1. Patients launch $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
    Check out the website, Facebook and Twitter. Join in donate and spread the word!
Lessons from ME/CFS: Finding Meaning in the Suffering
If you're aware of my previous articles here at Phoenix Rising then it's pretty clear that I don't generally spend my time musing upon the philosophy of the disease. I find it better to spend my time reading research and trying my best to break it down to its core elements and write...
Discuss the article on the Forums.

Learning CFS: the Lerner Antiviral Treatment Trial Succeeds

Discussion in 'Phoenix Rising Articles' started by Phoenix Rising Team, May 24, 2010.

  1. CBS

    CBS Senior Member

    Messages:
    1,364
    Likes:
    246
    Western US
    Cort,

    Thanks for a fantastic summary of some very interesting research. Two points, one personal and the other methodological. First, my experience on acyclovir has very much mirrored Dr. Lerner's study. I've been on acyclovir for 6 months and I am a "responder." I've moved from a 2.0-2.5 to a 3.5-4.0. I still have a long ways to go and my mantras are 'patience' and 'don't be an idiot - over doing it will just undo any recent progress." While improving, I can still provoke a crash much more easily that I ought to be able to.

    Dr. Montoya feels that the long term effect of these crashes may be cumulative (much like Dr. Lerner's take on heart damage). I've spoken with Dr. Montoya about the HIV Heart Clinic at UCSF (Dr. Hsue) and he's quite interested. I don't know if he's made contact with Dr. Hsue yet. I'll be asking at my June visit.

    My second point is that these types of studies do require systematically collected high quality data. The differences between HHV-6 and HHV-6 + patients would have never been noticed (clearly would have been washed out) if not for two factors unique to this study: a) they collected that data over a long period of time and b) they had a large sample size. It's my opinion that sample size was the issue at play with Montoya's second study. Small samples for one off studies require immediate blockbuster effects and so far in CFS that hasn't happened.

    Again, thanks for the great summary of this work. As I said earlier, I'm fortunate to be a "responder" (with multiple co-infections) and as such my experience has been very consistent with the results of this paper. I think that for many people it may present significant opportunity for improved health.
  2. Gerwyn

    Gerwyn Guest

    What journal is this study published in Cort.I cant find any scientific data thus far.I take it that it is retrospective and not a prospective study.Is there any statistical analysis done or anyobjective data apart from self reporting?
  3. Cort

    Cort Phoenix Rising Founder

    Messages:
    7,025
    Likes:
    439
    Raleigh, NC
    CBS I was struck reading the paper by their computer program: each patient was entered into a Microsoft Office Access 2007 database that was specfically designed for the study. (Kind of reminded of what you're doing with Dr. Bateman). They did a 100% audit of the patients - everybody was in there! - really a tribute to Dr. Lerner's confidence in his work.

    2.0ish to 3.5-4.0 is really a very big jump in functionality and I fervently hope it continues with you.

    I don't know much about statistics but this paper seems solid to me - so much data went into it, after all - I just can't imagine that its not going to open some eyes and kick down some doors. I think Dr. Lerner thinks it will. He said it was received better by the journals editors than papers in the past.

    I just hope it really jumpstarts more research in this area. Before XMRV this was where the WPI was focused, this is where Dr. Montoya and Dr. Lerner are focused, Dr. Glaser is focused here too. There is a group of researchers ready to run with this if they can get the funding.

    I think people in general just did not expect this therapy needed to be so longterm for some people.
  4. Sasha

    Sasha Fine, thank you

    Messages:
    8,070
    Likes:
    6,871
    UK
    It's going to take me a while to study and absorb this stuff, I think - it looks very interesting but I need to be careful to only approach my GP with stuff that looks convincing and that will convince a consultant down the line so I don't want to rush and make a mess of explaining it to him and so blow my chance. Also, this kind of material is outside my expertise so it can be a slow process for me. So, weeks not days, probably but if I proceed I'll post about how I got on.

    If any other UK bods approach their doctors I hope they'll also post - we're in a very different situation here from that in the US where patients can approach specialists directly (with cost being a huge barrier, though, obviously). We have to talk our way past the GP "gatekeepers" first.
  5. jackie

    jackie Senior Member

    Messages:
    591
    Likes:
    4
    I just feel like sitting down and crying...the success of this long study has given me added hope! (thank you cort for posting it in it's entirety!)

    I've been on high dose acyclovir for nearly 4 years without a break...and although I battle chronic shingles and even a new virus (hsv1) added to the mix...my "brain" problems are steadily improving (at times dramatically! in my ability to read, comprehend and express myself - which had been SUCH a problem previously!)

    To read that many in the "study" took their av's for 6-10 years to see the culmination of improvements gives me renewed enthusiasm for what I've been trying to do! I was told to expect to be taking acyclovir for many years (and my Neurologist went as far as saying to plan for "lifetime" use.)...so the YEARS - as oppposed to a short duration of therapy does not come as a surprise...but I'm so glad to hear of these much longer lengths of time, as being the norm for improvement. (not to mention the reassurance of the relative safety of long term high dose usage.) I hope to get better and better...with each year I take it!

    My most recent cd4 count was quite high, from a typical "low" count prior to the AV's - perhaps a bit TOO high...but that will most likely even out with time (personally, my "theory" is that it may have to do with a form of IRIS, uninvestigated as yet...just my thought - purely unscientific/unproven!)

    I wasn't part of any "study"...Dr. Chia started me on this protocol out of sympathy and compassion for my terrible plight...it was a gamble - and due to "our" perseverance, it is paying off!

    And to think that the "first" Acyclovir study (some 20 yrs ago, I think?) lasted a mere 30 DAYS! (and was deemed ineffective!)

    This "news" is a shot in the arm I don't mind at all!

    jackie:Retro wink:
  6. CBS

    CBS Senior Member

    Messages:
    1,364
    Likes:
    246
    Western US
    The Journal is Virus Adaptation and Treatment. Here's the link to a brief summary: http://www.dovepress.com/subset-dir...us-patients-with-c-peer-reviewed-article-VAAT

    The markers were as described below (click on the "Download the Article" link at the bottom of the summary for the entire article):
  7. Cort

    Cort Phoenix Rising Founder

    Messages:
    7,025
    Likes:
    439
    Raleigh, NC
    I believe its called retrospective and there are statistical analyses. I'd love to get your take on those Gerwyn since I'm pretty clueless. Although the statistics are not, I don't know, particularly sophisticated, it's looks strong to me....I love to hear from someone who knows because I think its the statistics that will mostly shape the reaction of the scientific community to this - are they going to find a way to discount it or is it pretty bulletproof?
  8. Sasha

    Sasha Fine, thank you

    Messages:
    8,070
    Likes:
    6,871
    UK
    It's odd but I seem to have lost all ability to judge how big a story is! XMRV has so dominated my focus since October that I can't really gauge the importance of other news. I strangely don't feel excited yet by this but I think that's probably my ignorance that prevents me from putting it in context.

    Thanks, Jackie, for helping me get the proper goggles on! I'd already decided to go through the process of studying it with a view of going to my doctor but in an "I owe it to myself to take the appropriate action" sort of way rather than a "Wow! Wow! I'm going to be cured!" sort of way.

    Burnout, I guess! :D
  9. CBS

    CBS Senior Member

    Messages:
    1,364
    Likes:
    246
    Western US
    This study also highlights the need for clearly defined cohorts. In this case it was Herpes Virus and Herpes Virus plus but with other issues with CFS it might be length of illness or type of onset. But without the data we'll never know. Poorly defined cohorts and weak design lead to bad data. Bad data is worse than no data as it leads to erroneous assumptions about what we know when it would be better to recognize that we don't know something.
  10. Sasha

    Sasha Fine, thank you

    Messages:
    8,070
    Likes:
    6,871
    UK
    Sorry, flybro, I only half-answered you! I haven't tested positive for any viral infection ever, which I suppose has always given me the impression that all the HHV/EBV etc. stuff didn't apply to me (actually I don't know if I've even been tested for HHV - 6). I think this is maybe why I don't feel excited (emotionally) even though I probably should - so far my excitement is intellectual only! My reaction isn't really making sense to me. Won't stop me pursuing it, though. :D
  11. Gerwyn

    Gerwyn Guest

    The paper is not scientific in any way i,m sorry to say


    Disclosure
    There was no grant support or pharmaceutical involvement in
    this research. Drs Lerner, Beqaj, and Fitzgerald have financial
    interests in CFS LLC which owns patents for diagnosis and
    treatment of CFS with antiviral agents.


    Fourteen Group A CFS patients with EBV
    received famciclovir for a mean of 0.88 years. The mean
    baseline EIPS value for these patients was 3.9, and the 24
    three-month interval EIPS value was 5.89 for the patients, all
    of whom received valacyclovir for portions of their antiviral
    treatment. The value of famciclovir in CFS illness cannot be
    estimated from these data.
    Discussion


    Only 30 patients had EBV infection and the who;e study only looked at 140 patients.It was not blinded in any way and the assessments were wholly subjective

    Dr Fitzgerald owns dove press in which the paper was published

    Graded
    exercise and psychotherapy alleviate some CFS symptoms,6,7 Dr Lerners views

    To cap it all he is using a scale that he developed himself and has subjectively decided what is a significant change

    Figure 2 Energy Index Point Score: A functional capacity measurement tool for
    CFS patients. The Energy Index Point Score (EIPS) chart provides the severity of
    patient fatigue. A change in EIPS level of 1 is a large significant change. The EIPS
    level is determined by agreement of physician and patient with the EIPS chart easily
    available for viewing at outpatient visits. As the EIPS level increases, CFS symptoms
    lessen and disappear. The EIPS system can be used in four easy steps: post the EIPS
    chart in examining room; ask the patient to evaluate his/her level of activity based
    on the prior two weeks; question the patient’s EIPS evaluation; record and track
    the EIPS level; report every 6–12 weeks. Copyright 2002 Prous Science, S.A. All

    In this study patients were given a diagnosis of CFS if they had an EIPS level(notice the trademark) of less than 5 but if you look closely level4 which is a non responder is actually more active than 7 which is a responder
    rights reserved. Adapted with permission from Lerner AM, Beqaj SH, Deeter RG,
    et al. A six-month trial of valacyclovir in the Epstein-Barr virus subset of chronic
    fatigue syndrome: Improvement in left ventricular function. Drugs of Today. 2002

    4
    Out of bed sitting, standing, walking 4–6 hours
    per day
    5
    Perform with difficulty sedentary job 40 hours a
    week, daily naps
    Recovery
    6
    Daily naps in bed, may maintain a 40-hour
    sedentary work week plus light, limited
    housekeeping and/or social activities
    7
    No naps in bed. Up 7:00 am to 9:00 pm. Able to
    work a sedentary job plus light housekeeping

    5 or less is a diagnosis of CFS 6 is a recoverer.Can anyone see the difference.To me being able to walk 6 hours a day 4 (cfs) is more active than 7 a recoverer. NO one actually got to seven.4 was the lowest point

    I therefore respectfully submit that the trial was anything but a success
  12. fairlight

    fairlight

    Messages:
    77
    Likes:
    0
    Cort-I just read your very informative May 24th, 2010 11:15 AM article. Very nice work. In the article did you mean anti-viral instead of anti-retroviral?
  13. CBS

    CBS Senior Member

    Messages:
    1,364
    Likes:
    246
    Western US
    I disagree with your assessment of the study. It was not a prospective study and one of the measures he used was a self-report instrument but to pronounce "The paper is not scientific in any way" is an overstatement and I'm afraid that such a broadly dismissive pronouncement does a disservice to other patients with CFS. Keeping the limitations of a study in perspective is always advisable. Dismissing every thing as unscientific because a study wasn't a double blind randomized trial? I'll go into more detail later.
  14. anncavan

    anncavan

    Messages:
    98
    Likes:
    5
    San Francisco, CA
    @Gerwyn - I'd like to first thank you for taking such a full review of Dr. Lerner's work. The discussion needs to happen. As a community we need to ask questions and keep conversations going. As a patient of Dr. Lerner's, and someone quite close to the research I'd like to answer some of your questions raised.

    Re: no grant support... The reason there were no grants or pharma involvement was his desire to keep the research clear of ulterior motives. He also has a really hard time with the idea of a double blind study. He couldn't stomach the idea of someone sick being given a placebo.

    Re: there being only 30 patients with EBV... only 30 of the 142 had EBV ONLY. If you look at the Table 2, and additional 56 had EBV plus either HHV6 and/or HCMV. The majority of group B (herpesvirus plus coinfection) also had EBV.

    Re: graded exercise/psychotherapy... Dr. Lerner does not believe in these treatments for CFS, in fact vehemently opposes exercise until you’re at least a 7, however is obligated to communicate them to provide the backdrop of the current “approved” treatment options in the field (it's a requirement by the publication).

    Re the EIPS scale: He created it because there was a need before anyone knew what CFS was. It is a peer reviewed and published scale tested against the commonly used Fatigue Severity Score (FSS) universally used for Multiple Sclerosis and other similar conditions. It’s based on the estimated caloric use per level of the scale and then given relatable concepts (sitting, standing, walking) so you're not stuck trying to count calories burned.

    Re the difference between a 4 and a 7... you have to remember that a 7 means you’re adding up the time it takes to get ready in the morning, get to work, up and around at work, and most importantly the cognitive strain used during a full day’s work. I am a 3.5-4 at best. I get about 4 hours a day to be productive physically (while assuming minimal strain cognitively due to no employment). After adding it up, it would take me 4 hours just to get myself ready in the morning, to work, up and around for lunch, drive home and get myself fed. Add on the cognitive strain of an 8 hour work day, it's a lot more than where I am now. I know people who are now 7's and they have a whole new life. I can't wait to get there!

    Hope some of this helped clarify any of the questions. Always happy to discuss further on- or off-line.

    Best,
    Anncavan
  15. jackie

    jackie Senior Member

    Messages:
    591
    Likes:
    4
    Anncavan...ONE questions as I dont remember reading about the dosages in the paper (i know they were using valacyclovir and what else? ..but were the dosages stable? were they titrated up through the years? any idea?) thanks! j
  16. Cort

    Cort Phoenix Rising Founder

    Messages:
    7,025
    Likes:
    439
    Raleigh, NC
    You have such a soft touch :rolleyes:

    I wonder what Dr. Fitzgerald at the Dept of Medical Education at the University of Michigan Medical School - the guy who did the statistical analysis would say about that - an utter waste of his precious time?

    The assessments were self-reported - hopefully in a fuller trial they'll focus more on antibody levels, etc - but the instrument - the EPIS - has been validated against other fatigue severity indexes - it works You've got to measure functionality somehow.....and its going to be self-report.

    I don't see how level four - out of bed - sitting, standing or walking four to six hours a day (or to put it another way being in bed from 18-20 hours/day)
    could be construed as more active than level 7 - out of bed 14 hours a day plus working at a job. They're going from in bed 18-20 hours a day to being in bed 10 hours a day PLUS they're working. That sounds like progress! :victory:

    I was a bit confused by the scale at first. The scales is not saying that people are walking 6 hours a day; the scale is saying that they are doing one of three activities either sitting, standing or walking 6 hours a day; they have to be doing something if they're out of bed.( I suppose he would have putting swimming in there as well or cycling...:)).those are just activities people do when they're not in bed

    Valacyclovir was the main drug tested; famiciclovir got very little testing; I don't see how that effects the main findings.

    Look at Figure 3 - the EIPS score steadily went up and up; the first three years showed the greatest benefit overall. The first 6 months there was typically little improvement; after two years most people had gained two functional levels! and then the average person went up another one - you just don't see that. Of course some people only gained a little bit but that also meant that some people zoomed up there to wellness.:D
  17. Hope123

    Hope123 Senior Member

    Messages:
    1,142
    Likes:
    539
    I'm glad this was published and will have to take the time/ energy to look at it more closely. I have always been impressed with Dr. Lerner's interest in CFS and his commitment to researching/ publishing on it.

    However, having read a number of his scientific articles, including the one that was validating his EIS scale, I still have my doubts. I think antivirals (note this does not refer to antiretrovirals) can help some people with cognition and others may recover fully but I think his results tend to be a bit overblown.

    While it could be argued that people who recover fully don't report back, I don't think that is the case. I've heard stories of people like Sue who see him for years and report no progress. Even when there is progress, it tends to be moderate and not dramatic. I think there must be some folks, ala Michael Manson, who recovered fully on Valcyte, that would be ecstatic about their recovery and report it widely and enthusiastically. (If you are such a person or know of such a person, please share with us!)

    Furthermore, I know a reputable CFS doc who has several patients that have been seen by Dr. Lerner and this doc says dramatic results have not been seen. Now you could argue that this doc doesn't see the folks that recovered but I think if the patients had, they would be reporting it back to this doc.

    All this is to say, good for Dr. Lerner to persist in his work and for the volunteers involved. But for us patients, as usual, we need to be careful about interpreting studies.
  18. MNC

    MNC Senior Member

    Messages:
    162
    Likes:
    38
    I was speaking on the phone some months ago with a lady from Florida who is cured thanks to Dr.Lerner and told me all her story. I emailed him asking if he could treat me on the phone because I couldn't travel from Spain to the USA and he told me he was sorry but only treated in person.

    I wonder for very long why Dr.Lerner is not more famous. For what I had read, he's been the one having more success rate in the whole world.
  19. Dolphin

    Dolphin Senior Member

    Messages:
    6,713
    Likes:
    5,538
    Best to follow the links above and comment there, if talking about Cort's article, I reckon.
  20. Dolphin

    Dolphin Senior Member

    Messages:
    6,713
    Likes:
    5,538

See more popular forum discussions.

Share This Page