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Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care

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

Authors

Edward Roddy e.roddy@keele.ac.uk

Kris Clarkson

Milica Blagojevic-Bucknall

Rajnikant Mehta

Raymond Oppong

Elaine M Hay

Carl Heneghan

Liz Hartshorne

Julie Hooper

Gemma Hughes

Sue Jowett

Martyn Lewis

Paul Little

Karen McCartney

Kamal R Mahtani

David Nunan

Miriam Santer

Sam Williams

Christian D Mallen



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)

Citation

Roddy, E., Clarkson, K., Blagojevic-Bucknall, M., Mehta, R., Oppong, R., Avery, A., …Mallen, C. D. (2020). 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, 79(2), 276-284. https://doi.org/10.1136/annrheumdis-2019-216154

Journal Article Type Article
Acceptance Date Oct 16, 2019
Online Publication Date Oct 30, 2019
Publication Date Feb 1, 2020
Deposit Date Nov 4, 2019
Publicly Available Date Nov 5, 2019
Journal Annals of the Rheumatic Diseases
Print ISSN 0003-4967
Electronic ISSN 1468-2060
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 79
Issue 2
Pages 276-284
DOI https://doi.org/10.1136/annrheumdis-2019-216154
Keywords Immunology; General biochemistry, Genetics and molecular biology; Immunology and allergy; Rheumatology
Public URL https://nottingham-repository.worktribe.com/output/3052079
Publisher URL https://ard.bmj.com/content/early/2019/10/30/annrheumdis-2019-216154
Additional Information This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 (CC BY 4.0) license. See: https://creativecommons.org/licenses/by/4.0/.

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