A clinical study of total glucosides palony in the treatment of rheumatoid arthritis: a multi-center trial

Objective To further evaluate the efficacy and safety of total glucosides palony (TGP) as a DMARD in the treatment of rheumatoid arthritis (RA). Methods Three hundred and seventy cases of RA were randomly divided into five groups: MTX, MTX plus TGP, MTX plus SSZ, TGP plus SSZ, and TGP group in a randomized, 24~48 week open trial. The registered indexes included joint pain, number and index of joint tenderness and joint swelling, duration of morning stiffness, grip strength, joint function status, ESR, CRP and RF. Results After 24 weeks of treatment, the clinical items improvement was similar among five groups except the index of joint swelling in TGP plus MTX group and morning stiffness in MTX group was better than that of the other groups. After 36 weeks the efficacy was better than other groups in 4 items for MTX group, 3 items for TGP+SSZ and 2 items for MTX plus SSZ and TGP groups. Efficacy was worse than other groups in 3 items for TGP plus MTX group. After 48 weeks, the efficacy was better than other groups in 5 items for MTX group, 3 items for TGP group, 2 items for MTX plus SSZ and TGP plus SSZ group. Meanwhile the efficacy was not as good as other groups in 3 items in TGP plus MTX group and one parameter in TGP plus SSZ and TGP group. ESR declined significantly after 24 and 48 weeks, CRP was decreased with similar pattern except for MTX plus TGP group. RF was invariable in TGP group after treatment for 24 and 48 weeks. MTX and TGP plus MTX group were more effective in RF reduction than TGP plus SSZ group and MTX plus SSZ group. TGP had an advantage in the improvement of joint function and later onset of effect than MTX. The primary side-effect for TGP was diarrhea/constipation with no severe adverse events happened in all groups. No other side-effect was observed in 48 weeks. Conclusion TGP, TGP combined with MTX or with SSZ may have an equivalent effect to MTX and MTX plus SSZ. It suggests that TGP may be an effective drug for RA with less side-effects and good safety.