Botox research studies

Botox research abstracts. All four of these studies refer to the cosmetic use of botulinium nerotoxin type A for the temporary remediation of facial wrinkles. I offer them for those readers who like to draw their own conclusions.

1. Botox research abstract #1: Patient-reported outcomes with botulinum neurotoxin type A. by Carruthers A, Carruthers J. from the Department of Dermatology and Skin Science, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada. Journal Cosmetic Laser Therapy . 2007;9 Suppl 1:32-7.

Clinical trials establishing the efficacy of botulinum neurotoxin type A historically have included as outcomes investigator assessments and general patient global assessments of treatment. However, these outcomes are of limited value in determining the specific benefits desired by patients who seek facial rejuvenation.

To address this issue, several patient-reported outcomes measures have been developed and utilized in clinical trials of botulinum neurotoxin type A (specifically, the BOTOX Cosmetic brand). The outcomes include the Self-Perception of Age (SPA) measure and the Facial Line Outcomes (FLO) questionnaire. On the FLO questionnaire, patients rate the degree to which their facial lines bother them; make them look older than they would like; prevent them from having a smooth facial appearance; and make them look tired, stressed, or angry when that is not how they feel.

Several clinical trials have demonstrated significant improvements in these outcomes from baseline and versus placebo for the treatment of multiple upper facial lines as well as for treating the glabella as a single region. These outcomes data help in understanding patient objectives and motivations, establishing a treatment plan, and ensuring patient satisfaction. Clinicians can use the SPA measure for all patients to help show the value of treatment. END of first Botox research abstract.

2. Botox Research Abstract #2 Efficacy and safety of 3- and 5-injection patterns (30 and 50 U) of botulinum toxin A (Dysport) for the treatment of wrinkles in the glabella and the central forehead region. by Rzany B, Ascher B, Fratila A, Monheit GD, Talarico S, Sterry W. Division of Evidence Based Medicine, Klinik für Dermatologie, Venerologie und Allergologie, Charité Universitätsmedizin, Berlin, Germany. Arch Dermatol. 2006 Mar;142(3):320-6.

OBJECTIVE: To investigate the efficacy and safety of 2 injection site patterns (3- and 5-injection patterns [30 and 50 U]) of botulinum toxin A (Dysport; Ipsen Pharma, Ettlingen, Germany), in the treatment of glabellar and central forehead wrinkles.

DESIGN: Multicenter, double-blind, placebo-controlled, randomized, 16-week trial.

SETTING: Twenty-three German dermatologic centers.

PATIENTS: Two hundred twenty-one patients with moderate or severe glabellar wrinkles when frowning maximally.Intervention Centers were randomly assigned to the 3-injection site pattern (3 injections of 10 U of botulinum toxin A or placebo) or 5-injection site pattern (5 injections of 10 U of botulinum toxin A or placebo). All centers used 3 sites in the procerus and corrugator muscles; the 2 additional sites were approximately 1-cm cranial from the corrugator sites.

MAIN OUTCOME MEASURE: Wrinkle severity was graded by 4 independent experts blinded to the treatment received using digital photographs and a standardized clinical scale (range, 0 [no wrinkles] to 3 [severe wrinkles]). A reduction of at least 1 point between weeks 0 and 4 was considered a therapeutic success (responder).

RESULT: One hundred ten patients (73 receiving botulinum toxin A vs 37 receiving placebo) received 3 injections; 111 patients (73 receiving botulinum toxin A vs 38 receiving placebo) received 5 injections. After 4 weeks, the proportions of responders were 86.1% vs 18.9% and 86.3% vs 7.9%, respectively (P<.001 for both). No major adverse effects were observed.

CONCLUSIONS: The 3 central injection sites are essential for the treatment of glabellar wrinkles. The 2 additional injection sites in the forehead region, targeting the frontalis muscle, did not significantly improve efficacy. END of Botox research abstract #2

3. Botox Research Abstract #3. Double-blind, placebo-controlled study of the safety and efficacy of botulinum toxin type A for patients with glabellar lines. by Carruthers JD, Lowe NJ, Menter MA, Gibson J, Eadie N; Botox Glabellar Lines II Study Group. Department of Ophthalmology, University of British Columbia, Vancouver, Canada. Plast Reconstr Surg. 2003 Sep 15;112(4):1089-98.

The objective of this study was to evaluate the efficacy and safety of botulinum toxin type A for the treatment of glabellar lines. Patients with moderate or severe glabellar lines at maximal frown received intramuscular injections of placebo or 20 U of botulinum toxin type A (Botox; Allergan, Inc., Irvine, Calif.) distributed among five injection sites (one in the procerus muscle and two in each corrugator supercilii). Follow-up assessments were performed at 7, 30, 60, 90, and 120 days after injections. Efficacy measures were the physician's rating of glabellar line severity at maximal frown and at rest (none, mild, moderate, or severe) and the patient's global assessment of changes in glabellar lines, from +4 (100 percent better) to -4 (100 percent worse). A total of 273 patients were enrolled (botulinum toxin, 202 patients; placebo, 71 patients).

All except five patients (botulinum toxin, two patients; placebo, three patients) completed the study. For the physician's rating at maximal frown, the responder rate (percentage of patients with severity ratings of none or mild in follow-up evaluations) for the botulinum toxin group peaked at 77 percent at day 30 and was significantly greater than that for the placebo group at every follow-up visit (p < 0.001). For the patient's assessment, the responder rate (percentage of patients with scores of +2 or more) for the botulinum toxin group peaked at 89 percent at day 30 and was significantly greater than that for the placebo group at every follow-up visit (p < 0.001). Rates of adverse events were similar for the two groups. The only adverse event with an incidence of >/=5 percent was headache (botulinum toxin, 11 percent; placebo, 20 percent). The incidence of blepharoptosis was 1 percent for the botulinum toxin group. Botulinum toxin type A was remarkably safe and effective in reducing glabellar lines. END of Botox research abstract #3

4. Botox Research Abstract #4. Cosmetic use of botulinum toxin type A in the elderly. Cheng CM. Department of Clinical Pharmacy, University of California, San Francisco, Clin Interv Aging. 2007;2(1):81-3.

Botulinum toxin type A injections are one of the most popular cosmetic procedures for diminishing the appearance of facial lines caused by habitual facial muscle contractions. Although the manufacturer's labeling recommends botulinum toxin only for the treatment of glabellar lines among adults younger than 65 years of age, there is widespread use of the toxin for other cosmetic purposes and for patients who may be older than 65. Evidence-based safety and efficacy data on botulinum toxin use in elderly patients is limited. However, given the age-related skin changes and multifactorial causes of wrinkles in the elderly, as well as the higher risk for potential side effects due to concomitant diseases and medications, a careful risk-benefit assessment should precede the decision to use botulinum toxin in the elderly patient.

END of Botox Research abstract list. If you wish to read the complete studies for anyone of these Botox research studies, you can obtain copies by asking your library to get a copy of the journal article.
Articles Source : http://www.anti-aging-articles.com

Botox relieves nerve disorders - Neurology - medical research - Brief Article

Botox represents one of the most dramatic reversals in modern medicine. Until a decade ago, it was known as a potent biologic toxin responsible for the disease botulism. Today, however, physicians at the Yale Botulinum Program, New Haven, Conn., are expanding its use as a therapeutic agent in order to combat neurological disorders that cause disabling muscle spasms and pain.

Botox has been making a lot of headlines for its use in cosmetic procedures to reduce frown lines and crow's-feet, but, since 2000, it has been approved by the Food and Drug Administration as a treatment for patients with cervical dystonia, a neurological movement disorder characterized by involuntary muscle contractions that force the head and neck into abnormal and sometimes painful positions. In addition to the neck, dystonia can affect the arms and legs. The Yale Botulinum Program also uses Botox to treat blepharospasm, which affects the eyelids; hemifacial spasms, which affect one side of the face; and general spasticity, which may occur when the brain is damaged by a stroke, head injury, multiple sclerosis, etc.

How does botulinum therapy work? Normally, the human brain sends electrical messages to the muscles so that they can contract and move. They are transmitted to the muscle by a substance called acetylcholine. Botox works to block the release of acetylcholine, and, as a result, the muscle doesn't receive the message to contract. Treatments last for approximately three months. At that point, another injection may be needed to provide relief. Most patients report minor, temporary discomfort. Effects are usually evident in about two weeks.
Ref : http://findarticles.com

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What is Botox?

Botulinum toxin is a medication and a neurotoxic protein produced by the bacterium Clostridium botulinum. It is the most toxic protein known[1][2] with an LD50 of roughly 0.005-0.05 µg/kg. Botulinum toxin is used in minute doses to treat muscle spasms in some parts of the world despite its inherent toxicity. It is sold commercially under the brand names Botox, BTXA, Dysport, Myobloc, Neurobloc and Xeomin which are used in the treatment of muscle spasms. Botox Cosmetic and Vistabel are available for cosmetic treatment.

For medical use, BOTOX® neurotoxin is approved to treat the following conditions:

Cervical dystonia (CD)—head tilting, neck pain, and neck muscle spasms
Blepharospasm, or eyelid spasms
Strabismus, also called crossed eyes
Severe underarm sweating when antiperspirants don’t work

BOTOX® treatment for CD

CD is a condition that affects muscles in the neck. If you have CD, those muscles may tighten or spasm without your control. This can force your head and neck into movements or positions that are painful and awkward. It often makes it difficult to do simple things such as dressing, shaving, housework, driving a car, or using a computer. Treatment can manage symptoms and may help you return to activities you enjoyed before your symptoms started.

Many people with CD get relief from BOTOX® injections. BOTOX® works directly on the muscles that spasm. After a BOTOX® treatment, many patients get relief from muscle spasms for up to 3 months. BOTOX® also helps reduce neck pain in patients with CD. Pain relief may happen first, before muscles become significantly relaxed.

BOTOX® treatment for blepharospasm (eyelid spasms)

Blepharospasm can also be treated with BOTOX®. This condition causes spasms in and around the eyelids. This results in frequent blinking and closing of the eyes that you can’t control. Because of these symptoms, it can be hard to see. Treatment with BOTOX® can reduce muscle spasms. This reduces blinking, which may help restore the ability to see.

BOTOX® treatment for strabismus (crossed eyes)

Crossed eyes happen when certain muscles tighten around the eye. This tightening pulls the eyeball to the side. BOTOX® treatment can relax the affected muscles. Then the eyeball can return to its normal position.

Are there other medical uses of BOTOX®?

BOTOX® is currently being evaluated for other conditions. At the present time, however, the FDA has only approved BOTOX® for the conditions discussed above. To find out if BOTOX® is right for you, talk to your doctor.

How Botox works?

The signals that cause pain and muscle spasms are sent to the muscles through the nerves. BOTOX® neurotoxin blocks the signals that cause muscle spasms directly in the affected muscles, resulting in relief. Similarly, BOTOX® is thought to block the signals that cause pain.

A study done in patients with CD showed that BOTOX® treatment can help reduce the intensity and frequency of pain. Pain relief may happen first, before muscles become significantly relaxed.
Ref :www.botoxmedical.com/MedicalUses.aspx


What is the most important information I should know about botulinum toxin type A?
The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have drooping eyelids, vision problems, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing. Some of these effects can occur up to several weeks after a botulinum toxin injection. Botulinum toxin injections should be given only by a trained medical professional, even when used for cosmetic purposes. Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be sure to tell your new provider how long it has been since your last botulinum toxin injection.
Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

You should not receive this medication if you are allergic to botulinum toxin, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected.
Before receiving a botulinum toxin injection, tell your doctor if you have ALS ( Lou Gehrig's disease), myasthenia gravis, Lambert-Eaton syndrome, or heart disease.

The effects of a botulinum toxin injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin.

What should I discuss with my healthcare provider before I receive botulinum toxin type A?
You should not receive this medication if you are allergic to botulinum toxin, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely receive this medication.

amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");

myasthenia gravis;

Lambert-Eaton syndrome; or

heart disease.

Botulinum toxin type A is made using human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether botulinum toxin is harmful to an unborn baby. Before you receive this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether botulinum toxin passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is botulinum toxin type A given?

Botulinum toxin type A is given as an injection into a muscle. A doctor, nurse, or other healthcare provider will give you this injection.

Botulinum toxin injections should be given only by a trained medical professional, even when used for cosmetic purposes.
Your botulinum toxin injection may be given into more than one area at a time, depending on the condition being treated.

While receiving botulinum toxin injections for an eye muscle conditions, you may need to use eye drops, ointment, a special contact lens or other device to protect the surface of your eye. Follow your doctor's instructions.

If you are being treated for excessive sweating, shave your underarms about 24 hours before you will receive your injection. Do not apply underarm antiperspirants or deodorants for 24 hours before you receive the injection. Avoid exercise and hot foods or beverages within 30 minutes before the injection.

It may take up to 2 weeks after injection before neck muscle spasm symptoms begin to improve. You may notice the greatest improvement at 6 weeks after injection.

It may take only 1 to 3 days after injection before eye muscle spasm symptoms begin to improve. You may notice the greatest improvement at 2 to 6 weeks after injection.

The effects of a botulinum toxin injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin. Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be sure to tell your new provider how long it has been since your last botulinum toxin injection.
Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

What happens if I miss a dose?

Since botulinum toxin has a temporary effect and is given at widely spaced intervals, missing a dose is not likely to be harmful.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.
Overdose symptoms may include muscle weakness, trouble swallowing, and weak or shallow breathing.

What should I avoid after receiving botulinum toxin type A?
Avoid using underarm antiperspirants or deodorants for 24 hours after a botulinum toxin injection if you are being treated for excessive underarm sweating.

Avoid going back to your normal physical activities too quickly after receiving a botulinum toxin injection.

Botulinum toxin type A side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have any of these serious side effects, some of which can occur up to several weeks after an injection:
trouble breathing, talking, or swallowing;

drooping eyelids;

unusual or severe muscle weakness (especially in a body area that was not injected with the medication);

loss of bladder control;

problems with vision or depth perception;

crusting or drainage from your eyes;

severe skin rash or itching; or

chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling.

Less serious side effects may include:

muscle weakness near where the medicine was injected;

bruising, bleeding, pain, or tenderness where the injection was given;

headache, muscle stiffness, neck or back pain;

fever, cough, sore throat, runny nose, nausea, flu symptoms,

dizziness, drowsiness, anxiety;

dry mouth, dry eyes;

increased sweating in areas other than the underarms;

itchy or watery eyes, increased sensitivity to light; or

eyelid swelling or bruising.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ref : http://www.drugs.com/mtm/botox.html

What other drugs will affect botulinum toxin type A?
Before you receive this medication, tell your doctor if you are also taking:

an antibiotic such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Mycifradin, Neo-Fradin, Neo-Tab), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, tobramycin (Nebcin, Tobi).

This list is not complete and there may be other drugs that can interact with botulinum toxin type A. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?
Your doctor or pharmacist can provide more information about botulinum toxin type A.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Botox cosmetic treatments

BOTOX ® Cosmetic treatments are becoming increasingly popular, and with good reason. In many cases, BOTOX is a very effective method for reducing wrinkles.

BOTOX injections can be used to smooth wrinkles in the neck and face to create a more youthful appearance. It is especially useful in the eye area. Removing wrinkles from between the eyes can dramatically change a person''s look from one of permanent anger or sadness to one of contentment and relaxation. It is also frequently used on the thin wrinkles that surround the eyes (often called "crow''s feet") and the mouth, but can also be used in other areas, such as along the chin and jaw.

The solution used in these treatments is made of botulinum A toxin, a purified protein made from botulism bacteria. This solution temporarily paralyzes nerves of the facial muscles so that they cannot contract and cause wrinkles in the area being treated.

BOTOX Cosmetic may also be helpful in treating migraine headaches, and can be used to decrease excess sweating of the palms and underarms.

If you''re considering BOTOX injections, the following information will provide you with a good introduction to the procedure. For more detailed information about how this procedure may help you, we recommend that you consult a plastic surgeon that is highly qualified and has completed a residency program that includes instruction in BOTOX Cosmetic.
What are some of the most common benefits of BOTOX® Cosmetic treatments?
BOTOX treatments are unique in that they can be used to remove dynamic wrinkles -- the wrinkles that are produced by facial movement.


What will happen at the initial consultation?
During the consultation, you will have the opportunity to talk to your surgeon about the changes that you'd like to make in your appearance. He/she will explain the different options available to you, the procedure itself, and the risks and limitations involved. He/she will also explain the kind of anesthesia required, surgical facility, and costs.

How are BOTOX® Cosmetic treatments performed?
BOTOX treatments are brief and simple. First, the skin is treated with a topical numbing agent, and you may be given a sedative as well. Next, very small amounts of BOTOX are strategically injected in different parts of the face. This is accomplished with thin needles that cause very little pain.

How long do BOTOX® Cosmetic treatments take?
on the number of BOTOX injections needed, the treatment may take 10 to 30 minutes.


Where are the treatments performed?
BOTOX treatments can be performed in the doctor's office or in a surgical suite. Anesthesia is rarely needed, but sedatives and numbing agents may be used.



How much pain is there?
There is some discomfort involved with the Botox injections, but the discomfort is slight. The feeling has been likened to an insect bite. After the procedure, there is virtually no pain.


What can I expect after BOTOX® Cosmetic treatment?
The results produced by BOTOX are generally visible within 3 to 5 days. Although results vary, the results of an individual treatment last for about 4 to 6 months. The procedure may be repeated and, with each new treatment, the results tend to last longer.


What is the recovery period like?
You'll probably be able to return to work or home immediately after the procedure. However, care must be taken to keep the head upright and avoid massaging the treated area, so that the BOTOX affects only the desired areas.

What is the long-term outcome like for most people?
Most people are very pleased with the results. For long-term results, the procedure will most likely need to be repeated.


How long do the results of BOTOX® Cosmetic last?
Although BOTOX results vary, the outcome of an individual treatment lasts for about 4 to 6 months. With each new treatment, the results tend to last longer.


Ideal candidate:
In general, the best candidates for BOTOX treatments are those:

With wrinkles in the face or neck
Who are knowledgeable about the procedure
In good physical and psychological health
Wanting to improve their appearance
Realistic in their expectations
Not using marijuana or anabolic steroids
Not a heavy user of alcohol
The above is only a partial list of the criteria that your surgeon will consider in determining whether or not Botox injections are appropriate for you. Be sure to ask your surgeon if he/she considers you an ideal candidate for this procedure
Other important information:
This procedure can remove or deter wrinkles by preventing the repeated facial expressions that contribute to their formation. It cannot improve the overall texture of the skin, but procedures such as laser skin resurfacing and dermabrasion can be used to accomplish this. It cannot tighten the facial skin either. Look for face lift and forehead lift for ways to accomplish this.

Risks:
Mild bruising or swelling may occur at the site of the injection. The treatment may also cause a brief headache. In rare cases, the side effects of Botox can include the eyebrow or upper eyelid to droop, but this condition is temporary and corrects itself without treatment within 2 to 3 weeks.

Source: http://www.ienhance.com/procedure/description.asp?ProcID=8&bodyid=1&specialtyid=1