Evidence map›Paper›PMID 35441683›Full record

Trial reportRheumatology (Oxford, England)2023

The effect of silver fibre gloves on Raynaud's phenomenon in patients with systemic sclerosis: a double-blind randomized crossover trial.

Sophie I E Liem, Eva M Hoekstra, Femke Bonte-Mineur, César Magro Checa, Anne Schouffoer, Cornelia F Allaart, Tom W J Huizinga, Sytske Anne Bergstra, Jeska K de Vries-Bouwstra

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Rheumatology (Oxford, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. Review
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

9 authors.

Sophie I E LiemDepartment of Rheumatology, Leiden University Medical Center, Leiden.
Eva M HoekstraDepartment of Rheumatology, Leiden University Medical Center, Leiden.
Femke Bonte-MineurDepartment of Rheumatology and Clinical Immunology, Maasstad Ziekenhuis, Rotterdam.
César Magro ChecaDepartment of Rheumatology, Zuyderland Medical Center, Heerlen.
Anne SchouffoerDepartment of Rheumatology, Haga Ziekenhuis, The Hague, The Netherlands.
Cornelia F AllaartDepartment of Rheumatology, Leiden University Medical Center, Leiden.
Tom W J HuizingaDepartment of Rheumatology, Leiden University Medical Center, Leiden.
Sytske Anne BergstraDepartment of Rheumatology, Leiden University Medical Center, Leiden.ORCID 0000-0002-7136-5248
Jeska K de Vries-BouwstraDepartment of Rheumatology, Leiden University Medical Center, Leiden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesSilver fibre gloves transport heat from the palm to the fingers, possibly reducing the burden of RP in SSc patients. We aim to evaluate the clinical efficiency of this intervention.

methodsA multicentre, double-blind, randomized trial was performed, accounting for interindividual differences and external factors using a crossover design. Patients were randomized in two groups: group 1 wore 8% silver fibre gloves in period 1 and normal gloves in period 2 and group 2 vice versa. Each period lasted 6 weeks. The primary outcome was the Raynaud Condition Score (RCS) over time (minimal clinical important difference 1.4), assessed three times per week using an online questionnaire. Secondary outcomes included vascular complications and Scleroderma-Health Assessment Questionnaire (SHAQ). Outcomes were evaluated before unblinding using linear mixed models.

resultsA total of 85 SSc patients were included, with 76 completing the study. The mean RCS during 2 weeks before the study (i.e. without gloves) was 6.4 (s.d. 1.6). Both with silver fibre gloves and normal gloves the mean RCS decreased to 3.9 (s.d. 2.3) with a similar course over time. There was no difference in mean RCS over time between the type of gloves [β = 0.067 (95% CI -0.006, 0.19)]. Of secondary outcomes, total SHAQ [β = 0.036 (95% CI 0.026, 0.046)] was slightly higher with silver fibre gloves, which is clinically irrelevant. Three patients developed new digital ulcers with normal gloves vs one patient with silver fibre gloves [odds ratio 3.2 (95% CI 0.32, 31.1)].

conclusionsWearing gloves in SSc patients clearly decreases the RP burden. Our results do not support the hypothesis that increased heat transport of 8% silver fibre gloves is associated with less disease burden as measured in this study by the RCS compared with normal gloves. CLINICAL TRIAL REGISTRATION NUMBER: Netherlands Trial register (https://www.trialregister.nl/) NL7904.

Indexed as

Raynaud DiseaseScleroderma, LocalizedScleroderma, SystemicCross-Over StudiesHumansSilverSkin UlcerSilvercrossover trialRPsclerodermasilver fibre glovesSSc

Identifiers

PMID35441683
PMCPMC9910564

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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.