If you are one of the more than 28 million migraine sufferers or the 10 million people with chronic daily headaches, you might find relief with BOTOX Cosmetic. While the Food and Drug Administration hasn't officially approved Botox for this use, physicians are using it in an off-label use capacity and seeing impressive results. At the March 2003 annual American Headache Society meeting, more than a dozen studies were released that showed BOTOX Cosmetic could cut the number of migraines, dampen symptoms and reduce the need for painkillers.

While researchers aren't entirely sure how BOTOX Cosmetic blunts headache pain, they do know that the toxin latches on to sensory nerve endings blocking the release of chemicals that ferry pain messages to the brain.

The biggest advantage to BOTOX Cosmetic is its lack of side effects, especially compared to other medications, said Dr. William Ondo of the Baylor College of Medicine in an AHA press release. It really is extremely safe and appears to be very effective for some people.

A study at Wake Forest noted possible slight drooping, bruising, bleeding or burning at the injection site as possible side effects. Patients receive ten or more injections at a time, and the results last around three to eight months.

At the AHA conference, researchers at the Mayo Clinic in Scottsdale, Arizona reported that of the 48 patients in one study, half reported the number of migraines they experienced dropped by half after the injections. Thirty percent of those people reported the migraines they did have were less severe.

In a controlled trial at the Baylor College of Medicine Headache Clinic, 55 percent of the participants who received BOTOX Cosmetic injections reported at least moderate improvements in their symptoms. Two of the participants who received the placebo also reported an improvement.

OVERACTIVE BLADDER / BLADDER DISFUNCTION

More than 17 million people are plagued by involuntary contractions of the bladder muscle resulting in the urgent need to empty their bladders and experience difficulty holding their urine leading to leakage. The causes are many including involuntary muscle contractions, spinal cord injuries, stroke or multiple sclerosis. For some, botulinum toxin may be a solution. A handful of small studies found that BOTOX Cosmetic injections into the bladder muscle resulted in improved bladder function in about 8 out of 10 patients.

Another study at the University of Pittsburgh School of Medicine found that 82 percent of patients with bladder dysfunction found relief for about six months after being injected with the toxin.

MUSCLE TENSION AND SPASMS

Blepharospasm (the involuntary contraction of the eye muscles), cervical dystonia (abnormal muscle tension in the neck area), dystonia (abnormal muscle tension) and spasmodic dysphonia (a neurological disorder that impacts the larynx) have all shown improvement with the use of BOTOX Cosmetic.

HYPERHIDROSIS/EXCESSIVE SWEATING

While only a few small studies have looked at the hope of botulinum toxin as a fix for excessive sweating, moderately positive results have been seen in the research that has been done. The largest study so far, conducted in 2001, found a greater than 50 percent reduction in underarm sweating after 16 weeks. In a smaller study, all of the patients experienced positive results. Results last from four months to a year, and it is believed the treatment can be repeated without a decrease in the result.

As a bonus, the injections may dial back underarm odor as well. Doctors at Ludwig-Maximilian University in Munich injected 16 volunteers with botulinum toxin. Researchers instructed the volunteers to skip dining on any known scent-offenders such as garlic and had the volunteers wear T-shirts for 24 hours. When the T-shirts were put to the sniff-test, researchers found that the T-shirts worn by those who received the injections had less offensive smells and smelled better than the T-shirts worn by the injection-free group.

STROKE RECOVERY

A study published in the August 8, 2002 issue of the New England Journal of Medicine illuminated the effectiveness of BOTOX Cosmetic injections in the treatment of uncontrollable tightening of the muscles in the arms or legs, known as post-stroke spasticity. While still not FDA approved for this use, researchers found in this two-year placebo-controlled study that the toxin improved muscle function in 40 of the 64 patients who received the drug. In the placebo group, just 17 of 62 patients showed any improvement.

LOW BACK PAIN

Researchers at Walter Reed Army Medical Center in Washington D.C. reported in the May 22 issue of Neurology that botulinum toxin injections can ease lower back pain. In a randomized, double-blind study of 31 patients plagued with chronic back pain an average of six years, 73 percent of those who received the drug reported a 50 percent decrease in pain. In the placebo group, just 25 percent of the patients reported an improvement in their symptoms.

At the American Society of Anesthesiologists annual meeting in October 2000, researchers at Louisiana State University Health Sciences Center in Shreveport reported that patients with lower back pain being treated at the LSU Pain Management Service reported less pain and greater mobility after being treated with botulinum toxin.

CLUB FOOT IN INFANTS

As many as 1 in 500 babies are born with their heels and toes twisted inward, or clubfoot. At Children's Hospital in Vancouver, Dr. Christina Alvarez skipped the traditional tendon lengthening surgery required before turning the infants' feet into the correct position and stabilizing them in casts for several months and instead used BOTOX Cosmetic to relax the tendons. The procedure was success on the more than 40 infants she treated.

Karmen B. Saran
DERMAdoctor Staff Writer

(Any topic discussed in this article is not intended as medical advice. If you have a medical concern, please check with your doctor.)

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