ArticleBMJ neurology open2022
Phase III, randomised, double-blind, placebo-controlled trial of Neuroaspis plp10 as an adjuvant treatment for relapsing multiple sclerosis: the MINERAL Study.
Article in BMJ neurology open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed, 2 citations in OpenAlex.
- Polyunsaturated Fatty Acid Supplementation in Multiple Sclerosis Management: A Scoping Review.Nutrients · 2026Article
- Nutritional interventional studies in patients with multiple sclerosis: a scoping review of the current clinical evidence.Journal of neurology · 2024Article
- DHA/EPA (Omega-3) and LA/GLA (Omega-6) as Bioactive Molecules in Neurodegenerative Diseases.International journal of molecular sciences · 2023Review
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Authors and funding
14 authors at 8 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objectives: To assess the effectiveness of Neuroaspis plp10 nutritional supplement when added to interferon (IFN)-β treatment in patients with relapsing-remitting multiple sclerosis (RRMS). Design: A 30-month phase III multicentre, randomised, double-blind, placebo-controlled trial. Randomisation stratified by centre using a computer-generated procedure with Neuroaspis plp10 versus placebo in 1:1 ratio. The first 6 months were used as both the pre-entry and normalisation period. Setting: 3 teaching hospitals in Greece and 1 Neurology Institute in Cyprus. Participants: 61 patients with RRMS on IFN-β were randomly assigned to receive Neuroaspis plp10 (n=32) or placebo (n=29), 20 mL, orally, once daily, for 30 months. Intervention: Neuroaspis plp10, a cocktail mixture, containing specific PUFA (12 150 mg) and γ-tocopherol (760 mg) versus virgin olive oil (placebo). Main outcome measure: The primary end point was the annual relapse rate (ARR) whereas the secondary ones were the rate of sustained progression of disability, as measured by the Expanded Disability Status Scale (EDSS) and the brain T2 and gadolinium-enhancing lesions, at 2 years. Results: For the intention-to-treat analyses Neuroaspis plp10 significantly reduced the ARR by 80%, (RRR, 0.20; 95% CI: 0.09 to 0.45; p=0.0001) and the risk of sustained progression of disability by 73% (HR, 0.27; 95% CI: 0.09 to 0.83; p=0.022) versus placebo, at 2 years. The number of T1 gadolinium-enhancing lesions and the number of new/enlarged T2-hyperintense lesions were significantly reduced (p=0.01 and p<0.0001, respectively). Both T1-enhancing and new/enlarging T2-hyperintense lesions were significantly reduced (p=0.05 and p<0.0001, respectively). No significant adverse events were reported. Conclusions: Neuroaspis plp10 added to IFN-β was significantly more effective than IFN-β alone in patients with RRMS. Trial registration number: ISRCTN06166891.
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