A Short writeup on SMP study by Rich

[Freddd]

I received this in the course of correspondence with Rich in a WORD .doc file. It has nothing of a personal nature in it and I think it would desireable to offer it here, unchanged. It is a snapshot of data from the study with Dr Nathan, 6 months in, as Rich describes in the text. The numbers given are percentages as he describes. It does make an important clarification about the 9 people that participated in the study that don't show up in the numbers. These people were not included in the numbers because they did not meet the criteria of disease definition, not becasue of side effects causing dropouts.

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March 10, 2011

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Symptoms Reported by PWCs and Improvements in Them after Treatment with the Simplified Treatment Approach for 6 Months​

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Rich Van Konynenburg, Ph.D.​

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Below is a list of symptoms that were included in the checklist used in the clinical study of the Simplified Treatment Approach conducted by Nathan and Van Konynenburg in 2008, reported in 2009*. These data apply to the 21 women who satisfied the strict diagnostic criteria for chronic fatigue syndrome (Fukuda et al. plus post-exertional fatigue and malaise), out of the total of 30 women who participated in the clinical study. The women were asked to indicate whether they did or did not have each symptom in the checklist, both initially and after six months of treatment, without specifying severity.



The symptoms are listed below in descending order of their reported prevalence at the beginning of the study. Note that these women had already been treated by Dr. Nathan for up to 12 years for various aspects of CFS, so the prevalence values for symptoms in this study may not be the same as would be found in a previously untreated CFS population.



For each symptom listed below, the first number shown is the percentage of women who reported the symptom initially. The second number is the percentage decrease in the number who reported the symptom after 6 months of treatment. The study actually ran for 9 months, and there were some changes in the symptoms reported after 9 months (both decreases and increases in the numbers), but individualized treatments were added to the Simplified Treatment Approach between 6 and 9 months, so the results at 9 months do not reflect the effect of the Simplified Treatment Approach alone, and have not been included here.



Note that fatigue was not included in the checklist, but the women were asked to rate their “energy” using a visual analogue scale. On a scale of 1 to 10, their initial average rating was 4.0 (SD 1.7), and their average rating at six months was 6.0 (SD 2.0), p<0.005. Seventy-six percent of the women reported improvement in their energy level.



Strictly speaking, low blood pressure, low body temperature, and hypoglycemia should be considered as signs rather than symptoms, but they were included in the symptoms checklist for this study.



Here are the results:



Chronic aching muscles 100, 33

Reduced task completion 95, 60

Depression 90, 42

Difficulty in staying asleep 90, 58

Joint pain, morning joint stiffness 90, 21

Tingling, “needles and pins” sensation 86, 39

Difficulty in word finding 81, 41

Impairment of concentration, difficulty in assimilating new information 81, 24

Pain in weight-bearing joints 76, 25

Ice pick-like pain or electrical pain that shoots into muscles 76, 25

Low body temperature 76, 62

Hypersensitivity to bright light 71, 27

Blurred vision 71, 47

Weight gain 71, 80

Difficulty with getting to sleep 15, 53

Excessive thirst or frequent urination 71, 47

Chronic sinus congestion 67, 43

Panic attacks or anxiety 67, 57

Ringing in the ears, tinnitus 67, 50

Mood swings 62, 46

Confusion, disorientation 62, 54

Tearing, redness of eyes 57, 50

Increased sensitivity to touch 57, 50

Vertigo, dizziness 57, 67

Night blindness 52, 18

Abdominal pain 48, 50

Rage or inappropriate anger 43, 56

Nausea 38, 37

Hypoglycemia 38, 75

Onset of menopause 38, 62

Shortness of breath 33, 57

Metallic taste or other unusual taste 29, 50

Chronic yeast infections 24, 80

Loss of appetite 24, 80

Chronic cough that mimics asthma 14, 67

Low blood pressure 14, 0 (Yes, zero. This represents only 3 patients.)

Nosebleeds 10, 100

Irregular vaginal bleeding 10, 50



*http://www.aboutmecfs.org/Trt/TrtMethylStudy09.pdf

 

[Uno]

That's helpful - thank you

 

[Freddd]

Hi Uno,

I thought it was important for people to see this. I'm preparing the results organized in different ways that willl hopefully shed light on this. I wish I had been designing the data collection on this, but what was done long ago can't be undone. I'm sure Rich would have designed it differently too. I've worked closely with doctors for 30+ years. They don't understand database design. For the fraudulant docs that makes them a lot easier to catch since they don't understand why their fake data is so relatively easy to see. For the well meaning ones doing research, it makes for flawed research which is unrecognized for lack of that knowledge. In a way, the data collected makes the form of the question that can be answered. Poorly formed questions make for poorly formed answers.

 

[Lotus97]

Hi Uno,

I thought it was important for people to see this. I'm preparing the results organized in different ways that willl hopefully shed light on this. I wish I had been designing the data collection on this, but what was done long ago can't be undone. I'm sure Rich would have designed it differently too. I've worked closely with doctors for 30+ years. They don't understand database design. For the fraudulant docs that makes them a lot easier to catch since they don't understand why their fake data is so relatively easy to see. For the well meaning ones doing research, it makes for flawed research which is unrecognized for lack of that knowledge. In a way, the data collected makes the form of the question that can be answered. Poorly formed questions make for poorly formed answers.

Since Rich based his most recent protocol (late 2012) largely on the results study (2009) I believe Rich was quite satisfied overall with how the study was conducted. I don't see why this thread is even necessary. There are a lot of people following your protocol. Maybe you should be spending your time helping them with that instead. I'm sure you're very busy and this doesn't really seem worth your time or effort. This is what Rich stated in his most recent protocol (late 2012)
http://forums.phoenixrising.me/inde...ation-protocol-august-25-2012-revision.19050/

In making this revision, I have been guided by the following goals:

1. To provide effective treatment to correct the vicious circle mechanism that I believe to be the core of the pathophysiology of ME/CFS, involving glutathione depletion, a functional B12 deficiency, a partial block of the methylation cycle, and loss of folates from the cells. This vicious circle mechanism is described by the Glutathione Depletion—Methylation Cycle Block hypothesis for the etiologies, pathogenesis and pathophysiology of ME/CFS. This hypothesis cannot be regarded as scientifically proven, but as far as I know, it is consistent with the current body of published research on ME/CFS.

2. To use only nonprescription nutritional supplements that are available via the internet.

3. To use supplements that are available from a single source, where possible.

4. To keep the protocol simple, with a minimum number of supplements, while preserving its effectiveness.

5. To keep the cost low while preserving effectiveness.

6. To improve the effectiveness of the protocol over that of the previous version, and in particular to increase its likelihood of being effective for more of the ME/CFS population.

7. To preserve the ability of individuals to adjust dosages of individual supplements to match their tolerances and needs.

8. To preserve the relevance of the clinical study of an earlier version of the protocol by Dr. Neil Nathan, M.D., and myself, to the degree possible.

Rich did make a small revision such as switching from phosphatidylserine complex (which was used in the study) to lecithin because he was concerned the PS complex would cause problems for those with low cortisol.

Lecithin: The role of lecithin is to help with repair of cell membranes, especially mitochondrial membranes, which have been damaged by oxidative stress. I suspect that the damaged mito membranes are one of the main reasons why many PWMEs have found that recovering their energy status is one of the slowest aspects of recovery from ME/CFS. In early versions of the SMP, I recommended phosphatidylserine complex to fill this role. However, the phosphatidylserine component tends to lower cortisol initially, and most PWMEs already have below-normal cortisol. Most lecithin is derived from soy, but for those who do not tolerate soy, lecithin is also available that is derived from sunflower, canola or eggs.

While the study used only hydroxocobalamin and 200 mcg of methylfolate, in his newest protocol Rich also gave people the option to switch to methylcobalamin and adenosylcobalamin if hydroxocobalamin wasn't effective and also suggested possibly raising the dosage of methylfolate for some people.

I had also considered changing the form of B12 to methylcobalamin. Some PWMEs do need to use this form, particularly if their glutathione and/or S-adenosylmethionine are very low. However, use of hydroxocobalamin is a “gentler” approach to lifting the partial methylation cycle block, and many PWMEs need such an approach. Use of hydroxocobalamin also keeps the cells in control of the rate of the methylation cycle, preventing it from being overdriven, which slows the rise of glutathione. So I have decided to stay with hydroxocobalamin as the first form of B12 to try. For people who do not get a response from the SMP within a couple of months, switching to methylcobalamin would be an option to try. Another option would be to try adding some adenosylcobalamin (dibencozide). However, I do not favor raising the overall dosage of B12 very much above 2,000 micrograms per day, and especially not when it is combined with dosages of methyfolate that are much above the RDA range of 400 to 800 micrograms per day. This combination can overdrive the methylation cycle and hinder the rise of glutathione.

 

[Freddd]

Hi Lotus,

"When no man pursuith..."

So what is your point? You act like you think I'm attacking something about Rich or anything by even posting this. What is your game?

I believe Rich was quite satisfied overall with how the study was conducted.

He had plenty of things he would have done differently. We talked about the data and lack thereof, and he appologized and said that he hadn't had a say in that part of the design. I know the frustration as well because many of the thigs I participated in and designed were based on specifications given to me. Rich had to work within the constraints of the study as designed. He never expressed dissatisfaction with the conduct as such. He wasn't pleased with the design. You need to understand that studies being conducted by a team are designed the way they are for all sorts of reasons including having nothing but heading off certain possible criticisms as well as an IRB in many cases. I know nothing about Dr Nathan, but I spend decades working with doctors. They often want to do thongs that are poor design. Many of them are very hard of listening to anybody without an MD. It was the managers that caused the Challanger disaster. The engineers were ignored. The managers were hard of listening to non-managers.

I don't see why this thread is even necessary.

Why do you not want to see whatever my anlaysis might show? I'm spending hours preparing this analysis on the hopes it will be USEFUL to me, to you and any others may benefit from a slightly different ways of looking at the data. Why is the pit bull reflex kicking in well in adavance of any imagined insult?.

We all know Rich changed the protocol twice after this study. I'm sure that what he learned in the study was an influence towards these changes. That's how these things work. You do something, observe the results, learn from those results or lack there of and you do it again, and again and again, building on what has been done before I don't beieve in this forum being a masoleum for old dead thoughts. It needs to have current attention and consciousness to build upon those thoughts and carry them forward and evolving. The moment this forum becomes a masoleum or Mutual Admiration Society, it will cease to be useful to all of us trying to figure out how healing works for so many od us damaged in so many ways. In programming we joke about having to keep pushing that car to the back up the hill so we can see why it stalls on the way down. This is a separation out of the rest of the study the PURE SMP results by Rich, not including the many changes and customizations Dr Nathan made with each person and incuded in the final results. As Rich said it changed some of the percentages up and down without really changing anything. The thing that it does is give a snapshot of purely the SMP as it existed at that time in this study..