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A randomized trial of coenzyme Q10 in patients with confirmed Statin Myopathy
Open accessAbstract
Background Coenzyme Q10 (CoQ10) supplementation is the most popular therapy for statin myalgia among both physicians and patients despite limited and conflicting evidence of its efficacy.Objective This study examined the effect of coenzyme Q10 (CoQ10) supplementation on simvastatin-associated muscle pain, muscle strength and aerobic performance in patients with confirmed statin myalgia.Methods Statin myalgia was confirmed in 120 patients with prior symptoms of statin myalgia using an 8-week randomized, double-blind crossover trial of simvastatin 20 mg/d and placebo. Forty-one subjects developed muscle pain with simvastatin but not with placebo and were randomized to simvastatin 20 mg/d combined with CoQ10 (600 mg/d ubiquinol) or placebo for 8 weeks. Muscle pain (Brief Pain Inventory [BPI]), time to pain onset, arm and leg muscle strength, and maximal oxygen uptake (VO2max) were measured before and after each treatment.Results Serum CoQ10 increased from 1.3 ± 0.4 to 5.2 ± 2.3 mcg/mL with simvastatin and CoQ10, but did not increase with simvastatin and placebo (1.3 ± 0.3 to 0.8 ± 0.2) (p < 0.05). BPI pain severity and interference scores increased with simvastatin therapy (both p < 0.01), irrespective of CoQ10 assignment (p = 0.53 and 0.56). There were no changes in muscle strength or VO2max with simvastatin with or without CoQ10 (all p > 0.10). Marginally more subjects reported pain with CoQ10 (14 of 20 vs 7 of 18; p = 0.05). There was no difference in time to pain onset in the CoQ10 (3.0 ± 2.0 weeks) vs. placebo (2.4 ± 2.1 wks) groups (p = 0.55). A similar lack of CoQ10 effect was observed in 24 subjects who were then crossed over to the alternative treatment.Conclusions Only 36% of patients complaining of statin myalgia develop symptoms during a randomized, double-blind crossover of statin vs placebo. CoQ10 supplementation does not reduce muscle pain in patients with statin myalgia. Trial RegistrationNCT01140308; www.clinicaltrials.gov.
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“Qu et al., appears to have misinterpreted the direction of the change in pain score for two included studies [8,12].”
From Effect of Coenzyme Q10 on statin-associated myalgia and adherence to statin therapy: A systematic review and meta-analysis (2020) · cites this paper as [12]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Of all seven studies, three studies reported a run-in period in which patients were asked to stop statin intake prior to the start of the trial to assure that the myopathic pain and other side effects are caused by the statin-intake.(34,40,41)”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [41]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“In this study, statin-intake caused an increased muscle pain intensity in the course of the trial, which was higher in the intervention group.(41)”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [41]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“As medication intake was only investigated in four studies,(34,39–41) effects of the intervention on the intensity of muscle pain might be underestimated in the remaining trials.(33,42,43)”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [41]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“The trials comparing statin-based therapy to placebo showed similar between-group incidence of muscle symptoms and statin-discontinuation rate. [20,21,25,26,43,47]”
From Safety outcomes of statin vs non-statin lipid-lowering interventions in patients with prior statin-associated muscle symptoms: A systematic review and meta-analysis (2025) · cites this paper as [21]
Experimental — accuracy not yet measured
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In the citing paper
“No deviations from the study protocol were reported, though only two studies had a perspective study protocol identified (both at ClinicalTrial.gov) [5,12].”
From Effect of Coenzyme Q10 on statin-associated myalgia and adherence to statin therapy: A systematic review and meta-analysis (2020) · cites this paper as [12]
The cited source says what the claim attributes to it.
In the citing paper
“All included studies were RCTs designed as parallel-group studies with a placebo arm [5,6,8,9,11,12,17].”
From Effect of Coenzyme Q10 on statin-associated myalgia and adherence to statin therapy: A systematic review and meta-analysis (2020) · cites this paper as [12]
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In the citing paper
“A number of these RCTs have reported that CoQ10 reduces SAMS [4-7], while other have failed to demonstrate a benefit [8-12].”
From Effect of Coenzyme Q10 on statin-associated myalgia and adherence to statin therapy: A systematic review and meta-analysis (2020) · cites this paper as [12]
The cited source says what the claim attributes to it.
In the citing paper
“This was the dose in all but one study which used 600 mg daily [12].”
From Effect of Coenzyme Q10 on statin-associated myalgia and adherence to statin therapy: A systematic review and meta-analysis (2020) · cites this paper as [12]
The cited source says what the claim attributes to it.
In the citing paper
“While all studies were randomised, double blinded and had allocation concealment, only three studies described the process in full [6,9,12].”
From Effect of Coenzyme Q10 on statin-associated myalgia and adherence to statin therapy: A systematic review and meta-analysis (2020) · cites this paper as [12]
The cited source says what the claim attributes to it.
In the citing paper
“A number of studies reported the attrition of patients but did not describe their baseline characteristics or interval outcomes [8,9,11,12].”
From Effect of Coenzyme Q10 on statin-associated myalgia and adherence to statin therapy: A systematic review and meta-analysis (2020) · cites this paper as [12]
The cited source says what the claim attributes to it.
In the citing paper
“Seven studies with 321 patients were included in the pooled analysis, of which 165 were treated with CoQ10 and 156 with placebo [5,6,8,9,11,12,17].”
From Effect of Coenzyme Q10 on statin-associated myalgia and adherence to statin therapy: A systematic review and meta-analysis (2020) · cites this paper as [12]
The cited source says what the claim attributes to it.
In the citing paper
“Four out of seven studies show a significant reduction of muscle pain intensity after CoQ10 supplementation compared to the control group,(33,39,40,42) while three studies do not show a significant change of muscle pain intensity(34,41,43) (Table 2).”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [41]
The cited source says what the claim attributes to it.
In the citing paper
“The intake of medication affecting the study outcomes, including pain medication, was considered in the eligibility criteria in four of the selected trials and led to exclusion of participants.(34,39–41)”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [41]
The cited source says what the claim attributes to it.
In the citing paper
“All selected trials investigate the impact of a daily oral CoQ10 supplementation on muscle pain under statin therapy.(33,34,39–43)”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [41]
The cited source says what the claim attributes to it.
In the citing paper
“Six out of seven studies administer CoQ10 supplements in the intervention group and a placebo supplement in the control group.(34,39–43) One trial compares the supplementation of CoQ10 in combination with n-3-fatty acids (n-3 FA) in the intervention group to a control group taking n-3 FA only.(33)”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [41]
The cited source says what the claim attributes to it.
In the citing paper
“In one study, a cross-over phase that was not part of the original protocol was added because less patients than expected experienced myalgia in a previous run-in-phase, resulting in a lower number of study participants than originally planned.(41)”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [41]
The cited source says what the claim attributes to it.
In the citing paper
“Four studies stated SAMS as inclusion criterion,(34,41–43) while three studies included patients with and without SAMS besides other side effects.(33,39,40)”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [41]
The cited source says what the claim attributes to it.
In the citing paper
“Further, an exclusion of patients without statin-induced pain was performed only in four studies(34,41–43) and among those only one confirmed SAMS by having a wash-out period.(41)”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [41]
The cited source says what the claim attributes to it.
In the citing paper
“23 studies were included for data extraction [20–26,35–50], with 9 RCTs analyzed quantitatively.”
The cited source says what the claim attributes to it.
In the citing paper
“New evidence on the management of SAMS have since become available both from randomized control trials (RCTs) and from observational data [20–26].”
The cited source says what the claim attributes to it.
In the citing paper
“We included 13 RCTs conducted between 2006–2023, of which five were parallel RCTs [40,46–49], five were crossover RCTs [20,21,23,26,43] and three were n-of-1 RCTs [22,24,25] (S4 File, Table 1).”
The cited source says what the claim attributes to it.
In the citing paper
“nine trials assessed statin against placebo [20–26,43]”
The cited source says what the claim attributes to it.
In the citing paper
“Most trials used statins with low to moderate intensity [20,21,24–26,40,43,46,48,49]”
The cited source says what the claim attributes to it.
In the citing paper
“Ten trials [20,21,25,26,40,43,46–49] provided data on incidence of muscle symptoms”
The cited source says what the claim attributes to it.
In the citing paper
“Data on incidence of muscle symptoms were available in five parallel-group RCTs [40,46–49], and three crossover RCTs [20,21,43].”
The check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“only two declared no funding from industry [6,12]”
From Effect of Coenzyme Q10 on statin-associated myalgia and adherence to statin therapy: A systematic review and meta-analysis (2020) · cites this paper as [12]
Experimental — accuracy not yet measuredThe check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“The risk of bias assessment shows an overall low risk of bias in four of the included studies with no considerable bias in all five underlying domains,(34,39,40,43) whereas the remaining three studies show an overall moderate to high risk of bias (Figure 2).(33,41,42)”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [41]
Experimental — accuracy not yet measuredThe check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“The domain “selection of reported results” causes a moderate to high risk of bias in two studies.(41,42)”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [41]
Experimental — accuracy not yet measuredThe check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“Two trials did not provide enough information on pre-specified outcomes to allow assessment of reporting bias [21,47].”
From Safety outcomes of statin vs non-statin lipid-lowering interventions in patients with prior statin-associated muscle symptoms: A systematic review and meta-analysis (2025) · cites this paper as [21]
Experimental — accuracy not yet measuredIn the citing paper
“A double-blind RCT and a meta-analysis,55,56 however, failed to substantiate that CoQ10, even at high doses, reduced symptoms in patients with SAMS.”
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Metadata
- Authors
- Taylor, B. A., Lorson, L., White, C. M., & Thompson, P. D.
- Affiliations
- Hartford Hospital (US)
- Venue
- Atherosclerosis
- Publisher
- Elsevier BV
- Published
- 2015-02
- Volume
- 238
- Issue
- 2
- Pages
- 329-335
- ISSN
- 0021-9150 (ISSN-L)
- PMC
- PMC4298455
- OpenAlex
- W1995622206
- Cited by
- 200
- References
- 27
- Citations by year
- 2026: 11 · 2025: 13 · 2024: 10 · 2023: 7 · 2022: 16 · 2021: 10 · 2020: 25 · 2019: 23 · 2018: 21 · 2017: 22 · 2016: 24 · 2015: 17
- FWCI
- 8.60
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Atherosclerosis (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- NCCAM (1RC1AT005836)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Coenzyme Q10 studies and effects
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
- Keywords
- coenzyme Q10, ubiquinol, statin-induced myopathy, simvastatin, myalgia, muscle strength, aerobic performance, coenzyme Q10 supplementation, crossover trial, exercise-induced myalgia, statin intolerance
- MeSH terms
- Aged, Connecticut, Double-Blind Method, Female, Humans, Male, Middle Aged, Oxygen Consumption, Pain Measurement, Surveys and Questionnaires, Severity of Illness Index, Time Factors, Ubiquinone, Treatment Outcome, Muscle, Skeletal, Cross-Over Studies, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Simvastatin, Muscle Strength, Myalgia
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