A traditional Chinese herbal remedy used to treat joint pain, fever, edema, and local inflammation was found noninferior to methotrexate for controlling active rheumatoid arthritis in an open-label, randomized clinical trial involving 207 patients.
Tripterygium wilfordii Hook F (TwHF) is a relatively inexpensive remedy (about $10 per month) often used alone or in combination with methotrexate for rheumatoid arthritis (RA) in China, but it has not been assessed in a rigorous controlled study until now.
©Qwert1234/Wikimedia Commons
Tripterygium wilfordii Hook F is a relatively inexpensive remedy often used for rheumatoid arthritis in China.
In this trial, patients at nine general hospitals in China were randomly assigned in a nonblinded fashion to receive 6 months of oral TwHF pills three times per day (69 patients), oral methotrexate once per week (69 patients), or TwHF plus methotrexate (69 patients), in addition to their stable doses of NSAIDs and oral corticosteroids, said Qian-wen Lv of the department of rheumatology and clinical immunology, Peking Union Medical College and the Chinese Academy of Medical Sciences, Beijing, and associates.
The primary efficacy measure was the proportion of patients who achieved an ACR50, or an American College of Rheumatology response of at least 50% improvement in tender and swollen joints and an improvement of at least 50% in three or more of the following: evaluator’s assessment of global health status, patient’s assessment of global health status, patient’s assessment of pain on a visual analog scale, patient’s assessment of function using the Health Assessment Questionnaire, and ESR or CRP level. This rate was 55.1% in the TwHF group, which was noninferior to the 46.4% rate in the methotrexate group. The combination of TwHF plus methotrexate was the most effective, with an ACR50 response rate of 76.8%.
A similar pattern was seen in secondary efficacy measures such as the remission rate, the ACR20 response, the ACR70 response, "good" responses on the Clinical Disease Activity Index, "good" responses on EULAR criteria, and the rate of Low Disease Activity. This pattern also persisted in a per-protocol analysis that excluded the 33 patients who withdrew from the study: The ACR50 response was 65.3% for TwHF alone, 59.2% for methotrexate alone, and 80.4% for combined TwHF plus methotrexate among patients who completed the study, the investigators said (Ann. Rheum. Dis. 2014 April 14 [doi:10.1136/annrheumdis.2013.204807]).
The main difference among the treatment groups in laboratory analyses was that TwHF monotherapy induced a much more rapid reduction in ESR than did methotrexate monotherapy. The numbers of adverse effects and severe adverse effects were comparable between TwHF and methotrexate, except that TwHF was associated with a slightly higher rate of irregular menses. This antifertility effect of the herbal remedy is well known in China, and study participants were warned about it before enrollment. It is usually reversible after treatment is discontinued, the investigators said.
This study was supported by the National Natural Science Foundation of China, the Beijing Municipal Natural Science Foundation, the Research Special Fund for Public Welfare Industry of Health, the Capital Health Research and Development of Special Fund, and the National Laboratory Special Fund. The investigators declared having no financial conflicts of interest.