Intra-articular orgotein in osteoarthritis of the knee: a placebo-controlled efficacy, safety, and dosage comparison

PURPOSE: Superoxide dismutase (orgotein for injection) has been used in managing osteoarthritis for more than seven years in Europe; however, well-controlled studies to establish an optimum dosage regimen have not been conducted. In this study, three orgotein dose/regimens were compared with placebo in terms of efficacy, safety, and duration of effect in patients with active osteoarthritis of the knee. PATIENTS AND METHODS: A total of 139 patients with osteoarthritis of the knee were enrolled in the study. Nonsteroidal anti-inflammatory agents were withdrawn to induce a flare of disease activity. Patients were then randomly assigned to receive one intra-articular injection of either placebo or orgotein (8 mg to 32 mg) each week for three weeks. Both investigators and patients evaluated disease activity and adverse experiences at a series of follow-up visits for three months. RESULTS: Orgotein was effective in reducing symptoms of osteoarthritis for up to three months after treatment; 16 mg given twice was the most effective and most best-tolerated regimen. Discomfort at the injection site was drug related, although this effect also occurred occasionally after injection of placebo. CONCLUSION: The long-lasting effects of intra-articular superoxide dismutase contribute to a favorable risk-benefit ratio and support the importance of the free-radical anion, superoxide (O2-), in the biochemical pathology of osteoarthritis.     

Clinical risk management: principles of consent and patient information.

Clinical Risk Management and its integral elements form part of the foundation of 'Clinical Governance'. An important principle within Clinical Risk Management is that of consent and patient information which, in a changing climate of complaint and litigation, means that it is essential that clinicians have a sound understanding of its importance. This paper provides a structured understanding of the background and practice of consent and patient information. With such knowledge clinicians can help patients achieve a better understanding of what they are undertaking, and so reduce the risk of complaint and litigation. This paper discusses the topics of: current indemnification, ethics, law, the information content required for consent, duration of consent, who should take consent, capacity to give consent, mental incapacity, and details of how to perform risk assessment. However, areas applicable to the Mental Health Act have been excluded.