HealthDay News — A plant extract used in traditional Chinese medicine was as effective as methotrexate for short-term rheumatoid arthritis (RA) treatment, and superior to methotrexate alone when used in combination with the medication, study findings indicate.
At six months, 55.1% of patients receiving extracts of herbal Tripterygium wilfordii Hook F (TwHF) and 46.4% of patients receiving methotrexate had RA symptoms improve by at least 50% using American College of Rheumatology (ACR50) criteria, according to Xuan Zhang, MD, of the Chinese Academy of Medical Sciences in Beijing, and colleagues
The difference in symptom improvements among the two monotherapy groups were significant (P=0.014) on noninferiority tests, as was the difference in symptom improvement between patients assigned to combination TwHF methotrexate versus monotherapy methotrexate (P<0.001), the researchers reported in Annals of the Rheumatic Diseases.
They randomly assigned 207 patients with RA (1:1:1) to receive either methotrexate 12.5 mg once a week or TwHF 20 mg three times a day, or the two in combination. The 28-joint count Disease Activity Score was used to assess reductions in active RA and, if these reductions were <30 percent at 12 weeks, patients were switched to combination methotrexate TwHF.Eighty-four percent of patients completed the trial.
The researchers found that the proportion of patients reaching the ACR50 response criteria at week 24 were: 46.4% of 69 patients in the methotrexate group, 55.1% of 69 in the TwHF group, and 76.8% of 69 in the methotrexate+TwHF group.
Outcomes among the methotrexate+TwHF group were superior to methotrexate alone on several measures:
- Higher treatment response rates at six months (P<0.05)
- ACR20: 92.8% vs. 63.8%
- ACR70: 43.5% vs. 23.2%
- Low disease activity: 55.1% vs. 27.5%
- Remission: 49% vs. 20.3%
All treatment arms achieved similar significant improvement in the Health Assessment Questionnaire and 36-item Short-Form Health Survey questionnaire scores from baseline to week 24 (P<0.05).
The most frequent side effects were gastrointestinal, reported by 43.5% of patients on methotrexate, 34.8% of those receiving the combination and 29% of those given TwHF.
“TwHF monotherapy was not inferior to, and MTX+TwHF was better than, MTX monotherapy in controlling disease activity in patients with active RA,” the researchers wrote.
Additional follow up of the study cohort through two years to evaluate radiographic disease progression is planned. One study limitation is the low 12.5 mg standard dose of methotrexate in Asia compared with the 15 to 20 mg standard dose in the United States, which may have influenced outcomes in the methotrexate monotherapy group.