Trial reportJournal of Korean medical science2016
Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjögren's Syndrome: a Double-Blind Randomized Control Study.
Trial report in Journal of Korean medical science, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01601028 (Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome), which is not on this map. Cited by 33 papers, 7 of them syntheses that pooled 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.
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.
Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome
Who cites it
33 citing papers in PubMed, 7 syntheses or guidelines pooled it, 70 citations in OpenAlex.
- Clinical practice guideline for the treatment of Sjögren's disease through off-label drug use in China (English edition).Clinical rheumatology · 2026Guideline
- British Society for Rheumatology guideline on management of adult and juvenile onset Sjögren disease.Rheumatology (Oxford, England) · 2025Guideline
- Hydroxychloroquine-Chloroquine, QT-Prolongation, and Major Adverse Cardiac Events: A Meta-analysis and Scoping Review.The Annals of pharmacotherapy · 2024Pooled it
- Systematic review and meta-analysis of the safety of chloroquine and hydroxychloroquine from randomized controlled trials on malarial and non-malarial conditions.Systematic reviews · 2021Pooled it
- Safety of hydroxychloroquine in COVID-19 and other diseases: a systematic review and meta-analysis of 53 randomized trials.European journal of clinical pharmacology · 2021Pooled it
- Pooled it
- Is hydroxychloroquine effective in treating primary Sjogren's syndrome: a systematic review and meta-analysis.BMC musculoskeletal disorders · 2017Pooled it
- Treatment effectiveness of hydroxychloroquine in patients with primary Sjögren's syndrome: a real-world Study.Clinical rheumatology · 2025Article
- The Role of Hydroxychloroquine in the Management of Rheumatic Disorders: A Comprehensive Review.Basic & clinical pharmacology & toxicology · 2025Review
- Hydroxychloroquine: A double‑edged sword (Review).Molecular medicine reports · 2025Review
- Executive summary: British Society for Rheumatology guideline on management of adult and juvenile onset Sjögren disease.Rheumatology (Oxford, England) · 2025Article
- Huashi Runzao decoction for primary Sjögren disease: a double-blind, randomized controlled trial combined with m6A and m5C RNA modification analysis.Frontiers in pharmacology · 2025Article
- Amplified Type I Interferon Response in Sjögren's Disease via Ectopic Toll-Like Receptor 7 Expression in Salivary Gland Epithelial Cells Induced by Lysosome-Associated Membrane Protein 3.Arthritis & rheumatology (Hoboken, N.J.) · 2024Article
- Treatment of non-systemic Sjögren's syndrome: Potential prevention of systematization with immunosuppressant agent/biotherapy.Journal of translational autoimmunity · 2024Article
- Chloroquine and Hydroxychloroquine in the Treatment of Dry Eye Disease.Diseases (Basel, Switzerland) · 2023Review
- Role of topical and systemic immunosuppression in aqueous-deficient dry eye disease.Indian journal of ophthalmology · 2023Review
- Salivary gland LAMP3 mRNA expression is a possible predictive marker in the response to hydroxychloroquine in Sjögren's disease.PloS one · 2023Article
- The Future of Targeted Treatment of Primary Sjögren's Syndrome: A Focus on Extra-Glandular Pathology.International journal of molecular sciences · 2022Review
- Sjögren's syndrome.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2022Article
- Efficacy and Safety of Acupuncture on Symptomatic Improvement in Primary Sjögren's Syndrome: A Randomized Controlled Trial.Frontiers in medicine · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The effect of hydroxychloroquine (HCQ) on dry eye has not been fully determined. This study aimed to compare the 12-week efficacy of HCQ medication with that of a placebo in the management of dry eye in primary Sjögren's syndrome (pSS). A double-blind, randomized control study was conducted in 39 pSS subjects from May 2011 through August 2013. pSS was diagnosed based on the classification criteria of the American-European Consensus Group. Subjects received 300 mg of HCQ or placebo once daily for 12 weeks and were evaluated at baseline, 6, and 12 weeks, with a re-visit at 16 weeks after drug discontinuance. The fluorescein staining score, Schirmer test score, tear film break-up time (TBUT), and ocular surface disease index (OSDI) were measured, and tears and blood were collected for ESR, IL-6, IL-17, B-cell activating factor (BAFF), and Th17 cell analysis. Color testing was performed and the fundus was examined to monitor HCQ complications. Twenty-six subjects completed the follow-up. The fluorescein staining score and Schirmer test score did not differ significantly. The OSDI improved with medication in the HCQ group but was not significantly different between the groups. TBUT, serum IL-6, ESR, serum and tear BAFF, and the proportion of Th17 cells did not change in either group. HCQ at 300 mg daily for 12 weeks has no apparent clinical benefit for dry eye and systemic inflammation in pSS (ClinicalTrials.gov. NCT01601028).
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Registered trials
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.