A real-world study to describe the effectiveness and usage patterns of hyoscine butylbromide plus tablets - study results and findings

Q: What is the purpose of the study described in the document?

The study evaluates the effectiveness, utilisation and safety of Buscopan Plus (hyoscine butylbromide plus paracetamol) for self-treating menstrual pain in real-world settings.

Q: How were outcomes such as pain relief measured?

Pain intensity was assessed using changes in numeric rating scale (NRS) scores, along with the percentage of NRS responders and time to pain relief, measured at set times after the first intake.

Q: What did the study find about safety and tolerability?

In the safety cohort, five non-serious treatment-emergent adverse events were reported, and the medicine was described as well tolerated.

Sep 28, 2026

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Dysmenorrhoea causes lower abdominal cramps during menstruation that reduce quality of life. This non-interventional, prospective cohort real-world study assessed effectiveness, utilisation and safety of Buscopan Plus tablets containing hyoscine butylbromide plus paracetamol for self-treating menstrual pain in German patients registered on an online platform. Participants were followed at multiple post-dose time points. Pain scores decreased significantly and most patients were responders, with few non-serious adverse events.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages16

Reading Time40 min

AccessFree to download

Abstract

Background, objectives, design and methods

Results

Conclusion

Plain Language Summary

Keywords

Introduction

A real-world study to describe the effectiveness and usage patterns of hyoscine butylbromide plus tablets inpatients with dysmenorrhoea Robert Lange 1, Caroline Amand2 and Lorraine Harrington3 Women’s Health Volume 22: 1–16 © The Author(s) 2026 Article reuse guidelines: [sagepub.com/journals-permissions](sagepub.com/journals-permissions)[ ](sagepub.com/journals-permissions)[DOI: 10.1177/17455057251406956](DOI: 10.1177/17455057251406956)[ ](DOI: 10.1177/17455057251406956)[journals.sagepub.com/home/whe](journals.sagepub.com/home/whe) Abstract Background: Dysmenorrhoea, a common gynaecological issue in women, is characterised by lower abdominal cramps during menstruation impacting quality of life (QoL). Objectives: This study evaluates the effectiveness, utilisation and safety of Buscopan® Plus (hyoscine butylbromide (HBB) Plus: 10 mg HBB + 500 mg paracetamol) for self-treating menstrual pain. Design: This non-interventional, prospective cohort real-world study included women with menstrual pain registered with Carenity, an online patient platform by Else Care SAS. Methods: Eligible German patients with the mean (standard deviation) age of 34.0 (8.0) years were enrolled between 15 September 2020 and 15 June 2022 and grouped into primary analysis or safety cohorts. A maximum of one to two tablets (thrice daily) were allowed, limited to 3 g paracetamol per day. Primary outcomes were pain intensity difference by mean change and percentage variation in numeric rating scale (NRS) score, percentage of NRS responders and time to pain relief; safety was a secondary outcome. All parameters were measured at 15 min, 30 min, 1 h, or 4 h following the first HBB Plus intake. Results: Of 1733 eligible women, 94% provided written consent and completed the baseline questionnaire, 56% met all inclusion criteria, 10% completed all intake assessments (primary analysis cohort) and 33% had ⩾ 1 dose of HBB Plus (safety cohort). Percent decrease in NRS score from baseline was 11.1%, 29.5%, 42.4%, 53.4% and 65.8% at 15 min, 30 min, 45 min, 1 h and 4 h (p < 0.001 at all-time points), respectively. Overall, 90.8% patients were categorised as responders up to 4 h post HBB Plus intake. Median time to first perceptible pain relief and meaningful pain relief was 30.0 and 37.5 min, respectively. In the safety analysis cohort, five non-serious treatment-emergent adverse events were reported. Conclusion: HBB Plus effectively reduced menstrual pain within 4 h of treatment and was well-tolerated, providing a viable option for self-management of pain and improving QoL. Plain Language Summary The study looked at how well HBB Plus works as an option for women to manage their menstrual pain and improve their quality of life Period pain, also called menstrual cramps, affects many women and often goes unnoticed or untreated. Our study examined how effective and safe Buscopan® Plus (which contains hyoscine butylbromide [HBB] and paracetamol) isin everyday use. The study included women in Germany, with an average age of 34, who experienced menstrual pain. 1 Opella, Frankfurt am Main, Germany 2Opella, Neuilly sur Seine, France 3Department of Anaesthesia and Pain Medicine, St John’s Hospital, Livingston, NHS Lothian, UK Corresponding author: Robert Lange, Opella, Frankfurt am Main, Germany. Email: [robert1.lange@sanofi.com](robert1.lange@sanofi.com) Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ([https://creativecommons.org/licenses/by-nc/4.0/](https://creativecommons.org/licenses/by-nc/4.0/)) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ([https://us.sagepub.com/en-us/nam/open-access-at-sage](https://us.sagepub.com/en-us/nam/open-access-at-sage)). They first filled out a questionnaire a

FAQs

What is the purpose of the study described in the document?

The study evaluates the effectiveness, utilisation and safety of Buscopan Plus (hyoscine butylbromide plus paracetamol) for self-treating menstrual pain in real-world settings.

How were outcomes such as pain relief measured?

Pain intensity was assessed using changes in numeric rating scale (NRS) scores, along with the percentage of NRS responders and time to pain relief, measured at set times after the first intake.

What did the study find about safety and tolerability?

In the safety cohort, five non-serious treatment-emergent adverse events were reported, and the medicine was described as well tolerated.

Sep 28, 2026

Uploaded by Blitz