1. Creatine monohydrate was not shown to improve or worsen clinical outcomes of Parkinson disease over a 5-year follow-up period.
2. No significant differences in benefits, adverse effects, laboratory values, or BMI were detected in the creatine group when compared to placebo.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Parkinson disease is a progressive neurodegenerative disorder with symptoms including slowed movement, tremors, muscle rigidity, and eventually depression and dementia. Current treatments offer symptomatic relief but have never been demonstrated to slow progression or result in cure. In 2001, the National Institute of Neurological Disorders and Stroke (NINDS) created the NINDS Exploratory Trials in Parkinson Disease program and tasked the program with evaluating potential medications that may slow the progression of the disease. This program selected creatine monohydrate for long-term evaluation based on the hypothesis that 5 years of creatine may slow the progression of Parkinson disease by 1 year.
This study found that, among patients with early Parkinson disease receiving dopaminergic treatment, creatine monohydrate neither improved nor worsened clinical progression of the disease over 5 years. Strengths of this study include the double-blind, placebo-controlled, randomized design as well as the ability to retain 76% of the original 1,741 participants. Limitations include the participant’s concurrent use of other Parkinson disease treatments that may have confounded results in the study groups. Overall, this study does not demonstrate results that support the use of creatine monohydrate supplementation in patients with early Parkinson disease.
In-Depth [randomized controlled trial]: This study involved a total of 1,741 patients. Inclusion criteria included diagnosis of Parkinson disease within the last five years and prior dopaminergic therapy use greater than 90 days but less than 2 years duration. Participants in both groups were allowed to continue other prescribed Parkinson drugs throughout the trial. At 5 years, 1,328 patients remained under observation. Median follow-up time was 4 years. About 76% of the 878 creatine patients and 77% of the placebo patients remained in the study as of 2013. The mean of summed ranks for placebo was 2,360 (95%CI 2249-2470) and the mean of summed ranks for creatine was 2,414 (95%CI 2304-2524), with worse outcomes indicated by higher summed ranks. There was no identifiable benefit or harm attributable to creatine at study termination (p=0.45). No significant difference in deaths occurred in either treatment group (n=44 creatine, n=36 placebo). No significant changes in BMI or other laboratory values were detected over time.
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