When outcomes at one year were compared with baseline, all the measures of patient health, apart from the SFMEN, showed a statistically significant improvement in the intervention group, (p</=0.001). Only the migraine headache intensity and duration were improved in the control group (p<0.001 and p=0.018, respectively).
When the two groups were compared, there were statistically significant improvements in all measured variables after one year in the treatment group versus the control group:
frequency (MH per month), 3.8 (+/- 0.4) versus 10.2 (+/- 1.7), (p<0.001);
MH intensity, 4.0 (+/- 0.3) versus 7.0 (+/- 0.3), (p<0.001);
MH duration, 0.35 (+/- 0.05) hours versus 0.99 (+/- 0.2) hours, (p=0.007);
MH index, 12.6 (+/- 3.1) versus 90.6 (+/- 33.6), (p=0.03);
MIDAS, 1.84 (+/- 0.18) versus 3.67 (+/- 0.59), (p<0.001);
MSQEM, 88.1 (+/- 2.6) versus 34.0 (+/- 5.7), (p<0.001);
MSQPRE, 89.7 (+/- 2.2) versus 57.2 (+/- 4.7), (p<0.001);
MSQRES, 83.1 (+/- 2.9) versus 38.2 (+/- 3.5), (p<0.001);
SFMEN, 48.1 (+/- 1.3) versus 40.2 (+/- 2.7), (p=0.014);
SFPH, 51.6 (+/- 1.3) versus 46.6 (+/- 1.6), (p=0.033).
Overall, 82 of the 89 patients in the treatment group (92%) benefited from the surgery, 31 (35%) reported elimination of MH and 51 (57%) experienced improvement. Only 3 of the 19 patients in the control group (15.8%) noted such improvement after one-year follow up, (p<0.001), and no patient reported the elimination of MH.
When changes over time (3, 6, 9 and 12 months after surgery) were compared, there was significant improvement in all measurements for the treatment group versus the control group, (p<0.001).
The authors reported the number of adverse effects following the BT-A injection. More specifically, discomfort at the injection site 27 (20 at occipital site 6 at temporal site and 1 frontal site), temple hollowing 19, neck weakness or stiffness 15, eyelid ptosis 9, flu-like symptoms 5, and bruising or swelling 6.
The number of adverse effects following surgery were temporary nasal dryness 12, rhinorrhoea 11, slight recurrence of septal deviation 8, intense itching 7, minor hair loss 5, abnormal intraoperative bleeding 4, short-term neck stiffness 3, epistaxis requiring desmopressin 3, sinus infection 3, long-term neck stiffness 1, haematoma 1, unilateral airway reduction 1, and significant major hair loss 1.