Evidence map›Paper›PMID 33476415›Full record

Trial reportDigestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society2021

Efficacy and safety of oral sulfate solution for bowel preparation in Japanese patients undergoing colonoscopy: Noninferiority-based, randomized, controlled study.

Yutaka Saito, Shiro Oka, Naoto Tamai, Toyoki Kudo, Nobutoshi Kuniyoshi, Tatsuya Shirakura, Yoshio Omae, Yukihiro Hamahata, Takehiro Arai, Shinji Tanaka and 9 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03794310 (A Phase III Comparison Study of NPF-08 in Patients Who Receive Colonoscopy), which is not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 14% 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.

NCT03794310 phase3completednot on this map

A Phase III Comparison Study of NPF-08 in Patients Who Receive Colonoscopy

TypeinterventionalSponsorNihon Pharmaceutical Co., LtdRan2019 to 2019Enrolled632ConditionsPatients Who Receive ColonoscopyArmsNPF-08 (1-day treatment), NPF-08 (2-day split dose), Moviprep(1-day treatment)
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Oral sulfate solution benefits polyp and adenoma detection during colonoscopy: Meta-analysis of randomized controlled trials.Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society · 2022
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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

19 authors at 18 institutions in 1 country.

Yutaka SaitoEndoscopy Division, National Cancer Center Hospital, Tokyo, Japan.
Shiro OkaDepartment of, Gastroenterology and Metabolism, Hiroshima University Hospital, Hiroshima, Japan.ORCID https://orcid.org/0000-0002-1652-0743
Naoto TamaiDepartment of, Endoscopy, The, Tokyo, Japan.
Toyoki KudoDigestive Disease Center, Showa University Northern Yokohama Hospital, Kanagawa, Japan.
Nobutoshi KuniyoshiDepartment of Internal Medicine, Kuniyoshi Hospital, Kochi, Japan.
Tatsuya ShirakuraColoproctology Center Matsushima Hospital, Kanagawa, Japan.
Yoshio OmaeDepartment of Gastroenterology, Kawasaki Saiwai Hospital, Kanagawa, Japan.
Yukihiro HamahataDepartment of Coloproctology, Tsujinaka Hospital Kashiwanoha, Chiba, Japan.
Takehiro AraiGastroenterology Division, Tokatsu-Tsujinaka Hospital, Chiba, Japan.
Shinji TanakaDepartment of, Endoscopy, Hiroshima University Hospital, Hiroshima, Japan.
Noriya UedoDepartment of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.
Seiji ShimizuDepartments of Gastroenterology and Hepatology, Osaka General Hospital of West Japan Railway Company, Osaka, Japan.
Masakatsu FukuzawaDepartment of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.
Toshio UraokaDepartment of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine, Gunma, Japan.
Shiori IchinoseNihon Pharmaceutical Co., Ltd., Tokyo, Japan.
Haruhiko OgataCenter for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan.
Kiyonori KobayashiResearch and Development Center for New Medical Frontiers, Kitasato University School of Medicine, Kanagawa, Japan.
Shoichi SaitoDepartment of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Hisao TajiriDepartment of, Innovative Interventional Endoscopy Research, The Jikei University School of Medicine, Tokyo, Japan.
Hiroshima University Hospital · JPGunma University · JPJikei University School of Medicine · JPKawasaki Hospital · JPKeio University · JPKitasato University · JPMatsushiro Seismological Observatory · JPMiyoshi Kasei (Japan) · JPNational Cancer Center Hospital East · JPNihon Pharmaceutical University · JPOsaka City General Hospital · JPOsaka International Cancer Institute · JPShowa University Northern Yokohama Hospital · JPTaoka Hospital · JPThe Cancer Institute Hospital · JPThe Japanese Society of Gastroenterological Surgery · JPTokatsu Hospital · JPTokyo Medical University · JP

Funding

Nihon Pharmaceutical Co., Ltd
6 · The paper itself

Abstract

objectivesTo compare the efficacy and safety of oral sulfate solution administered using the same-day dose and the split-dose regimens with those of polyethylene glycol plus ascorbate solution, used for bowel preparation in Japanese patients undergoing colonoscopy.

methodsThis multicenter (n = 13), randomized, active-controlled, colonoscopist- and image evaluator-blinded, noninferiority study with parallel-group comparison recruited 632 patients from December 2018 to June 2019. Of these, 602 patients were divided into the oral sulfate solution same-day dose group (n = 200); oral sulfate solution split-dose group (n = 202); and polyethylene glycol plus ascorbate same-day dose group (n = 200). Differences in the efficacy rates between the polyethylene glycol plus ascorbate group and each oral sulfate solution group were calculated using the asymptotic method. The safety of the oral sulfate solution was evaluated, based on the occurrence of adverse events and reactions.

resultsBoth oral sulfate solution protocols were confirmed as noninferior to the polyethylene glycol plus ascorbate protocol for bowel-cleansing. The occurrence of adverse reactions was significantly lower in the oral sulfate solution same-day dose group than in the polyethylene glycol plus ascorbate group (P = 0.010). The occurrence of adverse reactions was not significantly different between the oral sulfate solution split-dose and the polyethylene glycol plus ascorbate group.

conclusionsOral sulfate solution is not only safe and efficacious but also not inferior to polyethylene glycol plus ascorbate solution (active control). It could be used for bowel preparation in Japanese patients scheduled for colonoscopy (Clinical trial registration number: NCT03794310).

Indexed as

CatharticsColonoscopyHumansJapanPolyethylene GlycolsSulfatesCatharticsPolyethylene GlycolsSulfatescolonoscopyhumanoral sulfate solutionpolyethylene glycolsulfate

Identifiers

PMID33476415
PMCPMC8596579
OpenAlexW3124294037

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.