Table 1.
Patient Data
| Patient Data | PBCS Treatments | Baseline | 4 Weeks | 12 Weeks | 24 Weeks | 1 Year | 2 Years | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NO | Gen. | Age | ECH | CCH | Loc | Am/In | 14 D | 1 Y | 2 Y | Prophy Lactic Treatm. | A | P | T | A | P | T | A | P | T | A | P | T | A | P | T | A | P | T | |
| Responder | |||||||||||||||||||||||||||||
| 1 | m | 49 | 21 | 3 | l | 4 | 0 | 0 | V 360 | 1.3 | 6.7 | 0.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | ||
| 2 | m | 25 | 4.5 | 15 | l | a.i | 3 | 0 | – | sV | 1.5 | 7.0 | 0.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | – | – | – | |
| 3 | m | 38 | 20 | 2 | r | a | 4 | 4 | – | sV | 1.8 | 7.1 | 1.8 | 1.1 | 5.9 | 1.1 | 1.9 | 7.3 | 1.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | – | – | – | |
| 4 | m | 69 | 20 | 19 | r | i | 4 | 7 | 1 | M | 0.5 | 4.9 | 0.4 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | |
| 5 | f | 32 | 16 | 2 | l | a.i | 1 | 9 | 0 | V 960 | 2.5 | 7.0 | 2.5 | 0.0 | 0.0 | 0.0 | 0.6 | 3.3 | 0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | |
| 6 | m | 50 | 12 | 2 | l | 4 | 0 | 4 | V 240 | 3.7 | 6.3 | 3.7 | 0.1 | 0.4 | 0.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 1.3 | 3.3 | 0.1 | ||
| 7 | m | 32 | 11 | 10 | r | 4 | 0 | 3 | sV.L | 1 | 7.9 | 1.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | ||
| 8 | m | 50 | 20 | 16 | l | 4 | 5 | – | sV. T. C 20 mg | 1.7 | 4.9 | 1.7 | 1.6 | 2.4 | 1.0 | 1.0 | 2.4 | 0.7 | 0.1 | 0.4 | 0.1 | 0.0 | 0.0 | 0.0 | – | – | – | ||
| 9 | m | 58 | 12 | 2 | r | 4 | 2 | 4 | V 720 | 1.8 | 1.5 | 1.2 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 1.3 | 2.4 | 1.1 | 0.0 | 0.0 | 0.0 | ||
| 10 | m | 28 | 14 | 3 | r | a | 3 | 2 | 7 | sV. L | 4.0 | 9.0 | 4.0 | 0.90 | 3.6 | 0.6 | 0.4 | 1.3 | 0.0 | 0.1 | 0.4 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | |
| 11 | m | 50 | 6 | 1.5 | r | 4 | 9 | 4 | V 960 | 3.0 | 4.6 | 3.0 | 2.0 | 2.0 | 0 | 1.0 | 1.6 | 0.3 | 3.3 | 3.1 | 3.3 | 0.6 | 1.0 | 0.0 | 3.3 | 3.0 | 0.0 | ||
| 12 | f | 59 | 20 | l.r | a.i | 6 | 9 | 0 | Ca | 2.1 | 6.6 | 1.0 | 0.4 | 2.0 | 0.0 | 0.6 | 1.7 | 0.0 | 3.4 | 4.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | ||
| 13 | f | 39 | 20 | 1.5 | r | a | 4 | 12 | 3 | sV | 3.9 | 5.8 | 3.9 | 3.3 | 6.1 | 3.3 | 1.0 | 2.9 | 1.0 | 2.9 | 4.4 | 2.9 | 0.7 | 2.0 | 0.7 | 1.9 | 7.6 | 1.9 | |
| 14 | m | 62 | 11 | 4 | l.r | a | 4 | 9 | 9 | V 720 | 2.1 | 8.8 | 2.0 | 0.0 | 0.0 | 0.0 | 3.1 | 2.4 | 0.7 | 0.4 | 0.9 | 0.0 | 1.0 | 1.3 | 0.6 | – | – | – | |
| Mean | 45.8 | 14.8 | 6.2 | 3.8 | 4.9 | 3.2 | 2.2 | 6.3 | 2.0 | 0.7 | 1.6 | 0.4 | 0.7 | 1.6 | 0.3 | 0.7 | 1.0 | 0.4 | 0.3 | 0.5 | 0.2 | 0.6 | 1.4 | 0.2 | |||||
| STD | 13.7 | 5.6 | 6.4 | 1.1 | 4.3 | 2.9 | 1.1 | 1.9 | 1.3 | 1.0 | 2.2 | 0.9 | 0.9 | 2.0 | 0.5 | 1.3 | 1.6 | 1.1 | 0.4 | 0.8 | 0.4 | 1.1 | 2.5 | 0.6 | |||||
| Median | 49.5 | 15.0 | 3.0 | 4.0 | 4.5 | 3.0 | 2.0 | 6.7 | 1.8 | 0.1 | 0.2 | 0.0 | 0.5 | 1.5 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | |||||
| Min. | 25.0 | 4.5 | 1.5 | 1.0 | 0.0 | 0.0 | 0.5 | 1.5 | 0.4 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | |||||
| Max. | 69.0 | 21.0 | 19.0 | 6.0 | 12.0 | 9.0 | 4.0 | 9.0 | 4.0 | 3.3 | 6.1 | 3.3 | 3.1 | 7.3 | 1.6 | 3.4 | 4.4 | 3.3 | 1.3 | 2.4 | 1.1 | 3.3 | 7.6 | 1.9 | |||||
| Non-Responder | |||||||||||||||||||||||||||||
| 15 | f | 53 | 7 | 1.5 | l | 4 | - | - | V 480 | 6.4 | 6.3 | 6.4 | 5.0 | 6.4 | 5.0 | 5.0 | 6.4 | 5.0 | 5.0 | 6.4 | 5.0 | 4.9 | 6.4 | 4.9 | 6.0 | 6.0 | 6.0 | ||
| 16 | m | 49 | 20 | 2 | r | 3 | - | - | V 560. T 100 |
4.0 | 8.0 | 3.0 | 4.0 | 8.0 | 3.0 | 4.0 | 8.0 | 3.0 | 4.0 | 8.0 | 3.0 | 4.0 | 8.0 | 3.0 | 4.0 | 8.0 | 3.0 | ||
| 17 | m | 51 | 14 | 8 | l | NNH. SPG | 3 | - | - | V240. | 5.3 | 4.7 | 4.4 | 5.4 | 4.7 | 4.4 | 5.4. | 5.0 | 5.1 | 5.4. | 5.0 | 5.1 | 5.4. | 5.0 | 5.1 | - | - | - | |
| 18 | f | 24 | 10 | 8 | l | ONS | 4 | 2 | V480 | 4.9 | 6.5 | 4.9 | 4.9 | 6.0 | 4.9 | 2.7 | 5.1 | 2.7 | 4.7 | 6.1 | 4.7 | 4.7 | 6.1 | 4.7 | - | - | - | ||
| 19 | m | 30 | 4 | 3 | r | SPG | 6 | V720 | 0.8 | 10.0 | 0.5 | 0.6 | 4.3 | 0.4 | 0.6 | 4.3 | 0.4 | 0.6 | 4.3 | 0.4 | 0.6 | 4.3 | 0.4 | - | - | - | |||
| 20 | m | 48 | 3 | 6 | re | SPG. ONS | 4 | c 20 mg | 4.5 | 9.9 | 3.8 | 5.4 | 10 | 6.9 | 5.4 | 10 | 6.9 | 5.4 | 10 | 6.9 | 5.4 | 10 | 6.9 | - | - | - | |||
| Mean | 42.5 | 9.7 | 4.8 | 3.8 | 4.3 | 7.6 | 3.8 | 4.2 | 6.6 | 4.1 | 3.5 | 6.5 | 3.9 | 3.9 | 6.6 | 4.2 | 3.9 | 6.6 | 4.2 | 5.0 | 7.0 | 4.5 | |||||||
| STD | 12.3 | 6.5 | 3.0 | 1.6 | 1.9 | 2.1 | 2.0 | 1.8 | 2.1 | 2.2 | 1.9 | 2.2 | 2.3 | 1.9 | 2.1 | 2.2 | 1.9 | 2.1 | 2.2 | 1.4 | 1.4 | 2.1 | |||||||
| Median | 48.5 | 8.5 | 4.5 | 4.0 | 4.7 | 7.3 | 4.1 | 5.0 | 6.2 | 4.7 | 4.0 | 5.8 | 4.0 | 4.7 | 6.3 | 4.9 | 4.7 | 6.3 | 4.8 | 5.0 | 7.0 | 4.5 | |||||||
| Min. | 24.0 | 3.0 | 1.5 | 1.0 | 0.8 | 4.7 | 0.5 | 0.6 | 4.3 | 0.4 | 0.6 | 4.3 | 0.4 | 0.6 | 4.3 | 0.4 | 0.6 | 4.3 | 0.4 | 4.0 | 6.0 | 3.0 | |||||||
| Max. | 53.0 | 20.0 | 8.0 | 6.0 | 6.4 | 10.0 | 6.4 | 5.4 | 10.0 | 6.9 | 5.4 | 10.0 | 6.9 | 5.4 | 10.0 | 6.9 | 5.4 | 10.0 | 6.9 | 6.0 | 8.0 | 6.0 | |||||||
| Total | |||||||||||||||||||||||||||||
| Mean | 44.8 | 13.3 | 5.8 | 3.9 | 2.8 | 6.7 | 2.5 | 1.7 | 3.1 | 1.5 | 1.4 | 3.1 | 1.4 | 1.6 | 2.7 | 1.6 | 1.2 | 2.3 | 1.4 | 1.4 | 2.3 | 0.9 | |||||||
| STD | 13.0 | 6.2 | 5.5 | 1.0 | 1.7 | 2.0 | 1.7 | 2.1 | 3.2 | 2.2 | 1.8 | 3.0 | 2.1 | 2.1 | 3.2 | 2.3 | 1.9 | 3.2 | 2.2 | 2.0 | 3.2 | 1.9 | |||||||
| Median | 49.0 | 13.0 | 3.0 | 4.0 | 2.3 | 6.7 | 2.3 | 0.8 | 2.2 | 0.3 | 0.6 | 2.4 | 0.4 | 0.1 | 0.6 | 0.0 | 0.0 | 0.5 | 0.0 | 0.0 | 0.0 | 0.0 | |||||||
| Min. | 24.0 | 3.0 | 1.5 | 1.0 | 0.5 | 1.5 | 0.4 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | |||||||
| Max. | 69.0 | 21.0 | 19.0 | 6.0 | 6.4 | 10.0 | 6.4 | 5.4 | 10.0 | 6.9 | 5.4 | 10.0 | 6.9 | 5.4 | 10.0 | 6.9 | 5.4 | 10.0 | 6.9 | 6.0 | 8.0 | 6.0 | |||||||
| Patients observed versus patients without attacks and patients with at least 50% improvement | |||||||||||||||||||||||||||||
| No. of patients observed | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 | 12.0 | |||||||||||||||||||||||
| No. of patients without attacks | 0.0 | 7.0 | 6.0 | 8.0 | 10.0 | 7.0 | |||||||||||||||||||||||
| No. of patientes with improvement ≥ 50% | 0.0 | 10.0 | 11.0 | 11.0 | 13.0 | 8.0 | |||||||||||||||||||||||
Notes: NO = case number; Gen. = gender (m = male, f = female); Age (years); ECH = duration of episodic CH (years); CCH = duration of chronic CH (years); Loc. = site of pain (l = left, r = right); Am/In= additional treatment (in = inpatient treatment, am = ambulatory headache center); Baseline: all values are means of headache diary entries of at least the last 2 weeks; Prophylactic treatment (V=Verapamil, L = Lithium; T = Topiramate; M = Metamizole, C = Cortisone; Ca = Cafergot; s = stopped the prophylactic treatment); A = no. of attacks a day; P = pain level (0= no pain at all, 10 = unbearable pain); T = number of triptan applications a day; PBCS treatments = number of PBCS treatments (14 D = within 14 days, 1 Y = between 14 days and 1 year; 2 Y = between 1 year and 2 years); 4 weeks: all values are means of headache diary entries of day 21–28 after first day of therapy. Twelve weeks: all values are means of headache diary entry of day 77–84 after first day of therapy. Twenty-four weeks: day 161–168; 1 year: day 358–365; 2 years: day 723–730. STD = standarddeviation; Min. = minimum; Max = Maximum.