Botox: Effective, But Safe?

by D.M. Murdock

The rage over Botox, an injectable anti-wrinkle treatment made from the botulinum toxin (hence "bo-tox"), continues. Botox is well known to remove facial wrinkles, especially forehead wrinkles, frown lines between the eyes and whistle marks around the mouth. Botox does this miracle by causing "flaccid muscle paralysis," temporarily paralyzing the muscles needed to make the wrinkles. It is sometimes easy to spot a Botox-treated face, as it may look unnaturally smooth and relaxed. Botox treatment is a "nonablative technique," which means that it is non-surgical, with no post-operative down time. As concerns which type of Botox is more effective in reducing facial wrinkles, a study published in December 2005 concluded: "Botox [Cosmetic] 20 U provided better and more prolonged efficacy than Dysport 50 U in the treatment of glabellar lines."1

Through several years of testing, Botox has been shown to be very effective, as many people, especially celebrities, can attest. But, is it safe? Are there any longterm health hazards? Should it be used repeatedly and indefinitely? Are there any alternatives? Are they safer and more practical than Botox? And what about cost? Botox is generally out of the price range for most people.

Therapeutic uses of Botox

In addition to treating wrinkles, Botox has been approved for use in the treatment of several illnesses and ailments, but it is also being used for other non-approved indications. The spasticity associated with cerebral palsy has been widely treated for several years with Botox. Botox was also found to be a safe and effective treatment for the drooling associated with Parkinson's disease.2 Botox has also been used to treat severe chronic constipation after colostomy,3 and it is used during breast reconstruction following a mastectomy.4

Among 50 or so indications Botox has been used or is considered for are the following ailments, illnesses and syndromes:

• allergic rhinitis
• ALS
• aspiration pneumonia
• bladder problems, including overactivity
• brain injury5
• celebral palsy spasticity
• chronic anal fissure
• crossed eyes
• drooling
• esophageal spasms
• eye and eyelid deformities6
• eyelid spasms
• facial spasms and tics
• foot/sole muscle inflammation
• Frey's syndrome
• gingival (gum) display
• Grave's ophthalmopathy
• headaches
• hysterectomy related-urinary dysfunction
• incontinence
• Lesch-Nyhan syndrome-related self-mutilation7
• limb spasticity
• migraines
• muscle spasms
• multiple sclerosis-related spams8
• myasthenia gravis
• neck pain
• Parkinson's disease-related spasms and constipation
• prostate problems
• rigid spine syndrome
• scoliosis
• shoulder pain
• spasticity
• sphincter spasms
• strabismus
• sweating, excessive/hyperhidrosis
• TMJ disorders
• tendon and ligament pain9
• tennis elbow
• tinnitus
• urinary tract dysfunction
• wrinkles
• writer's cramp
• wryneck

Botox has been used to prophylactically treat headaches, including tension-type and migraine. A study published in early 2006 concluded that the "widespread use" of Botox for the treatment of headaches, such as tension-type and migraine, has not been found to be effective and "cannot currently be recommended."10 What this conclusion means, however, is that so far this use for Botox does not have FDA approval but it may still be found to be beneficial in the treatment of headaches.

One study concluded that botulin injections are not helpful in lessening the "frozen gait" associated with Parkinson's disease.11 A German study published in 2004 warned that "nonjudicious use of botulinum toxin outside a defined range of medical indications should be reassessed."12

Botox side effects

Called the "most poisonous poison" and "an unusally potent oral poison,"13 the botulinum neurotoxins are the "most toxic substances known to humankind"14 and are "identified as a potential bioterrorist threat."15 

Despite the fact that the botulinum toxins are deadly, however, intensive studies have concluded that the botulinum does not enter the bloodstream and that Botox itself is "generally well tolerated." A study published in early 2006 regarding Botox's widespread use for wrinkles stated that "its physiologic safety profile is considered to be excellent." The purpose of this study was to determine the psychological and social side effects of Botox-wrinkle treatment.16 No deaths have been reported relating to Botox injections for cosmetic purposes, and long-term cosmetic Botox use has been found to be both safe and effective.

While safe and effective, Botox is after all an injection, and injections can be painful, so it is recommended that a local anesthetic such as lidocaine be used first.17 Such treatments also may create reactions at the injection site, including swelling and rash. Long-term use to paralyze certain muscles may have its problems, indicated by a study entitled, "Botox induced muscle paralysis rapidly degrades bone."18 

Side effects of Botox used in therapeutic treatments, i.e., not for cosmetic purposes, include the following, reported in a very small percentage of users:

• allergic reaction
• arrhythmia
• bruising
• dysphasia
• epididymitis
• flu-like symptoms
• headaches
• hematoma
• incontinence
• muscle weakness, paralysis or drooping
• myocardial infarction
• nausea
• neck muscle weakness or pain
• pain upon swallowing
• pruritis
• skin rash
• upper respiratory infection

Another study concluded: "The spectrum of possible adverse effects of BTXA [Botox type A] is broad but fortunately those that have been observed with cosmetic use of this product are generally mild and transient."19 The Botox package insert, provided by the manufacturer, Allergan, Inc., states:

Serious and/or immediate hypersensitivity reactions have been rarely reported. These reactions include anaphylaxis, urticaria, soft tissue edema, and dyspnea.... Patients or caregivers should be advised to seek immediate medical attention if swallowing, speech or respiratory disorders arise.20

It is advisable for people with therapeutic indications of Botox to read the package insert. As is traditionally done, pregnant women and nursing mothers are advised not to use Botox.

Botox alternatives

What causes wrinkles? Aging, gravity, facial movements such as smiling or frowning, poor diet, smoking and sun damage are the major wrinkling agents. Who is most prone to wrinkles? Thin and fair-skinned individuals, as well as those who have spent much time in the sun, such as farmers. Dark skin tends to age and wrinkle less. Family genetics may play a role as well. In other words, if the elders in your family tend to be wrinkled, you may expect to be so.

There is no question that Botox is very effective in treating certain types of wrinkles, regardless of their cause. But, Botox can be very expensive - hundreds of dollars for each treated area - and needs to be repeated every 3-12 months, so what about alternatives to Botox? Do they work? One product that is getting quite a bit of attention is Hydroderm, an apparently potent anti-wrinkle cream. Since the Hydroderm company is giving away free samples, it may be worth a try. Nevertheless, a study published in early 2006 concluded that Botox was a better wrinkle treatment than several of the most popular skin creams, including Hydroderm: