Hyoscine butylbromide 100mg/5ml oral solution

Hyoscine butylbromide (HBB) is commonly used off-label in labour wards. However, a Cochrane review raised concerns about the quality of evidence on HBB in childbirth, leading to the WHO's disapproval of HBB for intrapartum care. Since then, newer non-Cochrane systematic reviews on HBB to shorten labour duration have emerged. We assessed the methodological quality of these reviews to determine their trustworthiness. We critically appraised the quality of conduct for one Cochrane and seven non-Cochrane reviews with randomised controlled trials on HBB to shorten labour duration using the AMSTAR 2 tool. We also documented the features forming the inclusion and exclusion criteria to determine the overlap of the reviews regarding their inclusion criteria and identify any underreported features. The AMSTAR overall confidence was critically low for all non-Cochrane reviews, with more than half of the critical domains rated flawed, and moderate for the Cochrane review, since it was exemplary overall, apart from the synthesis methods. We extracted 57 characteristics referring to different features. Most reviews described the outcomes (56.1%, n=32), followed by the participant characteristics (35.1%, n=20). Intervention and comparator received the least attention. Most outcomes pertained to maternal adverse events (n=13), followed by other labour-related characteristics and neonatal adverse events in a tie (n=7), and labour duration (n=5). The coverage of the reviews regarding the reported features ranged from 10.5% to 70.2%, pointing to insufficient reporting of their inclusion criteria. We documented 30 different databases, with 19 (63.3%) also considering grey literature. The Cochrane review used 11 databases, while the non-Cochrane reviews considered 4 to 13. There was a very high overlap, especially among almost all non-Cochrane reviews, exceeding 20%. However, only a handful of the trials detected in the Cochrane review were included in the subsequent non-Cochrane reviews. Our meta-research study revealed that newer non-Cochrane reviews on HBB to shorten labour duration, published since 2019, have suboptimal methodological quality, raising concerns about the trustworthiness of their findings. The methodological quality of their included trials requires scrutiny to determine whether a future well-conducted review on HBB to shorten labour duration would add value. There is an ongoing debate about the use of medical interventions for women with low-risk pregnancies. The World Health Organisation (WHO) promotes a woman-centred approach to care. This means focusing on respectful care for mothers and newborns and prioritising natural, non-medical approaches to childbirth unless a medical intervention is truly necessary. To speed up labour or help the cervix open (dilatation), many midwives and doctors use a drug called hyoscine butylbromide (HBB), which is among the frequently studied antispasmodics in medical research. Although HBB is not officially licensed for use in labour, it is a standard option in many countries, including Germany. However, since 2013, the WHO and the Cochrane review have advised against antispasmodics for labour until there is rigorous evidence to indicate that they actually help clinical practice. Since those warnings were issued, several clinical trials and systematic reviews have been published. We performed a meta-research study on published systematic reviews with clinical trials administering HBB to shorten labour. Our goal was two-fold: (i) to critically appraise the methodological quality of these new systematic reviews using a validated and well-established rating tool for systematic reviews (AMSTAR 2), and (ii) to explore if these systematic reviews were simply repeating the same data or adding new evidence. We identified seven non-Cochrane reviews published between 2019 and 2024 and compared them with the unique relevant Cochrane review published in 2013. We found that all non-Cochrane reviews had a very low methodological quality. Furthermore, almost all non-Cochrane reviews shared many of the included clinical trials; hence, they were essentially repeating the same evidence for the same research question without adding any new value. Only the Cochrane review provided evidence we could trust. The recent evidence from non-Cochrane reviews on HBB published up to 2024 should be interpreted with great caution. Midwives, doctors, and parents should be aware that the evidence for using HBB to shorten labour duration remains weak.

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BackgroundColonic motility in constipation can be assessed non-invasively using MRI.ObjectiveTo compare MRI with high-resolution colonic manometry (HRCM) for predicting treatment response.DesignPart 1: 44 healthy volunteers (HVs), 43 patients with irritable bowel syndrome with constipation (IBS-C) and 37 with functional constipation (FC) completed stool diaries and questionnaires and underwent oral macrogol (500-1000 mL) challenge. Whole gut transit time (WGTT), segmental colonic volumes (CV), MRI-derived Motility Index and chyme movement by 'tagging' were assessed using MRI and time to defecation after macrogol recorded. Left colonic HRCM was recorded before and after a 700 kcal meal. Patients then proceeded to Part 2: a randomised cross-over study of 10-days bisacodyl 10 mg daily versus hyoscine 20 mg three times per day, assessing daily pain and constipation.ResultsPart 1: Total CVs median (range) were significantly greater in IBS-C (776 (595-1033)) and FC (802 (633-951)) vs HV (645 (467-780)), pConclusionAn abnormally large colon is an important feature in constipation which predicts impaired manometric response to feeding and treatment responses. HRCM shows that IBS-C patients have reduced PPW activity.Trial registration numberThe study was preregistered on ClinicalTrials.gov, Reference: NCT03226145.

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IntroductionDysmenorrhea symptoms are frequent and often self-treated using non-prescription medicines.MethodsTo further characterize women with dysmenorrhea using a combination of hyoscine butylbromide plus paracetamol (PLUS) for self-management of their complaints, we performed a secondary analysis of a published pharmacy-based patient survey.ResultsA total of 314 women (mean age: 32.3 years) with dysmenorrhea reported a pain and cramps intensity of 7.45 ± 2.13 (means ± SD) on a 0-10 Likert scale, which was reduced to 2.86 ± 1.81 upon treatment. Associated impairments of work/daily chores, leisure activities, and sleep were improved by 64.6, 62.2, and 70.4%, respectively. The onset of symptom relief was within 60 min in 84.7%. Tolerability was rated as very good or good by 97.2%; 82.8% were repeat users, 97.5% reported their intention to purchase the product again, and 97.1% reported their intention to recommend it to relatives, friends, and colleagues.DiscussionThese findings confirm the efficacy and tolerability data on PLUS from randomized controlled trials in a larger group of women conducting self-management of their dysmenorrhea in a real-world setting. Future studies should compare PLUS to other non-prescription treatments.

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