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dbkiser
Member
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Posted: Wed Nov 12th, 2008 19:29 |
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I was just reviewing the Chart from the Porto Conference and notice that the total number reporting is 257 patients. In reading other posts, it appeared that there were at least 500 people in the Study cohort. I was just wondering about the low number reporting. What about the other 243 people? I think the dropout number should be reported.
Also, I know Dr. Marshall has said that the longer you have been ill, and the more severe your illness, the longer it may take on the MP. I am wondering about those who reported NO improvement after two years and beyond on the MP. Is there an opinion as to why those reporters had no improvement? Of course, since I have ME/CFS manifestation of Th1 inflammatory disease, I am most interested in those individuals who have the same dx who had no improvement.
The MP does require many lifestyle changes (and some ridicule from others, darn), so it would be a huge disappointment not to have improvement after a two- or three-year period of sacrifice. I have been on MP only 7 weeks, so I haven't had the type improvements reported by early adopters. I think some people are considering me a "nut case" for trying anything and everything that might help me, i.e. Armaund's guaifenisen protocol, testing for HPV-6 to attempt anti-viral treatment (as in a Ca. study that originally showed improvement in CFS in those w/ HPV-6 infection), taking thousands of dollars worth of supplements that were spread out all over my kitchen cabinet top, ordering a sleep aid drug that is considered a "street drug," and on and on. And, none of the things I've tried have worked (except the sleep aid). I know I'm sick, but I'm also sick of people not understanding and not seeing any improvement in my condition.
Thanks for your responses and comments.
Darlene
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ME/CFS/FM 9 yrs;IBS;OA;MCS;HBP;GERD;food sensitivities;Sleep Apnea;Lyme?(No/CDC, yes/Igenex);Insomnia;HHV-6 1:80; 45# wt gn; Ph1 9/27/08; D,25OH 10.3 NG/ML, D,1,25 44 pg/mL, Ph2 11/20/08; Non MP Rx's Cymbalta, Xyrem, Compounded Bi-est, Lasix, Metoprolol 5
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Dr Trevor Marshall
Research Team
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Posted: Wed Nov 12th, 2008 19:38 |
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Darlene,
The data reported at Porto was designed specifically to standards of the medical community, not for picking apart by patients
There have actually been about 1100 through the MP cohort, of which about 500 are fully active now. Those that drop out do so because, inter alia, they are doing well enough without posting, or their physician stops prescribing, or they move house and can't find a new physician, or they just can't take the rigors of IP during recovery.
You need to understand that Mainstream Medicine is looking for about a 16% improvement rate, not the 82+% we are able to document. Additionally, a "loss to followup" of 50% of the cohort is pretty routine, especially in seriously ill patients, and especially during longer studies.
People were left out of the reporting because they couldn't be bothered spending the time to fill out the questionnaires, or because they couldn't understand the questions, as well as a host of other things which you might well condone, but which big M Medicine does not condone.
I hope that helps
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dbkiser
Member
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Posted: Wed Nov 12th, 2008 19:45 |
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I was very impressed with Paul Albert's view of what needs to be done in order for the MP to be accepted by mainstream medicine.
I am wondering if the data ARF has collected would lend itself to a statistical study. I have a B.A. in Psychology and took Descriptive Statistics and Research Methodology courses. It would have been helpful to have a statistician review the study design prior to undertaking it, but it would also appear that the way the Study cohort reported would lend itself to statistical analysis. The reason being: it is impressive when you read an abstract and find that the chances of the result (improvement) occurring by chance (placebo effect) are <.01 or even <.05. It's not a double-blind study, but it is better than anecdotal, isn't it?
I am not up-to-date on statistics (and suffer brain fog most of the time) and think that the SAS software we utilized back in the 90's has been supplanted. Is it possible that a master's level professor might find this a viable undertaking for a class or classes? Or material for a thesis on taking available data already existing and putting it into a study design? Just some thoughts I have while TRYING to go to sleep at night.
Darlene (only 7 weeks in)
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ME/CFS/FM 9 yrs;IBS;OA;MCS;HBP;GERD;food sensitivities;Sleep Apnea;Lyme?(No/CDC, yes/Igenex);Insomnia;HHV-6 1:80; 45# wt gn; Ph1 9/27/08; D,25OH 10.3 NG/ML, D,1,25 44 pg/mL, Ph2 11/20/08; Non MP Rx's Cymbalta, Xyrem, Compounded Bi-est, Lasix, Metoprolol 5
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Dr Trevor Marshall
Research Team
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Posted: Wed Nov 12th, 2008 19:52 |
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Darlene,
You should start by mulling over the contents of this paper in some detail. It deals with the changes necessary in study analysis when the success rate is high, such as we are achieving. It was written (inter alia) by the Center for Evidence Based Medicine at Oxford Uni:
http://www.bmj.com/cgi/content/full/334/7589/349
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Sallie Q
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| Joined: | Sat Aug 9th, 2008 |
| Location: | Australia |
| Posts: | 57 |
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Posted: Wed Nov 12th, 2008 20:23 |
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Hi Darlene
When I failed statistics at uni there was no such thing as statistics software, but I like your question.
I’m out of brain fog enough to see it would be impossible to do a double blind study on this kind of research, quite apart from ethical questions on with-holding a curative treatment from people with serious and eventually life shortening illness. Even the most simpleminded placebo patient would soon know which group they were in.
If the doctors supervising MPers could select several patients with similar conditions who are unable or uninterested in MP and get permissions to collect long term data on general health and emergence of other serious issues… 20 years would be highly significant I imagine. Hope I live long enough to see something like that come out
May the fog clear from your thinking cap in good time (hey I got my second good nights sleep last night since starting mino and I’m on 100.. change is due)  Sallie
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fatigue,Sjogrens 1,25D(??)Phase1:20Sep08 NoIRslowLuxEtc 25D13.2(Jly08)independent PCPProfessionalsForum NoAltMeds appendectomy~9yrs b.cancer1990 some calcification old scans.HotFlush20yrs D-dysregulated~60%signs
modPh2done 25Dnow~6.5 eGFR49 creatinine100
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dbkiser
Member
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Posted: Wed Nov 12th, 2008 22:10 |
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Dr Trevor Marshall wrote: Darlene,
The data reported at Porto was designed specifically to standards of the medical community, not for picking apart by patients . . . . . . . as well as a host of other things which you might well condone, but which big M Medicine does not condone.
Dr. Marshall, I'm used to intellectual condescension and unkindess. I worked for lawyers for over 25 years, but I have to admit I had a bit of a physical reaction to your responses. Your chart "designed specifically to standards of the medical communiity, not for picking apart by patients" is a simple table. If the medical community doesn't ask similar questions, we can certainly understand why they can't grasp your protocol and adopt it.
The second quote, I don't understand why you think I "might well condone" reasons for dropouts. Why would you make that assumption? I'm afraid you don't know me.
I appreciate very much that you are making your protocol available to all of us suffering from Th1 inflammatory disease; you suffered with the disease much longer than I have. Do you address the medical professionals the same way you do us? I've read many similar posts to a number of questions from all of us who make up the numbers you want to report to the medical community. A little kindness goes a long way. The smiley faces are nice but don't make up. And, the posting directions tell us to be respectful to one another.
I'm trying to get my husband to go on MP; not as ill as I; still working and concerned about herxing; has right hand tremors, sleep apnea, mild COPD, RLS, gum disease. I've also e-mailed a high school classmate who also has ME/CFS (Th1 inflammatory disease) about the MP. I believe; how do we get others to believe? I had to sign a Release at my doctor's office in order for him to put me on the MP so if anything bad happens while on MP (since I'm ignoring most of his advice), he won't be held liable.
In for the long haul (just trying to suggest ways to get the MP accepted by more),
Thanks for your reply and the cite (woops, "site"); I'll go there now,
Darlene
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ME/CFS/FM 9 yrs;IBS;OA;MCS;HBP;GERD;food sensitivities;Sleep Apnea;Lyme?(No/CDC, yes/Igenex);Insomnia;HHV-6 1:80; 45# wt gn; Ph1 9/27/08; D,25OH 10.3 NG/ML, D,1,25 44 pg/mL, Ph2 11/20/08; Non MP Rx's Cymbalta, Xyrem, Compounded Bi-est, Lasix, Metoprolol 5
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dbkiser
Member
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Posted: Wed Nov 12th, 2008 22:20 |
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Hi, Sallie,
Thanks for your reply and your comments. Yeah, it's a given that a double-blind study can't be done. I got my Psyc degree in '92 at age 42 while working full-time and raising two kids. Lots of long nights and 50-mile (round trip) commutes. As you can tell, I USED to have energy! Ha.
As for my doc, he has seen the progression of disease in me over 7+ years. When I was first diagnosed in '01 (ill since early '99), I would say I was functioning at 60-70% of normal; in the past 3 years I'm functioning at a MUCH lower level, 20-30%.
I just started Mino 100. I hope I have a change in my sleep! That's been a big problem for me, really since '97 (menopause).
Thanks for your comments. Forward to a healthy future!
Darlene
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ME/CFS/FM 9 yrs;IBS;OA;MCS;HBP;GERD;food sensitivities;Sleep Apnea;Lyme?(No/CDC, yes/Igenex);Insomnia;HHV-6 1:80; 45# wt gn; Ph1 9/27/08; D,25OH 10.3 NG/ML, D,1,25 44 pg/mL, Ph2 11/20/08; Non MP Rx's Cymbalta, Xyrem, Compounded Bi-est, Lasix, Metoprolol 5
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Dr Trevor Marshall
Research Team
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Posted: Wed Nov 12th, 2008 22:21 |
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Do you address the medical professionals the same way you do us?
Darlene, I would throw this question straight back at you.
Although you might think I am being condescending in my answer, and maybe I am, you need to respect that I have been planning clinical trials since 1978, on multiple continents. I have come across a lot of ideas and concepts during that time which form part of my decision-base, but which I can guarantee do not form part of yours.
I am one of the very few at the leading edge of medicine whom you will find freely discussing issues on the Internet. Please do not allow your aggression and self-confidence to discourage me from continuing to do that.
And no, I do not interact with all my colleagues in the same way. It all depends on how they interact with me, and what they bring to the conversation.
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dbkiser
Member
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Posted: Fri Nov 14th, 2008 02:22 |
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Dr. Marshall,
You are right. I do respect what you have been doing by way of research. I have nothing to add and will certainly not be making any more suggestions regarding your studies. Hopefully, those who are healed and out there living their lives will tell others about the Protocol, which I guess is all we lay people can do.
Aggressive, no. Defensive, yes.
Actually, my continuing care doctor was very respectful of me when I asked him if he would oversee my care while on the MP. He respectfully explained to me why I should not do it (played devil's advocate) and what it might mean by way of bone health, cancer, etc. to lower my "Vitamin" D levels. He was very respectful of me when I explained that nothing else had helped me (even though he had been treating me by various modes which had been helpful to other patients) in the 7+ years I have been seeing him. He was very respectful when he asked what prescriptions I needed to begin the MP. He was very respectful of me when he asked me to sign a Release of Liability. He's been to the websites; he has two other patients on MP; and he still is not convinced.
In fact, he has always been very respectful and listened to my various concerns and about "stuff" I had found on the internet. Not all the doctors I've seen since becoming ill in 1999 (probably 15 or more) have been so respectful, nor did they have answers for me, after all their testing came up with normal results. It was very difficult to get a diagnosis, since ME/CFS doesn't show up on the usual tests like RA, MS, Sarcoidosis, etc. do. In the meantime, you are a "nut case," "hormonal," "depressed," need diet and exercise, etc. I'm very excited about your Protocol and hope that I may have success on it. I read and re-read Paul's and Amy's stories, especially, since their Th1 inflammatory disease manifested itself as mine did.
Thank you for being available for us shut-ins (for now).
Respectfully yours,
Darlene
"Oh wad some power the giftie gie us
to see oursels as ithers see us!"
Burns
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ME/CFS/FM 9 yrs;IBS;OA;MCS;HBP;GERD;food sensitivities;Sleep Apnea;Lyme?(No/CDC, yes/Igenex);Insomnia;HHV-6 1:80; 45# wt gn; Ph1 9/27/08; D,25OH 10.3 NG/ML, D,1,25 44 pg/mL, Ph2 11/20/08; Non MP Rx's Cymbalta, Xyrem, Compounded Bi-est, Lasix, Metoprolol 5
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Dr Trevor Marshall
Research Team
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Posted: Fri Nov 14th, 2008 02:44 |
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Suggestions regarding studies are always welcome. We try to think of everything, but nobody is perfect.
CFS was being claimed as an Autoimmune condition at the recent Porto conference. Apparently there are some antibodies which appear to be associated with CFS. That is good news on two fronts - first, the physician-researchers at the Porto conference are some of the best in the world, and we want them working on solving CFS, and second, it sounds as though a decent diagnostic test might be possible at some point (besides the D metabolites)
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dbkiser
Member
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Posted: Fri Nov 14th, 2008 03:10 |
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| Thank you, Dr. Marshall. Diagnostic tests for CFS would be so helpful. Those two years without a diagnosis were awful!
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ME/CFS/FM 9 yrs;IBS;OA;MCS;HBP;GERD;food sensitivities;Sleep Apnea;Lyme?(No/CDC, yes/Igenex);Insomnia;HHV-6 1:80; 45# wt gn; Ph1 9/27/08; D,25OH 10.3 NG/ML, D,1,25 44 pg/mL, Ph2 11/20/08; Non MP Rx's Cymbalta, Xyrem, Compounded Bi-est, Lasix, Metoprolol 5
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jcwat101
Health Professional
| Joined: | Wed Oct 17th, 2007 |
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Posted: Sat Nov 15th, 2008 02:27 |
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I wanted to clarify a few things with regard to the data. The brevity of the talk did not allow time to go into it.
The 500 number includes people with Lyme and sarcoidosis and other diagnoses that were not included in this study for various reasons.
One can't simply add up the numbers on the chart, either.
Some people had multiple diagnoses and so would be counted twice.
If they had thyroiditis and fibromyalgia for instance, and both conditions had improved, they would show as improved cases in both parts of the chart. If one improved and the other did not, they would show up as improved for one and not for the other.
There were 100 patients with Autoimmune diagnoses who filled out surveys (not counting those who only had fibromyalgia). This reflects an approximately 75% response rate to the survey. Thus, 25% of the people who were sent surveys did not respond. We don't know if they are on the MP still or not, or how they are doing in most cases -- for all I know they might not even have received the survey.
The response rate (% who completed the survey of those who were sent it) among those with only fibromyalgia (from the list of conditions we surveyed) was lower -- 50%. I speculate that the lower response rate may be that they think they have more options, as there are so many alternative medicine approaches that are marketed to them and so perhaps they feel less willing to stick out the IP. I don't think we can conclude it is necessarily that they have more trouble or something -- we just don't know.
Joyce Waterhouse
Last edited on Sat Nov 15th, 2008 02:29 by jcwat101
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20 years with CFS/FM/Lyme/IBS, mostly recovered from MCS and food sensitivities after 3 years on MP.
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Joyful
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Posted: Tue Nov 18th, 2008 09:34 |
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For a peek at the new MP Knowledge Base pages regarding this topic, please refer to here and here.
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Lyme?1980 Babs?05 Bart?05 CFS?06 | 125D50 Ph1Jul07 ModPh2Sep07 Ph2Feb08 Ph3Aug08 | 25D15 Oct08 | ABC of MP
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jcwat101
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Posted: Tue Nov 18th, 2008 16:08 |
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Joyful,
Those look good. Thanks for all your work on that.
Another thing I should add is that the CFS data is only a subset of CFS patients on the MP-- those who also had FM or an AI disease. We had not originally intended to include CFS due to time constraints, but since we asked all patients if their fatigue had improved, we had some data on their improvement. We might have underestimated their improvement rate, since if some other CFS symptom other than fatigue had improved (like sore throats, or sleep etc..), we would have missed it. We also can't know for sure whether the improvement rate would be the same for people who had CFS, but did not have FM or an AI disease as well.
Unfortunately, we could not include all diagnoses. We had limited time and so we had to focus on the autoimmune diseases that we did not yet have data on.
Joyce Waterhouse
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20 years with CFS/FM/Lyme/IBS, mostly recovered from MCS and food sensitivities after 3 years on MP.
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dbkiser
Member
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Posted: Wed Nov 19th, 2008 02:52 |
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I really appreciate the clarification of the Porto presentation. My doc tells me that he has had great success improving patients with fibromyalgia, but not those with ME/CFS. It may be that there is an easier way (than the MP) for fibromyalgia patients to regain health.
Darlene
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ME/CFS/FM 9 yrs;IBS;OA;MCS;HBP;GERD;food sensitivities;Sleep Apnea;Lyme?(No/CDC, yes/Igenex);Insomnia;HHV-6 1:80; 45# wt gn; Ph1 9/27/08; D,25OH 10.3 NG/ML, D,1,25 44 pg/mL, Ph2 11/20/08; Non MP Rx's Cymbalta, Xyrem, Compounded Bi-est, Lasix, Metoprolol 5
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dbkiser
Member
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Posted: Wed Nov 19th, 2008 03:23 |
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Thank you, Joyful. The Perez transcript was very helpful, and your graph does show an encouraging positive trend. Thanks, again.
Darlene
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ME/CFS/FM 9 yrs;IBS;OA;MCS;HBP;GERD;food sensitivities;Sleep Apnea;Lyme?(No/CDC, yes/Igenex);Insomnia;HHV-6 1:80; 45# wt gn; Ph1 9/27/08; D,25OH 10.3 NG/ML, D,1,25 44 pg/mL, Ph2 11/20/08; Non MP Rx's Cymbalta, Xyrem, Compounded Bi-est, Lasix, Metoprolol 5
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Dr Trevor Marshall
Research Team
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Posted: Wed Nov 19th, 2008 05:44 |
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My doc tells me that he has had great success improving patients with fibromyalgia
Show us the beef. We have bared our soul to you, it is only reasonable for us to expect the same level of data gathering be shared in return...
Otherwise, please do not make statements about treatment options. Please apply the same level of objectivity, and scrutiny, to data from all sources.
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dbkiser
Member
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Posted: Thu Nov 20th, 2008 22:43 |
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jcwat101 wrote: The response rate (% who completed the survey of those who were sent it) among those with only fibromyalgia (from the list of conditions we surveyed) was lower -- 50%. I speculate that the lower response rate may be that they think they have more options, as there are so many alternative medicine approaches that are marketed to them and so perhaps they feel less willing to stick out the IP. I don't think we can conclude it is necessarily that they have more trouble or something -- we just don't know.
Joyce Waterhouse
I was referring to the above.
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ME/CFS/FM 9 yrs;IBS;OA;MCS;HBP;GERD;food sensitivities;Sleep Apnea;Lyme?(No/CDC, yes/Igenex);Insomnia;HHV-6 1:80; 45# wt gn; Ph1 9/27/08; D,25OH 10.3 NG/ML, D,1,25 44 pg/mL, Ph2 11/20/08; Non MP Rx's Cymbalta, Xyrem, Compounded Bi-est, Lasix, Metoprolol 5
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JoshR
Advocate
| Joined: | Mon Aug 18th, 2008 |
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Posted: Fri Nov 21st, 2008 12:08 |
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| Joyce didn't say that any of those alternative approaches actually work.
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5/6 CFS criteria, 125D36 Ph1Jul08 Ph2Sep08 25D8(Sep08) NoIRs covered up (except hands) low lux home minimal light exp r/t work
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dbkiser
Member
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Posted: Sat Nov 22nd, 2008 05:39 |
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Josh, woops, didn't mean to send that incomplete message.
We know that there may be remissions (palliative treatment), and it's just a matter of time before their disease progresses. I used to have pretty good remissions in my disease and would work for awhile, until the next crash, but not in the past three years.
Thanks for your comment.
Darlene
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ME/CFS/FM 9 yrs;IBS;OA;MCS;HBP;GERD;food sensitivities;Sleep Apnea;Lyme?(No/CDC, yes/Igenex);Insomnia;HHV-6 1:80; 45# wt gn; Ph1 9/27/08; D,25OH 10.3 NG/ML, D,1,25 44 pg/mL, Ph2 11/20/08; Non MP Rx's Cymbalta, Xyrem, Compounded Bi-est, Lasix, Metoprolol 5
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