KARAOKE: Krill oil versus placebo in the treatment of knee osteoarthritis: protocol for a randomised controlled trial.

BACKGROUND: Knee osteoarthritis (OA) is a common and important cause of pain and disability, but interventions aimed at modifying structures visible on imaging have been disappointing. While OA affects the whole joint, synovitis and effusion have been recognised as having a role in the pathogenesis of OA. Krill oil reduces knee pain and systemic inflammation and could be used for targeting inflammatory mechanisms of OA. METHODS/DESIGN: We will recruit 260 patients with clinical knee OA, significant knee pain and effusion-synovitis present on MRI in five Australian cities (Hobart, Melbourne, Sydney, Adelaide and Perth). These patients will be randomly allocated to the two arms of the study, receiving 2 g/day krill oil or inert placebo daily for 6 months. MRI of the study knee will be performed at screening and after 6 months. Knee symptoms, function and MRI structural abnormalities will be assessed using validated methods. Safety data will be recorded. Primary outcomes are absolute change in knee pain (assessed by visual analog score) and change in size of knee effusion-synovitis over 24 weeks. Secondary outcomes include improvement in knee pain over 4, 8, 12, 16 and 20 weeks. The primary analyses will be intention-to-treat analyses of primary and secondary outcomes. Per protocol analyses adjusting for missing data and for treatment compliance will be performed as the secondary analyses. DISCUSSION: This study will provide high-quality evidence to assess whether krill oil 2 g/day reduces pain and effusion-synovitis size in older adults with clinical knee OA and knee effusion-synovitis. If krill oil is effective and confirmed to be safe, we will provide compelling evidence that krill oil improves pain and function, changes disease trajectory and slows disease progression in OA. Given the lack of approved therapies for slowing disease progression in OA, and moderate cost of krill oil, these findings will be readily translated into clinical practice. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616000726459. Registered on 02 June 2016. Universal Trial Number (UTN) U1111-1181-7087.

Analysis of hospital cost outcome of DHA-rich fish-oil supplementation in pregnancy: Evidence from a randomized controlled trial.

OBJECTIVE: Recent research emphasized the nutritional benefits of omega-3 long chain polyunsaturated fatty acids (LCPUFAs) during pregnancy. Based on a double-blind randomised controlled trial named "DHA to Optimize Mother and Infant Outcome" (DOMInO), we examined how omega 3 DHA supplementation during pregnancy may affect pregnancy related in-patient hospital costs. METHOD: We conducted an econometric analysis based on ordinary least square and quantile regressions with bootstrapped standard errors. Using these approaches, we also examined whether smoking, drinking, maternal age and BMI could influence the effect of DHA supplementation during pregnancy on hospital costs. RESULTS: Our regressions showed that in-patient hospital costs could decrease by AUD92 (P<0.05) on average per singleton pregnancy when DHA supplements were consumed during pregnancy. Our regression results also showed that the cost savings to the Australian public hospital system could be between AUD15 - AUD51 million / year. CONCLUSION: Given that a simple intervention like DHA-rich fish-oil supplementation could generate savings to the public, it may be worthwhile from a policy perspective to encourage DHA supplementation among pregnant women.

Considerations for incorporating eicosapentaenoic and docosahexaenoic omega-3 fatty acids into the military food supply chain.

The U.S. military may consider exploring the inclusion of the long-chain omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), in the diets of active duty military personnel. To be successful, certain challenges must be overcome including determining appropriate dosage, ensuring cost efficiency, and optimizing stability. To increase EPA and DHA intake, the military should consider using one of three strategies, including mandates or recommendations on omega-3 supplement usage, contracts to purchase commercially available foods for distribution in the food supply chain, or direct addition of EPA and DHA into currently consumed foods. This review presents the challenges and strategies and provides potential suggestions to the military to increase the likelihood of success.

A cost-effectiveness analysis of n-3 PUFA (Omacor) treatment in post-MI patients.

This study evaluates the cost-effectiveness of Omacor treatment as a standard prevention measure post-MI in the UK. A cost-effectiveness model was developed based on the GISSI-P trial, combining a survival and a Markov model, over a lifetime period. The base case results for Omacor, at 4 years and over a lifetime, respectively, were: cost [corrected] per QALY gained: pound15,189 and 3,723; [corrected] cost per life years gained (LYG): pound12,011 and pound2,812 [corrected] The cost per death avoided at 4 years was pound31,786. Deterministic and probabilistic sensitivity analyses did not change the base case results substantially. The use of Omacor as a standard post-MI prevention treatment seems warranted in the UK, both on the basis of its efficacy, which is in addition to other prophylactic treatments as evidenced by the results of the GISSI-P trial, and on cost-effectiveness grounds - both at 4 years and over a lifetime's time-horizon, using the current cost-effectiveness thresholds.