A phase I study of ethyl acetate extract of the Chinese antirheumatic herb Tripterygium wilfordii Hook F in rheumatoid arthritis

X. Tao, J. J. Cush, M. Garret, P. E. Lipsky

Research output: Contribution to journalArticle

120 Citations (Scopus)

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. Conclusion. 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.

Original languageEnglish (US)
Pages (from-to)2160-2167
Number of pages8
JournalJournal of Rheumatology
Volume28
Issue number10
StatePublished - Oct 20 2001
Externally publishedYes

Fingerprint

Tripterygium
Rheumatoid Arthritis
ethyl acetate
Autoimmune Diseases

Keywords

  • Antirheumatic therapy
  • Disease modifying antirheumatic drug
  • Ethyl acetate extract
  • Herbal remedies Tripterygium wilfordii Hook F

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

Cite this

A phase I study of ethyl acetate extract of the Chinese antirheumatic herb Tripterygium wilfordii Hook F in rheumatoid arthritis. / Tao, X.; Cush, J. J.; Garret, M.; Lipsky, P. E.

In: Journal of Rheumatology, Vol. 28, No. 10, 20.10.2001, p. 2160-2167.

Research output: Contribution to journalArticle

@article{73461ac0230d4113adec45594b74b167,
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. Conclusion. 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.",
keywords = "Antirheumatic therapy, Disease modifying antirheumatic drug, Ethyl acetate extract, Herbal remedies Tripterygium wilfordii Hook F",
author = "X. Tao and Cush, {J. J.} and M. Garret and Lipsky, {P. E.}",
year = "2001",
month = "10",
day = "20",
language = "English (US)",
volume = "28",
pages = "2160--2167",
journal = "Journal of Rheumatology",
issn = "0315-162X",
publisher = "Journal of Rheumatology",
number = "10",

}

TY - JOUR

T1 - A phase I study of ethyl acetate extract of the Chinese antirheumatic herb Tripterygium wilfordii Hook F in rheumatoid arthritis

AU - Tao, X.

AU - Cush, J. J.

AU - Garret, M.

AU - Lipsky, P. E.

PY - 2001/10/20

Y1 - 2001/10/20

N2 - 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. Conclusion. 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.

AB - 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. Conclusion. 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.

KW - Antirheumatic therapy

KW - Disease modifying antirheumatic drug

KW - Ethyl acetate extract

KW - Herbal remedies Tripterygium wilfordii Hook F

UR - http://www.scopus.com/inward/record.url?scp=0034785173&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0034785173&partnerID=8YFLogxK

M3 - Article

C2 - 11669150

AN - SCOPUS:0034785173

VL - 28

SP - 2160

EP - 2167

JO - Journal of Rheumatology

JF - Journal of Rheumatology

SN - 0315-162X

IS - 10

ER -