Trial Results - Gupta Programme

[Ashok Gupta]

Hi Everyone

I posted a reply to a thread about phobias and CFS, and about full recovery stories. I am reposting it here:

Hi Everyone

PHOBIAS

Let me clear up some things here. Firstly let's deal with whether this is a phobic response. Amygdala trauma in ME/CFS may share some commonalities with phobias, but there are also some differences. Both occur in the amygdala, but in ME/CFS, the severity and levels of conditioning are much higher and more extreme. Why? Because with phobias you generally can avoid the thing you are phobic of. In ME/CFS you cannot, which means that the response becomes continual and automatic and extreme unlike in a phobia. Secondly the response from the nervous system is so extreme that it takes the body completely out of it homeostatic state, stimulating aspects of the immune system, allowing opportunistic viruses to take hold, and many other issues unique to each patient. Furthermore there are secondary sensitivities that occur related to the primary conditioning, such as sensitivitis to people, situations, events etc which may make the condition worse.

FULL RECOVERIES

I have dealt with this time and time again, and will keep repeating what I said before:

- people who recover do not hang out on chat forums on ME/CFS! when people go onto the internet, they go with a specific need, but when you are well you don't want to bother. I have spoken to lots of people who have done my programme who have FULLY recovered, and they don't want to even come on these chat forums. And why? Because what they find is that if they do post, people either accuse them of being plants, or just ignore them and accuse them of some vested interest (or being part of a cult!). I finally got to speak to Thomas Henri today who has agreed to come onto the site and post his experiences directly in a couple of weeks. He has consistently been able to do 2 hour gym sessions from being housebound and is now setting up a full time business. I could contact all the people on the original trial, but I am flat out working on some other trials which are my priority, because they will be independently run.

- there are billions of websites on the internet! Relatively there are not that many people doing the gupta programme, so to think that you can in any way have an accurate reflection of full recovery stories is not scientific.

- I have already posted a thread with many full recovery stories here:
http://www.chronicfatiguetreatments.com ... vt683.html and http://www.chronicfatiguetreatments.com ... vt686.html
but was then accused of making them up (!), so I can't really win here! I was going to be doing a 2 year follow up on the patients from the trial that I did, but I wanted to focus my energies on the new trial that I may be doing with Dr Lapp and other respected names in the field. Dr Lapp is a trusted physician in this area and has had some of his patients make a full recovery, so he is intrigued and wants to test this further.

This comes down to the way that we think as human beings. We interpret information the way that our dominant beliefs guide us. So even if there is lots of information that is supporting something, we will discount that information and only remember information which opposes it because it fits with our dominant belief about it.

TRIAL RESULTS

I have not been posting the trial results because I have been waiting for the publication. The paper is scheduled to be published in June 09, but I can give you the initial results here. Basically in the trial of 33 patients (average years of illness 10.5 years), this is a quote from the study paper:

"Out of the total 33 participants, 27 participants completed the programme. Comparing the percentage self assessment score out of 100 for each participant, 92% of participants (25 out of 27) reported improvements in functioning levels. Pre-treatment, the mean functioning score was 41.5% (+/- 16.0) which improved to a mean score of 77.0% (+/- 27.6) post-treatment. Two thirds of participants (18 out of 27) made considerable recoveries reaching “full functioningâ€

[Recovery Soon]

Dear Ashok,

Thanks for addressing these concerns. The reason the Full Recovery issue has yet to be resolved, not just by me, but by many, is because your definition is ambiguous.

"full functioning is defined at being 80-100% of pre-illness levels. These participants stated that they did not feel that they were suffering from CFS any more, and instead that they were in a transition phase from being ill to adjusting back into normal life."

I don't even understand what this means. Have the symptoms stopped, or haven't they?

I am full functioning according to this criteria, yet exercise is out of the question. So do I tell people I am recovered? Or am I in a "transition stage?"

And yes, this forum is a small subset, one which has not seen a single person fully extinguish the CFS symptoms, which is my definition of full recovery. Unless they are recovering and leaving the forum as you pointed out, but it seems unlikely that one would not return for a farewell post. Especially the one's we have gotten to know.

I don't know if my illness is so much different from others, as is my expectation of what constitutes a recovery. Many people are happy that they can walk around the block when they were once bed bound. This is wonderful, and a credit to you and your work, but this is not recovery. Yet many people have been convinced it is.

Like you said, we tend to include information that fits out belief systems. Your definition gives people lots of latitude in this regard.

I realize you may feel I am not accepting your explanations. But I do not feel satisfied that you have illuminated the concerns.

Kind Regards.

[Ashok Gupta]

The two thirds of patients that I am referring to went from an average rating of 47.9% to 94.2% - so the vast majority did not have any symptoms but were getting used to doing new things. As you will appreciate 94.2% as an average self rating is very high for two-thirds of patients on any trial. Many of these patients were 100% and could exercise fully after a year, a few could not.

I appreciate that it is not a fully clear picture given that I was not using standard statistical analysis, and the debates going on in this forum I have learned from. I have learned that:

- any future trials need to incorporate standard statistical analysis where they can be effectively compared to other data
- we need to do a 18 month and 2 year statistical follow-up to incorporate those who cannot fully exercise after 1 year.

As you will appreciate, my priority is getting the independent data that can verify the claims rather than relying on what kind of patients happen to frequent an internet forum, and that's what I am working on.

Kind regards
Ashok

[Recovery Soon]

Yes, 94.2 is a very high number.

I believe your modifications will go far in clearing up the ambiguity. Pleased to hear you are planing them based on our frank discussions here on the forum. Seems they have yielded something positive.

I'm sure no one advocates basing your studies on anecdotes from forum visitors, though we do appreciate your popping by to exchange in an open discussion. Naturally, independent, comparable data is the accepted scientific method. And we look forward to those results.

Kind regards.

[dmbaken]

I think that after an average of 10 years of haing ME it must be difficult for someone to know if they have made a full recovery. For example, If you are 60 when you get ME and then 70 when you do the program, how do you seperate loss of function from aging and not yet fully recovered. That must be hard for people to judge.

Just a thought.

Don

[cfs_since_1998]

Ashok Gupta: "...people who recover do not hang out on chat forums on ME/CFS...there are billions of websites on the internet...I have already posted a thread with many full recovery stories here..."

That is a really lame excuse. People with MS/CFS do come to forums, some of them eventually try the Gupta Programme, they continue to post updates, and there is no reason to believe they wouldn't inform us of a recovery. We have several people here who have been trying the program much longer than 6 months and haven't recovered. This is completely beside the point anyway. The problem isn't a lack of personal testimonials.

Ashok Gupta: "So even if there is lots of information that is supporting something..."

That is the problem, there IS NO scientific information supporting it. Again, just congecture, leaps of logic, and personal anecdotes. Those things are not real evidence.

Ashok Gupta: "I have not been posting the trial results because I have been waiting for the publication. The paper is scheduled to be published in June 09, but I can give you the initial results here. Basically in the trial of 33 patients (average years of illness 10.5 years), this is a quote from the study paper..."

1. It's a non-controlled study? Where is the control group? Without one, this study is useless.

2. The only evaluation was a self assesment questionairre? This is not valid, especially after you make considerable effort trying to change patients' perception of what "recovery" is. Where are the measurements of HPA function, of immune system function, of oxygen uptake, of postural blood pressure?

Defending the program with scienceless "evidence" like this is futile. Try again. I stand by my use of the word "cult."

cult: "any system for treating human sickness that originated by a person usually claiming to have sole insight into the nature of disease, and that employs methods regarded as unorthodox or unscientific."

Sounds familiar doesn't it.

[dmbaken]

cfssince1998

I agreed that it is important to understand the limitations of uncontrolled trials. But it is also important to understand that many trials of treatments initially start with such small trials and when they show promise they move to larger, more expensive RCTs. The results of Ashoks first trial are not proof, but they are an indication that there may be something here. I've actually seen scientifically poorer studies presented at medical ME scientific meetings.

Regards

Don

[Recovery Soon]

His point was that his next study, the one with Dr. Lapp, will have control groups.

As far as the science, I don't know what markers are used to indicate CFS. I thought they hadn't nailed down any reliable indicators yet.

If they have, and you know of them, I would PM him, or directly email him at the site. He seems to be taking suggestions, and you might want to get that out to him before he starts prepping the funded study.

I want to see this thing done perfectly, so there is no more debate about any of this.

[dmbaken]

I think that with Dr Lapp involved they will have the Dx of ME and study design pretty well sorted. I am thrilled that they are doing the study! We are getting very good results in our family but we can only really talk about us. However, we are in a similar position in with this program as people are with lots of the suppliments. People take lots of suppliments based on anecdotal evidence that they hear about on websites.

Regards

Don

[cfs_since_1998]

dmbaken: "However, we are in a similar position in with this program as people are with lots of the suppliments. People take lots of suppliments based on anecdotal evidence that they hear about on websites."

I take supplements. Yes, the evidence is sometimes only anecdotal. But it's backed by multiple researchers with no financial incentives who independently came up with similar hypotheses, hypotheses based on scientific theories and demonstrated by specific biomarkers. This is opposed to the Gupta Program which one person who has amazingly discovered a miracle treatment completely on his own, a treatment not endorsed by any researcher other than himself, and is only administered by that one person (that is the exact definition of a cult as stated above). Even if he can prove his program helps CFS patients, there is still no evidence to suggest that it's caused by the amygdala.

[Recovery Soon]

To Don Baken:

I agree.

I've been pretty persistent on many of these points, and I hope the end result is some data that we can all feel comfortable with.

Something still rings true with this theory, even though Gupta himself basically told me to stop trying. (Unless that was his diplomatic way of saying 'Go away').

Don't know, don't care. Just know that I will keep working the program, and really look forward to this study. Though I can't see it getting published before 2011.

Hopefully I'll be reading about it on a treadmill. On level 10.

To CFS Since 1998- I think we should give Gupta a shot. I'm pretty skeptical too, but the theory does make sense. Of course its not proven yet. And time will tell. But I can't throw it away just yet. His collaborative research with Lapp sounds on the up and up. If its bogus the scientific community will let the world know.

Right now, none us really know.

BTW- Gupta is sincere with the money back guarantee. You have to respect that no matter what you think of the theory.

[dmbaken]

cfs_since_1998

I personally do not think that Ashok is out on his own on this one.

Firstly, Dr Lapp has told me personally that he uses the program with a number of his patients and has found some good results. He encourage my family to continue using it.

Secondly, other researchers are proposing similar theories. Dr Jones from the CDC has a theory with similarities which he has had published.

The Dubbo group also have a similar theory. You can read about this in Cort Johnson's review of The Symposium on Viruses in Chronic Fatigue Syndrome (ME/CFS) (June 2008): Part II. In that review Cort even says that Dr white said that Ashoks program was good.

Now there is some debate about what part of the limbic system is involved. But our understanding of the limbic system is very limited and so this is not surprising. Also this is a developing theory and therefore it would be expected that there will be refinement in it over time.

This is still not to say that the theory is true but it is interesting that others are thinking the same way. For me it was reading about others who were also thinking in the same way that encouraged me that we should try it. However, that was our call.

Kind regards

Don

[Recovery Soon]

What really attracted me to this program in the first place was the work of Dr. Jon Kabat-Zinn. He started a mediation program 25 years ago called Mindfulness Based Stress Reduction, in Massachusetts. In clinical trials the program - an 8 week regimen of meditation, has been shown to cure psoriasis. Dr. Kabat-Zinn also noted that people with grave illnesses recovered much better than control groups when using mindfulness meditation. The instructions for these patients were to fully go in to their symptoms...very much like the soften and flow.

It is clear to me that the GAR program is helpful for a variety of reasons. My question has always been, is it really striking at the cause of CFS, or is it just a very effective mind-body program that would yield positive results with any illness? That's kind of why I'm so curious about recovery rates and such.

Would MS patients get positive results from this as well? The meditation alone is bound to help anything in a certain way.

[Sylvia]

http://phoenix-cfs.org/ConHHV6PtII.html


Here is a link to what dmbakon said about Dubbo

[cfs_since_1998]

dmbaken:

The similarities to other hypotheses are superficial. I haven't heard of a single other physician or researcher focused on the amygdala.

Recovery Soon: "My question has always been, is it really striking at the cause of CFS, or is it just a very effective mind-body program that would yield positive results with any illness?"

I don't think GAR is striking at the cause of the illness. I'm sure that certain types of meditation and psychotherapy can help CFS as well as any illness, but that is a far cry from being able to say GAR cures CFS. I bet that it is possible to come up with a much shorter, simpler, and cheaper video tutorial, audio program, or written manual that would be identically as effective as GAR.