Evidence map›Paper›PMID 31685813›Full record

Trial reportTranslational psychiatry2019

Effect of topiramate on eating behaviours in Prader-Willi syndrome: TOPRADER double-blind randomised placebo-controlled study.

Angèle Consoli, Sophie Çabal Berthoumieu, Marie Raffin, Denise Thuilleaux, Christine Poitou, Muriel Coupaye, Graziella Pinto, Said Lebbah, Noel Zahr, Maïthé Tauber and 2 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Translational psychiatry, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
4.8field-weighted citation impact, top 5% 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

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 51 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Review
  6. Review
  7. Review
  8. Clinical Trials in Prader-Willi Syndrome: A Review.International journal of molecular sciences · 2023
    Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. Hypothalamic syndrome.Nature reviews. Disease primers · 2022
    Review
  17. Review
  18. Article
  19. Review
  20. 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

12 authors at 8 institutions in 1 country.

Angèle ConsoliDépartement de Psychiatrie de l'Enfant et de l'Adolescent, AP-HP, Groupe-Hospitalier Pitié-Salpêtrière, Paris, France. angele.consoli@aphp.fr.
Sophie Çabal BerthoumieuUnité d'Endocrinologie, Obésité, Maladies Osseuses, Génétique et Gynécologie Médicale. Centre de Référence du Syndrome de Prader-Willi, Hôpital des Enfants, Toulouse, France.
Marie RaffinDépartement de Psychiatrie de l'Enfant et de l'Adolescent, AP-HP, Groupe-Hospitalier Pitié-Salpêtrière, Paris, France.
Denise ThuilleauxAssistance-Publique Hôpitaux de Paris (AP-HP), Hopital Marin de Hendaye, French Reference Center for Prader-Willi Syndrome, Hendaye, France.
Christine PoitouAssistance Publique-Hôpitaux de Paris (APHP), Pitié-Salpêtrière Hospital, French Reference Center for Prader-Willi Syndrome, Nutrition Department, CRNH Ile de France, F-75013, Paris, France.
Muriel CoupayeAssistance Publique-Hôpitaux de Paris (APHP), Pitié-Salpêtrière Hospital, French Reference Center for Prader-Willi Syndrome, Nutrition Department, CRNH Ile de France, F-75013, Paris, France.
Graziella PintoAssistance-Publique Hôpitaux de Paris (AP-HP), Necker Enfants Malades Hospital University Hospital, Pediatric Endocrinology, Diabetology and Gynecology Department, F-75015, Paris, France.
Said LebbahAssistance-Publique Hôpitaux de Paris (AP-HP), Pitié-Salpêtrière Hospital, Department of Biostatistics, F-75013, Paris, France.
Noel ZahrAssistance-Publique Hôpitaux de Paris (AP-HP), Pitié-Salpêtrière Hospital, Department of Pharmacology, F-75013, Paris, France.
Maïthé TauberUnité d'Endocrinologie, Obésité, Maladies Osseuses, Génétique et Gynécologie Médicale. Centre de Référence du Syndrome de Prader-Willi, Hôpital des Enfants, Toulouse, France.
David CohenDépartement de Psychiatrie de l'Enfant et de l'Adolescent, AP-HP, Groupe-Hospitalier Pitié-Salpêtrière, Paris, France.
Olivier BonnotService Universitaire de Psychiatrie de l'Enfant et de l'Adolescent, CHU de Nantes, Nantes, France.
Sorbonne Université · FRAssistance Publique – Hôpitaux de Paris · FRHôpital des Enfants · FRCentre Hospitalier Universitaire de Nantes · FRHôpital Marin de Hendaye · FRHôpital Necker-Enfants Malades · FRInserm · FRPitié-Salpêtrière Hospital · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Prader-Willi Syndrome (PWS) is a rare genetic syndrome leading to severe behavioural disorders and mild cognitive impairment. The objective of this double-blind randomised placebo-controlled trial was to study the efficacy and tolerance of topiramate on behavioural disorders in patients with PWS. Participants (aged 12-45 years) had genetically confirmed PWS and severe irritability/impulsivity, eating disorders and/or obesity, and skin picking. Thirty-two participants received a placebo (PBO), and 30 participants received topiramate (TOP) (50-200 mg/day) for 8 weeks. The primary outcome was the rate of responders using the Clinical Global Impression-Improvement (CGI-I) scale. The secondary outcome measures included the Aberrant Behaviour Checklist, the Dykens Hyperphagia Questionnaire (DHK), the Self-Injurious Behaviour Scale (SIBS) and the body mass index (BMI). We found no significant difference in the primary outcome (the CGI-I): 9 (30%) patients were very much or much improved in the TOP group compared to 7 (22.6%) patients in the PBO group. However, the DHK behaviour and severity scores improved significantly more over time in patients treated with topiramate versus those receiving a placebo, with a significant dose-effect relationship. DHK scores were also significantly associated with genetic subtypes and hospitalisation status. The effects of topiramate on eating behaviours remained significant after adjusting for genetic subtype and hospitalisation. Topiramate had therefore a significant effect on eating disorders, with a dose-effect relationship. Given the burden of eating disorders in PWS, we believe that topiramate may become the first psychotropic option within the global care of obesity in individuals with PWS.

Indexed as

AdolescentAdultBody Mass IndexChildDouble-Blind MethodFeeding BehaviorFemaleFranceHumansHyperphagiaLogistic ModelsMaleMiddle AgedNeuroprotective AgentsObesityPrader-Willi SyndromeNeuroprotective AgentsTopiramate

Identifiers

PMID31685813
PMCPMC6828670
OpenAlexW2989226351

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.