Background Osteoarthritis (OA), a common disabling condition, is the commonest type of arthritis worldwide. Knee OA is the 4th leading cause of disability in women. Pain is the leading symptom and is often chronic in nature leading to significant morbidity and decreased quality of life. Synovitis is prevalent in knee OA and treatment to relieve this synovitis may reduce pain.
Objectives A randomized double-blind placebo-controlled trial was conducted to assess whether 6 weeks of daily low dose oral prednisolone would improve pain, mobility and systemic low-grade inflammation, in the short term and to determine if it sustained long term at 12 weeks in older adults with moderate to severe knee OA.
Methods 125 community-dwelling older adults aged 65 years and above with primary knee OA diagnosed according to the ACR criteria for diagnosis of primary OA of the knee were randomized 1:1. Sixty three received 7.5 mg/day of prednisolone and 62 received placebo together with their usual therapy for 6 weeks. The primary outcome measure was pain reduction. Secondary outcome measures included reduction in systemic inflammation and improvements in physical functioning scores. Alterations in dosage of analgesic/NSAID drugs used were recorded. Safety and tolerability were also assessed. Data was collected at baseline, 6 weeks and at 12 weeks to determine any change in results from those obtained at 6 weeks. Exclusion criteria included any inflammatory or serious medical condition.
Knee OA was documented by radiographic examination using the Kellgren-Lawrence scale. Symptomatic OA was defined as the need to take NSAIDs daily and LequesneAlgofunctional Index (LFI)score >4. Clinical assessment included: Visual Analogue Pain Scale (VAS, 0-100), self-reported physical function as measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores, and six-minute walk distance (6MWD). All patients underwent a physical examination and were questioned about the number of flares, pain and analgesic use. Blood samples were collected and serum levels of IL-1, IL-6, TNF-alpha and hsCRP were measured in all patients.
Results A total of 118 of the 125 patients completed the study. There was a statistically significant reduction in knee pain in the intervention group compared to the placebo group, p<0.001 at 6 weeks which was sutained to the 12th week. Furthermore, there was a significant improvement in physical function and 6MWD together with significant reductions in the serum levels of IL-1, IL-6, TNF-alpha and hsCRP at 6 weeks and at 12 weeks in the intervention group when compared to the placebo group. NSAID use was significantly less in the intervention group compared to the placebo group, p<0.05. No serious side effects were reported.
Conclusions The findings of the present study provide evidence that low dose oral glucocorticoids have both a short term and a longer sustained effect resulting in less knee pain, better physical function, and attenuation of systemic inflammation in older patients with knee osteoarthritis.
Disclosure of Interest None Declared
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