Placebo use and outcome quality: a protocol for systematic review and meta-analysis
Background: 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 p...
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ri-123456789-553292023-11-14T19:09:15Z Placebo use and outcome quality: a protocol for systematic review and meta-analysis Piuvezam, Grasiela Silva, Juliana Carvalho Rocha 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 https://orcid.org/0000-0002-2343-7251 clinical trials new drugs new pharmaceutical products placebo systematic review Background: 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 trials 2023-11-14T19:08:46Z 2023-11-14T19:08:46Z 2020 article PIUVEZAM, 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. https://repositorio.ufrn.br/handle/123456789/55329 http://dx.doi.org/10.1097/md.0000000000022915 en https://creativecommons.org/licenses/by/4.0/deed.pt-br application/pdf Medicine |
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clinical trials new drugs new pharmaceutical products placebo systematic review |
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clinical trials new drugs new pharmaceutical products placebo systematic review Piuvezam, Grasiela Silva, Juliana Carvalho Rocha 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: a protocol for systematic review and meta-analysis |
| description |
Background: 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 trials |
| author2 |
https://orcid.org/0000-0002-2343-7251 |
| author_facet |
https://orcid.org/0000-0002-2343-7251 Piuvezam, Grasiela Silva, Juliana Carvalho Rocha 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 |
| format |
article |
| author |
Piuvezam, Grasiela Silva, Juliana Carvalho Rocha 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 |
| author_sort |
Piuvezam, Grasiela |
| title |
Placebo use and outcome quality: a protocol for systematic review and meta-analysis |
| title_short |
Placebo use and outcome quality: a protocol for systematic review and meta-analysis |
| title_full |
Placebo use and outcome quality: a protocol for systematic review and meta-analysis |
| title_fullStr |
Placebo use and outcome quality: a protocol for systematic review and meta-analysis |
| title_full_unstemmed |
Placebo use and outcome quality: a protocol for systematic review and meta-analysis |
| title_sort |
placebo use and outcome quality: a protocol for systematic review and meta-analysis |
| publisher |
Medicine |
| publishDate |
2023 |
| url |
https://repositorio.ufrn.br/handle/123456789/55329 http://dx.doi.org/10.1097/md.0000000000022915 |
| work_keys_str_mv |
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| _version_ |
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