January 2017
Elísabet Alcocer‐Gómez, Ognjen Culic, José M. Navarro‐Pando, José A. Sánchez‐Alcázar, and Pedro Bullón
Fibromyalgia (FM) is a common chronic pain syndrome accompanied by a myriad of variable physical and psychopathological symptoms such as fatigue, muscle stiffness, sleep disorders, morning tiredness, cognitive complaints, as well as depression and anxiety 1.
Despite the fact that it affects up to 5% of the general population worldwide, its pathogenic mechanism remains elusive. Recently, the hypothesis that oxidative stress and mitochondrial dysfunction are important events in the pathogenesis of FM 2 was proposed. Furthermore, coenzyme Q10 (CoQ10) deficiency has been described in patients with FM 3.
CoQ10 plays a critical role in the mitochondrial ATP production and cellular metabolism. CoQ10 also regulates mitochondrial uncoupling proteins, mitochondrial permeability transition pore, and ROS production 2. Recently, preliminary data showed an interesting improvement in clinical symptoms in patients with FM after oral supplementation with CoQ10 4, 5, including the control of the depressive symptom with the regulation of the serotoninergic system 6.
In addition to biological and clinical parameters, other psychopathological events have been involved in the pathophysiology of FM. Psychological factors, a high prevalence of depression and anxiety symptoms have been widely reported 7. Following our earlier work about the therapeutic effects of CoQ10 on FM in a clinical trial (ISRCTN 21164124) 5, here we show the effect of 40 days of CoQ10 versus placebo supplementation in psychopathological profiles from patients with FM using a multidimensional psychological screening instrument, namely the Symptom Checklist‐90‐R' (SCL‐90‐R).
The study protocol was reviewed and approved by the Ethical Committee of the University of Sevilla. All the participants to the study gave their written informed consent before initiating the study. This study was carried out in compliance with the Declaration of Helsinki, and all the International Conferences on Harmonisation and Good Clinical Practice Guidelines.
Twenty patients diagnosed with FM were distributed in a clinical trial as described in reference 5. Data in tables are given as means ± SD. Data between different groups were analyzed statistically using ANOVA on Ranks with SigmaPlot and SigmaStat statistical software (SPSS for Windows, 19, 2010, SPSS, Inc). A value of P < 0.05 was considered significant.
To compare the trial results from patients treated with CoQ10 or placebo, a two‐way variance (ANOVA) analysis was used. The patients were diagnosed with FM by exclusion of other diseases and syndromes, and in accordance with the American College of Rheumatology criteria. Subjects were randomized in a double‐blind fashion, according to a 1:1 ratio, to CoQ10 or placebo. Ten subjects (age: 44.3 ± 9.7 years) received CoQ10 (Pharma Nord, Vejle, Denmark) in soft gel capsules for 40 days (300 mg/day CoQ10 divided into three daily doses), while another group of ten subjects (age: 55 ± 5 years) with similar characteristics received a matching placebo (Table (Table1).1). After 40 days, no changes were observed about BMI in the patients (baseline: 27.6 ± 4 kg/m2 vs. placebo: 27.3 ± 4.8 kg/m2 or CoQ10 group: 26 ± 4.8 kg/m2).
However, important molecular changes were induced by CoQ10 after treatment such as increment in mitochondrial biogenesis and antioxidants gene expression and reduction in inflammation accompanied by an improvement in the clinical symptoms determined by Fibromyalgia Impact Questionnaire (FIQ), Pittsburgh Sleep Quality Index (PSQI) and tender points 5 and corroborated in other studies 4, 6.
After evaluating the effect of CoQ10 on the psychopathological symptoms, a clinically significant improvement was observed in all subscores from SCL‐90‐R, being statistically significant for the reduction in interpersonal sensitivity (P < 0.001), depression (P < 0.001), anxiety (P < 0.001), hostility (P < 0.001), and psychoticism (P < 0.001) items, and a moderate statistical significance in somatization (P < 0.05) and obsessive–compulsive (P < 0.05; Table 2).
