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Q&A Session (held Feb. 1) with Charles W. Lapp, MD - a World Authority on ME/CFS/FM Evaluation and Management

  [ 394 votes ]   [ 6 Comments ]
www.ProHealth.com • February 24, 2008


Q&A Session (held Feb. 1) with Charles W. Lapp, MD - a World Authority on ME/CFS/FM Evaluation and Management
Welcome to ProHealth's Live Chat Q&A with Dr. Charles Lapp, MD, Held Friday, February 1 in the ImmuneSupport.com Community Chat Room

Dr. Charles Lapp is a world authority on ME/CFS and Fibromyalgia. He has been treating patients hands-on for more than 20 years and plays a lead role in international research, advocacy, and physician education.

Dr. Lapp is one of the pioneer physicians who first brought CFS to national attention in the U.S., and now directs the Hunter-Hopkins Center in Charlotte, NC - a practice dedicated to ME/CFS/FM consultation, testing, and treatment. He is also a board member of the International Association for CFS/ME and American Fibromyalgia Syndrome Association, medical advisor to the CFIDS Association of America, author of physician education courses and materials for the CDC, and a past member of the federal CFS Advisory Committee, which advises the Secretary of Health and Human Services.

To read a personal profile of Dr. Lapp, see “Charles W. Lapp, MD – CFS Pioneer, Researcher, and Clinician.” And to review his treatment theory, see “The Stepwise Approach.”

___________________________

Dr. Lapp: Hello, everyone. I am delighted to be with you all this evening!

* * * *

Q: Hello, doctor! Thank you so much for being here. I’d like to know, do you still feel Chronic Fatigue Syndrome and Fibromyalgia are one and the same? Can you share with us how you feel they may be similar/dissimilar?

Dr. Lapp: In the past I have said that ME/CFS and FM are the same because the symptoms overlap so closely. The difference? PWFs have more pain, PWCs have more fatigue and cognitive problems.

We now know that there are subtle biochemical and genomic differences, and slight differences in the triggers and the outcomes. For the most part, though, I see them as about the same.

* * * *

Q: Sorry, what does PWF mean?

Dr. Lapp: PWF means Person with FM and PWC means Person with CFS/ME

* * * *

Q: Do you feel that ME/CFS is constituted by subgroups; and if so, how would you categorize the subgroups?

Dr. Lapp: Yes. There is no doubt that there are differences - with different age groups, races, gender; whether Fibromyalgia is present; abruptness of onset, severity at onset, duration of illness, etc.

* * * *

Q: Doctor, what diagnostic ME/CFS test/procedure do you think is good for the local internist or GP to use now?

Dr. Lapp: There is no diagnostic lab test for ME/CFS – no blood test, urine test, or X-ray. The only way to diagnose ME/CFS is to apply the CDC Case Definition, which can be found at the CDC website (http://www.cdc.gov/cfs click on “definition”).

I recently wrote a QUICK START GUIDE to help your personal doctor diagnose and start treatment for ME/CFS. Have him or her go to http://www.cfstreatment.info and download diagnostic information, forms, teaching material – everything that’s needed for the first 3 office visits.

* * * *

Q: What effective treatments for ME/CFS/FM are you currently using or hope to use in the near future?

Dr. Lapp: The most important “treatment” is to pace yourself by resting frequently, set reasonable limits on your activity, and stay physically active (but not so active as to trigger a flare). Once that is accomplished it is important to treat sleep problems first, then pain, fatigue, orthostatic intolerance, and hormonal deficiencies. Remember, THERE IS NO CURE, but management can provide great improvement, even recovery!

* * * *

Q: Dr. Lapp, what could you recommend specifically for fatigue? (Medication, supplements, vitamins, etc.) Anything that could help with fatigue.

Dr. Lapp: Fatigue is difficult to manage. It depends on what is the cause. For example, if you have fatigue from lack of sleep, then sleep therapy is first. Patients who are sleepy (as opposed to just ‘tired’) during the day can respond to stimulants such as Provigil (modafinil), Adderall, Ritalin, etc.

* * * *

Q: When Stage 3-4 sleep is a problem, what treatments do you recommend?

Dr. Lapp: One of the most common sleep disorders we see in ME/CFS & FM is the absence of deep (or Stage 3-4) sleep. This probably helps explain why you all experience “non-refreshing sleep” - because you never really get relaxed and rested.

There are only 4 drugs in the U.S. that reliably improve Stage 3-4 sleep: Desyrel/trazadone, Remeron/mirtazapine, Xyrem/oxybutyrate, and possibly Gabitril. But if you can sleep deeply with melatonin, diphenhydramine, or sleeping pills, that helps.

* * * *

Q: Why is Klonopin often prescribed?

Dr. Lapp: Klonopin is one of my favorite drugs because it is a relaxing drug (like Valium) but it also induces sleep and (by virtue of its anti-epileptic properties) blocks jerking (myoclonus) at night.

In small doses of 0.5 to 1.5mg it makes for a perfect sleep inducer. We used to ask patients, "If you could only have one drug, what would it be?" The usual answer was (1) Klonopin and (2) injectible B12.

We have some other great drugs now, so maybe people would answer differently.

* * * *

Q: Is Klonopin addictive?

Dr. Lapp: Klonopin is a benzodiazepine, like Valium. Therefore, one can become habituated to it. All that means is that you should never stop it suddenly. Always taper off of Klonopin if used regularly.

* * * *

Q: Can Klonopin be used in conjunction with the drugs you noted for improving Stage 3/4 sleep (Desyrel/trazadone, Remeron/mirtazapine, Xyrem/oxybutyrate, and possibly Gabitril)?

Dr. Lapp: Yes, Klonopin is used to initiate sleep, but you may also want to take something to MAINTAIN sleep. Consider Benadryl, Tylenol PM, melatonin, amitriptyline, doxepin, or my favorite, trazadone.

* * * *

Q: Has LyricaTM shown to be helping a lot? [Lyrica/pregabalin became the first FDA-approved drug for treatment of Fibromyalgia in June 2007. It is thought to work by affecting seizure-causing impulses and pain signals in the brain.]

Dr. Lapp: Yes, Lyrica has helped quite a few of our patients. We've been studying the drug for pain for three years now and had some remarkable responses.

* * * *

Q: Dr. Lapp, what causes the relapses in ME/CFS? My wife had a very severe relapse, leaving her bed-bound for 5 months. She is now housebound.

Dr. Lapp: I teach my patients that the major causes of relapse are S-O-S: That stands for:

  • STRESS (or infection),
  • OVEREXERTION,
  • And SLEEP deprivation.
  • * * * *

    Q: Has there been a link between trauma and Fibromyalgia?

    Dr. Lapp: For years we have argued about "post-traumatic Fibromyalgia." Clearly large numbers of PWFs had the illness triggered by trauma - even a fender bender.

    Disability agencies and insurers don't like this, however, because of the liability. So they have asked us to stop using "post-traumatic FM" as a diagnosis. I call it as I see it. :o)

    * * * *

    Q: You have been quite involved in the FDA review of [the experimental antiviral/immune modulatory drug] Ampligen. Do you think it will have universal ME/CFS potential? Or will it be targeted for a specific subgroup, and if so, which one?

    Dr. Lapp: I have nothing to do with the FDA review except that I have been doing research with Ampligen since 1988 or 1989, and a lot of that data has been submitted. (See http://www.drlapp.net/ampligen.htm.) We have had some real successes with Ampligen, but I do not consider it a “cure.” Many patients get better with Ampligen, not necessarily cured.

    We have not seen any “subgroup.” In fact, patients of all ages, severities, and duration (even a decade or more) have benefited. I can’t wait until Ampligen is approved and available to all!

    * * * *

    Q: When do you anticipate Ampligen will be available?

    Dr. Lapp: I am told that the New Drug Application (NDA) was complete in October, and that the FDA expects to take at least 6 months for a decision.

    * * * *

    Q: Can you describe a home evaluation process that we might use to self evaluate neurally mediated hypotension (NMH)? For example, for how long should one be lying down/sitting down before checking blood pressure and how long standing up, etc.? [NMH is a type of orthostatic intolerance; involves an abnormal drop in blood pressure associated with prolonged standing or rising from prone to upright position, common in ME/CFS and FM patients and involving dysregulation of the autonomic nervous system.]

    Dr. Lapp: We’ve had patients get REALLY sick during tilt table testing so I don’t really recommend home testing. But the way it is done is to stand (in a corner, with help nearby!) and have someone check heart rate and blood pressure every 5 minutes for up to 30 minutes.

    PWCs have a worsening of symptoms (pain, nausea, headache, etc.) within minutes of standing. There are several possible positive responses: HR (heart rate) increases more than 30; BP (blood pressure) drops more than 20; fainting. Fainting is usually delayed by 15 to 20 minutes.

    P.S. Don’t tell anyone that I recommended this!

    * * * *

    Q: Is there a reason why some patients react to even baby doses of medicines?

    Dr. Lapp: PWFs and PWCs both experience hypersensitivity. They are sensitive to light, sound, smell, touch, and even medications. You are probably sensitive to motion and room temp too.

    * * * *

    Q: Could you please tell me what the name is of the thyroid test that will give the most accurate reading of how your thyroid is truly functioning? I remember reading about it and it is not one of the ones that are usually done.

    Dr. Lapp: Thanks for asking! Because the Hypothalamic-Pituitary-Adrenal Axis (or HPA Axis) is usually suppressed in ME/CFS, you must rely on the actual hormone levels. They are free T4 and T3. Don’t let your doctor rely on TSH (thyroid-stimulating hormone) alone!

    * * * *

    Q: Have you heard about the use of guaifenesin for the treatment of fibro, and if so what is your opinion? [Guaifenesin is a bark extract long employed as a mucous-thinning expectorant, and used in the experimental “Guaifenesin Protocol” developed by R. Paul St. Amand, MD.]

    Dr. Lapp: I have not been a fan of guaifenesin for treatment. I am well aware of Dr. St. Amand's theory. He suggests that [phosphate] in muscles may cause fibro pain.

    There is no real evidence for this. Double blind studies of guaifenesin in CFS/ME and FM have NOT shown any benefit, and that is my personal experience also. On the other hand, guaifenesin is "harmless" and if you wish to try it, I cannot imagine any harm.

    * * * *

    Q: What if anything do you believe 'cognitive behavioral therapy' (CBT) can help, and what not?

    Dr. Lapp: It depends on your meaning of CBT.

    We prefer to call it “coaching.” Our patients don’t need psycho-babble, they need help understanding their illness, coping with day-to-day issues, and regular support.

    We have several psychologists who provide such “coaching” by telephone, if needed. They include Nancy Waring, PhD (retired from private practice to work with the Carmel Counseling Center), Katrina Berne, PhD (author with Drs. Robert Bennett and Daniel Peterson of Chronic Fatigue Syndrome, Fibromyalgia, and Other Invisible Illnesses – The Comprehensive Guide), Patricia Fennell, MSW, LCSW-R (Albany Health Management), and Bill Collinge, PhD (Collinge and Associates) – really super people, and super supporters!

    There is a really great source of “coaching” and support on line for patients. If you haven’t checked out Bruce Campbell’s CFS/FM Toolkit, PLEASE go to http://www.cfidsselfhelp.org. I recommend it to all our patients, and hand out copies of Bruce’s book in the office. [Dr. Bruce Campbell, PhD, is a recovered ME/CFS patient and former consultant to self-help programs for chronic illness at Stanford Medical School. His nonprofit site offers articles, low-cost online self help courses in moderated discussion group format, and free follow-up programs.]

    * * * *

    Q: Do you recommend pool therapy for Fibromyalgia? Or for CFS?

    Dr. Lapp: Pool therapy is probably the very best "activity" for PWCs. But you MUST find an arthritis or FM program - not a full aerobic workout. Alternatively, you can just water walk, tread water, paddle around in the pool.

    * * * *

    Q: Dr. Lapp, why since I got ME/CFS have my immunity levels been low, and is there anything at all I can try or do to alleviate it - and stop feeling so cold also?

    Dr. Lapp: Immunity is a difficult thing to treat! No good therapies! If you are having frequent infections, have your doctor check immunoglobulin (antibody) levels and IgG (immunoglobulin G) subclasses. If either is low, you may be a candidate for gamma globulin to build up your resistance.

    Otherwise, I recommend using an antiviral (amantadine or acyclovir) plus zinc, Echinacea, and olive leaf or colloidal silver. They can all suppress infections.

    * * * *

    Q: Have you found any patients who carry chronic fevers with ME/CFS, also diagnosed with the virus EBV (Epstein-Barr virus/mononucleosis), CMV (cytomegalovirus, a member of the herpes virus family,) or HHV-6 (human herpesvirus-6)?

    Dr. Lapp: I usually do NOT see chronic fevers in ME/CFS. Most of my patients have subnormal temps. I would be concerned about another problem going on if fevers are truly documented.

    * * * *

    Q: Dr. Lapp, do you believe that Epstein-Barr virus can recur in patients from time to time?

    Dr. Lapp: EBV does "recur" - for sure. When the immune system gets "low" so to speak, latent viruses like EBV can escape and reproduce, causing symptoms.

    Your doctor can tell when EBV is "escaped" or reactivated because the test for "early antigen" becomes positive. Some doctors feel that this can be treated with high dose Valtrex or other antivirals.

    * * * *

    Q: If Epstein-Barr virus has been previously positive, but not currently active, what if any relevance does that have to ME/CFS? By what process would you further evaluate that factor, if at all?

    Dr. Lapp: It appears that EBV is one of many possible triggers for CFS/ME. Again, we know that when the immune system gets weak, EBV can reactivate and reproduce. Then the “early antigen” appears. Some feel that this reactivation is associated with mono symptoms.

    Dr. Paul Cheney and I tried to treat this reactivation with antivirals (acyclovir) in the early 1990s, with some success, and Dr. Martin Lerner is advocating valcyclovir (Valtrex) in some cases now. [Paul Cheney, MD, directs the Cheney Clinic in Asheville, NC, and is a former partner of Dr. Lapp. Martin Lerner, MD, is an infectious diseases specialist at Wayne State University, Detroit. His presentation on valcyclovir therapy is described in Dr. Lapp’s summary of the 2007 IACFS/ME Conference.]

    * * * *

    Q: There are some concerns that ME/CFS and FMS are contagious. Have you heard anything about this, and what are your thoughts?

    Dr. Lapp: PLEASE don't start rumors that ME/CFS is contagious. There is absolutely no evidence to support that! You can hug or kiss anyone you like without fear! ;o)

    On the other hand, we occasionally hear ANECDOTAL stories that an accidental needlestick or blood transfusion has triggered CFS in someone. Is it true? I don't know, but I do not recommend that our patients donate blood or organs until we have the answers to these questions.

    * * * *

    Q: Do you use supplements in your treatment plans; and if so, which ones?

    Dr. Lapp: Yes. My favorites are high dose (injectible) B12, NADH, Vitamin D, magnesium malate, DHEA, CoQ10, and carnitine – in that order. ProHealth has some really great vitamins that we recommend too.

    * * * *

    Q: What are your thoughts about Vitamin D deficiency and effects of Vit D in Fibro & CFS? What tests do you recommend?

    Dr. Lapp: In the last year it has become clear that virtually all persons with ME/CFS and FM have VERY low Vitamin D levels. Measure 25-hydroxy vitamin D. Below 40 is abnormal, below 20 is severe deficiency. I recommend using 1000 to 2000 units of Vitamin D daily. It’s over-the-counter (OTC).

    By the way, Vitamin D is also a hormone - and low levels are associated with pain in the long bones, increased cancer rates, and possibly heart disease and stroke. It’s important to supplement Vitamin D daily, even if you get lots of sun.

    * * * *

    Q: Your thoughts on the IV treatments that seem so popular these days?

    Dr. Lapp: Be cautious with IV (intravenous) therapies. Dr. David Bell and I have used saline (salt water) infusions for years. They give a temporary boost, probably just by increasing blood or plasma volume.

    However, you cannot go around forever with an IV in the arm, so it is not a practical therapy for everyone. We save IVs for "crashes" or before operations, or after over-exertion - say when someone has to attend a wedding or graduation.

    I have not found that Meyers' Cocktail or any other specialty infusion has been any more helpful than salt water. [The Meyers' Cocktail is an intravenous vitamin and mineral protocol developed in the 1970s by a physician at Johns Hopkins.]

    * * * *

    Q: What about magnesium as an injectible?

    Dr. Lapp: Cellular magnesium levels are frequently low in CFS/ME/FM, and low magnesium causes fatigue, weakness, etc. Sound familiar? Oral supplementation may help (especially if linked to malate), but injections are faster and more reliable. They sting like fire though! We use 2cc of 50% magnesium sulfate IM (intramuscular) every 3-7 days.

    * * * *

    Q: What is the difference between getting B12 injections and taking supplements?

    Dr. Lapp: We have studied various B12 preparations and have had the best, most reliable results from SQ (subcutaneous) or IM (intramuscular) injections. We found that 2000 mcg every 3 days was about the minimum effective dose. I use 1000 mcg every other day or 3000 mcg every 2-3 days in my patients. Oral, rectal, and nasal preps have never been as effective.

    * * * *

    Q: Other than B12 injections, are there any that the patient can do on her own?

    Dr. Lapp: There are lots of things that patients can do on their own! I am developing a website with Dr. Bruce Campbell to address this. You can see the work in progress at http://www.cfstreatment.info.

    Until we get specific recommendations online, however, PLEASE go to Dr. Campbell's website at http://www.cfidsselfhelp.org or consider taking his excellent online course! Highly recommended. Tell Bruce I sent you! :o)

    * * * *

    Q: New research appears to link CFS & serotonergic hypersensitivity. Might this explain reactions (anxiety) to Prozac, Maxalt, 5-HTP, etc.? Any implications regarding use of SSRI or norepinephrine inhibitors like Cymbalta (duloxetine)? Would that increase anxiety? [Serotonin has been called a “happiness” neurotransmitter. SSRIs – selective serotonin reuptake inhibitors – are a class of antidepressants that inhibit serotonin reabsorption, leaving more available in the brain. Maxalt is a serotonin “agonist” that mimics the effect of serotonin. 5-HTP is a natural serotonin precursor. Norepinephrine is known as a “stress hormone.”]

    Dr. Lapp: I believe you are right! I see many patients who are sensitive to SSRIs - get nervous and jittery with Prozac, Lexapro, Celexa, etc.

    Recall that chronic illness and pain may drain serotonin, norepinephrine, OR dopamine from the brain, so sometimes we have to try different agents. Best for norepinephrine are duloxetine and venlafaxine. For dopamine I use Wellbutrin instead of an SSRI.

    * * * *

    Q: What proportion of your patients do you think may have Lyme disease? Do you think it’s separate from ME/CFS, a trigger, or?

    Dr. Lapp: Only a very small number of my patients have Lyme, and we test just about everybody!

    Lyme can clearly be a trigger for ME/CFS. If untreated it can perpetuate ME/CFS and cause terrible symptoms. There is no evidence that IV or long term treatment is needed.

    * * * *

    Q: You and Dr. Leonard Jason co-authored the CDC's free online CFS training course for primary care doctors. Is that generating positive results?

    Dr. Lapp: I have heard good reports about the Provider Course, and I understand that professionals are taking it on a regular basis. They get education credits too. Get your doctor to log on and take the course at http://www.cdc.gov/cfs/cfscontineducatHCP.htm or http://www.cfids.org/treatcfs/default.asp

    This raises a major concern in my mind: There are only a handful of doctors in the U.S. who study and treat ME/CFS, and they are aging rapidly. Some have retired, and others will be doing so soon. WE NEED TO BE TRAINING new providers to take their place.

    I urge you to contact the CFIDS Association, the IACFS/ME, local support groups, ProHealth – anybody with influence – and encourage them to develop a training program for providers. We would love to do that in Charlotte – all it takes is time, a little money, and interest!

    * * * *

    Q: Can you think of some things that can be done to speed up the education of doctors to knowing that FMS and CFS are real illnesses? There is so much “medical racism” out there, done against us.

    Dr. Lapp: The CDC Provider Course is a good start. Also, if your doctor hasn’t seen it, download the CFS Toolkit from the CDC website at http://www.cdc.gov/cfs/toolkit.htm. And the CFIDS Association offers a kit for providers. Write and ask that it be sent to your doctor.

    I offer a really great turnkey program for primary care docs at http://www.cfstreatment.info. Your doctor can click on Quick Start and download instructions and forms for diagnosing and treating ME/CFS.

    I have also lobbied the CFIDS Association and the International Association for CFS/ME to put on courses around the nation for doctors to learn how to diagnose and treat ME/CFS. The IACFS/ME has a speaker’s bureau and could probably provide someone if you could set up a meeting in your area!

    * * * *

    Q: Is any of this available for Canada?

    Dr. Lapp: Why not in Canada? Or any other country.

    * * * *

    Q: I have recently been plagued by tingling on the soles of my feet. Do you have any thoughts? I have FM and CFIDS.

    Dr. Lapp: Two thoughts come to mind:

    1. Tingling is actually a weak form of pain. Pain starts as an itch, then tingling, then burning, then pain. Such neuropathic pain (associated with damaged or dysfunctional nerve fibers) is best relieved by anti-epileptic drugs such as Neurontin or Lyrica. Pain medications could possibly help too.

    2. On the other hand, tingling may be due to a peripheral neuropathy (distortion in transmission of information between parts of the body and the brain/spinal cord), in which case the anti-epileptics would be best.

    * * * *

    Q: Topamax - less weight gain?

    Dr. Lapp: Topamax is a reasonable choice too. Higher doses can exacerbate cognitive dysfunction, however.

    * * * *

    Q: If you have ME/CFS, and have a major surgery such as a pancreatic Whipple [an operation named for the surgeon Allan Whipple], how much more difficult would the recovery be?

    Dr. Lapp: Most of us who deal with PWCs and PWFs have seen that recovery is slightly slowed, and of course pain can be a bit more problematic. Nothing insurmountable! There are recommendations for your surgeon or anesthesiologist available on ImmuneSupport.com (Dr. Lapp's "Recommendations for Persons with Chronic Fatigue Syndrome (or Fibromyalgia) Who Are Anticipating Surgery" available on ImmuneSupport.com. Or go to my website (http://www.drlapp.net) and send me an e-mail. I'll be glad to send the recommendations to you.

    * * * *

    Q: Why is shortness of breath a problem for many ME/CFS patients?

    Dr. Lapp: Wow! Shortness of breath is a very common symptom in ME/CFS and FM. What causes it is unknown, however. I recently asked a half dozen experts how they deal with it, and I got 6 different answers back!

    My personal feeling is that most PWCs are chest or thoracic breathers, and don't really get a good breath. In my office we teach patients to take deep abdominal breaths, and that resolves the problem. Other causes may include hyperventilation, lung diseases (sarcoid – an inflammatory immune disorder - or others), mild asthma (common in PWCs), and I recently had two patients state that a gluten free diet cured them. Figure!

    * * * *

    Q: Doctor, before our time is up – I know you’re involved in the Campaign for a Fair Name (http://www.afairname.org). It doesn’t seem to me that we’ll be able to change the name ‘Chronic Fatigue Syndrome’ unless we get the CDC to change the name. What is your thinking on this?

    Dr. Lapp: Don’t be so pessimistic! In 1992 you patients changed the name to CFIDS just by using that name over and over. WE CAN DO IT AGAIN! I don’t care if the CDC uses the name CFS forever… everyone else will know it as ME if we just keeping using those two letters! (You can go to http://www.afairname.org and get involved.)

    Closing Comments

    The Q&A is now drawing to a close. We thank Dr. Lapp for his steadfast dedication to patients, his good humor, and his generosity in joining us today. And we thank all of you for contributing to this informative exchange.

    Thanks Doctor Lapp. You are the best!

    Thank you Doctor Lapp, from a grateful Brit.

    Just a quick note to personally say that Doctor Lapp is by far the most brilliant doctor I have ever dealt with (out of around 15 to 20 doctors). Thank you, Doctor.

    Dr. Lapp: How nice. I’ve seen messages from so many who say “Hi”! The ProHealth staff tells me that we have set new records for Chat Room volume of questions tonight. Sadly, there are many more than I can possibly answer, but I would love to do this again with you.

    You have been a WONDERFUL audience and sent lots of excellent questions. I hope that I have helped you in some small way. Please copy and paste my website and visit me again soon! It is http://www.drlapp.net. Thank you, God bless.

    ___
    Note: This information has not been evaluated by the FDA. It is generic and is not intended to prevent, diagnose, treat, or cure any condition, illness, or disease. It is very important that you make no change in your healthcare plan or health support regimen without researching and discussing it in collaboration with your professional healthcare team.



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    There is EVIDENCE that long term antibiotics treatment helps lyme disease!
    Posted by: Bettyg
    Feb 6, 2008
    www.cumc.columbia.edu/newsroom MEDIA CONTACT: Elizabeth Streich (212-305-6535; eas2125@columbia.edu) WEDNESDAY, OCT. 10, 2007 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.” - ### - Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, public health professionals, dentists, nurses, and scientists at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. www.cumc.columbia.edu PATIENT QUERIES: - To schedule a clinical evaluation for patients with neurocognitive or neuropsychiatric problems from Lyme disease, please call 212-543-6508. - To schedule a research evaluation for possible participation in a diagnostic study, please call 212-543-6510. - Please note: As of June 4, 2007, the center is not currently conducting any active treatment trials.
    Reply Reply

     
    This abstract & article in the ProHealth Library
    Posted by: minnesota
    Feb 6, 2008
    The abstract with a link to the press release is at http://www.immunesupport.com/library/showarticle.cfm?id=8445 It's a little easier to read.

     


    dr. lapp's Q and A session
    Posted by: scottyojai
    Feb 6, 2008
    Dr Lapps session is excellent, and there are many things that i will bring to my doctor. However, my doctor never seems to have the time for one more bit of info, let alone several. I can download the entire session ( and will) but i have no illusions that he will read it. My doctor is good and very understanding, and has been my doc for 25 years....18 of those years he has been trying to treat my ME/cfids. And he is willing to try almost anything i bring him from online support groups, but his time is very limited, and so i have to see him often...usually bringing him info on one thing at a time. This is time consuming, trial and error, (mostly error). I am going to try to see if i can fly to Charlotte ( i'm on the west coast) and see if i can get many issues taken care of quickly with Dr Lapp. My wife also has ME/cfs of 20 years duration, same problems, but we keep on trying! scott eckersley ojai, ca.
    Reply Reply

    Lyme in PWC's
    Posted by: teach6
    Feb 26, 2008
    I have to disagree with Dr.Lapp's comments regarding the incidence of Lyme within the PWC community. A large percentage of Lyme patients were previously diagnosed with CFS/ME. My own doctor has found that at least 50% of his CFS patients actually have Lyme. I have been on antibiotic therspy for almost two years now. I am getting better. I've taken Dr. Campbell's course and even with all I've learned through it and the follow up groups I wasn't getting any better. I would also wager to guess that those who are experiencing shortness of breath are actually dealing with Babesiosis, a tick-borne infection. One of the symptoms is air hunger. When my health plummeted it was one of my scariest symptoms, made worse by "profound dysautonomia," in my doctor's own words. As I treat Babesia this is improving. The above article cited by bettyg is an excellent example of reseach showing that long-term antibiotics do work. The form it is in on this site makes it difficult for most of us with cognitive problems to read. She has those problems herself, so I know she would have posted this differently if she could have. Finally, I urge PWC's to keep an open mind about Lyme. I can't thank enough those who were diagnosed with Lyme prior to me for urging me over and over to pursue this diagnosis. When I got it I was given hope again. Hope that I will be able to get better. And I am. Please know that most Lyme tests are highly unreliable, as recently backed up by a study at John's Hopkins. For proper diagnosis is one needs to see what is known as a Lyme Literate doctor, one who is specially trained in the treatment of Lyme Disease.
    Reply Reply

    dr. lapp's interview
    Posted by: loriadonahue
    Feb 27, 2008
    I have been a patient of Dr. Lapp's for a few years now and I think he is brilliant and kind. I went to him in the middle of a bad flare-up having already been diagnosed in 1990 by Dr. Cheney. I left his office with many tools to recover and have continued to implement them into my daily life. Kudos to Dr. Lapp for caring so much about the CFS/ME patient.
    Reply Reply

    guiafenisen protocol
    Posted by: lynchmob3
    Mar 6, 2008
    I am so tired of hearing other doctors not recommending Dr. St. Amand's protocol because it hasn't been "proven" to be effective. Is there a treatment out there that has been "proven" to be effective??? Has your treatment been PROVEN??? I tried the B12 injections and they worked great, for about 3 months then they stopped working. The same thing happened for everything else I have tried. Prescription medications, herbal medications and so on. It works for awhile and then stops. I have been on the guaifenisen protocol for 3 years and it IS working for me! Check out www.fibromyalgiatreatment.com and you can read more about it.
    Reply Reply


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