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Coenzyme Q10 supplementation decreases statin-related mild-to-moderate muscle symptoms: a randomized clinical study

Ajda Skarlovnik, Miodrag Janić, Mojca Lunder, Martina Turk, Mišo Šabovič
Medical Science Monitor 2014 20:2183-2188

Bibliography

PubMed
PMID 25375075
PubMed Central
PMC4226312
DOI
10.12659/MSM.890777
Funding
A specific study funding statement was not identified in the full-text article record checked during this audit. The tested CoQ10 product was supplied/manufactured by MGC Company, Japan.
Competing interests
A specific author conflict-of-interest statement was not identified in the full-text article record checked during this audit.

Study snapshot

DesignRandomized placebo-controlled clinical trial
ModelRandomized, double-blind, placebo-controlled parallel trial in adults with persistent mild-to-moderate statin-associated muscle symptoms after prior clinical attempts to modify statin therapy.
Sample50 randomized participants: 25 CoQ10 and 25 placebo.
InterventionWater-soluble CoQ10 50 mg twice daily (100 mg/day; MGC Company, Japan) versus identical placebo for 30 days while assigned statin therapy was continued.
Duration30 days.
EndpointsBrief Pain Inventory Pain Severity Score (PSS); Brief Pain Inventory Pain Interference Score (PIS); Creatine kinase; Liver enzymes; Fasting lipid profile; Clinical response to statin-associated muscle symptoms

What the study showed, in plain terms

This 30-day randomized double-blind trial enrolled 50 statin-treated adults with persistent mild-to-moderate muscle symptoms despite prior clinical attempts such as dose reduction, dechallenge/rechallenge or switching statins. Participants continued their statin and received water-soluble CoQ10 100 mg/day or identical placebo.

Pain scores improved substantially in the CoQ10 arm. Mean Pain Severity Score fell from 3.9 ± 0.4 to 2.9 ± 0.4, while Pain Interference Score fell from 4.0 ± 0.4 to 2.6 ± 0.4 (both p<0.001 within group). Relative reductions were greater than placebo for both severity (-33.1% vs -0.4%) and interference (-40.3% vs -11.5%), with between-group p<0.05.

The trial supports a short-term symptom signal, but it was small, only one month long, and relied on subjective pain outcomes. It did not measure plasma or muscle CoQ10 concentrations and therefore cannot establish a mechanistic link. Its positive result also sits within a conflicting literature that includes a later rigorously confirmed statin-myalgia trial showing no benefit.

Key findings

Pain severity: PSS decreased from 3.9 ± 0.4 to 2.9 ± 0.4 with CoQ10 (p<0.001). Relative PSS change was -33.1 ± 5.7% with CoQ10 versus -0.4 ± 6.3% with placebo (p<0.05 between groups).

Pain interference: PIS decreased from 4.0 ± 0.4 to 2.6 ± 0.4 with CoQ10 (p<0.001). Relative PIS change was -40.3 ± 7.0% versus -11.5 ± 10.2% with placebo (p<0.05).

The authors reported decreased statin-related muscle symptoms in approximately 75% of CoQ10-treated patients.

Creatine kinase, liver enzymes and cholesterol did not materially change; baseline CK was generally normal, consistent with symptomatic SAMS rather than overt myonecrosis.

Randomization/allocation: balanced computerized 1:1 randomization; independent pharmacist packed identical treatments; allocation sequence was concealed in a sealed envelope held by an independent physician.

Background statins included rosuvastatin (22), atorvastatin (20), simvastatin (4), fluvastatin (3) and lovastatin (1).

What this study can and cannot tell us

Small sample (50 participants) and very short 30-day treatment period.

Primary outcomes were subjective pain scores, which are especially vulnerable to placebo/nocebo effects in statin-associated muscle symptoms.

The study enrolled mild-to-moderate symptoms and cannot be generalized to severe myopathy or rhabdomyolysis.

Plasma and skeletal-muscle CoQ10 concentrations were not measured, so the study could not connect symptom changes to restoration of CoQ10 status.

Later evidence using a randomized statin-versus-placebo confirmation phase before CoQ10 treatment did not replicate a symptom benefit, so this positive trial should be interpreted in the context of conflicting higher-stringency evidence.

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology