A real-world study to describe the effectiveness and usage patterns of hyoscine butylbromide plus tablets in patients with dysmenorrhoea

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.