Nutraceutical Trial: too good to be true?

Why are so many dietary studies in MS done so poorly? #MSBlog #MSResearch

Rezapour-Firouzi  et al.Association of Expanded Disability Status Scale and Cytokines after Intervention with Co-supplemented Hemp Seed, Evening Primrose Oils and Hot-natured Diet in Multiple Sclerosis Patients. Bioimpacts. 2013;3(1):43-7.

INTRODUCTION: MS is an inflammatory demyelinating disease of the central nervous system (CNS). Because of limited efficacy and adverse side effects, identifying novel therapeutic and protective agents is important. The aim of this study is to examine the correlations between expanded disability status scale (EDSS) and cytokines after intervention with co-supplemented hemp seed and evening primrose oils and hot-natured diet in RRMSers.

METHODS: They studied a group of 23 RRMSers, with EDSS<6 who received co-supplemented hemp seed and evening primrose oils who were advised to follow a hot-natured diet. Clinically EDSS and immunological factors (plasma cytokines of IL-4, IFN-γ and IL-17) were assessed at baseline and after 6 months.

RESULTS: Mean follow-up was 180±2.9 days (n=23, 7 Male and 16 Females aged 25.0±7.5 years with disease duration 6.26±3.9 years). After 6 months, significant improvements in extended disability status score were found in the MSers in agreement with decrease cytokines of IFN-γ and IL-17 and increase cytokines of IL-4. Clinical and immunological parameters showed improvement in the MSers after the intervention.

CONCLUSION: This study shows that co-supplemented hemp seed and evening primrose oils with hot-natured diet can have beneficial effects in improving clinical symptoms in relapsing remitting MS patients and significant correlation was found between EDSS and immunological findings.

“There is saying that states we are what we eat. Diet is important and is likely to impact on our health in numerous ways. This is why I always promote a healthy diet. However, the evidence that one specific diet is better for MSers than another is simply not there; i.e. we don’t have data from randomised controlled trials. I promote the British Heart Foundation’s diet, which is based on the so called ‘Mediterranean Diet’. Why this diet? Simply, because we have evidence for its benefits in other aspects of general health. The latter is important as we are now beginning to see good data that MSers with comorbidities doing worse than MSers who don’t have other diseases, e.g. hypertension, diabetes, cardiovascular disease, stroke and smoking. Yes, smoking is a disease it is an addiction and needs to be treated. MSers who smoke progress much quicker than MSers who don’t smoke.”

“This study  is very small and uncontrolled, it needs a placebo control group to make any inferences. This study is a good example of poor science. It is full of potential biases; both open and hidden biases. For example, MSers are more likely to volunteer if they have had a recent relapse. Although this is not stated in the methods and results, it is a well known phenomenon in the field of MS research. If more active MSers are selected they are then more likely to become inactive on the intervention, i.e. a so called regression to the mean. The changes in cytokines could simply reflect regression to the mean, a natural drop off in inflammation that occurs in MSers who have recently had a relapse. This could also explain the improvement in EDSS, i.e. a recovery in disability from a recent relapses. Having a control group would have allowed you to assess this phenomenon.”

About the author

Prof G

Professor of Neurology, Barts & The London. MS & Preventive Neurology thinker, blogger, runner, vegetable gardener, husband, father, cook and wine & food lover.

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