Closer Look at a New Study on CoQ10 for Parkinson's Disease Reveals Faults with Study Design, According to VitalineFormulas.com

Monday May 21, 8:15 am ET
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GREEN BAY, Wis., May 21 /PRNewswire/ -- A new study reported in the Archives of Neurology published online (May, 14, 2007) suggests that CoQ10 may not provide benefits to individuals with Parkinson's disease. These findings contradict results from earlier studies involving a high purity CoQ10 supplement, Vitaline® CoQ10.(1)(2) Richard M. Delany, M.D., FACC, and founder of Personalized Preventive Medicine, finds that a closer review of this latest study design reveals important weaknesses, including the use of a short study duration (3 months) and a low daily dosage (300 mg), and failure to use the clinically proven CoQ10 product, Vitaline CoQ10.

One earlier 16-month multi-center, randomized, parallel-group, placebo- controlled, double-blind study, published in the Archives of Neurology, found CoQ10 supplementation reduced the progression of Parkinson's Disease as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) -- which evaluates severity of PD. The most dramatic results were seen in the 1200 mg/day group (the highest dosage), who experienced a 44% less functional decline compared to individuals receiving placebo.(1) Another study, published in 2004, examined the safety and tolerability of escalating dosages of Vitaline CoQ10 (up to 3,000 mg daily). This study discovered that blood levels of CoQ10 reached their peak at 2,400 mg dosage, thereby suggesting increased benefit at this higher dose.(2)

"Although this new study utilized nanoparticular CoQ10, there has been no correlation between nanoparticular dose and a traditional CoQ10 dose. The 300 mg dose utilized in this study might be ineffective simply because it is a very low regimen for Parkinson's Disease," states Dr. Delany.

The second point to consider is the study duration of only 3 months. According to Dr. Delany, "Neurodegenerative disease studies typically span between 6 months to several years. Six months may allow researchers to establish a trend or to evaluate the safety of a product, but three months will not be sufficient to establish benefit."

Although the clinical findings were not positive, the results may be attributed to poor study design. Further analysis using a more effective dosage level and duration may confirm efficacy.

(1) Shults CW, Oakes D, Kieburtz K, et al. Effects of Coenzyme Q10 in
Early Parkinson Disease. Arch Neurol. 2002:59:1541-1550.
(2) Shults CW, Flint Beal M, Song D, Fontaine D. Pilot trial of high
dosages of coenzyme Q10 in patients with Parkinson's disease. Exp
Neurol. 2004 Aug;188(2):491-4.



Vol. 59 No. 10, October 2002
Effects of Coenzyme Q10 in Early Parkinson Disease
Full-

Evidence of Slowing of the Functional Decline

Clifford W. Shults, MD; David Oakes, PhD; Karl Kieburtz, MD; M. Flint Beal, MD; Richard Haas, MB Chir; Sandy Plumb, BS; Jorge L. Juncos, MD; John Nutt, MD; Ira Shoulson, MD; Julie Carter, RN, MS, ANP; Katie Kompoliti, MD; Joel S Perlmutter, MD; Stephen Reich, MD; Matthew Stern, MD; Ray L. Watts, MD; Roger Kurlan, MD; Eric Molho, MD; Madaline Harrison, MD; Mark Lew, MD; and the Parkinson Study Group

Arch Neurol. 2002;59:1541-1550.

Background Parkinson disease (PD) is a degenerative neurological disorder for which no treatment has been shown to slow the progression.

Objective To determine whether a range of dosages of coenzyme Q10 is safe and well tolerated and could slow the functional decline in PD.

Design Multicenter, randomized, parallel-group, placebo-controlled, double-blind, dosage-ranging trial.

Setting Academic movement disorders clinics.

Patients Eighty subjects with early PD who did not require treatment for their disability.

Interventions Random assignment to placebo or coenzyme Q10 at dosages of 300, 600, or 1200 mg/d.

Main Outcome Measure The subjects underwent evaluation with the Unified Parkinson Disease Rating Scale (UPDRS) at the screening, baseline, and 1-, 4-, 8-, 12-, and 16-month visits. They were followed up for 16 months or until disability requiring treatment with levodopa had developed. The primary response variable was the change in the total score on the UPDRS from baseline to the last visit.

Results The adjusted mean total UPDRS changes were +11.99 for the placebo group, +8.81 for the 300-mg/d group, +10.82 for the 600-mg/d group, and +6.69 for the 1200-mg/d group. The P value for the primary analysis, a test for a linear trend between the dosage and the mean change in the total UPDRS score, was .09, which met our prespecified criteria for a positive trend for the trial. A prespecified, secondary analysis was the comparison of each treatment group with the placebo group, and the difference between the 1200-mg/d and placebo groups was significant (P = .04).

Conclusions Coenzyme Q10 was safe and well tolerated at dosages of up to 1200 mg/d. Less disability developed in subjects assigned to coenzyme Q10 than in those assigned to placebo, and the benefit was greatest in subjects receiving the highest dosage. Coenzyme Q10 appears to slow the progressive deterioration of function in PD, but these results need to be confirmed in a larger study.

From the Department of Neurosciences, University of California–San Diego, La Jolla (Drs Shults and Haas); Veterans Affairs San Diego Healthcare System, San Diego (Dr Shults); Departments of Biostatistics (Dr Oakes) and Neurology (Drs Kieburtz, Shoulson, and Kurlan and Ms Plumb), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Neurology and Neuroscience, Weill Medical College of Cornell University, New York, NY (Dr Beal); Department of Neurology and Wesley Woods Center, Emory University, Atlanta, Ga (Drs Juncos and Watts); Parkinson's Disease Research, Education and Clinical Center–Veterans Affairs Medical Center (Dr Nutt) and Oregon Health and Science University (Dr Nutt and Ms Carter), Portland; and the Departments of Neurology, Rush Presbyterian/St. Luke's Medical Center, Chicago, Ill (Dr Kompoliti), Washington University, St. Louis, Mo (Dr Perlmutter), The Johns Hopkins University, Baltimore, Md (Dr Reich), University of Pennsylvania and Parkinson's Disease Research, Education and Clinical Center–Veterans Affairs Medical Center, Philadelphia (Dr Stern), Albany Medical College, Albany, NY (Dr Molho), University of Virginia, Charlottesville (Dr Harrison), and University of Southern California, Los Angeles (Dr Lew). Dr Shults and Mr Meese are coinventors in a pending patent application. The application is jointly owned by Enzymatic Therapy, Inc, Green Bay, Wis (owner of Vitaline Corp, Ashland, Ore), and The Regents of the University of California.

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