements
- Government
- California Institute for Regenerative Medicine
- Company
- Pfizer
- Company
- Teva Pharmaceutical Industries
- Company
- Voyager Therapeutics
- Government
- National Institutes of Health
- Company
- Novartis Institutes for BioMedical Research
- Government
- National Institute of Neurological Disorders and Stroke
- Government
- National Center for Advancing Translational Sciences
- Government
- National Center for Complementary and Integrative Health
- Government
- NINDS NIH HHS
- Government
- NCCIH NIH HHS
- Authors
- At least one author declares a financial tie to industry
- Grants
- 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)
Based on 13 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2017-07-13 · Neurology · vol. 89 · issue 6 · pp. 594–601
- Publisher
- Lippincott Williams & Wilkins
- Cited
- 97 citations · more than 96% of similar papers · 4.4× the field average
- Impact
- Top 10% most cited in its field
- References
- 28 works
- Access
- Open access (hybrid journal) · CC-BY-NC-ND
- Research areas
- Genetic Neurodegenerative Diseases · Fibromyalgia and Chronic Fatigue Syndrome Research · Muscle metabolism and nutrition
- Keywords
- 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 authors
From US
- Steven M. HerschMedical University of South Carolina; University of Rochester Medicine; National Center for Complementary and Integrative Health; Massachusetts General Hospital
- Giovanni SchifittoMedical University of South Carolina; University of Rochester Medicine; National Center for Complementary and Integrative Health; Massachusetts General Hospital
- David OakesMedical University of South Carolina; University of Rochester Medicine; National Center for Complementary and Integrative Health; Massachusetts General Hospital
- Amy‐Lee BredlauMedical University of South Carolina; University of Rochester Medicine; National Center for Complementary and Integrative Health; Massachusetts General Hospital
- Catherine M. MeyersMedical University of South Carolina; University of Rochester Medicine; National Center for Complementary and Integrative Health; Massachusetts General Hospital
- Richard L. NahinMedical University of South Carolina; University of Rochester Medicine; National Center for Complementary and Integrative Health; Massachusetts General Hospital
Abstract
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.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC-ND).
Community trust
Loading…
How much do you trust this study's findings?
Comments
Sign in to rate, comment on or flag this study.Sign inSomething wrong here?
Flag this study if its information, labels or funding look wrong. An editor reviews every flag.
Sign in to rate, comment on or flag this study.Sign inEducational information about published research. Not medical advice, and not a recommendation to start or stop anything.