Using corneal confocal microscopy to compare Mecobalamin intramuscular injections vs oral tablets in treating diabetic peripheral neuropathy: a RCT

Abstract This randomized controlled study used corneal confocal microscopy (CCM) to compare the efficacy of Mecobalamin intramuscular injections vs oral tablets in treating mild to moderate diabetic peripheral neuropathy (DPN) by detecting early nerve fiber repair. Enrolled patients were randomized...

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Autores principales: Yuanjin Zhang, Dongsheng Fan, Yixuan Zhang, Shuo Zhang, Haikun Wang, Ziyuan Liu, Hongli Wang
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Publicado: Nature Portfolio 2021
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Acceso en línea:https://doaj.org/article/3b227810c4da4d5eae75b0994a9d0ae4
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spelling oai:doaj.org-article:3b227810c4da4d5eae75b0994a9d0ae42021-12-02T16:17:34ZUsing corneal confocal microscopy to compare Mecobalamin intramuscular injections vs oral tablets in treating diabetic peripheral neuropathy: a RCT10.1038/s41598-021-94284-42045-2322https://doaj.org/article/3b227810c4da4d5eae75b0994a9d0ae42021-07-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-94284-4https://doaj.org/toc/2045-2322Abstract This randomized controlled study used corneal confocal microscopy (CCM) to compare the efficacy of Mecobalamin intramuscular injections vs oral tablets in treating mild to moderate diabetic peripheral neuropathy (DPN) by detecting early nerve fiber repair. Enrolled patients were randomized approximately 1:1 to receive Mecobalamin intramuscular injections (0.5 mg/day, 3 times/week) or Mecobalamin oral tablets (1.5 mg/day) for 8 weeks. Primary outcome was change of inferior whorl length (IWL) from baseline. Secondary outcomes included changes of corneal nerve fibre length (CNFL), corneal nerve fibre density (CNFD), corneal nerve branch density (CNBD) and the Survey of Autonomic Symptoms (SAS). 15 (93.75%) patients in the injection group and 17 (89.47%) patients in the tablet group completed the study. The injection treatment significantly improved patients’ IWL from baseline (21.64 ± 3.00 mm/mm2 vs 17.64 ± 4.83 mm/mm2, P < 0.01) while the tablet treatment didn’t. Additionally, the injection treatment led to significantly improved CNFL, CNBD and SAS from baseline (all P < 0.05) while the tablet treatment did not. No patient experienced any adverse events. In conclusion, CCM is sensitive enough to detect the superior efficacy of 8-week Mecobalamin intramuscular injection treatment for DPN compared to the oral tablet treatment. ClinicalTrials.gov registration number: NCT04372316 (30/04/2020).Yuanjin ZhangDongsheng FanYixuan ZhangShuo ZhangHaikun WangZiyuan LiuHongli WangNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-10 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Yuanjin Zhang
Dongsheng Fan
Yixuan Zhang
Shuo Zhang
Haikun Wang
Ziyuan Liu
Hongli Wang
Using corneal confocal microscopy to compare Mecobalamin intramuscular injections vs oral tablets in treating diabetic peripheral neuropathy: a RCT
description Abstract This randomized controlled study used corneal confocal microscopy (CCM) to compare the efficacy of Mecobalamin intramuscular injections vs oral tablets in treating mild to moderate diabetic peripheral neuropathy (DPN) by detecting early nerve fiber repair. Enrolled patients were randomized approximately 1:1 to receive Mecobalamin intramuscular injections (0.5 mg/day, 3 times/week) or Mecobalamin oral tablets (1.5 mg/day) for 8 weeks. Primary outcome was change of inferior whorl length (IWL) from baseline. Secondary outcomes included changes of corneal nerve fibre length (CNFL), corneal nerve fibre density (CNFD), corneal nerve branch density (CNBD) and the Survey of Autonomic Symptoms (SAS). 15 (93.75%) patients in the injection group and 17 (89.47%) patients in the tablet group completed the study. The injection treatment significantly improved patients’ IWL from baseline (21.64 ± 3.00 mm/mm2 vs 17.64 ± 4.83 mm/mm2, P < 0.01) while the tablet treatment didn’t. Additionally, the injection treatment led to significantly improved CNFL, CNBD and SAS from baseline (all P < 0.05) while the tablet treatment did not. No patient experienced any adverse events. In conclusion, CCM is sensitive enough to detect the superior efficacy of 8-week Mecobalamin intramuscular injection treatment for DPN compared to the oral tablet treatment. ClinicalTrials.gov registration number: NCT04372316 (30/04/2020).
format article
author Yuanjin Zhang
Dongsheng Fan
Yixuan Zhang
Shuo Zhang
Haikun Wang
Ziyuan Liu
Hongli Wang
author_facet Yuanjin Zhang
Dongsheng Fan
Yixuan Zhang
Shuo Zhang
Haikun Wang
Ziyuan Liu
Hongli Wang
author_sort Yuanjin Zhang
title Using corneal confocal microscopy to compare Mecobalamin intramuscular injections vs oral tablets in treating diabetic peripheral neuropathy: a RCT
title_short Using corneal confocal microscopy to compare Mecobalamin intramuscular injections vs oral tablets in treating diabetic peripheral neuropathy: a RCT
title_full Using corneal confocal microscopy to compare Mecobalamin intramuscular injections vs oral tablets in treating diabetic peripheral neuropathy: a RCT
title_fullStr Using corneal confocal microscopy to compare Mecobalamin intramuscular injections vs oral tablets in treating diabetic peripheral neuropathy: a RCT
title_full_unstemmed Using corneal confocal microscopy to compare Mecobalamin intramuscular injections vs oral tablets in treating diabetic peripheral neuropathy: a RCT
title_sort using corneal confocal microscopy to compare mecobalamin intramuscular injections vs oral tablets in treating diabetic peripheral neuropathy: a rct
publisher Nature Portfolio
publishDate 2021
url https://doaj.org/article/3b227810c4da4d5eae75b0994a9d0ae4
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