Evidence map›Paper›PMID 37513930›Full record

ArticlePharmaceuticals (Basel, Switzerland)2023

Efficacy of Pregabalin and Duloxetine in Patients with Painful Diabetic Peripheral Neuropathy (PDPN): A Multi-Centre Phase IV Clinical Trial-BLOSSOM.

Martin Rakusa, Iris Marolt, Zorica Stevic, Sandra Vuckovic Rebrina, Tatjana Milenkovic, Adam Stepien

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Pharmaceuticals (Basel, Switzerland), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04246619 (Efficacy of Pregabalin and Duloxetine in Patients With Painful Diabetic Peripheral Neuropathy), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.1field-weighted citation impact, top 24% 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.

NCT04246619 phase4terminatednot on this map

Efficacy of Pregabalin and Duloxetine in Patients With Painful Diabetic Peripheral Neuropathy (PDPN): the Effect of Pain on Cognitive Function, Sleep and Quality of Life (BLOSSOM)

TypeinterventionalSponsorKRKARan2019 to 2021Enrolled254ConditionsPainful Diabetic Peripheral NeuropathyArmsPregabalin, Duloxetine
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
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 6 institutions in 5 countries.

Martin RakusaDivision of Neurology, University Medical Centre Maribor, 2000 Maribor, Slovenia.ORCID 0000-0003-4433-3985
Iris MaroltOutpatient Diabetes Clinic, Community Health Centre Koper, 6000 Koper, Slovenia.
Zorica StevicNeuropathy Center, Neurology Clinic, Clinical Center of Serbia, 11000 Belgrade, Serbia.
Sandra Vuckovic RebrinaUniversity Clinic Vuk Vrhovac, Clinical Hospital Merkur, 10000 Zagreb, Croatia.
Tatjana MilenkovicUniversity Clinic of Endocrinology, Diabetes and Metabolic Disorders, 1000 Skopje, North Macedonia.ORCID 0000-0001-5762-9596
Adam StepienDepartment of Neurology, Military Institute of Medicine-National Institute of Science, 04-052 Warsaw, Poland.ORCID 0000-0003-0214-4940
Community Health Centre Ljubljana · SIKlinička bolnica Merkur · HRPHI University Psychiatric Clinic - Skopje · MKUniversity of Belgrade · RSUniversity of Maribor · SIWojskowy Instytut Medycyny Lotniczej · PL

Funding

Krka (Slovenia) Blossom
6 · The paper itself

Abstract

introductionOur trial (ClinicalTrials.gov Identifier: NCT04246619) evaluates the efficacy of two generic medications, pregabalin and duloxetine, for treating pain in PDPN patients.

methodsThe patients were randomised either into the pregabalin (99) or the duloxetine (102) arm. Pain was evaluated using the DN-4 questionnaire, and visual analogue scales (VASs, 0-100 mm) were used to measure the average pain intensity (API), worst pain intensity (WPI) in the last 24 h and current pain intensity (CPI).

resultsThe proportion of patients with a clinically significant improvement in the API at Week 12 was 88.3% [CI 81.7%, 94.8%] in the pregabalin arm and 86.9% [CI 76.7%, 97.1%] in the duloxetine arm. After 12 weeks, the CPI, API, and WPI decreased by -35.3 [-40.5, -30.0], -37.0 [-41.4, -32.6], and -41.6 [-46.6, -36.5] in the pregabalin arm, and by -35.0 [-39.2, -30.7], -36.9 [-41.5, -32.3], and -40.0 [-44.8, -35.2] in the duloxetine arm (all in mm, all

conclusionOur results demonstrate that pregabalin and duloxetine are effective medications for treating pain in PDPN in more than 86% of all randomised patients.

Indexed as

diabetic polyneuropathyduloxetineneuropathic painpregabalinrandomised clinical trial

Identifiers

PMID37513930
PMCPMC10386018
OpenAlexW4384825475

What OpenQuestion holds

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LicenceCC BY
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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.