Roddy, E, Clarkson, K, Blagojevic-Bucknall, M, Mehta, R, Oppong, R, Avery, A, Hay, EM, Heneghan, C, Hartshorne, L, Hooper, J, Hughes, G, Jowett, S, Lewis, M, Little, P, McCartney, K, Mahtani, KR, Nunan, D, Santer, M, Williams, S and Mallen, CD (2019) Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care. Annals of the Rheumatic Diseases.

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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).

Item Type: Article
Additional Information: This is the final published version of the article (version of record). It first appeared online via BMJ at http://dx.doi.org/10.1136/annrheumdis-2019-216154 - please refer to any applicable terms of use of the publisher.
Uncontrolled Keywords: colchicine, gout, naproxen, primary care, randomised trial
Subjects: R Medicine > RC Internal medicine > RC925 Diseases of the musculoskeletal system
Related URLs:
Depositing User: Symplectic
Date Deposited: 22 Nov 2019 12:11
Last Modified: 22 Nov 2019 12:13
URI: https://eprints.keele.ac.uk/id/eprint/7280

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