Tripterygium wilfordii Hook F. (TwHF) based therapy has been proved as effective in
treating rheumatoid arthritis (RA), yet the predictors to its response remains unclear. A
two-stage trial was designed to identify and verify the baseline symptomatic predictors of
this therapy. 167 patients with active RA were enrolled with a 24-week TwHF based therapy
treatment and the symptomatic predictors were identified in an open trial; then in a
randomized clinical trial (RCT) for verification, 218 RA patients were enrolled and
classified into predictor positive (P+) and predictor negative (P−) group, and were randomly
assigned to accept the TwHF based therapy and Methotrexate and Sulfasalazine combination
therapy (M&S) for 24 weeks, respectively. Five predictors were identified (diuresis,
excessive sweating, night sweats for positive; and yellow tongue-coating, thermalgia in the
joints for negative). In the RCT, The ACR 20 responses were 82.61% in TwHF/P+ group,
significantly higher than that in TwHF/P− group (P = 0.0001) and in M&S/P+ group
(P < 0.05), but not higher than in M&S/P− group. Similar results were
yielded in ACR 50 yet not in ACR 70 response. No significant differences were detected in
safety profiles among groups. The identified predictors enable the TwHF based therapy more
efficiently in treating RA subpopulations.
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