Botox as a medicine for migraines?

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Botox as a medicine for migraines? Experts criticize the approval due to insufficient data.

Studies had shown that botox turned out 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 migraines in the USA and Great Britain. A corresponding authorization procedure has also been applied for in Germany with the pharmaceutical authorities. But experts are critical of an approval, the data evaluation of the available studies is insufficient, as it was said.

Will the botox nerve poison for the treatment of migraine symptoms be approved as a regular drug in Germany in the future? A corresponding procedure is currently underway at the drug approval authority. The request for approval is based on various studies that claim that Botox helps patients survive attacks better. It was observed that injections in the head and neck provided the patients with a reduction in the symptoms. Two “PREEMPT studies” (Phase III Research Evaluating Migraine Prophylaxis Therapy) suggested that pain was reduced by a good 50 percent during botox injections. In addition, the subjects would have had to take fewer conventional headache pills while taking botox therapy. If the botox treatment is used correctly and in a specialized manner, the side effects should be correspondingly low, the study authors claim. Based on these results, Botox has already been approved by health authorities in the United States and the United Kingdom.

Side effects and increase in symptoms
However, experts have expressed considerable doubts as to whether the botox nerve poison (botulinum toxin) actually alleviates the symptoms and even reduces the occurrence of a chronic migraine. The editors of the "Drug and Therapeutics Bulletin" accuse the British drug agency of having approved the expensive neurotoxin, although the available data and knowledge are still insufficient. According to the experts, the symptoms would actually worsen in every tenth patient if they were exposed to such therapy. In about ten percent of the cases, side effects such as severe itching, stiffness in the neck, rashes and cramps would also occur. In rare cases, patients could even experience anaphylactic shock. Such a shock can be life-threatening because organ failure can result from an overreaction of the immune system.

According to the authors, the available studies leading to approval are extremely deficient. The majority of the subjects did not suffer from chronic migraines, but from headaches caused by excessive use of medication, as the authors write. According to scientific standards that are internationally recognized, even a migraine diagnosis is excluded. "Because of these contradictions and the limited indications for a benefit, it is difficult for us to imagine a place of botulinum toxin in the treatment of chronic migraines," criticize the authors in the recognized science magazine.

It was striking in the comparative study that the placebo effect was relatively large. While the botox subjects experienced a decrease in the headache days by an average of 8.8 days, the headache also decreased with the placebo injections by 6.6 days (44 percent). At the time of going to press, it was not yet clear when the German authorities would decide on the application for admission. The findings of the English scientists are likely to raise considerable doubts among the German authorities. (sb)

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Headache radiating from the back of the head

Image: Uta Herbert /

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Video: BOTOX for Migraines, Animation.

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