Background Tong Luo Hua Shi Capsule (TLHS) is a new drug modified from Wu-wei-gan-lu Decoction, which has been used as one of the basic prescriptions of the Tibetan Medicine for the treatments of different diseases, especially the Rheumatoid arthritis (RA), for hundreds of years in China. The previous clinical trials showed its anti-arthritis effect and the tolerance in healthy participants. However, there was no further clinical trial reported.
Objectives The purpose of this study is to investigate the efficacy and safety of Tong Luo Hua Shi Capsule on the participants with RA.
Methods This is a multicenter, randomized, double-blinded, placebo controlled, dose finding study, and reported following the recommendation of the CONSORT.
In this randomized, double-blinded, placebo controlled, dose finding study, 236 patients with active RA from five medical centers were administered 3 doses (1.6g, 1.2g or 0.8g t.i.d.) of TLHS or 4 pieces of placebo capsule t.i.d. peroral administration daily for 8 weeks. During the clinic visits, investigators obtained multiple blood samples, observed physical exams, and assessed swollen, tender, painful joints. The clinical manifestations and laboratory findings were examined every 2 weeks after starting treatment up to the 8th week. The trial registration number is ChiCTR-TRC-12003871.
Results 236 participants from 5 centers were screened with written informed consent, 4 participants were excluded and 20 dropped out for the lost follow-up or empty treatment. there is no significant difference in the incidences of adverse event (P=0.963) or adverse drug reactions (P=0.878) among the groups. No serious adverse events occurred in the trial. After the 8-week-administration, the improvement rates of the ACR 20 in the TLHS 4.8g and 3.6g groups were significantly higher than the control group (P<0.01 and P<0.05). The improvement rate of the ACR 50 in the TLHS 4.8g group is significantly higher compared with the control group (P<0.01). The results obtained in the FAS and PPS were similar.
Conclusions The outcomes show that TLHS can ameliorate the improvement in the ACR criteria and other endpoints, such as pain, tender, swollen, morning stiffness of joints, patients' grip strength and physician's assessment. Moreover, TLHS is safe for patients, besides of the occurrence of transitory adverse events.
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Disclosure of Interest : W. Liu: None declared, Y.-H. Wu: None declared, S.-Y. Hu: None declared, M.-L. Gao: None declared, H.-Y. Wang: None declared, Y.-J. Song: None declared, B.-Z.-X. Yang: None declared, H. Yao Grant/research support: drug supplier, X.-B. Qi: None declared, G. Li: None declared