Randomized, Double-blind, Placebo-Controlled Trial on Symptomatic Effects of Coenzyme Q10 in Parkinson Disease
Abstract
BACKGROUND: Major hallmarks in the pathophysiology of Parkinson disease are cellular energy depletion and oxidative stress leading to cellular dysfunction and death. Coenzyme Q(10) (CoQ(10)) is an electron acceptor bridging mitochondrial complexes I and II/III and a potent antioxidant that consistently partially recovers the function of dopaminergic neurons. OBJECTIVE: To determine whether nanoparticular CoQ(10) is safe and displays symptomatic effects in patients with midstage Parkinson disease without motor fluctuations. DESIGN: Multicenter, randomized, double-blind, placebo-controlled, stratified, parallel-group, single-dose trial. SETTING: Academic and nonacademic movement disorder clinics. PATIENTS: One hundred thirty-one patients with Parkinson disease without motor fluctuations and a stable antiparkinsonian treatment. Intervention Random assignment to placebo or nanoparticular CoQ(10) (100 mg 3 times a day) for a treatment period of 3 months. Stratification criterion was levodopa treatment. MAIN OUTCOME MEASURE: The subjects underwent evaluation with the Unified Parkinson's Disease Rating Scale (UPDRS) at each visit on a monthly basis. The primary outcome variable was the change of the sum score of the UPDRS parts II and III between the baseline and 3-month visits. RESULTS: One hundred thirty-one subjects were randomized according to the protocol. The mean changes of the sum UPDRS parts II/III score were -3.69 for the placebo group and -3.33 for the CoQ(10) group (P = .82). Statistical analysis according to the stratification did not result in significant changes of the primary outcome variable. No secondary outcome measure showed a significant change between the placebo group and the CoQ(10) group. The frequency and quality of adverse events were similar in both treatment groups. CONCLUSIONS: Nanoparticular CoQ(10) at a dosage of 300 mg/d is safe and well tolerated and leads to plasma levels similar to 1200 mg/d of standard formulations. Add-on CoQ(10) does not display symptomatic effects in midstage Parkinson disease.
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CoQ10 does not exert symptomatic effects.
“A recent study showed that CoQ10 does not exert symptomatic effects163.”
From Mitochondrial Approaches for Neuroprotection (2008) · cites this paper as [163]
Clinical trials using antioxidants to scavenge ROS have consistently failed, and in some cases, actually increased mortality.
“This line of thinking has led to multiple clinical trials using antioxidants to scavenge ROS, yet these trials have consistently failed, and in some cases, actually increased mortality 84–87.”
From Mitochondrial reactive oxygen species regulate cellular signaling and dictate biological outcomes (2010) · cites this paper as [84]
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Bergamini, C., Moruzzi, N., Sblendido, A., Lenaz, G., & Fato, R. (2012) · PLoS ONE · doi:10.1371/journal.pone.0033712 · Cited by 84 · see citing works
“The use of CoQ10 in neurodegenerative disorders failed to demonstrate any positive result in patients with Huntington’s [14] and Parkinson’s diseases [15] or amyotrophic lateral sclerosis [16].”
BackgroundProgress in neuroprotection in Parkinson’s disease
Schapira, A. H. V. (2008) · European Journal of Neurology · doi:10.1111/j.1468-1331.2008.02055.x · Cited by 82 · see citing works
Coenzyme Q10: Clinical Applications beyond Cardiovascular Diseases
Testai, L., Martelli, A., Flori, L., Cicero, A. F. G., & Colletti, A. (2021) · Nutrients · doi:10.3390/nu13051697 · Cited by 82 · see citing works
“, in 2002, no significant changes in UPDRS were observed, suggesting that in a mid-stage of PD, the CoQ10 supplementation does not induce symptomatic effects [77].”
BackgroundTargeting mitochondrial dysfunction in neurodegenerative disease: Part II
Burchell, V., Gandhi, S., Deas, E., Wood, N. W., Abramov, A. Y., & Plun‐Favreau, H. (2010) · Expert Opinion on Therapeutic Targets · doi:10.1517/14728221003730434 · Cited by 82 · see citing works
Mitochondrial Dysfunction in Parkinson's Disease: Pathogenesis and Neuroprotection
Mounsey, R. B., & Teismann, P. (2010) · Parkinson s Disease · doi:10.4061/2011/617472 · Cited by 82 · see citing works
“[177] A.”
BackgroundMitochondrial Pathology in Parkinson's Disease
Schapira, A. H. V. (2011) · Mount Sinai Journal of Medicine A Journal of Translational and Personalized Medicine · doi:10.1002/msj.20303 · Cited by 80 · see citing works
Targeting the Progression of Parkinsons Disease
George, J., Mok, S., Moses, D., Wilkins, S., Bush, A., Cherny, R., & Finkelstein, D. (2009) · Current Neuropharmacology · doi:10.2174/157015909787602814 · Cited by 77 · see citing works
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“Other evidence found that while CoQ10 supplementation increased plasma levels of CoQ10 in patients with Parkinson’s disease, it had no effect on Parkinsonian symptoms after a 3-month period (Storch et al., 2007).”
BackgroundLesser, G. J., Case, D., Stark, N. N., Williford, S., Giguere, J. K., Garino, L. A., Naughton, M. J., Vitolins, M. Z., Lively, M. O., & Shaw, E. G. (2012) · The Journal of Supportive Oncology · doi:10.1016/j.suponc.2012.03.003 · Cited by 75 · see citing works
Parkinson Disease and Exercise
Earhart, G. M., & Falvo, M. J. (2013) · Comprehensive physiology · doi:10.1002/cphy.c100047 · Cited by 77 · see citing works
Oxidative Stress in Neurodegenerative Diseases
Simonian, N. A. (1996) · The Annual Review of Pharmacology and Toxicology · doi:10.1146/annurev.pharmtox.36.1.83 · Cited by 74 · see citing works
A Review of the Clinical Evidence for Complementary and Alternative Therapies in Parkinson’s Disease
Bega, D., González-Latapí, P., Zadikoff, C., & Simuni, T. (2014) · Current Treatment Options in Neurology · doi:10.1007/s11940-014-0314-5 · Cited by 71 · see citing works
Medical Management of Parkinson's Disease
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Clinical neuroprotection in Parkinson's disease — Still waiting for the breakthrough
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Insights from late-onset familial parkinsonism on the pathogenesis of idiopathic Parkinson's disease
Volta, M., Milnerwood, A. J., & Farrer, M. J. (2015) · The Lancet Neurology · doi:10.1016/s1474-4422(15)00186-6 · Cited by 68 · see citing works
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“The neuroprotective and symptomatic actions of CoQ10 in PD have recently been reported and this agent has been found to be well tolerated as both monotherapy and adjuvant medication in PD patients (Storch 2007; Storch et al., 2007).”
Neuroprotection in Parkinson’s disease: facts and hopes
Salamon, A., Zádori, D., Szpisjak, L., Klivènyi, P., & Vécsei, L. (2019) · Journal of Neural Transmission · doi:10.1007/s00702-019-02115-8 · Cited by 66 · see citing works
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“Surprisingly, a later multicentre, randomized, parallel-group, placebo-controlled, double-blind, stratified, single-dose trial in mid-stage PD did not indicate any significant amelioration [189].”
BackgroundIron Brain Menace: The Involvement of Ferroptosis in Parkinson Disease
Lin, K.-J., Chen, S., Lin, K.-L., Liou, C., Lan, M., Chuang, Y., Wang, P., Lee, J., Wang, F., Lin, H., et al. (2022) · Cells · doi:10.3390/cells11233829 · Cited by 68 · see citing works
“CoQ10 (add-on) 300 mg/d, placebo Phase II, III DBRCT (131) (multicenter, Germany) midstage PD, on stabilized PD regimens 3 months Add-on CoQ10 does not display symptomatic effects in midstage Parkinson disease NCT00180037 (2003–2009) [193]”
BackgroundCoQ10Function and Role in Heart Failure and Ischemic Heart Disease
Ayer, A., Macdonald, P. S., & Stocker, R. (2015) · Annual Review of Nutrition · doi:10.1146/annurev-nutr-071714-034258 · Cited by 64 · see citing works
Targeting mitochondrial dysfunction in neurodegenerative disease: Part I
Burchell, V., Gandhi, S., Deas, E., Wood, N. W., Abramov, A. Y., & Plun‐Favreau, H. (2010) · Expert Opinion on Therapeutic Targets · doi:10.1517/14728221003652489 · Cited by 63 · see citing works
Szalárdy, L., Klivènyi, P., Zádori, D., Fülöp, F., Toldi, J., & Vécsei, L. (2012) · Current Medicinal Chemistry · doi:10.2174/092986712800167365 · Cited by 60 · see citing works
Naoi, M., Maruyama, W., & Shamoto‐Nagai, M. (2020) · Journal of Neural Transmission · doi:10.1007/s00702-020-02150-w · Cited by 58 · see citing works
Lipophilic antioxidants in neurodegenerative diseases
Chang, K., Cheng, M., Chiang, M.-C., & Chen, C. (2018) · Clinica Chimica Acta · doi:10.1016/j.cca.2018.06.031 · Cited by 55 · see citing works
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Targeting Ferroptosis in Parkinson’s Disease: Mechanisms and Emerging Therapeutic Strategies
Zhou, M., Xu, K., Ge, J., Luo, X., Wu, M., Wang, N., & Zeng, J. (2024) · International Journal of Molecular Sciences · doi:10.3390/ijms252313042 · Cited by 50 · see citing works
Swerdlow, R. H. (2013) · British Journal of Pharmacology · doi:10.1111/bph.12394 · Cited by 50 · see citing works
“A phase II placebo-controlled trial of CoQ in PD patients initially suggested those receiving it declined less over time than those receiving placebo (Shults et al., 2002), but this finding remains to be confirmed in a definitive trial (Storch et al., 2007).”
BackgroundYoung, J. M., Florkowski, C. M., Molyneux, S. L., McEwan, R. G., Frampton, C. M., Nicholls, M. G., Scott, R. S., & George, P. M. (2012) · American Journal of Hypertension · doi:10.1038/ajh.2011.209 · Cited by 59 · see citing works
Gorgone, G., Currò, M., Ferlazzo, N., Parisi, G., Parnetti, L., Belcastro, V., Tambasco, N., Rossi, A., Pisani, F., Calabresi, P., et al. (2012) · NeuroMolecular Medicine · doi:10.1007/s12017-012-8174-1 · Cited by 48 · see citing works
“observations deriving from two investigations (Shults et al. 2002; Storch et al. 2007).”
Targeting Mitochondria for Neuroprotection in Parkinson's Disease
Schapira, A. H. V. (2012) · Antioxidants and Redox Signaling · doi:10.1089/ars.2011.4419 · Cited by 46 · see citing works
Coenzyme Q10 and Neurological Diseases
Mancuso, M., Orsucci, D., Calsolaro, V., Choub, A., & Siciliano, G. (2009) · Pharmaceuticals · doi:10.3390/ph203134 · Cited by 46 · see citing works
Attia, H. N., & Maklad, Y. A. (2017) · Behavioural Pharmacology · doi:10.1097/fbp.0000000000000342 · Cited by 46 · see citing works
Neuroprotection in Parkinson's disease
Schapira, A. H. V. (2009) · Parkinsonism & Related Disorders · doi:10.1016/s1353-8020(09)70834-x · Cited by 45 · see citing works
Liu, C.-Y., Lee, C.-F., & Wei, Y.-H. (2009) · Journal of the Formosan Medical Association · doi:10.1016/s0929-6646(09)60380-6 · Cited by 52 · see citing works
Dean, O. M., Turner, A., Malhi, G. S., Ng, C. H., Cotton, S., Dodd, S., Sarris, J. J., Samuni, Y., Tanious, M., Dowling, N. L., et al. (2014) · Brazilian Journal of Psychiatry · doi:10.1590/1516-4446-2013-1341 · Cited by 43 · see citing works
Does High-Dose Coenzyme Q 10 Improve Oxidative Damage and Clinical Outcomes in Parkinson's Disease?
Seet, R. C. S., Lim, E. C. H., Tan, J. J. H., Quek, A. M. L., Chow, A. W. L., Chong, W.-L., Ng, M. P.-E., Ong, C. N., & Halliwell, B. B. (2014) · Antioxidants and Redox Signaling · doi:10.1089/ars.2013.5801 · Cited by 39 · see citing works
“(using nanoparticular CoQ10 at a dose equivalent to 1200 mg/day of standard formulations) did not demonstrate symptomatic benefits in mid-stage PD subjects treated with CoQ10 for 3 months (9).”
MethodTreatment of Mitochondrial Disorders
Enns, G. M. (2014) · Journal of Child Neurology · doi:10.1177/0883073814538509 · Cited by 39 · see citing works
“Coenzyme Q10 has also been evaluated in randomized, controlled trials involving disorders associated with secondary mitochondrial dysfunction, such as Parkinson disease; treatment is well tolerated and safe, but no clear clinical benefit has been demonstrated.(24,25) A phase 3, placebo-controlled, double-blind, random…”
BackgroundMüller, T. H. (2013) · Expert Review of Neurotherapeutics · doi:10.1586/ern.13.50 · Cited by 40 · see citing works
Macronutrients intake and risk of P arkinson's disease: A meta‐analysis
Wang, A., Lin, Y., Wu, Y., & Zhang, D. (2014) · Geriatrics and gerontology international/Geriatrics & gerontology international · doi:10.1111/ggi.12321 · Cited by 38 · see citing works
- Authors
- Storch, A.
- Affiliations
- Technische Universität Dresden (DE)
- Corresponding author
- Storch, Alexander
- ORCID
- Storch, Alexander
- Venue
- Archives of Neurology
- Publisher
- American Medical Association (AMA)
- Published
- 2007-07-01
- Volume
- 64
- Issue
- 7
- Pages
- 938
- ISSN
- 0003-9942 (ISSN-L)
- OpenAlex
- W2144592798
- Cited by
- 205
- References
- 29
- Citations by year
- 2026: 3 · 2025: 8 · 2024: 8 · 2023: 5 · 2022: 7 · 2021: 5 · 2020: 8 · 2019: 5 · 2018: 7 · 2017: 9 · 2016: 7 · 2015: 8 · 2014: 14 · 2013: 16 · 2012: 21
- FWCI
- 8.30
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Neurology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Coenzyme Q10 studies and effects
- Health Sciences › Medicine › Neurology › Parkinson's Disease Mechanisms and Treatments
- Life Sciences › Neuroscience › Neurology › Neurological diseases and metabolism
- Keywords
- coenzyme Q10, Parkinson's disease, levodopa, dopaminergic neurons, oxidative stress, mitochondrial bioenergetics, antioxidants, adjunctive therapy, drug safety and tolerability, Unified Parkinson's Disease Rating Scale
- MeSH terms
- Adult, Aged, Antioxidants, Coenzymes, Dopamine, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Energy Metabolism, Female, Humans, Levodopa, Male, Middle Aged, Neurons, Parkinson Disease, Placebos, Substantia Nigra, Ubiquinone, Vitamins, Treatment Outcome, Oxidative Stress, Cell Respiration
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