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Multicenter Study
. 2020 Feb;79(2):276-284.
doi: 10.1136/annrheumdis-2019-216154. Epub 2019 Oct 30.

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

Edward Roddy  1   2 , Kris Clarkson  3   4 , Milica Blagojevic-Bucknall  3   4 , Rajnikant Mehta  5 , Raymond Oppong  6 , Anthony Avery  7 , Elaine M Hay  3 , Carl Heneghan  8 , Liz Hartshorne  3   4 , Julie Hooper  9 , Gemma Hughes  3   4 , Sue Jowett  3   6 , Martyn Lewis  3   4 , Paul Little  9 , Karen McCartney  7 , Kamal R Mahtani  8 , David Nunan  8 , Miriam Santer  9 , Sam Williams  9 , Christian D Mallen  3
Affiliations
Multicenter Study

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

Edward Roddy et al. Ann Rheum Dis. 2020 Feb.

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).

Keywords: colchicine; gout; naproxen; primary care; randomised trial.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Participant flow. CTU, Clinical Trials Unit. ITT, intention-to-treat.
Figure 2
Figure 2
Comparison of pain scores (primary outcome measure) at follow-up (intention-to-treat analysis).
See this image and copyright information in PMC

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