Evidence map›Paper›PMID 19148734›Full record

Trial reportJournal of autism and developmental disorders2009

A double-blind, placebo-controlled trial of oral human immunoglobulin for gastrointestinal dysfunction in children with autistic disorder.

Benjamin L Handen, Raun D Melmed, Robin L Hansen, Michael G Aman, David L Burnham, Jon B Bruss, Christopher J McDougle

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of autism and developmental disorders, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 18% 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, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Delivery of Orally Administered Digestible Antibodies Using Nanoparticles.International journal of molecular sciences · 2021
    Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Complementary and alternative medicine in autism: an evidence-based approach to negotiating safe and efficacious interventions with families.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2010
    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

7 authors at 6 institutions in 2 countries.

Benjamin L HandenUniversity of Pittsburgh School of Medicine, Pittsburgh, PA 15203, USA. handenbl@upmc.edu
Raun D Melmed
Robin L Hansen
Michael G Aman
David L Burnham
Jon B Bruss
Christopher J McDougle
Indiana University School of MedicineSouthwest Autism Research & Resource Center · USThe Ohio State University Wexner Medical Center · USUniversity of California, Davis · USUniversity of International Business · KZUniversity of Pittsburgh · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Controversy exists regarding the extent and possible causal relationship between gastrointestinal symptoms and autism. A randomized, double-blind, placebo-controlled, parallel groups, dose-ranging study of oral, human immunoglobulin (IGOH 140, 420, or 840 mg/day) was utilized with 125 children (ages 2-17 years) with autism and persistent GI symptoms. Endpoint analysis revealed no significant differences across treatment groups on a modified global improvement scale (validated in irritable bowel syndrome studies), number of daily bowel movements, days of constipation, or severity of problem behaviors. IGOH was well-tolerated; there were no serious adverse events. This study demonstrates the importance of conducting rigorous trials in children with autism and casts doubt on one GI mechanism presumed to exert etiological and/or symptomatic effects in this population.

Indexed as

Administration, OralAdolescentAutistic DisorderChildChild, PreschoolConstipationDose-Response Relationship, DrugDouble-Blind MethodFemaleGastrointestinal DiseasesHumansImmunoglobulinsIrritable Bowel SyndromeMalePsychiatric Status Rating ScalesSeverity of Illness IndexImmunoglobulins

Identifiers

PMID19148734
OpenAlexW2119410570

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.