Botox as a medicine for migraine?

Botox as a medicine for migraine? Experts criticize the approval due to a lack of data.

12/02/2011

Studies had shown that Botox proved to be an effective remedy for migraine attacks. Botox, which is actually used to tighten the skin, has already been approved for the treatment of migraine in the United States and the United Kingdom. In Germany, too, a corresponding authorization procedure was requested from the drug regulatory agency. But experts see a license critical, the data analysis of the available studies is insufficient, as it was said.

Will the neurotoxin Botox be approved as a regular drug in Germany for the treatment of migraine symptoms in the future? A similar procedure is currently underway with the drug regulatory agency. The petition for approval is based on several studies claiming that Botox helps to better withstand patient attacks. Thus it could be observed that injections in the head and neck gave the patients a reduction of the complaints. Two „PREEMPT studies“ (Phase III Research Evaluating Migraine Prophylaxis Therapy) suggested that Botox injections reduced pain by a good 50 percent. In addition, the subjects would have had to take less conventional headache pills while they were taking Botox therapy. If the Botox treatment is used properly and specialized, the side effects should be correspondingly low, the study authors claim. Based on these findings, Botox has already been approved by the health authorities in the United States and the United Kingdom.

Side effects and increase in symptoms
However, experts express considerable doubts whether the neurotoxin Botox (botulinum toxin) actually alleviates the symptoms and even reduces the occurrence of chronic migraine. The publishers of the „Drug and Therapeutics Bulletin“ accuse the UK Food and Drug Administration of authorizing the expensive neurotoxin, although the available data and findings are still insufficient. In the opinion of the experts, the symptoms would even worsen in every tenth patient, if they exposed themselves to such a therapy. In about ten percent of cases, side effects such as severe itching, stiffness in the neck, rashes and cramps would also occur. In rare cases, patients may even experience an anaphylactic shock. Such a shock can be life-threatening because an organ failure threatens due to an overreaction of the immune system.

The available studies leading to approval are, according to the authors, extremely deficient. Because the majority of the subjects did not suffer from a chronic migraine, but from a headache by an excessive intake of medication, as the authors write. By scientific standards, which are internationally recognized, exclude even a migraine diagnosis. „Because of these contradictions and the limited evidence of utility, it is difficult to imagine a place of botulinum toxin in the treatment of chronic migraine“, criticize the authors in the recognized science magazine.

It was noticeable in the comparative study that the placebo effect was relatively large. While Botox subjects experienced an average headache reduction of 8.8 days, headache also decreased by 6.6 days (44 percent) with placebo injections. When the German authorities decide on the application for approval, was not yet determined at the time of going to press. The findings of the English scientists are likely to raise considerable doubts among the German authorities. (Sb)

Read about botox and migraine:
Botox approved as a migraine remedy
Botox is said to help with chronic migraines
Magnetic impulses against migraine
New study: Acupuncture in the brain is effective?
Migraine: increased heart attack and stroke risk
Headache, radiating from the back of the head

Picture: Uta Herbert