Botox Effective For Relief Of Incapacitating Chronic Pain
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Botox Effective For Relief Of Incapacitating Chronic Pain

ORLANDO, FL -- November 19, 1999 -- People who suffer from a variety of chronic pain syndromes may obtain relief with injections of Botox(R) (botulinum toxin type A), a product of Allergan, Inc., according to a group of clinical studies presented at the International Conference 1999: Basic and Therapeutic Aspects of Botulinum and Tetanus Toxins held in Orlando, Florida.

"Chronic pain whether it is migraine, whiplash or back pain, can significantly interfere with the activities of daily living," said Dr. Mike Royal, Department of Anesthesiology/Pain Management, University of Oklahoma, Tulsa OK, who presented his study on the use of botulinum toxin type A (BTX-A) in patients suffering from back pain. Treatment with Botox provides an alternative therapy that is effective when these debilitating conditions do not respond to conventional treatment."

"Botulinum toxin type A produces prolonged muscle relaxation which is dose dependent and can be easily targeted to affected muscles," said Dr. Marvin Schwartz, from the University of Toronto, Pickering, Ontario, Canada, who presented data on whiplash at Toxins '99.

Myofascial pain syndrome is a chronic, painful condition associated with areas of increased muscle tone, which are clinically felt as tight bands punctuated by small areas that are very tender to pressure, often called trigger points. Myofascial pain is often treated with conventional therapies such as non-steroidal anti-inflammatories, analgesics and physical therapy. These therapies however, have limitations and are associated with side effects.

In a retrospective study conducted at the Pain Evaluation & Treatment Center in Tulsa, OK, 70 percent of patients with myofascial pain in the back and extremities who received BTX-A injections over a two-year period reported good (15.5 percent) to excellent (54.5 percent) pain relief lasting an average of 2.5 to 3.6 months. Ten percent were free of pain at the one-year follow up. Patients experience relief from symptoms within one week after the first injection. The treatment was well tolerated with only a few patients having mild and very transient reactions. With the BTX-A injections, patients were able to tolerate more aggressive therapeutic exercise.

In addition, according to a randomized double-blind placebo controlled study conducted at the University of Toronto, Canada and presented at the Toxins '99 meeting, 26 patients suffering from whiplash associated disorder (WAD) treated with BTX-A demonstrated a significant improvement (p<0.01) in total range of neck motion and subjective pain compared to the placebo
group. No side effects were reported in this study.

Additional studies on BTX-A indicated that:

-- Low back myofascial pain can be safely and effectively treated with BTX-A injections even when the pain does not respond to conventional therapies.

-- The efficacy of BTX-A is superior and longer lasting than conventional steroid therapy for myofascial pain.

-- BTX-A may be more effective than lidocaine in the treatment of myofascial pain.

-- In patients with TMD, BTX-A showed statistically significant improvement in pain experience, function, mouth opening and tenderness to palpation in TMD patients.

Botox blocks the excessive release of a neurotransmitter called acetylcholine from the terminal where the nerve transmits signals to the muscle. The affected terminals are not able to cause muscle contraction. Clinical effects are usually seen within one week of injection and typically relief endures for three to four months or more. Repeat injections of Botox may be required to maintain the desired clinical effect.

Migraine is a condition that affects some 25 million Americans (three times as many women as men). The condition is characterized by moderate to severe pain, generally localized on one side of the head and exacerbated by movement or physical activity. Attacks, which may last as long as four to 72 hours, are often accompanied by nausea, vomiting, and sensitivity to light and sound. While new treatments have been developed to manage migraine, there have been few developments in the therapies to prevent migraine. New data, however, suggests that Botox may be effective as prophylactic therapy for migraine.

A multi-center, double-blind, placebo-controlled trial of BTX-A showed that injection of 25 U BTX-A provided significantly reduced the frequency and incidence of migraine and associated vomiting for at least three months following injection. The 25 patients that received BTX-A measured significantly better on frequency of migraines, number of migraines, reduction in migraine severity, reduction of vomiting and reduction in the number of days in which acute migraine medications were used.

Other studies on treatment of migraine with BTX-A indicated:

-- Intramuscular injections of BTX-A are effective in preventing chronic tension-type headache when standard therapy fails.

-- Headache severity was significantly decreased following intramuscular injections into the most tender pericranial muscles with BTX-A.

Botox works by blocking the excessive release of acetylcholine from the peripheral nerve terminal at the neuromuscular junction (where the nerve transmits signals to the muscle). The affected terminals are inhibited from stimulating muscle contraction, resulting in muscle relaxation. Over a period of several months the beneficial effects gradually fade. Side effects of treatment with Botox are usually transient and mild to moderate in nature.

A highly stable, purified form of botulinum toxin type A is currently marketed in the U.S. under the brand name Botox(R) by Allergan, Inc. for the treatment of strabismus and blepharospasm associated with dystonia (disorder of the eye muscle that controls blinking). Researchers across the country are also studying its uses in a number of other disorders including cervical dystonia (involuntary muscle spasms in the neck and shoulders), post-stroke spasticity, back pain, migraine and tension headache.

Related Link: Allergan, Inc.

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