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The efficacy and safety of total glucosides of peony in the treatment of primary Sjögren’s syndrome: a multi-center, randomized, double-blinded, placebo-controlled clinical trial

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A Correction to this article was published on 03 December 2018

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Abstract

To evaluate the efficacy and safety of total glucosides of peony (TGP) in adults with primary Sjögren’s syndrome (pSS). A multi-center, randomized, double-blinded, placebo-controlled study was conducted between March 2012 and July 2014 at ten Chinese hospitals. In total, 320 pSS patients—classified according to the 2002 American-European Consensus Group Criteria—were randomized (2:1 ratio) to receive TGP(600 mg, tid) in the TGP group or placebo for 24 weeks in the placebo group. Study personnel, investigators, and patients were blinded to the treatment grouping. The primary endpoint was the improvement of EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) at week 24. The secondary endpoints were dry eyes/mouth/skin/nose/throat/vagina visual analogue scale (VAS), pain and discomfort VAS, fatigue VAS, mental discomfort VAS, patient global assessment (PGA), EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI), Schirmer’s test, basal/stimulated salivary flow-rate values, and erythrocyte sedimentation rate (ESR). All adverse events were recorded during the trial period. ESSPRI improved more in the TGP than the placebo group (p < 0.001). Dry eyes/throat/vagina VAS, fatigue VAS, mental discomfort VAS, PGA, Schirmer’s test, and ESR also improved more in the TGP group than in the placebo group (all p < 0.05). Stimulated salivary flow-rate values increased in the TGP group at week 12 but not at week 24. Adverse events in TGP group were 10.9%. TGP can alleviate some dryness symptoms as well as disease activity in pSS patients over 24 weeks. TGP was well tolerated by study subjects. TGP seems to be an effective and safe treatment for pSS.

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Change history

  • 03 December 2018

    The authors regret that the Fig. 1 in the original version of this article contained an error. In the left column, 211 cases in the TGP group should be followed up for 8 weeks before 12 weeks. The correct figure presented in this article.

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Author notes

  1. Xia Liu and Xiaomei Li contributed equally to this work.

Authors and Affiliations

  1. Department of Rheumatology, China-Japan Friendship Hospital, No.2, East Yinghua Road, Chaoyang District, Beijing, 100029, China

    Xia Liu, Bing Lin & Guochun Wang

  2. Department of Rheumatology and Immunology, Anhui Provincial Hospital, Hefei, Anhui, China

    Xiaomei Li, Xiangpei Li & Yingbo Zhou

  3. Department of Rheumatology and Immunology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China

    Zhijun Li & Jing Chen

  4. Department of Rheumatology and Immunology, Changhai Hospital, Shanghai, China

    Dongbao Zhao & Yafei Pang

  5. Department of Rheumatology and Immunology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China

    Shengyun Liu & Lei Zhang

  6. Department of Rheumatology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

    Miaojia Zhang & Xiaoxuan Sun

  7. Department of Rheumatology, Hebei General Hospital, Shijiazhuang, Hebei, China

    Fengxiao Zhang & Zhibo Yu

  8. Department of Clinical Immunology, Xi-Jing Hospital, Xi’an, Shaanxi, China

    Ping Zhu & Yun Jia

  9. Division of Rheumatoid Immunology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China

    Jinwei Chen & Jia Wang

  10. Department of Rheumatology and Immunology, Tianjin Medical University General Hospital, Tianjin, China

    Wei Wei & Wenwen Sun

  11. Boon Pharmaceutical Research Ltd., 45 Topanga, Irvine, CA, 92602, USA

    Frank Chiu & Liping Pang

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  1. Xia Liu
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Correspondence to Guochun Wang.

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Supplementary Figure 1

Difference from baseline in dry skin VAS, dry nose VAS, dry throat VAS, dry vagina VAS, pain discomfort VAS, mental discomfort VAS at weeks 4, 8, 12, 18, and 24. p < 0.01 is considered significant after Bonferroni adjustment between TGP and placebo groups (PNG 207 kb)

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Liu, X., Li, X., Li, X. et al. The efficacy and safety of total glucosides of peony in the treatment of primary Sjögren’s syndrome: a multi-center, randomized, double-blinded, placebo-controlled clinical trial. Clin Rheumatol 38, 657–664 (2019). https://doi.org/10.1007/s10067-018-4315-8

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