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Placebo administration for dry eye disease: a level I evidence based systematic review and meta-analysis
BACKGROUND: The efficacy of various common treatment options for dry eye disease (DED) has been investigated against placebo. However, the potential beneficial effect of placebo in the management of DED is still unclear. AIM: This meta-analysis investigated the impact of placebo administration in DE...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9618542/ https://www.ncbi.nlm.nih.gov/pubmed/35939178 http://dx.doi.org/10.1007/s11096-022-01439-y |
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author | Prinz, Julia Maffulli, Nicola Fuest, Matthias Walter, Peter Hildebrand, Frank Migliorini, Filippo |
author_facet | Prinz, Julia Maffulli, Nicola Fuest, Matthias Walter, Peter Hildebrand, Frank Migliorini, Filippo |
author_sort | Prinz, Julia |
collection | PubMed |
description | BACKGROUND: The efficacy of various common treatment options for dry eye disease (DED) has been investigated against placebo. However, the potential beneficial effect of placebo in the management of DED is still unclear. AIM: This meta-analysis investigated the impact of placebo administration in DED in Ocular Surface Disease Index (OSDI), Schirmer I test (SIT), tear breakup time (TBUT), corneal staining, and complications. METHOD: This meta-analysis and systematic review was conducted according to the 2020 PRISMA guidelines. In March 2022, Pubmed, Web of Science, Google Scholar, and Embase were accessed. All the randomised clinical trials which investigated any active treatment against a placebo control group were considered. The following data were extracted at baseline and at last follow-up: Ocular Surface Disease Index (OSDI), tear breakup time test (TBUT), Schirmer I test (SIT), corneal staining. RESULTS: Data from 56 studies (12,205 patients) were retrieved. Placebo administration is not effective in improving TBUT (P = 0.3), OSDI (P = 0.2), SIT (P = 0.1) and corneal staining (P = 0.1) from baseline to last follow-up. Active treatment led to a higher TBUT and SIT compared to placebo administration (P < 0.0001). The active treatment resulted in a lower OSDI compared to placebo administration (P = 0.0005). Five studies reported data on the corneal staining. No difference was found between placebo administration and active treatment (P = 0.8). CONCLUSION: Placebo administration does not impact symptoms of DED and can be successfully employed to evaluate the efficacy of active treatments. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11096-022-01439-y. |
format | Online Article Text |
id | pubmed-9618542 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-96185422022-11-01 Placebo administration for dry eye disease: a level I evidence based systematic review and meta-analysis Prinz, Julia Maffulli, Nicola Fuest, Matthias Walter, Peter Hildebrand, Frank Migliorini, Filippo Int J Clin Pharm Review Article BACKGROUND: The efficacy of various common treatment options for dry eye disease (DED) has been investigated against placebo. However, the potential beneficial effect of placebo in the management of DED is still unclear. AIM: This meta-analysis investigated the impact of placebo administration in DED in Ocular Surface Disease Index (OSDI), Schirmer I test (SIT), tear breakup time (TBUT), corneal staining, and complications. METHOD: This meta-analysis and systematic review was conducted according to the 2020 PRISMA guidelines. In March 2022, Pubmed, Web of Science, Google Scholar, and Embase were accessed. All the randomised clinical trials which investigated any active treatment against a placebo control group were considered. The following data were extracted at baseline and at last follow-up: Ocular Surface Disease Index (OSDI), tear breakup time test (TBUT), Schirmer I test (SIT), corneal staining. RESULTS: Data from 56 studies (12,205 patients) were retrieved. Placebo administration is not effective in improving TBUT (P = 0.3), OSDI (P = 0.2), SIT (P = 0.1) and corneal staining (P = 0.1) from baseline to last follow-up. Active treatment led to a higher TBUT and SIT compared to placebo administration (P < 0.0001). The active treatment resulted in a lower OSDI compared to placebo administration (P = 0.0005). Five studies reported data on the corneal staining. No difference was found between placebo administration and active treatment (P = 0.8). CONCLUSION: Placebo administration does not impact symptoms of DED and can be successfully employed to evaluate the efficacy of active treatments. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11096-022-01439-y. Springer International Publishing 2022-08-08 2022 /pmc/articles/PMC9618542/ /pubmed/35939178 http://dx.doi.org/10.1007/s11096-022-01439-y Text en © The Author(s) 2022 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/) . |
spellingShingle | Review Article Prinz, Julia Maffulli, Nicola Fuest, Matthias Walter, Peter Hildebrand, Frank Migliorini, Filippo Placebo administration for dry eye disease: a level I evidence based systematic review and meta-analysis |
title | Placebo administration for dry eye disease: a level I evidence based systematic review and meta-analysis |
title_full | Placebo administration for dry eye disease: a level I evidence based systematic review and meta-analysis |
title_fullStr | Placebo administration for dry eye disease: a level I evidence based systematic review and meta-analysis |
title_full_unstemmed | Placebo administration for dry eye disease: a level I evidence based systematic review and meta-analysis |
title_short | Placebo administration for dry eye disease: a level I evidence based systematic review and meta-analysis |
title_sort | placebo administration for dry eye disease: a level i evidence based systematic review and meta-analysis |
topic | Review Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9618542/ https://www.ncbi.nlm.nih.gov/pubmed/35939178 http://dx.doi.org/10.1007/s11096-022-01439-y |
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