ArticlePain and therapy2025
Impact of Headache and Over-the-Counter Treatment on Pain and Functional and Cognitive Parameters: A Real-World Study across Three Geographies.
Article in Pain and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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3 citing papers in PubMed.
- Impact of Migraine and its Management in 5 Gulf Countries: Results of Social Media Platforms Listening Study.JMIR formative research · 2026Article
- Chronic headache disorders as a threat to brain health among employees of a city office in the Tokyo metropolitan area.The journal of headache and pain · 2025Article
- A real-world study to describe the effectiveness and usage patterns of hyoscine butylbromide plus tablets in patients with dysmenorrhoea.Women's health (London, England)Article
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10 authors.
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Abstract
introductionIndividuals with headache choose over-the-counter (OTC) medications to relieve pain and associated symptoms. This real-world evidence study investigated the effect of three OTC headache treatments on headache intensity and the associated impairment of cognitive and functional parameters in headache sufferers in Germany, Brazil, and Japan.
methodsThis prospective, multinational, observational eDiary-based study included adults experiencing headache for ≥ 6 months, with ≥ 2 headache episodes per month requiring treatment and using one of the three OTC headache treatments (Germany: ibuprofen 400 mg + caffeine 100 mg; Brazil: dipyrone 1 g; Japan: ibuprofen 100 mg + caffeine 40 mg). The primary endpoint was change in headache intensity (11-point numeric rating scale [NRS]) from baseline (headache onset) to 2 h post-treatment. Secondary endpoints were association between NRS scores for headache intensity and for cognitive and functional parameters and change in these parameters from baseline to 2 h post-treatment.
resultsOf the 32,623 individuals screened, 1239 were enrolled in the study, with 607 having their first headache episode treated using one of the OTC treatments. Baseline demographics and characteristics were similar across the cohorts. At 2 h post-treatment, headache intensity significantly improved, with the mean change from baseline being 3.4 (3.1, 3.7, 95% confidence interval), 4.2 (3.9, 4.5), and 3.0 (2.7, 3.3) for German, Brazilian, and Japanese cohorts, respectively. Improvement was observed in all cognitive and functional parameters. The NRS score for headache intensity significantly predicted NRS scores of all cognitive and functional parameters (P < 0.0001).
conclusionsThe study shows that headache intensity significantly affects cognitive and functional aspects, as well as overall quality of life, for sufferers globally. It confirms the effectiveness of OTC medications and suggests using headache intensity as a self-assessment tool for symptom severity, highlighting the need for new parameters in the OTC domain to improve public health benefits.
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