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

Edward Roddy, Kris Clarkson, Milisa Blagojevic-Bucknall, Rajnikant Mehta, Raymond Oppong, Anthony Avery, Elaine Hay, Carl Heneghan, Liz Hartshorne, Julie Hooper, Gemma Hughes, Sue Jowett, Martyn Lewis, Paul Little, Karen McCartney, Kamal Mahtani, David Nunan, Miriam Santer, Sam Williams, Christian Mallen

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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).

Original languageEnglish
Pages (from-to)276-284
Number of pages9
JournalAnnals of the Rheumatic Diseases
Volume79
Issue number2
Early online date30 Oct 2019
DOIs
Publication statusPublished - Feb 2020

Keywords

  • Gout
  • Primary care
  • Naproxen
  • Colchicine
  • Randomised trial

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