Long‐Term Outcome of Patients With Intractable Chronic Cluster Headache Treated With Injection of Onabotulinum Toxin A Toward the Sphenopalatine Ganglion – An Observational Study

Abstract

ObjectivesTo investigate long‐term outcomes in per‐protocol chronic cluster headache patients (n = 7), 18 and 24 months after participation in “Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic cluster headache.”MethodsData were collected prospectively through headache diaries, HIT‐6, and open questionnaire forms at 18 and 24 months after the first treatment. Patients had access to repeated injections when needed.ResultsAn overall significant reduction in cluster headache attack frequency per month (57.3 ± 35.6 at baseline vs 12.4 ± 15.2 at month 18 and 24.6 ± 19.2 at month 24) was found. In addition, there was a reduction in attacks with severe and unbearably intensity (50.0 ± 38.3 at baseline vs 10.1 ± 14.7 at month 18 and 16.6 ± 13.7 at month 24) and an increase in attack free days (4.2 ± 5.9 at baseline vs 19.1 ± 9.4 at month 18 and 12.9 ± 8.8 at month 24).ConclusionsOur findings suggest sustained headache relief after repeated onabotulinumtoxinA injections toward the sphenopalatine ganglion in intractable chronic cluster headache. A placebo‐controlled trial with long‐term follow‐up is warranted.

Incorporation of health technologies: The importance of drug treatment of primary headaches in the Brazilian unified health system

“…[17][18][19][20][21][22][23][24][25][26][27] The NLEM update in 2022 did not incorporate any technology to treat the main primary headaches, nor did it expand access to medications already incorporated for headaches, such as the use of topiramate medications. [28][29][30][31][32][33] and botulinum toxin A [34][35] , already incorporated into the unified health system to treat other conditions.…”

History of cluster headache

“…106 Others successfully infiltrated the sphenopalatine ganglion, using, in contrast to Sluder (see above), onabotulinumtoxin A. 107,108 Let it be emphasised that unilateral and bilateral cranial autonomic symptoms may occur during migraine attacks as well. 109,110 However, in migraine, they appear during the attack rather than at its beginning.…”

Cluster headache: state of the art of pharmacological treatments and therapeutic perspectives

“…The implication of the trigeminal autonomic arc reflex through the SPG incited Bratbak et al to perform an open-label study to assess BTA injection at 25 IU in SPG blockage to treat cCH patients [139]. The number of CH attacks was very significantly reduced in the intention-to-treat analysis ( [140]. In another study, Lampl et al assessed the efficacy and tolerability of BTA injection in refractory cCH, with a different method [141].…”

“…Eleven adverse events were reported, including 1 severe (posterior epistaxis). Another observational long‐term study of outcome in patients with intractable cCH treated with BTA injection toward the SPG reported similar results, with reduced frequency of attack per month (57.3 ± 35.6 to 12.4 ± 15.2 at 18 months ( P = 0.018) and to 24.6 ± 19.2 at 24 months ( P = 0.018)) and of severe attacks per month (50.0 ± 38.3 to 10.1 ± 14.7 at 18 months ( P = 0.018) and to 16.6 ± 13.7 at 24 months ( P = 0.028)) [140]. In another study, Lampl et al assessed the efficacy and tolerability of BTA injection in refractory cCH, with a different method [141].…”