ESPEN 2012 - Late breaking abstract submission

Topic: Late Breaking Abstract

Abs n°:ESPEN12-1863

Abs Title: ORAL NUTRACEUTICAL FORMULA (PLP10) FOR THE TREATMENT OF RELAPSING REMITTING MULTIPLE SCLEROSIS: DOUBLE-BLIND, RANDOMIZED CLINICAL TRIAL

I. S. Patrikios ^1,*M. C. Pantzaris ¹G. N. Loukaides ¹E. E. Ntzani ²

¹Neurology, The Cyprus Institute of Neurology and Genetics (CING), Nicosia, Cyprus, ²Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece

Rationale: Available multiple sclerosis (MS) treatments are products of reductionism, partially effective with no (re)myelinating/neuroprotective abilities associated with significant side-effects. We aimed to assess whether our novel interventions, formulated based on systems medicine (SM), comprising specific polyunsaturated fatty acids (PUFA) and vitamins reduce disease activity in patients with relapsing remitting (RR)MS.

Methods: We contacted a 30-month randomized, double-blind, placebo-controlled, proof-of-concept clinical study at the CING. Of a total of 80 patients, 20 were randomly assigned to receive intervention A (DHA/ EPA (3:1 w/w) omega-3, LA/ GLA (2:1 w/w) omega-6 FA, omega-3/omega-6 (1:1 w/w), other specific PUFA, monounsaturated FA, minor quantity of specific saturated FA, vitamin A and vitamin E), 20 to receive γ-tocopherol, intervention C, 20 to receive the combination of A and C, intervention B (PLP10) and 20 to receive placebo, as an oral solution, once daily. The primary end point was the annual relapse rate (ARR) and the secondary end point was the time to disability progression. ISRCTN87818535.

Results: PLP10 reduced the ARR (primary end-point) by 58% (95% CI 0.10 to 0.79, p=0.016) and significantly reduced the risk of sustained progression of disability (secondary end-point) by 86% over the 2-year period (Hr, 0.11; 95% CI 0.01-0.97, p=0.047) vs. placebo. More patients in the PLP10 (72%) vs. placebo group (20%) were free from new or enlarging T2-weighted lesions on brain MRI over the 2-year study. No adverse events were reported. Interventions A and C showed no significant efficacy.

Conclusion: PLP10 treatment significantly reduced the ARR, and the risk of sustained disability progression without any adverse or significant side effects. This is the first clinical study of SM approach formula holding strong promise as an effective treatment for RRMS. 

Disclosure of Interest: I. Patrikios Grant/Research Support from: Cyprus Ministry of Commerce, Industry and TourismM. Pantzaris Grant/Research Support from: Cyprus Ministry of Commerce, Industry and TourismG. Loukaides Grant/Research Support from: Cyprus Ministry of Commerce, Industry and TourismE. Ntzani: None Declared

Keywords: Nutraceutical, Multiple Sclerosis