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

Roddy, E; Clarkson, K; 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; Mallen, CD

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., Bucknall, M., Mehta, R., Oppong, R., Avery, A., …Mallen, C. (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, 79(2), https://doi.org/10.1136/annrheumdis-2019-216154

• Journal Article Type: Article
• Acceptance Date: Oct 16, 2019
• Online Publication Date: Jan 27, 2020
• Publication Date: Oct 30, 2019
• Journal: Annals of the Rheumatic Diseases
• Print ISSN: 0003-4967
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 79
• Issue: 2
• DOI: https://doi.org/10.1136/annrheumdis-2019-216154
• Keywords: colchicine, gout, naproxen, primary care, randomised trial
• Publisher URL: http://dx.doi.org/10.1136/annrheumdis-2019-216154