[Tupelo3]

Despite early promise and a great deal of interest in creatine monohydrate as a possible treatment for Parkinson's disease (PD), a large new double-blind, placebo-controlled trial found that this treatment does not improve clinical outcomes in patients with PD.

The new findings "do not support the use of creatine" in patients with early PD treated with background dopaminergic therapy, the study authors, with corresponding author Karl Kieburtz, MD, MPH, from the University of Rochester Center for Human Experimental Therapeutics, New York, conclude.

The trial was terminated early for futility on the basis of an interim analysis of 955 participants who had completed 5 years of follow-up.

"Unfortunately, I think this study is truly the nail in the coffin for creatine in Parkinson's disease," commented Alberto Espay, MD, associate professor, neurology, Gardner Center for Parkinson's Disease and Movement Disorders, University of Cincinnati, Ohio, and spokesperson for the International Parkinson and Movement Disorder Society, who was not part of the study group.

http://www.medscape.com/viewarticle/839567

[badboy99]

I can not access. Do not have a medscape account.

Got it.

[Tupelo3]

Originally Posted by badboy99

I can not access. Do not have a medscape account.

Got it.

I do have an account. Sorry, do you need me to post a different link?

http://medicalxpress.com/news/2015-0...n-disease.html

I can PM to you also

[badboy99]

This study is in no way Definitive.

[badboy99]

Originally Posted by Tupelo3

I do have an account. Sorry, do you need me to post a different link?

http://medicalxpress.com/news/2015-0...n-disease.html

I can PM to you also

I got in Thank you.

[Tupelo3]

Originally Posted by badboy99

This study is in no way Definitive.

It will be if funding dries up and the research stops. Similar to what happened with CoQ10.

[soccertese]

http://forum.parkinson.org/index.php...pped-by-ninds/

[johnt]

Let me say at the outset that in spite of the negative outcome that I think the creatine study was worth doing: both for its own sake (there was a reasonable a priori case as to why creatine might be effective); and also because it has created a large amount of longitudinal data that can be used in other studies. My concern is that it has taken so long and I presume (I don't have the figures) cost so much to reach this conclusion. Unless lessons are learnt to shorten trial lengths and reduce costs, we will only be able to trial a few of the many potential therapies for PD.

The paper describing the work in detail has been published [1]. Unfortunately this is behind a pay wall. However, the abstract is available, and this gives much interesting information.

Number of participants = 1741, enrolled in 45 investigative sites. With so many sites there may be confounding issues in areas such as the consistency of subjective assessment, differences between the efficacy of the various treatment regimes, any variations in geographical rates of progression.

They used a basket of five outcome measures. "All outcomes were coded such that higher scores indicated worse outcomes and were analyzed by a global statistical test. Higher summed ranks (range, 5-4775) indicate worse outcomes". Unless these measure independent features of PD, this aggregation may add little in terms of accuracy. (Separating the results from each test will give interesting results about the correlation of the tests to each other).

"The trial was terminated early for futility based on results of a planned interim analysis of participants enrolled at least 5 years prior to the date of the analysis (n = 955). The median follow-up time was 4 years. Of the 955 participants, the mean of the summed ranks for placebo was 2360 (95% CI, 2249-2470) and for creatine was 2414 (95% CI, 2304-2524)".

What strikes me here is that when the trial finished the results show creatine doing slightly worse than placebo. This is probably not statistically significant, but it makes it very unlikely that the true result is positive and even more unlikely that the true benefit is big enough to justify taking the drug, more than 5%, say. Could the call to end the trial have been made earlier?

Working with a cohort answers some questions, but doesn't answer the most important question: does creatine help me? It will be interesting to see if they have analysed any subgroups.

Working with only a placebo and creatine doesn't answer the question of whether the idea of taking creatine is beneficial. It could be that the placebo effect for creatine is large.

It seems to me the way forward involves:
- using proper biomarkers;
- cheap, objective tests;
- high frequency testing (daily);
- asking a different question.

Reference:

[1] "Effect of Creatine Monohydrate on Clinical Progression in Patients With Parkinson Disease"
JAMA. 2015;313(6):584-593. doi:10.1001/jama.2015.120.
http://jama.jamanetwork.com/article....icleid=2108890


John

[Aunt Bean]

I started taking creatine before summer. I can say that it has improved my strength at getting work done. Don't know if it has done anything for the PD. I only take 1/3 of the scoop provided for recommended dose...so am on just a trace amount...planning to keep taking it though. Aunt Bean

[lurkingforacure]

We tried creatine several years ago. It did not seem to help, and one side effect was rather horrible muscle cramps. It seemed that we could lessen or sometimes actually avoid those cramps by drinking a HUGE amount of water with the creatine (instead of just a glass of water).

Even though this did not help us, ours is just one person's experience. Since no one knows what causes PD, and symptoms vary considerably from person to person (meaning PD is really just a name given to a flexible bundle of symptoms), it could help others.