LDN Trial in the UK for MS By Dr Tom Gilhooly

[Guest guest]

LDN Research Trial in the UK for MS

By Dr Tom Gilhooly

One 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 Summary

Eligibility 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