Evidence map›Paper›PMID 31205487›Full record

ArticleTherapeutic advances in gastroenterology2019

Efficacy and safety of a ready-to-drink bowel preparation for colonoscopy: a randomized, controlled, non-inferiority trial.

Lawrence Hookey, Gerald Bertiger, Kenneth Lee Johnson, Julia Ayala, Yodit Seifu, Stuart P Brogadir

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Therapeutic advances in gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03017235 (A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution Versus Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Powder for Oral Solution), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 25% 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.

NCT03017235 phase3completednot on this map

A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution Versus Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Powder for Oral Solution (PREPOPIK®) for Colon Cleansing in Preparation for Colonoscopy

TypeinterventionalSponsorFerring PharmaceuticalsRan2017 to 2017Enrolled917ConditionsBowel PreparationArmsSodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution, Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Efficacy of ultra-low volume (≤1 L) bowel preparation fluids: Systematic review and meta-analysis.Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society · 2022
    Pooled it
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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

6 authors at 5 institutions in 2 countries.

Lawrence HookeyDepartment of Medicine, Queen's University, Kingston, ON, Canada.
Gerald BertigerHillmont GI, 1811 Bethlehem Pike, Bldg C-300, Flourtown, PA 19031, USA.
Kenneth Lee JohnsonVidant Medical Group, Kinston, NC, USA.
Julia AyalaFerring Pharmaceuticals Inc., Parsippany, NJ, USA.
Yodit SeifuFerring Pharmaceuticals Inc., Parsippany, NJ, USA Merck & Co., Inc., Kenilworth, NJ.
Stuart P BrogadirFerring Pharmaceuticals Inc., Parsippany, NJ, USA Hackensack University Medical Center, Hackensack, NJ, USA.
Ferring Pharmaceuticals (United States) · USHackensack University Medical Center · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USQueen's University · CAVidant Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe performed a randomized, controlled, assessor-blinded, multicenter, non-inferiority (NI) study to compare the safety and efficacy of a ready-to-drink formulation of sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) with a powder formulation (P/MC powder) for oral solution.

methodsEligible participants (adults undergoing elective colonoscopy) were randomized 1:1 to split-dose SPMC oral solution or P/MC powder. The primary efficacy endpoint assessed overall colon-cleansing quality with the Aronchick Scale (AS), and the key secondary efficacy endpoint rated quality of right colon cleansing with the Boston Bowel Preparation Scale (BBPS). Assessments were performed by a treatment-blinded endoscopist. Tolerability was assessed using the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events and laboratory evaluations.

resultsThe study included 901 participants: 448 for SPMC oral solution; 453 for P/MC powder. SPMC oral solution demonstrated non-inferiority to P/MC powder {87.7% (393/448) responders

conclusionsReady-to-drink SPMC oral solution showed superior efficacy of overall colon cleansing compared with P/MC powder, with similar safety and tolerability.[ClinicalTrials.gov identifier: NCT03017235.].

Indexed as

bowel preparationcolon cleansinginadequate bowel preparationoral solutionscreening colonoscopy

Identifiers

PMID31205487
PMCPMC6535705
OpenAlexW2946059666

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.