Abstract

Background:Fibromyalgia syndrome (FMS) is a multidimensional chronic disorder characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, cognitive dysfunction, depressive episodes, and anxiety [1]. Management of FMS remains challenging and treatment strategies are required to be multidisciplinary. Among nonpharmacological therapies, nutrition is a promising tool, since oxidative stress and/or an imbalance of nutritional components have demonstrated to play a critical role in the pathophysiology of FMS [2,3].Objectives:We conducted a pilot study (FATMIA Study) to investigate the efficacy and tolerability of a dietary supplementation (NSC) containing coenzyme Q10, magnesium and tryptophan in FMS patients.Methods:This was a prospective, double-blind, placebo-controlled, two-period pilot study conducted between March 2017-October 2017. All patients underwent two 3-month treatments with NSC and placebo, with a 1-month washout period in between. To evaluate the most prevalent clinical manifestations of FMS, the Combined Index of Severity of Fibromyalgia questionnaire (ICAF) [4] was used. A sample of 23 patients aged from 18 to 80 years, with a formal diagnosis of fibromyalgia of at least two years, was included in the study.Results:Twenty patients completed the study, while three (13.0%) dropped out because they failed to attend all clinical visits (n=2) or presented an adverse event (n=1). Participant demographics are presented in Table 1. All participants were female with a mean age of 51.9 (7.2) years. Depression and anxiety were reported in 65.0% (13/20) and 30.0% (6/20) of cases, respectively. All patients were under pharmacological treatment for FMS symptoms. The most commonly reported medications were paracetamol (60.0%, 12/20), selective serotonin reuptake inhibitors (45.0%, 9/20), and tramadol (40.0%, 8/20). Physical symptoms such as fatigue, functional capacity, pain and sleep quality improved at the end of the study treatment, whereas they mainly declined after placebo treatment. However, no statistically significant differences were found among the studied variables. Total ICAF score improved after NSC treatment, and declined after placebo treatment. NSC treatment was well tolerated, with a low incidence of adverse events (5.0%, 1/20).Table 1.Patient demographicsParameterValueAge, years [mean (SD]51.9 (7.2)Sex (F/M)20/0Weight, kg [mean (SD]69.3 (13.1)Height, cm [mean (SD]160.4 (6.5)Years since first FMS diagnosis [mean (SD)]7.7 (6.3)Occupational status, n (%) Working full-time/part-time10 (50.0) At home3 (15.0) Not working/receiving pension5 (25.0) Retired or unemployed2 (10.0)Smoking patients, n (%)8 (40.0)Patients on alcohol consumption, n (%)0 (0.0)Patients on physical activity, n (%)2 (10.0)F/M: female/maleConclusion:The results of this study constitute the first investigation of the effect of a nutritional supplement containing CoQ10, magnesium and tryptophan on FMS. Although the results should be confirmed in larger studies, they suggest that NSC treatment for 3 months, in addition to pharmacological therapy, may be of interest in the management of FMS. This treatment appeared to primarily improve physical symptoms, such as fatigue and pain, with low risk of adverse events.

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