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Therapies

Botox therapy

What Is It?
How Does It Work?
What You Can Expect
Health Benefits
How To Choose a Practitioner
Cautions
References

Evidence Based Rating Scale
 
 

What Is It?

Botox therapy is the injection of an extremely diluted, purified form of botulinum toxin type A (made from the bacteria that causes botulism food poisoning) into specific muscles. This causes a localized and temporary paralysis of those muscles and prevents them from contracting. Botox was initially used in rehabilitation medicine for treating severe muscle imbalances in people physically impaired by strabismus (crossed eyes), stroke, brain injury, and cerebral palsy. In recent years, it has become a popular cosmetic technique for temporarily erasing wrinkles in the face or neck. In addition to relieving symptoms caused by muscle spasms, Botox is being studied for the treatment of a wide variety of other complaints, from migraine, fibromyalgia, and chronic back pain, to overly sweaty armpits.

Type A toxin's paralytic effect on muscles was first discovered in the 1950's by Vernon Brooks, a doctor working in Montreal. During the 1960's and 1970's, Dr. Alan B. Scott of the Smith-Kettlewell Eye Research Foundation in San Francisco furthered Brooks' research in an attempt to determine if the toxin could be an effective treatment for crossed eyes (strabismus). Over the course of the next 20 years, Scott worked with Dr. Edward Schantz of the Food Research Institute at the University of Wisconsin to create the first botulinum toxin type A product, which they called Oculinum. In the late 1980's, the pharmaceutical company Allergan purchased the rights to distribute Oculinum, and changed its name to Botox.

Although by 1989 Botox had received FDA approval for treating both crossed eyes and uncontrollable blinking (blepharospasm), it was not until 2002 that it was approved to temporarily improve the appearance of moderate to severe lines between the eyebrows. Government sanction was merely a formality, however: dermatologists and plastic surgeons had already been using Botox "off-label" for frown lines and other wrinkles since 1987, when Jean Carruthers, a Vancouver ophthalmologist, accidentally discovered that it did far more than help her patients' blinking problems.

Today Botox is the leading nonsurgical cosmetic treatment in the United States. According to statistics released by the American Society of Plastic Surgeons, 5.7 million procedures were performed in 2011, a 5% increase over the previous year and a whopping 621% increase since 2000. (1)

How Does It Work?

When Botox is injected into a muscle, it attaches itself to nerve endings in the injected area and blocks the transmission of acetylcholine, a Neurotransmitter that relays messages from nerves to muscles and tells muscles to contract. When these messages are blocked, temporary muscle paralysis results.

Over the next three to six months, new nerve endings will form to replace the paralyzed ones, once again allowing for communication between the nerves and muscles. At this time, the muscles--and the related wrinkles, for example--will return to their previous state. In order to maintain results, the therapy must be repeated with a new set of injections.

What You Can Expect

Cosmetic Botox treatments are available in a number of clinical settings, including dermatologists' offices, ophthalmologists' offices, and even some dental practices. Recently, the treatment has become available at some spas and gyms.

While the FDA has only approved Botox for wrinkles between the brows, physicians nevertheless can (and do) inject Botox into various other spots, including horizontal lines on the forehead, crow's feet, lower-eye lids, lines on the side of the nose, the upper lip, and occasionally the muscle bands on the neck. Botox should not be used for the furrows around the mouth, an area that has to remain pliable for chewing, kissing, and talking.

Although anesthesia is not required for Botox treatments, the practitioner may choose to numb the area being treated with a cold pack or an anesthetic cream prior to treatment. The procedure itself consists of several quick injections of the toxin into the targeted muscles using fine needles. It is quick and essentially painless, with the entire session taking about 10 to 15 minutes.

There is no recovery time needed after receiving Botox. Because the skin does not feel numb or change in texture and there is generally no swelling or irritation, the patient will be able to resume regular activities immediately. The practitioner will advise the patient, however, not to massage or rub the treated area and to remain upright for several hours. This prevents the Botox from moving into areas around the injection site, where it could adversely affect other muscles. Patients will also be told not to exercise for 24 hours.

Do not expect an immediate transformation after a single visit. For most people, it takes between four and seven days for the drug to have full effect. Once it does, however, results last between three and six months. If the next set of injections is repeated before the first treatment wears off, the muscles (and wrinkles) will not completely return to their previous state.

The good news is that the body seems to have a learned memory when it comes to Botox, and those who receive treatments on a regular basis are often able to go longer between sessions. Conversely, some clients develop that create resistance to Botox, so that the treatment is no longer effective for them. For reasons unknown, a few people simply do not respond to Botox at all.

The cost of a single treatment averages between $400 and $500 for cosmetic Botox treatments, and can run anywhere from $300 to more than $1500 for medical Botox therapy, depending on the complaint and how much of the toxin is used. Although insurance companies do not cover the use of Botox for cosmetic purposes, its use for rehabilitation of impaired muscles and for other health problems may be covered by certain health plans, as well as by Medicare and Medicaid, under their "medical necessity" guidelines.

Health Benefits

First studied and put to use in the treatment of eye disorders, botulinum toxin type A's dominant use is currently for the temporary reduction of wrinkles. Though to date Botox is only approved for wrinkles between the eyebrows, some practitioners do use it to treat other types of wrinkles on the face and neck.

Botox, in "off-label" usage, has shown promise as a treatment for many other conditions. The drug already has FDA approval for treating cervical dystonia (a disorder characterized by involuntary spasms of the head and neck). And numerous studies are being conducted to document its efficacy in treating such conditions as chronic back pain, carpal tunnel syndrome, fibromyalgia, migraine, excessive sweating, post-stroke spasticity, and urinary incontinence. It may also relieve muscle spasms caused by juvenile cerebral palsy and by Tourette syndrome. Preliminary research also indicates that Botox may also help in the treatment of anal fissures, of post-operative pain from hemorrhoid surgery, and of chronic pain in cancer patients.

Specifically, Botox may help to:

Improve facial lines. Studies have shown that Botox is a safe and effective treatment for wrinkles around the eyes, face, and neck. (2-3) A study published in 2002 concluded that Botox is a safe and effective treatment for crow's feet. Researchers in this study also reported longer-lasting effects after a second session, when compared to results attained from the first injections. (2) A 2003 study reported positive results using Botox to treat wrinkles in the mid and lower face (such as around the lower eyelids, nose, and mouth) and neck. (4) Long-term treatment with Botox has been shown to prevent the development of crow's feet and other facial wrinkles. An interesting 2006 study compared facial wrinkles in two identical twins: one twin had received regular Botox treatments in the forehead two to three times a year for 13 years and in the crow's feet twice in the two years prior to the study. The other twin had received only two treatments in the 13-year period. The regularly treated twin did not appear to have wrinkles in the forehead or between the eyebrows, but wrinkles were visible in those areas in the minimally treated twin. Crow's feet were also less noticeable when the regularly treated twin smiled (even at seven months after treatment) than when the minimally treated twin smiled. Untreated facial areas showed comparable aging in both twins. (5) In a 2011 study of 45 women ages 30 to 50 with moderate to severe lines between the eyebrows, regular Botox treatments for 20 months seemed to significantly reduce and, in some cases, eliminate those wrinkles for up to six months after the last treatment. (6)

Relieve chronic low back pain. Preliminary evidence indicates Botox may relieve chronic low back pain (LBP) when injected into muscles along the spine. A 2001 study of 31 people with chronic LBP found that Botox injections into five muscles along the spine reduced the severity of the pain by more than 50% in over half of those who received the treatment compared to Placebo. Both pain relief and improved function were noted at three and eight weeks after treatment. (7) In a 2006 prospective, open-label study of 75 patients with chronic LBP who received repeated Botox treatments for 14 months, 39 participants (53%) reported significant improvements in severity of pain, number of pain-free days, and back function within the first month of treatment. Of these responders, 32 who completed the study noted significant improvements with repeat treatments over the following 12 months. In one patient, a single treatment resulted in sustained relief for 12 months. While no serious side effects were found, after the first treatment three patients experienced mild flu-like symptoms that lasted two to five days. (8) More studies are needed.

Prevent migraine headaches. Migraine headaches are described as having an intense pulsing and throbbing in one area of the head that can last from a few minutes to several days. These debilitating headaches can also be accompanied by nausea, vomiting, and sensitivity to light and sound. Botox injections around the head and neck area have been shown to reduce pain and dull future headache symptoms associated with a migraine, A 2002 study of 112 migraine sufferers at the Houston Headache Clinic who received Botox treatments reported a 75% reduction in migraine-associated disability, number of days with headaches, severity of headaches, and use of drugs. Subjects also reported better quality of life after treatment. (9) In a 2003 study reported in Dermatologic Surgery, Botox was injected into acupuncture points on 10 women who had experienced long-lasting severe migraines. After 14 days, nine of the patients were pain-free, and one had minimal pain. Positive results were maintained for three to six months. (10) In a five-year study of more than 1,300 patients suffering from chronic daily headaches (both tension and migraine), regular Botox treatments were shown to be safe, well tolerated, and effective in reducing headache episodes. After 12 months of treatment, patients were free of attacks for 23 days per month. (11) In a 2007 randomized, double-blind, placebo-controlled trial involving 369 participants, multiple treatments with Botox were safe, well tolerated and reduced monthly headache frequency by 50%. (12) After a large study involving 1,384 participants, known as the PREEMPT trial (phase 3 research evaluating migraine prophylaxis therapy), showed Botox to be safe and effective as a preventative migraine drug, the FDA approved its use for treatment of chronic migraine in 2010. Thus, Botox became the first drug approved for preventing migraine. (13-15)  

Treat post-stroke spasticity: This painful condition characterized by stiff, tight muscles in the elbow, wrist, and fingers – often the result of a stroke – can be severely debilitating and prevent patients from performing simple tasks. Studies have shown that injecting Botox into the affected muscles can temporarily block the connections between nerves and muscles, reducing the muscle contractions and pain. In 2002, the New England Journal of Medicine published a study testing the efficacy of Botox in treating muscle spasticity in the wrist and fingers following a stroke. Subjects were asked to select a target for treatment--personal hygiene, dressing, pain, or limb position. Six weeks after the injections, 62% of the subjects reported improvement in their treatment target. (16) In a 2008 meta-analysis, Botox was shown to be safe and effective in treating spasticity in both upper and lower limbs after stroke. Patients and caregivers noted significant improvements within four to six weeks after injection. (17) In 2010, the FDA approved Botox for the treatment of increased muscle stiffness in the elbow, wrist, and fingers in adults with upper limb spasticity. (18) 

Reverse carpal tunnel syndrome. Preliminary evidence indicates Botox injections may help to reverse symptoms of carpal tunnel syndrome (CTS). In a small pilot study in Taiwan, Botox injections into the carpal tunnel (a space in the wrist through which the tendons to the fingers pass) seemed to reduce pain and weakness in female patients with CTS caused by repetitive movements of the hand and wrist. Out of five patients in the study, three indicated improvement, one participant showed no improvement, and one experienced pains that were more serious after treatment. (19) More research is needed.  

Reduce urinary incontinence. The FDA has approved the use of Botox to treat urinary incontinence associated with neurologic conditions, such as multiple sclerosis. (20) Urinary incontinence, or involuntary leakage of urine, often occurs in patients with some neurologic disorders that lead to cause overactive bladder. Botox injections in the bladder result in relaxation of the bladder, an increase in its storage capacity, and a decrease in urinary incontinence. In two clinical studies involving 691 patients with urinary incontinence from spinal injury or multiple sclerosis, Botox treatments resulted in a significant decrease in the weekly frequency of incontinence episodes compared to placebo. (21, 22) 

Excessive sweating (hyperhidrosis): Those who suffer hyperhidrosis literally drip sweat from their hands, feet, and armpits. In a multicenter study conducted in 14 dermatology clinics in Germany, Belgium, and the UK, 207 individuals received one or more treatments with Botox injection into the underarm space. Four weeks after the first treatment, 96.1% of the treatment group compared to 34.7% of the placebo group, had greater than 50% reduction in underarm perspiration. Botox treatment was well-tolerated for up to 16 months in this study. (23) Botox is FDA approved for the treatment of excessive underarm sweating.   

How To Choose a Practitioner

Though Botox therapy is safe and easy, it is best administered by a licensed health-care professional who practices in a clinical setting. Those who are seeking Botox as a cosmetic procedure to smooth wrinkles should find a dermatologist, ophthalmologist, or cosmetic surgeon who regularly gives the injections. Though a wide range of physicians, including dentists, cardiologists, and radiologists may do cosmetic Botox treatments, they may not have as much experience or knowledge as a practitioner who deals with problems of the skin, face, and eyes.

For Botox for a medical condition related to spasticity, the therapy may be administered by the physician already treating the patient. Many neurologists and physical medicine specialists now offer Botox to relieve various spastic muscle disorders.

Be sure to inquire about how long the practitioner has been using Botox to treat the specific condition, and what kinds of negative side effects patients may have experienced with this treatment. For cosmetic Botox treatments, ask to see some "before and after" photos of clients the practitioner has treated.

To verify a practitioner's credentials or to find a qualified practitioner nearby, contact one of the following organizations:

  • The American Society of Plastic Surgeons, Arlington Heights, IL. Call 1-888-4-PLASTIC (www.plasticsurgery.org)

  • The American Board of Dermatology, Detroit, MI. Call 313-874-1088 (www.abderm.org)

  • The Botox Information Center (www.botox-info.com)

  • The American Board of Medical Specialties, Evanston, IL. Call 866-ASK-ABHS (www.abms.org)

Cautions

Few side effects have been reported with the use of Botox, and any that do occur are usually temporary, subsiding as the toxin wears off. These include: headache, flu-like symptoms, respiratory infection, nausea, drooling, and temporary drooping of the eyebrows, eyelids, or mouth. However, long-term effects of using Botox have not been studied.

To reduce possible bruising in the area of needle insertion, avoid medications and supplements that may prolong bleeding (have anti-coagulant properties) for a week before Botox treatment.  

Be sure to let the practitioner know about any medications the patient is currently taking; Botox may interfere with certain prescription medications. 

Patients who are about to have surgery or dental work should let the surgeon or dentist know about any prior Botox injections. 

Cosmetic use of Botox is not recommended for children, although it is approved for anyone over the age of 18. Medically it is approved to treat cervical dystonia (muscle weakness) in patients over the age of 16, and to treat blepharospasm (uncontrolled blinking) or strabismus (crossed eyes) in those over the age of 12. It may be used "off-label" by specialists in the rehabilitative care of children with other muscle spasm problems. 

Research is limited on the effects of Botox on those over the age of 65. Consult a physician about starting at a lower dose. 

Pregnant and breast-feeding women should not receive Botox. Studies have not been regarding safety for unborn or infant children. 

Anyone with a muscle-weakening condition such as multiple sclerosis, Bell's palsy, or Lou Gehrig's disease should not use Botox. 

Patients with an infection in the area to be treated by Botox should wait until the infection subsides to proceed with Botox injections. 

As a safer alternative to Botox for facial wrinkles, patients may want to try microcurrent electrical stimulation of the facial muscles, a variation of electroacupuncture.

References

1. American Society of Plastic Surgeons. "2011 Cosmetic Plastic Surgery Statistics: Cosmetic Procedure Trends." http://www.plasticsurgery.org/Documents/news-resources/statistics/2011-statistics/2011-cosmetic-procedures-trends-statistics.pdf. Accessed March 7, 2012.
2. Lowe N, Lask G, Yamauchi P, Moore D. Bilateral, double-blind, randomized comparison of three doses of botulinum toxin type A and placebo in patients with crow's feet. J Am Acad Dermatol. Dec 2002;47(6):834-840.
3. Levy JL, Servant JJ, Jouve E. Botulinum toxin A: a 9-month clinical and 3D in vivo profilometric crow's feet wrinkle formation study. J Cosmet Laser Ther. 2004 May;6(1):16-20.
4. Carruthers J, Carruthers A. Aesthetic Botulinum A toxin in the Mid and Lower Face and Neck. Dermatol Surg. 6 May 2003;29(5):468-76.
5. Binder WJ. Long-term effects of botulinum toxin type A (Botox) on facial lines: a comparison in identical twins. Arch Facial Plast Surg. 2006 Nov-Dec;8(6):426-31.
6. Dailey RA, Philip A, Tardie G. Long-term treatment of glabellar rhytides using onabotulinumtoxina. Dermatol Surg. 2011 Jul;37(7):918-28.
7. Foster L, Clapp L, Erickson M, Jabbari B. Botulinum toxin A and chronic low back pain: a randomized, double-blind study. Neurology. May 22, 2001;56(10):1290-3.
8. Jabbari B, Ney J, Sichani A, et al. Treatment of refractory, chronic low back pain with botulinum neurotoxin A: an open-label, pilot study. Pain Med. 2006 May-Jun;7(3):260-4.
9. Mathew NT, Kaup AO. The Use of Botulinum Toxin Type A in Headache Treatment. Curr Treat Options Neurol. 2002 Sep;4(5):365-373.
10. Tamura BM, Chang B. Botulinum toxin: Application into acupuncture points for migraine. Dermatol Surg. 29 July 2003;749-54.
11. Farinelli I, Coloprisco G, De Filippis S, Martelletti P. Long-term benefits of botulinum toxin type A (BOTOX) in chronic daily headache: a five-year long experience. J Headache Pain. 2006 Dec;7(6):407-12.
12. Aurora SK, Gawel M, Brandes JL, et al. Botulinum toxin type a prophylactic treatment of episodic migraine: a randomized, double-blind, placebo-controlled exploratory study. Headache. 2007 Apr;47(4):486-99.
13. U.S. Food and Drug Administration. "FDA approves Botox to treat chronic migraine." http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm229782.htm. Accessed March 15, 2012.
14. Göbel H, Heinze A. Botulinum toxin type A in the prophylactic treatment of chronic migraine. Schmerz. 2011 Sep;25(5)563-70.
15. Aurora SK, Winner P, Freeman MC, et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011 Oct;51(9):1358-73.
16. Brashear A, Gordon MF, Elovic E, et al. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med. 2002 Aug 8;347(6):395-400.
17. Rosales RL, Chua-Yap AS. Evidence-based systematic review on the efficacy and safety of botulinum toxin-A therapy in post-stroke spasticity. J Neural Transm. 2008;115(4):617-23.
18. U.S. Food and Drug Administration. "FDA approves Botox to treat spasticity in flexor muscles of the elbow, wrist and fingers." http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm203776.htm. Accessed March 15, 2012.
19. Tsai CP, Liu CY, Lin KP, Wang KC. Efficacy of botulinum toxin type a in the relief of Carpal tunnel syndrome: A preliminary experience. Clin Drug Investig. 2006;26(9):511-515.
20. U.S. Food and Drug Administration. "FDA approves Botox to treat specific form of urinary incontinence." http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm269509.htm. Accessed March 15, 2012.21. Hansen RB, Biering-Sørensen F, Kristensen JK. Urinary incontinence in spinal cord injured individuals 10-45 years after injury. Spinal Cord. 2010 Jan;48(1):27-33.
22. Ginsberg D, et al. Phase 3 Efficacy and Safety Study of OnabotulinumtoxinA in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity. Presented at 107th Annual Meeting of the American Urological Association, Washington, DC. May 2011.
23. Naumann M, Lowe NJ, Kumar CR, Hamm H; Hyperhidrosis Clinical Investigators Group. Botulinum toxin type a is a safe and effective treatment for axillary hyperhidrosis over 16 months: a prospective study.Arch Dermatol. 2003 Jun;139(6):731-6.

Evidence Based Rating Scale

The Evidence Based Rating Scale is a tool that helps consumers translate the findings of medical research studies and what our clinical advisors have found to be efficacious in their personal practice into a visual and easy to interpret format. This tool is meant to simplify the information on supplements and therapies that demonstrate promise in the treatment of certain conditions.

 

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Date Published: 04/19/2005
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