Evidence map›Paper›PMID 29975462›Full record

Trial reportJournal of diabetes investigation2019

Aldose reductase inhibitor ranirestat significantly improves nerve conduction velocity in diabetic polyneuropathy: A randomized double-blind placebo-controlled study in Japan.

Kenji Sekiguchi, Nobuo Kohara, Masayuki Baba, Tetsuo Komori, Yutaka Naito, Tomihiro Imai, Jo Satoh, Yasuyuki Yamaguchi, Tatsuto Hamatani, Ranirestat Group

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of diabetes investigation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 2 pooled it
2.7field-weighted citation impact, top 9% 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

32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 51 citations in OpenAlex.

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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

10 authors at 8 institutions in 1 country.

Kenji SekiguchiDivision of Neurology, Kobe University Graduate School of Medicine, Kobe, Hyogo, Japan.ORCID http://orcid.org/0000-0003-4100-7316
Nobuo KoharaDepartment of Neurology, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan.
Masayuki BabaDepartment of Neurology, Aomori Prefectural Central Hospital, Aomori, Japan.
Tetsuo KomoriDepartment of Neurology, National Hakone Hospital, Kanagawa, Japan.
Yutaka NaitoDepartment of Neurology, Japanese Red Cross Ise Hospital, Ise, Mie, Japan.
Tomihiro ImaiDepartment of Occupational Therapy, Sapporo Medical University School of Health Sciences, Sapporo, Japan.
Jo SatohTohoku Medical and Pharmaceutical University Wakabayashi Hospital, Sendai, Miyagi, Japan.
Yasuyuki YamaguchiSumitomo Dainippon Pharma Co., Ltd, Osaka, Japan.
Tatsuto HamataniSumitomo Dainippon Pharma Co., Ltd, Osaka, Japan.ORCID http://orcid.org/0000-0002-9555-6057
Ranirestat Group
Sumitomo Dainippon Pharma (Japan) · JPAomori Prefectural Central Hospital · JPHakodate National Hospital · JPIse Red Cross Hospital · JPKobe City Medical Center General Hospital · JPKobe University · JPSapporo Medical University · JPTohoku Medical and Pharmaceutical University Hospital · JP

Funding

Sumitomo Dainippon Pharma Co., Ltd
6 · The paper itself

Abstract

AIMS/

introductionDiabetic polyneuropathy is one of the most frequent diabetic complications, and impairs patients' quality of life. We evaluated the efficacy and safety of ranirestat (40 mg/day) in patients with diabetic polyneuropathy. MATERIALS AND

methodsThis was a multicenter, placebo-controlled, randomized double-blind, parallel-group, phase III study in which 557 patients were randomly assigned to either the ranirestat or placebo group and assessed for 52 weeks. The co-primary end-points were the changes in tibial motor nerve conduction velocity and total modified Toronto Clinical Neuropathy Score as a measure of clinical symptoms.

resultsThere was a significant increase in tibial motor nerve conduction velocity in the ranirestat group compared with the placebo group. The difference between groups in the change at last observation was 0.52 m/s (P = 0.021). Increases in nerve conduction velocity in the ranirestat group were found not only in the tibial motor nerves, but also in the median motor nerves, proximal median sensory nerves and distal median sensory nerves. No significant differences in modified Toronto Clinical Neuropathy Score or safety parameters were found between the two groups.

conclusionsRanirestat (40 mg/day) was well tolerated and improved nerve conduction velocity. Regarding symptoms and signs, no detectable benefits over the placebo were observed in the ranirestat group during the 52 weeks of treatment.

Indexed as

Quality of LifeAdultAgedAldehyde ReductaseDiabetic NeuropathiesDouble-Blind MethodEnzyme InhibitorsFemaleFollow-Up StudiesHumansJapanMaleMiddle AgedNeural ConductionPrognosisPyrazinesAldehyde ReductaseEnzyme InhibitorsPyrazinesranirestatSpiro CompoundsDiabetic polyneuropathyNerve conduction velocityRanirestat

Identifiers

PMID29975462
PMCPMC6400176
OpenAlexW2881565875

What OpenQuestion holds

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LicenceCC BY-NC
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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.