Chinese Herbal Formula Huayu-Qiangshen-Tongbi Decoction Compared With Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis: An Open-Label, Randomized, Controlled, Pilot Study
Background: Traditional Chinese Medicine is complementary and an alternative to modern medicine. The combination therapies of herbal products with disease-modifying anti-rheumatic drugs are gradually and widely adopted in the management of rheumatoid arthritis (RA) in China.Purpose: To evaluate the...
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Frontiers Media S.A.
2020-09-01
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| Online Access: | https://www.frontiersin.org/article/10.3389/fmed.2020.00484/full |
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| author | Jiaqi Wu Xianghong Chen Yuan Lv Kaixin Gao Zehao Liu Yue Zhao Xiumin Chen Xiumin Chen Xiumin Chen Xiaohong He Yongliang Chu Xiaodong Wu Aihua Ou Zehuai Wen Jianyong Zhang Jianhong Peng Zhisheng Huang Per-Johan Jakobsson Qingchun Huang Runyue Huang Runyue Huang Runyue Huang |
| author_facet | Jiaqi Wu Xianghong Chen Yuan Lv Kaixin Gao Zehao Liu Yue Zhao Xiumin Chen Xiumin Chen Xiumin Chen Xiaohong He Yongliang Chu Xiaodong Wu Aihua Ou Zehuai Wen Jianyong Zhang Jianhong Peng Zhisheng Huang Per-Johan Jakobsson Qingchun Huang Runyue Huang Runyue Huang Runyue Huang |
| author_sort | Jiaqi Wu |
| collection | DOAJ |
| description | Background: Traditional Chinese Medicine is complementary and an alternative to modern medicine. The combination therapies of herbal products with disease-modifying anti-rheumatic drugs are gradually and widely adopted in the management of rheumatoid arthritis (RA) in China.Purpose: To evaluate the efficacy and safety of Huayu-Qiangshen-Tongbi (HQT) decoction, a Chinese medicine formula, combined with methotrexate (MTX) in the treatment of patients with active RA, in comparison with the combination therapy of MTX with leflunomide (LEF).Methods: This pilot study was a monocenter, open-label, randomized controlled trial with two parallel arms. Ninety patients with active RA were randomly allocated to receive either HQT at a dose of 250 ml twice daily or LEF at a dose of 20 mg once daily, and all participants received MTX at a dose of 10–15 mg once weekly. The primary efficacy endpoint was the proportion of patients who achieved a 20% improvement in the American College of Rheumatology criteria (ACR20) after a 24-week treatment.Results: 84.4% (76/90) patients completed the 24-week observation. In the intention-to-treat analysis, the percentage values of patients achieving the ACR20 response criteria were 72.1% (31/43) in MTX + HQT group and 74.4% (32/43) in MTX + LEF group (p = 0.808). No significant difference was observed in other parameters, including ACR50, ACR70, clinical disease activity index good responses, European League Against Rheumatism good response, remission rate, and low disease activity rate. The results of the per-protocol analysis showed consistency with those of the intention-to-treat analysis. The mean change from baseline at week 24 for the van der Heijde modified total sharp score had no significant difference between two groups (3.59 ± 4.75 and 1.34 ± 8.67 in the MTX + HQT group and MTX + LEF group, respectively, p = 0.613). The frequency of adverse events was similar in both groups (11 cases in the MTX + HQT and 17 cases in the MTX + LEF, p > 0.05).Conclusions: In patients with active RA, treatment with the combination of HQT and MTX was associated with improvement in signs, symptoms, and physical function. With a beneficial clinical response and acceptable tolerability, HQT or other Chinese medicine formula may be a good therapeutic option in combination with MTX for RA treatment.Trial registration: Chinese Clinical Trails Registry, ChiCTR-INR-16009031, Registered on 15th August 2016, http://www.chictr.org.cn/enindex.aspx. |
| first_indexed | 2024-12-14T08:05:23Z |
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| last_indexed | 2024-12-14T08:05:23Z |
| publishDate | 2020-09-01 |
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| series | Frontiers in Medicine |
| spelling | doaj.art-718faf01e33d4a2a9ff988497696c4062022-12-21T23:10:13ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2020-09-01710.3389/fmed.2020.00484535628Chinese Herbal Formula Huayu-Qiangshen-Tongbi Decoction Compared With Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis: An Open-Label, Randomized, Controlled, Pilot StudyJiaqi Wu0Xianghong Chen1Yuan Lv2Kaixin Gao3Zehao Liu4Yue Zhao5Xiumin Chen6Xiumin Chen7Xiumin Chen8Xiaohong He9Yongliang Chu10Xiaodong Wu11Aihua Ou12Zehuai Wen13Jianyong Zhang14Jianhong Peng15Zhisheng Huang16Per-Johan Jakobsson17Qingchun Huang18Runyue Huang19Runyue Huang20Runyue Huang21The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, ChinaThe Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, ChinaSecond Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, ChinaSecond Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, ChinaRuikang Hospital Affiliated to Guangxi University of Chinese Medicine, Guangxi, ChinaThe Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, ChinaThe Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, ChinaSecond Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, ChinaGuangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, and State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, ChinaThe Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, ChinaThe Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, ChinaThe Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, ChinaThe Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, ChinaThe Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, ChinaShenzhen Hospital of Traditional Chinese Medicine, Shenzhen, ChinaDongguan Hospital of Traditional Chinese Medicine, Dongguan, ChinaGuangzhou Hospital of Integrated Traditional Chinese and Western Medicine, Huadu, ChinaRheumatology Unit, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, Stockholm, SwedenThe Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, ChinaThe Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, ChinaSecond Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, ChinaGuangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, and State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, ChinaBackground: Traditional Chinese Medicine is complementary and an alternative to modern medicine. The combination therapies of herbal products with disease-modifying anti-rheumatic drugs are gradually and widely adopted in the management of rheumatoid arthritis (RA) in China.Purpose: To evaluate the efficacy and safety of Huayu-Qiangshen-Tongbi (HQT) decoction, a Chinese medicine formula, combined with methotrexate (MTX) in the treatment of patients with active RA, in comparison with the combination therapy of MTX with leflunomide (LEF).Methods: This pilot study was a monocenter, open-label, randomized controlled trial with two parallel arms. Ninety patients with active RA were randomly allocated to receive either HQT at a dose of 250 ml twice daily or LEF at a dose of 20 mg once daily, and all participants received MTX at a dose of 10–15 mg once weekly. The primary efficacy endpoint was the proportion of patients who achieved a 20% improvement in the American College of Rheumatology criteria (ACR20) after a 24-week treatment.Results: 84.4% (76/90) patients completed the 24-week observation. In the intention-to-treat analysis, the percentage values of patients achieving the ACR20 response criteria were 72.1% (31/43) in MTX + HQT group and 74.4% (32/43) in MTX + LEF group (p = 0.808). No significant difference was observed in other parameters, including ACR50, ACR70, clinical disease activity index good responses, European League Against Rheumatism good response, remission rate, and low disease activity rate. The results of the per-protocol analysis showed consistency with those of the intention-to-treat analysis. The mean change from baseline at week 24 for the van der Heijde modified total sharp score had no significant difference between two groups (3.59 ± 4.75 and 1.34 ± 8.67 in the MTX + HQT group and MTX + LEF group, respectively, p = 0.613). The frequency of adverse events was similar in both groups (11 cases in the MTX + HQT and 17 cases in the MTX + LEF, p > 0.05).Conclusions: In patients with active RA, treatment with the combination of HQT and MTX was associated with improvement in signs, symptoms, and physical function. With a beneficial clinical response and acceptable tolerability, HQT or other Chinese medicine formula may be a good therapeutic option in combination with MTX for RA treatment.Trial registration: Chinese Clinical Trails Registry, ChiCTR-INR-16009031, Registered on 15th August 2016, http://www.chictr.org.cn/enindex.aspx.https://www.frontiersin.org/article/10.3389/fmed.2020.00484/fullcombination therapyChinese medical formulaHuayu-Qiangshen-Tongbi decoctionrandomized controlled clinical trialpilot study |
| spellingShingle | Jiaqi Wu Xianghong Chen Yuan Lv Kaixin Gao Zehao Liu Yue Zhao Xiumin Chen Xiumin Chen Xiumin Chen Xiaohong He Yongliang Chu Xiaodong Wu Aihua Ou Zehuai Wen Jianyong Zhang Jianhong Peng Zhisheng Huang Per-Johan Jakobsson Qingchun Huang Runyue Huang Runyue Huang Runyue Huang Chinese Herbal Formula Huayu-Qiangshen-Tongbi Decoction Compared With Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis: An Open-Label, Randomized, Controlled, Pilot Study Frontiers in Medicine combination therapy Chinese medical formula Huayu-Qiangshen-Tongbi decoction randomized controlled clinical trial pilot study |
| title | Chinese Herbal Formula Huayu-Qiangshen-Tongbi Decoction Compared With Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis: An Open-Label, Randomized, Controlled, Pilot Study |
| title_full | Chinese Herbal Formula Huayu-Qiangshen-Tongbi Decoction Compared With Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis: An Open-Label, Randomized, Controlled, Pilot Study |
| title_fullStr | Chinese Herbal Formula Huayu-Qiangshen-Tongbi Decoction Compared With Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis: An Open-Label, Randomized, Controlled, Pilot Study |
| title_full_unstemmed | Chinese Herbal Formula Huayu-Qiangshen-Tongbi Decoction Compared With Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis: An Open-Label, Randomized, Controlled, Pilot Study |
| title_short | Chinese Herbal Formula Huayu-Qiangshen-Tongbi Decoction Compared With Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis: An Open-Label, Randomized, Controlled, Pilot Study |
| title_sort | chinese herbal formula huayu qiangshen tongbi decoction compared with leflunomide in combination with methotrexate in patients with active rheumatoid arthritis an open label randomized controlled pilot study |
| topic | combination therapy Chinese medical formula Huayu-Qiangshen-Tongbi decoction randomized controlled clinical trial pilot study |
| url | https://www.frontiersin.org/article/10.3389/fmed.2020.00484/full |
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