Placebo use and outcome quality: a protocol for systematic review and meta-analysis

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dc.contributor.authorPiuvezam, Grasiela
dc.contributor.authorSilva, Juliana Carvalho Rocha Alves da
dc.contributor.authorAzevedo, Kesley Pablo Morais de
dc.contributor.authorFarinasso, Cecília Menezes
dc.contributor.authorSilva, Dayde Lane Mendonça da
dc.contributor.authorStefani, Cristine
dc.contributor.authorFigueiredo, Ana Cláudia Morais Godoy
dc.contributor.authorSouza, Patrícia Medeiros de
dc.contributor.authorCapucho, Helaine Carneiro
dc.contributor.authorIDhttps://orcid.org/0000-0002-2343-7251pt_BR
dc.date.accessioned2023-11-14T19:08:46Z
dc.date.available2023-11-14T19:08:46Z
dc.date.issued2020
dc.description.resumoBackground: The Pharmaceutical industry sponsorship, research outcome and quality has been already evaluated for clinical trials in order to analyze if this kind of sponsorship affects the results of clinical trials. In this sense, this study has the aim to investigate whether placebo use allows positive outcomes regarding efficacy and safety compared to synthetic medicines. Methods: We designed and registered a study protocol for a systematic review for methodology data. We will only randomized clinical trials that use placebo as comparator. The main outcome will be the evaluation of placebo use regarding the tendency for positive results (efficacy and security) when comparing to synthetic medicines. PubMed, Cochrane, LILACS (BVS), Web of Science, Scopus, and Excerpta Medica dataBASE (EMBASE) databases will be searched. Gray literature will be identified through the databases Proquest (Dissertation and Theses), OpenGrey and Google Scholar. Two review authors will independently assess trial quality and will extract data in accordance with standard Cochrane methodology. If necessary, we will also contact authors for additional information. The Cochrane Collaboration’s risk of bias tool will be used. If feasible, it means homogenous data, we will conduct random effects meta-analysis. Subgroup analyses will be conducted for different justifications for placebo use and for studies sponsored/not sponsored by the pharmaceutical industry. Results: Our present findings will indicate the effects of placebo use as comparator regarding efficacy and safety of the oral synthetic medicines. Discussion: This systematic review will identify, summarize, and analyze if there is a trend for positive efficacy and safety results for synthetic medicines in clinical trials when compared with placebo and if the justification for placebo use is considered ethically acceptable. Systematic review registration: PROSPERO CRD42018110829 Abbreviation: RCTs = randomized controlled clinical trialspt_BR
dc.identifier.citationPIUVEZAM, Grasiela; SILVA, Juliana C. R. Alves da; AZEVEDO, Kesley Pablo Morais de; FARINASSO, Cecília Menezes; SILVA, Dayde Lane Mendonça da; STEFANI, Cristine; FIGUEIREDO, Ana Cláudia Morais Godoy; SOUZA, Patrícia Medeiros de; CAPUCHO, Helaine Carneiro. Placebo use and outcome quality. Medicine, [S.l.], v. 99, n. 44, p. 22915, 30 out. 2020. Ovid Technologies (Wolters Kluwer Health). DOI http://dx.doi.org/10.1097/md.0000000000022915. Disponível em: https://journals.lww.com/md-journal/fulltext/2020/10300/placebo_use_and_outcome_quality__a_protocol_for.54.aspx. Acesso em: 9 nov. 2023.pt_BR
dc.identifier.doihttp://dx.doi.org/10.1097/md.0000000000022915
dc.identifier.urihttps://repositorio.ufrn.br/handle/123456789/55329
dc.languageenpt_BR
dc.publisherMedicinept_BR
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/deed.pt-br
dc.subjectclinical trialspt_BR
dc.subjectnew drugspt_BR
dc.subjectnew pharmaceutical productspt_BR
dc.subjectplacebopt_BR
dc.subjectsystematic reviewpt_BR
dc.titlePlacebo use and outcome quality: a protocol for systematic review and meta-analysispt_BR
dc.typearticlept_BR

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