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MS research update - Small trial of a dietary supplement - 24 April 2013

Summary

A small trial of a specially prepared fatty acid/vitamin mix, which included omega-3 and omega-6 fatty acids, vitamin A and vitamin E, suggests that relapse rate and disabilty progression can be reduced in people with relapsing remitting MS. The trial only included a small number of people but the researchers hope to undertake a much more extensive trial to see if the results are replicated in a larger number of people.

Background

For many people with MS, eating healthily is part of managing their condition – something that can be done relatively easily to be as well as possible. Along with considering what might constitute a healthy diet, many people ask whether taking vitamins or other dietary supplements could be helpful. This is an area of MS research where few high quality studies have taken place. The research published this week aims to address this through a double-blind, placebo-controlled, parallel design, phase II proof-of-concept clinical study.

How this study was carried out

Participants with relapsing remitting MS in Cyprus were recruited who were aged 18 to 65 and could walk without a walking aid (EDSS score of between zero and 5.5).

Potential participants were excluded from the trial if they had experienced a relapse in the past 30 days, had received immunosuppressant or monoclonal antibody therapy in the past two years or were pregnant or nursing. People were also excluded if they had already taken any food supplements, vitamins or any form of polyunsaturated fatty acids.

80 people who met the criteria for the trial were randomly divided into four equal sized groups. Each group took a different dietary supplement or a placebo as a liquid once every day, 30 minutes before dinner, for two and a half years. Participants did not know which dietary supplement they were taking and neither did the staff who were in direct contact with the participants (this is known as a double blind trial). The supplements were formulated just for this clinical trial.

Group A: took equal amounts of omega-3 and omega-6 polyunsaturated fatty acids (details of which fatty acids are in the full text of this research paper), minor quantities of other specific polyunsaturated, monounsaturated and saturated fatty acids as well as vitamin A and vitamin E (alpha tocopherol).

Group B: took PLP10 which was the same supplement mix as Group A but with gamma tocopherol added. Gamma tocopherol is another form of vitamin E.

Group C: took gamma tocopherol only

Group D: took a placebo

The researchers key comparison was the yearly rate of relapses for each group after two years. However, they also examined the time it took for disability to progress by at least one point on the EDSS scale and examined MRI scans

What was found

39 out of 80 participants dropped out of the trial - 29 of them because of the unpleasant taste and smell of the supplements and another 5 became pregnant so were no longer eligible. This left only 41 people who completed the two and a half year trial.

The researchers observed eight relapses in the 10 participants taking PLP10 (group B) which gave an annualised relapse rate of 0.40. In comparison, the 12 participants taking placebo (Group D) experienced 25 relapses between them which is an annualised relapse rate of 1.04. This is a reduction of almost two thirds (64%) for those taking the PLP10 supplements.

The time to disability progression, was significantly longer for Group B who took PLP10 supplements. Similarly, the probability of disability progression at 2 years was 10% in the PLP10 group compared with 58% in the placebo group

MRI results supported the above observations as only 29% from the PLP10 group, compared with 67% from the placebo group, developed new or enlarging T2 lesions.

Groups A and C did not show the benefits experienced by group B so it appears that the it is the unique combination of all the ingredients in PLP10 which is required for the supplement to work.

No safety issues were seen in any of the four groups.

What does it mean?

The authors conclude that the dietary supplement PLP10 is safe and significantly reduces the relapse rate and the risk of sustained disability progression in this small trial. However, they believe that larger studies are needed to further assess the safety and effectiveness of PLP10.

Comment

This trial is very interesting as it tried to take a very carefully controlled approach to a difficult topic. It has some strengths but there are also some areas of concern.

The strengths of the study include its design which is a double-blind, placebo-controlled, parallel design. It is a phase II proof of concept trial so it can only begin to determine the effectiveness of the PLP10 treatment. A phase III trial would be needed to more accurately assess the potential of PLP10 in a larger number of people.

This trial used a number of well established outcome measures which are common to many clinical trials in MS: relapse rates, disability progression and MRI scan results. It also followed people over a long period (two and a half years) whereas some trials only look for an effect after a few months.

There are some areas of concern and questions that arise from the results of this trial. Firstly, the drop out rate was very high. This was largely due to the unpleasant taste and smell of the liquid supplements despite the fact that the researchers had included a citrus aroma in the formulation. The researchers say that this level of drop out is common in trials which use oily preparations. This meant that the number of people taking part in the study was reduced to half of what had been planned and this affects the strength of the conclusions.

Secondly, the annual relapse rate seen in the placebo group is quite high by modern standards and this has been questioned by an MS specialist neurologist.

Overall, this study is promising but illustrates some of the difficulties of doing research in this field. It will be interesting to see the results of a much larger trial of this supplement which was made just for this study so is not commercially available.

Pantzaris MC, Loukaides GN, Ntzani EE, et al.
A novel oral nutraceutical formula of omega-3 and omega-6 fatty acids with vitamins (PLP10) in relapsing remitting multiple sclerosis: a randomised, double-blind, placebo-controlled proof-of-concept clinical trial.
BMJ Open. 2013 Apr 17;3(4).
abstract
Read the full text of this paper

More about dietary supplements

You can read more about diet in the A to Z of MS.

A recent article by a dietician in the MS Trust newsletter Open Door discusses aspects of diet including the types of fat, omega-3 and omega-6 used in this trial. Omega-3 is usually obtained from fish oil and omega-6, including linoleic acid, is most commonly found in sunflower and safflower oil. There is more information about linoleic acid in the A to Z of MS.

Some people with MS take vitamin D supplements as it is important for a healthy immune system and may be important in MS. It is thought that low levels of vitamin D may contribute to the risk of developing MS and may increase the number of relapses and affect the course of the disease.

Research by topic areas...

Diagnosis

Simon J.
Very early MS--insights from MRI.
Mult Scler. 2012 Oct;18(10):1372-6.
abstract

Symptoms and symptom management

Alfonsi E, Bergamaschi R, Cosentino G, et al.
Electrophysiological patterns of oropharyngeal swallowing in multiple sclerosis.
Clin Neurophysiol. 2013 Apr 16. doi:pii: S1388-2457(13)00217-4.
abstract

Disease modifying treatments

Freedman MS, Selchen D, Arnold DL, et al.
Treatment optimization in MS: Canadian MS working group updated recommendations.
Can J Neurol Sci. 2013 May;40(3):307-23.
abstract

Lanzillo R, Quarantelli M, Bonavita S, et al.
Natalizumab vs interferon beta 1a in relapsing-remitting multiple sclerosis: a head-to-head retrospective study.
Acta Neurol Scand. 2012 Nov;126(5):306-14.
abstract

Epidemiology

Iuliano G.
Multiple sclerosis: long time modifications of seasonal differences in the frequency of clinical attacks.
Neurol Sci. 2012 Oct;33(5):999-1003.
abstract

Assessment tools

Dagenais E, Rouleau I, Demers M, et al.
Value of the MoCA test as a screening instrument in multiple sclerosis.
Can J Neurol Sci. 2013 May;40(3):410-5.
abstract

Rabadi MH, Vincent AS.
Comparison of the Kurtkze Expanded Disability Status Scale and the Functional Independence Measure: measures of multiple sclerosis-related disability.
Disabil Rehabil. 2013 Apr 19. [Epub ahead of print]
abstract

Erbayat Altay E, Fisher E, Jones SE, et al.
Reliability of classifying multiple sclerosis disease activity using magnetic resonance imaging in a multiple sclerosis clinic.
JAMA Neurol. 2013 Mar 1;70(3):338-44.
abstract

Paediatric MS

Rubin JP, Kuntz NL.
Diagnostic criteria for pediatric multiple sclerosis.
Curr Neurol Neurosci Rep. 2013 Jun;13(6):354.
abstract

Psychological aspects

Wakefield JR, Bickley S, Sani F.
The effects of identification with a support group on the mental health of people with multiple sclerosis.
J Psychosom Res. 2013 May;74(5):420-6.
abstract

Brissart H, Morele E, Baumann C, et al.
Verbal episodic memory in 426 multiple sclerosis patients: impairment in encoding, retrieval or both?
Neurol Sci. 2012 Oct;33(5):1117-23.
abstract

Physical activity

Nogueira LA, Dos Santos LT, Sabino PG, et al.
Factors for lower walking speed in persons with multiple sclerosis.
Mult Scler Int. 2013;2013:875648.
abstract

Taylor P, Barrett C, Mann G, et al.
A feasibility study to investigate the effect of functional electrical stimulation and physiotherapy exercise on the quality of gait of people with multiple sclerosis.
Neuromodulation. 2013 Apr 19. doi: 10.1111/ner.12048. [Epub ahead of print]
abstract

Motl RW, McAuley E, Sandroff BM.
Longitudinal change in physical activity and its correlates in relapsing-remitting multiple sclerosis.
Phys Ther. 2013 Apr 18. [Epub ahead of print]
abstract

Motl RW.
Ambulation and multiple sclerosis.
Phys Med Rehabil Clin N Am. 2013 May;24(2):325-36.
abstract

Sosnoff JJ, Socie MJ, Sandroff BM, et al.
Mobility and cognitive correlates of dual task cost of walking in persons with multiple sclerosis.
Disabil Rehabil. 2013 Apr 18. [Epub ahead of print]
abstract

Pathophysiology

Weinstock-Guttman B, Zivadinov R, et al.
Lipid profiles are associated with lesion formation over 24 months in interferon-ß treated patients following the first demyelinating event.
J Neurol Neurosurg Psychiatry. 2013 Apr 17. [Epub ahead of print]
abstract

Falls

Cameron MH, Nilsagård YE.
Measurement and treatment of imbalance and fall risk in multiple sclerosis using the international classification of functioning, disability and health model.
Phys Med Rehabil Clin N Am. 2013 May;24(2):337-54.
abstract

Finlayson ML, Peterson EW, Asano M.
A cross-sectional study examining multiple mobility device use and fall status among middle-aged and older adults with multiple sclerosis.
Disabil Rehabil Assist Technol. 2013 Apr 18. [Epub ahead of print]
abstract

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