Evidence map›Paper›PMID 26345602›Full record

Trial reportJournal of diabetes research2015

Treatment with α-Lipoic Acid over 16 Weeks in Type 2 Diabetic Patients with Symptomatic Polyneuropathy Who Responded to Initial 4-Week High-Dose Loading.

Hector Garcia-Alcala, Celia Isabel Santos Vichido, Silverio Islas Macedo, Christelle Nathalie Genestier-Tamborero, Marissa Minutti-Palacios, Omara Hirales Tamez, Carlos García, Dan Ziegler

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

Trial report in Journal of diabetes research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02439879 (Treatment With Alpha-lipoic Acid Over 16 Weeks in Type 2 Diabetic Patients With Symptomatic Polyneuropathy Who Responded to Initial 4-week High-dose Loading), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
2.6field-weighted citation impact, top 12% 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.

NCT02439879 phase4completednot on this map

Treatment With Alpha-lipoic Acid Over 16 Weeks in Type 2 Diabetic Patients With Symptomatic Polyneuropathy Who Responded to Initial 4-week High-dose Loading

TypeinterventionalSponsorUniversidad Popular Autónoma del Estado de PueblaRan2009 to 2010Enrolled45ConditionsDiabetic NeuropathyArmsAlpha lipoic acid
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 44 citations in OpenAlex.

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  15. Insights on Localized and Systemic Delivery of Redox-Based Therapeutics.Oxidative medicine and cellular longevity · 2018
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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

8 authors at 3 institutions in 2 countries.

Hector Garcia-AlcalaDepartamento de Ciencias de Salud, Facultad de Medicina, Universidad Popular Autónoma del Estado de Puebla, Calle 21 Sur 1103, Barrio de Santiago, 72410 Puebla, Mexico.
Celia Isabel Santos VichidoOutpatient Diabetes Clinic PEMEX, Calle 46 Poniente 1502, Colonia Cleotilde Torres, 72050 Puebla, Mexico.
Silverio Islas MacedoHospital Universitario de Puebla, Benemerita Universidad Autonoma de Puebla, Avenida 25 Poniente 1301, Colonia Los Volcanes, 72410 Puebla, Mexico.
Christelle Nathalie Genestier-TamboreroDepartamento de Ciencias de Salud, Facultad de Medicina, Universidad Popular Autónoma del Estado de Puebla, Calle 21 Sur 1103, Barrio de Santiago, 72410 Puebla, Mexico.
Marissa Minutti-PalaciosDepartamento de Ciencias de Salud, Facultad de Medicina, Universidad Popular Autónoma del Estado de Puebla, Calle 21 Sur 1103, Barrio de Santiago, 72410 Puebla, Mexico.
Omara Hirales TamezDepartamento de Ciencias de Salud, Facultad de Medicina, Universidad Popular Autónoma del Estado de Puebla, Calle 21 Sur 1103, Barrio de Santiago, 72410 Puebla, Mexico.
Carlos GarcíaDepartamento de Ciencias de Salud, Facultad de Medicina, Universidad Popular Autónoma del Estado de Puebla, Calle 21 Sur 1103, Barrio de Santiago, 72410 Puebla, Mexico.
Dan ZieglerInstitute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University, Auf'm Hennekamp 65, 40225 Düsseldorf, Germany ; Department of Endocrinology and Diabetology, Medical Faculty, Heinrich Heine University, Moorenstraße 5, 40225 Düsseldorf, Germany.
Universidad Popular Autónoma del Estado de Puebla · MXBenemérita Universidad Autónoma de Puebla · MXDeutsches Diabetes-Zentrum e.V. · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Effective treatment of diabetic sensorimotor polyneuropathy remains a challenge. To assess the efficacy and safety of α-lipoic acid (ALA) over 20 weeks, we conducted a multicenter randomized withdrawal open-label study, in which 45 patients with type 2 diabetes and symptomatic polyneuropathy were initially treated with ALA (600 mg tid) for 4 weeks (phase 1). Subsequently, responders were randomized to receive ALA (600 mg qd; n = 16) or to ALA withdrawal (n = 17) for 16 weeks (phase 2). During phase 1, the Total Symptom Score (TSS) decreased from 8.9 ± 1.8 points to 3.46 ± 2.0 points. During phase 2, TSS improved from 3.7 ± 1.9 points to 2.5 ± 2.5 points in the ALA treated group (p < 0.05) and remained unchanged in the ALA withdrawal group. The use of analgesic rescue medication was higher in the ALA withdrawal group than ALA treated group (p < 0.05). In conclusion, in type 2 diabetic patients with symptomatic polyneuropathy who responded to initial 4-week high-dose (600 mg tid) administration of ALA, subsequent treatment with ALA (600 mg qd) over 16 weeks improved neuropathic symptoms, whereas ALA withdrawal was associated with a higher use of rescue analgesic drugs. This trial is registered with ClinicalTrials.gov Identifier: NCT02439879.

Indexed as

Administration, OralAdolescentAdultAnalgesicsAntioxidantsDiabetes Mellitus, Type 2Diabetic NeuropathiesDrug Administration ScheduleFemaleHumansMaleMiddle AgedPolyneuropathiesSymptom AssessmentThioctic AcidTreatment OutcomeAnalgesicsAntioxidantsThioctic Acid

Identifiers

PMID26345602
PMCPMC4539458
OpenAlexW1564843335

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.