title: Brazilian oral herbal medication for osteoarthritis: a systematic review protocol.
abstract: BACKGROUND
  Osteoarthritis affects 1 % of the world's population and is the most common cause of musculoskeletal impairment in the elderly. Herbal medications are commonly used in Brazil to manage symptoms associated with osteoarthritis, and some of them are financed by the Brazilian government; however, the effectiveness of most of these agents is uncertain. The aim was to systematically review the efficacy and safety of 13 oral herbal medications used in Brazil for the treatment of osteoarthritis.
  
  
  METHODS
  Randomized clinical trials eligible for our systematic review will enroll adults with osteoarthritis treated by a Brazilian herbal medication or a control group (placebo or active control). Using terms to include all forms of osteoarthritis combined with herbal medications, we will search the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; CINAHL; Web of Science; Health Star; AMED, the database of the Cochrane Complementary Medicine Field, LILACS; CAB abstracts, Clinical trial.gov, WHO trials registry, and Bank of Brazil Thesis (CAPES), to 31 January 2016, without restrictions concerning language or status of publication. Outcomes of interest include the following: symptom relief (e.g., pain), adverse events (gastrointestinal bleeding, epigastric pain, nausea, and allergic reactions), discontinuation due to adverse events, quality of life, and the satisfaction with the treatment. Dichotomous data will be summarized as risk ratios; continuous data will be given as standard average differences with 95 % confidence intervals. A team of reviewers will assess each citation independently for eligibility and in duplicate it. For eligible studies, the same reviewers will perform data extraction, bias risk assessment, and determination of the overall quality of evidence for each of the outcomes using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) classification system.
  
  
  CONCLUSIONS
  This is the first study that will evaluate the use of herbal medications used in Brazil for the treatment of pain caused by osteoarthritis. The results could guide prescribers in decision-making in clinical practice, to inform the patients with pain caused by osteoarthritis in relation to effective and safe treatment options and to inform the managers of the public health system which of the plants could actually be financed by the Brazilian government.
  
  
  BACKGROUND
  PROSPERO 42015019793.
authors.affiliation: Department of Pharmaceutical Sciences, University of Sorocaba, Sorocaba, São Paulo, Brazil.
authors.forename: Mariana Del Grossi
authors.initials: Mdel G
authors.lastname: Moura
authors.affiliation: Department of Pharmaceutical Sciences, University of Sorocaba, Sorocaba, São Paulo, Brazil.
authors.forename: Luciane Cruz
authors.initials: LC
authors.lastname: Lopes
authors.affiliation: Pharmaceutical Department, Federal University of Florianopolis, Florianopolis, Santa Catarina, Brazil.
authors.forename: Maique Weber
authors.initials: MW
authors.lastname: Biavatti
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.|Department of Anesthesia, Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Ontario, Canada.|Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Jason W
authors.initials: JW
authors.lastname: Busse
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Li
authors.initials: L
authors.lastname: Wang
authors.affiliation: Department of Diagnostic Radiology, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Sean Alexander
authors.initials: SA
authors.lastname: Kennedy
authors.affiliation: Health Sciences Library, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Neera
authors.initials: N
authors.lastname: Bhatnaga
authors.affiliation: Department of Pharmaceutical Sciences, University of Sorocaba, Sorocaba, São Paulo, Brazil. cristiane.motta@prof.uniso.br.
authors.forename: Cristiane de Cássia
authors.initials: Cde C
authors.lastname: Bergamaschi
mesh_terms: D029743:Boswellia; D001938:Brazil; D020948:Cat's Claw; D027464:Chenopodium ambrosioides; D031213:Cordia; D030024:Curcuma; D007887:Fabaceae; D031684:Harpagophytum; D006801:Humans; D010003:Osteoarthritis / Q000188:drug therapy*; D027421:Persea; D008517:Phytotherapy; D028321:Plant Preparations / Q000627:therapeutic use*; D032108:Salix; D000078202:Systematic Reviews as Topic; D016896:Treatment Outcome; D032070:Uncaria
chemical_list: D028321:Plant Preparations