Evidence map›Paper›PMID 31138170›Full record

Trial reportBMC pediatrics2019

Minoxidil versus placebo in the treatment of arterial wall hypertrophy in children with Williams Beuren Syndrome: a randomized controlled trial.

Behrouz Kassai, Philippe Bouyé, Brigitte Gilbert-Dussardier, François Godart, Jean-Benoit Thambo, Massimiliano Rossi, Pierre Cochat, Pierre Chirossel, Stephane Luong, André Serusclat and 11 more

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pediatrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00876200 (The Efficacy of Minoxidil in Children With Williams-Beuren Syndrome), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.9field-weighted citation impact, top 27% 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.

NCT00876200 phase2completednot on this map

The Efficacy of Minoxidil in Children With Williams-Beuren Syndrome: a Randomized Clinical Trial.

TypeinterventionalSponsorHospices Civils de LyonRan2009 to 2015Enrolled21ConditionsWilliams Beuren SyndromeArmsMinoxidil, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Williams syndrome.Nature reviews. Disease primers · 2021
    Review
  7. Review
  8. Elastic fibers in orthopedics: Form and function in tendons and ligaments, clinical implications, and future directions.Journal of orthopaedic research : official publication of the Orthopaedic Research Society · 2020
    Review
  9. Article
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

21 authors at 7 institutions in 1 country.

Behrouz KassaiHospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Service de Pharmacotoxicologie, CHU-Lyon, F-69677, Bron, France. behrouz.kassai-koupai@chu-lyon.fr.ORCID 0000-0002-1712-120X
Philippe BouyéCHU d'Angers, department of Vascular Studies, Centre de Recherche Clinique Angers, Angers, France.
Brigitte Gilbert-DussardierCHU de Poitiers, la Milétrie Service de génétique médicale, F-86021, Poitiers, France.
François GodartCHRU de Lille, université Lille 2, EA 2693, service de cardiologie infantile et congénitale, Nord de France, hôpital cardiologique, F-59000, Lille, France.
Jean-Benoit ThamboCHU de Bordeaux, université de Bordeaux, service des cardiopathies congénitales, hôpital cardiologique du Haut-Lévêque, Inserm U-1045, LIRYC, institut de rythmologie et modélisation cardiaque, Bordeaux, France.
Massimiliano RossiHospices Civils de Lyon, Service de génétique médicale, INSERM U1028, CNRS UMR5292, Centre de Recherche en Neurosciences de Lyon, GENDEV Team, F-69500, Bron, France.
Pierre CochatHospices Civils de Lyon, Service de Néphrologie Pédiatrique, et centre de référence maladies rénales rares- Néphrogones, Filière ORKiD, -69500, Bron, France.
Pierre ChirosselHospices Civils de Lyon, Service d'exploration fonctionnelle vasculaire, hôpital Louis Pradel, F-69500, Bron, France.
Stephane LuongHospices Civils de Lyon, Service d'exploration fonctionnelle vasculaire, hôpital Louis Pradel, F-69500, Bron, France.
André SerusclatHospices Civils de Lyon, Service d'exploration fonctionnelle vasculaire, hôpital Louis Pradel, F-69500, Bron, France.
Isabelle CanterinoHospices Civils de Lyon, Service de Radiologie F-69500, Bron, France.
Catherine MercierUniversité de Lyon, F-69000, Lyon, France ; Université Lyon 1, CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, F-69622, Villeurbanne, France.
Muriel RabilloudUniversité de Lyon, F-69000, Lyon, France ; Université Lyon 1, CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, F-69622, Villeurbanne, France.
Christine PivotHospices Civils de Lyon, Pharmacie à Usage Intérieur, plateforme Fripharm, F-69437, Lyon, France.
Fabrice PirotUniversité de Lyon, F-69000, Lyon, France ; Université Lyon 1, CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, F-69622, Villeurbanne, France.
Tiphanie GinhouxHospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Service de Pharmacotoxicologie, CHU-Lyon, F-69677, Bron, France.
Stéphanie CoopmanLille University Hospital, Centre d'Investigation Clinique, CIC-1403-Inserm-CH&U, F-59000, Lille, France.
Guillaume GrenetUniversité de Lyon, F-69000, Lyon, France ; Université Lyon 1, CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, F-69622, Villeurbanne, France.
François GueyffierUniversité de Lyon, F-69000, Lyon, France ; Université Lyon 1, CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, F-69622, Villeurbanne, France.
Sylvie Di-FillippoHospices Civils de Lyon, Service de cardiologie pédiatrique, F-69500, Bron, France.
Aurélia Bertholet-ThomasHospices Civils de Lyon, Service de Néphrologie Pédiatrique, et centre de référence maladies rénales rares- Néphrogones, Filière ORKiD, -69500, Bron, France.
Hospices Civils de Lyon · FRUniversité Claude Bernard Lyon 1 · FRInserm · FRCentre Hospitalier Universitaire d'Angers · FRCentre Hospitalier Universitaire de Lille · FRCentre Hospitalier Universitaire de Poitiers · FRCentre National de la Recherche Scientifique · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInsufficient elastin synthesis leads to vascular complications and arterial hypertension in children with Williams-Beuren syndrome. Restoring sufficient quantity of elastin should then result in prevention or inhibition of vascular malformations and improvement in arterial blood pressure.

methodsThe aim of this study was to assess the efficacy and safety of minoxidil on Intima Media Thickness (IMT) on the right common carotid artery after twelve-month treatment in patient with Williams-Beuren syndrome. We performed a randomized placebo controlled double blind trial. All participants were treated for 12 months and followed for 18 months. The principal outcome was assessed by an independent adjudication committee blinded to the allocated treatment groups.

resultsThe principal outcome was available for 9 patients in the placebo group and 8 patients in the minoxidil group. After 12-month treatment, the IMT in the minoxidil group increased by 0.03 mm (95% CI -0.002, 0.06) compared with 0.01 mm (95%CI - 0.02, 0.04 mm) in the placebo group (p = 0.4). Two serious adverse events unrelated to the treatment occurred, one in the minoxidil and 1 in the placebo group. After 18 months, the IMT increased by 0.07 mm (95% CI 0.04, 0.10 mm) in the minoxidil compared with 0.01 mm (95% CI -0.02, 0.04 mm) in the placebo group (p = 0.008).

conclusionOur results suggest a slight increase after 12 and 18-month follow-up in IMT. More understanding of the biological changes induced by minoxidil should better explain its potential role on elastogenesis in Williams-Beuren syndrome. TRIALS REGISTRATION: US National Institutes of Health Clinical Trial Register (NCT00876200). Registered 3 April 2009 (retrospectively registered).

Indexed as

AdolescentCarotid Artery, CommonCarotid Intima-Media ThicknessChildDouble-Blind MethodElastinFemaleHumansHypertensionHypertrophyMaleMinoxidilPlacebosVasodilator AgentsWilliams SyndromeElastinMinoxidilPlacebosVasodilator AgentsChildrenRandomized Controlled TrialsRare Disease

Identifiers

PMID31138170
PMCPMC6537216
OpenAlexW2946945375

What OpenQuestion holds

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LicenceCC BY
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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.