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Botox: A revolutionary tool or hazard to your health?

 

Krista Whalen

October 5, 2009

Introduction:

Kim Carney, MSNBC.com (http://www.msnbc.msn.com/id/22546056/)

Almost since human life has existed, men and women alike have sought everlasting youth and beauty. This obsession with physical attractiveness often proves dangerous; in ancient times, arsenic, mercury, and lead were used in cosmetics  (http://www.msnbc.msn.com/id/22546056/). While we now know those substances are harmful, other toxic substances are used today. Botox, for example, is derived from the potentially lethal neurotoxin found in contaminated food and soil that causes botulism poisoning. Millions of men and women have elected to have this dangerous substance injected into their bodies to improve the appearance of wrinkles, control sweating, improve the symptoms of cervical dystonia, and a variety of other uses.

 

This web site is intended to explore the risks and rewards of botox, including long and short term psychological effects and current research involving botox’s off-label uses.

 

What is Botox?

Purpose:

http://botox.com/

        According Botox®’s website (http://botox.com/):

                Botox is a prescription medicine that is injected into muscles and used:

-to treat the adnormal head position and neck pain that happens with cervical dystonia (CD) in adults

-to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older…

Botox® is injected into the skin to treat the symptoms of severe underarm sweating…Botox® Cosmetic is a prescription medicine that is injected into muscles and used to improved the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults younger than 65 years of age for a short period of time (temporary)

 

        Rationale:

To understand Botox and the potential benefits and dangers associated with it, it is essential to understand the botulinum bacteria, clostridia botulinum:

 

What is botulism?

 

http://libn.com/thetechnofile/2009/06/23/bnls-botulism-buster-2/

According to Singh and Kelly (2003, 273), botox is derived from the “crystalline form of exotoxin type A produced by the bacterium clostridium botulinum.” Clostridium botulinum is a botulinum neurotoxin, or BoNT, which can cause botulism poisoning in humans when ingested or introduced into an open cut or sore. Research by Lu and Lippitz (2009) explains BoNT attacks the nerve cells of its victims, inhibiting the release of Ach and, in turn, paralyzing nearby muscles. Full functioning of the affected muscles can be recovered after as little as 2 days to as long as 90 days after contact with the bacteria. The U.S. experiences an average of 24 deaths per year due to the bacteria.

 

The 3 types of botulism are (http://dhs.wisconsin.gov/communicable/factsheets/BotulismFoodborne):

1.   Food

2.   Infant Botulism

3.   Wound Botulism

 

Food:

http://files.egeneralmedical.com/info/info-botulism2.jpg

Food-borne botulism is the most common form of botulism in humans. It is caused when food is not properly sterilized, and can be identified by odd color or odor. The problem usually arises in home-preserved or canned goods, though commercially-produced foods can be affected as well (http://dhs.wisconsin.gov/communicable/factsheets/BotulismFoodborne).      

 

Infant:

Botulinum bacteria are especially dangerous for infants ages 6 weeks to 6 months. Infants can fall ill by eating foods infected with the bacterium or ingesting soil containing the spores (https://www.google.com/health/ref/Infant+botulism).

 

Wound Botulism:

The botulinum bacterium can be introduced to the human body by entering through open cuts or sores that have come into contact with dirt or other substances where the bacteria breed. Rusty nails, broken glass, and needles are a few examples (http://www.sfcdcp.org/woundbot.html).

 

Symptoms of Botulism Poisoning:

        Barbano attests (2006, E18) botulism poisoning is identified by symptoms such as “dry eyes, dry mouth, and muscle weakness.” It is important to note bacteria target not only muscle cells in the limbs and face, but also in the digestive tract, which can lead to constipation and difficulty breathing or swallowing.

 

How does Botox work?

There are three types of botox treatments approved by the FDA for 3 distinct uses. They work in similar ways:

First, Botox Cosmetic, a division of Allergan Inc., explains on their website that Botox Cosmetic works by reducing muscle contractions that create deep wrinkles. Wrinkles form over time as muscle contractions in the face cause “pleating” of overlying skin that eventually leads to wrinkles (http://www.botoxcosmetic.com/how_botox_works/why_skin_ages.aspx).

http://www.drweitzul.com/How_wrinkle_lines_Form.png.jpg

 

According to an article by Lu and Lippitz, BoNT blocks receptors for neurotransmitters such as acetylcholine (Ach), which inhibits muscles from contracting.

http://www.locateadoc.com/articles/botox-cosmetic-a-look-at-looking-good-1235.html

 

In addition to Botox Cosmetic, Allergan Inc. offers Botox Severe Sweating, which “…helps control severe underarm sweating by temporarily blocking the chemical signals from the nerves that stimulate the sweat glands. When the sweat glands don’t receive chemical signals, the severe sweating stops” (http://www.botoxseveresweating.com/can_botox_help/can_botox_help.aspx).

 

Finally, Botox neurotoxin is used to treat cervical dystonia (CD), a condition that causes neck muscles to “tighten or spasm” uncontrollably (http://www.botoxmedical.com/SignsCervicalDystonia.aspx). In adults, this can cause changes in posture, neck and shoulder pain, shaking, sleeplessness, or problems swallowing. Botox supposedly binds to the receptors that cause these muscle spasms and reduces symptoms.

 

        Mechanisms:

Botox is FDA-approved for the treatment of wrinkles on the face, CD, and severe sweating (http://www.biojobblog.com/tags/botox/). The Botox website explains a simple, fast outpatient procedure in which the doctor injects BoNT into the targeted muscles. Anesthesia is not required, although some doctors use local anesthesia such as ice or numbing cream (http://www.botoxcosmetic.com/how_botox_works/injection_process.aspx).

 

Effectiveness:

 

http://www.biojobblog.com/tags/botox/

        According to Lu and Lippitz, Botox has been used since 1992 for the treatment of glabellar (frown) lines. Their report identified Botox as the most popular noninvasive cosmetic procedure performed in the U.S. The Botox website offers several testimonials for each of the product’s uses.

Allergan, Inc. also provides statistical analysis of a randomized, double-blind clinical trial they conducted in which one treatment of botox was tested against a placebo (http://www.allergan.com/assets/pdf/botox_cosmetic_pi.pdf). Of 537 subjects in their study, a disproportionate number (405) were given Botox, with only 132 receiving the placebo. The study found “the severity of glabellar lines was reduced for up to 120 days in the Botox Cosmetic group compared to the placebo group.” Severity of lines was evaluated by the investigator and the subject.

While Allergan provides support for the product they sell, it is important to realize their study does not discuss long-term risks, nor does it provide statistical analysis for adverse effects in their clinical trial. Allergan Inc. mentions the possibility of hypersensitivity reactions and difficulty breathing in addition to “spread of toxin effect,” a condition in which the patient exhibits symptoms of botulism poisoning (http://www.allergan.com/assets/pdf/botox_cosmetic_pi.pdf). In making the decision to get botox, it is important to gather information from scientific sources uninvolved in the production of the product. Seek sources that have nothing to gain from your decision to buy the product that will provide unbiased findings.

 

The following outlines some of the scientific literature available regarding the side effects and off-label uses of Botox.

 

“Complications of botulinum neurotoxin”

        According to research by Lu and Lippitz (2009), there have been no reported deaths from the cosmetic use of botox. However, a study conducted in 2005 revealed when used to treat spastic muscle conditions in the face and neck, 217 adverse events were “considered serious” by the FDA; 28 resulted in death. Of these deaths, “6 were attributed to respiratory arrest, 5 to myocardial infarction, 3 to cerebrovascular accident, 2 to pulmonary embolism, and 2 to pneumonia, with 1 known to be aspiration pneumonia” (205). Other reactions included pain, swelling at injection site, redness, eccymosis (bruising or ruptured blood vessels), headache, sensitivity, rash at the injection site, nausea, fatigue, flu-like symptoms, or a metallic taste. The spread of toxin effect is also discussed; this can result in brow, eye lid or lip ptosis (muscle weakness causing drooping).

        Lu and Lippitz (2009) also found lower dosages of BoNT were positively correlated with lower instances of adverse effects. However, the article goes on to explain other research has suggested “higher concentration and therefore smaller volumes of BoNT…promote a longer duration of action and limit the potential for the diffusion of BoNT to unintended areas” (207). Furthermore, complications can be avoided by not administering BoNT to individuals with asthma, heart murmur, or body dysmorphic disorder.

 

“Complications and adverse reactions with the use of botulinum toxin”

Research by Klein indicates Botox has been successful with few negative side effects in treating muscle contraction conditions such as dystonia and spasticity (2001, 110). Relief from symptoms of muscular conditions is typically realized within 1 to 14 days of botox treatment, “peaks within 2 to 6 weeks, and begins to wear off by 10 to 12 weeks post injection” (110). Some CD patients have reported resistance to botox therapy after repeated high dosages. However, the prevalence is low, 5%; this means botox will no longer serve as an effective treatment for these individuals.

Further, according to Klein (2001), supposed adverse effects of Botox Cosmetic are merely anecdotal, and no long-term effects have been identified. Reactions such as nausea, fatigue, malaise, rash, and flu-like symptoms were identified, although they have not been linked to the toxin itself; rather, they may be local or immunologic results.

Klein (2001) describes the adverse effects for botox cosmetic injections in the brow, glabella, crows-feet, upper lip, nose and chin. The most common negative outcome is pstosis, which is sagging or drooping of the affected area.  

        The article also explores the use of botox to treat hyperhidrosis, or excessive sweating, in the palms. According to Klein, weakness of grip was reported as a side effect. Touch-ups were often necessary 2 weeks posttreatment.

       

“Botox: and ‘elixir of youth?’”

This article by Singh and Kelly (2003) poses the question of the psychological side effects of botox, something that has been largely ignored in the research. According to the authors, injections can conjure significant anxiety, including worry regarding the actual procedure, its outcome, and most importantly to the authors, fear of growing old. Singh and Kelly pose an interesting point—botox can become an unhealthy addiction to being young. For some people, the treatment can be a healthy boost of self-esteem, but for individuals who are not happy with their own lives or lack a “well-balanced sense of self and social functioning,” (274) it can be a coping strategy.

This article puts into perspective society’s fascination with physical beauty and quick fixes. It is imperative an individual is able to create a firm sense of self without using cosmetic procedures.

 

“Psychosocial aspects of botox in aesthetic surgery”

Singh, Hankins, Dulku, and Kelly conducted a cross-sectional study focused on the psychosocial aspects of botox cosmetic procedures, including 1) anxiety regarding the procedure, 2) worry about the changes that will occur, 3) expectations, 4) dependence, or “the desire for repetitive administration” (2006, 72). The researchers administered questionnaires to 81 participants recruited from clinics. The experimental group was comprised of Botox Cosmetic recipients, and the control used noninvasive beauty products such as cosmetics. The questionnaires measured psychosocial beliefs and attitudes regarding the 4 aspects described above.

The results showed patients receiving botox were more conscious of psychosocial factors than the control group. Singh, et al., found the botox group scored significantly higher in distress and worry categories, possibly due to fear of needles or “comorbid fear” of being injected with the dangerous toxin botulinum (75). Results from the botox group also reflected participants were psychologically unprepared for the outcomes, unsure of what to expect or how to express emotion once their facial muscles have been effected by the treatment. Additionally, botox subjects had higher expectation scores than worry scores, showing that the decision to get the treatment involves weighing risks and perceived benefits, which was hypothesized by the researchers prior to the study.

The researchers concluded that botox was in fact more physiologically and psychologically distressing than the control group. In effect, botox patients should be advised of the effects of botox prior to treatment, and emphasize the positive effects it can have on body image posttreatment.

 

“The impact of cosmetic interventions on quality of life”

Research by Sadick proposed cosmetic procedures including the “treatment of facial lines with botulinum toxin” (2008, 5) can impact quality of life. The study used the Freiberg questionnaire posttreatment to measure quality of life and found over 80% of patients (N=30) thought the treatment was beneficial; all reported they would “recommend the treatment to others”; 75% “felt more comfortable with their bodies”; 30% reported increased emotional well-being (5).

This research is important because it deals with the psychological and psychosocial aspects of botox, an area of research that has been overlooked in the past. However, this study does not address adverse side effects of botox treatment.           

 

Other uses for botox…

 

“Effect of botulinum toxin in the treatment of drooling: a controlled clinical trial”

This study, conducted by Jongerius, van den Hoogen, van Limbeek, Gabreels, van Hulst, and Rotteveel, tested the “clinical effectiveness of BoNT to reduce drooling in children with cerebral palsy (CP)” over a period of 24 weeks (2004, 620). Of the 45 children enrolled in the study, 48.7% responded to BoNT until 24 weeks after injection.        Compared to scopolamine, another treatment to improve drooling, Jongerius et al. suggests BoNT had only few “nonsevere, incidental side effects,” which included flu-like symptoms and difficulties swallowing (2004, 625). Moderate to severe side effects were reported in 71.1% of the patients who were given scopolamine; however, it improved drooling for a longer period of time than botox. No significant differences in the effectiveness of the two treatments were observed. Rather, differences in side effects and length of effectiveness were noted in the two treatments. To avoid adverse effects of BoNT, the researchers suggested using ultrasound guidance. In concluding, the researchers proposed recurrent treatments of botox could prolong the effects of botox. 

 

“Botulinum toxin as preventive treatment for migraine: A randomized double-blind study”

The trial, conducted by Petri, Tolle, Straube, Pfaffenrath, Stefenelli, and Ceballos-Baumann, tested the effectiveness of botox in reducing the frequency and severity of migraine headaches over a period of 22 weeks (2009, 204). 127 participants were randomly assigned to three groups: (1) an experimental group receiving 210 units dysport (BoNT) injected into pericranial and cervical muscles; (2) receiving 80 units dysport injected into pericranial muscles and placebo injected into cervical muscles; and (3) a control group that received placebo injected into both muscle groups. Participants recorded incidence, duration, and severity of migraines in daily diaries using a numerical rating scale. The researchers did not find the difference in reduction of migraines between the two experimental groups to be statistically significant. The study was inconclusive as to which treatment was best for decreased frequency and severity of headaches.

 

Summary and Conclusions:

        The scientific literature verifies that botox is a powerful substance that has been used to treat a variety of conditions. Sometimes treatments have been successful and included few side effects; other times studies were inconclusive or resulted in unwanted effects. While there is substantial evidence supporting the idea botox can treat many off-label conditions, these are not approved by the FDA, and they often carry risks. Thus, it is imperative to discuss these risks with a doctor before making a decision. Further, the scientific literature today lacks sufficient information regarding the long term effects of botox, since the treatment was created and approved only recently. Perhaps in the coming years, botox will be identified as a completely poisonous substance to humans; or maybe the adverse effects will be disproved. It remains under investigation.

 

Literature Cited

 

Barbano, R (2006). Risks of erasing wrinkles: Buyer beware! [Electronic version].        Neurology, 67, E17-E18.

 

Jongerius, P. H., van den Hoogen, F., van Limbeek, J., Gabreels, F.J., van Hulst, K., an        Rotteveel, J. J. (2004). Effect of botulinum toxin in the treatment of drooling: A        controlled clinical trial [Electronic version]. Pediatrics: Official Journal of the American Academy of        Pediatrics, 114(3), 620-627.

 

Klein, A. (2001). Complications and adverse reactions with the use of botulinum toxin        [Electronic version]. Seminars in cutaneous medicine and surgery, 20(2), 109-        120.

 

Lu, D., and Lippitz, J. (2009). Complications of botulinum neurotoxin [Electronic        version].Diseases-a-month, 55, 198-211.

 

Petri, S., Tolle, T., Straube, A., Pfaffenrath, V., Stefenelli, U., and Ceballos-Baumann, A.        (2009). Botulinum toxin as preventive treatment for migraine: A randomized        double-blind study [Electronic version]. European Neurology, 62, 204-211.

 

Sadick, N. (2008). The impact of cosmetic interventions on quality of life. Dermatology        Online Journal, 18(8), 1-11. Retrieved October 1, 2009, from        http://dermatology.cdlib.org/148/commentary/qualityoflife/sadick.html

 

Singh, G., Hankins, M., Dulku, A., and Kelly, M. (2006). Psychosocial aspects of botox   in aesthetic surgery [Electronic version]. Aesthetic Plastic Surgery, 30, 71-76.

 

Singh, G., and Kelly, M. (2006). Botox: An ‘elixir of youth?’ [Electronic version].        European Journal of Plastic Surgery, 26, 273-274.

 

 

 

 

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