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.
“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]
The Results section (page unavailable) reports that pain scores increased with statin therapy in both treatment groups, establishing the direction of change in this study. The paper does not assess Qu et al.’s interpretation or report the pain-score direction for the second study, so it cannot by itself establish the alleged two-study error. (LLM, conf=0.78)
Experimental — accuracy not yet measuredThree studies reported a run-in period in which patients stopped statin intake prior to trial start to assure that myopathic pain and other side effects were caused by statin intake.
“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]
The Methods section (“Confirmation of Statin-Associated Myalgia”) says subjects stopped cholesterol medications for four weeks before a crossover lead-in trial designed to confirm statin-related muscle pain. This supports the cited paper as an example of the reported procedure, but it does not say that the procedure confirmed other side effects. (LLM, conf=0.85)
Experimental — accuracy not yet measuredIn Taylor et al., statin intake caused increased muscle pain intensity during the trial, which was higher in the intervention group.
“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]
The Results report that pain severity increased with statin therapy in both the CoQ10 and placebo groups. They found no difference between groups in pain severity or pain interference scores, so the claim that pain intensity was higher in the intervention group is not supported. A marginally higher proportion of CoQ10 recipients reported muscle pain at treatment end, but that measures occurrence, not intensity. (LLM, conf=0.90)
Experimental — accuracy not yet measuredBecause medication intake was investigated in only four studies, effects of the intervention on the intensity of muscle pain might be underestimated in the remaining trials.
“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]
The Methods (Measurement of Muscle Pain) and Results show that this trial measured muscle-pain intensity and compared CoQ10 with placebo. The paper does not say that unmeasured medication intake might have caused the intervention’s effect on pain intensity to be underestimated. Its Methods (Medication Compliance Assessment) describe tracking adherence to the study pills, which does not establish whether other medication intake was assessed. (LLM, conf=0.78)
Experimental — accuracy not yet measuredThe trials comparing statin-based therapy to placebo showed similar between-group incidence of muscle symptoms and statin-discontinuation rate.
“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]
The Discussion (page unavailable) reports muscle pain during simvastatin and placebo phases of a crossover trial; its percentages imply broadly similar overall symptom incidence. The paper does not report comparable statin-discontinuation rates between those phases. The discontinuations described in Methods were from a later comparison of statin plus CoQ10 versus statin plus placebo, not statin versus placebo. (LLM, conf=0.85)
Experimental — accuracy not yet measured
Only two included studies had a prospective study protocol identified.
“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]
All included studies were randomised controlled trials designed as parallel-group studies with a placebo arm.
“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]
A number of randomised controlled trials have reported that CoQ10 reduces statin-associated muscle symptoms, while others have failed to demonstrate a benefit.
“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 CoQ10 dose was 100-300 mg daily in all but one included study, which used 600 mg daily.
“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]
Only three included studies described the randomisation/allocation process in full.
“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]
A number of included studies reported attrition of patients but did not describe baseline characteristics or interval outcomes.
“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]
Seven studies with 321 patients were included in the pooled analysis, of which 165 were treated with CoQ10 and 156 with placebo.
“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]
Four out of seven included studies show a significant reduction of muscle pain intensity after CoQ10 supplementation compared to control, while three studies do not show a significant change.
“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]
Intake of medication affecting study outcomes was considered in eligibility criteria in four trials and led to exclusion of participants.
“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]
All selected trials investigate the impact of daily oral CoQ10 supplementation on muscle pain under statin therapy.
“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]
Six out of seven studies administered CoQ10 in the intervention group and placebo in the control group; one trial compared CoQ10 plus n-3 fatty acids to n-3 fatty acids only.
“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]
One study added a cross-over phase not part of the original protocol because fewer patients than expected experienced myalgia, resulting in a lower number of participants than planned.
“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]
Four studies stated SAMS as inclusion criterion, while three studies included patients with and without SAMS besides other side effects.
“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]
Exclusion of patients without statin-induced pain was performed in only four studies, and among those only one confirmed SAMS by having a wash-out period.
“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]
23 studies were included for data extraction, with 9 RCTs analyzed quantitatively.
“23 studies were included for data extraction [20–26,35–50], with 9 RCTs analyzed quantitatively.”
New evidence on the management of SAMS has become available from randomized controlled trials and observational data.
“New evidence on the management of SAMS have since become available both from randomized control trials (RCTs) and from observational data [20–26].”
13 RCTs conducted between 2006-2023 were included, of which five were parallel, five crossover, and three n-of-1.
“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).”
Nine trials assessed statin against placebo.
“nine trials assessed statin against placebo [20–26,43]”
Most trials used statins with low to moderate intensity.
“Most trials used statins with low to moderate intensity [20,21,24–26,40,43,46,48,49]”
Ten trials provided data on incidence of muscle symptoms.
“Ten trials [20,21,25,26,40,43,46–49] provided data on incidence of muscle symptoms”
Data on incidence of muscle symptoms were available in five parallel-group RCTs and three crossover RCTs.
“Data on incidence of muscle symptoms were available in five parallel-group RCTs [40,46–49], and three crossover RCTs [20,21,43].”
Only two included studies declared no funding from industry.
“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]
The Methods section identifies a corporation that supplied study capsules, but does not say whether the trial received industry funding or declared that it received none. Searches for funding, grants, disclosures, and an explicit no-industry-funding statement found no passage establishing the claim for this study; the cited paper also cannot establish the citing review’s count of two studies. (LLM, conf=0.68)
Experimental — accuracy not yet measuredRisk of bias assessment shows an overall low risk of bias in four included studies and moderate to high risk in three studies.
“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]
The Methods describe this trial’s design and blinding, and the Discussion mentions seven previous trials, but neither section assesses risk of bias across seven included studies. Searches for risk-of-bias ratings and the five domains found no passage supporting the claimed four-versus-three classification. (LLM, conf=0.78)
Experimental — accuracy not yet measuredSelection of reported results causes a moderate to high risk of bias in two studies.
“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]
The Methods (Statistical Analyses) describe the trial’s planned and revised analyses, and the Discussion describes a design change. Neither section assesses bias from selection of reported results or assigns a moderate-to-high risk rating. Searches for selective reporting and risk of bias found no such assessment in our copy. (LLM, conf=0.72)
Experimental — accuracy not yet measuredTwo trials did not provide enough information on pre-specified outcomes to allow assessment of reporting bias.
“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]
The Methods (Statistical Analyses; page unavailable) describe planned pain analyses, and the Abstract (Trial Registration; page unavailable) gives a registration number. Neither passage assesses whether information on pre-specified outcomes was sufficient to judge reporting bias. A second trial and that comparative assessment are not addressed in this paper. (LLM, conf=0.72)
Experimental — accuracy not yet measuredA double-blind RCT and a meta-analysis failed to substantiate that CoQ10, even at high doses, reduced symptoms in patients with SAMS.
“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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- 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 › Surgery › 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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