Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis.

Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis. An Eight-Weeks Double Blind Randomized Placebo-Controlled Clinical Trial.

Through an eight-week randomized, double-blind, placebo-controlled clinical trials formula to evaluate Chinese herbal compound OA2 improve osteoarthritis of efficacy and safety.

This trial was a 8 weeks' randomized, double-blind, placebo-controlled study. The study was approved by the Institutional Review Board of Chung Shan Medical University hospital, and signed informed consent was obtained from each patient. Eighty-one patients of osteoarthritis of knees or hips were enrolled in this study. Inclusion criteria were: age 20 to 80 years; primary osteoarthritis in at least 1 knee, verified radiologically and scored (as normal, minimal, moderate or marked) for joint-space narrowing and marginal osteophytes in the medial, lateral and patellofemoral compartments; at least moderate pain during the 2 weeks before random assignment to treatment, as identified with the Western Ontario and McMaster Universities (WOMAC) LK3.0 Osteoarthritis Index pain subscale. Primary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis index at week 4. Secondary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis index at week 2; Visual analogue scale (VAS), Quality of life by SF-36, patient global assessment (PGA), at week 2 and 4; The PGA was scored from 0 to 4 (0 representing very good); Biomarkers: Hs-CRP, ESR.

The investigators use VAS to compared the difference between the week 4 and week 0, week 8 and week 0

The investigators use PGA to compared the difference between the week 4 and week 0, week 8 and week 0

The investigators use SF-36 to compared the difference between the week 4 and week 0, week 2 and week 0

Inclusion Criteria: Age ≥20 years old Written informed consent obtained Been diagnosed with knee or hip osteoarthritis The physician interpretation of X-ray identification and joint space narrowing or bone spurs confirmed In randomized trials before entering if used steroids or non-steroid medications osteoarthritis stable doses required at least one week The WOMAC osteoarthritis index of the degree of pain assessment in the past two weeks at least> 4ppm pain Exclusion Criteria: Pregnant or breast-feeding women. Chemotherapy or radiation therapy in cancer patients