Protocol proposal: N-of-1 clinical trials in equine osteoarthritis

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Osteoarthritis (OA) is a chronic degenerative disease characterized by joint pain and stiffness due to degeneration of the articular cartilage and remodeling of the subchondral bone. It is a common clinical condition in equines and is the leading cause of loss of performance and early retirement [1]. The aim of this study is to propose innovative therapeutic management for the control of this condition when it is mild or moderate, using a commercial homeopathic complex Drenareuma WP® (Curitiba, Brazil) composed of Bryonia alba 4cH, Mezereum 6cH, Ranunculus bulbosus 5cH, Rhus Toxicodendron 5cH, Ruta graveolens 5cH and excipients, administered in tablets. The placebo will be made with inert tablets, not embedded with the complex. Six equines will be selected, in sequence, at the veterinary polyclinic of UNIP, São José dos Campos, Brazil, according to inclusion and exclusion criteria and with the written consent of the owner, to be submitted to a N of 1 trial series, that is a single-subject, crossover, multiple-trial clinical trial [2]. Using key methodological elements, N-of-1 trials provide rigorous evidence of intervention effects for individuals, individually or in series, and offer opportunities to improve patient-centered, evidence-based care. Each patient's treatment (verum) or placebo period will be organized in two series of alternate blocks (or cycles) of 90 days. On days zero and 90 (D0 and D90) of each block, the most affected joint will be carefully examined, the claudication scored [3], and the local temperature will be measured with a thermal camera. They will be subjected to diagnostic imaging techniques in orthogonal radiographic projections and longitudinal and transversal sections of ultrasound images. The thickness and spaces of the analyzed structures will be scored from an adaptation of a standard knee scale [4]. The whole dataset will be assessed using Bayesian statistics, comparing D0 to D90 in each period and in the total cycle. Before any intervention, this protocol will be submitted to the animal ethical committee for approval.