Evidence map›Paper›PMID 39592167›Full record

Trial reportJournal of gastroenterology and hepatology2024

Investigation of the effects of a new transdermal formulation of systemic diclofenac on the upper gastrointestinal mucosa in patients with low back pain: A comparative study with oral diclofenac.

Hiroyuki Fukase, Seiji Futagami, Takatsugu Yamamoto, Tatsuhiro Masaoka, Takaaki Terahara, Koji Okawa, Yusuke Tanaka, Tsuyoshi Mita

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Journal of gastroenterology and hepatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Observational
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

8 authors.

Hiroyuki FukaseICR Clinical Research Hospital Tokyo, Tokyo, Japan.ORCID https://orcid.org/0000-0002-3870-5351
Seiji FutagamiDivision of Gastroenterology, Nippon Medical School, Tokyo, Japan.ORCID https://orcid.org/0000-0003-0502-8646
Takatsugu YamamotoDepartment of Medicine, Teikyo University School of Medicine, Tokyo, Japan.
Tatsuhiro MasaokaCenter for Endoscopy, Kawasaki Municipal Hospital, Kawasaki, Japan.
Takaaki TeraharaHisamitsu Pharmaceutical Co., Inc., Tokyo, Japan.
Koji OkawaHisamitsu Pharmaceutical Co., Inc., Tokyo, Japan.
Yusuke TanakaHisamitsu Pharmaceutical Co., Inc., Tokyo, Japan.
Tsuyoshi MitaHisamitsu Pharmaceutical Co., Inc., Tokyo, Japan.

Funding

Hisamitsu Pharmaceutical Co., Inc
6 · The paper itself

Abstract

BACKGROUND AND

aimNon-steroidal anti-inflammatory drugs (NSAIDs) are associated with gastrointestinal mucosal damage attributed to a topical effect of NSAIDs on the gastrointestinal mucosa after oral administration and cyclooxygenase-1 inhibition. Diclofenac sodium systemic patch (DSSP), a transdermal patch from which diclofenac sodium is absorbed through the skin to exert its effects through the circulating blood, is considered to reduce the occurrence of gastrointestinal mucosal damage compared with oral diclofenac. This study aimed to compare the effect of DSSP on the upper gastrointestinal mucosa with that of an orally administered diclofenac sodium tablet (DST).

methodsThis randomized, evaluator-blinded study included Japanese patients with low back pain (LBP). The patients were administered with either DSSP (150 mg/day) or DST (75 mg/day) for 2 weeks. The primary endpoint was the incidence of gastroduodenal ulcers and/or erosions on upper gastrointestinal endoscopy after the study treatment.

resultsThirty patients each were randomly assigned to the DSSP and DST groups. The incidence of gastroduodenal ulcers and/or erosions was 26.7% and 86.2% in the DSSP and DST groups, respectively. The difference in the incidence was -59.5% (95% confidence interval: -77.0 to -34.6). No adverse events (AEs) were observed in the DSSP group, and 20.0% (6/30 patients) reported mild AEs in the DST group (excluding ulcers and erosions).

conclusionDSSP is associated with a lower risk of gastrointestinal mucosal damage than DST, which has the same active ingredient but uses a different route of administration, in patients with LBP.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalDiclofenacLow Back PainAdministration, CutaneousAdministration, OralAdultAgedEndoscopy, GastrointestinalFemaleGastric MucosaHumansIntestinal MucosaMaleMiddle AgedPeptic UlcerTabletsAnti-Inflammatory Agents, Non-SteroidalDiclofenacTabletsdiclofenac sodium(gastrointestinal) mucosal damagelow back painnon‐steroidal anti‐inflammatory drugs (NSAIDs)patch

Identifiers

PMID39592167
PMCPMC11660207

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Registered trials

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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.