The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis

The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis, a Controlled and Randomized Trial

The purpose of this study is to access the effect (week 12/week 24) of puerarin injection on carotid intima-media thickness (CIMT) in rheumatoid arthritis (RA) patients despite routine anti-rheumatic treatment.

• Controlled, randomized trial
• RA patients under routine anti-rheumatic care were randomized to receive the treatment with or without 400 mg puerarin injection
• Assessments were made at entry, 12 and 24 weeks
• The overall sample size was assessed before the enrollment
• Randomization was performed using concealed random allocation method
• The collected data was processed and assessed by two reviewers
• All the measurement and analysis procedures concerning CIMT were performed by a single ultra sonographer and a single reader, who were blinded to patient profiles and group assignment
• The reproducibility of the ultrasonographic method was test before the trial

Inclusion Criteria:

• patients with a definite diagnose of rheumatoid arthritis(RA) were included if they met the classification criteria for RA established by the American Rheumatism Association (ACR) and European League Against Rheumatism (EULAR) in 2010
• aged from 18 to 75 years
• without conflict to the written, informed consent signed prior to the enrollment
• no severe hepatic or renal disorders
• no known carotid artery stenosis
• no coagulation disorders
• no hypertension

Exclusion Criteria:

• being in pregnancy, lactation period or under a pregnancy plan
• being allergic to the test drug
• not compatible for the trial medication
• without full legal capacity