Tier 3 — preclinical

Can coenzyme q10 improve clinical and molecular parameters in fibromyalgia?

Mario D Cordero, Elísabet Alcocer-Gómez, Manuel de Miguel, Ognjen Culic, Angel M Carrión, José Miguel Alvarez-Suarez, Pedro Bullón, Maurizio Battino, Ana Fernández-Rodríguez, José Antonio Sánchez-Alcazar
Antioxidants & Redox Signaling 2013 19(12):1356-1361

Bibliography

PubMed
PMID 23458405
DOI
10.1089/ars.2013.5260
Funding
No trial-specific funding statement was identified in the accessible publication record reviewed for this audit.
Competing interests
No trial-specific competing-interest statement was identified in the accessible publication record reviewed for this audit.

Study snapshot

DesignRandomized, double-blind, placebo-controlled pilot trial; registered as ISRCTN21164124.
ModelPatients with fibromyalgia.
Sample20 participants.
InterventionCoQ10 300 mg/day versus placebo.
Duration40 days.
EndpointsFibromyalgia Impact Questionnaire (FIQ); FIQ pain, fatigue and morning-tiredness subscales; Pain visual scale; Tender points; Inflammatory markers; Antioxidant enzymes; Mitochondrial biogenesis markers; AMPK expression/activity

What the study showed, in plain terms

This 20-person pilot RCT tested 300 mg/day of CoQ10 for 40 days in fibromyalgia. Clinical symptom scores improved versus placebo, including total Fibromyalgia Impact Questionnaire score, pain, fatigue, morning tiredness, pain visual scale and tender-point count.

Reported significance included FIQ reduction p<0.001, pain p<0.001, fatigue/morning tiredness p<0.01, pain visual scale p<0.01 and tender points p<0.01. The investigators also reported normalization of several inflammatory, antioxidant, mitochondrial-biogenesis and AMPK-related molecular measures.

The trial is mechanistically interesting but extremely small. Its large apparent effects are unstable and should be considered pilot evidence requiring independent replication.

Key findings

  • FIQ total score decreased versus placebo (p<0.001).
  • FIQ pain improved (p<0.001); fatigue and morning tiredness improved (p<0.01).
  • Pain visual scale and tender-point count improved (both p<0.01).
  • Molecular findings included changes in inflammation, antioxidant enzymes, mitochondrial biogenesis and AMPK expression/phosphorylation.
  • Trial registration: ISRCTN21164124.

What this study can and cannot tell us

  • Only 20 participants; effect estimates from a sample this small are highly unstable and vulnerable to chance and baseline imbalance.
  • Only 40 days of treatment; long-term symptom control and safety were not established.
  • Multiple clinical and molecular outcomes were measured, increasing multiplicity concerns in a very small pilot.
  • This single pilot should not be used alone to make broad fibromyalgia-treatment claims.

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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