• Juliana C R Alves da Silva, de Azevedo Kesley Pablo Morais KPM Department of Public Health, Postgraduate Program in Public Health, Federal University of Rio Grande do Norte, University Campus Lagoa , Cecília Menezes Farinasso, Dayde Lane Mendonça da Silva, Cristine Stefani, Ana Cláudia Morais Godoy Figueiredo, Patrícia Medeiros de Souza, Grasiela Piuvezam, and Helaine Carneiro Capucho.
• University of Brasilia, University Campus Darcy Ribeiro Asa Norte, Brasília, Distrito Federal.
• Medicine (Baltimore). 2020 Oct 30; 99 (44): e22915.

BackgroundThe 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.MethodsWe 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.ResultsOur present findings will indicate the effects of placebo use as comparator regarding efficacy and safety of the oral synthetic medicines.DiscussionThis 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 RegistrationPROSPERO CRD42018110829.

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