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Report: Botox for Head Pain, Largest Study Yet

A report from the American Headache Society Annual Scientific Meeting

By

Updated: July 9, 2006

AHS 45th Annual Scientific Meeting

Overview:

  • A new study, the largest to date, adds to the evidence that Botox alleviates and prevents headache and Migraine pain.
  • For the patient who is difficult to treat, Botox actually may be less expensive than standard therapy.
  • Botox tends to cause fewer side effects than standard medications.
  • Insurance often does not pay for Botox as a headache or Migraine treatment.

Botulinum toxin type A, brand name Botox®, is an effective preventative therapy for headache and Migraine pain in chronic sufferers, according to the largest study performed to date, presented at the 45th Annual Scientific Meeting of the American Headache Society (AHS) in June.

Eighty percentof patients in the study said that after treatment with Botox, their head pain was less frequent, less intense, or both. The study focused on 271 patients who suffer from Migraines and other head pain, three-quarters of whom had tried many other therapies, without success. Half had been over-using medications in an effort to relieve pain.

"Many of these patients otherwise would be left with narcotics as their best option," said Andrew M. Blumenfeld, M.D., principal investigator of the study and chief of neurology at Kaiser Permanente in San Diego. "Our study also shows Botox causes fewer side effects than many of the standard medications." Research published previously by Dr. Blumenfeld suggests treating chronic head painpatients with Botox is less expensive than standard therapy.

In the study, patients were treated every three months, with a minimum of 2 treatments and a maximum of 5 treatments.

  • 80% (217) said their head pain episodeswere less frequent, less intense or both.
  • 60.5% (164) reported good to excellent pain relief.
  • 19.5% (53) reported some pain relief.
  • 20% (54) reported no relief.

Compared to standard medications, which can cause a number of side effects, such as upset stomach, drowsiness and weight gain, side effects from Botox treatment are relatively rare. About 95% of patients in his study reported no side effects, said Dr. Blumenfeld. Among the side effects people did experiencewere:

  • eyelid drooping (1%)
  • eyebrow drooping (1%)
  • neck muscle weakness (1%)
  • other effects such as flu-like symptoms or head pain(2%).

Botox is given in the form of a liquid injected under the skin, usually but not always, into muscles. Dr. Blumenfeld uses about 30 injections per treatment, and generally favors a moderately low dose of Botox.

Researchers are unsure why Botox relieves head pain. For its other uses -- including alleviating wrinkles and treating certain medical conditions -- the purified protein relaxes the overactive muscle by blocking nerve impulses that trigger contractions. For Migraines, there is no muscle component. Scientists believe Botox works by blocking the protein that carries the message of pain to the brain.

Relief typically takes effect two to three weeks after injections. The longer the treatments continue, the better the pain relief, said Dr. Blumenfeld. He said some patients who had overused oral medications were able to stop taking those medications entirely after being treated with Botox.

Botox is approved by the Food and Drug Administration (FDA) for treatment of blepharospasm (eyelid spasm), strabismus (crossed eyes), cervical dystonia (painful neck spasms) and wrinkles between the eyebrows, but not for headache or Migraine. Studies to obtain FDA approval for that use are proceeding. As with most other headache and Migraine preventive drugs, Botox is currently being prescribed legally, off-label.

Many private insurers do not pay for Botox for headache and Migraine prevention, although sometimes it is covered on a case-by-case basis. Medicare in four states -- Indiana, Kentucky, Ohio and West Virginia -- pays for Botox therapy for headaches and Migraine. Private insurance companies often follow Medicare’s lead in paying for treatments.

Reference:

American Headache Society. Botox Relieved Headache With Few Side Effects, Suggests Largest Study Yet. June, 2003.

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