Botulinum Toxin
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in CPPS.
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.
acetylcholine from the
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.
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