There were 214 subjects evaluated for the open label period, of which 170 progressed into the randomized, blinded treatment p eriod (88 in the BOTOX group, 82 in the placebo group). Patient evaluations continued for at least 10 weeks post-injection. The primary outcome for the study was a dual endpoint, requiring evidence of both a change in the Cervical Dystonia Severity Scale (CDSS) and an increase in the percentage of patients showing any improvement on the Physician Global Assessment Scale at 6 weeks after the injection session. The CDSS quantifies the severity of abnormal head positioning and was newly devised for this study. CDSS a llots 1 point for each 5 degrees (or part thereof) of head deviation in each of the three planes of head movement (range of scores up to theoretical maximum of 54). The Physician Global Assessment Scale is a 9 category scale scoring the physician's evaluation of the patients' status compared to baseline, ranging from 4 to +4 (very marked worsening to complete improvement), with 0 indicating no change from baseline and +1 slight improvement. Pain is also an important symptom of cervical dystonia and was evaluated by separate assessments of pain frequency and severity on scales of 0 (no pain) to 4 (constant in frequency or extremely severe in intensity). Study results on the primary endpoints and the pain-related secondary endpoints are shown in Table 35.
Potential Botox side effects include pain at the injection site, infection, inflammation, swelling, redness, bleeding and bruising. Some of these symptoms may indicate an allergic reaction; other allergy symptoms are itching, wheezing, asthma, a rash, red welts, dizziness and faintness. Tell your doctor immediately if you have any breathing issues or a faint or dizzy feeling.
Most physicians pay roughly the same amount of money to purchase a vial of Botox. However, the cost of a Botox treatment is not the same among all providers. Botox is not an ordinary commodity such as wheat or sugar or flour. Botox is a medical procedure that requires nuance, experience and expertise. All Botox providers are not equal in education or skill and some are actually quite poor. Most Botox providers charge either by the amount of Botox used or by the region of the face treated. I feel that charging by the amount of Botox used is the most equitable.
Severe side effects are very rare but can happen if the botulinum toxin unexpectedly spreads throughout the body from the site of the shots. This can cause muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids. The breathing and swallowing problems can be life-threatening. If this happens, seek medical attention right away.
"Botox is a toxin that is extracted from a certain bacteria. It's been used for a couple of hundred years in medicine. It was first used in neurological conditions rather than cosmetic ones. It was first approved to treat spasms of the face and eye muscles. Only later was it discovered coincidentally that it could world for cosmetic purposes, like wrinkles," he says.
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.
In patients who are not catheterizing, post-void residual (PVR) urine volume should be assessed within 2 weeks post treatment and periodically as medically appropriate up to 12 weeks, particularly in patients with multiple sclerosis or diabetes mellitus. Depending on patient symptoms, institute catheterization if PVR urine volume exceeds 200 mL and continue until PVR falls below 200 mL. Instruct patients to contact their physician if they experience difficulty in voiding as catheterization may be required.
But for some conditions, step therapy can be downright harmful. In a 2016 op-ed in The Boston Globe, a patient with ulcerative colitis wrote that his health insurance forced him to try a cheaper treatment for six months, instead of the pricier meds his doctor wanted to prescribe. In those six months, his colon deteriorated so badly it had to be removed.
Overall, with the exception of Overactive Bladder (see below), clinical studies of BOTOX did not include sufficient numbers o f subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. There were too few patients over the age of 75 to enable any comparisons. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease o r other drug therapy.
It may be the most well known, but Botox is just one type of neurotoxin on the market. Other, next-level neurotoxins are Dysport, FDA-approved in 2009, and Xeomin, FDA-approved in 2011. “They all originate from the same strain of bacteria, therefore they work essentially in the same way,” explains Z. Paul Lorenc, MD, a board certified aesthetic plastic surgeon in Manhattan. “There are some nuanced differences between the three,” he adds. Xeomin is a purified neurotoxin, also called a “naked molecule,” because it doesn’t contain any extra surface proteins, the way Botox and Dysport do. This “pure” neurotoxin migrates deeper into skin, works faster, and poses less risk of an allergic reaction. “Theoretically, decreasing the protein load also lessens the chance of becoming a non-responder, meaning it lessens the chance that the patient will become immune to the neuromodulator being injected,” Dr. Lorenc says. Dysport tends to spread a little more than Botox, so it’s good for areas that would otherwise need multiple injections. It also kicks in faster than the other two, typically showing effects after two to three days opposed to seven to ten days with Botox, and five to six days with Xeomin. Once you try the different neurotoxins, you might decide you like one brand better than the others.
How Was the Botox Mixed? A factor that many patients are unaware of is that Botox and Dysport come in a powder form that must be mixed with sterile saline to reconstitute the vial. The amount of water that is mixed with the Botox or Dysport can vary and will determine the concentration of the medicine. Some doctors and nurses dilute the powder too much so that the final concentration of Botox or Dysport is weak. So if you go to a provider who advertises a cheap price (for instance below the wholesale price) the injections you may be getting may be very dilute and may not be as effective as a more concentrated (more expensive) injection.
It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or in lower limb muscles other than those in the ankle and toes. BOTOX® has not been shown to help people perform task-specific functions with upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. BOTOX® is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed.