The median duration of response in study NDO-3, based on patient qualification for re-treatment was 362 days (52 weeks) for the BOTOX 100 Units dose group compared to 88 days (13 weeks) for placebo. To qualify for re-treatment, at least 12 weeks must have passed since the prior treatment, post-void residual urine volume must have been less than 200 mL and patients must have reported at least 2 urinary incontinence episodes over 3 days with no more than 1 incontinence -free day.
Two double-blind, placebo-controlled, randomized, multi-center clinical studies were conducted in patients with urinary incontinence due to detrusor overactivity associated with a neurologic condition who were either spontaneously voiding or using catheterization (Studies NDO-1 and NDO-2). A total of 691 spinal cord injury (T1 or below) or multiple sclerosis patients, who had an inadequate response to or were intolerant of at least one anticholinergic medication, were enrolled. These patients were randomized to receive either 200 Units of BOTOX (n=227), 300 Units of BOTOX (n=223), or placebo (n=241).
In a long term, open-label study evaluating 326 cervical dystonia patients treated for an average of 9 treatment sessions with the current formulation of BOTOX, 4 (1.2%) patients had positive antibody tests. All 4 of these patients responded to BOTOX therapy at the time of the positive antibody test. However, 3 of these patients developed clinical resistance after subsequent treatment , while the fourth patient continued to respond to BOTOX therapy for the remainder of the study.
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea. If such a reaction occurs, further injection of BOTOX should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was us ed as the diluent, and consequently the causal agent cannot be reliably determined.
Botox can be bought by essentially any person with a DEA certificate. Allergan sells it in 50 and 100 unit vials. They are shipped overnight delivery on dry ice to keep the toxin effective it should be opened, reconstituted and used the same day ideally. The Botox will work best this way. Price points will change by who the injector is and what their motives are. Botox can be reconstituted so that you getting a very dilute amount of product. So a by the area approach may really only give you a small amount of product. Or you could be getting old Botox that is a week old and will not last for very long.
When moving a spastic limb through its range of motion, one feels a resistance to movement that increases with the speed at which one moves the limb. This is the definition of spasticity, but other terms such as increased muscle tone, hypertonicity, spastic dystonia, or flexor / extensor spasms are used to describe this resistance. In clinic the term "muscle spasticity" will be used to reduce confusion of terms.
Many people who experience excessive sweating, whether on their hands, hairline, or even under their breasts or butt, are turning to Botox and other neuromodulators (like Xeomin or Dysport). "They help prevent excessive sweating by acting on the sweat glands directly," says NYC board-certified plastic surgeon Z. Paul Lorenc, MD. "The neuromodulator is injected into the sweat glands to relax the muscle and help combat excessive sweating."
BTX-A is now a common treatment for muscles affected by the upper motor neuron syndrome (UMNS), such as cerebral palsy, for muscles with an impaired ability to effectively lengthen. Muscles affected by UMNS frequently are limited by weakness, loss of reciprocal inhibition, decreased movement control and hypertonicity (including spasticity). In January 2014, Botulinum toxin was approved by UK's Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of ankle disability due to lower limb spasticity associated with stroke in adults. Joint motion may be restricted by severe muscle imbalance related to the syndrome, when some muscles are markedly hypertonic, and lack effective active lengthening. Injecting an overactive muscle to decrease its level of contraction can allow improved reciprocal motion, so improved ability to move and exercise.
So people told me I looked tired, overlooking the grape-size purple bruise smack dab in the center of my forehead. As one RealSelf reviewer wrote: “My head feels too tight, my eyebrow position has dropped enough to lose my nice pretty arch and my eyelids seem hooded. My eyes look smaller.” Now, if it works, looking a bit tired is a small price to pay for a few more days each month of migraine freedom and function. And bruises can be covered with makeup.
In 1895 (seventy-five years later), Émile van Ermengem, professor of bacteriology and a student of Robert Koch, correctly described Clostridium botulinum as the bacterial source of the toxin. Thirty-four attendees at a funeral were poisoned by eating partially salted ham, an extract of which was found to cause botulism-like paralysis in laboratory animals. Van Ermengem isolated and grew the bacterium, and described its toxin, which was later purified by P Tessmer Snipe and Hermann Sommer.
Much like other fillers, Botox is slowly metabolized in the system, so for it to remain effective, patients have to get the procedure every three months or so (however, as Ravitz told me during a recent visit, you can't get it done too frequently or your body will develop antibodies). I've now had four additional rounds of Botox since my initial procedure and have learned a lot about how my body reacts to it. Read on for both Ravitz's insight and information about my experience with five rounds of Botox.
Kybella helps patients lose their dreaded double chin and regain the taut, sculpted profile of their youth. The ingredients in Kybella are naturally made by the body, which means that you’re very likely to be satisfied with the results. It works by destroying the fat cells under the chin, making them unable to store fat any longer. Each treatment only requires 15-20 minutes, which leaves enough time to grab some sushi before you head back to the office. You’ll pay out somewhere between $1200 and $1800, but a chin tuck can cost anywhere from $1500 to $4000. Plus, Kybella doesn’t require the healing time that traditional skin liposuction does.
Each vial of BOTOX contains either 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride; 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride; or 200 Units of Clostridium botulinum type A neurotoxin complex, 1 mg of Albumin Human, and 1.8 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.
How does BOTOX work in migraines? The current theory is that BOTOX disrupts the trigeminal nerve terminal end. This leads to down-regulation of the trigeminal nerve cells and suppression of neurotransmitter release in two critical areas: central neuronal glutamate release and peripheral nerve inflammatory-inducing compounds such as CGRP in the cerebral blood vessels.
In 1998, David E.I. Pyott became CEO of Allergan. He was enthusiastic about Botox's wrinkle-reducing potential, he says, and pushed the company to conduct a series of studies on the matter. In 2002, Botox earned FDA approval for so-called frown lines--wrinkles between eyebrows--marking the first time a pharmaceutical drug was given the green light for a strictly cosmetic purpose. In 2001, the year before Botox was approved for wrinkles, it generated about $310 million in sales. By 2013, the year it was approved for overactive bladder, Allergan reported nearly $2 billion in revenue from Botox.
If you undergo Botox treatments for migraines, your doctor will typically administer them once every three months. Depending on your response to Botox, your doctor will recommend a length of time for your treatment plan. Each session will last between 10 and 15 minutes. During the sessions, your doctor will inject multiple doses of the medicine into specific points along the bridge of your nose, your temples, your forehead, the back of your head, your neck, and your upper back.
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Migraine is not a synonym for just a really bad headache, Galli says, which is one of the biggest misconceptions of this disease. It’s a full-body experience that affects your daily life. Being able to break that stigma and, instead, making migraine a synonym of the “this huge debilitating monster of a disease” is one way to change that. Knowledge is a powerful tool for migraine management. The American Migraine Foundation maintains a comprehensive resource library full of fact sheets, toolkits and advice sourced directly from the nation’s leading migraine specialists. Visit AMF’s website to learn more and to find a headache doctor near you.
Most people tolerate the injection discomfort well. But you may want your skin to be numbed beforehand, especially if your palms or soles are being treated for excessive sweating. Your doctor might use one or more of various methods available to numb the area, such as topical anesthesia, ice and vibration anesthesia, which uses massage to reduce discomfort.
Some critics say Botox makes you lose all the personality from your face, leaving you with a significantly less range of motion when you laugh, or get angry or upset. While it’s true that your movement will be restricted, a moderate amount of Botox will still allow you to react and communicate in a lively way. “Botox relaxes the wrinkle-forming facial muscles at the sight of injection, such as crow’s feet, glabella (the ‘furrows’ in between the brows), and frontalis (forehead lines),” Dr. Waibel says. “Botox does not affect other facial muscles that are used for overall facial expressions.”
Botox is a drug made from a neurotoxin produced by the bacterium Clostridium botulinum called botulinum toxin. "It's a poison secreted by the bacteria," plastic surgeon Norman Rowe, M.D., tells SELF. Botulinum toxin has proven to be a successful and valuable therapeutic protein when dosage, frequency of treatment and variety of treated clinical conditions are considered, according to Howard Sobel, M.D., a dermatologist in New York. Basically: when it's done right. When it's done wrong—like, really, really wrong—it can cause "botulism-like symptoms," according to Mayo Clinic, which may include muscle weakness, trouble breathing, speaking or swallowing, bladder control issues, and vision problems. That is "very unlikely," but a more than convincing enough reason not to go bargain hunting for Botox.
Another factor to consider, more high volume practices have more patient incentives from Allergan and the other manufacturers. My patient's receive rebates from the company, instant savings at the checkout, and regular reminders about upcoming treatments and specials that are sponsored by Allergan. This program is only available to the nation's busiest, most successful practices.
That Groupon offer might be tempting, but Dr. Tutela recommends doing a thorough vetting of your practitioner’s history and methods before signing up for treatment. “I think it is important to ask any provider if they perform that procedure frequently, to gauge their experience,” he says. He also suggests to ask if they’ve experienced any major complications and to check their online reviews. “You can get a sense of how you will be treated and what kind of experience other patients have had,” Dr. Tutela says. “Many of those low-cost, high-volume practices are loaded with horrible reviews from disappointed patients.”
"A migraines is an inherited neurological condition that features headaches as the most common symptom," says Robbins. "Headaches are not the only symptoms people can have. They can have sensitivity to the environment around them like light and sound. They can have nausea, which can lead to vomiting. They can have blurred vision. In a minority, but sizable number of people, it can progress to what we call chronic migraines."
Just like any medical procedure the Botox treatment rarely comes with a few possible side-effects that are temporary. The frequency of complications generally decreases the more knowledge of facial anatomy that your injector possesses and the greater the experience of knowing where and how much to inject.That is not to say that complications can occur in anyones hands but the incidence decreases with greater experience.Allergic reactions to Botox or Dysport is exceedingly rare in my experience.
Though there's still more research to be done on Botox for migraines and doctors aren't yet completely sure why the procedure is effective, they have some ideas. Ravitz tells me, "What [Botox] does is paralyze nerve terminals. Essentially, nerve terminals transmit pain, but they also produce pain substances while they’re doing that, and it completely paralyzes that process." She says that it stops the process of pain patterning and it also relaxes the muscles.
BOTOX® increases the incidence of urinary tract infection. Clinical trials for overactive bladder excluded patients with more than 2 UTIs in the past 6 months and those taking antibiotics chronically due to recurrent UTIs. Use of BOTOX® for the treatment of overactive bladder in such patients and in patients with multiple recurrent UTIs during treatment should only be considered when the benefit is likely to outweigh the potential risk.
In this study the median total BOTOX dose in patients randomized to receive BOTOX (N=88) was 236 Units, with 25th to 75th percentile ranges of 198 Units to 300 Units. Of these 88 patients, most received injections to 3 or 4 muscles; 38 received in jections to 3 muscles, 28 to 4 muscles, 5 to 5 muscles, and 5 to 2 muscles. The dose was divided amongst the affected muscles in quantities shown in Table 36. The total dose and muscles selected were tailored to meet individual patient needs.
Botox is so commonplace these days that you can get it done at some gyms and spas, but in these cases, you never know what you’re getting, how old the product is, with what it's mixed, and whether the injector knows what he or she is doing. Dr. Matarasso suggests only getting it done by what he calls the “core four”: a board-certified physician who is either a dermatologist, a plastic surgeon, an ear-nose-and-throat doctor, or an ophthalmologist.
As the only Facial Plastic Surgeon in North Texas to have Diamond status with Allergan, we have found that in today's economic environment, patients want value as well as quality. Understand that when you go to a non-physician med-spa for injectible treatments, there are more hands in the "cookie jar" diluting the price for your treatment. For example, the med-spa that is owned by a non-physician, with a nurse injector, is the hardest model to stay competitive in today's world. In that scenario, the patient is paying for the cost of the Botox; PLUS the cost of the nurse to inject the product; PLUS the fee for the medical director to sign off on the nurse doing the injections; AND the profit for the medspa. By going to a physician, the patient can cut out 2 of the middle-people. The chances of getting more product for the same price is greater by going to a doctor's office for your treatment.
Safety and effectiveness of BOTOX® have not been established for the treatment of other upper or lower limb muscle groups or 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.
Costs to consider: immediate out-of-pocket costs, long-term higher cost of insurance, your time, and the pain of injections. Botox for migraine costs approximately $525 per vial (100 units) and a typical migraine dose is 155 units. Depending on what your doctor charges in addition to the Botox itself, it’ll set you back $1500 – $2300 to test it out. And then there’s the needle pain. Don’t make the mistake of going to get a Botox injection if you’re in the midst of an attack, because it’ll be more painful than ever. Better to reschedule.
Ophthalmologists specializing in eye muscle disorders (strabismus) had developed the method of EMG-guided injection (using the electromyogram, the electrical signal from an activated muscle, to guide injection) of local anesthetics as a diagnostic technique for evaluating an individual muscle’s contribution to an eye movement. Because strabismus surgery frequently needed repeating, a search was undertaken for non-surgical, injection treatments using various anesthetics, alcohols, enzymes, enzyme blockers, and snake neurotoxins. Finally, inspired by Daniel Drachman’s work with chicks at Johns Hopkins, Alan B Scott and colleagues injected botulinum toxin into monkey extraocular muscles. The result was remarkable: a few picograms induced paralysis that was confined to the target muscle, long in duration, and without side-effects.
Study responders were defined as patients who showed at least a 2-grade improvement from baseline value on the HDSS 4 weeks after both of the first two treatment sessions or had a sustained response after their first treatment session and did not receive re-treatment during the study. Spontaneous resting axillary sweat production was assessed by weighing a filter paper held in the axilla ov er a period of 5 minutes (gravimetric measurement). Sweat production responders were those patients who demonstrated a reduction in axillary sweating from baseline of at least 50% at week 4.
The patient is placed in a somewhat raised position on the exam table, and the areas to be injected are cleansed with a nonalcohol cleanser, such as Hibiclens or Betadine. Some physicians will apply a topical anesthetic, such as EMLA cream or some alternative, at this time. The Botox is then injected into the desired areas. Typical injection patterns include about four or five areas on each side of the forehead and two or three areas on either eye area. More areas can be injected by skilled physicians, depending on the type of wrinkles and the desired effect for the patient. It is common for pressure to be applied if an area seems to be bleeding after the injection. While ice is sometimes applied beforehand for comfort reasons, direct pressure is much more effective than ice for control of bleeding and bruising.
The procerus is a small triangular-shaped muscle that intermingles with the inferior aspect of the frontalis muscle. The muscle runs from the aponeurotic fascia on the nasal bones and inserts into the skin of the inferior forehead. The medial portion of the eyebrow and the skin of the lower forehead are drawn down by the procerus muscle, producing transverse wrinkle lines over the bridge of the nose.
In both studies, significant improvements compared to placebo in the primary efficacy variable of change from baseline in daily frequency of urinary incontinence episodes were observed for BOTOX 100 Units at the primary time point of week 1 2. Significant improvements compared to placebo were also observed for the secondary efficacy variables of daily frequency of micturition episodes and volume voided per micturition. These primary and secondary variables are shown in Tables 19 and 20, and Figures 5 and 6.
Launched in 2002, Practical Neurology is a publication uniquely dedicated to presenting current approaches to patient management, synthesis of emerging research and data, and analysis of industry news with a goal to facilitate practical application and improved clinical practice for all neurologists. Our straightforward articles give neurologists tools they can immediately put into practice.
Jump up ^ Dodick DW, Turkel CC, DeGryse RE, Aurora SK, Silberstein SD, Lipton RB, Diener HC, Brin MF (June 2010). "OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program". Headache. 50 (6): 921–36. doi:10.1111/j.1526-4610.2010.01678.x. PMID 20487038.
Botox is said to decrease the frequency of migraine days by an average of 50 percent for those who suffer chronically (people who experience 15 or more headache days per month). After going through hell with my insurance to get approval, I scheduled an appointment with New York City neurologist and pain-management specialist Risa Ravitz. She was kind enough to speak with me about the wonders of Botox while we did my first procedure in June 2017.
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Prior to injection, reconstitute each vacuum-dried vial of BOTOX with only sterile, preservative-free 0.9% Sodium Chloride Injection USP. Draw up the proper amount of diluent in the appropriate size syringe (see Table 1, or for specific instructions for detr usor overactivity associated with a neurologic condition see Section 2.3), and slowly inject the diluent into the vial. Discard the vial if a vacuum does not pull the diluent into the vial. Gently mix BOTOX with the saline by rotating the vial. Record the date and time of reconstitution on the space on the label. BOTOX should be administered within 24 hours after reconstitution. During this time period, reconstituted BOTOX should be stored in a refrigerator (2° to 8°C).
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, further injection of BOTOX® should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent, and consequently the causal agent cannot be reliably determined.
Study 2 compared 3 doses of BOTOX with placebo and included 91 patients [BOTOX 360 Units (N=21), BOTOX 180 Units (N=23), BOTOX 90 Units (N=21), and placebo (N=26)] with upper limb spasticity (expanded Ashworth score of at least 2 for elbow flexor tone and at least 3 for wrist flexor tone) who were at least 6 weeks post-stroke. BOTOX and placebo were injected with EMG guidance into the flexor digitorum profundus, flexor digitorum sublimis, flexor carpi radialis, flexor carpi ulnaris, and bic eps brachii (see Table 27).
Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist f or several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised.
Warnings and Precautions: In patients using LUMIGAN® (bimatoprost ophthalmic solution) or other prostaglandin analogs for the treatment of elevated intraocular pressure (IOP), the concomitant use of LATISSE® may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including LUMIGAN® for IOP reduction should only use LATISSE® after consulting with their physician and should be monitored for changes to their intraocular pressure.
The recommended dilution is 200 Units/4 mL or 100 Units/2 mL, with a final concentration of 5 Units per 0.1 mL (see Table 1). The recommended dose for treating chronic migraine is 155 Units ad ministered intramuscularly using a sterile 30-gauge, 0.5 inch needle as 0.1 mL (5 Units) injections per each site. Injections should be divided across 7 specific head/neck muscle areas as specified in the diagrams and Table 2 below. A one inch needle may be needed in the neck region for patients with thick neck muscles. With the exception of the procerus muscle, which should be injected at one site (midline), all muscles should be injected bilaterally with half the number of injection sites administered to the left, and half to the right side of the head and neck. The recommended re-treatment schedule is every 12 weeks.
The trapezius muscle is a large, triangular, superficial muscle. It attaches proximally in the medial third of the superior nuchal line, external occipital protuberance, nuchal ligament, and spinous processes of the C7-T12 vertebrae. Distal attachment of the trapezius occurs at the lateral third of the clavicle and acromion and spine of the scapula. The action of the muscle includes neck extension and stabilization of the scapula and support for the arm. The muscle fibers proximal to the inflection point of the neck (ie, necklace line) run vertically and are involved with neck extension. According to the PREEMPT injection paradigm, one injection of 5 units of onabotulinumtoxinA to each of three sites on either side of the trapezius, for a total of 30 units divided across six sites, is given. The first injection site can be identified by visually dividing the upper portion of the trapezius muscle in half, from the inflection point of the neck (ie the necklace line) to the acromion (acromio-clavicular joint); the midpoint of this location is where the injection should be administered. The second injection is located at the midpoint of the first injection site and the acromion. The third injection should be administered at the midpoint between the first injection site and the necklace line. Injections should occur in the supraclavicular portion of the muscle, lateral to the neckline, and medial to the deltoid and the acromio-clavicular joint. The injections into the trapezius should be administered horizontally and superficially to avoid injecting too deep.
The biological blocking powers of Botox are used to treat migraines, muscular disorders, and some and bowel disorders. It can treat muscle stiffness, muscle spasms, overactive bladder, or loss of bladder control, too. It's also used to stop excessive sweating. "Botox blocks glands the same way it blocks nerves in muscles," Sobel tells SELF. However, don't expect to stop sweating entirely, he says. "You've got to sweat somewhere." What's more, Botox will last far longer in these sweaty situations since the glands are far smaller than the muscles treated, says Rowe.
Besides the volume of product used, Baby Botox is about the technique, says Doris Day, a board-certified dermatologist in New York City and author of Beyond Beautiful. "If you're very precise in where you put the product, you can use lower doses," she tells Allure. These super targeted micro injections deliver the more natural, tailored look Baby Botox is so coveted for.
There are no limits on therapy or activity after the session. For patients that don’t normally use a device to help them walk, at first it may seem like their walking has gotten worse. They need some time to get used to the feeling of the sudden change in the way their muscle contracts when they walk. This most often improves quickly over one to two weeks. Some very young children may have discomfort in their heel cord from rapid stretching. The child may limp or refuse to put weight on it. Again, this most often resolves quickly in the first week.
30+ year migraine warrior, wife, mother, corporate exec turned health advocate, Paula is Migraine Again Managing Editor and Chief Encouragement Officer. She champions patient's needs as an American Migraine Foundation Board Member, CHAMP Coalition Leader, IHS Patient Advocate and co-author of CaMEO and My Migraine Voice research studies. In addition to hosting the Migraine Again Podcast and producing the Migraine World Summit, Paula is a frequent speaker at industry, health care and public policy events. She's also the Founder and CEO of the World Health Education Foundation, a 501c3. Follow her on LinkedIn or Facebook.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported.
There are eight types of botulinum toxin, named type A–H. Types A and B are capable of causing disease in humans, and are also used commercially and medically. Types C–G are less common; types E and F can cause disease in humans, while the other types cause disease in other animals. Type H is considered the deadliest substance in the world – an injection of only 2 ng can cause death to an adult. Botulinum toxin types A and B are used in medicine to treat various muscle spasms and diseases characterized by overactive muscle. Commercial forms are marketed under the brand names Botox and Dysport, among others.