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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

  • Xia Liu
  • Xiaomei Li
  • Xiangpei Li
  • Zhijun Li
  • Dongbao Zhao
  • Shengyun Liu
  • Miaojia Zhang
  • Fengxiao Zhang
  • Ping Zhu
  • Jinwei Chen
  • Wei Wei
  • Bing Lin
  • Yingbo Zhou
  • Jing Chen
  • Yafei Pang
  • Lei Zhang
  • Xiaoxuan Sun
  • Zhibo Yu
  • Yun Jia
  • Jia Wang
  • Wenwen Sun
  • Frank Chiu
  • Liping Pang
  • Guochun Wang
Original Article

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.

Keywords

Randomized controlled trials Sjögren’s syndrome Total glucosides of peony 

Notes

Acknowledgments

None.

Source(s) of support

None.

Compliance with ethical standards

Conflict of interests

All authors declare that they have no conflicts of interest.

Supplementary material

10067_2018_4315_Fig5_ESM.png (207 kb)
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)

10067_2018_4315_MOESM1_ESM.tif (943 kb)
High resolution image (TIF 942 kb)

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Copyright information

© International League of Associations for Rheumatology (ILAR) 2018

Authors and Affiliations

  • Xia Liu
    • 1
  • Xiaomei Li
    • 2
  • Xiangpei Li
    • 2
  • Zhijun Li
    • 3
  • Dongbao Zhao
    • 4
  • Shengyun Liu
    • 5
  • Miaojia Zhang
    • 6
  • Fengxiao Zhang
    • 7
  • Ping Zhu
    • 8
  • Jinwei Chen
    • 9
  • Wei Wei
    • 10
  • Bing Lin
    • 1
  • Yingbo Zhou
    • 2
  • Jing Chen
    • 3
  • Yafei Pang
    • 4
  • Lei Zhang
    • 5
  • Xiaoxuan Sun
    • 6
  • Zhibo Yu
    • 7
  • Yun Jia
    • 8
  • Jia Wang
    • 9
  • Wenwen Sun
    • 10
  • Frank Chiu
    • 11
  • Liping Pang
    • 11
  • Guochun Wang
    • 1
  1. 1.Department of RheumatologyChina-Japan Friendship HospitalBeijingChina
  2. 2.Department of Rheumatology and ImmunologyAnhui Provincial HospitalHefeiChina
  3. 3.Department of Rheumatology and ImmunologyThe First Affiliated Hospital of Bengbu Medical CollegeBengbuChina
  4. 4.Department of Rheumatology and ImmunologyChanghai HospitalShanghaiChina
  5. 5.Department of Rheumatology and ImmunologyThe First Affiliated Hospital of Zhengzhou UniversityZhengzhouChina
  6. 6.Department of RheumatologyThe First Affiliated Hospital of Nanjing Medical UniversityNanjingChina
  7. 7.Department of RheumatologyHebei General HospitalShijiazhuangChina
  8. 8.Department of Clinical ImmunologyXi-Jing HospitalXi’anChina
  9. 9.Division of Rheumatoid ImmunologyThe Second Xiangya Hospital of Central South UniversityChangshaChina
  10. 10.Department of Rheumatology and ImmunologyTianjin Medical University General HospitalTianjinChina
  11. 11.Boon Pharmaceutical Research Ltd.IrvineUSA

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