New Lyme Disease Study

Discussion in 'Lyme Disease Archives' started by mezombie, Oct 10, 2007.

  1. mezombie

    mezombie Member

    Columbia University Medical Center Leads First Placebo-Controlled
    Study of Cognitive Impairment Due to Chronic Lyme Disease



    Findings Show Severe Physical Dysfunction Among Patients & Benefit of
    Repeated IV Antibiotic Therapy to Provide Long-Term Symptom Relief



    NEW YORK – Findings from the first placebo-controlled study of chronic cognitive impairment after treated Lyme disease (also known as chronic Lyme encephalopathy) demonstrate that patients report moderate cognitive impairment, physical dysfunction comparable to patients with congestive heart failure, and fatigue comparable to patients with multiple sclerosis. In the study, repeated intravenous (IV) antibiotic therapy was shown to be effective in treating cognitive dysfunction and the debilitating pain, fatigue and physical dysfunction associated with this disease.



    The study, titled “A Randomized, Placebo-Controlled Trial of Repeated IV Antibiotic Therapy for Lyme Encephalopathy,” will be published on-line by the journal Neurology on Oct. 10, 2007. The study was led by Principal Investigator Brian Fallon, M.D., M.P.H., director of the recently established Lyme and Tick-borne Disease Research Center at Columbia University Medical Center (http://www.cumc.columbia.edu/news/press_releases/fallon_lyme_center.html). The research was conducted jointly at the Columbia University Medical Center and New York State Psychiatric Institute and was funded by the National Institute of Neurological Disorders and Stroke (NINDS).



    “These findings replicate results from a prior placebo-controlled trial of post-Lyme fatigue, which found positive treatment results from repeated antibiotic therapy. They also replicate the degree of physical impairment results demonstrated in another prior study of chronic Lyme disease,” said Dr. Fallon (*see citations below). “The door should be left open for physicians to prescribe medications as warranted, after a careful discussion with the patient of the potential risks and benefits.”



    Dr. Fallon and his research team identified patients with cognitive problems that developed after being diagnosed with Lyme disease and which persisted or relapsed despite prior treatment, in order to determine whether patients who have already received the “standard” course of antibiotic treatment (three weeks of IV antibiotic therapy), would benefit from an additional 10 weeks of antibiotic therapy. They also set out to determine whether patients relapse when taken off antibiotics or whether the alleviation of symptoms is sustained or enhanced with time.



    Study participants (57 subjects: 37 patients with a history of Lyme disease and 20 controls) were divided into three subject groups: patients with a history of treated Lyme disease who were randomized to IV treatment with an antibiotic called ceftriaxone for 10 weeks; patients with a history of treated Lyme disease who were randomized to IV placebo for 10 weeks; and, healthy controls who were tested at the same time points as the patients to help to control for the practice effect on neuropsychological testing. All patients had to meet criteria for memory impairment at the start of the study and they were also required to have a positive IgG Western blot for Lyme disease at study entry.



    Key findings from the Neurology paper are as follows:



    Cognition

    § There was significantly greater improvement in cognition in the antibiotic treated sample at the primary end point for efficacy (week 12).

    § When patients were retested three months after antibiotic treatment, the initial gains in cognition for the ceftriaxone-randomized sample were no longer present.

    § Patients lose their cognitive improvement when IV antibiotic therapy is stopped.



    Pain, Fatigue and Physical Dysfunction

    § Among patients with greater severity at the start of the study, those randomized to ceftriaxone had more significant symptom relief of pain, fatigue, and physical dysfunction at week 12, as compared to those patients who did not receive ceftriaxone.

    § Patients initially randomized to IV ceftriaxone who had greater severity of symptoms at baseline continued to show reduced pain and improved physical functioning at week 24. Improvement in fatigue continued, but was no longer statistically different from placebo at week 24.

    § Repeated IV antibiotic therapy is effective in improving cognition, and among the more impaired, in improving pain, fatigue, and physical dysfunction.



    Safety

    § 18.9 percent of the 37 patients had serious adverse effects associated with either the IV line or a reaction to the antibiotic itself. Although all fully recovered, IV antibiotic therapy has the potential for serious risks, such as systemic infection, thrombus formation, or allergic reactions.



    Clinical Recommendations

    § Repeated IV antibiotic therapy should be considered a valuable option with long-term benefit for managing the disabling symptoms associated with chronic Lyme disease.

    § Given the risks and benefits associated with IV antibiotic therapy, physicians and patients need to have a thoughtful discussion prior to initiating treatment.



    *Citations from Recently Published Research

    § The percentage of patients with meaningful improvement in fatigue noted at six months in this Neurology study (66.7 percent for patients treated with ceftriaxone vs. 25 percent for placebo) was comparable to the improvement in fatigue noted after repeated IV ceftriaxone therapy in a prior placebo controlled study (64 percent for drug vs. 18.5 percent for placebo) (Krupp et al., Neurology, 2003).

    § The degree of physical impairment (comparable to congestive heart failure) was comparable to the impairment noted in another chronic Lyme study (Klempner et al., NEJM, 2001).





    “Future research needs to focus on identifying a treatment approach that either allows not only for acute efficacy, but also long-term cognitive improvement; or, a treatment that could be given after the IV antibiotic therapy that would allow for sustained or enhanced cognitive improvement over time. Our Lyme and Tick-borne Disease Research Center continues to work towards finding these solutions,” said Dr. Fallon. “The most important lesson of this study is that physicians and patients need to collaborate openly to design an individual treatment plan to manage the long-term and complex suffering from symptoms of chronic Lyme disease.”



  2. mollystwin

    mollystwin New Member

    I have high hopes for the Lyme Research center at Columbia University. I am hoping that they will help validate our treatments and help find better testing.

    God Bless Brian Fallon and the rest of them at Columbia for helping us!

    dar
  3. victoria

    victoria New Member

    Thanks mezombie, I missed this until today... did you post this on the CF/FM board? It should be!

    all the best,
    Victoria

  4. Daisys

    Daisys Member

    I appreciate knowing of this research, so thank you for posting it. It seems I saw it on the CFS/FM board, so maybe you already posted over there.

    The thread that started with a negative feeling for posing about lyme there became very interesting. There's a lot of cross involvement between these illnesses. I feel that when all the "CFS" subgroups finally get sorted out, they will include lyme disease to a large extent.

    Actually, as more gets known about all of these illnesses, it might be a good idea to put LD with the CFS/LM message board!
  5. mollystwin

    mollystwin New Member

    I thought it was very interesting that most people responded to this post positivly and wanted lyme posts to continue on that board. And they really should! I know that a number of people are now being treated for lyme because they read about it on that board!!

    I was just reading some other posts over there today where people were describing numbing symptoms. That was my first lyme symptom, in the exact same places as the poster! I really wanted to post a comment, but I know many are getting tired of me suggesting lyme. Most often when I respond with lyme as a possible solution I get ignored.

    Its just that I suffered for so many years without a diagnosis. I know that there are folks over there with lyme who do not know it yet!!!
    [This Message was Edited on 10/13/2007]
  6. victoria

    victoria New Member

    which is why I always make the statement that all the stealth bacteria and virii should be considered too, like mycoplasma, HHVs, chlam. pneumonia (cpn), etc ...

    so far, it seems, good, seems to deflect criticism as far as I've seen... as these are also good possibilities.

    Somebody put together a whole list of possibilities on the other board once, but don't remember who it was; was an excellent idea overall, imho. Anybody remember? It should probably be "sticky-noted" at the top of all the boards.

    all the best,
    Victoria
  7. cherylsue

    cherylsue Member

    I've had 7 years of remitting/relapsing CFS and was officially diagnosed with CFS. However, from reading some of the posts on the CFS board I started to think about Lyme this summer. Although I've had 3 negative ELISA tests, I ordered am Igenex test out of my own pocket.

    Guess what? I have Lyme! I don't remember a tick bite or rash. I just got back from a LLMD in Missouri. He said I had Lyme absolutely.

    So, if it weren't for the CFS board and your postings, I'd be in CFS LaLaLand hoping I would get better somehow.

    I started cumanda/burbur, etc. last summer, and after 3 months of herxing, finally reached the therapeutic dose and have seen improvement. I'll be starting Amoxicillin and Nystatin shortly.

    I'll let you know how it goes.

    Thanks for your posts. They pointed me in the right direction.

    Hugs,
    CherylSue
  8. tansy

    tansy New Member

    Hi

    I was originally Dx with ME and my LLMD Dx both ME and neuroborreliosis (a term used in Europe). Lyme, with neurological involvement, is very similar to ME as defined by Malvin Ramsay.

    Currently I am having the unique experience of watching a friend with acute lyme and seeing a replay of what happened to me in the early 80s. Recognised the rash, though I had more than one. He's had a prolonged course of Doxy and now his GP is watching and waiting to see how things progress; my friend is slowly improving and already well informed on lyme.

    This study will help to confirm the potential gains from long term ABx.

    TC, Tansy[This Message was Edited on 10/14/2007]
  9. victoria

    victoria New Member

    regarding his study, above ... from a newspaper article, in IndyStar:


    "(Dr. Fallon's) findings replicate results from prior placebo-controlled trials of post-Lyme disease symptoms. Fallon said he does not believe live bacteria persist in patients and cause their symptoms, but that certain antibiotics have properties beyond killing bacteria and act on neurotransmitters in the brain. As a result of that role, chronic Lyme symptoms are controlled.

    But Dr. Richard Horowitz, president-elect of the International Lyme and Associated Diseases Society, said he treats patients with prolonged antibiotic therapy because he has laboratory tests that show the bacteria persist in patients.
    The public row revolves around whether chronic Lyme disease is real.

    Doctors from Yale, Harvard, the Centers for Disease Control and Prevention, the Infectious Diseases Society of America and New York Medical College say the diagnosis is questionable.
    Dr. Raymond Dattwyler, who studied Lyme disease for years at Stony Brook University Medical Center, said there "is no such thing as chronic Lyme disease."

    ----

    I'd really like to know what Dattwyler thinks it really is and how to treat it, haven't seen any of them come up with any real treatments... it seems to me that they've effectively thrown up their hands... and not bothering with more research except to disprove continued infection?

    Hope I'm wrong, as in the end I don't care what anyone finds is the origin of "chronic" OR "post lyme", as long as there's a way to stop 'symptoms'...

    right now the debate over 'what' it is is getting in the way of treating one way or the other imho.