Add-on Supplement May Bolster Interferon Therapies for RRMS
Small trial finds relapse rate, disability progression benefits with Neuroaspis plp10
A dietary supplement called Neuroaspis plp10 significantly lowered relapse rates and slowed disability progression among people with relapsing-remitting multiple sclerosis (RRMS) on interferon beta medications, according to a small clinical trial in Greece.
“The results of this study suggest that Neuroaspis plp10 may offer greater benefit to patients with RRMS when used as an [add-on] to the existing RRMS treatments,” its researchers wrote.
The study, “Phase III, randomised, double-blind, placebo-controlled trial of Neuroaspis plp10 as an adjuvant treatment for relapsing multiple sclerosis: the MINERAL Study,” was published in BMJ Neurology Open.
Multiple sclerosis supplement containing polyunsaturated fatty acids, antioxidants
It’s usually advised that people with MS consume plenty of polyunsaturated fatty acids (PUFAs) — fats found in fish and nuts, which are thought to have anti-inflammatory properties and are important for nervous system repair — as well as antioxidants that can reduce oxidative stress, a type of cell damage induced by inflammation.
Neuroaspis plp10, marketed in Europe by Aniva International, is a dietary supplement that contains a combination of PUFAs alongside several antioxidants, namely vitamin E and gamma-tocopherol. This supplement showed an ability to reduce relapses and slow MS disability progression in a proof-of-concept trial.
To confirm the findings, a team led by scientists in Cyprus conducted a Phase 3 clinical trial (ISRCTN06166891). The study tested the efficacy of Neuroaspis plp10 as an add-on, or adjuvant, treatment for RRMS patients who were receiving interferon-based therapies, such as Avonex (interferon beta-1a) or Extavia (interferon beta-1b).
In the study, 28 people on interferon treatment for at least six months were given oral Neuroaspis plp10, taken daily 30 minutes before dinner. Another 27 patients were given a placebo (virgin olive oil). Participants were instructed not to alter their normal dietary or exercise habits.
The trial’s primary goal was to determine if two years of Neuroaspis plp10 supplementation lowered relapse rates. The time to confirmed disability progression, defined as a sustained increase in expanded disability status scale (EDSS) scores lasting at least six months, was a key secondary goal.
“This is a phase III, double-blind, randomised, placebo-controlled clinical trial study that specifies definite clinical end points, in an attempt to demonstrate possible adjuvant therapeutic effects on disease-modifying therapy (DMT) in MS by a specific dietary/nutrition formula,” the team wrote.
The study, which lasted for over two years, was completed by 19 patients in the Neuroaspis plp10 group and 20 in the placebo group. The most common reasons for stopping early included changes in MS treatment, patient choice, and pregnancy.
After one year, average annual relapse rates were 0.13 for Neuroaspis plp10 patients and 0.63 for those on a placebo. This difference, representing an 80% relative reduction in the annual relapse rate, persisted out to two years and remained statistically significant after adjustments for age, sex, years since MS diagnosis, and clinical factors at the trial’s start.
The probability of sustained disability progression also was significantly lower after two years for patients on Neuroaspis plp10 than a placebo (18.8% vs. 47.4%). This represents a relative 73% decrease in the risk of sustained disability progression with Neuroaspis plp10, the researchers said.
After 30 months, MRI data showed that rates of new or enlarging lesions were 51% lower among patients on Neuroaspis plp10 compared to a placebo. Rates of actively inflamed lesions were 71% lower with the dietary supplement.
Over the course of the study, no severe side effects related to Neuroaspis plp10’s use were reported.
“This novel oral treatment formulation, associated with no significant side effects, [given] as adjuvant to the previously considered ‘first-line’ drugs such as [interferon therapies] and possibly with the rest of the newer medications … can introduce a safe and increased treatment effect” to complement “the reported efficacy of the DMTs alone,” the scientists concluded.