Dataset Information

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

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).

SUBMITTER: Roddy E

PROVIDER: S-EPMC7025732 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Publications

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

Roddy Edward E Clarkson Kris K Blagojevic-Bucknall Milica M Mehta Rajnikant R Oppong Raymond R Avery Anthony A Hay Elaine M EM Heneghan Carl C Hartshorne Liz L Hooper Julie J Hughes Gemma G Jowett Sue S Lewis Martyn M Little Paul P McCartney Karen K Mahtani Kamal R KR Nunan David D Santer Miriam M Williams Sam S Mallen Christian D CD

Annals of the rheumatic diseases 20191030 2

<h4>Objectives</h4>To compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care.<h4>Methods</h4>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- ...[more]

PMID: 31666237

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Dataset Information

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

Objectives

Methods

Results

Conclusion

Trial registration number

Publications

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

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