Evidence map›Paper›PMID 38360684›Full record

ArticleBMC complementary medicine and therapies2024

Electroacupuncture efficacy in diabetic polyneuropathy: Study protocol for a double-blinded randomized controlled multicenter clinical trial.

María Fernanda Pérez Hernández, Alejandra Calderón Vallejo, Sergio de Jesús Aguilar Castillo, Daniel Cuauhtémoc Gómez Jiménez, Eduardo Rodríguez Guerrero, Fátima Aguilar Morales, Macedonia Guadalupe Moreno Tovar, Miguel Alfredo Zurita Muñóz, Antonio Eduardo Bautista Cortéz, Claudia Camelia Calzada Mendoza and 17 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC complementary medicine and therapies, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05521737 (Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy and Its Correlation With Nerve Conduction Changes), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
6.4field-weighted citation impact, top 4% 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.

NCT05521737 naunknown statusnot on this map

Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy and Its Correlation With Nerve Conduction Changes

TypeinterventionalSponsorInstituto Mexicano del Seguro SocialRan2021 to 2025Enrolled200ConditionsElectroacupuncture, Acupuncture, Diabetic Polyneuropathy, Diabetic Peripheral NeuropathyArmsElectroacupuncture, Sham Acupuncture
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Review
  6. Review
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

27 authors at 8 institutions in 1 country.

María Fernanda Pérez HernándezUnidad de Investigación Médica en Bioquímica, Unidad Médica de Alta Especialidad "Dr. Bernardo Sepúlveda", Centro Médico Nacional Siglo XXI, IMSS, Mexico City, 06720, Mexico.
Alejandra Calderón VallejoDepartamento de Neurología de la Unidad Médica de Alta Especialidad "Dr. Bernardo Sepúlveda", Centro Médico Nacional Siglo XXI, IMSS, Mexico City, 06720, Mexico.
Sergio de Jesús Aguilar CastilloDepartamento de Neurofisiología de la Unidad Médica de Alta Especialidad "Dr. Bernardo Sepúlveda", Centro Médico Nacional Siglo XXI, IMSS, Mexico City, 06720, Mexico.
Daniel Cuauhtémoc Gómez JiménezSección de Estudios de Posgrado e Investigación, Especialidad en Acupuntura Humana, Escuela Nacional de Medicina y Homeopatía, Instituto Politécnico Nacional, Mexico City, 07320, Mexico.
Eduardo Rodríguez GuerreroSección de Estudios de Posgrado e Investigación, Especialidad en Acupuntura Humana, Escuela Nacional de Medicina y Homeopatía, Instituto Politécnico Nacional, Mexico City, 07320, Mexico.
Fátima Aguilar MoralesUnidad de Medicina Familiar No. 41, IMSS, Mexico City, 07760, Mexico.
Macedonia Guadalupe Moreno TovarUnidad de Medicina Familiar No. 41, IMSS, Mexico City, 07760, Mexico.
Miguel Alfredo Zurita MuñózUnidad de Medicina Familiar No. 20, IMSS, Mexico City, 07760, Mexico.
Antonio Eduardo Bautista CortézUnidad de Medicina Familiar No. 44, IMSS, Mexico City, 07320, Mexico.
Claudia Camelia Calzada MendozaSección de Estudios de Posgrado e Investigación, Escuela Superior de Medicina, Instituto Politécnico Nacional, Mexico City, 11340, Mexico.
Mónica Ascención De Nova OcampoSección de Estudios de Posgrado e Investigación, Escuela Nacional de Medicina y Homeopatía del Instituto Politécnico Nacional. Maestría en Ciencias en Biomedicina Molecular, Mexico City, 07320, Mexico.
Juan Manuel Ordóñez RodríguezSección de Estudios de Posgrado e Investigación, Especialidad en Acupuntura Humana, Escuela Nacional de Medicina y Homeopatía, Instituto Politécnico Nacional, Mexico City, 07320, Mexico.
Mónica Luz Gómez EsquivelSección de Estudios de Posgrado e Investigación, Especialidad en Acupuntura Humana, Escuela Nacional de Medicina y Homeopatía, Instituto Politécnico Nacional, Mexico City, 07320, Mexico.
Alberto García MéndezUnidad de Medicina Familiar No. 41, IMSS, Mexico City, 07760, Mexico.
Octavio Flores GilCoordinación de Internado y Servicio Social, Escuela Nacional de Medicina y Homeopatía, Instituto Politécnico Nacional, Mexico City, 07320, Mexico.
Víctor Manuel Macías ZaragozaCarrera de Médico Cirujano Facultad de Estudios Superiores Zaragoza, UNAM, Mexico City, 09239, Mexico.
Gabriela Yanet Cortés MorenoSubdirección de Servicios de Salud, Petróleos Mexicanos (PEMEX), Mexico City, 11311, México.
Citlaltepetl Salinas LaraRed MEDICI. Carrera de Médico Cirujano. FES Iztacala, UNAM, Estado de México, State of Mexico, 54090, Mexico.
Germán Velázquez GarcíaRed MEDICI. Carrera de Médico Cirujano. FES Iztacala, UNAM, Estado de México, State of Mexico, 54090, Mexico.
Héctor Iván Saldivar CerónRed MEDICI. Carrera de Médico Cirujano. FES Iztacala, UNAM, Estado de México, State of Mexico, 54090, Mexico.
Lucia Monserrat Pérez NavarroDepartamento de Nefrología, Hospital General de México "Dr. Eduardo Liceaga", Mexico City, 06720, Mexico.
Laura Ávila JiménezCoordinación Auxiliar Médica de Investigación en Salud, Jefatura de Servicios de Prestaciones Médicas, Delegación Estatal Morelos, IMSS, Cuernavaca, Morelos, 62000, Mexico.
Jaime Héctor Gómez ZamudioUnidad de Investigación Médica en Bioquímica, Unidad Médica de Alta Especialidad "Dr. Bernardo Sepúlveda", Centro Médico Nacional Siglo XXI, IMSS, Mexico City, 06720, Mexico.
Margarita Díaz FloresUnidad de Investigación Médica en Bioquímica, Unidad Médica de Alta Especialidad "Dr. Bernardo Sepúlveda", Centro Médico Nacional Siglo XXI, IMSS, Mexico City, 06720, Mexico.
Miguel Cruz LópezUnidad de Investigación Médica en Bioquímica, Unidad Médica de Alta Especialidad "Dr. Bernardo Sepúlveda", Centro Médico Nacional Siglo XXI, IMSS, Mexico City, 06720, Mexico.
María Esther Ocharan HernándezSección de Estudios de Posgrado e Investigación, Escuela Superior de Medicina, Instituto Politécnico Nacional, Mexico City, 11340, Mexico.
José de Jesús Peralta RomeroUnidad de Investigación Médica en Bioquímica, Unidad Médica de Alta Especialidad "Dr. Bernardo Sepúlveda", Centro Médico Nacional Siglo XXI, IMSS, Mexico City, 06720, Mexico. drjperalta@hotmail.com.
Instituto Politécnico Nacional · MXCentro Medico Nacional Siglo XXI · MXMexican Social Security Institute · MXHospital General de México · MXInstituto Nacional de Neurología y Neurocirugía · MXInstituto Tecnológico y de Estudios Superiores de Occidente · MXPemex (Mexico) · MXUniversidad Intercultural del Estado de México · MX

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDiabetic peripheral neuropathy (DPN) is the most common complication of type 2 diabetes mellitus (T2DM); its diagnosis and treatment are based on symptomatic improvement. However, as pharmacological therapy causes multiple adverse effects, the implementation of acupunctural techniques, such as electroacupuncture (EA) has been suggested as an alternative treatment. Nonetheless, there is a lack of scientific evidence, and its mechanisms are still unclear. We present the design and methodology of a new clinical randomized trial, that investigates the effectiveness of EA for the treatment of DPN.

methodsThis study is a four-armed, randomized, controlled, multicenter clinical trial (20-week intervention period, plus 12 weeks of follow-up after concluding intervention). A total of 48 T2DM patients with clinical signs and symptoms of DPN; and electrophysiological signs in the Nerve Conduction Study (NCS); will be treated by acupuncture specialists in outpatient units in Mexico City. Patients will be randomized in a 1:1 ratio to one of the following four groups: (a) short fibre DPN with EA, (b) short fibre DPN with sham EA, (c) axonal DPN with EA and (d) axonal DPN with sham EA treatment. The intervention will consist of 32 sessions, 20 min each, per patient over two cycles of intervention of 8 weeks each and a mid-term rest period of 4 weeks. The primary outcome will be NCS parameters, and secondary outcomes will include DPN-related symptoms and pain by Michigan Neuropathy Screening Instrument (MNSI), Michigan Diabetic Neuropathy Score (MDNS), Dolour Neuropatique Score (DN-4), Semmes-Westein monofilament, Numerical Rating Scale (NRS) for pain assessment, and the 36-item Short Form Health Survey (SF-36). To measure quality of life and improve oxidative stress, the inflammatory response; and genetic expression; will be analysed at the beginning and at the end of treatment. DISCUSSION: This study will be conducted to compare the efficacy of EA versus sham EA combined with conventional diabetic and neuropathic treatments if needed. EA may improve NCS, neuropathic pain and symptoms, oxidative stress, inflammatory response, and genetic expression, and it could be considered a potential coadjutant treatment for the management of DPN with a possible remyelinating effect.

trial registrationClinicalTrials.gov. NCT05521737 Registered on 30 August 2022. International Clinical Trials Registry Platform (ICTRP) ISRCTN97391213 Registered on 26 September 2022 [2b].

Indexed as

Acupuncture TherapyDiabetes Mellitus, Type 2Diabetic NeuropathiesElectroacupunctureHumansMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicAcupunctureControlled clinical trialDiabetesDiabetic neuropathyElectroacupuncture

Identifiers

PMID38360684
PMCPMC10868023
OpenAlexW4391846483

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.