Nine databases, grey literature, clinical trial registers, and websites of companies specialising in R. Canina fruit supplements will be searched with no language restriction placed on publications. Randomised controlled (placebo or active control) parallel and crossover trials examining the effects and safety of oral R. Canina fruit for treating osteoarthritis will be included.
Trials with participants of all ages with a clinical or radiographic diagnosis of OA according to the American College of Rheumatology (ACR) criteria or the equivalent European League Against Rheumatism (EULAR) criteria will be included. We will accept any intervention involving an orally-administered plant preparation of, or including, R. Canina fruit, compared with placebo, active control or usual care. Primary outcomes include pain, physical function and stiffness, joint structure, and quality of life.
Two reviewers will screen for eligibility, perform quality appraisal using the Cochrane Collaboration risk of bias tool, and conduct data extraction independently. Disagreements will be resolved by discussion or referral to a third reviewer. When possible, the analyses will be based on intention to treat data from the individual trials. For each trial, we will present outcome data with the mean and SD for continuous outcomes and risk ratio (RR) with corresponding 95% confidence interval for dichotomous outcomes. If different scales are used to measure the same outcome or concept, standardised mean difference (SMD) will be used. It is anticipated there might be moderate or high heterogeneity among trials due to variation in R. Canina intervention and outcomes, if appropriate, a random-effects model will be used to pool the data. Where a study is defined as a crossover trial, data will be extracted only up to the point of crossover, given the potential for carry-over effects of these particular interventions to bias the treatment effect following crossover.
This is a collaborative work between University of Southampton and Keele University. Where the results from this Cochrane review suggest that further research is warranted, it will lead to a pilot feasibility study on R. Canina for osteoarthritis in primary care.
INVESTIGATORS: Michael Moore, Christian Mallen, Lily Lai, Nadia Corp, Jeanne Trill
FUNDER: NIHR SPCR
Duration: July 2016 to July 2017
Contact: X.Hu@soton.ac.uk