Clinical and Immunomodulatory Effect of Fun-boi, an Herbal Medicine, in Rheumatoid Arthritis.

Crude preparations of Fun-boi (Fen-fan-ji in Chinese), a traditional anti-rheumatic herb, have been used safely over millennia. To begin to study the efficacy of Fun-boi on the disease activity and the peripheral lymphocyte subsets, we performed a 12-week, open-label trial of Fun-boi extract (a decoction of Fun-boi 10 g/day) in 29 patients with rheumatoid arthritis (RA). Most clinical and immunological variables: swollen joint count, physician's and patient's assessment, pain score and IgM rheumatoid factor, showed statistically significant improvement. Seven (24%) of the enrolled patients met the American College of Rheumatology (ACR) criteria for a 20 percent improvement in measures of disease activity (ACR20) and 3 (10%) met those for ACR50. The CD3+CD8+ lymphocytes were increased significantly. Accordingly, the CD4/CD8 ratio was decreased; however, these changes did not show any clear correlation with clinical response. Two patients (7%) experienced some minor transient adverse events. In conclusion, Fun-boi is safe and showed beneficial effect in some patients for the treatment of the relatively mild RA seen in the patients studied. Further controlled studies are indicated. Clinicians should keep an open mind about possible benefits of these still incompletely studied herbal agents.