Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis

Does low does naltrexone (LDN) improve quality of life in PwMS?

A study in 80 PwMS was performed to evaluate the effect of 8 weeks of treatment with LDN (4.5mg taken at night). Although LDN was associated with significant improvement in some mental health quality of life measures, the trial was too small to draw definitive conclusions.

Interpretation: this study was too small to be definitive. However, it provides further support for a large definitive study of LDN in MS. Unfortunately, the current “Big Pharma” business model does not support investigating drugs that are off patent. May be “Big Pharma” will now try and develop a follow-on me-to drug to test in PwMS.

Cree et al. Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis. Ann Neurol. 2010 Aug;68(2):145-50.

Vitamin D and the genome

New research shows the effect of vitamin D on the genome is widespread and localises to genes and areas of the genome associated with increased susceptibility to MS and other autoimmune diseases. This paper is very important in that it provides a clue to why the effects of vitamin D are so widespread and potentially why vitamin D deficiency is associated with so many different diseases.

Click here for article

Please see the following press releases on the significance of this work:

1. The Guardian
2. The Metro

Cord blood banking; what to advise regarding stem cell therapies

My response to a question about banking cord blood from a newborn baby to treat a family member with severe MS.

“The potential of stem cell therapies for neurological conditions has been over-hyped by both the basic scientists involved and the media. This is great pity as it raises false expectations of a breakthrough for vulnerable people with disabling conditions.

At present the research is a long way from reaching the clinic with some early exploratory safety studies underway in the UK and elsewhere. The science suggests that mesenchymal stem cells, i.e. those derived from skin, and bone-marrow derived stem cells may work as immunomodulatory therapies rather than as a neuro-restorative therapies; this means that they will be of benefit early in the course of the disease to modify the clinical course. They will not help people who are already disabled.

Embryonic stem cells, which are derived from foetal tissue, are unlikely to be used in humans as they have a propensity to cause primitive tumours because of their ability to differentiate in numerous cell types; there are several reports of this occurring already. In my opinion, routine storage of cord blood cells should therefore be done for altruistic reasons to support research. To do it specifically for an unproven therapy or a potential therapy in the future cannot be recommended at this stage.”

Genes determine low levels of vitamin D: implications for MS

Vitamin D is crucial for maintenance of the immune system and vD deficiency has been implicated in the causal pathway of MS. In this study genetic variants at three places in the genome were associated with vD levels. Subjects with a score that combined all three variants were at increased risk of having low vD concentrations. These variants in the genome are near genes involved in cholesterol metabolism and vD transport. It will be very important to see if these areas are associated with MS. This study tells us that the story behind vD and MS will be very complex; it will take a lot of hard work to pin down how vD deficiency contributes to the pathogenesis of MS.

Wang et al. Lancet. 2010 Jul 17;376(9736):148-9.

More news on CCSVI

Using virtually identical ultrasound techniques to try and reproduce the results by Dr Zamboni, Florian Doepp and colleagues in Berlin have not been able to reproduce the results that put CCSVI on the map. Their results seriously challenge the hypothesis that cerebral venous congestion plays a significant role in the pathogenesis of MS.

What are the implications of these findings for people with MS?

Clearly we need to wait for other studies in this area to clarify the discrepency in the results of these studies. From a clinical perspective we continue to advise against undergoing any interventional therapy until there is clarity on whether or not CCSVI is a real entity or not.

Please click here for an abstract on the study

Sativex for MS-related spasticity

It has been a long haul, but finally another option for people with MS-related spasticity.

Click here for press release

The signficance of this license cannot be under estimated; particularly as the registration study will probably set a precedent for how spasticity studies are done in the future. The Ashworth Scale has had its day and is seriously flawed as an outcome measure. This result can also be viewed as a victory for patient-related outcome measures or PROMS.