OnabotulinumtoxinA injection towards the SPG for treating symptoms of refractory chronic rhinosinusitis with nasal polyposis: a pilot study.

BACKGROUND AND OBJECTIVE: The main objective of this prospective, open, uncontrolled pilot study was to investigate the safety of administering onabotulinumtoxinA (BTA) towards the sphenopalatine ganglion (SPG) in 10 patients with refractory chronic rhinosinusitis with nasal polyposis (CRSwNP) using a novel injection tool, the MultiGuide®. MATERIAL AND METHODS: A one-month baseline period was followed by bilateral injections of 25 U BTA in the SPG and a follow-up of 12 weeks. The primary outcome was adverse events (AE), and the main efficacy outcome was a 50% reduction in visual analogue scale (VAS) symptoms for nasal obstruction and rhinorrhea in months 2 and 3 post-treatment compared to baseline. RESULTS: We registered 13 AEs, none of which were serious, however, one patient experienced diplopia which moderately affected his daily activities. The symptoms slowly improved and resolved 4 weeks after injection. Five patients were treatment responders with at least 50% median reduction in the nasal obstruction, and four were treatment responders concerning rhinorrhea. CONCLUSIONS: Injection of BTA toward the SPG using the MultiGuide® in patients with CRSwNP appears to be safe but with a potential for moderately disabling side effects. The study indicates a beneficial effect on nasal obstruction.

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

OBJECTIVES: To 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." METHODS: Data 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. RESULTS: An 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). CONCLUSIONS: Our 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.

Depicting the pterygopalatine ganglion on 3 Tesla magnetic resonance images.

PURPOSE: The pterygopalatine ganglion has yet not been identified on medical images in living humans. The primary aim of this study was to evaluate whether the pterygopalatine ganglion could be identified on 3 T MR imaging. METHODS: This study was performed on medical images of 20 Caucasian subjects on both sides (n = 40 ganglia) with an exploratory design. 3 T MR images were assessed by two physicians for the presence and size of the pterygopalatine ganglion. The distance from the pterygopalatine ganglion to four bony landmarks was registered from fused MR and CT images. In an equivalence analysis, the distances were compared to those obtained in an anatomical cadaveric study serving as historical controls (n = 50). RESULTS: A structure assumed to be the pterygopalatine ganglion was identified on MR images in all patients on both sides by both physicians. The mean size was depth 2.1 ± 0.5 mm, width 4.2 ± 1.1 mm and height 5.1 ± 1.4 mm, which is in accordance with formerly published data. Equivalence of the measurements on MR images and the historical controls was established, suggesting that the structure identified on the MR images is the pterygopalatine ganglion. CONCLUSION: Our findings suggest that the pterygopalatine ganglion can be detected on 3 T MR images. Identification of the pterygopalatine ganglion may be important for image-guided interventions targeting the pterygopalatine ganglion, and has the potential to increase the efficacy, safety and reliability for these treatments.

Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic migraine.

Objective The main objective of this pilot study was to investigate the safety of administering onabotulinumtoxinA towards the sphenopalatine ganglion in 10 patients with intractable chronic migraine with an open, uncontrolled design. We also collected efficacy data to provide an indication as to whether future placebo-controlled studies should be performed. Method In a prospective, open-label, uncontrolled study after one-month baseline, we performed bilateral injections of 25 IU onabotulinumtoxinA (total dose 50 IU) toward the sphenopalatine ganglion in a single outpatient session in 10 patients with intractable migraine with a follow-up of 12 weeks. The primary outcome was adverse events and the main efficacy outcome was frequency of moderate and severe headache days in month 2 post-treatment compared to baseline. Results All 10 patients experienced a total of 25 adverse events. The majority of these were different types of local discomfort in the face and jaw, and none were classified as serious. In an intention-to-treat analysis of the main efficacy outcome, a statistically significant reduction of moderate and severe headache days in baseline versus month 2 was observed (16.3 ± 6.2 days baseline versus 7.6 ± 7.6 days month 2, p = 0.009). Eight out of 10 patients experienced an at least 50% reduction of moderate and severe headache days compared to baseline. Conclusion The result warrants randomised, placebo-controlled studies to establish both safety and efficacy of this potential novel treatment of chronic migraine.

Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic cluster headache.

OBJECTIVE: The main object of this pilot study was to investigate the safety of administering onabotulinumtoxinA (BTA) towards the sphenopalatine ganglion (SPG) in intractable chronic cluster headache. Efficacy data were also collected to provide indication on whether future placebo-controlled studies should be performed. METHOD: In a prospective, open-label, uncontrolled study, we performed a single injection of 25 IU (n = 5) or 50 IU BTA (n = 5) towards the SPG in 10 patients with intractable chronic cluster headache with a follow-up of 24 weeks. The primary outcome was adverse events (AEs) and the main efficacy outcome was attack frequency in weeks 3 and 4 post-treatment. RESULTS: A total of 11 AEs were registered. There was one severe adverse event (SAE): posterior epistaxis. The number of cluster headache attacks (main efficacy outcome) was statistically significantly reduced in the intention-to-treat analysis from 18 ± 12 per week in baseline to 11 ± 14 (p = 0.038) in weeks 3 and 4, and five out of 10 patients had at least 50% reduction of attack frequency compared to baseline. The cluster attack frequency was significantly reduced for five out of six months post-treatment. CONCLUSION: Randomised, placebo-controlled studies are warranted to establish the potential of this possible novel treatment of cluster headache.