TJ-114 (Sairei-To), an Herbal Medicine in Rheumatoid Arthritis

The search for better treatments for malignancies has been enhanced by use of a relatively inexpensive clinical protocol that encourages the preliminary screening of a large number of potential anticancer drugs with early elimination of those that are clearly ineffective, preserving resources for more intensive evaluation of those that show some evidence of benefit. We adapted this method to determine whether the herbal medicine TJ-114 was worthy of further study for the treatment of rheumatoid arthritis (RA) patients. TJ-114 is a traditional herbal medicine that has been used extensively in Japan for the treatment of RA, Reports suggest that it may be a useful second-line agent, well-tolerated and safe. For these reasons, a 6-month, open prospective pilot study to evaluate the efficacy, safety and tolerability of TJ-114 in United States RA patients was undertaken. Thirty patients were enrolled; 18 completed the study. There were five responders by predefined composite criteria. Twelve patients withdrew from the trial, six for lack of efficacy, four for non-compliance, one for diarrhea and one for constipation and abdominal pain. The anti-cancer drug screening protocol stipulates that the drug be discarded if there are no responders among the first 14 patients and only 1 or 2 among the first 30 patients. Using this approach, the response rate found in this study justifies placebo-controlled, double-blind studies to determine the relative efficacy and toxicity of TJ-114 in a more definitive manner.