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Unlike some resurfacing or surgical procedures, after which there is possible pigmentation or scarring, when Botox is done correctly, it can be done on all skin tones. “This is a procedure [and] product that crosses all divides,” says Dr. Matarasso. “Men, women, Caucasian, African-American, Asian, Indian. I don’t think there is a demographic that has not enjoyed the benefit of this product.”
Key secondary endpoints included Physician Global Assessment, finger flexors muscle tone, and thumb flexors tone at Week 6. The Physician Global Assessment evaluated the response to treatment in terms of how the patient was doing in his/her life using a scale from -4 = very marked worsening to +4 = very marked improvement. Study 1 results on the primary endpoint and the key secondary endpoints are shown in Table 26.
Safety and effectiveness of BOTOX have not been established for the treatment of other upper or lower limb muscle groups. Safety and effectiveness of BOTOX have not been established for the treatment of spasticity in pediatric patients under age 18 years. BOTOX has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. Treatment with BOTOX is not intended to substitute for usual standard of care rehabilitation regimens.
Though botulinum toxin is available under different names, Botox is the only one that is FDA-approved for migraine prevention. To be considered for Botox, patients must have migraines 15 days or more per month, which is considered chronic daily migraine. About 4 million Americans have such migraines, according to the Migraine Research Foundation. Also, patients must have tried and failed on at least 2 other medications first.
Andrew M. Blumenfeld is director of The Headache Center of Southern California. Most of his research has focused on the use of OnabotulinumtoxinA in the treatment of chronic migraine. He helped develop the injection paradigm approved by the United States Food and Drug Administration and has taught providers around the world on practical aspects of this treatment option.
The other method of calculating the cost of Botox is to pay by the area being treated. Doctors will specify the total cost for a designated region of the face -- for example, in the United States it should cost between $250 and $500 to treat horizontal forehead lines. However, it’s important to note that the forehead is treated as two seperate areas--the forehead lines that run horizontally across the forehead, and the frown lines that appear at the glabella. If you were to pay per area treated you would need to pay for two different areas. This method of pricing can sometimes mean you pay for more than what you need, especially if you don’t have deeply-etched wrinkles. At the same time, there’s an advantage to knowing how much the treatment will cost before you undergo the procedure, leaving no room for any unwelcome surprises.
Since then, several randomized control trials have shown botulinum toxin type A to improve headache symptoms and quality of life when used prophylactically for patients with chronic migraine who exhibit headache characteristics consistent with: pressure perceived from outside source, shorter total duration of chronic migraines (<30 years), "detoxification" of patients with coexisting chronic daily headache due to medication overuse, and no current history of other preventive headache medications.
The recommended dilution is 200 Units/2 mL, 200 Units/4 mL, 100 Units/1 mL, or 100 Units/2 mL with preservative-free 0.9% Sodium Chloride Injection, USP, depending on volume and number of injection sites desired to achieve treatment objectives (see Table 1). In general, no more than 50 Units per site should be administered using a sterile needle (e.g., 25-30 gauge) of an appropriate length. Localization of the involved muscles with electromyographic guidance may be useful.
Other things to know about Botox treatments: Some providers charge a consultation fee, which is waived if you choose to proceed with the injections but charged if you decline. Also, who is doing the injection? Make sure it’s a trained, certified professional. As in many other things, training and credentials are important. In some practices, a junior employee may perform the procedure for a lesser rate. Make sure that’s what you want.
Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.