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Use of Oral Prednisolone Or Naproxen for the Treatment of Gout Arthritis: a Double-Blind, Randomised Equivalence Trial

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Use of Oral Prednisolone Or Naproxen for the Treatment of Gout Arthritis: a Double-Blind, Randomised Equivalence Trial Articles Use of oral prednisolone or naproxen for the treatment of gout arthritis: a double-blind, randomised equivalence trial Hein J E M Janssens, Matthijs Janssen, Eloy H van de Lisdonk, Piet L C M van Riel, Chris van Weel Summary Lancet 2008; 371: 1854–60 Background Non-steroidal anti-infl ammatory drugs and colchicine used to treat gout arthritis have gastrointestinal, See Comment page 1816 renal, and cardiovascular adverse eff ects. Systemic corticosteroids might be a benefi cial alternative. We investigated Department of General Practice equivalence of naproxen and prednisolone in primary care. (H J E M Janssens MD, E H van de Lisdonk PhD, Methods We did a randomised clinical trial to test equivalence of prednisolone and naproxen for the treatment of Prof C van Weel PhD) and Department of Rheumatology monoarticular gout. Primary-care patients with gout confi rmed by presence of monosodium urate crystals were (Prof P L C M van Riel PhD), eligible. 120 patients were randomly assigned with computer-generated randomisation to receive either prednisolone Radboud University Nijmegen (35 mg once a day; n=60) or naproxen (500 mg twice a day; n=60), for 5 days. Treatment was masked for both patients Medical Centre, Nijmegen, and physicians. The primary outcome was pain measured on a 100 mm visual analogue scale and the a priori margin Netherlands; and Department of Rheumatology, Rijnstate for equivalence set at 10%. Analyses were done per protocol and by intention to treat. This study is registered as an Hospital, Arnhem, Netherlands International Standard Randomised Controlled Trial, number ISRCTN14648181. (M Janssen PhD) Correspondence to: Findings Data were incomplete for one patient in each treatment group, so per-protocol analyses included 59 patients Dr Hein J E M Janssens, Radboud in each group. After 90 h the reduction in the pain score was 44·7 mm and 46·0 mm for prednisolone and naproxen, University Nijmegen Medical Centre, PO Box 9101, 6500 HB respectively (diff erence 1·3 mm; 95% CI –9·8 to 7·1), suggesting equivalence. The diff erence in the size of change in Nijmegen, Netherlands pain was 1·57 mm (95% CI –8·65 to 11·78). Adverse eff ects were similar between groups, minor, and resolved by [email protected] 3 week follow-up. Interpretation Oral prednisolone and naproxen are equally eff ective in the initial treatment of gout arthritis over 4 days. Funding Rheumatology Research Fund Arnhem, Netherlands. Introduction window,10,11 its disadvantage in the case of renal failure,12 Gout is a painful infl ammatory arthritis with a sudden and the availability of NSAIDs. The fi rst choice of drug onset and tendency to recur.1 The gold standard for the treatment is now NSAIDs,13,14 despite their diagnosis of gout is the microscopic identifi cation of gastrointestinal15,16 and cardiovascular risks.17 About 40% of monosodium urate crystals in synovial fl uid or tophi. upper gastrointestinal bleeding events are attributable to Acute severe pain prompts most patients to seek medical NSAIDs (risk is highest during the fi rst week of use),16,18 care immediately. and the cardiovascular risks prompted the American The history of gout is marked by famous patients, Heart Association recently to recommend restricted use.19 including Desiderius Erasmus, Holy Roman Emperor Loss of renal function, fl uid retention, and interaction Charles V and Immanuel Kant; by impressive scientifi c with anticoagulants, further discourage the use of researchers like Antoni van Leeuwenhoek, who fi rst NSAIDs. The drawbacks of the NSAIDs are especially identifi ed monosodium urate crystals from a tophus important in the case of gout,13 because patients are at with his hand-held microscope in the 1600s, Anton Von high risk for the gastrointestinal side-eff ects, most of Störck, who laid the foundations for the modern use of them are middle aged or elderly,20,21 and many have colchicine in the 1800s, and Sir Alfred Baring Garrod, comorbid renal and cardiovascular diseases.6,12,21–23 who fi rst postulated in the 1900s that deposits of serum As a consequence, safer therapeutic approaches are urate were the cause not the consequence of gout; by needed.14 Systemic corticosteroids might be a safe various prescientifi c treatments, such as diets, plasters, alternative, particularly in elderly people.13,14,21 Although baths, herbal remedies, opium; and by many disputes they are associated with side-eff ects such as osteoporosis, about the triggering factors, including socioeconomic fl uid retention, and hyperglycaemia when used long status, alcohol, food, and drugs.2–7 Gout has a substantial term, systemic corticosteroids do not have important eff ect on the population. An estimated 1–2% of adults in drawbacks in the short term.24,25 However, the only developed countries have the disorder,4,8 which creates a evidence on the eff ectiveness of systemic corticosteroids substantial burden of work-related and medical costs.9 in the treatment of gout is from three studies included in The most widely used drugs for gout arthritis are a recent systematic Cochrane review:26 two small, colchicine and non-steroidal anti-infl ammatory drugs unblinded, non-randomised studies,27,28 and another in (NSAIDs). Colchicine is the most longstanding treatment, patients with gout-like arthritis not confi rmed with tests but its use has declined because of its narrow therapeutic for monosodium urate crystals.29 1854 www.thelancet.com Vol 371 May 31, 2008 Articles We aimed to investigate whether oral prednisolone is equivalent to naproxen in patients with confi rmed gout 381 patients with monoarthritis diagnosed arthritis. by family doctors Methods 165 patients without MSU crystals: 81 arthritis unknown cause Patients 84 arthritis other causes* We designed a randomised, double-blind, active- comparator, controlled trial to test for equivalence of 216 patients with gout confirmed by prednisolone and naproxen for the treatment of gout presence of MSU crystals assessed for eligibility arthritis. The study took place in the eastern part of the 96 patients excluded† Netherlands in a population of about 330 000 inhabitants. In the Netherlands, patients are listed with a personal family doctor who provides primary care for about 120 patients randomly assigned to trial treatments 2250 people and refers patients for secondary medical care if needed. From March 24, 2004, until July 14, 2006, family doctors were asked to send all patients with monoarthritis to the 60 assigned to 60 assigned to trial centre, even if gout was not the most likely diagnosis, prednisolone (ITT) naproxen (ITT) to minimise the risk of missing potential study participants. Patients were assessed in the trial centre for 1 patient had 1 patient had inclusion eligibility within 1 day after they visited their incomplete data‡ incomplete data‡ family doctor. Participants were patients with a monoarticular gout arthritis confi rmed by identifi cation of monosodium 59 patients 59 patients (per protocol) (per protocol) urate crystals in the synovial fl uid of the aff ected joint. All patients provided written informed consent. The study was done according to good clinical practice Figure 1: Trial profi le guidelines and approved by the regional ethics review *Tested positive for cyclic citrullinated peptide antibodies or rheumatoid factor positive or had progression towards rheumatoid arthritis (12); psoriatic arthritis (six); pseudogout (14); reactive arthritis (one); committee (CMO Arnhem-Nijmegen). Because of post-streptococcal reactive arthritis (fi ve); arthritis secondary to infl ammatory bowel disease (4); Lyme-arthritis ethical considerations, the study had no placebo control (three); bacterial arthritis (three); palindromic rheumatism (fi ve); osteoarthritis (19); no arthritis (12). †86 men, group. ten women, mean age 60·5 years (12·8). Reasons for exclusion: contemporary use of NSAID or colchicine (49); Exclusion criteria were unstable condition (prevalent history of gastrointestinal ulcer or bleeding (six); contemporary use of acenocoumarol (24); serious renal problems (eight); serious other comorbidity (three); refusal (six). ‡Both drop outs had arthritis of the leg or foot. angina pectoris, myocardial infarction, manifest heart ITT=intention to treat. failure, severe renal failure, renal transplant, or cancer); chronic rheumatic diseases; current use of anticoagulants; and medical history of upper gastrointestinal diseases. One of the investigators (MJ) reviewed all patients by Patients were not excluded on the basis of age. We did means of a standardised interview and physical not allow the use of NSAIDs or other analgesics examination. The following data were recorded: current (including colchicine) within 24 h before baseline joint pain (eg, intensity, duration); other current assessments or for the duration of the trial. complaints; medical history (former arthritis, urolithiasis, cardiovascular morbidity); lifestyle Procedures (smoking, use of alcohol); use of medication before Patients were randomly assigned to one of two oral study inclusion (eg, analgesics, urate-lowering drugs, treatments (prednisolone or naproxen) given for 5 days. diuretics); family history (gout); the status of the An independent trial monitor used a computer-generated aff ected joint (redness, swelling); the status of the other randomisation procedure to create an allocation joints; presence of tophi; cardiovascular parameters sequence list with a block randomisation of four (blood pressure, body mass index); laboratory fi ndings treatments, each treatment being given twice. (eg, uric acid, C-reactive protein, ESR, glomerular Consecutive patients received drugs following the fi ltration rate). allocation list: either prednisolone 35 mg once a day and The aff ected joint of each patient was aspirated. look-alike placebo naproxen twice a day, or naproxen Aspirated fl uid was analysed for monosodium urate 500 mg twice a day and a placebo capsule prednisolone crystals under a polarisation microscope. (double-dummy design). Patients took their fi rst dose in When monosodium urate crystals could not be the presence of one of the investigators.
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