Effect of an enteric-coated fish-oil preparation on relapses in Crohn's disease
Belluzzi A, Brignola C, Campieri M, Pera A, Boschi S, Miglioli M
The New England journal of medicine · 442 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 1996-06-13 · N Engl J Med · vol. 334 · número 24 · págs. 1557–1560
- Editorial
- Massachusetts Medical Society
- Citado
- 766 citas · más que el 100% de estudios similares · 21.7× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 33 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Inflammatory Bowel Disease · Fatty Acid Research and Health · Rheumatoid Arthritis Research and Therapies
- Palabras clave
- Crohn's disease, fish oil, omega-3 fatty acids, enteric-coated capsules, relapse prevention, remission maintenance, anti-inflammatory therapy, gastrointestinal adverse effects
- MeSH
- humans, crohn disease, recurrence, fatty acids, omega-3, fatty acids, unsaturated, fatty acids, omega-6, fish oils, anti-inflammatory agents, capsules, tablets, enteric-coated, treatment outcome, multivariate analysis, logistic models, double-blind method, adult, aged, middle aged, female, male, biomarkers
6 autores
- Andrea Belluzzi🇮🇹University of Bologna
- Corrado Brignola🇮🇹University of Bologna
- Massimo Campieri🇮🇹University of Bologna
- Angelo Pera🇮🇹Azienda Ospedaliero Universitaria San Giovanni Battista
- Stefano Boschi🇮🇹University of Bologna
- Mario Miglioli🇮🇹University of Bologna
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Patients with Crohn's disease may have periods of remission, interrupted by relapses. Because fish oil has antiinflammatory actions, it could reduce the frequency of relapses, but it is often poorly tolerated because of its unpleasant taste and gastrointestinal side effects.
Methods
We performed a one-year, double-blind, placebo-controlled study to investigate the effects of a new fish-oil preparation in the maintenance of remission in 78 patients with Crohn's disease who had a high risk of relapse. The patients received either nine fish-oil capsules containing a total of 2.7 g of n-3 fatty acids or nine placebo capsules daily. A special coating protected the capsules against gastric acidity for at least 30 minutes.
Results
Among the 39 patients in the fish-oil group, 11 (28 percent) had relapses, 4 dropped out because of diarrhea, and 1 withdrew for other reasons. In contrast, among the 39 patients in the placebo group, 27 (69 percent) had relapses, 1 dropped out because of diarrhea, and 1 withdrew for other reasons (difference in relapse rate, 41 percentage points; 95 percent confidence interval, 21 to 61; P < 0.001). After one year, 23 patients (59 percent) in the fish-oil group remained in remission, as compared with 10 (26 percent) in the placebo group (P = 0.003). Logistic-regression analysis indicated that only fish oil and not sex, age, previous surgery, duration of disease, or smoking status affected the likelihood of relapse (odds ratio for the placebo group as compared with the fish-oil group, 4.2; 95 percent confidence interval, 1.6 to 10.7).
Conclusions
In patients with Crohn's disease in remission, a novel enteric-coated fish-oil preparation is effective in reducing the rate of relapse.
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