There have been a multitude of news articles recently about a JAMA article on Botox for Migraine and headache, and they've resulted in quite a bit of confusion and many questions. Let me start by saying that the JAMA article contained no new data. The authors were reviewing data from 31 previously conducted studies.
After pages of going back through the data of all the clinical trials conducted with onabotulinum toxin A (Botox) for Migraine and headache, the authors concluded:
"In conclusion, botulinum toxin A is not associated with greater benefit than placebo in prophylactic treatment of episodic migraine or chronic tension-type headaches. Botulinum toxin A may be associated with benefit in prophylaxis of chronic daily headaches and chronic migraine headaches. This beneficial association appears limited to patients with chronic migraine headaches and the absolute reduction in the number of headaches is only 2 to 3 days a month."1
In the PREEMPT (Phase III Research Evaluating Migraine Prophylaxis Therapy) trials of Botox, which involved 1,384 participants in 122 study sites in North America and Europe:5
- Participants who received Botox averaged eight to nine fewer headache/Migraine days per month from baseline when compared to participants treated with placebo, who averaged six to seven fewer days.
- Many patients treated with Botox had a 50% or greater reduction in headache/Migraine days each month after two treatment cycles.
- Chronic Migraine participants treated with Botox also had total cumulative reduction in headache/Migraine hours on headache/Migraine days each month totaling nearly a full work week compared to placebo (107 to 134 hours for participants treated with Botox compared to 70 to 95 hours for those treated with placebo).
- Nearly 70% of the participants treated with Botox over 56 weeks had a 50% or greater reduction in Migraine days from baseline, which exceeds the clinically meaningful responder rate established by the International Headache Society.
Summary and comments:
It's not clear to me why this study or paper was undertaken for JAMA in the first place. Botox is FDA approved only for the treatment of chronic Migraine. I've seen no papers calling for it's use for episodic Migraine or chronic tension-type headache, nor have I heard any doctors recommending it for those purposes. It appears that the JAMA authors are, for some reason, attempting to minimize 1) how much effect Botox can have, and 2) how significant any reduction in headache/Migraine days is to the person living with chronic Migraine.
Some of the mainstream media are, again, grabbing what will make the most sensational headlines rather than what's most balanced and accurate.
This JAMA paper is nothing new and changes nothing. Botox has been shown to be effective in the treatment of chronic Migraine, but not in the treatment of episodic Migraine or for tension-type headache.
1 Jackson, Jeffrey L, MD, MPH; Kuriyama, Akira, MD; Hayashino, Yasuaki, Hayashino, MD, DMSc, MPH. "Botulinum Toxin A for Prophylactic Treatment of Migraine and Tension Headaches in Adults: A Meta-Analysis." JAMA. 2012;307(16):1736-1745.
2 Press Release. "Botox Injections Associated with Only Modest Benefit for Chronic Migraine and Daily Headaches." Chicago. JAMA. April 23, 2012.
3 Park, Alice. "Botox Treatments Not So Effective for Migraine Headache Relief." Time. April 25, 2012. http://healthland.time.com/2012/04/25/botox-treatments-not-so-effective-for-migraine-headache-relief/
4 Pittman, Genevra. "Botox ingredient has limited effect on headaches: study." Reuters Health. April 25, 2012.
5 Response Statement. "Allergan Statement Regarding JAMA Publication: Botulinum Toxin A for Prophylactic Treatment of Migraine and Tension Headaches in Adults: A Meta-Analysis." Allergan, Inc. April 23, 2012.