"Botox is no better than acute withdrawal in frequent migraine with medication overuse

Acute withdrawal from pain medication is as good as botox in patients with high frequency chronic migraine and medication overuse. The Leiden University Medical Center Headache Group conclude this from a large-scale randomized controlled clinical study. They published the results in the magazine Brain.

Acute withdrawal from pain medication is as good as botox in patients with high frequency chronic migraine and medication overuse. The Leiden University Medical Center Headache Group conclude this from a large-scale randomized controlled clinical study. They published the results in the magazine Brain.

In most patients with migraine, overuse of simple (over-the-counter) analgesics and prescription acute antimigraine medications has triggered progressive increase of the migraine attack frequency, resulting in transition from low frequency episodic migraine to high frequency chronic migraine which is extremely difficult to treat. Chronic migraine is a highly disabling form of migraine with headaches on at least 15 days a month. The frequently recurring migraines significantly interfere with work, school, social activities and quality of life.

In North America and certain European countries, patients with chronic migraine and medication overuse are often treated with Botulinum toxin A (Botox), although scientific evidence for this therapy is only modest. In The Netherlands and some other European countries, acute withdrawal for 3 months is often advocated as a potentially better and certainly cheaper alternative, but has never been formally compared with Botox. 

Researchers from the Leiden headache group led by neurologist Gisela Terwindt are now showing for the first time that botox treatment does not work better than stopping all pain medication. They did this by including 179 patients with chronic migraine and medication in a large, randomized, double-blind, placebo-controlled, clinical trial. All patients were instructed to withdraw acutely from all medications for 12 weeks in an outpatient setting. In addition, half of them randomly received 31 injections with Botox according to well established standard protocols and the other half with placebo.
 
Unblinding due to lack of forehead wrinkling in the placebo group, was successfully prevented by administering placebo-treated participants an additional double-blind very low dose of Botox in the forehead. This “local masking dose” was sufficient to cause loss of forehead wrinkling, but was too low to afford clinical benefit. 

After withdrawal, mean number of headache days had decreased by 5 days (from 20 days at baseline = 25% reduction). Migraine days had dropped by 6–7 days (from 15 days at baseline = 45% reduction). Botox did not afford any additional benefit over acute withdrawal alone, also not after nearly a year of follow-up. In total 60% of patients had reverted back to low frequency migraine and over 30% of participants did not need preventive medication anymore. Withdrawal was well tolerated and the majority of patients would recommend withdrawal to peer patients.

“These results confirm that withdrawal is well-tolerated and associated with meaningful improvement. In patients with chronic migraine and medication overuse, acute withdrawal should be tried first rather than initiating more expensive treatment with Botox”, says Terwindt.

Read the publication "Acute withdrawal and botulinum toxin A in chronic migraine with medication overuse: a double-blind randomized controlled trial" in Brain:

https://academic.oup.com/brain/advance-article/doi/10.1093/brain/awz052/5457721