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Botox approved by the FDA as a migraine remedy in the USA The popular anti-wrinkle agent Botox has one more method of use. In the United States, the FDA has approved the botox nerve poison, which is currently mainly used to smooth wrinkles, for the preventive treatment of chronic migraines.
Preventive effects of botox for migraines According to the pharmaceutical manufacturer "Allergan", around 3.2 million people in the US suffer from chronic migraines, which occur on average 15 days a month and last for one to four hours. With the approval of Botox for the preventive treatment of chronic headache relapses, those affected have once again hope of an efficient treatment. The two PREEMPT studies (Phase III Research Evaluating Migraine Prophylaxis Therapy), which are the basis for the approval, come to the conclusion that the headache days are reduced by an average of more than 50 percent due to the injection of botox. 1,384 adults with chronic migraines were treated with either botox or a placebo preparation as part of the studies, with 31 to 39 injections in seven muscles of the head and neck area every 12 weeks. The number of monthly headache days decreased by 8.8 days on average due to treatment with Botox. It is striking, however, that the headache decreased in patients treated with placebo injections by 6.6 days or 44 percent. A remarkable placebo effect, which shows that botox only increases the success of the treatment by almost 15 percent.
In addition, the health status of one percent of the test subjects treated with Botox deteriorated in the first week to such an extent that they had to be admitted to the hospital. Numerous side effects such as head and neck pain, facial paralysis, droopy eyelids, bronchitis and muscle weakness, pain and spasms also occurred in the context of the PREEMPT studies. The side effects seen in 62.4 percent of participants after botox and 51.7 percent after placebo injections, however, were only mild to moderate in the study. The number of dropouts was also negligible at 3.8 percent.
Constantly new fields of application for botox Despite the widespread skepticism among medical professionals, the American FDA, to the delight of the manufacturer “Allergan”, has now followed the example of the British authorities and has approved botox for use in chronic migraine sufferers as a second country. A corresponding application for approval is also planned for Germany. The active ingredient, which was developed on the basis of the bacterial toxin botulinum toxin A, was first approved in the USA in 1989 for the treatment of eyelid cramps and certain forms of squinting. Medicine took advantage of the muscle-relaxing effects of neurotoxin. From 2002, the same effect was approved for cosmetic treatments to smooth out wrinkles between the eyebrows. Numerous other fields of treatment have been added over the years. Botox is now approved for 20 different indications and is used in 80 countries worldwide.
In Germany, for example, the use of botox against wrinkles has been permitted since 2006. According to estimates by the German Neurological Society, well over a million people in Germany meet the inclusion criteria for the new treatment method for migraine prophylaxis. In total, about eight million people suffer from migraines in Germany, according to the German Migraine and Headache Society. However, botox treatment is limited to chronic migraine sufferers only, because according to the FDA botox does not work for patients who suffer less from migraines.
Strongest natural neurotoxin However, it is not without reason that the manufacturer's technical information contains warnings in which doctors and patients are made aware that the active ingredient is the strongest known natural neurotoxin. This could migrate in the body after the injection, so that life-threatening swallowing and breathing difficulties are possible, according to the information from the pharmaceutical manufacturer. However, this has not been able to stop the growing number of people who are inferior to the beauty craze from being treated. Chronic migraine sufferers are likely to be even more positive about a corresponding therapy, since they usually cling to any straw that offers the prospect of a few more pain-free days. (fp, 20.10.2010)
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