Food additives and supplements as an adjunctive treatment in Parkinson's Disease

Research Research discussion
1
The Group may be interested in a difficulty with a proposed trial. In summary it will be:
Summary of proposed trial
'Efficacy of a combination of food additives and supplements as an adjunctive treatment in Parkinson's Disease (Ecombi study)'

Based on experience with an informal trial programme – see (www.brainhelp.info) the proposed formal study will comprise:
1. Selection of 120 people with Parkinson's divided as follows:
15 newly diagnosed to use the mixture for 12 months as well as any medication prescribed
15 newly diagnosed to use only prescribed medication (control group)

15 diagnosed 3 yrs ago to use the mixture 12 mths with usual medication
15 diagnosed 3 yrs ago to use usual medication (control group)

15 diagnosed 6 yrs ago to use the mixture 12 mnths with usual medication
15 diagnosed 6 yrs ago to use usual medication (control Group)

15 diagnosed 10 yrs ago to use the mixture 12 months with usual medication
15 diagnosed 10 yrs ago to use usual medication (control group)

2. Baseline assessment of all subjects and controls using a recognised scale (UPDRS)
Baseline assessment of all caregivers using a recognised burden scale

3. Monthly domiciliary reassessment by trained research assistants of all subjects and caregivers in study group for first 6 months of study and thereafter bi-monthly to 12 months using same scales as at baseline

4. Four monthly domiciliary reassessment by trained research assistants of all control group subjects and caregivers using same scales as at baseline

5. Continuation of supply of mixture on a named-patient basis to study subjects found to have benefited from its use
6. Evaluation of results and conveyance of them to all subjects and controls



Ecombi (This mix is currently in use as 'PIPmix' but this name is searchable on the internet so renaming is required for the study)

Label: Provided by the NHS for use only in the Ecombi study

Each 450ml contains:

6-o-palmitoyl-l-ascorbate (E-304) 50gm

Trehalose 210gm

Lemon fish oil 130ml

Extra virgin olive oil 40ml

Extra virgin rapeseed oil 40ml

STIR THE MIX THOROUGHLY EACH DAY BEFORE USE

Take 15ml (dessertspoonful) daily

Sufficient for 30 days

Safety margins daily intake (from MSDS worst case scenarios)
PA intake 1.6gm 0.9% of LD-50 >3000mg/kg (guinea pig)
Trehalose 7.0gm 1.09% of LD-50 7000mg/kg (guinea pig)
Fish oil, olive oil, rapeseed oil no LD-50 available (foodstuffs)
Folic acid 0.4mg 0.006% of LD-50 120mg/kg (guinea pig)

Subjects also take sub-lingual Vit B12 powder (200microgm B12) every other day
and Danone fruit layer yoghurt and Actimel L.casei drink daily (bought fresh).

Summary
All items used are recognised food additives or foodstuffs
No subject will be asked to cease or modify prescribed medications
(NB. some may find that in the course of the study less medication is needed and may reduce daily intake of medications in consultation with neurologists)
Case reports as examples of possible outcomes.
Case report P
Yr of birth: 1950
History: fractures following accident 1994 - subsequent stress/fatigue/tremor
PD diagnosed: 1999
Retired from teaching music 2001
2002 – 2007 Obsessive Compulsive Disorder (OCD) following agonist treatment which was eventually discontinued
Gait unsteady even using walking stick, unable to ride cycle or play musical instruments
2008 (October) started on Parkinson's Improvement Programme
(November) after three weeks ran for 20 minutes and could ride mountain bike again
(December) improved 'wellbeing' and walking, less pain, increased facial expression.
2009 (January) Stronger and more alert, sleeping better
(February) More alert and confident, resumed serious mountain biking on steep, rough ground, reduced 'off' time.
(April) Resumed tuning and playing stringed instruments (after a gap of many years) improved fine motor control evident
(June) Mountain biking up to two hours, reduced dose of Sinemet by 8%
2010 (September) resumed playing tennis regularly
(November) getting good sleep, tennis 3x per week, biking every day, playing guitar and accordion
2011 (February) Entertaining 30 people at club, cycling, exercising daily, reduced Sinemet dose further
(April) Tennis three sets three times a week, offering music tuition on stringed instruments, daily cycling and running.
(October) Continues in good health as above

Notes in explanation of the case reports
Parkinson's Disease (PD) is usually treated with levodopa formulations, in this case Sinemet, to boost dopamine levels in the nervous system. It is frequently treated with 'dopamine agonists' to encourage increased dopamine production in the patient.
Some times (maybe even up to a disputed 25%) there are unwanted agonist side effects (OCD) including obsessive collecting, re-arranging of items, excessive interest in pornography and sex, gambling to excess. Cessation of agonist treatment allows a return to more normal state but with increased PD symptoms again.
There are no prescribed PD medications which provide positive revival of failed systems such as lack of facial expression, loss of sense of smell and fine control of movement, loss of sense of balance, poor sleep patterns.
The Parkinson's Improvement Programme was devised primarily to improve gut health as that had been shown to be useful. It was also intended to provide the nutrients needed for brain repair previously thought (and taught in my day) to be impossible. The recommended daily intake is a dessertspoonful (10 – 15 ml) of a premixed product 'PIPmix' supplied in a jar and formulated as:
E V Olive oil 40ml
Lemon fish oil 130ml
EV rapeseed oil 40ml
Trehalose 210gm Palmitoyl ascorbate 50gm
Folic acid 12.0mg

This jar lasts 30 days (approx) and is supplemented with fresh probiotics and sublingual B12

Case report D
Year of birth: 1951
PD diagnosed: 1999
Symptoms: mild until neck operation 2009 then rapid deterioration, Bell's palsy and eczema July 2010
Gait unsteady, poor balance, walking stiffly on tiptoe with support, speech impaired and depression, severe constipation (common PD symptom).
2010 (July) Started on PIPmix, B12 and probiotics
(August) Feels better, steadier on feet, better balance with armswing when walking, constipation cured, back in his workshop able to work on car. Speech more normal.
Takes his wife breakfast in bed upstairs carrying tray with no spillage.
(December) Reduced prescribed medication by 50%, has more energy. Wife says he spends all day in workshop (keeps and maintains 5 old cars)
2011 (February) Walking well, more energy, good balance, delighted.
(May) Servicing all 5 cars using pit in garage, walking well, feels fine
(October) Building new workshop himself. Walking well, feels fine.


Now there is a difference of opinion from MHRA - one office has said registration of this as a clinical trial is not required because it is not a medicine on trial but another office says it must be a medicine because it improves the symptoms of Parkinson's!! Watch this space.
2
Hi Everybody
We have moved this post from the discussion about the Cure Parkinson's Action group as it is referring to a different subject


Tim
3
Do you need subjects? I'm 5 yeras diagnosed on no meds but currently using supplements
4
Hi everyone, thanks for the thread - diet and supplements are a very interesting area.

At the moment, there is very little scientific evidence to suggest that following any particular diet is helpful for people with Parkinson's. And generally, people should get all of the vitamins and minerals they need by following a healthy and balanced diet without the need for supplements.

There's a good section on our website which addresses diet and Parkinson's - including an excellent Q&A with a dietician:

http://www.parkinsons.org.uk/default.aspx?page=10885

If you are interested in diet and Parkinson's you could ask your GP or nurse to refer you to a dietician.
5
I agree with the research folk that there is no real evidence that supplements work for Parkinsons. However it is equally true that there is little evidence they don't work (with Vit E and COQ10 as exceptions but even so, few studies)I don't want to be cynical but it is understandable that drug companies who fund much of the research have little to gain by exploring the value of cheap non-patentable supplements.
Well done chewexpert for working to get some more research findings on this topic. I fear that whatever you discover will be discounted due to the low statistical power of the sample group sizes but it will move us forward a bit I hope.
Thanks to the research team for ensuring we keep our feet on the ground.
:wink:
6
I would be very interested in joining this trial. I contacted you about it a couple of years back but had an h-pylori test which came up negative. Is the trial still ongoing?

Trixiedee
7
I had h-pylori test recently and it to proved negative so i was advised by GP that going on the course would not benefit. Its really for those who the test comes up positive.

Out of interest who is RESEARCHER ?

Would be nice to have a name then the forum group, ie Ezinda (ADMIN)
8
Free food, where do I sign.

It seems full of oil. A sponfull of castor oil or liquid parafin would suffice. An empty bowel and increased running whilst holding your bottom closed would account for the increased energy levels.

Seemples, ands you dont needs a laptop-a-ma-bob to work that out.
9
Not all research is funded by the pharmaceutical companies, Parkinson's UK has over the years poured a fair amount of money into it!
To me, the list of supplements/potion ingredients seems to make it potentially difficult to distinguish at the end of the trials between the effective substances and the worthless(or even some harmful ones in the long term?)
10
Hi CHewexpert,
I was fascinated to read the latest trial you have going. Good results so far! I am happy to be include in any further trial you are doing. I come into the category of six years since diagnosis.
Regards,
Weedy