Evidence map›Paper›PMID 35672606›Full record

Trial reportEuropean archives of psychiatry and clinical neuroscience2022

Omega-3/6 supplementation for mild to moderate inattentive ADHD: a randomised, double-blind, placebo-controlled efficacy study in Italian children.

Sara Carucci, Roberta Romaniello, Giovanni Demuru, Paolo Curatolo, Clementina Grelloni, Gabriele Masi, Francesca Liboni, Alessandra Mereu, Paolo Contu, Marco Lamberti and 2 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in European archives of psychiatry and clinical neuroscience, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 3 pooled it
2.5field-weighted citation impact, top 10% 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

11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. New findings on attention/hyperactivity disorder: what is (not) known?European archives of psychiatry and clinical neuroscience · 2022
    Article
  11. 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

12 authors at 4 institutions in 1 country.

Sara CarucciDepartment of Biomedical Sciences, Section of Neuroscience and Clinical Pharmacology, University of Cagliari, Cagliari, Italy. sara.carucci@gmail.com.ORCID http://orcid.org/0000-0001-5776-5555
Roberta RomanielloDepartment of Biomedical Sciences, Section of Neuroscience and Clinical Pharmacology, University of Cagliari, Cagliari, Italy.
Giovanni DemuruDepartment of Biomedical Sciences, Section of Neuroscience and Clinical Pharmacology, University of Cagliari, Cagliari, Italy.
Paolo CuratoloChild Neurology and Psychiatry Unit, System Medicine Department, Tor Vergata University Hospital, Rome, Italy.
Clementina GrelloniChild Neurology and Psychiatry Unit, System Medicine Department, Tor Vergata University Hospital, Rome, Italy.
Gabriele MasiScientific Institute of Child Neurology and Psychiatry, IRCCS Stella Maris, Calambrone, Pisa, Italy.
Francesca LiboniScientific Institute of Child Neurology and Psychiatry, IRCCS Stella Maris, Calambrone, Pisa, Italy.
Alessandra MereuDepartment of Medical Science and Public Health, University of Cagliari, Cagliari, Italy.
Paolo ContuDepartment of Medical Science and Public Health, University of Cagliari, Cagliari, Italy.
Marco LambertiDivision of Child Neurology and Psychiatry, Department of Pediatrics, University of Messina, Messina, Italy.
Antonella GaglianoDepartment of Biomedical Sciences, Section of Neuroscience and Clinical Pharmacology, University of Cagliari, Cagliari, Italy.
Alessandro ZuddasDepartment of Biomedical Sciences, Section of Neuroscience and Clinical Pharmacology, University of Cagliari, Cagliari, Italy.
University of Cagliari · ITFondazione Stella Maris · ITUniversity of Messina · ITUniversity of Rome Tor Vergata · IT

Funding

Vifor Pharma unrestricted educational research grant
6 · The paper itself

Abstract

Recently there has been a growing interest in non-pharmacological treatments for ADHD. We evaluated the efficacy of a specific Omega-3/6 dietary supplement (two capsules containing 279 mg eicosapentaenoic acid [EPA], 87 mg Docosahexaenoic Acid [DHA], 30 mg gamma linolenic acid [GLA] each) in ameliorating inattentive symptoms in inattentive-ADHD children (6-12 years) with a baseline ADHD-RS-Inattention score ≥ 12. Secondary objectives included changes in global functioning, severity of illness, depression, and anxiety symptoms, learning disorders and in the fatty acids blood levels. The study was a randomised, double-blind, placebo-controlled efficacy and safety trial with a 6-month double-blind evaluation of Omega-3/6 vs placebo (Phase-I) and a further 6-month-open-label treatment with Omega-3/6 on all patients (Phase-II). In total 160 subjects were enrolled. No superiority of Omega-3/6 supplement to placebo was observed on the primary outcome (ADHD-RS-inattention score) after the first 6-months, with 46.3% of responders in the Omega-3/6 group and 45.6% in the placebo group; a slight (not statistically significant) reduction in Omega-6/3 ratio blood levels was measured in the active treatment group. Twelve months after enrolment, percentages of responders were similar between groups. A mild statistical, although not clinically significant, improvement was observed on the ADHD-RS-total score in the Omega-3/6 group but not on the ADHD-RS-Inattention score; a slight (not-statistically significant) reduction in Omega-6/3 ratio was observed in the group taking active treatment only during Phase II. In conclusion, no clinical beneficial effects of Omega-3/6 were detected on inattentive symptoms, suggesting a limited role of Omega-3/6 dietary products in children with mild ADHD-I.Trial registration: At the time of the Ethical submission, according to the clinical trial Italian law, registration was not mandatory for food additive as Omega 3/6 were then classified. The trial was approved by the Ethical Committee of the Cagliari University Hospital (resolution n. 662; September 22nd, 2011).

Indexed as

Attention Deficit Disorder with HyperactivityFatty Acids, Omega-3ChildDietary SupplementsDocosahexaenoic AcidsDouble-Blind MethodHumansTreatment OutcomeDocosahexaenoic AcidsFatty Acids, Omega-3ADHDChild and adolescent psychiatryFatty acidsRandomized controlled trial

Identifiers

PMID35672606
OpenAlexW4281715805

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.