1. Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care
- Author
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Gemma Hughes, Martyn Lewis, Raymond Oppong, K McCartney, Kamal R Mahtani, David Nunan, Paul Little, Milica Blagojevic-Bucknall, Elaine M Hay, Julie Hooper, Williams Samuel Cameron, Carl Heneghan, Sue Jowett, Liz Hartshorne, Christian D Mallen, Kris Clarkson, Anthony J Avery, Miriam Santer, Rajnikant Mehta, and Edward Roddy
- Subjects
Male ,medicine.medical_specialty ,Naproxen ,Constipation ,Crystal Arthropathies ,Immunology ,Symptom Flare Up ,Primary care ,General Biochemistry, Genetics and Molecular Biology ,colchicine ,Gout Suppressants ,03 medical and health sciences ,chemistry.chemical_compound ,primary care ,0302 clinical medicine ,gout ,Rheumatology ,RC925 ,Internal medicine ,medicine ,Immunology and Allergy ,Colchicine ,Humans ,naproxen ,030212 general & internal medicine ,030203 arthritis & rheumatology ,Intention-to-treat analysis ,Primary Health Care ,business.industry ,Middle Aged ,medicine.disease ,Pragmatic trial ,randomised trial ,Gout ,Treatment Outcome ,chemistry ,Female ,medicine.symptom ,business ,medicine.drug - Abstract
ObjectivesTo compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care.MethodsThis 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.ResultsBetween 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).ConclusionWe 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 numberISRCTN (69836939), clinicaltrials.gov (NCT01994226), EudraCT (2013-001354-95).
- Published
- 2020