Fish oil in recent onset rheumatoid arthritis: a randomised, double-blind controlled trial within algorithm-based drug use
Proudman SM, James MJ, Spargo LD, Metcalf RG, Sullivan TR, Rischmueller M, Flabouris K, Wechalekar MD, Lee AT, Cleland LG
Annals of the rheumatic diseases · 106 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Royal Adelaide Hospital
- Gobierno
- Medical Research Council
Según 2 financiadores declarados.
Publicación
- Publicado
- 2013-10-01 · Ann Rheum Dis · vol. 74 · número 1 · págs. 89–95
- Editorial
- BMJ
- Citado
- 163 citas · más que el 99% de estudios similares · 9.7× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 28 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Rheumatoid Arthritis Research and Therapies · Fatty Acid Research and Health · Systemic Lupus Erythematosus Research
- Palabras clave
- fish oil, omega-3 fatty acids, eicosapentaenoic acid, docosahexaenoic acid, rheumatoid arthritis, early rheumatoid arthritis, treat-to-target, combination DMARD therapy, methotrexate, sulfasalazine, hydroxychloroquine, disease-modifying antirheumatic drugs, dose comparison
- MeSH
- humans, arthritis, rheumatoid, sulfasalazine, isoxazoles, methotrexate, hydroxychloroquine, docosahexaenoic acids, eicosapentaenoic acid, fish oils, antirheumatic agents, blood sedimentation, treatment outcome, drug therapy, combination, remission induction, double-blind method, adult, aged, middle aged, female, male, early medical intervention, leflunomide
10 autores
- Susanna Proudman🇦🇺 · autor de correspondenciaRoyal Adelaide Hospital; The University of Adelaide
- Michael J. James🇦🇺Royal Adelaide Hospital; The University of Adelaide
- Llewellyn DJ Spargo🇦🇺Royal Adelaide Hospital
- Robert G. Metcalf🇦🇺Royal Adelaide Hospital
- Thomas Sullivan🇦🇺The University of Adelaide
- Maureen Rischmueller🇬🇧Queen Elizabeth Hospital
- Katerina Flabouris🇦🇺The University of Adelaide
- Mihir D. Wechalekar🇦🇺Royal Adelaide Hospital
- Anita T Lee🇦🇺Royal Adelaide Hospital
- Leslie G. Cleland🇦🇺Royal Adelaide Hospital; The University of Adelaide
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
The effects of fish oil (FO) in rheumatoid arthritis (RA) have not been examined in the context of contemporary treatment of early RA. This study examined the effects of high versus low dose FO in early RA employing a 'treat-to-target' protocol of combination disease-modifying anti-rheumatic drugs (DMARDs).
Methods
Patients with RA <12 months' duration and who were DMARD-naïve were enrolled and randomised 2:1 to FO at a high dose or low dose (for masking). These groups, designated FO and control, were given 5.5 or 0.4 g/day, respectively, of the omega-3 fats, eicosapentaenoic acid + docosahexaenoic acid. All patients received methotrexate (MTX), sulphasalazine and hydroxychloroquine, and DMARD doses were adjusted according to an algorithm taking disease activity and toxicity into account. DAS28-erythrocyte sedimentation rate, modified Health Assessment Questionnaire (mHAQ) and remission were assessed three monthly. The primary outcome measure was failure of triple DMARD therapy.
Results
In the FO group, failure of triple DMARD therapy was lower (HR=0.28 (95% CI 0.12 to 0.63; p=0.002) unadjusted and 0.24 (95% CI 0.10 to 0.54; p=0.0006) following adjustment for smoking history, shared epitope and baseline anti-cyclic citrullinated peptide. The rate of first American College of Rheumatology (ACR) remission was significantly greater in the FO compared with the control group (HRs=2.17 (95% CI 1.07 to 4.42; p=0.03) unadjusted and 2.09 (95% CI 1.02 to 4.30; p=0.04) adjusted). There were no differences between groups in MTX dose, DAS28 or mHAQ scores, or adverse events.
Conclusions
FO was associated with benefits additional to those achieved by combination 'treat-to-target' DMARDs with similar MTX use. These included reduced triple DMARD failure and a higher rate of ACR remission.
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