Abstract
ObjectiveTo determine whether spironolactone could benefit older people with osteoarthritis (OA), based on a previous study showing that spironolactone improved quality of life.MethodsThis parallel‐group, randomized, placebo‐controlled, double‐blind trial randomized community‐dwelling people ages ≥70 years with symptomatic knee OA to 12 weeks of 25 mg daily oral spironolactone or matching placebo. The primary outcome was between‐group difference in change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores. Secondary outcomes included WOMAC stiffness and physical function subscores, EuroQol 5‐domain (EQ‐5D) 3L score, and mechanistic markers. Analysis was by intent to treat, using mixed‐model regression, adjusting for baseline values of test variables.ResultsA total of 421 people had eligibility assessed, and 86 were randomized. Mean ± SD age was 77 ± 5 years and 53 of 86 (62%) were women. Adherence to study medication was 99%, and all participants completed the 12‐week assessment. No significant improvement was seen in the WOMAC pain score (adjusted treatment effect 0.5 points [95% confidence interval (95% CI) − 0.3, 1.3]; P = 0.19). No improvement was seen in WOMAC stiffness score (0.2 points [95% CI −0.6, 1.1]; P = 0.58), WOMAC physical function score (0.0 points [95% CI −0.7, 0.8]; P = 0.98), or EQ‐5D 3L score (0.04 points [95% CI −0.04, 0.12]; P = 0.34). Cortisol, matrix metalloproteinase 3, and urinary C‐telopeptide of type II collagen were not significantly different between groups. More minor adverse events were noted in the spironolactone group (47 versus 32), but no increase in death or hospitalization was evident.ConclusionSpironolactone did not improve symptoms, physical function, or health‐related quality of life in older people with knee OA.
Highlights
Osteoarthritis (OA) affects over half of the population ages $60 years
No improvement was seen in WOMAC stiffness score (0.2 points [95% CI 20.6, 1.1]; P 5 0.58), WOMAC physical function score (0.0 points [95% CI 20.7, 0.8]; P 5 0.98), or EuroQol 5-domain (EQ-5D) 3L score (0.04 points [95% CI 20.04, 0.12]; P 5 0.34)
Inclusion criteria were as follows: symptomatic idiopathic knee OA according to American College of Rheumatology clinical and radiographic criteria [6], moderate or more severe pain at screening in at least 2 of 5 WOMAC pain score items, and receipt of 1 or more analgesic agents at a therapeutic dose for at least 2 months
Summary
Osteoarthritis (OA) affects over half of the population ages $60 years. Management aims to reduce pain, improve function, and improve quality of life, while minimizing the adverse effects of therapy [1]. An appreciable proportion of patients with OA have an inadequate response to existing analgesic treatments [2]. T. McMurdo, MBChB, MD, Deepa Sumukadas, MBChB, MD, Peter T. MSc, PhD, Petra Rauchhaus, PhD, Ishbel Argo, RGN, Helen Waldie, RGN, Allan D. BMBCh, PhD: University of Dundee, Dundee, UK; 2Vera Cvoro, MBChB, MD: Victoria Hospital, Kirkcaldy, Fife, UK; 3Roberta Littleford, PhD: Ninewells Hospital and Medical School, Dundee, UK. T. McMurdo, MBChB, MD, Ageing and Health, Mail Box 1, Ninewells Hospital and Medical School, Dundee DD1 9SY, UK. Submitted for publication May 21, 2015; accepted in revised form September 8, 2015
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