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Efficacy and safety of duloxetine in painful diabetic peripheral neuropathy: a systematic review and meta-analysis of randomized controlled trials

BACKGROUND: Painful diabetic peripheral neuropathy (PDPN) is a key concern in clinical practice. In this systematic review and meta-analysis, we compared duloxetine and placebo treatments in terms of their efficacy and safety in patients with PDPN. METHODS: Following the PRISMA guidelines, we search...

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Autores principales: Wu, Chung-Sheng, Huang, Yu-Jui, Ko, Yuan-Chun, Lee, Che-Hsiung
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10031998/
https://www.ncbi.nlm.nih.gov/pubmed/36945033
http://dx.doi.org/10.1186/s13643-023-02185-6
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author Wu, Chung-Sheng
Huang, Yu-Jui
Ko, Yuan-Chun
Lee, Che-Hsiung
author_facet Wu, Chung-Sheng
Huang, Yu-Jui
Ko, Yuan-Chun
Lee, Che-Hsiung
author_sort Wu, Chung-Sheng
collection PubMed
description BACKGROUND: Painful diabetic peripheral neuropathy (PDPN) is a key concern in clinical practice. In this systematic review and meta-analysis, we compared duloxetine and placebo treatments in terms of their efficacy and safety in patients with PDPN. METHODS: Following the PRISMA guidelines, we searched the Cochrane Library, PubMed, and Embase databases for relevant English articles published before January 11, 2021. Treatment efficacy and safety were assessed in terms of pain improvement, patient-reported health-related performance, and patients’ quality of life. RESULTS: We reviewed a total of 7 randomized controlled trials. Regarding pain improvement, duloxetine was more efficacious than placebo (mean difference [MD] − 0.89; 95% confidence interval [CI] − 1.09 to − 0.69; P < .00001). Furthermore, duloxetine significantly improved the patients’ quality of life, which was assessed using the Clinical Global Impression severity subscale (MD − 0.48; 95% CI − 0.61 to − 0.36; P < .00001), Patient Global Impression of Improvement scale (MD − 0.50; 95% CI − 0.64 to − 0.37; P < .00001), and European Quality of Life Instrument 5D version (MD 0.04; 95% CI 0.02 to 0.07; P = .0002). Severe adverse events were rare, whereas nausea, somnolence, dizziness, fatigue, constipation, and decreased appetite were common; approximately, 12.6% of all patients dropped out because of the common symptoms. CONCLUSIONS: Duloxetine is more efficacious than placebo treatments in patients with PDPN. The rarity of severe adverse events indicates that duloxetine is safe. When a 60-mg dose is insufficient, 120 mg of duloxetine may improve PDPN symptoms. Our findings may help devise optimal treatment strategies for PDPN. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021225451 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13643-023-02185-6.
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spelling pubmed-100319982023-03-23 Efficacy and safety of duloxetine in painful diabetic peripheral neuropathy: a systematic review and meta-analysis of randomized controlled trials Wu, Chung-Sheng Huang, Yu-Jui Ko, Yuan-Chun Lee, Che-Hsiung Syst Rev Research BACKGROUND: Painful diabetic peripheral neuropathy (PDPN) is a key concern in clinical practice. In this systematic review and meta-analysis, we compared duloxetine and placebo treatments in terms of their efficacy and safety in patients with PDPN. METHODS: Following the PRISMA guidelines, we searched the Cochrane Library, PubMed, and Embase databases for relevant English articles published before January 11, 2021. Treatment efficacy and safety were assessed in terms of pain improvement, patient-reported health-related performance, and patients’ quality of life. RESULTS: We reviewed a total of 7 randomized controlled trials. Regarding pain improvement, duloxetine was more efficacious than placebo (mean difference [MD] − 0.89; 95% confidence interval [CI] − 1.09 to − 0.69; P < .00001). Furthermore, duloxetine significantly improved the patients’ quality of life, which was assessed using the Clinical Global Impression severity subscale (MD − 0.48; 95% CI − 0.61 to − 0.36; P < .00001), Patient Global Impression of Improvement scale (MD − 0.50; 95% CI − 0.64 to − 0.37; P < .00001), and European Quality of Life Instrument 5D version (MD 0.04; 95% CI 0.02 to 0.07; P = .0002). Severe adverse events were rare, whereas nausea, somnolence, dizziness, fatigue, constipation, and decreased appetite were common; approximately, 12.6% of all patients dropped out because of the common symptoms. CONCLUSIONS: Duloxetine is more efficacious than placebo treatments in patients with PDPN. The rarity of severe adverse events indicates that duloxetine is safe. When a 60-mg dose is insufficient, 120 mg of duloxetine may improve PDPN symptoms. Our findings may help devise optimal treatment strategies for PDPN. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021225451 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13643-023-02185-6. BioMed Central 2023-03-21 /pmc/articles/PMC10031998/ /pubmed/36945033 http://dx.doi.org/10.1186/s13643-023-02185-6 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Wu, Chung-Sheng
Huang, Yu-Jui
Ko, Yuan-Chun
Lee, Che-Hsiung
Efficacy and safety of duloxetine in painful diabetic peripheral neuropathy: a systematic review and meta-analysis of randomized controlled trials
title Efficacy and safety of duloxetine in painful diabetic peripheral neuropathy: a systematic review and meta-analysis of randomized controlled trials
title_full Efficacy and safety of duloxetine in painful diabetic peripheral neuropathy: a systematic review and meta-analysis of randomized controlled trials
title_fullStr Efficacy and safety of duloxetine in painful diabetic peripheral neuropathy: a systematic review and meta-analysis of randomized controlled trials
title_full_unstemmed Efficacy and safety of duloxetine in painful diabetic peripheral neuropathy: a systematic review and meta-analysis of randomized controlled trials
title_short Efficacy and safety of duloxetine in painful diabetic peripheral neuropathy: a systematic review and meta-analysis of randomized controlled trials
title_sort efficacy and safety of duloxetine in painful diabetic peripheral neuropathy: a systematic review and meta-analysis of randomized controlled trials
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10031998/
https://www.ncbi.nlm.nih.gov/pubmed/36945033
http://dx.doi.org/10.1186/s13643-023-02185-6
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