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Headache treatment with the fixed dose combination ibuprofen plus caffeine (400/100 mg)

Results from a pharmacy-based patient survey

EFSM: 2024;4:240019DOI: 10.52778/efsm.24.0019Publikováno dne: 23.03.2024
Thomas Weiser

Headache affects many people and can – in most cases – be successfully treated with over-the-counter analgesics. What are the patients’ characteristics? How do they experience the effects of the treatment with ibuprofen plus caffeine (400/100 mg; IbuCaff)? How does the treatment response to IbuCaff compare with other treatments? A pharmacy-based patient survey run in German community pharmacies sheds light on these questions.

Two recent publications report on a pharmacy-based study on patients treating headache with over-the-counter medicines [1, 2]. Data from patients who were buying an IbuCaff product and gave their consent to fill out a questionnaire at their own discretion after intake of the product to treat an acute pain episode were collected [1]. The questionnaires were to be sent to the institute which collected and analyzed the data (Winecker Norimed GmbH, Nuremberg, Germany). The survey was completely anonymous.

In total, 1124 analyzable questionnaires were collected. IbuCaff was taken by 895 participants (304 without, and 538 with concomitant shoulder/neck pain) to treat headache, 229 provided no data or used the product for other types of pain (these data were not analyzed further). Mean age of headache sufferers was ≈42 years, the majority were female (≈70%). Mean pain intensity was higher in those suffering from concomitant shoulder/neck pain (6.3 points on a 10-point pain scale), compared to those without (5.8 points). 

In both groups, pain reduction at 2 h after intake was similar (to about 1.5 points) (Fig. 1A). Pain reduction by 50% at 2 h was reached in 90% of patients, and 57% (64%) became pain-free within 2 h. Onset of pain relief within 15 min was reported by 38%, and within 30 min by 79% (Fig. 1B). The rating “very fast” or “fast” onset of action was given by 70% of participants. Efficacy and tolerability were rated as “very good” or “good” by 93% and 97%, respectively (Fig 1C and 1D). Early onset of pain relief was positively correlated with percent pain reduction at 2 h, assessment of efficacy, and interestingly also with assessment of tolerability. 

In addition to the treatment effects participants perceived, they were asked which analgesic they have taken for the last similar pain period, and how IbuCaff compared to it (in terms of onset of analgesic effect, perceived efficacy and tolerability) Ibuprofen and ibuprofen lysinate were taken by about 34 and 24%, other fixed-dose combinations by about 13%, paracetamol by 12%, and aspirin by 8%; data from [2]; Fig. 2). Only low percentages rated IbuCaff as worse compared to the last other pain treatment. Efficacy was ranked better by 35% (in comparison to ibuprofen lysinate) to 65.5% (in comparison to paracetamol) (Fig. 2A). Between 37.5% (ibuprofen lysinate) and 66.1% (paracetamol) found IbuCaff to act faster (Fig. 2B), and tolerability was ranked higher by 12.8% (ibuprofen lysinate) to 44.9% (naproxen) (Fig. 2C).

According to data from clinical trials this relatively positive assessment of IbuCaff is not surprising. In a head-to-head comparison of IbuCaff with 400 mg ibuprofen, 100 mg caffeine and placebo in the dental extraction pain model IbuCaff showed faster onset of action, better pain reduction, and a higher response rate than ibuprofen alone (as well as the other treatments; [3]). The high response rate in this model (about 70% of patients experienced relevant pain relief) is usually only reached with prescription-only analgesics [4].


Taken together this real-world evidence study in patients treating their headache with the fixed-dose combination ibuprofen plus caffeine (400/100 mg) showed that patients reported fast onset of action and robust pain reduction at 2 h. High percentages assessed efficacy and tolerability as “very good” or “good”. Many patients found IbuCaff to act faster, more effective, and at least as tolerable compared to their last headache treatment. 


  1. Gaul C, Gräter H, Weiser T, Michel MC, Lampert A, Plomer M, Förderreuther S. Impact of the neck and/or shoulder pain on self-reported headache treatment responses – Results from a pharmacy-based patient survey. Front Neurol. 2022;13:902020. doi: 10.3389/fneur.2022.902020. PMID: 35923833; PMCID: PMC9339896.
  2. Gaul C, Förderreuther S, Lehmacher W, Weiser T. Correlation of effectiveness and tolerability assessments from a pharmacy-based observational study investigating the fixed-dose combination of 400 mg ibuprofen plus 100 mg caffeine for the treatment of acute headache. Front Neurol. 2023;14:1273846. doi: 10.3389/fneur.2023.1273846. PMID: 37941578; PMCID: PMC10628638.
  3. Weiser T, Richter E, Hegewisch A, Muse DD, Lange R. Efficacy and safety of a fixed-dose combination of ibuprofen and caffeine in the management of moderate to severe dental pain after third molar extraction. Eur J Pain. 2018;22(1):28–38. doi: 10.1002/ejp.1068. Epub 2017 Aug 14. PMID: 28805281; PMCID: PMC5763370.
  4. Moore RA, Derry S, McQuay HJ, Wiffen PJ. Single dose oral analgesics for acute postoperative pain in adults. Cochrane Database Syst Rev. 2011;(9):CD008659. doi: 10.1002/14651858.CD008659.pub2. Update in: Cochrane Database Syst Rev. 2015;9:CD008659. PMID: 21901726; PMCID: PMC4160790.

Acknowledgements: The author thanks Paula Fontanilla, PhD, for critically reviewing the manuscript for scientific content.

Conflict of interest: T. Weiser is a Sanofi employee.

Disclosure: Publication funded by Sanofi.

Pracoviště/Korespondenční adresa: Thomas Weiser, PhD, Sanofi, Industriepark Hoechst, 65026 Frankfurt am Main, Germany
Odesláno dne: 28.11.2023Přijato dne: 31.01.2024Publikováno dne: 23.03.2024
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