Abstract

Background

Migraine is a highly disabling condition for the individual and also has wide‐reaching implications for society, healthcare services, and the economy. Sumatriptan is an abortive medication for migraine attacks, belonging to the triptan family.

Objectives

To determine the efficacy and tolerability of oral sumatriptan compared to placebo and other active interventions in the treatment of acute migraine attacks in adults.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, online databases, and reference lists for studies through 13 October 2011.

Selection criteria

We included randomised, double‐blind, placebo‐ and/or active‐controlled studies using oral sumatriptan to treat a migraine headache episode, with at least 10 participants per treatment arm.

Data collection and analysis

Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate relative risk (or 'risk ratio') and numbers needed to treat to benefit (NNT) or harm (NNH) compared to placebo or a different active treatment.

Main results

Sixty‐one studies (37,250 participants) compared oral sumatriptan with placebo or an active comparator. Most of the data were for the 50 mg and 100 mg doses. Sumatriptan surpassed placebo for all efficacy outcomes. For sumatriptan 50 mg versus placebo the NNTs were 6.1, 7.5, and 4.0 for pain‐free at two hours and headache relief at one and two hours, respectively. NNTs for sustained pain‐free and sustained headache relief during the 24 hours postdose were 9.5 and 6.0, respectively. For sumatriptan 100 mg versus placebo the NNTs were 4.7, 6.8, 3.5, 6.5, and 5.2, respectively, for the same outcomes. Results for the 25 mg dose were similar to the 50 mg dose, while sumatriptan 100 mg was significantly better than 50 mg for pain‐free and headache relief at two hours, and for sustained pain‐free during 24 hours. Treating early, during the mild pain phase, gave significantly better NNTs for pain‐free at two hours and sustained pain‐free during 24 hours than did treating established attacks with moderate or severe pain intensity.

Relief of associated symptoms, including nausea, photophobia, and phonophobia, was greater with sumatriptan than with placebo, and use of rescue medication was lower with sumatriptan than with placebo. For the most part, adverse events were transient and mild and were more common with the sumatriptan than with placebo, with a clear dose response relationship (25 mg to 100 mg).

Sumatriptan was compared directly with a number of active treatments, including other triptans, paracetamol (acetaminophen), acetylsalicylic acid, non‐steroidal anti‐inflammatory drugs (NSAIDs), and ergotamine combinations.

Authors' conclusions

Oral sumatriptan is effective as an abortive treatment for migraine attacks, relieving pain, nausea, photophobia, phonophobia, and functional disability, but is associated with increased adverse events.

Author(s)

Christopher J Derry, Sheena Derry, R Andrew Moore

Abstract

Plain language summary

Sumatriptan (oral route of administration) for acute migraine attacks in adults

Sumatriptan is one of the triptan family of drugs used to treat migraine attacks. It is widely available as an oral tablet. This review found that a single dose was effective in relieving migraine headache pain and associated symptoms of nausea, sensitivity to light, and sensitivity to sound. Pain was reduced from moderate or severe to no pain by two hours in about 3 in 10 people (32%) taking sumatriptan 100 mg, compared with about 1 in 10 (11%) taking placebo. Pain was reduced from moderate or severe to no worse than mild pain by two hours in 6 in 10 people (61%) taking sumatriptan 100 mg, compared with about 3 in 10 (32%) taking placebo. Almost a quarter (24%) of people taking sumatriptan 100 mg had freedom from pain at two hours which was sustained during 24 hours without the use of rescue medication, compared with fewer than 1 in 10 (8%) taking placebo. In addition to relieving headache pain, sumatriptan also relieved symptoms of nausea and sensitivity to light and sound by two hours in about half of those who took it, compared with about one‐third of those taking placebo. Adverse events were mostly of short duration and mild or moderate in severity, and were experienced by about 4 in 10 (43%) of people taking sumatriptan 100 mg, and by 2 in 10 (23%) taking placebo. The 50 mg dose had slightly lower efficacy, but was associated with fewer adverse events. Treating attacks while pain was still mild was more effective than treating established attacks with moderate or severe pain intensity.

Author(s)

Christopher J Derry, Sheena Derry, R Andrew Moore

Reviewer's Conclusions

Authors' conclusions 

Implications for practice 

Oral sumatriptan is an effective treatment for the relief of headache pain, other symptoms associated with migraine, and functional disability, with single doses of 25 mg or more providing clinically useful levels of relief in some people. Higher doses are effective in more individuals, but at the expense of greater numbers of adverse events. Most events were described as mild and of short duration. The number of participants experiencing headache relief by one hour after administration is low, and the number pain‐free by one hour is not clinically useful. Treating attacks early, during the mild pain phase, results in significantly greater efficacy, but does not significantly change the incidence of adverse events.

These data support the general guideline advice to use 50 mg as the starting dose, with increases to 100 mg if necessary and tolerated. Some experienced patients may find that a 25 mg dose is sufficient.

Implications for research 

A useful line of research would be to investigate whether sumatriptan is a useful second‐line treatment for individuals who fail to get an adequate response with simple analgesics, such as ibuprofen or aspirin.

There is an abundance of data on the efficacy of sumatriptan in terms of pain relief, but in general, reporting of long‐term (sustained to 24 hours or 48 hours) and secondary outcomes such as relief of headache‐associated symptoms, functional disability, and adverse events is less good. Future studies should address sustained outcomes and consistently report relief of associated symptoms, functional disability and adverse events using standard definitions.

More studies are needed to establish whether treating pain early, while still mild, gives better short‐term (two‐hour) and long‐term (sustained to 24 hours or 48 hours) outcomes, and better patient satisfaction.

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