About this trial
Fibromyalgia is a chronic disease, characterized by chronic widespread pain, physical exhaustion, sleep problems, and unexplained pain in both joints and muscles. Fibromyalgia's causes still unknown, but there are various risk factors that can cause fibromyalgia such as genetic causes, physical shock, and infections. Fibromyalgia typically presents in young or middle aged females, it occurs in females more than males, and it is characterized with widespread pain throughout the whole body in both sides such as arms, shoulders, head, and abdominal areas. The etiology of fibromyalgia still unclear, but there are several factors such as alterations in the sleep pattern, changes in the neuroendocrine transmitters such as cortisol, growth hormones and serotonin, dysfunction of central and autonomic nervous systems, psychiatric aspects and external stressors . The pain seems to result from neurochemical imbalances in the central nervous system that lead to a "central amplification" of pain perception characterized by allodynia (a heightened sensitivity to stimuli that are not normally painful) and hyperalgesia (an increased response to painful stimuli). this interventional study aims to study effect of silymarin and hesperidin/diosmin combination on fibromyalgia patients and compare their effect with control patients on the following
1. Management of pain. 2. Inflammatory biomarkers. 3. Quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed written consent.
Participant must meet the American College of Rheumatology 2016 revised classification criteria for Fibromyalgia: Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5, or WPI 3 to 6 and SS scale score ≥ 9
Age >18 years old (males and females)
Diagnosis of FM confirmed by a rheumatologist.
Disqualifiers
Pain due to other conditions (e.g. diabetic peripheral neuropathic pain or post-herpetic neuralgia) that would confound assessment or self-evaluation of the pain associated with FM.
Patients with pain due to any widespread inflammatory musculoskeletal disorder (e.g. rheumatoid arthritis, lupus) or widespread rheumatic disease other than FM.
Allergy to silymarin or diosmin or hesperidin.
Cognitive deficits that could impair understanding of the study, completion of questionnaires, or adherence to therapy.
Trial design
Parallel
Treatments tested in this trial
Silymarin (LEGALON)
Drugoral silymarin (legalon) 140 mg will be taken 3 times daily for 12 weeks with the standard treatment
Diosmin / Hesperidin (Daflon)
DrugDiosmin / Hesperidin (Daflon) 500 mg will be taken once daily for 12 weeks with the standard treatment
no intervention (control group)
Other interventionthis group will receive no intervention (only the standard treatment)
Treatment groups
Trial outcomes
Primary outcomes
pain assessment through Fibromyalgia impact questionnaire (FIQ)
Change in Fibromyalgia impact questionnaire (FIQ) score will be assessed by the end of the study, the score ranges from 0 to 100 higher score means worse condition
Secondary outcomes
Erythrocyte sedimentation rate (ESR)
ESR will be measured at baseline and after four months of treatment
C-reactive protein level (CRP)
CRP will be measured at baseline and after four months of treatment
Health-related quality-of-life through Short Form 12 health survey SF-12
quality of life will be assessed through Short Form 12 health survey SF-12 (Questionnaire of health) at baseline and after 4 months the score ranges from 0 to 100 higher scores indicate better health
pain assessment through visual analogue scale (VAS)
visual analogue scale (VAS) score will be assessed at baseline and after four months of treatment, the score ranges from 0 to 10 cm higher score means worse condition
Sponsors and contacts
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