Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care. Issue 2 (30th October 2019)

• Record Type: Journal Article
• Authors: Roddy, Edward; Clarkson, Kris; Blagojevic-Bucknall, Milica; Mehta, Rajnikant; Oppong, Raymond; Avery, Anthony; Hay, Elaine M; Heneghan, Carl; Hartshorne, Liz; Hooper, Julie; Hughes, Gemma; Jowett, Sue; Lewis, Martyn; Little, Paul; McCartney, Karen; Mahtani, Kamal R; Nunan, David; Santer, Miriam; Williams, Sam; Mallen, Christian D
• Is Part Of: Annals of the rheumatic diseases. Volume 79:Issue 2(2020)
• Page Start: 276
• Page End: 284
• Publication Date: 2019-10-30
• Subjects: gout -- primary care -- naproxen -- colchicine -- randomised trial; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2019-216154
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Objectives: To compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care. Methods: This was a multicentre open-label randomised trial. Adults with a gout flare recruited from 100 general practices were randomised equally to naproxen 750 mg immediately then 250 mg every 8 hours for 7 days or low-dose colchicine 500 mcg three times per day for 4 days. The primary outcome was change in worst pain intensity in the last 24 hours (0–10 Numeric Rating Scale) from baseline measured daily over the first 7 days: mean change from baseline was compared between groups over days 1–7 by intention to treat. Results: Between 29 January 2014 and 31 December 2015, we recruited 399 participants (naproxen n=200, colchicine n=199), of whom 349 (87.5%) completed primary outcome data at day 7. There was no significant between-group difference in average pain-change scores over days 1–7 (colchicine vs naproxen: mean difference −0.18; 95% CI −0.53 to 0.17; p=0.32). During days 1–7, diarrhoea (45.9% vs 20.0%; OR 3.31; 2.01 to 5.44) and headache (20.5% vs 10.7%; 1.92; 1.03 to 3.55) were more common in the colchicine group than the naproxen group but constipation was less common (4.8% vs 19.3%; 0.24; 0.11 to 0.54). Conclusion: We found no difference in pain intensity over 7 days between people with a gout flare randomised to either naproxen or low-dose colchicine. Naproxen caused fewer side effects supporting naproxen as first-line treatment for gout flares in primary care in the absence of contraindications. Trial registration number: ISRCTN (69836939), clinicaltrials.gov (NCT01994226 ), EudraCT (2013-001354-95).