title: A phase I study of ethyl acetate extract of the chinese antirheumatic herb Tripterygium wilfordii hook F in rheumatoid arthritis.
abstract: OBJECTIVE
  To explore the efficacy and safety of ethyl acetate (EA) extracts of the Chinese herbal remedy Tripterygium wilfordii Hook F (TWHF) for treatment of patients with a variety of inflammatory and autoimmune diseases including rheumatoid arthritis (RA).
  
  
  METHODS
  The roots of TWHF were extracted sequentially by ethyl alcohol and ethyl acetate and the content of the extract documented. An open label, dose escalation Phase I study was performed in 1993 in 13 patients with established RA. Clinical manifestations and laboratory findings were examined before and every 4 weeks after starting treatment with the EA extract.
  
  
  RESULTS
  Three patients withdrew from the trial during the first 16 weeks of the dose escalation. These patients received a maximum dosage of 180 mg/day. There were no adverse effects or disease improvement observed in these patients. Nine of the remaining 10 patients tolerated the EA extract up to a dosage of 570 mg/day. There were no withdrawals related to adverse events in the trial except for one patient who developed diastolic hypertension at a dose of 180 mg/day of EA extract. Six of 10 patients treated with 180 mg/day of EA extract showed disease improvement. Eight of the 9 patients who received EA extract at doses > 360 mg/day experienced improvement in both clinical manifestations and laboratory findings. One patient met American College of Rheumatology criteria for remission.
  
  
  CONCLUSIONS
  The EA extract of TWHF at dosages up to 570 mg/day appeared to be safe, and doses > 360 mg/day were associated with clinical benefit in patients with RA.
authors.affiliation: Harold C. Simmons Arthritis Center, The University of Texas Southwestern Medical Center at Dallas, USA.
authors.forename: X
authors.initials: X
authors.lastname: Tao
authors.forename: J J
authors.initials: JJ
authors.lastname: Cush
authors.forename: M
authors.initials: M
authors.lastname: Garret
authors.forename: P E
authors.initials: PE
authors.lastname: Lipsky
mesh_terms: D000085:Acetates; D000368:Aged; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D018517:Plant Roots / Q000737:chemistry; D016896:Treatment Outcome; D029757:Tripterygium
chemical_list: D000085:Acetates; D018501:Antirheumatic Agents; D004365:Drugs, Chinese Herbal; C007650:ethyl acetate