Ibuprofen for acute treatment of episodic tension-type headache in adults
- PMID: 26230487
- PMCID: PMC6457940
- DOI: 10.1002/14651858.CD011474.pub2
Ibuprofen for acute treatment of episodic tension-type headache in adults
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 We sought unpublished studies by asking personal contacts and searching on-line clinical trial registers and manufacturers' websites.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.
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
Update of
- doi: 10.1002/14651858.CD011474
References
References to studies included in this review
Diamond 2000 {published data only}
-
- Diamond S, Balm TK, Freitag FG. Ibuprofen plus caffeine in the treatment of tension‐type headache. Clinical Pharmacology and Therapeutics 2000;68(3):312‐9. [PUBMED: 11014413] - PubMed
Kubitzek 2003 {published data only}
-
- Kubitzek F, Ziegler G, Gold MS, Liu JM, Ionescu E. Low‐dose diclofenac potassium in the treatment of episodic tension‐type headache. European Journal of Pain 2003;7(2):155‐62. [PUBMED: 12600797] - PubMed
Lange 1995 {published data only}
-
- Lange R, Lentz R. Comparison ketoprofen, ibuprofen and naproxen sodium in the treatment of tension‐type headache. Drugs under Experimental and Clinical Research 1995;21(3):89‐96. [PUBMED: 7555617] - PubMed
Laveneziana 1996 {published data only}
-
- Laveneziana D, Speranza R, Raulli P, Paredi G. Comparative efficacy of ibuprofen arginine and betacyclodextrin piroxicam as treatment for tension‐type headache. Clinical Drug Investigation 1996;11 (Suppl 1):22‐6.
NCT01077973 {unpublished data only}
-
- Pfizer Inc. Evaluation of the efficacy of a novel ibuprofen formulation in the treatment of episodic tension‐type headache. www.clinicaltrials.gov/ct2/results?term=NCT01077973&Search=Search (Accessed 15 January 2015) 2012. [CTG: NCT01077973]
NCT01362491 {unpublished data only}
-
- Pfizer Inc. Ibuprofen sodium tension headache study. clinicaltrials.gov/ct2/show/record/NCT01362491?term=NCT01362491&rank=1 (Accessed 21 January 2015) 2014.
NL9701 {unpublished data only}
-
- 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}
-
- Reckitt Benckiser. A double‐blind, crossover, multicentre trial comparing S+ ibuprofen (S+Nurofen) with racemic ibuprofen (Nurofen) in the treatment of muscle contraction (tension) headache. Supplied by Reckitt Benckiser 2104.
Packman 2000 {published data only}
Schachtel 1988 {published data only}
-
- Schachtel BP, Thoden WR. Onset of action of ibuprofen in the treatment of muscle‐contraction headache. Headache 1988;28(7):471‐4. [PUBMED: 3072316] - PubMed
Schachtel 1996 {published data only}
van Gerven 1996 {published data only}
-
- Gerven JM, Schoemaker RC, Jacobs LD, Reints A, Ouwersloot‐van der Meij MJ, Hoedemaker HG, et al. Self‐medication of a single headache episode with ketoprofen, ibuprofen or placebo, home‐monitored with an electronic patient diary. British Journal of Clinical Pharmacology 1996;42(4):475‐81. [DOI: 10.1046/j.1365-2125.1996.43613.x] - DOI - PMC - PubMed
References to studies excluded from this review
NCT01755702 {unpublished data only}
-
- 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}
-
- 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}
-
- GlaxoSmithKline. Clinical study to evaluate efficacy of new paracetamol formulation compared to ibuprofen in headache. clinicaltrials.gov/ct2/results?term=NCT01842633&Search=Search (Accessed 21 January 2015) 2014. [CTG: NCT01842633 ]
Additional references
Ad Hoc Committee 1962
-
- Ad Hoc Committee on Classification of Headache. Classification of headache. JAMA 1962;179:717‐8.
BASH 2010
-
- MacGregor EA, Steiner TJ, Davies PTG, for the British Association for the Study of Headache. Guidelines for all healthcare professionals in the diagnosis and management of migraine, tension‐type, cluster, and medication overuse headache. 3rd edition (1st revision). Available at: http://www.bash.org.uk/wp‐content/uploads/2012/07/10102‐BASH‐Guidelines‐.... (accessed 21 July 2014) September 2010.
Bendtsen 2010
-
- Bendsten L, Evers S, Linde M, Mitsikostas DD, Sandrini G, Schoenen J. EFNS guideline on the treatment of tension‐type headache ‐ report of an EFNS taskforce. European Journal of Neurology 2010;17(11):1318‐25. [PUBMED: 20482606] - PubMed
Brainin 2004
-
- Brainin M, Barnes M, Baron JC, Gilhus NE, Hughes R, Selmaj K, et al. for the Guideline Standards Subcommittee of the EFNS Scientific Committee. Guidance for the preparation of neurological management guidelines by EFNS scientific task forces‐revised recommendations 2004. European Journal of Neurology 2004;11(9):577‐81. [PUBMED: 15379736] - PubMed
ClinicalTrials.gov
-
- National Library of Medicine. ClinicalTrials.gov. http://www.nlm.nih.gov. Accessed 4 December 2010.
Cook 1995
Cristofolini 2008
-
- Cristofolini A, Dalla Serra P, Scherillo G, Orrico D, Micciolo R. The prevalence of headache in a population of health care workers and the effects on productivity costs. La Medicina del Lavoro 2008;99(1):8‐15. - PubMed
Derry 2009
Edmeads 1993
-
- Edmeads J, Findlay H, Tugwell P, Pryse‐Phillips W, Nelson RF, Murray TJ. Impact of migraine and tension‐type headache on life‐style, consulting behaviour, and medication use: a Canadian population survey. Canadian Journal of Neurological Sciences 1993;20(2):131‐7. [PUBMED: 8334575] - PubMed
Fernández‐de‐Las‐Peñas 2010
-
- Fernández‐de‐las‐Peñas C, Madeleine P, Caminero AB, Cuadrado ML, Arendt‐Nielsen L, Pareja JA. Generalized neck‐shoulder hyperalgesia in chronic tension‐type headache and unilateral migraine assessed by pressure pain sensitivity topographical maps of the trapezius muscle. Cephalalgia 2010;30(1):77‐86. [DOI: 10.1111/j.1468-2982.2009.01901.x] - DOI - PubMed
FitzGerald 2001
-
- FitzGerald GA, Patrono C. The coxibs, selective inhibitors of cyclooxygenase‐2. New England Journal of Medicine 2001;345(6):433‐42. - PubMed
Forward 1998
-
- Forward SP, McGrath PJ, MacKinnon D, Brown TL, Swann J, Currie EL. Medication patterns of recurrent headache sufferers: a community study. Cephalalgia 1998;18(3):146‐51. [PUBMED: 9595208] - PubMed
Fumal 2008
Green 2009
-
- Green MW. Primary and secondary headaches. In: Rowland LP, Pedley TA editor(s). Merritt's Neurology. 12th Edition. Philadelphia: Lippincott Williams and Wilkins, 2009:951‐60.
Haag 2011
-
- Haag G, Diener HC, May A, Meyer C, Morck H, Straube A, et al. Self‐medication of migraine and tension‐type headache: summary of the evidence‐based recommendations of the Deutsche Migräne und Kopfschmerzgesellschaft (DMKG), the Deutsche Gesellschaft für Neurologie (DGN), the Österreichische Kopfschmerzgesellschaft (ÖKSG) and the Schweizerische Kopfwehgesellschaft (SKG). Journal of Headache and Pain 2011;12(2):201‐17. [DOI: 10.1007/s10194-010-0266-4] - DOI - PMC - PubMed
Harpole 2005
Hawkey 1999
-
- Hawkey CJ. Cox‐2 inhibitors. Lancet 1999;353(9149):307‐14. - PubMed
Hawkey 2011
-
- Hawkey C, Burnett I, Gold MS, Garsed K, Stevenson D, Mannath J, et al. Endoscopic evaluation of the gastro‐duodenal tolerance of short‐term analgesic treatment with 25 mg diclofenac‐K liquid capsules. Alimentary Pharmacology and Theraputics 2012;35(7):819‐27. [DOI: 10.1111/j.1365-2036.2012.05030.x] - DOI - PubMed
Higgins 2011
-
- Higgins JPT, Altman DG, Sterne JAC (editors). Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.
ICTRP 2010
-
- World Health Organization. International Clinical Trials Registy Platform Search Portal. http://apps.who.int/trialsearch/ (accessed 1 September 2010).
IHS 2010
-
- Bendtsen L, Bigal ME, Cerbo R, Diener HC, Holroyd K, Lampl C, et al. on behalf of the International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in tension‐type headache: second edition. Cephalalgia 2010;30(1):1‐16. [DOI: 10.1111/j.1468-2982.2009.01948.x] - DOI - PubMed
IHS 2013
Jadad 1996a
-
- Jadad AR, Carroll D, Moore A, McQuay H. Developing a database of published reports of randomised clinical trials in pain research. Pain 1996;66(2‐3):239‐46. - PubMed
Jadad 1996b
-
- Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJM, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Controlled Clinical Trials 1996;17(1):1‐12. - PubMed
Kernick 2008
L'Abbé 1987
-
- L'Abbé KA, Detsky AS, O'Rourke K. Meta‐analysis in clinical research. Annals of Internal Medicine 1987;107(2):224‐33. - PubMed
Lavados 1998
-
- Lavados PM, Tenhamm E. Epidemiology of tension‐type headache in Santiago, Chile: a prevalence study. Cephalalgia 1998;18(8):552‐8. [Art. No.: 82.1998.DOI: 10.1046/j.1468‐2982.1998.1808552.x; PUBMED: 9827247] - PubMed
Lyngberg 2005
Mannix 2001
Monteith 2010
Moore 1998
Moore 2008
-
- Moore RA, Barden J, Derry S, McQuay HJ. Managing potential publication bias. In: McQuay HJ, Kalso E, Moore RA editor(s). Systematic Reviews in Pain Research: Methodology Refined. Seattle: IASP Press, 2008:15‐24. [ISBN: 978‐0‐931092‐69‐5]
Moore 2011
Moore 2013a
Moore 2013b
Moore 2014a
Moore 2014b
Moore 2015
Morris 1995
Oshinaike 2014
Pop 2002
-
- Pop PH, Gierveld CM, Karis HA, Tiedink HG. Epidemiological aspects of headache in a workplace setting and the impact on the economic loss. European Journal of Neurology 2002;9(2):171‐4. - PubMed
Rabbie 2013
Rasmussen 2001
-
- Rasmussen BK. Epidemiology of headache. Cephalalgia 2001;21(7):774‐7. [PUBMED: 11595011] - PubMed
RevMan 2014 [Computer program]
-
- The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
Russell 2005
Sahler 2012
Schmidt‐Wilcke 2005
-
- Schmidt‐Wilcke T, Leinisch E, Straube A, Kämpfe N, Draganski B, Diener HC, et al. Gray matter decrease in patients with chronic tension type headache. Neurology 2005;65(9):1483‐6. - PubMed
Schwartz 1998
-
- Schwartz BS, Stewart WF, Simon D, Lipton RB. Epidemiology of tension‐type headache. JAMA 1998;279(5):381‐3. [PUBMED: 9459472] - PubMed
Steiner 2004
Stovner 2007
-
- Stovner LJ, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher AI, et al. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia 2007;27(3):193‐210. [PUBMED: 17381554] - PubMed
Tramèr 1997
Verhagen 2006
-
- Verhagen AP, Damen L, Berger MY, Passchier J, Merlin V, Koes BW. Is any one analgesic superior for episodic tension‐type headache?. Journal of Family Practice 2006;55(12):1064‐72. [PUBMED: 17137543] - PubMed
Vos 2012
-
- Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990‐2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012;380(9859):2163‐96. [DOI: 10.1016/S0140-6736(12)61729-2] - DOI - PMC - PubMed
WHO 2007
-
- World Health Organization. WHO model list of essential medicines. 15th edition. March 2007. www.who.int/medicines/publications/essentialmedicines/en/index.html (accessed 1 September 2010).
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