OnabotulinumtoxinA for Tension-Type Headache: Research vs Real-Life Settings
Tension-type headache is typically treated with simple analgesics and non-pharmacological therapies including cognitive behavioral therapy and acupuncture.
Tension-type headache (TTH) is the most common type of headache, occurring in up to three-quarters of the general population.1 Despite its prevalence, the diagnosis and treatment of TTH is often complicated by overlapping symptoms and a weak understanding of TTH etiology.
While TTH is typically treated with simple analgesics and non-pharmacological therapies including cognitive behavioral therapy and acupuncture, there is a growing body of research that suggests that treatment with onabotulinumtoxinA may be effective.
In a 2017 review published in Toxins by Wieckiewicz and colleagues, investigators reported a significant correlation between treatment with onabotulinumtoxinA and reduced TTH intensity and severity in 10 of 11 studies included in the analysis.2
In direct contrast to these findings, the 2016 practice guidelines3 issued by the American Academy of Neurology (AAN) reported that new evidence of sufficient quality has not emerged to change previous guidance (based on Level B evidence from 2 Class I studies), and that onabotulinumtoxinA injection is not likely to be effective in the treatment of chronic TTH.4
In an interview, Neurology Advisor spoke with 3 clinical practitioners to evaluate their experience and use or non-use of onabotulinumtoxinA for TTH.
Samuel Maiser, MD and Thuy An Hoang-Tienor, MD, both clinicians in the neurology clinic of Hennepin County Medical Center in Minneapolis, Minnesota, reported separately that they do not treat TTH with onabotulinumtoxinA, although they do use it for migraine. “I refer several patients (5 to 10) a year for onabotulinumtoxinA for chronic migraine,” Dr Maiser told Neurology Advisor. “My experience is favorable for chronic migraine. The majority of my patients get relief and use less oral medications over time.”
Peter McAllister, MD, medical director of the New England Institute for Neurology and Headache in Stamford, Connecticut, explained that the real root of these contradictory recommendations may actually be the diagnosis of the headache in the first place. “Tension headache is unbelievably misdiagnosed, particularly by primary care doctors. There are some patients who come to me with a diagnosis of chronic tension-type headache, and it turns out that what they're really having is migraines. If I diagnose someone with chronic tension-type headache — which are actually quite rare — onabotulinumtoxinA would not be appropriate to use.”
In the Toxins review, Wieckiewicz, et al wrote that, “TTH treatment should be multilevel. It often consists of taking pain medication, muscle relaxants, antidepressants, using biofeedback therapy, acupuncture, and attending behavioral therapy. Several clinical trials also suggest that botulinum toxin may be an effective treatment option for such patients.”
However, Dr McAllister disagreed. “I don't use onabotulinumtoxinA for TTH because there have been negative studies. Not only is there not [enough] data, the data is negative,” he said, referring to the AAN consensus. “Years ago, we thought that because it has muscle relaxing properties, onabotulinumtoxinA would work great in tension headache, and even better than [in] migraine, because when you think of muscle contraction you think of tension. It turns out, it doesn't.”
The Wieckiewicz review used the 2013 International Headache Society (IHS) classification that categorized TTH as either episodic or chronic, with a headache frequency of ≥15 days per month, which mirrors the criteria used for chronic migraine in the United States. “Patients are selected if they meet FDA [US Food and Drug Administration] criteria for chronic migraine, which is >15 days of headache per month lasting 4 hours a day or longer over the past 3 months,” Dr Maiser said.
The use of onabotulinumtoxinA by US clinicians for the treatment of migraine, however, is a well-accepted practice. “The data is pretty good,” Dr McAllister said. “That's why the FDA approved it. Anecdotally, what most experienced injectors around the country feel is that it's about 65% to 70% effective. There's still about a third of people who come in and try it — and you really have to give it at least 2 goes — and even if they're excited to get it, it just doesn't work. But about two-thirds get a pretty good to great or life-changing response.”
“These patients should have tried at least 2 to 3 other chronic migraine medications before using onabotulinumtoxinA. Either those medications did not work, were not effective enough, [they] the patients did not tolerate them, or they were contraindicated,” Dr Maiser said. “I tell patients that onabotulinumtoxinA can help reduce the frequency and severity of chronic migraines, but it will probably not eliminate headaches entirely. You will receive multiple injections along your forehead and neck. It will take about 2 weeks to have an effect, and should last for about 3 months.”
According to the 2010 PREEMPT study,5 which Dr McAllister participated in, a specific determination has been made regarding which injection sites are the most effective. “It took about 10 years of data to try to figure out the best spots, which turned out to be 31 injections in 7 different areas of the face, side of the head, back of the head, neck, and shoulders.”
Overall, the review by Wieckiewicz and colleagues, which reported that onabotulinumtoxinA injections seem to be an effective treatment for chronic TTH, appears to conflict with clinical practice indicating that onabotulinumtoxinA, while effective for migraine, is specifically not effective for the treatment of chronic TTH. The difference in these positions may reflect the clinical definitions used to diagnose TTH, which may be a far less common occurrence than the 30% to 78% prevalence currently reported.
- The International Classification of Headache Disorders, 3rd edition (beta). IHS Classification ICHD-3 Beta. https://www.ichd-3.org/2-tension-type-headache/. Accessed January 16, 2018.
- Wieckiewicz M, Grychowska N, Zietek M, Wieckiewicz G, Smardz J. Evidence to use botulinum toxin injections in tension-type headache management: a systematic review. Toxins. 2017;9(11):370.
- Simpson DM, Hallett M, shman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. Neurology. 2016;86:1818-1826.
- Simpson M, Gracies JM, Graham HK, et al; for the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Assessment: botulinum neurotoxin for the treatment of spasticity (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2008;70:1691-1698.
- Blumenfeld A, Silberstein SD, Dodick DW, et al. Method of injection of onabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program. Headache. 2010;50:1406-1418.