BOTOX SUMMARY
BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain
Clostridium botulinum
type A grown in a medium containing casein hydrolysate, glucose and yeast extract. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin (Human) and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.
BOTOX® is indicated for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.
BOTOX® is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.
BOTOX® is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.
The efficacy of BOTOX® treatment in deviations over 50 prism diopters, in restrictive strabismus, in Duane's syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has not been established. BOTOX® is ineffective in chronic paralytic strabismus except when used in conjunction with surgical repair to reduce antagonist contracture.
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NEWS HIGHLIGHTSMedia Articles Related to Botox (Botulinum Toxin Type A)
The Lowe Law Firm Files Suit Over Alleged Botox Overdose
Source: Cosmetic Medicine / Plastic Surgery News From Medical News Today [2009.11.09]
St. Louis-based The Lowe Law Firm has filed a lawsuit on behalf of a man who experienced partial respiratory paralysis and other side effects after receiving an overdose of the Botox being used to treat his muscle spasticity. The suit, Richard A. Hart v. Yi Pan, Tenet HealthSystem SL Inc., d/b/a St. Louis University Hospital and Allergan USA Inc., cause no. 0922-CC09485, was filed in St. Louis Circuit Court on Oct. 21.
Botox as a Breast Lift?
Source: MedicineNet Human Immunodeficiency Virus (HIV, AIDS) Specialty [2009.10.27]
Title: Botox as a Breast Lift?
Category: Health News
Created: 10/27/2009 10:02:00 AM
Last Editorial Review: 10/27/2009 10:02:27 AM
Cleavage Rejuvenation, Do-It-Yourself Lasers, Botox® Breast Lift - Hype Or Reality?
Source: Cosmetic Medicine / Plastic Surgery News From Medical News Today [2009.10.26]
Whether their effectiveness is fact or fiction, less invasive cosmetic procedures such as cleavage rejuvenation, do-it-yourself (DIY) cosmetic therapies, and using Botox® to "lift" the breasts are making headlines, but are they safe? Plastic surgeons are discussing if these, and more, are cutting edge new discoveries or just "buyer beware" marketing hype at the American Society of Plastic Surgeons (ASPS) Plastic Surgery 2009 conference, Oct. 23 - 27, in Seattle.
Scientific Studies Confirm The Value Of Botulinum Toxin Type A (Botox) In Treating And Preventing Chronic Migraine
Source: Headache / Migraine News From Medical News Today [2009.09.16]
Four separate studies[i] representing the findings of clinical trials in the U.S., Canada and Europe have confirmed the value of onabotulinumtoxinA in treating and preventing chronic migraine in adults. These studies found that treatment with botulinum toxin type A was associated with significantly fewer headache days, less headache-related disability, and significantly improved quality of life.
Dysport, a Botox Competitor, Approved
Source: MedicineNet Botulism Specialty [2009.05.01]
Title: Dysport, a Botox Competitor, Approved
Category: Health News
Created: 5/1/2009 2:00:00 AM
Last Editorial Review: 5/1/2009
Published Studies Related to Botox (Botulinum Toxin Type A)
Effect of Botulinum Toxin Injection on Nocturnal Bruxism: A Randomized Controlled Trial. [2009.09.26]
Lee SJ, McCall WD, Jr., Kim YK, Chung SC, Chung JW: Effect of botulinum toxin injection on nocturnal bruxism: A randomized controlled trial. OBJECTIVE:: To evaluate the effect of botulinum toxin type A on nocturnal bruxism... CONCLUSIONS:: Our results suggest that botulinum toxin injection reduced the number of bruxism events, most likely mediated its effect through a decrease in muscle activity rather than the central nervous system. We controlled for placebo effects by randomizing the interventions between groups, obtaining subjective and objective outcome measures, using the temporalis muscle as a control, and collecting data at three postinjection times. Our controlled study supports the use of botulinum toxin injection as an effective treatment for nocturnal bruxism.
Effects of different dilutions of botulinum toxin type A treatment for children with cerebral palsy with spastic ankle plantarflexor: a randomized controlled trial. [2009.09]
OBJECTIVE: The aim of this study was to investigate the influence of different volumes of saline vehicle on the effects of botulinum toxin type A in reducing ankle plantarflexor spasticity and improving gait pattern in children with cerebral palsy... CONCLUSION: Botulinum toxin type A improved physical findings and gait pattern in patients with cerebral palsy. The volume of saline mixed with botulinum toxin type A did not result in significant differences in physical evaluation or gait analysis. However, the large-volume group revealed side-effects more frequently and showed no clinical benefits compared with the small-volume group. We conclude that 2 ml of dilution is preferable for botulinum toxin type A treatment in children.
A preliminary assessment of the benefits of the addition of botulinum toxin a to a conventional therapy program on the function of people with longstanding stroke. [2009.09]
OBJECTIVE: To determine if botulinum toxin type A (BTX-A) combined with therapy can facilitate improved upper-extremity (UE) functional status versus therapy alone... CONCLUSION: A focused therapy program showed the most improvement in function in this defined stroke population. BTX-A combined with a focused traditional therapy program slightly enhanced the functional status of stroke subjects beyond that obtained with therapy alone 12 weeks after injection.
A randomized controlled trial to compare two botulinum toxin injection techniques on the functional improvement of the leg of children with cerebral palsy. [2009.09]
OBJECTIVE: To compare the efficacy of botulinum toxin type A injection guided by different localizing techniques, electrical stimulation and palpation, to treat spasticity of the ankle plantar flexors... CONCLUSIONS: Botulinum toxin injection guided by electrical stimulation plus physiotherapy is likely to be best in improving spasticity and functional performance in children with cerebral palsy.
Comparison of intravesical botulinum toxin type A injections plus hydrodistention with hydrodistention alone for the treatment of refractory interstitial cystitis/painful bladder syndrome. [2009.09]
OBJECTIVE: To compare the clinical effectiveness of botulinum toxin type A (BoNT-A) injections followed by hydrodistention (HD) with HD alone in patients with interstitial cystitis/painful bladder syndrome (IC/PBS)... CONCLUSION: Intravesical injections of BoNT-A followed by HD produced significantly better clinical results than HD alone in patients with IC/PBS.
Clinical Trials Related to Botox (Botulinum Toxin Type A)
Comparison of Korean Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm [Completed]
To compare the efficacy and safety of Korean botulinum toxin A (KbtxA, Pacific
Pharmaceuticals, Korea) against Botox in the treatment of essential blepharospasm, we
performed a double-blinded, randomized, comparative trial comparing KbtxA and Botox for
treatment of blepharospasm in 60 patients of the intention to treat population and 52
patients (26 patients from each group) of the per protocol population. The improvement of
severity of spasm (SS) at 4 weeks post-injection as a primary efficacy outcome, qualifying
non inferiority to the control group, Changes in eyelid closure force (CF) and functional
visual status (FVS) after injection for secondary efficacy outcomes, and adverse effects for
safety evaluation. Improvement of SS was noted in 90. 3% of the KbtxA group and 86. 2% of the
Botox group. There were no significant differences between treatment groups in the changes of
CF and FVS after injection (p>0. 05). Adverse effects developed in 16. 1% of the KbtxA group
and 27. 6% of the Botox group, but no serious adverse events were found in either group. KbtxA
was not inferior to Botox in treatment efficacy and was clinically safe with no serious
adverse effects when used to treat essential blepharospasm.
Comparative Study of the Effect of Dysport and Botox [Completed]
The purpose of this study is to test the effect of Dysport and Botox on forehead wrinkles and
EMG activity.
Study to Determine If the Volume Used to Dilute BOTOX Cosmetic™ for Injection Affects Its Overall Effect and Duration. [Completed]
It is thought that the amount of fluid used to dilute Botox for injection has an effect on
the quality of the result and the duration of effect on the treatment of upper face rhytides,
even though the dose remains the same.
The study was designed to test this thinking, using the crow's feet wrinkles as the treatment
area.
Botulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment in Patients With Primary Myofascial Pain Syndrome [Completed]
The main purpose of this study is to determine the effectiveness and safety of one dose of
botulinum toxin type A (Dysport) associated with rehabilitation treatment on pain control in
patients with a type of back pain called primary myofascial pain syndrome.
Comparative Efficacy of Three Preparations of Botox-A in Treating Spasticity [Active, not recruiting]
The study seeks to compare the effectiveness of three preparations of BOTOX-A® in treating
muscle tightness and spasms in the feet and ankles of people with stroke.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 4 ratings/reviews, Botox has an overall score of 7.25. The effectiveness score is 10 and the side effect score is 7.50. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Botox review by 51 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | migraines |
| Dosage & duration: | | 1 vial (dosage frequency: every 3-6 months) for the period of five plus years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I used to have near-daily migraines. I tried every migraine medication on the market. Either they didn't have any effect, or I was unable to tolerate them due to side-effects. With Botox injections administered by a very knowledgable neurologist who is also a pain specialist, I am virtually migraine-free for months. |
| Side effects: | | Sometimes I had some minor swelling at an injection site. It went away within days. |
| Comments: | | My neurologist injects the tiny cranial muscles as well as muscles along my neck and upper shoulder. He uses a tiny needle and injects very little at each site. He determines where the trigger points are before administering the Botox. PLEASE NOTE: If using Botox for migraines, do go to a neurologist who is experienced with migraine pain. DO NOT have this done by a cosmetic surgeon! |
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| | Botox review by 59 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | forehead frown lines |
| Dosage & duration: | | don't recall (dosage frequency: once) for the period of once |
| Other conditions: | | goiter |
| Other drugs taken: | | levothyroid | | |
Reported Results |
| Benefits: | | the frown lines on the forehead were diminished for a period of abut 3 months |
| Side effects: | | Approximately one week after injection the brow line swelled to the point of losing the upper nasal curvature for about 2 days. There was webbing of the upper eyelids in a diagonal line from the inner canthus to the outer eyebrow that lasted throughout the effect of the botox |
| Comments: | | the drug was injected in one appointment to the frown lines of the forehead. There was no immediate swelling, bleeding, or other adverse reaction. |
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| | Botox review by 59 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | forehead frown lines |
| Dosage & duration: | | don't recall (dosage frequency: once) for the period of once |
| Other conditions: | | goiter |
| Other drugs taken: | | levothyroid | | |
Reported Results |
| Benefits: | | the frown lines on the forehead were diminished for a period of abut 3 months |
| Side effects: | | Approximately one week after injection the brow line swelled to the point of losing the upper nasal curvature for about 2 days. There was webbing of the upper eyelids in a diagonal line from the inner canthus to the outer eyebrow that lasted throughout the effect of the botox |
| Comments: | | the drug was injected in one appointment to the frown lines of the forehead. There was no immediate swelling, bleeding, or other adverse reaction. |
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Page last updated: 2009-11-09
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