Evidence map›Paper›PMID 30280368›Full record

Trial reportClinical rheumatology2019

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 and 14 more

Erratum issuedAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical rheumatology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 15 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 4 pooled it
0.5field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 4 syntheses or guidelines pooled it, 19 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors at 10 institutions in 1 country.

Xia LiuDepartment of Rheumatology, China-Japan Friendship Hospital, No.2, East Yinghua Road, Chaoyang District, Beijing, 100029, China.
Xiaomei LiDepartment of Rheumatology and Immunology, Anhui Provincial Hospital, Hefei, Anhui, China.
Xiangpei LiDepartment of Rheumatology and Immunology, Anhui Provincial Hospital, Hefei, Anhui, China.
Zhijun LiDepartment of Rheumatology and Immunology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Dongbao ZhaoDepartment of Rheumatology and Immunology, Changhai Hospital, Shanghai, China.
Shengyun LiuDepartment of Rheumatology and Immunology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
Miaojia ZhangDepartment of Rheumatology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
Fengxiao ZhangDepartment of Rheumatology, Hebei General Hospital, Shijiazhuang, Hebei, China.
Ping ZhuDepartment of Clinical Immunology, Xi-Jing Hospital, Xi'an, Shaanxi, China.
Jinwei ChenDivision of Rheumatoid Immunology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.
Wei WeiDepartment of Rheumatology and Immunology, Tianjin Medical University General Hospital, Tianjin, China.
Bing LinDepartment of Rheumatology, China-Japan Friendship Hospital, No.2, East Yinghua Road, Chaoyang District, Beijing, 100029, China.
Yingbo ZhouDepartment of Rheumatology and Immunology, Anhui Provincial Hospital, Hefei, Anhui, China.
Jing ChenDepartment of Rheumatology and Immunology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Yafei PangDepartment of Rheumatology and Immunology, Changhai Hospital, Shanghai, China.
Lei ZhangDepartment of Rheumatology and Immunology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
Xiaoxuan SunDepartment of Rheumatology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
Zhibo YuDepartment of Rheumatology, Hebei General Hospital, Shijiazhuang, Hebei, China.
Yun JiaDepartment of Clinical Immunology, Xi-Jing Hospital, Xi'an, Shaanxi, China.
Jia WangDivision of Rheumatoid Immunology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.
Wenwen SunDepartment of Rheumatology and Immunology, Tianjin Medical University General Hospital, Tianjin, China.
Frank ChiuBoon Pharmaceutical Research Ltd., 45 Topanga, Irvine, CA, 92602, USA.
Liping PangBoon Pharmaceutical Research Ltd., 45 Topanga, Irvine, CA, 92602, USA.
Guochun WangDepartment of Rheumatology, China-Japan Friendship Hospital, No.2, East Yinghua Road, Chaoyang District, Beijing, 100029, China. guochunwang@hotmail.com.
Anhui Provincial Hospital · CNChina-Japan Friendship Hospital · CNChanghai Hospital · CNFirst Affiliated Hospital of Bengbu Medical College · CNFirst Affiliated Hospital of Zhengzhou University · CNHebei General Hospital · CNNanjing Medical University · CNTianjin Medical University General Hospital · CNCentral South University · CNSecond Xiangya Hospital of Central South University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

PaeoniaPhytotherapyPlant RootsAdultDiarrheaDouble-Blind MethodFatigueFemaleHumansMaleMiddle AgedPain MeasurementPlant ExtractsSalivary EliminationSeverity of Illness IndexSjogren's SyndromePlant ExtractsRandomized controlled trialsSjögren’s syndromeTotal glucosides of peony

Identifiers

PMID30280368
OpenAlexW2894575019

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.