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Sunday, December 20, 2009

BOTOX VS TOPOMAX IN MIGRAINE TREATMENT

This study in Headache. 2009 Nov-Dec;49(10):1401 was evaluating effects of Botox (onabotulinumtoxinA) vs Topomax (topiramate) on 60 patients (90% female). The reports site that they have similar success however only 40-42% of patients had a 50% decrease in symptoms. 24% in the topiramate had adverse effects from the drugs compard to only 7% in the onabotulinumtoxinA group.

There were adverse reactions (AE) in 9 out of 60 patients. Only 36/60 even lasted the 9 months of the study. It reported
"Forty-one treatment-related AEs were reported in 18 onabotulinumtoxinA-treated patients vs 87 in 25 topiramate-treated patients, and 2.7% of patients in the onabotulinumtoxinA group and 24.1% of patients in the topiramate group reported AEs that required permanent discontinuation of study treatment. CONCLUSIONS: OnabotulinumtoxinA and topiramate demonstrated similar efficacy in the prophylactic treatment of CM. Patients receiving onabotulinumtoxinA had fewer AEs and discontinuations."

The Advantage of Neuromuscular dentistry is a high success rate (80-95% of patients exhibit substantial improvement) and adverse drug reactions are not a problem. This is a relatively short term study and does not address AE's from long term use.

While there is a place for these drugs in the treatment of migraines they definitely have limits of both safety and effectiveness.

An enormous plus with neuromuscular treatment is that significant reductions in Tension-Type headaches, Chronic daily headaches as well as migraine being reduce in frequency and severity. Many additional symptoms are also relieve simultaneously including ear pain, ear pressure, tinnitus or ring in the ear, sinus pain and/or pressure, retroorbital pain, pain and clicking ot the TM Joint (TMJ). TMD is often called The Great Imposter (http://www.sleepandhealth.com/story/suffer-no-more-dealing-great-impostor)

PubMed Abstract
A double-blind comparison of onabotulinumtoxina (BOTOX) and topiramate (TOPAMAX) for the prophylactic treatment of chronic migraine: a pilot study.
Mathew NT, Jaffri SF.

Houston Headache Clinic-Neurology, 1213 Herman Drive, Houston, TX 77004, USA.
Comment in:

Headache. 2009 Nov-Dec;49(10):1401.
BACKGROUND: There is a need for effective prophylactic therapy for chronic migraine (CM) that has minimal side effects. OBJECTIVE: To compare the efficacy and safety of onabotulinumtoxinA (BOTOX), Allergan, Inc., Irvine, CA) and topiramate (TOPAMAX), Ortho-McNeil, Titusville, NJ) prophylactic treatment in patients with CM. METHODS: In this single-center, double-blind trial, patients with CM received either onabotulinumtoxinA, maximum 200 units (U) at baseline and month 3 (100 U fixed-site and 100 U follow-the-pain), plus an oral placebo, or topiramate, 4-week titration to 100 mg/day with option for additional 4-week titration to 200 mg/day, plus placebo saline injections. OnabotulinumtoxinA or placebo saline injection was administered at baseline and month 3 only, while topiramate oral treatment or oral placebo was continued through the end of the study. The primary endpoint was treatment responder rate assessed using Physician Global Assessment 9-point scale (+4 = clearance of signs and symptoms and -4 = very marked worsening [about 100% worse]). Secondary endpoints included the change from baseline in the number of headache (HA)/migraine days per month (HA diary), and HA disability measured using Headache Impact Test (HIT-6), HA diary, Migraine Disability Assessment (MIDAS) questionnaire, and Migraine Impact Questionnaire (MIQ). The overall study duration was approximately 10.5 months, which included a 4-week screening period and a 2-week optional final safety visit. Follow-up visits for assessments occurred at months 1, 3, 6, and 9. Adverse events (AEs) were documented. RESULTS: Of 60 patients randomized to treatment (mean age, 36.8 +/- 10.3 years; 90% female), 36 completed the study at the end of the 9 months of active treatment (onabotulinumtoxinA, 19/30 [63.3%]; topiramate, 17/30 [56.7%]). In the topiramate group, 7/29 (24.1%) discontinued study because of treatment-related AEs vs 2/26 (7.7%) in the onabotulinumtoxinA group. Between 68% and 83% of patients for both onabotulinumtoxinA and topiramate groups reported at least a slight (25%) improvement in migraine; response to treatment was assessed using Physician Global Assessment at months 1, 3, 6, and 9. Most patients in both groups reported moderate to marked improvements at all time points. No significant between-group differences were observed, except for marked improvement at month 9 (onabotulinumtoxinA, 27.3% vs topiramate, 60.9%, P = .0234, chi-square). In both groups, HA/migraine days decreased and MIDAS and HIT-6 scores improved. Patient-reported quality of life measures assessed using MIQ after treatment with onabotulinumtoxinA paralleled those seen after treatment with topiramate in most respects. At month 9, 40.9% and 42.9% of patients in the onabotulinumtoxinA and topiramate groups, respectively, reported > or =50% reduction in HA/migraine days. Forty-one treatment-related AEs were reported in 18 onabotulinumtoxinA-treated patients vs 87 in 25 topiramate-treated patients, and 2.7% of patients in the onabotulinumtoxinA group and 24.1% of patients in the topiramate group reported AEs that required permanent discontinuation of study treatment. CONCLUSIONS: OnabotulinumtoxinA and topiramate demonstrated similar efficacy in the prophylactic treatment of CM. Patients receiving onabotulinumtoxinA had fewer AEs and discontinuations.

PMID: 19912346 [PubMed - in process]

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posted by Dr Shapira at 1:43 PM

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