Re: LDN Trial in the UK for MS By Dr Tom Gilhooly

[Guest guest]

Hi ,

Great news!

I'd like to add this to Case Health's database to help spread the word but I'd prefer to include your website address instead of your email address (to manage risk of spam). OK with you?

Regards,

Cris

[low dose naltrexone] LDN Trial in the UK for MS By Dr Tom Gilhooly

LDN Research Trial in the UK for MSBy Dr Tom GilhoolyOne of the challenges for those of us involved in prescribing LDN, is the lack of research to support what we do. "Where's the evidence?" is a common question asked by other medics, when we explain what we are doing with their patients. Most are understanding and keen to see anything help their MS patients, but some are suspicious, and some downright hostile. The problem with research into LDN is that there is no monetary incentive for the pharmaceutical industry to fund this, and in fact, for some, there is a distinct disincentive. If LDN was shown to be as effective as some of the much more expensive treatments, it would be inevitably bad for business. There is no conspiracy to suppress LDN research, but even the MS society has failed to support it. The LDN Research Trust is dedicated to bringing that research to the wider public, and the problem that faces us is one of funding and of expertise. My experience in prescribing LDN has been a positive one; it is beneficial for the vast majority of patients who have been taking it. It is difficult, however, to demonstrate this improvement using the standard rating scales such as Expanded Disability Status Scale (EDSS). It is perfectly feasible for someone to feel better, and indeed be better, but when seen by the neurologist, the rating with EDSS remains the same. The problem is not LDN or the patient, but the sensitivity of the tool. It would be pointless to design a study using an insensitive tool, as this could fail to demonstrate any positive impact on the patient's health. This would only confirm the bias against LDN in the medical community, and may close the door on any further research on the subject. What we need is a well designed study, using a tool sensitive enough to measure improvements that may not show up on the EDSS. One of the most common areas of improvement is in bladder function; even at doses as low as 1mg of LDN, which is regarded as sub-therapeutic by many, patients report improved bladder function. One patient in particular informed me that his night time visits to the toilet were reduced from 5 - 10 per night to none! This had had a significant effect on his quality of life, considerably reducing his fatigue. As bladder dysfunction affects 70% or more MS patients, it struck me that this would be a prime area for study.I have some research experience, and a few publications in the addiction field, so I have a fair idea of how to structure a good research project. Dr Bob Lawrence and myself are currently working on the design of a study into the impact of LDN on bladder dysfunction. We face several obstacles (as always) with research, but we have no doubts this study will not only be completed, but will be the first to demonstrate to the world that LDN has an impact on quality of life for people with MS. One of the challenges is funding, but we intend to design this as cheaply as possible, and fully expect the cost to be met from sales of the MS Baseline, our multi-nutrient capsule, which will be on sale from January 2006. The study will be a randomised double blind placebo control trial which, for the layman, means that neither the patient nor the researcher will know if they are taking active LDN or a placebo. Most of the work will be done by post, so we cut out the costs of researchers. We are hopeful of receiving the LDN and placebo free of charge, which will again keep prices low. The trial will be on MS patients with bladder problems, specifically: frequency, nocturia (getting up at night), and incontinence. It will last for three months, and we will start recruiting as soon as ethical approval has been obtained. We will be looking for individuals who have MS confirmed by MRI scan and lumbar puncture, with significant bladder dysfunction. They will have to understand that this is not a way to get onto LDN, but a trial of a limited period, and that they may well end up getting a placebo for the duration of the trial. We would of course make every effort to continue prescribing for those who were doing well on the drug after the three month period, although this would be by way of a private prescription. This is a very exciting time, but we must make absolutely sure that this study is as scientifically rigorous and robust as possible. The results, if positive, will make it much harder to ignore LDN, and that will not please the medical establishment, who would rather bury the whole subject. Expect this study, no matter how good, to be rubbished by many so-called "experts". As Bernard Shaw said: "all progress depends on unreasonable man". We have a duty, in this case, to be unreasonable. We will have more details of the study in the New Year, but it will probably take about three months to get everything in place. As a wise old researcher once told me: "double your expected timescales", so it may be the summer before we get it going; but the most important thing is, we are now closer to realising the ambition of getting LDN into the regime of MS patients throughout the world. If you know of anyone who may be willing to take part in this study, please send your details to at the Trust. They would have to be UK residents, and meet the criteria outlined here. LDN Research Trial SummaryEligibility for the LDN Bladder Trial & #61656; MS diagnosis, by MRI and lumbar puncture. (All types of MS.) & #61656; Have significant bladder problems, frequency, urgency, nocturia (getting up at night), or incontinence. & #61656; Aged 18 - 60 years.Exclusions & #61656; Must not self-catheterise, or use a catheter. & #61656; People who have previously tried LDN. & #61656; Pregnant women. & #61656; Those taking an interferon drug, steroids or an immune suppressant.Taking part in the trial doesn't guarantee that you will be able to be prescribed LDN once the trial has finished, although, every effort will be made to supply LDN with a private prescription to those that have responded positively.We will be looking for 80 people with MS that fit the above criteria; it doesn't matter where people live, as long as they are UK residents.Please spread the word to people you think might be interested; they will be added to our database, and contacted in due course. Email Elsegood at elsegood@.... All emails will be responded to.We desperately need to raise a further £5,000; if anyone is able to help with fund raising, we would like to hear from you. Donations as always, are more then welcome

[Guest guest]

Hi Cris,

Any help we get spreading the word is more than welcome.

Thank you for your support.