Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care
<p><strong>Objectives:</strong> To compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care.</p> <p><strong>Methods:</strong> This was a multicentre open-label randomised trial. Adult...
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
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BMJ Publishing Group
2019
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| _version_ | 1797091013889622016 |
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| author | Roddy, E Clarkson, K Blagojevic-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 |
| author_facet | Roddy, E Clarkson, K Blagojevic-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 |
| author_sort | Roddy, E |
| collection | OXFORD |
| description | <p><strong>Objectives:</strong> To compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care.</p>
<p><strong>Methods:</strong> 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.</p>
<p><strong>Results:</strong> 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).</p>
<p><strong>Conclusion:</strong> 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.</p>
<p><strong>Trial registration number:</strong> ISRCTN (69836939), clinicaltrials.gov (NCT01994226), EudraCT (2013-001354-95).</p> |
| first_indexed | 2024-03-07T03:26:57Z |
| format | Journal article |
| id | oxford-uuid:b95f92bb-e933-42c0-828e-1723aecf93fb |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T03:26:57Z |
| publishDate | 2019 |
| publisher | BMJ Publishing Group |
| record_format | dspace |
| spelling | oxford-uuid:b95f92bb-e933-42c0-828e-1723aecf93fb2022-03-27T05:02:29ZOpen-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:b95f92bb-e933-42c0-828e-1723aecf93fbEnglishSymplectic ElementsBMJ Publishing Group2019Roddy, EClarkson, KBlagojevic-Bucknall, MMehta, ROppong, RAvery, AHay, EMHeneghan, CHartshorne, LHooper, JHughes, GJowett, SLewis, MLittle, PMcCartney, KMahtani, KRNunan, DSanter, MWilliams, SMallen, CD<p><strong>Objectives:</strong> To compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care.</p> <p><strong>Methods:</strong> 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.</p> <p><strong>Results:</strong> 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).</p> <p><strong>Conclusion:</strong> 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.</p> <p><strong>Trial registration number:</strong> ISRCTN (69836939), clinicaltrials.gov (NCT01994226), EudraCT (2013-001354-95).</p> |
| spellingShingle | Roddy, E Clarkson, K Blagojevic-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 Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care |
| title | Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care |
| title_full | Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care |
| title_fullStr | Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care |
| title_full_unstemmed | Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care |
| title_short | Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care |
| title_sort | 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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