Fish oil administration in older adults: is there potential for adverse events? A systematic review of the literature
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Date
2013-05-01Author
Villani, Anthony M
Cleland, Leslie G
James, Michael J
Fraser, Robert J L
Cobiac, Lynne
Miller, Michelle Deanne
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Show full item recordAbstract
ackground: Omega-3 (n-3) fatty acid supplementation is becoming increasingly popular. However given its
antithrombotic properties the potential for severe adverse events (SAE) such as bleeding has safety implications,
particularly in an older adult population. A systematic review of randomized control trials (RCT) was conducted to
explore the potential for SAE and non-severe adverse events (non-SAE) associated with n-3 supplementation in
older adults.
Methods: A comprehensive search strategy using Medline and a variety of other electronic sources was conducted.
Studies investigating the oral administration of n-3 fish oil containing eicosapentaenoic acid (EPA), docosahexaenoic
acid (DHA) or both against a placebo were sourced. The primary outcome of interest included reported SAE
associated with n-3 supplementation. Chi-square analyses were conducted on the pooled aggregate of AEs.
Results: Of the 398 citations initially retrieved, a total of 10 studies involving 994 older adults aged ≥60 years were
included in the review. Daily fish oil doses ranged from 0.03 g to 1.86 g EPA and/or DHA with study durations
ranging from 6 to 52 weeks. No SAE were reported and there were no significant differences in the total AE rate
between groups (n-3 intervention group: 53/540; 9.8%; placebo group: 28/454; 6.2%; p= 0.07). Non-SAE relating to
gastrointestinal (GI) disturbances were the most commonly reported however there was no significant increase in
the proportion of GI disturbances reported in participants randomized to the n-3 intervention (n-3 intervention
group: 42/540 (7.8%); placebo group: 24/454 (5.3%); p= 0.18).
Conclusions: The potential for AEs appear mild-moderate at worst and are unlikely to be of clinical significance. The
use of n-3 fatty acids and the potential for SAE should however be further researched to investigate whether this
evidence is consistent at higher doses and in other populations. These results also highlight that well-documented data
outlining the potential for SAE following n-3 supplementation are limited nor adequately reported to draw definitive
conclusions concerning the safety associated with n-3 supplementation. A more rigorous and systematic approach for
monitoring and recording AE data in clinical settings that involve n-3 supplementation is required.