Re: Fallon in print

[Guest guest]

Part of the problem is probably with the drug being used. And I really doubt if monotherapy with any current known drug is going to cut it. penny <usenethod@...> wrote: I have the abstract only. From it I can't make out whether there areany statistically significant findings or no. Anyway, from my personalstudy of anecdotal reports, I think ten weeks is a marginal treatmentduration at best, especially for a monotherapy, given the need toachieve

significance at 0.05 with only 37 patients. I'm stronglyinclining for now towards not taking the results very seriously.Whereas the disappointing (barely-)negative results of the quitelarge, hard-hitting (three-drug) P Gibson Crohn's study I take veryseriously, so far, though I still haven't read it in full.1: Neurology. 2007 Oct 10; [Epub ahead of print]Click here to read LinksA randomized, placebo-controlled trial of repeated IV antibiotictherapy for Lyme encephalopathy.Fallon BA, Keilp JG, Corbera KM, Petkova E, Britton CB, Dwyer E,Slavov I, Cheng J, Dobkin J, DR, Sackeim HA.From the Department of Psychiatry (B.A.F., J.G.K., K.M.C., E.P.,I.S., J.C., H.A.S.), Department of Biostatistics (E.P.), Department ofNeurology (C.B.B.), Department of Medicine (E.D., J.D.), and New YorkState Psychiatric Institute (B.A.F., J.G.K., K.M.C., E.P., I.S., J.C.,H.A.S.), Columbia University, New York; and Department of

Cell andMolecular Biology, University of Rhode Island, Kingston (D.R.N.).BACKGROUND: Optimal treatment remains uncertain for patients withcognitive impairment that persists or returns after standard IVantibiotic therapy for Lyme disease. METHODS: Patients hadwell-documented Lyme disease, with at least 3 weeks of prior IVantibiotics, current positive IgG Western blot, and objective memoryimpairment. Healthy individuals served as controls for practiceeffects. Patients were randomly assigned to 10 weeks of double-maskedtreatment with IV ceftriaxone or IV placebo and then no antibiotictherapy. The primary outcome was neurocognitive performance at week12-specifically, memory. Durability of benefit was evaluated at week24. Group differences were estimated according to longitudinalmixed-effects models. RESULTS: After screening 3368 patients and 305volunteers, 37 patients and 20 healthy individuals enrolled.

Enrolledpatients had mild to moderate cognitive impairment and marked levelsof fatigue, pain, and impaired physical functioning. Across sixcognitive domains, a significant treatment-by-time interaction favoredthe antibiotic-treated group at week 12. The improvement wasgeneralized (not specific to domain) and moderate in magnitude, but itwas not sustained to week 24. On secondary outcome, patients with moresevere fatigue, pain, and impaired physical functioning who receivedantibiotics were improved at week 12, and this was sustained to week24 for pain and physical functioning. Adverse events from either thestudy medication or the PICC line were noted among 6 of 23 (26.1%)patients given IV ceftriaxone and among 1 of 14 (7.1%) patients givenIV placebo; these resolved without permanent injury. CONCLUSION: IVceftriaxone therapy results in short-term cognitive improvement forpatients with posttreatment Lyme

encephalopathy, but relapse incognition occurs after the antibiotic is discontinued. Treatmentstrategies that result in sustained cognitive improvement are needed.PMID: 17928580 [PubMed - as supplied by publisher]