Abstract
BackgroundBiqi capsule is a traditional Chinese medicine widely used as a complementary and alternative treatment for rheumatoid arthritis (RA). The objective is to understand the efficacy, safety and mechanism of Biqi combined with methotrexate (MTX) in RA.MethodsWe present a randomized, controlled pilot trial on Biqi combined with MTX against patients with active RA. Seventy patients were randomized 1:1 to receive Biqi + MTX or Leflunomide (LEF) + MTX for 24 weeks, and were assessed at baseline, 4, 12 and 24 weeks. Serum and urine samples were collected for metabolomics.ResultsOverall, 81.2% patients in Biqi group achieved ACR20 at 24 weeks. No statistically significant differences were observed in primary or secondary outcomes between the two groups. A better safety profile was observed for Biqi with significantly fewer adverse effects reported (11.4%) compared to LEF group (40%, P < 0.05). Comparison between treatment responders and non-responders indicated a unique urine metabolic profile of enriched fatty acids and decreased acylcarnitines associated with Biqi responders, indicating a restored energy homeostasis in response to Biqi. The gene targets of these metabolites were significantly enriched in interleukin-4 and interleukin-13 pathways, implying that Biqi could ameliorate Th2-derived inflammatory response. Multivariate network analysis indicated that patient morning stiffness and SJC were key factors associated with metabolomics in Biqi-treated patients, whereas CRP was the main factor in LEF group. Therefore, Biqi and LEF likely work by influencing different patient clinical parameters.ConclusionsOur study suggests that Biqi capsule can be a promising alternative option in combination with MTX for RA treatment, and demonstrates the capability of using metabolomics to interrogate mechanism of action for traditional Chinese medicine.Trial registration This trial is registered with ChiCTR, No. ChiCTR-IPR-16009029. Registered August 15, 2016. http://www.chictr.org.cn/showprojen.aspx?proj=15034
Highlights
Biqi capsule is a traditional Chinese medicine widely used as a complementary and alternative treatment for rheumatoid arthritis (RA)
Comparable clinical efficacy for Biqi and LEF treatment groups Overall similar clinical efficacy was observed for the two treatment arms. 81.2% of patients in Biqi group and 81.5% of patients in LEF group achieved ACR20 response as the primary outcome at 24 weeks (Fig. 3a)
The ACR20, ACR50 and ACR70 rates were comparable between two groups during 4 and 12 weeks, except for a notable higher ACR50 rate for Biqi compared to LEF group at 12 weeks (51.5% versus 35.4%, P = 0.17)
Summary
Biqi capsule is a traditional Chinese medicine widely used as a complementary and alternative treatment for rheumatoid arthritis (RA). Leflunomide (LEF) is another DMARD with different mode of action from MTX [7] It was considered as one of the fundamental therapeutics for RA by the European League Against Rheumatism (EULAR) in 2010 [3]. The combination of LEF and MTX (MTX + LEF) has been widely applied for treatment of refractory RA [8]. While it shows improved efficacy, there are increasing risks of hepatotoxicity, bone marrow suppression, tuberculosis and infection [9,10,11,12], which has led an increasing number of RA patients to seek complementary and integrative medicine [13]
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