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Oral sumatriptan for acute migraine

Clinical bottom line:

Oral sumatriptan 100 mg has been tested in thirteen randomised trials with about 3500 patients. The NNT for two hour headache response was 3.3 (3.0 to 3.7). The NNT for two hour pain free was 4.7 (4.1 to 5.5) in 2,205 patients in eight trials. The NNT for two hour headache response sustained for 24 hours with no additional analgesic was 6.7 (5.0 to 9.9) in 1,632 patients in four trials.

Oral sumatriptan 50 mg has been tested in six randomised trials with about 5500 patients. The NNT for two hour headache response was 4.1 (3.4 to 5.2). The NNT was 4.1 (3.4 to 5.2). The NNT for two hour pain free was 7.8 (6.1 to 11) in 1,083 patients in four trials. The NNT for two hour headache response sustained for 24 hours with no additional analgesic was 6.0 (4.0 to 12) in 539 patients in two trials.


Reference

AD Oldman, LA Smith, HJ McQuay, RA Moore. A systematic review of treatments for acute migraine. Pain 2002 97: 247-257.

Inclusion criteria were: treatment of acute migraine; randomised allocation to treatment groups; double-blind design; adult population and headache outcomes.

Search

Comprehensive searches of the following databases were made: MEDLINE (1966 - July 2001), EMBASE (1980 - June 2001), Cochrane Library (Issue 3, 2001), PubMed (to September 2001) and the Oxford Pain Relief Database (1950 - 1994). A series of free text searches were undertaken, using generic and trade names. There was no restriction to language. Retrieved reports were searched for additional trials. Neither individual authors nor pharmaceutical companies were contacted for unpublished data.

Findings

Tables with all included trials and excluded trials are available.

Oral sumatriptan 100 mg

Results for oral sumatriptan 100 mg were consistent between trials, and those for two hour headache response are shown in Figure 1.

Figure 1: Headache response at two hours

Table 1: Results for oral sumatriptan 100mg

Number/total with outcome (%)

Outcome

Number of trials

Treatment

Placebo

NNT
(95%CI)

Two hour headache response

13

1346/231
(58)

336/1211
(28)

3.3 (3.0 to 3.7)

Two hour pain free

8

415/1461
(28)

53/744
(7)

4.7 (4.1 to 5.5)

Headache response at 2 hours sustained to 24 hours

4

472/1190
(40)

109/442
(25)

6.7 (5.0 to 9.9)

For oral sumatriptan 100 mg in 13 trials, 1346/2311 patients (58%) had a headache response at two hours compared with 336/1211 (28%) with placebo. The NNT was 3.3 (3.0 to 3.7). The NNT for two hour pain free was 4.7 (4.1 to 5.5) in 2,205 patients in eight trials. The NNT for two hour headache response sustained for 24 hours with no additional analgesic was 6.7 (5.0 to 9.9) in 1,632 patients in four trials.

Oral sumatriptan 50 mg

Figure 1: Headache response at two hours

Table 1: Results for oral sumatriptan 50mg

Number/total with outcome (%)

Outcome

Number of trials

Treatment

Placebo

NNT
(95%CI)

Two hour headache response

6

532/1042
(51)

137/510
(27)

4.1 (3.4 to 5.2)

Two hour pain free

4

131/711
(18)

21/372
(6)

7.8 (6.1 to 11)

Headache response at 2 hours sustained to 24 hours

2

157/362
(43)

47/177
(27)

6.0 (4.0 to 12)

For oral sumatriptan 50 mg in six trials, 532/1042 patients (51%) had a headache response at two hours compared with 137/510 (27%) with placebo. The NNT was 4.1 (3.4 to 5.2). The NNT for two hour pain free was 7.8 (6.1 to 11) in 1,083 patients in four trials. The NNT for two hour headache response sustained for 24 hours with no additional analgesic was 6.0 (4.0 to 12) in 539 patients in two trials.

Adverse effects

Adverse effects are not reported in any way that makes obvious sense because efficacy was measured over 24 hours and adverse events for up to 10 days.

Comment

Sumatriptan is clearly effective in the treatment of acute migraine, in several doses and by three routes of administration. There is considerable evidence from large, well-conducted randomised trials, with large numbers of patients.