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LDN Conference 2010 in Glasgow

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Category: Medical Info and Drug Trials

Published on Monday, 03 May 2010 10:00

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What was the conference all about?

Low dose Naltrexone (LDN) is a drug that was developed to combat drug addiction and overdoses but has found to be effective in combating other conditions when used at a much lower dose. The conference had particular relevance for fibromyalgia as the preliminary results of a trial of LDN’s use as a treatment for fibromyalgia were unveiled.

When LDN is prescribed for other conditions off list by doctors there is still the difficulty in obtaining it and getting it in the right dosage. Stephen Dickinson of Dickinson Pharmacy spoke of the supply chain, the process of obtaining LDN and the possible medications to avoid while taking LDN as well as those that can be taken at the same time. This Glasgow pharmacy is now supplying 2500+ patients from all over the UK with LDN prescriptions. These prescriptions are being written by over 680 GPs. And as more people are taking LDN more information is being found about suitability and interaction with other medications.

We also heard of personal stories from people that had benefited from this treatment and the differences in the level of acceptance that LDN was receiving since the previous year’s conference.

Stanford Study

Doctor Jarred Younger and his team had previously carried out a single blind pilot study on the use of LDN in the treatment of fibromyalgia and the results were an improvement in 6 out of the 10 people involved in the trial. And with this positive result the Stanford team were eager to carry out a further expanded trial to see if they could replicate the results.

Dr Younger presented his results on a video to the conference before answering some questions via a video link. He stressed that these results and the analysis were very preliminary and it will take some time to produce the finished results. However, even though the study had only recently been completed, he had processed the data to present some conclusions.

This second study looked at 30 women taking both LDN and a placebo in a double blind study.  The drug was given 1 hour before bedtime and a dosage of 4.5mg was administered. Respondents entered data into a palm pilot device by answering some simple Q&A scenarios. They also attended the lab every two weeks to upload the palm pilot data and have further tests with the staff.  The mean age of respondents was 43, who all had fibromyalgia from between 8 to 10 years and experienced a pain score of around 6/10.

Results

Even with the preliminary status of the data Jarred Younger was able to say that LDN “has a statistically significant effect” and the tolerability of the drug was the same as the placebo which will be of significance to those patients with drug sensitivities. A complication of the data analysis was raised by the fact that the drug appeared to continue to have a positive effect for a short period after it had stopped being taken. This means a positive benefit for patients and provides a further curiosity for the researchers. However from a research point of view it makes the analysis of the data more difficult. Further studies may require adjustment to account for this event.

A curious side effect was again found in this study. 47% of respondents reported an increase in the vividness of dreams. This was described as things like colour rather than content such as nightmares. The drug was reduced from 4.5mg to 3mg in cases where the dreams were considered an issue and this seemed to be more acceptable.

Thoughts on how LDN may work

LDN is an immune modulator and can possibly boost the immune system to help increase the production of endorphins. It was explained that the method by which LDN may help people with FM is that it would affect the behaviour of some cells in the brain called microglia. Microglias are a type of glial cells that are the resident white blood cells of the brain and spinal cord, and thus act as the first and main form of active immune defence in the central nervous system (CNS).

It was put forward that the microglia become stuck in an activated state and flares are perhaps a microglial response. Clearly more work is required to replicate these results and delve further into mechanisms, possible side effects and treatment protocol.

Further Work or trials

It was mentioned that work would be needed to complete the analysis of the data and the creation of new models to represent the data effectively. However beyond this the team had identified the following as future work:

• Identifying suitability of patients as LDN candidates
• Further study into long term safety and effects
• Identifying and proving the mechanism by which LDN operates
• Optimisation of dosage and delivery to better fit fibromyalgia patients

Johns Hopkins are conducting research into using PET scans to observe the actions and behaviour of microglia and this could be of interest. There are also other projects related to LDN and one in Australia is looking at the splitting of LDN into smaller components and this could be of great interest if they still prove effective as a treatment. By developing a new process or compound a patent could be applied for which would draw interest from pharmaceutical companies and therefore more research interest and the finance to make it happen. However this would be longer term as clinical trials would be required to prove any new component part.

Conclusion

I found the conference very interesting and the future of LDN and fibromyalgia could be very exciting. However this excitement must be tempered as more trials and more evidence are required.

Long term operation and safety are one part of the equation but there is also the need for trials conducted on larger groups of fibromyalgia patients, more types of these patients as well as further geographic areas sampled. We have seen other results of clinical trials into other conditions / drugs elsewhere that have failed to be replicated in other environments or countries.

I do think that the anecdotal evidence from personal accounts and this clinical trial provide a cautionary light towards a relief of suffering for some and the medical and community needs to shine this light in as many places as possible and find out why LDN works and perhaps where it does not as this will increase our understanding of fibromyalgia, LDN and more along the way. This accumulation of information will only make the lot of those people still to be diagnosed with fibromyalgia in the future an easier one.

Regards
Des Quinn
Vice Chair FMA UK