Clinical trials with multiple endpoints can establish a correlation, but not (yet) causality, between dietary supplementation with omega-3 fatty acids and keratoconjunctivitis sicca

Abstract

Comparability of omega-3 therapeutic efficacy and effectiveness remains a major challenge in dry eye disease management. Notwithstanding its multi-factorial character, addressing prevailing methodological and empirical issues in clinical trials will help reduce knowledge gaps and normative choices among eye physicians and patients alike. In this regard, pharmacoeconomics offers a useful and robust toolset through which analysis of cost-minimization, cost-effectiveness, and cost-utility as well as meta-analysis can be comparatively pursued. Blending measures of costs and outcomes puts in perspective the heterogeneity of clinical endpoints in keratoconjunctivitis sicca.

Can Multi-Attribute Utility Instruments Adequately Capture Net Health Gains in Vision-Related Quality of Life (QoL)?

“…Dietary supplementation with omega-3 fatty acids (omega-3s) in keratoconjunctivitis sicca (colloquially known as dry eye disease) is illustrative of healthcare interventions in which patient comfort and relief from signs and symptoms are the anticipated primary gains in QoL. This contrasts with prescription drugs and medical devices for which QALYs are typically derived to adjust or correct life expectancy based on additional life years and levels of health-related QoL predicted for a patient in a given condition (Mendoza, 2018).…”

The Protective Effect of Polyunsaturated Fatty Acids against Dry Eye Disease: A Literature Review

“…Evidence accumulated from studies conducted within the past decades indicates that supplementation with PUFAs, particularly ω3, may help the treatment of DED [85].…”

“…The daily intake of a moderate dose of ω3 was also shown to have beneficial effect against MGD [84]. Meanwhile, the safety profiles of PUFAs have not been paid much attention to, as studies regarding the PUFAs supplementation in patients with DED have rarely reported adverse effects of the PUFAs [85].…”

“…This has been attributed to the following reasons. (1) Clinical trials have had considerably heterogeneous compositions, doses, and durations, making it difficult to establish guidelines [85]. (2) There are few well-controlled long-term clinical trials involving a large population.…”

“…Nonetheless, FDA recommends the consumption of ≥8 ounces (227 g) of seafood every week for American adults, and also advises that the consumption of seafood containing relatively low levels of mercury, e.g., salmon, sardine, herring, cod, haddock, anchovy, oyster, scallop, shrimp, and canned light tuna, up to 12 ounces (340 g) per week may be safe [88]. Although this literature review has a limitation that systematic analysis or meta-analysis of the results of the studies were not performed, we believe this review may provide readers with new information as the results of the studies recently reported was introduced [34,[36][37][38]42,[60][61][62]74,75,83,85], This review also included the results of experimental studies [47][48][49][50].…”