Do We Need Clinical Trials for MS Lifestyle Treatments?

We have been discussing lifestyle factors, such as diet and exercise, a lot recently on MStranslate.  This has been presented both in terms of the reported benefits of these approaches from anecdotal evidence of people living with multiple sclerosis, as well as by summarising studies that have been conducted in these areas.

One of the key discussion points about alternative treatment options is whether or not clinical trials are needed to provide a ‘gold-standard’ level of proof about their benefits.  This becomes particularly important, especially when members of our community regularly talk about these options not being presented to them as part of an MS management plan by their neurologists or healthcare professionals.

Therefore, we have two questions that we have to think about:

1. Is it realistic to undertake clinical trials to test these approaches?
2. Is it necessary to have this level of testing when it comes to lifestyle modifications?

The answer to both of these questions are complicated and have many factors, not all of which will be discussed in this article.  I will focus on a couple of key issues as I see them and hopefully we will be able to engage in more conversation under the post and in a follow-up Facebook Live video that I will do in the near future.

Let’s look at question 1 first – how realistic are clinical trials for these types of treatments?

I would say that one of the critical components of conducting a rigorous clinical trial is having a control group – that is, a group that does not receive the treatment.  Generally, this control group takes some form of placebo to ensure that the trial is blinded.  This means that no person in the trial knows whether they are taking the active treatment or not, so that they don’t report ‘feeling’ better based on a placebo effect alone.

If we think about this type of scenario in terms of testing dietary approaches, it becomes quite difficult.  Firstly, all meals would have to be provided to both groups and there would need to be some way of ensuring that only these foods were consumed.  Secondly, what would the control group be given to eat?  Potentially it would work if you were testing a very specific type of food or supplement, whereby everything else in the diet was kept exactly the same.  In this way, it is more like testing a compound, rather than an overall diet.

Unfortunately, this raises another potential problem.  Considering there are now quite large amounts of both anecdotal evidence and published studies for many dietary factors (e.g plant based polyunsaturated fatty acids), is it ethical to have a control group and restrict their access to something that seems to provide benefits?  In a similar way, this has been an issue that has held up participant recruitment for studies investigating the benefits of Vitamin D.  Would you risk receiving a placebo for 1-2 years when you could just get access to something over the counter that seems to provide benefits or, at the very least, not be harmful?

Aside from the difficulties with control groups and blinding, I think the other problem comes from how many different variables and factors are involved when we begin to discuss lifestyle modification.  I mean this in two ways.  Firstly, it is really hard to be able to eliminate every difference between people in terms of their lifestyle to just assess one thing of interest.  Secondly, it is likely that many different changes are needed and many factors have to be addressed for benefits to be observed.  Therefore, if we just try and isolate one lifestyle factor at a time and see what benefits it has for people with multiple sclerosis, we may not see anything.  However, if it is used in a combination with other approaches, we may begin to see an improvement in some symptoms and quality of life.

For example, if you begin to exercise without also doing something to manage energy production problems….will you really get the full picture?  You may wish to revisit our MS: Many Story articles by Andrew to get a feeling for how many different factors he addresses to create his own overall multiple sclerosis management plan.

Ok, there are obviously some big topics that we’ve just talked about that probably deserve a much longer discussion, but I think that is a good starting point.  Let’s look at question 2 now – are these trials even necessary?

Again, this is difficult to answer and remember that this is just purely my own opinion.  For me, if we are going to talk about clinical trials purely for lifestyle modification in areas such as diet and exercise, it comes down to what are the potential negatives.  Generally, most of the recommended approaches so far involve trying to maintain a healthy, balanced diet and committing to undertaking some regular exercise that is within any potential limitations that you may have.  In these respects, there probably isn’t any large negatives that demonstrate a need for large, expensive and potentially unhelpful clinical trials to be undertaken.

In saying that, I think that studies in this area are certainly useful to help build more knowledge about specific approaches that may be more beneficial than others and why they work.  This should help raise awareness about these alternatives, make them more accepted by healthcare professionals and also improve our understanding of multiple sclerosis in general.  As well as this, I think that it is always important that if anyone is intending to start on a new diet, begin a new exercise routine or make any other big lifestyle changes that this is done in consultation with medical professionals to ensure that it is done correctly and without any negative side-effects.

So these are my thoughts, what are yours?  I would love to hear what you have to say on the topic, you can either drop a comment under this article or on the associated Facebook post.  Alternatively, you can e-mail me via brett@mstranslate.com.au to share your opinions.