Evidence map›Paper›PMID 31749986›Full record

SynthesisRMD open2019

Efficacy and safety of topical and systemic medications: a systematic literature review informing the EULAR recommendations for the management of Sjögren's syndrome.

Pilar Brito-Zerón, Soledad Retamozo, Belchin Kostov, Chiara Baldini, Hendrika Bootsma, Salvatore De Vita, Thomas Dörner, Jacques-Eric Gottenberg, Aike A Kruize, Thomas Mandl and 7 more

Open access · goldAbstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in RMD open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 1 pooled it
5.1field-weighted citation impact, top 4% 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

46 citing papers in PubMed, 1 synthesis or guideline pooled it, 81 citations in OpenAlex.

  1. Pooled it
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  8. Article
  9. The Oral Microbial Ecosystem in Age-Related Xerostomia: A Critical Review.International journal of molecular sciences · 2024
    Review
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  16. Manifestations and management of Sjögren's disease.Arthritis research & therapy · 2024
    Review
  17. Article
  18. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 16 institutions in 9 countries.

Pilar Brito-ZerónAutoimmune Diseases Unit, Department of Medicine, Hospital CIMA-Sanitas, Barcelona, Spain.
Soledad RetamozoDepartment of Rheumatology, Instituto Modelo de Cariología Privado S.R.L, Instituto Universitario de Ciencias Biomédicas de Córdoba, Cordoba, Argentina.ORCID 0000-0003-0075-4454
Belchin KostovResearch Primary Healthcare Transversal Research Group, CAP Les Corts, CAPSBE, IDIBAPS, Barcelona, Spain.ORCID 0000-0002-2126-3892
Chiara BaldiniRheumatology Unit, Universita degli Studi di Pisa, Pisa, Italy.
Hendrika BootsmaDepartment of Rheumatology and Clinical Immunology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Salvatore De VitaClinic of Rheumatology, University Hospital Santa Maria della Misericordia, Udine, Italy.
Thomas DörnerDepartment of Medicine/Rheumatology and Clinical Immunology and DRFZ, Charité Universitätsmedizin Berlin Campus Charite Mitte, Berlin, Germany.
Jacques-Eric GottenbergDepartment of Rheumatology, Strasbourg University Hospital, National Reference Center for Rare Systemic Autoimmune Diseases, CNRS, IBMC, UPR 3572, Université de Strasbourg, Strasbourg, France.
Aike A KruizeDepartment of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
Thomas MandlDepartment of Rheumatology, Skane University Hospital Malmö, Lund University, Lund, Sweden.
Wan-Fai NgNIHR Newcastle Biomedical Research Centre, Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne, UK.
Raphaele SerorDepartment of Rheumatology, Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Paris-Sud, Le Kremlin-Bicêtre, Le Kremlin-Bicetre, France.
Athanasios G TzioufasDepartment of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Claudio VitaliVilla San Giuseppe, Istituto S. Stefano, Como, Italy.
Simon BowmanDepartment of Rheumatology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Xavier MarietteDepartment of Rheumatology, Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Paris-Sud, Le Kremlin-Bicêtre, Le Kremlin-Bicetre, France.
Manuel Ramos-CasalsLaboratory of Autoimmune Diseases Josep Font, CELLEX, IDIBAPS, Barcelona, Spain.ORCID 0000-0001-5709-6734
Université Paris-Sud · FRCentre National de la Recherche Scientifique · FRCharité - Universitätsmedizin Berlin · DEConsorci d’Atenció Primària de Salut Barcelona Esquerra · ESConsorci Institut D'Investigacions Biomediques August Pi I Sunyer · ESHospital Clínic de Barcelona · ESLund University · SENational and Kapodistrian University of Athens · GRNIHR Newcastle Biomedical Research Centre · GBOspedale San Giuseppe · ITOspedale Santa Maria della Misericordia di Udine · ITUniversidad Nacional de Córdoba · ARUniversity Hospitals Birmingham NHS Foundation Trust · GBUniversity Medical Center Groningen · NLUniversity Medical Center Utrecht · NLUniversity of Pisa · IT

Funding

Medical Research Council G0800629
6 · The paper itself

Abstract

Objective: To evaluate current evidence on the efficacy and safety of topical and systemic medications in patients with primary Sjögren syndrome (SjS) to inform European League Against Rheumatism treatment recommendations. Methods: The MEDLINE, EMBASE and Cochrane databases were searched for case-control/prospective cohort studies, randomised controlled trials (RCTs) and systematic reviews. Results: Current evidence in primary SjS patients fulfilling the 2002 criteria is based on the data from 9 RCTs, 18 prospective cohort studies and 5 case-control studies. Two Cochrane systematic literature reviews (SLRs) have reported that topical treatments for dry mouth and dry eye are safe and effective. Ocular cyclosporine A was safe and effective in two RCTs including 1039 patients with dry eye syndrome. Two Cochrane SLRs on serum tear drops and plugs showed inconsistency in possible benefits, both for symptoms and objective measures. Five RCTs reported significant improvements in oral dryness and salivary flow rates for pilocarpine and cevimeline. An RCT showed no significant placebo-differences for hydroxychloroquine 400 mg/day for the primary outcome (visual analogue scale (VAS) composite of dryness, fatigue and pain). We identified seven RCTs carried out in primary SjS patients. RCTs using infliximab, anakinra and baminercept found no placebo-differences for the primary outcomes. The two largest RCTs randomised 255 patients to receive rituximab or placebo and reported no significant results in the primary outcome (VAS composite), while prospective studies suggested efficacy in systemic disease. Conclusion: The current evidence supporting the use of the main topical therapeutic options of primary SjS is solid, while limited data from RCTs are available to guide systemic therapies.

Indexed as

Clinical Trials as TopicCombined Modality TherapyDisease ManagementHumansSjogren's SyndromeTreatment Outcomemultidisciplinary team-careSjøgren's syndrometreatment

Identifiers

PMID31749986
PMCPMC6827762
OpenAlexW2982656933

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.