Impact of Major Ozone Autohemotherapy on Sarcopenia Parameters in Fibromyalgia

Fibromyalgia syndrome (FMS) is a chronic and heterogeneous disorder characterizedprimarily by widespread pain, accompanied by sleep disturbances, fatigue, depressivesymptoms, and cognitive dysfunction. Although multiple therapeutic options are available,no curative treatment currently exists. Previous studies have demonstrated increasedoxidative stress, dysregulation of the hypothalamic‐pituitary‐adrenal (HPA) axis, and apredisposition to sarcopenia in patients with FMS.Ozone therapy has increasingly been used in chronic diseases due to its regulatoryeffects on oxidative stress. Although ozone is inherently an oxidative molecule, whenadministered at therapeutic doses it may induce antioxidant responses at the cellularlevel and exert anti‐inflammatory effects by modulating inflammatory mediators. However,limited studies have evaluated the efficacy and underlying mechanisms of major ozoneautohemotherapy (MOA) in FMS.This controlled, prospective, single‐blind study aims to investigate the effects of majorozone autohemotherapy on clinical parameters of FMS, as well as its impact on HPA axisfunction and sarcopenia‐related parameters. A total of 60 patients with FMS will beenrolled and randomized into two groups: (1) exercise therapy alone and (2) exercisetherapy plus major ozone autohemotherapy. MOA will be administered twice weekly for atotal of 10 sessions at a dose of 20‐40 μg/mL.Participants will be evaluated at baseline, at week 6, and at 3 months. Outcome measureswill include Visual Analog Scale (VAS), Fibromyalgia Impact Questionnaire (FIQ), FatigueSeverity Scale (FSS), Pittsburgh Sleep Quality Index (PSQI), Short Form‐12 (SF‐12), andHospital Anxiety and Depression Scale (HADS). Morning fasting serum cortisol levels willbe measured to assess HPA axis function. Sarcopenia assessment will include handgripstrength measured by Jamar dynamometer, and ultrasonographic evaluation of muscle mass,muscle thickness, pennation angle, fascicle length, echogenicity, and cross‐sectionalarea. Physical performance will be assessed using the Short Physical Performance Battery(SPPB).Unlike previous studies, this trial includes a 3‐month follow‐up evaluation aftercompletion of ozone therapy to assess longer‐term effects. By incorporating objectivesarcopenia and endocrine assessments alongside validated clinical scales, the study aimsto provide comprehensive evidence regarding the role of major ozone autohemotherapy inFMS management. This will be the first study to specifically evaluate the effects ofmajor ozone autohemotherapy on sarcopenia parameters in patients with FMS.