Abstract
BackgroundOsteoarthritis 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.MethodsRandomized 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.DiscussionThis 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.Systematic review registrationPROSPERO 42015019793Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-016-0261-1) contains supplementary material, which is available to authorized users.
Highlights
Osteoarthritis affects 1 % of the world’s population and is the most common cause of musculoskeletal impairment in the elderly
Eligibility criteria Inclusion criteria Patients: Adults (>18 years old) with a diagnosis of osteoarthritis according to the criteria of American College of Rheumatology (ACR): Western Ontario and McMaster Universities (WOMAC) [25] or the equivalent criterion of European League Against Rheumatism (EULAR): Lequesne index [26]
Our review will evaluate the available evidence for 13 oral Brazilian herbal interventions for osteoarthritis, provide estimates of the effectiveness of treatments and their associated harms, and evaluate the quality of the evidence in a thorough and consistent manner using the GRADE approach [43]
Summary
Standards The systematic review will be performed according to the recommendations specified in the Cochrane Handbook for Interventional Reviews and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement [24] (see Additional file 1). Confidence in pooled estimates of effect We will independently rate the quality of evidence from randomized trials for each of the outcomes by using GRADE approach [32, 33]. We will use random effects meta-analyses [35], which are conservative in that they consider within-studies and betweenstudies differences in calculating the error term used in the analysis. E.g., pain score, function score, we will use weighted mean differences (WMD) and its 95 % CI as effect measure after we convert them into same scale of Western Ontario and McMaster Universities osteoarthritis index (WOMAC) pain score (0–100) and function score (0–100), in which high score indicates worse outcome. We will only apply these approaches to outcomes that meet the following criteria: show a significant treatment effect and report sufficient missing participant data to potentially introduce clinically important bias. If the meta-analysis is not appropriate due to excessive heterogeneity of population, intervention, comparator, outcome, or methodology, we will construct summary tables and provide a narrative synthesis
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