Hyoscine butylbromide Plus tablets produced rapid and clinically meaningful reductions in menstrual pain, with perceptible relief reported within a median of 30 minutes and 91% of patients achieving a clinically meaningful response within 4 hours, according to a prospective real-world cohort study conducted in Germany.
Pain intensity, measured using the numeric rating scale (NRS), declined significantly at all postdose assessments, with mean reductions of 2 points at 30 minutes and 4 points at 4 hours, corresponding to a 66% decrease from baseline.
The noninterventional study assessed the effectiveness, utilization patterns, and safety of a fixed-dose combination of Hyoscine butylbromide (HBB) 10 mg and paracetamol 500 mg for self-treatment of dysmenorrhea. Adult women with menstrual pain were recruited via Carenity, a German online patient platform, between September 15, 2020, and June 15, 2022. Participants completed a baseline questionnaire followed by repeated assessments at 15 minutes, 30 minutes, 45 minutes, 1 hour, and 4 hours following the first intake. Patients were permitted to take 1 to 2 tablets up to three times daily, not exceeding 3 g of paracetamol per day.
Among 1,733 women who initiated contact, 972 met inclusion criteria. The primary analysis cohort included 98 patients who completed all required assessments, while 325 patients who took at least one dose comprised the safety cohort. The mean age in the primary cohort was 34 years, and most patients reported moderate to severe pain at baseline, with 57% reporting severe pain and 37% reporting moderate pain. A clinically meaningful response was defined as a reduction of at least 30% from baseline in NRS score.
Pain reductions were statistically significant at all measured time points, beginning as early as 15 minutes following dosing. Patients with severe baseline pain experienced the greatest percentage reductions over time. Median time to meaningful pain relief was 38 minutes. The proportion of patients reporting at least one dysmenorrhea symptom decreased from 96% at baseline to 70% at 4 hours.
"Overall, this real-world study demonstrated that treatment with HBB Plus is effective and well-tolerated, as there was a decrease in the proportion of symptoms with treatment over time," wrote lead study author Robert Lange, of Opella in Frankfurt, Germany, and colleagues.
More than 90% of patients reported they were satisfied or very satisfied with treatment effectiveness.
The study had limitations. It was observational and did not include a comparator group. The primary analysis cohort included only 98 patients, and the study population was limited to Germany. Outcomes were based on self-reported data collected through a digital platform, which may have introduced selection bias toward participants with greater technology affinity.
Utilization data indicated most patients used 1 to 2 tablets per day over a median of 3 days during menstruation. In the safety cohort, five nonserious treatment-emergent adverse events were reported, including severe pain, palpitations, and iron deficiency. None required hospitalization or emergency care.
The study was funded by Opella. Lange and one coauthor are Opella employees and may hold shares in the company. One researcher reported no conflicts of interest.
Source: Women's Health
