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Meta-Analysis
. 2015 Jul 31;2015(7):CD011474.
doi: 10.1002/14651858.CD011474.pub2.

Ibuprofen for acute treatment of episodic tension-type headache in adults

Affiliations
Meta-Analysis

Ibuprofen for acute treatment of episodic tension-type headache in adults

Sheena Derry et al. Cochrane Database Syst Rev. .

Abstract

Background: Tension-type headache (TTH) affects about one person in five worldwide. It is divided into infrequent episodic TTH (fewer than one headache per month), frequent episodic TTH (1 to 14 headaches per month), and chronic TTH (15 headaches a month or more). Ibuprofen is one of a number of analgesics suggested for acute treatment of headaches in frequent episodic TTH.

Objectives: To assess the efficacy and safety of oral ibuprofen for treatment of acute episodic TTH in adults.

Search methods: We searched CENTRAL (The Cochrane Library), MEDLINE, EMBASE, and our own in-house database to January 2015. We sought unpublished studies by asking personal contacts and searching on-line clinical trial registers and manufacturers' websites.

Selection criteria: We included randomised, placebo-controlled studies (parallel-group or cross-over) using oral ibuprofen for symptomatic relief of an acute episode of TTH. Studies had to be prospective and include at least 10 participants per treatment arm.

Data collection and analysis: Two review authors independently assessed studies for inclusion, and extracted data. Numbers of participants achieving each outcome were used to calculate risk ratio (RR) and number needed to treat for an additional beneficial outcome (NNT) or number needed to treat for an additional harmful outcome (NNH) of oral ibuprofen compared to placebo for a range of outcomes, predominantly those recommended by the International Headache Society (IHS).

Main results: We included 12 studies, all of which enrolled adult participants with frequent episodic TTH. Nine used the IHS diagnostic criteria, but two used the older classification of the Ad Hoc Committee, and one did not describe diagnostic criteria but excluded participants with migraines. While 3094 people with TTH participated in these studies, the numbers available for any form of analysis were lower than this; placebo was taken by 733, standard ibuprofen 200 mg by 127, standard ibuprofen 400 mg by 892, and fast-acting ibuprofen 400 mg by 230. Participants had moderate or severe pain at the start of treatment. Other participants were either in studies not reporting outcomes we could analyse, or were given one of several active comparators in single studies.For the IHS-preferred outcome of being pain free at 2 hours the NNT for ibuprofen 400 mg (all formulations) compared with placebo was 14 (95% confidence interval (CI), 8.4 to 47) in four studies, with no significant difference from placebo at 1 hour (moderate quality evidence). The NNT was 5.9 (4.2 to 9.5) for the global evaluation of 'very good' or 'excellent' in three studies (moderate quality evidence). No study reported the number of participants experiencing no worse than mild pain at 1 or 2 hours. The use of rescue medication was lower with ibuprofen 400 mg than with placebo, with the number needed to treat to prevent one event (NNTp) of 8.9 (5.6 to 21) in two studies (low quality evidence).Adverse events were not different between ibuprofen 400 mg and placebo; RR 1.1 (0.64 to 1.7) (high-quality evidence). No serious adverse events were reported.

Authors' conclusions: Ibuprofen 400 mg provides an important benefit in terms of being pain free at 2 hours for a small number of people with frequent episodic tension-type headache who have an acute headache with moderate or severe initial pain. There is no information about the lesser benefit of no worse than mild pain at 2 hours.

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Conflict of interest statement

SD has no conflicts relating to this review or any similar product.

RAM has no conflicts relating to this review or any similar product.

PW has no conflicts relating to this review or any similar product.

LB has no conflicts relating to this review or any similar product.

For transparency, we acknowledge that we have received research support from charities, government, and industry sources at various times, but none relate to this review. We are funded by the NIHR for work on a series of reviews informing the unmet need of chronic pain relief and providing the evidence for treatments of pain but this review is not supported by that funding.

Figures

1
1
Study flow diagram. CSR = clinical study report
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Forest plot of comparison: 1 ibuprofen 400 mg versus placebo, outcome: 1.1 Pain‐free at 2 hours.
1.1
1.1. Analysis
Comparison 1 ibuprofen 400 mg versus placebo, Outcome 1 Pain‐free at 2 hours.
1.2
1.2. Analysis
Comparison 1 ibuprofen 400 mg versus placebo, Outcome 2 Pain‐free at 1 hour.
1.3
1.3. Analysis
Comparison 1 ibuprofen 400 mg versus placebo, Outcome 3 Patient Global Evaluation.
1.4
1.4. Analysis
Comparison 1 ibuprofen 400 mg versus placebo, Outcome 4 Any adverse event.
1.5
1.5. Analysis
Comparison 1 ibuprofen 400 mg versus placebo, Outcome 5 Participants using rescue medication over 6 hours.

Update of

  • doi: 10.1002/14651858.CD011474

References

References to studies included in this review

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NCT01362491 {unpublished data only}
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NL9701 {unpublished data only}
    1. Reckitt Benckiser. A randomised, double‐blind, placebo‐controlled, double‐dummy, parallel group comparison of commercial ibuprofen (single dose of 400 mg) versus commercial paracetamol (single dose of 1000 mg) in patients with tension type headache. Supplied to authors by Reckitt Benckiser 2014.
NU2104 {unpublished data only}
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Packman 2000 {published data only}
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NCT01755702 {unpublished data only}
    1. GlaxoSmithKline. Paracetamol with caffeine to treat episodic tension type headache. clinicaltrials.gov/ct2/show/NCT01755702?term=NCT01755702&rank=1 (Accessed 21 January 2015) 2013. [CTG: NCT01755702]

References to studies awaiting assessment

NCT01464983 {unpublished data only}
    1. Bayer. Placebo and active controlled, double dummy study to compare efficacy of aspirin and ibuprofen in treatment of episodic tension‐type headache. clinicaltrials.gov/ct2/show/NCT01464983?term=NCT01464983&rank=1 (Accessed 21 January 2015) 2014. [CTG: NCT01464983]

References to ongoing studies

NCT01842633 {unpublished data only}
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