Efficacy and safety of Xinfeng capsule in patients with rheumatoid arthritis: a multi-center parallel-group double-blind randomized controlled trial.

Abstract

OBJECTIVE:

To evaluate the efficacy. and safety of Xinfeng capsule in patients suffering rheumatoid arthritis (RA).

METHODS:

A multi-center parallel-group designed, double-blind, randomized, controlled trial was conducted. Totally 304 RA patients were assigned to two groups: one group was administered Xinfeng capsule (XFC) plus the placebo of leflunomide and the other given leflunomide (LEF) plus the placebo of XFC for twelve weeks. The clinical and laboratory parameters were compared at baseline and fourth, eighth, and twelfth weeks.

RESULTS:

After twelve-week treatment, patients in two groups all showed some trend of effectiveness when compared in terms of American Rheumatism Association (ACR) recommended 20%, 50%, 70% improvement criteria, but it was insignificant. The validity in ameliorate modified disease activity score (DAS28) and laboratory indexes as erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF) were also found no difference. The score of health assessment questionnaire (HAQ), self-rating anxiety scale (SAS), self-rating depression scale (SDS) and quality of life questionnaire with rheumatoid arthritis (RAQOL) both lower than the first week and the changes showed no difference. However, the score of SDS dropped more in XFC group than in the other. A total of 147 adverse reaction cases were reported, which shows no difference between the two groups. The most common adverse reactions were hepatic impairment, anemia, leukocytopenia, epigastric discomfort and phalacrosis.

CONCLUSION:

XFC demonstrated better improvement in the scores of SDS and compared with those of LEF group.

• Authors: Jian Liu, Yuan Wang, Chuanbing Huang, Jianhua Xu, Zhijun Li, Liang Xu, Liyun He, Yue Sun, Yali Wang, Shengqian Xu, Ping Zhao, Tongjun Mao, Bin Tan, Fubing Zhu, Pingheng Zhang, Li Fang
• Journal: Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan (J Tradit Chin Med) Vol. 35 Issue 5 Pg. 487-98 (Oct 2015) ISSN: 0255-2922 [Print] China
• PMID: 26591677 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Drugs, Chinese Herbal
• xinfeng

Topics

• Adolescent
• Adult
• Aged
• Anxiety
• Arthritis, Rheumatoid (drug therapy, psychology)
• Double-Blind Method
• Drugs, Chinese Herbal (administration & dosage)
• Female
• Humans
• Male
• Middle Aged
• Quality of Life
• Treatment Outcome
• Young Adult