Comparison of combination therapy with methotrexate and sinomenine or leflunomide for active rheumatoid arthritis: A randomized controlled clinical trial

Huang, Run‐Yue; Pan, Hudan; Wu, Jiaqi; Zhou, Hua; Li, Zhanguo; Qiu, Ping; Zhou, Yingyan; Chen, Xiumin; Xie, Zhi-xin; Xiao, Yao; Huang, Qingchun; Liu, Liang

doi:10.1016/j.phymed.2018.12.030

Cited by 58 publications

(35 citation statements)

References 31 publications

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“…They evaluated, through a series of cases, 65 patients with established RA and MTX failure to which LEF was added. After 24 weeks, they reported that 71.6% of patients reached the target [15]. In the same way and with the same objective, John Londono et al Published another series of similar cases that included 88 patients and obtained an ACR20 improvement in 76% of the cases [14].…”

Section: Discussionmentioning

confidence: 87%

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Metothrexate Plus Leflunomide Step-Up Therapy in Early Rheumatoid Arthritis Patients with Non-Response to Initial Methotrexate Monotherapy

Carlevaris¹,

Citera²,

Pellet³

et al. 2019

Rheumatology

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Methods: We included a cohort of patients with diagnosis of early RA of less than 2 years of disease duration who not respond to MTX monotherapy, according to medical judgment, and added step-up combination with LEF. Data were collected every 3 months, including sociodemographic characteristics, functional status, disease activity and treatment. The primary outcome was the time to remission with the combined therapy, defined according to disease activity index of 28 joints (DAS28). Combination treatment failure was defined as not achieving remission. Time of outcome was assessed from date of the start of MTX plus LEF combination to date of remission or last follow-up. The Kaplan-Meier product limit method was used to estimate the probability of each outcome. Results: A total of 106 patients were included. The median disease duration was 4 (IQR 2-8) months. Median followup was 34 ± 18 months (300 patients-year). Mean age was 50 ± 12 years and 83% were female. At the time of LEF addition, 95 (90%) of patients were not in remission. During follow-up, 47 (50%) achieved clinical remission at a median time of 8 months. The rest of the patients failed to achieve remission. The overall probability of remission per patients-months of follow-up was 0.49. Twenty seven out of 47 patients (58%) were still in remission at the last follow up visit (median follow-up after first remission=19 months).

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Section: Discussionmentioning

confidence: 87%

“…Methotrexate (MTX) should always be considered the first therapeutic option in patients who do not have contraindications for its administration. Multiple studies have shown that approximately 50% of patients who start MTX achieve control of the disease [2,[14][15][16][17].…”

Section: Introductionmentioning

confidence: 99%

Metothrexate Plus Leflunomide Step-Up Therapy in Early Rheumatoid Arthritis Patients with Non-Response to Initial Methotrexate Monotherapy

Carlevaris¹,

Citera²,

Pellet³

et al. 2019

Rheumatology

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“…After exclusion of duplicates, 221 studies were screened. rough further evaluation, 20 studies (Wu et al [31]; Lu et al [32]; Zhao and Liu [33]; Liu et al [34]; Li et al [35]; Lin et al [36]; Zhao and Wang [37]; Huang et al [38]; Yu and Yu [39]; Wang et al [40]; Chen et al [41]; Wang and Tao [42]; Qian et al [43]; Jiang et al [44]; Zhang et al [45]; Wang [46]; Chen [47]; Du et al [48]; Yang et al [49]; and Huang et al [50]) met the predefined inclusion criteria and were included in this metaanalysis.…”

Section: Study Search and Selectionmentioning

confidence: 99%

“…For most of the items in the included trials, the risks of bias were low or unclear. All the studies included were described as RCTs; among them, 13 studies [32,34,35,37,40,[42][43][44][45][46][48][49][50] adequately represented the random methods. Allocation concealment and blinding methods were poorly reported.…”

Section: Description Of the Studiesmentioning

confidence: 99%

Efficacy and Safety of Integrated Traditional Chinese Medicine and Western Medicine on the Treatment of Rheumatoid Arthritis: A Meta‐Analysis

Xing

et al. 2020

Evidence-Based Complementary and Alternative Medicine

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Objective. Integrated therapy of traditional Chinese medicine (TCM) and Western medicine (WM) has gradually been applied to the treatment of rheumatoid arthritis (RA). Recently published studies have provided a wealth of data and information about the effectiveness of combination treatments, but high-quality evidence-based meta-analysis on this issue is not available yet. This study was conducted to compare and evaluate the efficacy and safety of the integrated therapy for RA. Methods. PubMed, EMBASE, and the Cochrane Library were searched up to January 2020. Randomized controlled trials (RCTs) that compared the efficacy and safety of integrative TCM-WM with WM alone for RA were included. The outcome measures contained therapeutic effects (TEs), tender joint count (TJC), swollen joint count (SJC), duration of morning stiffness (DMS), grip strength (GS), disease activity score in 28 joints (DAS28), rheumatoid factor (RF), anti-cyclic peptide containing citrulline (anti-CCP), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and adverse events (AEs) to assess the efficacy and safety of different treatments. Results. A total of 20 RCTs with 2269 patients met the inclusion criteria. TCM used in these studies included Chinese herbal decoctions and tablets or capsules made from herbs and their extracts, while WM included disease-modifying antirheumatic drugs (DMARDs), nonsteroidal anti-inflammatory drugs (NSAIDs), and glucocorticoids (GC). Compared with patients receiving WM treatment alone, patients with integrative TCM-WM treatment showed better TEs (OR = 3.03, 95% CI [2.36, 3.88]). The integrative treatment group showed reductions in TJC (MD = −1.17, 95% CI [−2.12, −0.21]), SJC (MD = −0.87, 95% CI [−1.85, 0.10]), DMS (SMD = −0.69, 95% CI [−0.98, −0.41]), DAS28 (MD = −0.43, 95% CI [−0.57, −0.29]), RF (SMD = −0.59, 95% CI [−0.91, −0.27]), anti-CCP (SMD = −0.21, 95% CI [−0.36, −0.06]), ESR (MD = −8.36, 95% CI [−12.60, −4.12]), and CRP (MD = −6.73, 95% CI [−9.38, −4.08]), and increment in GS (SMD = 0.12, 95% CI [−0.63, 0.87]). AEs, especially gastrointestinal disorders, abnormal liver function, leukopenia, skin allergies and rashes, headaches and dizziness, and alopecia, significantly decreased (OR = 0.37, 95% CI [0.29, 0.47]) in the integrative treatment group. Conclusions. The findings of this meta-analysis indicate that integrative TCM-WM could obtain effective and safe results in the treatment of RA. Using TCM as an adjunctive therapy in RA has great prospects for further development.

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“…Although insightful, results of these studies warrant further validation in the clinical settings. On the other hand, while a few RCTs have been conducted to assess the efficacy of TCMs in RA [23], a comprehensive understanding of MoA for TCMs by directly measuring the metabolic perturbation and immune response of patients has been lacking. Metabolomics emerge as a useful tool to provide novel insights into the therapeutic effects and underlying mechanisms of multi-biochemical component medicines.…”

Section: Introductionmentioning

confidence: 99%

Traditional Chinese medicine Biqi capsule compared with leflunomide in combination with methotrexate in patients with rheumatoid arthritis: a randomized controlled trial

Wang

et al. 2020

Chin Med

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Background: Biqi 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. Methods: We 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. Results: Overall, 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. Conclusions: Our 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. chict r.org.cn/showp rojen .aspx?proj=15034

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Comparison of combination therapy with methotrexate and sinomenine or leflunomide for active rheumatoid arthritis: A randomized controlled clinical trial

Cited by 58 publications

References 31 publications

Metothrexate Plus Leflunomide Step-Up Therapy in Early Rheumatoid Arthritis Patients with Non-Response to Initial Methotrexate Monotherapy

Metothrexate Plus Leflunomide Step-Up Therapy in Early Rheumatoid Arthritis Patients with Non-Response to Initial Methotrexate Monotherapy

Efficacy and Safety of Integrated Traditional Chinese Medicine and Western Medicine on the Treatment of Rheumatoid Arthritis: A Meta‐Analysis

Traditional Chinese medicine Biqi capsule compared with leflunomide in combination with methotrexate in patients with rheumatoid arthritis: a randomized controlled trial

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