Efficacy, safety, and potential industry bias in using deoxycholic acid for submental fat reduction ‒ A systematic review and meta-analysis of randomized clinical trials
Main Author: | |
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Publication Date: | 2023 |
Other Authors: | , , , , , , |
Format: | Other |
Language: | eng |
Source: | Repositório Institucional da UNESP |
Download full: | http://dx.doi.org/10.1016/j.clinsp.2023.100220 https://hdl.handle.net/11449/309800 |
Summary: | Lipolytic substance injections to reduce localized fat have been extensively used because it is a low-invasive method. This review aimed to evaluate the efficacy and safety of deoxycholic acid in submental fat reduction compared to a placebo and investigate the potential industry sponsorship bias in the results of randomized clinical trials on this topic. Ten electronic databases were extensively searched for randomized clinical trials without restriction on language and year of publication. Two reviewers extracted the data and assessed the individual risk of bias in the studies with the RoB 2.0 tool. The industry sponsorship bias was evaluated according to citations in the articles regarding industry funding/sponsorship throughout the texts. Fixed and random effects meta-analyses were performed, and the results were reported in Risk Ratio (RR) at a 95% Confidence Interval (95% CI). The initial search provided 5756 results, of which only five were included. Only two studies had a low risk of bias. All studies showed a potential industry bias. The meta-analysis showed that patients treated with deoxycholic acid had significant positive results for all efficacy outcomes and a higher risk of fibrosis, pain, erythema, numbness, swelling, edema, pruritus, nodules, headache, and paresthesia. The low to moderate certainty of evidence found allows concluding that deoxycholic acid is effective in submental fat reduction, causing well-tolerated adverse effects. However, all eligible studies showed a potential industry bias. |
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Efficacy, safety, and potential industry bias in using deoxycholic acid for submental fat reduction ‒ A systematic review and meta-analysis of randomized clinical trialsDeoxycholateDeoxycholic acidLipolysisLipolytic substance injections to reduce localized fat have been extensively used because it is a low-invasive method. This review aimed to evaluate the efficacy and safety of deoxycholic acid in submental fat reduction compared to a placebo and investigate the potential industry sponsorship bias in the results of randomized clinical trials on this topic. Ten electronic databases were extensively searched for randomized clinical trials without restriction on language and year of publication. Two reviewers extracted the data and assessed the individual risk of bias in the studies with the RoB 2.0 tool. The industry sponsorship bias was evaluated according to citations in the articles regarding industry funding/sponsorship throughout the texts. Fixed and random effects meta-analyses were performed, and the results were reported in Risk Ratio (RR) at a 95% Confidence Interval (95% CI). The initial search provided 5756 results, of which only five were included. Only two studies had a low risk of bias. All studies showed a potential industry bias. The meta-analysis showed that patients treated with deoxycholic acid had significant positive results for all efficacy outcomes and a higher risk of fibrosis, pain, erythema, numbness, swelling, edema, pruritus, nodules, headache, and paresthesia. The low to moderate certainty of evidence found allows concluding that deoxycholic acid is effective in submental fat reduction, causing well-tolerated adverse effects. However, all eligible studies showed a potential industry bias.Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)Postgraduate Program in Dentistry Faculdade de Odontologia Universidade Federal de Uberlândia, MGDivision of Morphology Centro de Ciências da Saúde e Biológicas Universidade Federal de Sergipe, SEDepartment of Restorative Dentistry Endodontics Division Faculdade de Odontologia de Piracicaba Universidade Estadual de Campinas (UNICAMP), SPDivision of Preventive and Community Dentistry Faculdade de Odontologia Universidade Federal de Uberlândia, MGDepartment of Dental Materials and Prothesis Instituto de Ciência e Tecnologia Universidade Estadual Paulista Júlio de Mesquita Filho, SPDepartment of Dental Materials and Prothesis Instituto de Ciência e Tecnologia Universidade Estadual Paulista Júlio de Mesquita Filho, SPUniversidade Federal de Uberlândia (UFU)Universidade Federal de Sergipe (UFS)Universidade Estadual de Campinas (UNICAMP)Universidade Estadual Paulista (UNESP)Inocêncio, Gabriel Santiago GiuglioMeneses-Santos, DanielaCosta, Marcelo Dias Moreira de AssisVieira, Walbert A.de Almeida, Vinicius LimaRodrigues, Renata Prata Cunha BernardesRode, Sigmar de Mello [UNESP]Paranhos, Luiz Renato2025-04-29T20:16:45Z2023-01-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/otherhttp://dx.doi.org/10.1016/j.clinsp.2023.100220Clinics, v. 78.1807-5932https://hdl.handle.net/11449/30980010.1016/j.clinsp.2023.1002202-s2.0-85173150133Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengClinicsinfo:eu-repo/semantics/openAccess2025-04-30T13:33:22Zoai:repositorio.unesp.br:11449/309800Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestrepositoriounesp@unesp.bropendoar:29462025-04-30T13:33:22Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
Efficacy, safety, and potential industry bias in using deoxycholic acid for submental fat reduction ‒ A systematic review and meta-analysis of randomized clinical trials |
title |
Efficacy, safety, and potential industry bias in using deoxycholic acid for submental fat reduction ‒ A systematic review and meta-analysis of randomized clinical trials |
spellingShingle |
Efficacy, safety, and potential industry bias in using deoxycholic acid for submental fat reduction ‒ A systematic review and meta-analysis of randomized clinical trials Inocêncio, Gabriel Santiago Giuglio Deoxycholate Deoxycholic acid Lipolysis |
title_short |
Efficacy, safety, and potential industry bias in using deoxycholic acid for submental fat reduction ‒ A systematic review and meta-analysis of randomized clinical trials |
title_full |
Efficacy, safety, and potential industry bias in using deoxycholic acid for submental fat reduction ‒ A systematic review and meta-analysis of randomized clinical trials |
title_fullStr |
Efficacy, safety, and potential industry bias in using deoxycholic acid for submental fat reduction ‒ A systematic review and meta-analysis of randomized clinical trials |
title_full_unstemmed |
Efficacy, safety, and potential industry bias in using deoxycholic acid for submental fat reduction ‒ A systematic review and meta-analysis of randomized clinical trials |
title_sort |
Efficacy, safety, and potential industry bias in using deoxycholic acid for submental fat reduction ‒ A systematic review and meta-analysis of randomized clinical trials |
author |
Inocêncio, Gabriel Santiago Giuglio |
author_facet |
Inocêncio, Gabriel Santiago Giuglio Meneses-Santos, Daniela Costa, Marcelo Dias Moreira de Assis Vieira, Walbert A. de Almeida, Vinicius Lima Rodrigues, Renata Prata Cunha Bernardes Rode, Sigmar de Mello [UNESP] Paranhos, Luiz Renato |
author_role |
author |
author2 |
Meneses-Santos, Daniela Costa, Marcelo Dias Moreira de Assis Vieira, Walbert A. de Almeida, Vinicius Lima Rodrigues, Renata Prata Cunha Bernardes Rode, Sigmar de Mello [UNESP] Paranhos, Luiz Renato |
author2_role |
author author author author author author author |
dc.contributor.none.fl_str_mv |
Universidade Federal de Uberlândia (UFU) Universidade Federal de Sergipe (UFS) Universidade Estadual de Campinas (UNICAMP) Universidade Estadual Paulista (UNESP) |
dc.contributor.author.fl_str_mv |
Inocêncio, Gabriel Santiago Giuglio Meneses-Santos, Daniela Costa, Marcelo Dias Moreira de Assis Vieira, Walbert A. de Almeida, Vinicius Lima Rodrigues, Renata Prata Cunha Bernardes Rode, Sigmar de Mello [UNESP] Paranhos, Luiz Renato |
dc.subject.por.fl_str_mv |
Deoxycholate Deoxycholic acid Lipolysis |
topic |
Deoxycholate Deoxycholic acid Lipolysis |
description |
Lipolytic substance injections to reduce localized fat have been extensively used because it is a low-invasive method. This review aimed to evaluate the efficacy and safety of deoxycholic acid in submental fat reduction compared to a placebo and investigate the potential industry sponsorship bias in the results of randomized clinical trials on this topic. Ten electronic databases were extensively searched for randomized clinical trials without restriction on language and year of publication. Two reviewers extracted the data and assessed the individual risk of bias in the studies with the RoB 2.0 tool. The industry sponsorship bias was evaluated according to citations in the articles regarding industry funding/sponsorship throughout the texts. Fixed and random effects meta-analyses were performed, and the results were reported in Risk Ratio (RR) at a 95% Confidence Interval (95% CI). The initial search provided 5756 results, of which only five were included. Only two studies had a low risk of bias. All studies showed a potential industry bias. The meta-analysis showed that patients treated with deoxycholic acid had significant positive results for all efficacy outcomes and a higher risk of fibrosis, pain, erythema, numbness, swelling, edema, pruritus, nodules, headache, and paresthesia. The low to moderate certainty of evidence found allows concluding that deoxycholic acid is effective in submental fat reduction, causing well-tolerated adverse effects. However, all eligible studies showed a potential industry bias. |
publishDate |
2023 |
dc.date.none.fl_str_mv |
2023-01-01 2025-04-29T20:16:45Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/other |
format |
other |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://dx.doi.org/10.1016/j.clinsp.2023.100220 Clinics, v. 78. 1807-5932 https://hdl.handle.net/11449/309800 10.1016/j.clinsp.2023.100220 2-s2.0-85173150133 |
url |
http://dx.doi.org/10.1016/j.clinsp.2023.100220 https://hdl.handle.net/11449/309800 |
identifier_str_mv |
Clinics, v. 78. 1807-5932 10.1016/j.clinsp.2023.100220 2-s2.0-85173150133 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Clinics |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.source.none.fl_str_mv |
Scopus reponame:Repositório Institucional da UNESP instname:Universidade Estadual Paulista (UNESP) instacron:UNESP |
instname_str |
Universidade Estadual Paulista (UNESP) |
instacron_str |
UNESP |
institution |
UNESP |
reponame_str |
Repositório Institucional da UNESP |
collection |
Repositório Institucional da UNESP |
repository.name.fl_str_mv |
Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP) |
repository.mail.fl_str_mv |
repositoriounesp@unesp.br |
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1834482378845716480 |