Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases

Inclusion Criteria:

• Aged > 20 years
• Diagnosis at least one of the following

1. Rheumatoid arthritis according to American College of Rheumatology/ The EuropeanAlliance of Associations for Rheumatology 2010(ACR/EULAR2010) with at least onejoint swelling or tenderness or
2. Psoriatric arthritis according to CASPAR classification criteria with at leastone joint swelling or tenderness, or at least one site dactylitis or enthesitisor Psoriasis by dermatologist with active skin lesion
3. No previous treatment with methotrexate or treatment with methotrexate within 30day before randomization
4. No previous treatment with other conventional synthetic DMARDs other thanmethotrexate such as sulfasalazine, hydroxycholoquine, leflunomide
5. No previous treatment with biologic DMARDs such as anti-TNF
6. Can follow the treatment protocal

Exclusion Criteria:

• Pregnancy or planning for pregnancy
• Breastfeeding women
• Ongoing treatment with active malignancy
• GFR < 30 ml/min/1.73m2
• Previous documented of HIV infection
• Chronic alcohol drinking ≥ 3 times/wk or drug abuse within 6 months prior torandomization
• Positive of HbsAg, anti HCV
• Previous documented of preexisting liver disease such as alcoholic liver disease,liver cirrhosis, autoimmune hepatitis
• AST or ALT > ULN ( 0-50 U/L )
• WBC < 3,000/ul or platelet < 100,000 /ul, ANC < 1,500/ul
• ILD diagnosed by rheumatologist and pulmonologist from chest X ray and HRCT
• History documented silymarin hypersensitivity or severe adverse effects diagnosed byphysician or pharmacist from PMK hospital or from history drug allergy or symptomssuch as rash, chest tightness, dyspnea, diarrhea and hypotension
• Cannot follow up on treatment protocal