Evidence map›Paper›PMID 33177798›Full record

Trial reportWorld journal of gastroenterology2020

Pediatric bowel preparation: Sodium picosulfate, magnesium oxide, citric acid

Carmen Cuffari, Steven L Ciciora, Masakazu Ando, Mena Boules, Joseph M Croffie

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in World journal of gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 38% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. The unmet needs for identifying the ideal bowel preparation.JGH open : an open access journal of gastroenterology and hepatology · 2021
    Review
  4. Bowel Preparation for Pediatric Colonoscopy.Frontiers in pediatrics · 2021
    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

5 authors at 4 institutions in 1 country.

Carmen CuffariDepartment of Pediatrics, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States. ccuffari@jhmi.edu.
Steven L CicioraDepartment of Pediatrics, The Ohio State University College of Medicine, Colombus, OH 43205, United States.
Masakazu AndoDepartment of Statistics, Ferring Pharmaceuticals Inc, Parsippany, NJ 07054, United States.
Mena BoulesDepartment of Medical Affairs, Ferring Pharmaceuticals Inc, Parsippany, NJ 07054, United States.
Joseph M CroffieDepartment of Pediatrics, Indiana University School of Medicine, Indianapolis, IN 46202, United States.
Ferring Pharmaceuticals (United States) · USIndiana University – Purdue University Indianapolis · USJohns Hopkins University · USThe Ohio State University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBowel preparation in children can be challenging.

aimTo describe the efficacy, safety, and tolerability of sodium picosulfate, magnesium oxide, and citric acid (SPMC) bowel preparation in children.

methodsPhase 3, randomized, assessor-blinded, multicenter study of low-volume, divided dose SPMC enrolled children 9-16 years undergoing elective colonoscopy. Participants 9-12 years were randomized 1:1:1 to SPMC ½ dose × 2, SPMC 1 dose × 2, or polyethylene glycol (PEG). Participants 13-16 years were randomized 1:1 to SPMC 1 dose × 2 or PEG. PEG-based bowel preparations were administered per local protocol. Primary efficacy endpoint for quality of bowel preparation was responders (rating of 'excellent' or 'good') by modified Aronchick Scale. Secondary efficacy endpoint was participant's tolerability and satisfaction from a 7-item questionnaire. Safety assessments included adverse events (AEs) and laboratory evaluations.

results78 participants were randomized, 48 were 9-12 years, 30 were 13-16 years. For the primary efficacy endpoint in 9-12 years, 50.0%, 87.5%, and 81.3% were responders for SPMC ½ dose × 2, SPMC 1 dose × 2, and PEG groups, respectively. Responder rates for 13-16 years were 81.3% for SPMC 1 dose × 2 and 85.7% for PEG. Overall, 43.8% of participants receiving SPMC 1 dose × 2 reported it was 'very easy' or 'easy' to drink, compared with 20.0% receiving PEG. Treatment-emergent AEs were reported by 45.5% of participants receiving SPMC 1 dose × 2 and 63.0% receiving PEG.

conclusionSPMC was an efficacious and safe for bowel preparation in children 9-16 years, with comparable efficacy to PEG. Tolerability for SPMC was higher compared to PEG.

Indexed as

Magnesium OxideOrganometallic CompoundsCatharticsChildCitratesCitric AcidColonoscopyHumansPicolinesPolyethylene GlycolsCatharticsCitratesCitric AcidMagnesium OxideOrganometallic CompoundsPicolinespicosulfate sodiumPolyethylene GlycolsChildrenColon cleansingColonoscopyPolyethylene glycolSodium picosulfate, magnesium oxide, and citric acid

Identifiers

PMID33177798
PMCPMC7596638
OpenAlexW3096273315

What OpenQuestion holds

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LicenceCC BY-NC
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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.