Silymarin versus hesperidin/diosmin for fibromyalgia symptom relief

The Effect of Silymarin Versus Hesperidin/Diosmin Combination on Patients With Fibromyalgia

This project will test whether silymarin or a hesperidin/diosmin combination can ease symptoms in adults with fibromyalgia who continue to have pain despite conventional therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Ain Shams University (Academic / other)
• Locations: 1 site (Cairo)
• Trial ID: NCT07293767 on ClinicalTrials.gov

What this trial studies

Adults with rheumatologist-confirmed fibromyalgia who meet the ACR 2016 criteria and have persistent symptoms despite conventional treatment will be assigned to receive silymarin (Legalon), a diosmin/hesperidin combination (Daflon), or no active treatment (control). Participants must be older than 18 and not have used Daflon or Legalon in the prior six months; those with other widespread inflammatory or neuropathic pain conditions or allergies to the study compounds are excluded. Symptoms and pain burden will be followed using standard fibromyalgia measures (including Widespread Pain Index and symptom severity scoring) over the treatment period. The trial is conducted at the Rheumatology outpatient unit of Ain Shams Hospitals in Cairo.

Who should consider this trial

Good fit: Ideal candidates are adults (age >18) with rheumatologist-confirmed fibromyalgia meeting the ACR 2016 criteria who continue to have symptoms despite conventional therapy and have not used Daflon or Legalon in the past six months.

Not a fit: Patients whose widespread pain is due to other inflammatory rheumatic disorders or neuropathic conditions, those allergic to silymarin/diosmin/hesperidin, or those with cognitive impairment preventing adherence are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, readily available plant-derived therapies could reduce pain and fatigue and offer a lower-cost treatment option for some adults with fibromyalgia.

How similar studies have performed: Use of silymarin and diosmin/hesperidin for fibromyalgia is largely novel and well-controlled evidence in this condition is limited, so prior success is minimal.

Eligibility criteria

Inclusion Criteria:

* 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.
* Persistent pain syndrome on conventional therapy.
* Not taking Daflon or Legalon for 6 months.

Exclusion Criteria:

* 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.
* Pregnant or planning pregnancy women and breastfeeding women.
* Major comorbidities like renal impairment, severe liver disease, chronic hepatitis C, history of alcohol or drug addiction.
* Current severe or uncontrolled major depressive disorder or anxiety disorders.
* Patients will be excluded if there is no compliance to the medication.

Where this trial is running

Cairo

• Outpatients clinic of department of Internal medicine- Rheumatology unit Ain shams hospitals. — Cairo, Egypt (Recruiting)

Study contacts

• Study coordinator: menna s teaching assistant of clinical pharmacy/ master's student

Conditions Fibromyalgia; fibromyalgia; silymarin; hesperidin; diosmin