Botulinum aids stroke, headache patients

DENVER, April 19 (UPI) -- Minute doses of one of the world's most deadly poisons -- botulinum toxin -- appear to help disabled stroke patients perform daily tasks, may prevent migraine headaches and can even calm trembling voices, researchers reported Friday.

"For some people, botulinum toxin can really make a substantial difference in a person's quality of life," said Dr. Mark Gordon, associate professor of clinical neurology at Albert Einstein College of Medicine in The Bronx, N.Y.

Researchers at the American Academy of Neurology annual meeting in Denver, Colo., described experimental uses for botulinum toxin, which is already approved to correct eye conditions and smooth forehead wrinkles.

Gordon reported on a continuing study of 110 patients who have suffered strokes that left them partially paralyzed, often with their arms bent and nearly frozen against their chest, their fists tightly clenched.

"In some of these cases, the patients are in a great deal of pain," Gordon told United Press International, "and we can usually relieve pain with the injections."

Co-author Catherine Turkel, director of clinical development at Allergan Inc. in Irvine, Calif., which makes botulinum toxin -- commonly known as Botox -- and sponsored the study, said, "Some patients cannot even get the arm through the sleeve of a blouse or a robe. So if we are able to make those muscles relax enough so that a person can dress himself or herself or be dressed by a caretaker, that is a great quality of life improvement."

Gordon said he and his colleagues have "(seen) this condition commonly among people who have had paralyzing strokes or strokes that have left arm muscles weakened," Gordon said. He noted that 80 percent of patients achieved some improvement in relief of impairment or pain, and a few patients achieved substantial improvement.

"Especially for people with pain," said Dr. Ryan Uitti, MD, associate professor of neurology at the Mayo Clinic, Jacksonville, Fla. "This treatment seems to be reasonable. My concern is that people with profound disability due to stroke would seek this treatment in hopes of recovering greater function."

In other studies with botulinum at the meeting:

*Researchers reported in two studies that patients appeared to get relief from migraine headache symptoms when the toxin was injected into several muscles in the head.

"Some patients have had up to 13 treatments over a three and a half year period," said Dr. Alexander Mauskop, director of the New York Headache Center. In reviewing the records of 80 patients, Mauskop said the benefits of the treatment are its simplicity, minimal unwanted side effects, no concern about compliance problems in patients taking medicine on time, apparent efficacy and reductions in hospital visits for migraine that would make the treatment cost-effective.

Another migraine researcher, Dr. Eric Eross of the Mayo Clinic in Scottsdale, Ariz., said his study of 48 patients found that they were able to decrease the impact of the headaches on their daily living activities by more than 50 percent -- especially among migraine sufferers under age 40.

But neither Mauskop or Eross's studies included control groups, making comparisons and effectiveness judgments difficult.

Dr. Peter Goadsby, professor of clinical neurology at University College in London said he remains skeptical about whether botulinum works for migraine. Since migraine is thought to be a disease of the blood vessels in the head, he said "it is completely implausible to me that by injecting botulinum into the muscles of the head you would have an impact on a condition that is vascular in nature. This treatment should be considered experimental until a well-designed clinical trial is completed."

* In a study of 13 patients with vocal tremor, Dr. Charles Adler, professor of neurology at the Mayo Clinic in Scottsdale, Ariz., found that small doses of botulinum could relieve patients with voice tremor for several months.

His patients, 11 women and two men, were between ages 54 and 81. He injected botulinum in three doses directly into the muscles around the voice box.

Although some patients decided that the side effects of treatment -- a breathy, Marilyn Monroe-type voice that persisted for two to three weeks in some subjects -- Adler said several patients continue to return to the clinic when the botulinum wears off, in about three months, and tremor returns.

"Using botulinum toxin for vocal tremor would be a legitimate treatment for the people who need it," said Dr. David Lichter, associate professor of neurology at the University at Buffalo, New York. "However, I think the side effects of the treatment are underplayed. It can cause problems in swallowing. But overall it appears safe and certainly didn't cause any severe problems."

Dr. Ashok Verma, associate professor of neurology at the University of Miami in Florida, injected botulinum into muscles in the face of patients with the degenerative disease amyotrophic lateral sclerosis, also known as ALS or Lou Gerhig's disease, named after the famed New York Yankees "Ironman" who was felled by ALS in the 1930s.

"People with bulbar ALS," Verma told UPI, "are first affected by the disease in their head and neck. One complication is excessive saliva production which causes drooling."

Often, he said, the rest of the person's activities are not affected by the disease but by social embarrassment due to the sialorrhea or drooling.

Using paper tissue counts as a way of determining success of treatment, Verma said his patients reduced tissue use from 80 a day to 55, a significant reduction. But a questionnaire on the patients' quality of life showed an even greater improvement.

Dr. Nicholas Schlageter, a neurologist from St. Charles, Ill., said that oral drugs can also slow sialorrhea, but those medications can cause sedation and headaches.

He said that even though the cost for botulinum toxin is relatively high, "these treatments can offer a lot of people help."