Safety and tolerability of prescription omega-3 fatty acids: A systematic review and meta-analysis of randomized controlled trials
Chang CH, Tseng PT, Chen NY, Lin PC, Lin PY, Chang JP, Kuo FY, Lin J, Wu MC, Su KP
Prostaglandins, leukotrienes, and essential fatty acids · 74 citas
Cómo se estudió
- Diseño
- Metaanálisis (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Kaohsiung Veterans General Hospital
Según 1 financiador declarado.
Publicación
- Publicado
- 2018-01-05 · Prostaglandins Leukot Essent Fatty Acids · vol. 129 · págs. 1–12
- Editorial
- Elsevier BV
- Citado
- 103 citas · más que el 90% de estudios similares · 2.6× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 68 trabajos
- Acceso
- Acceso abierto (copia en repositorio) · CC-BY-NC-ND
- Áreas de investigación
- Fatty Acid Research and Health · Pharmacovigilance and Adverse Drug Reactions · Pharmacology and Obesity Treatment
- Palabras clave
- eicosapentaenoic acid, docosahexaenoic acid, drug safety, tolerability, adverse effects, dysgeusia, skin abnormalities, gastrointestinal adverse effects, LDL cholesterol elevation, alanine aminotransferase, fasting blood glucose
- MeSH
- humans, dysgeusia, eczema, exanthema, blood glucose, docosahexaenoic acids, eicosapentaenoic acid, dietary supplements, cholesterol, ldl, randomized controlled trials as topic, patient safety
10 autores
- Cheng‐Ho Chang🇹🇼National Pingtung University of Science and Technology; Kaohsiung Veterans General Hospital
- Ping‐Tao Tseng
- Nai‐Yu Chen🇹🇼Kaohsiung Veterans General Hospital; National Cheng Kung University
- Pei‐Chin Lin🇹🇼Kaohsiung Medical University; Chang Gung University; Kaohsiung Chang Gung Memorial Hospital; Kaohsiung Veterans General Hospital
- Pao‐Yen Lin🇹🇼Kaohsiung Medical University; Chang Gung University; Kaohsiung Chang Gung Memorial Hospital; Kaohsiung Veterans General Hospital
- Jane Pei‐Chen Chang🇬🇧🇹🇼King's College London; China Medical University; China Medical University Hospital
- Feng Yu Kuo🇹🇼Kaohsiung Veterans General Hospital
- Jenshinn Lin🇹🇼National Pingtung University of Science and Technology
- M. C. WU🇹🇼 · autor de correspondenciaNational Pingtung University of Science and Technology
- Kuan‐Pin Su🇹🇼 · autor de correspondenciaChina Medical University; China Medical University Hospital
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Omega-3 fatty acids [eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)] are widely recommended for health promotion. Over the last decade, prescription omega-3 fatty acid products (RxOME3FAs) have been approved for medical indications. Nonetheless, there is no comprehensive analysis of safety and tolerability of RxOME3FAs so far.
Methods
A systematic review of randomized controlled trials (RCTs) was carried out based on searches in six electronic databases. The studies involving marketed RxOME3FA products were included, and adverse-effect data were extracted for meta-analysis. Subgroup analysis and meta-regression were conducted to explore the sources of potential heterogeneity.
Results
Among the 21 included RCTs (total 24,460 participants; 12,750 from RxOME3FA treatment cohort and 11,710 from control cohort), there was no definite evidence of any RxOME3FA-emerging serious adverse event. Compared with the control group, RxOME3FAs were associated with more treatment-related dysgeusia (fishy taste; p = 0.011) and skin abnormalities (eruption, itching, exanthema, or eczema; p < 0.001). Besides, RxOME3FAs had mild adverse effects upon some non-lipid laboratory measurements [elevated fasting blood sugar (p = 0.005); elevated alanine transaminase (p = 0.022); elevated blood urea nitrogen (p = 0.047); decreased hemoglobin (p = 0.002); decreased hematocrit (p = 0.009)]. Subgroup analysis revealed that EPA/DHA combination products were associated with more treatment-related gastrointestinal adverse events [eructation (belching; p = 0.010); nausea (p = 0.044)] and low-density lipoprotein cholesterol elevation (p = 0.009; difference in means = 4.106mg/dL).
Conclusion
RxOME3FAs are generally safe and well tolerated but not free of adverse effects. Post-marketing surveillance and observational studies are still necessary to identify long-term adverse effects and to confirm the safety and tolerability profiles of RxOME3FAs.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
Confianza de la comunidad
Cargando…
¿Cuánto confías en los hallazgos de este estudio?
Comentarios
¿Algo está mal aquí?
Señala este estudio si su información, etiquetas o financiación parecen incorrectas. Un editor revisa cada señalamiento.
Información educativa sobre investigación publicada. No es consejo médico ni una recomendación para empezar o dejar nada.