Please take the time to browse through the FAQ.
The Northeast ALS Consortium (NEALS) did a survey of clinicians and clinical researchers who concluded that any therapy that resulted in a change of 20% or greater in the slope of the ALSFRS-R would be clinically meaningful, but there was no therapy available to achieve it at that time. However, it would now appear that the clinical evidence indicates that RCH4 far exceeds the safety and efficacy of any treatment to date.
We must rely on the monthly monitoring reports from our PALS friends in fourteen countries (86% Europe & North America. Four Ethnicities) over some years, the accuracy of which we cannot independently verify. Accordingly, we make no claims about efficacy nor do we offer any interpretation of the data (as treatment is ongoing, data can change). There are many reports on the Internet by users of RCH4 discussing safety and efficacy. For example, the ‘Patients Like Me’ forum is possibly the most accurate and reliable forum on the Internet. However there are very minor errors in their software, e.g. total numbers of patients do not tally, starting dates are not all correct, number of evaluations do not tally exactly, etc.
As the ALSFRS-R score is a subjective observation, it will likely be scored differently by any two different people. It is said that the PALS must be scored by a specialist medical professional - but this is not the case. See the evaluation study on the accuracy of online self-reporting here (Journal Amyotrophic Lateral Sclerosis Volume 13, 2012 - Issue 2)
In fact the precise ALSFRS-R score is not particularly relevant. What matters is the CHANGE in the score over exactly the same time periods. Provided that the SAME person (e.g., the patient or a caregiver) does the scoring every month over a long time, the submitted change in data is very accurate. Further, scoring by the same person over extended time ensures elimination of patient or carer bias as the submitted data would rapidly exceed the envelope of credibility.
Monthly monitoring reports are submitted to us by all our PALS friends. This monthly information comprises 6 health parameters. One of these parameters is the ALSFRS-R score. This is an ongoing record of points allocated to 12 questions. As every monthly report form is submitted, the information is automatically picked up by a database, and the statistics updated in real-time. All interventions are known to aﬀect the course of disease (e.g., NIV, Trach., gastrostomy, etc.) are tracked. We, therefore, maintain a very accurate analysis of each PALS, enabling pro-active ongoing management of their RCH4 treatment if possible.
We have long experience in dealing with ALS victims, some for years of continuous treatment with RCH4, and have clearly identified the greatest dangers. Prevention is imperative SEE HERE
Infections. Primarily lung, urinary tract, and gastrostomy or tracheostomy tube sites. Installing cheap isopropyl alcohol hand sanitizers throughout the household and used frequently by everyone - including every visitor - dramatically lowers infection occurrence.
Weight loss. Every effort MUST be made to increase weight. Great attention must be paid to nutrition
Maintaining a positive mental attitude and control of depression. Refer to the last paragraph on this page
Falls and accidents resulting in injuries not recovered from, e.g., falling down stairs or onto a hard surface in the kitchen or bathroom. Installing a carpet or donning a cycle helmet will offer some protection in hard floor / tiled areas. Never use rugs as they cause tripping.-
Pressure sores. These are totally avoidable with proper care. e.g., moving the patient at least every hour or more frequently. They are caused by restricted blood flow to the skin and can appear very quickly. Pressure sores can lead to serious complications.
For pressure sores we find the following treatment can be very effective:
After flushing, the wound/pressure sore with sterile water, dry the surrounding area.
Cover the wound with a layer of collagen powder about 2mm thick. This provides a framework to assist the new cells trying to fill in from the edges of the wound. The collagen does not need to be removed as the enzymes in the wound dissolve it over some time.
Use manuka honey dressing on top of the collagen. The high sugar content kills the surface bioburden due to osmosis and keeps it sterile for a few days until it the honey dries or absorbed. Being of similar viscosity too thick treacle at body temperature, honey impregnated dressings do not adhere to the wound and are removed without any discomfort.
Cover the honey dressing with a thick layer of soft cotton wool to offer protection from pressure or impact on the wound.
Keep the cotton wool/honey dressing/collagen in place with adhesive tape.
Repeat the procedure every few days.
Whereas being ready-made and are very convenient, we do not recommend the commercially manufactured feeding formulae as being suitable for this condition.
We have a lot of experience in this field. It is considered that some favorite ingredients often used in these manufactured products are inappropriate, for example, soy protein. In the case of soy protein, among other issues, it contains phytic acid which reduces the absorption and restricts bioavailability. Further, some of these otherwise innocuous ingredients are contraindicated in the case of neurodegenerative conditions as they can contain neurotoxins which under normal circumstances would be well tolerated. But undesirable in ALS/MND. A further example of an inappropriate ingredient normally found in commercial formulae is cheap corn syrup, whereas honey would be eminently more desirable but more expensive. For those who have a gastrostomy, the diet must comprise of a high calorie, high fat, high animal (not a vegetable) protein diet. A normal “bad” diet (taking into account the previous sentence) of high cholesterol foods can be liquidized. Even `Big Mac` or `Kentucky Chicken` meals complete with their french fries (“chips”) are far better than any commercial liquid feeding product.
Although it has to be prepared, an example of the following put through a liquidizer is far more effective and preferable: Chicken stock (which is highly nutritious and readily absorbed) should be used to adjust the viscosity of the following example ingredients: Eggs (raw, hard-boiled, or fried) Oily fish - perhaps sardines in oil, mackerel, etc. Fatty lamb or beef Rice and low roughage fresh vegetables
Avoid roughage as it only acts as a filler with little nutritional value. Constipation is easily dealt with using a stool softener or laxative if required. We recommend that you discuss the foregoing with your nutritionist or doctor. Do bear in mind that a nutritionist may have little experience with ALS which requires particular consideration. Maintaining weight, or gaining it if at all possible, is very important for the long-term future.
Whereas doctors rightly recommend that their patient should exercise to keep limbs and joints flexible as possible, but that must not be interpreted as doing workouts in the gym - or whatever. A physical therapist may be likely to set exertion goals for the patient to achieve - which is well-meaning, but a very bad idea and counterproductive for a PALS. Stretching is good, but not strenuous exertion. PALS are hypermetabolic, therefore should avoid strenuous exercise, conserve energy and focus on trying to maintain, or increase weight.
Vitamins can indeed be helpful for general health in modest amounts but have no proven discernable benefit for ALS.
There is a vast range of supplements promoted by commercial entities. Some of which are recommended by PALS but are entirely unsuitable for ALS /MND, just leading to more problems. Some supplements actually exacerbate the neurological situation. Numerous studies have been done in a range of supplements, but none showed any statistical evidence of efficacy. In general, unless your doctor has a specific reason to recommend a particular supplement, we prefer if our PALS friends take none at all other than Vitamin C or/and Vitamin D and in some cases possibly B6 - in modest amounts.
There are some well-known “Protocols” that are virtually guaranteed to shorten the life of any PALS.
Popular diets are unhelpful. Many of our PALS friends have a history of following fad diets, went to the gym more than once per week, were fitness enthusiasts, had a trauma accident, were in the military, or sold supplements. Therein surely rests a lesson. If you are a PALS, do not go to a gym. The diet which PALS should focus on is one of high fat, high protein, and high calorific value together with fresh green vegetables, and avoid high roughage content foods - again unless their doctor has a specific reason to recommend otherwise. PALS are hypermetabolic in that they burn some one-third more energy than average resulting in weight and muscle loss. Thus the high fat, high calorific diet is essential to counteract weight and energy loss. We do not recommend winter Flu jabs for PALS because the risk of complications may outweigh the benefits, but you must be guided by your doctor. However, in order to protect the PALS from Influenza, it is recommended that caregivers themselves get the `Flu jab`.
Unless a formal, authorized clinical trial, again, under no circumstances consider stem cell treatment from any of the many clinics advertising their services in this field. None of them can demonstrate any evidence of realistic efficacy, there are confirmed reports of some catastrophic outcomes and they charge very large sums of money. Even FDA-approved formal stem cell trials have never demonstrated a long-term slowing of the progression. If your clinic is reputable, they will advise you of this under the rules of “Informed Patient Consent”.
They are widely available from online “reputable” so-called “non-profit” entities. These counterfeits mostly originate from China and India. We estimate that some 30% of all ALS drugs (by value) in circulation are now counterfeit. Under no circumstances buy these lower-cost fakes. Commonly, their modus operandi is to offer free telephone “advice” or “consultation”, which in essence is a sales pitch for their counterfeit drugs. Sometimes their “doctor” issues the prescription. A medical doctor cannot legally issue a treatment prescription without examining the patient and/or having access to the patients' complete clinical file and history. Do not send them money, especially to those whose website registration is hidden by a proxy and cannot be traced.