Objective:

2

To explore the efficacy and safety of Juan Bi Pill (JBP) in treatment of active rheumatoid arthritis (RA).

Methods:

2

From February 2017 to May 2018

115 participants from 4 centers were randomly divided into JBP group (57 cases) and placebo group (58 cases) in a 1:1 ratio using a random number table method. Participants received a dose of JBP (4 g

twice a day

orally) combined with methotrexate (MTX

10 mg per week) or placebo (4 g

twice a day

orally) combined with MTX for 12 weeks. Participants were required with follow-up visits at 24 and 48 weeks

attending 7 assessment visits. Participants were undergo disease activity assessment 7 times (at baseline and 2

4

8

12

24

48 weeks) and safety assessments 6 times (at baseline and 4

8

12

24

48 weeks). The primary endpoint was 28-joint Disease Activity Score (DAS28-ESR and DAS28-CRP). The secondary endpoints included American College of Rheumatology (ACR) criteria for 20% and 50% improvement (ACR20/50)

Health Assessment Questionnaire Disability Index (HAQ-DI)

clinical disease activity index (CDAI)

visual analog scale (VAS)

Short Form-36 (SF-36) score

Medial Outcomes Study (MOS) sleep scale score

serum erythrocyte sedimentation rate (ESR)

C-reactive protein (CRP)

tender joint count

swollen joint count

and morning stiffness. The adverse reactions were observed during the treatment.

Results:

2

After 12 weeks of treatment

DAS28-ESR and DAS28-CRP scores in both groups were lower than before treatment (both

P

<

0.01)

while the remission rate of DAS28-ESR and DAS28-CRP and low disease activity of JBP group were higher than those in the placebo group (both

P

<

0.01). JBP demonstrated better efficacy on ACR20 and ACR50 compliance rate at 12 and 48 weeks comparing to placebo (all

P

<

0.05). The CDAI and HAQ-DI score

pain VAS and global VAS change of RA patients and physicians

the serum ESR and CRP levels

and the number of tenderness and swelling joints were lower than before treatment at 4

8

12

24

48 weeks in both groups (

P

<

0.05 or

P

<

0.01)

while the reduction of above indices in the JBP group was more obvious than those in the placebo group at 12 weeks (ESR and CRP

both

P

<

0.05 ) or at 12 and 48 weeks (all

P

<

0.01). There was no difference in adverse reactions between the 2 groups during treatment (

P

=0.75).

Conclusion:

2

JBP combined with MTX could effectively reduce disease activity in patients with RA in active stage

reduce the symptoms of arthritis

and improve the quality of life

while ensuring safety

reliability

and fewer adverse effects. (Trial registration: ClinicalTrials.gov

No. NCT02885597)