Table 1 Pooled characteristics of all patients included in the efficacy evaluable population (i.e. all subjects who treated at least one headache in both treatment periods) in the four randomized, controlled studies included in the meta-analysis

Number of patients

1369

1376

689

1717

Number of headache episodes treated

2737

2748

1376

6861

Mean age (SD), y

34.1 (9.7)

34.1 (9.7)

34.5 (10.0)

34.2 (9.8)

Sex (F), n (%)

1129 (82.5)

1140 (82.9)

563 (81.7)

1416 (82.5)

Race, n (%)

 Caucasian

1238 (90.4)

1245 (90.5)

625 (90.7)

1554 (90.5)

 Other

131 (9.6)

131 (9.5)

64 (9.3)

163 (9.5)

Mean no. headache episodes/month (SD)

6.4 (2.1)

6.4 (2.1)

6.4 (2.1)

6.4 (2.1)

Mean age at onset (SD), y

22.1 (8.7)^a

22.2 (8.6)^b

21.9 (8.6)^c

22.1 (8.6)^d

Onset, n (%)

 Gradual

983 (71.9)

989 (71.9)

478 (69.4)

1225 (71.4)

 Rapid

385 (28.1)

386 (28.1)

211 (30.6)

491 (28.6)

Location, n (%)

 Suboccipital

288 (21.0)

285 (20.7)

133 (19.3)

353 (20.6)

 Occipital

411 (30.0)

388 (28.2)

201 (29.2)

500 (29.1)

 Parietal

95 (6.9)

98 (7.1)

49 (7.1)

121 (7.1)

 Temporal

640 (46.8)

659 (47.9)

309 (44.9)

804 (46.8)

 Frontal

750 (54.8)

759 (55.2)

385 (55.9)

947 (55.2)

 Whole head

205 (15.0)

205 (14.9)

106 (15.4)

258 (15.0)

Character, n (%)

 Non-throbbing

404 (29.5)

397 (28.9)

207 (30.0)

504 (29.4)

 Throbbing

341 (24.9)

343 (24.9)

182 (26.4)

433 (25.2)

 Combination

624 (45.6)

636 (46.2)

300 (43.5)

780 (45.4)

Usual severity (history), n (%)

 Mild

12 (0.9)

8 (0.6)

8 (1.2)

14 (0.8)

 Moderate

789 (57.6)

784 (57.0)

375 (54.4)

974 (56.7)

 Severe

546 (39.9)

563 (40.9)

293 (42.5)

701 (40.8)

 Very severe

22 (1.6)

21 (1.5)

13 (1.9)

28 (1.6)

Severity at baseline, n (%)

 Mild

0 (0.0)

1 (0.04)

0 (0.0)

1 (0.01)

 Moderate

1879 (68.7)

1846 (67.2)

920 (66.9)

4645 (67.7)

 Severe

858 (31.3)

901 (32.8)

456 (33.1)

2215 (32.3)