Cervical ripening with vaginal Misoprostol plus Hyoscine-N-Butylbromide versus vaginal Misoprostol alone among pregnant women: a double-blind randomised controlled trial.

Objective: To compare cervical ripening time with the use of vaginal Misoprostol plus Hyoscine-N-Butylbromide, with vaginal Misoprostol alone. Design: A double-blind randomized controlled trial with Pan-African Clinical Trials Registry (PACTR) approval number PACTR202112821475292. Setting: Federal Medical Centre, Asaba, Nigeria. Participants: A total of 126 eligible antenatal patients for cervical ripening were enrolled. Interventions: Participants in Group A had 25µg of vaginal misoprostol with 1ml of intramuscular placebo, and those in Group B had 25µg of vaginal misoprostol with 20mg of Intramuscular Hyoscine (1 ml). Oxytocin infusion was used when indicated, and the labour was supervised as per departmental protocol. Main outcome measure: Cervical ripening time. Results: The mean cervical ripening time was statistically significantly shorter in the hyoscine group (8.48±4.36 hours) than in the placebo group (11.40±7.33 hours); p-value 0.02, 95% CI 0.80-5.05. There was no statistically significant difference in the mean induction-delivery interval in Group A (7.38±5.28 hours) compared to Group B (7.75±5.04 hours), with a value of 0.54. The mode of delivery was comparable. However, women in Group B (53, 84.1%) achieved more vaginal deliveries than women in Group A (50, 79.4%); p-value 0.49. Thirteen women in Group A (20.6%) had a caesarean section, while ten women (15.9%) in Group B had a caesarean section (p-value 0.49, RR 0.94, CI 0.80-1.11). Adverse maternal and neonatal outcomes were not statistically significant between the two groups. Conclusion: Intramuscular hyoscine was effective in reducing cervical ripening time when used as an adjunct to vaginal Misoprostol, with no significant adverse maternal or neonatal outcome. Funding: None declared.

Effect of Prophylactic Subcutaneous Scopolamine Butylbromide on Death Rattle in Patients at the End of Life: The SILENCE Randomized Clinical Trial.

Importance: Death rattle, defined as noisy breathing caused by the presence of mucus in the respiratory tract, is relatively common among dying patients. Although clinical guidelines recommend anticholinergic drugs to reduce the death rattle after nonpharmacological measures fail, evidence regarding their efficacy is lacking. Given that anticholinergics only decrease mucus production, it is unknown whether prophylactic application may be more appropriate. Objective: To determine whether administration of prophylactic scopolamine butylbromide reduces the death rattle. Design, Setting, and Participants: A multicenter, randomized, double-blind, placebo-controlled trial was performed in 6 hospices in the Netherlands. Patients with a life expectancy of 3 or more days who were admitted to the participating hospices were asked to give advance informed consent from April 10, 2017, through December 31, 2019. When the dying phase was recognized, patients fulfilling the eligibility criteria were randomized. Of the 229 patients who provided advance informed consent, 162 were ultimately randomized. The date of final follow-up was January 31, 2020. Interventions: Administration of subcutaneous scopolamine butylbromide, 20 mg four times a day (n = 79), or placebo (n = 78). Main Outcomes and Measures: The primary outcome was the occurrence of a grade 2 or higher death rattle as defined by Back (range, 0-3; 0, no rattle; 3, rattle audible standing in the door opening) measured at 2 consecutive time points with a 4-hour interval. Secondary outcomes included the time between recognizing the dying phase and the onset of a death rattle and anticholinergic adverse events. Results: Among 162 patients who were randomized, 157 patients (97%; median age, 76 years [IQR, 66-84 years]; 56% women) were included in the primary analyses. A death rattle occurred in 10 patients (13%) in the scopolamine group compared with 21 patients (27%) in the placebo group (difference, 14%; 95% CI, 2%-27%, P = .02). Regarding secondary outcomes, an analysis of the time to death rattle yielded a subdistribution hazard ratio (HR) of 0.44 (95% CI, 0.20-0.92; P = .03; cumulative incidence at 48 hours: 8% in the scopolamine group vs 17% in the placebo group). In the scopolamine vs placebo groups, restlessness occurred in 22 of 79 patients (28%) vs 18 of 78 (23%), dry mouth in 8 of 79 (10%) vs 12 of 78 (15%), and urinary retention in 6 of 26 (23%) vs 3 of 18 (17%), respectively. Conclusions and Relevance: Among patients near the end of life, prophylactic subcutaneous scopolamine butylbromide, compared with placebo, significantly reduced the occurrence of the death rattle. Trial Registration: trialregister.nl Identifier: NTR6264.

The BUSCOPAN study: a randomized-controlled non-inferiority trial of a continuous butylscopolamine infusion versus placebo in patients with a renal colic not responding to oral non-steroidal anti-inflammatory drugs.

PURPOSE: To investigate whether placebo is non-inferior to continuous infusion of butylscopolamine in patients with renal colic. METHODS: We conducted a placebo-controlled, multicenter, double-blind randomized clinical trial (RCT) including 128 patients with renal colic (confirmed by ultrasound or CT-scan). Patients were randomized to receive either continuous IV butylscopolamine 100 mg/24 h or placebo (saline). Primary outcome is the amount of opioid escape medication used, measured in doses administered. Secondary outcomes are pain measured on a Numeric Rating Scale (NRS), side effects, and time of drug administration. Non-inferiority was assessed using linear regression with robust standard errors, with non-inferiority limit set at 0.5 units of escape medication. RESULTS: Median number of doses of escape medication was one in both groups. The number of extra doses in the placebo group compared with the butylscopolamine group was 0.05, with a 95% robust confidence interval (CI) of 0.38-0.47. Upper limit of the CI remained below the non-inferiority limit of 0.5 (p = 0.04). No differences in secondary endpoints were seen between the groups. CONCLUSION: Placebo is non-inferior to continuous IV butylscopolamine for pain relief in patients with renal colic. Based on this study and previous evidence, there is no role for continuous butylscopolamine IV in the treatment of renal colic. Trial NL7819.

Effect of hyoscine-N-butylbromide on labor duration among nullipara in a southwestern Nigerian teaching hospital: A randomized controlled trial.

OBJECTIVE: To assess the effectiveness of hyoscine-N-butylbromide on the duration of the first stage of labor among nulliparous women. METHODS: A randomized double-blind placebo-controlled study among 126 nulliparous women admitted in the active phase of labor to a teaching hospital in Sagamu, Nigeria, from January to August 2018. Based on the inclusion criteria, women were recruited and randomized to the study or control group, and given intravenous hyoscine-N-butylbromide 20 mg (1 mL) or sterile water (1 mL), respectively, during the active phase. Labor progress and outcomes were compared between the groups. RESULTS: The mean ± SD duration of active phase of first stage of labor was significantly shorter in the hyoscine-N-butylbromide group (324.9 ± 134.6 min) than in the control group (392.7 ± 119.6 min) (P = 0.004). The rate of cervical dilatation was 1.4 ± 0.8 cm/h in the hyoscine-N-butylbromide group and 1.0 ± 0.5 cm/h in the control group (P = 0.004). There were no significant differences in fetal heart rate, maternal vital signs, or Apgar scores between the two groups. CONCLUSION: Hyoscine-N-butylbromide was found to be effective in shortening the duration of the first stage of labor without adverse outcomes for mother or neonate. The trial was registered with the Pan African Clinical trials Registry (PACTR), protocol number: PACTR201808146688942 (https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3532).

The effect of hyoscine n- butylbromide on labor progress: A systematic review.

BACKGROUND: The objective of this systematic review and meta-analysis was to assess the effectiveness of hyoscine n-butylbromide in labor progress. METHODS: The databases including PubMed, the Cochrane Library, Science-Direct, Scopus and Web of Science were searched for studies published up to December 2019. Articles that published as randomized controlled trials (RCTs), and full-text articles published in English or other languages were included and participants were primi or multigravida women who were in active phase of labor. The intervention included HBB compared to placebo (normal saline) that was used during active phase of labor. Pooled estimates were measured using the fixed or random effect model, while the overall effect was reported in a mean difference (MD). All data were analyzed using Review Manager 5.3. RESULTS: Twenty studies involving 3108 women were included in meta-analysis. Based on subgroup analysis by parity, use of HBB significantly reduced the duration of the first stage of labor in primigravida women (MD = - 57.73; 95% CI: [- 61.48, - 53.60]) and in multigravida women (MD = - 90.74; 95% CI: [- 97.24, - 84.24]). Administering HBB could reduce the second stages of labor in primigravidas and multigravidas about 6 min and 4 min respectively. Also, HBB reduced the duration of the third stage of labor in multigravidas about 3 min. APGAR score at one and 5 min after birth was not affected. The main maternal adverse effect was tachycardia and dry mouth. Labor duration in studies in which the participants were primi-and multigravida was not presented based on separate parities except for four papers, and the route of HBB administration was not the same across all studies. CONCLUSIONS: Although, the effect of HBB was minimal when multigravidas and primigravidas women were considered together, the HBB was clinically effective in primigravida and multigravida women for shortening the first and the second stages of labor. Also, HBB could reduce the length of the third stage of labor in multigravidas.

MR enterography - Impact on image quality between single- versus split-dose Buscopan.

INTRODUCTION: MR enterography (MRE) is the most common imaging modality used to assess small bowel pathology, particularly patients with suspected Crohn's disease. Spasmolytic agents, most commonly Buscopan, are routinely used to reduce or cease movement/bowel activity in order to reduce blurring of the images which would otherwise reduce its diagnostic quality. The purpose of this study was to determine if administering an evenly split dose of Buscopan would improve the quality of images obtained relative to the standard single dose performed at our institution. METHODS: Cine sequences through the anterior and mid-abdomen were performed to assess and document small bowel peristalsis. Additional analysis was performed by the use of digital subtraction and measuring the signal-to-noise ratio value on the subtracted image, which was used to compare the amount of small bowel movement. RESULTS: A total of 34 patients who presented to the Department of Medical Imaging between October 2018 and April 2019 were included. In the anterior section, those in the split-dose group had a mean difference of 2.4 lower number of peristalsing bowel loops compared to the single-dose group (P = 0.001), while in the mid-section, those in the split-dose group had a mean difference of 2.5 lower number of peristalsing bowel loops compared to the single-dose group (P-value = 0.001). CONCLUSION: Our findings indicate that split-dose Buscopan significantly reduced peristalsis compared to single-dose Buscopan, and a reduction in peristalsis reduces one aspect of motion artefact, which translates to better images.

Diclofenac versus a combination of hyoscine and diclofenac for outpatient hysteroscopy: A placebo controlled randomized clinical trial.

OBJECTIVE: to compare the effect of administering diclofenac sodium and/or oral hyoscine in pain perception during and after outpatient diagnostic hysteroscopy without anesthesia. STUDY DESIGN: a randomized, double-blind placebo-controlled clinical trial was performed in an University Hospital. We included 217 patients submitted to office hysteroscopy for the following indications: diagnosis of abnormal uterine bleeding, endometrial polyps, submucous myomas, infertility and recurrent miscarriage. Patients were allocated into 3 groups: (Group 1) placebo, (Group 2) diclofenac sodium 50 mg and (Group 3) diclofenac sodium 50 mg plus Hyoscine-N-Butylbromide 10 mg. The primary outcome was the visual analogue score immediately after the procedure. The secondary outcomes included Likert acceptance scale, the need for extra analgesia after the procedure, need to stay in the observation room and the occurrence of vagal symptoms. RESULTS: Groups were similar according to age, color, age of menarche, gravity, c-section, abortion, presence of pelvic pain, presence of uterine scar, height and body mass index. Patients in all three groups demonstrated similar visual pain scores when submitted to office hysteroscopy (Group 1: 4.18 ± 3.1, Group 2: 4.68 ± 2.9, group 3: 4.45 ± 2.9, P = 0.59). Moreover, patients presented high acceptance scores of the procedure, similar between groups. We performed a subgroup analysis in patients in treatment for chronic pelvic pain and, in this subgroup, prior medication with diclofenac sodium isolated or associated with hyoscine were both effective in decreasing pain levels when compared to placebo (Group 1: 6.0 ± 1.9, Group 2: 3.6 ± 2.1, group 3: 4.2 ± 1.5, P = 0.04). CONCLUSION(S): Office hysteroscopy is a well tolerated procedure and prior use of analgesic medication was not effective in decreasing pain. In selected patients with chronic pelvic pain the use prior analgesic medication may be beneficial.

Effect of Premedication Hyoscine-N-Butylbromide before Hysterosalpingography for Diagnosis of Proximal Tubal Obstruction in Infertile Women: A Randomized Double-Blind Controlled Trial.

STUDY OBJECTIVE: To assess the effect of hyoscine-N-butylbromide (HBB) as premedication on the rate of proximal tubal obstruction during hysterosalpingography (HSG). DESIGN: A randomized, double-blind controlled trial (Canadian Task Force classification I). SETTING: The Infertility Clinic of Songklanagarind Hospital. PATIENTS: One hundred and forty-six infertile women indicated for HSG investigation. INTERVENTIONS: Between May 1, 2016, and March 31, 2017, patients were assigned at random to receive either oral HBB 20 mg or placebo 30 minutes before the HSG procedure. If proximal tubal obstruction was found, participants were be assigned to undergo a second confirming HSG or laparoscopy with chromopertubation within 6 months. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the rate of proximal tubal obstruction. The secondary outcome was the false-positive result of proximal tubal occlusion from HSG. Proximal tubal obstruction was found in 6 of 70 patients in the HBB group and in 16 of 71 in the placebo group. The rate of proximal tubal obstruction was significantly lower in the HBB group than in the placebo group (8.6% vs 22.5%; p = .04; absolute difference, 13.9%; 95% confidence interval [CI], 0.02-0.26; relative risk, 0.38; 95% CI, 0.16-0.92). After the second HSG or laparoscopy was performed (n = 22), the rate of false occlusion was 20% (1 of 6 patients) in the HBB group, compared with 69.2% (9 of 16 patients) in the placebo group. CONCLUSION: Premedication with HBB before HSG can reduce the rate of diagnosis of proximal tubal obstruction and false occlusion.

Oral Diclofenac Potassium Versus Hyoscine-N-Butyl Bromide in Reducing Pain Perception during Office Hysteroscopy: ARandomized Double-blind Placebo-controlled Trial.

STUDY OBJECTIVE: To compare the efficacy of oral diclofenac potassium versus hyoscine-N-butyl bromide (HBB) in reducing pain perception in patients undergoing diagnostic office hysteroscopy (OH). DESIGN: A randomized double-blind placebo-controlled trial (Canadian Task Force classification I). SETTING: A university hospital. INTERVENTIONS: One-hundred twenty-nine patients were divided randomly into 3 groups (n = 43 in each group); group 1 received 50mg diclofenac potassium, group 2 received 20mg HBB, and group 3 received placebo tablets. All tablets were taken orally 1hour before OH. The primary outcome was the participant's self-rated pain perception using the 10-point visual analog scale during the procedure. The secondary outcomes included the visual analog scale score 30 minutes after OH, ease of OH assessment using a 10-cm scale, duration of OH, and adverse effects of the study medications. MEASUREMENTS AND MAIN RESULTS: Both the diclofenac and HBB groups showed significant pain score reduction compared with the placebo group (p = .001). The mean pain score in the diclofenac group was significantly lower than the HBB group (2.12 ± 1.03vs 3.02 ± 1.55, respectively; p = .002). The pain scores in the diclofenac and HBB groups immediately after OH were significantly lower than the placebo group (p = .001), and the mean pain score in the diclofenac group was significantly lower than the HBB group (1.23 ± 0.57vs 1.56 ± 0.73, respectively; p = .024). The ease of procedure score was significantly lower in the diclofenac and HBB groups than the placebo group (p = .003 and p = .005, respectively). The mean duration of the procedure was significantly less in the diclofenac group (p = .01). Fourteen women (32.6%) in the HBB group experienced dizziness and 2 women (4.6%) had nausea, whereas only 4 women (9.3%) in the diclofenac group had dizziness and 2 women (4.6%) had vomiting. CONCLUSION: Oral diclofenac potassium administration 1hour before diagnostic OH reduces the procedure pain with subsequent easier and shorter OH duration. Oral HBB is less effective than diclofenac potassium with more adverse effects.

Prophylactic effect of scopolamine butylbromide, a competitive antagonist of muscarinic acetylcholine receptor, on irinotecan-related cholinergic syndrome.

BACKGROUND/AIM: Cholinergic syndrome frequently occurs within the first 24 h after irinotecan injection. We evaluated the prophylactic effect of scopolamine butylbromide on irinotecan-related cholinergic syndrome. PATIENTS AND METHODS: Fifty-nine patients who received irinotecan-based regimens at our outpatient chemotherapy clinic between April 2013 and May 2014 were enrolled. Patients who developed irinotecan-related cholinergic syndrome were prophylactically administered scopolamine butylbromide at the next scheduled treatment. Risk factors for irinotecan-related cholinergic syndrome were determined using logistic regression analysis. RESULTS: Irinotecan-related cholinergic syndrome occurred in 50.8% of patients. Scopolamine butylbromide administration significantly reduced the incidence to 3.4% (P < 0.01). The irinotecan dose (≥ 150 mg/m2) was the only risk factor associated with irinotecan-related cholinergic syndrome. The incidence of cholinergic syndrome in patients with this risk factor was 75%. CONCLUSION: Scopolamine butylbromide was effective in preventing irinotecan-related cholinergic syndrome. It is recommended for patients receiving ≥ 150 mg/m2 irinotecan who may develop cholinergic syndrome at high frequency.

Hyoscine Butylbromide for the Management of Death Rattle: Sooner Rather Than Later.

CONTEXT: Death rattle (DR) is a dramatic sign in the dying patient. Existing studies with anticholinergic agents are controversial, as this class of drugs has been commonly administered without considering the rationale of the mechanism of action. A meaningful use of these drugs may provide a better outcome. OBJECTIVES: The aim of this study was to assess the efficacy of hyoscine butylbromide (HB), given prophylactically in comparison with HB administered once DR occurs. METHODS: Dying patients having a score of ≥3 in the Richmond Agitation-Sedation Scale-palliative version were included in the study. HB (60 mg/day) was given when DR occurred (Group 1) or as pre-emptive treatment (Group 2). The onset of DR (death rattle free time) and intensity of DR were recorded at intervals until death. RESULTS: Eighty-one and 51 patients were randomized to Group 1 and 2, respectively. Patients in Group 2 survived longer than those in Group 1 (P < 0.05). DR occurred in 49 (60.5%) and three patients (5.9%) in Group 1 and 2, respectively (P = 0.001). A significant difference in the number of patients reporting DR was found at intervals examined (30 minutes, one hour, and then every six hours until death [P = 0.001]). In Group 1 and 2, DR free time was 20.4 (20.5) and 27.3 hours (25.2), respectively (P = 0.001). In Group 1, the treatment was considered effective in 10 patients (20.4%) only, after a mean of 14.4 hours (SD 8.57). CONCLUSION: The prophylactic use of HB is an efficient method to prevent DR, whereas the late administration produces a limited response, confirming data from traditional studies performed with anticholinergics. This could be considered a new paradigm to manage a difficult and dramatic sign, such as DR.

The pharmacokinetics of orally administered butylscopolamine in greyhound dogs.

The oral tablet formulation of butylscopolamine, which is available without prescription, is commonly used by trainers of racing greyhounds to treat functional urethral obstruction. As medication control of butylscopolamine is therefore required for such use to ensure the integrity of greyhound racing, an administration study was performed in six greyhounds to determine the pharmacokinetics of orally administered butylscopolamine. A single dose of one 10 mg butylscopolamine tablet was administered orally to simulate this use in greyhound racing. Blood, urine and faeces were collected at regular intervals from the greyhounds for up to 9 days and butylscopolamine concentrations determined. There was some, but very limited, absorption of butylscopolamine, with rapid elimination from plasma with a mean half-life of 2 hr. Urine concentrations initially declined in a similar manner to the plasma pharmacokinetics but then entered a much longer half-life of approximately 50 hr. Faecal concentrations declined to very low levels between 48 and 120 hr. The use of orally administered butylscopolamine for functional urethral obstruction in greyhounds is unjustified due to this very limited drug absorption. Medication control of butylscopolamine's antispasmodic effect on the digestive tract is possible by setting screening limits based on the urinary and faecal drug levels as determined in this study.

Hyoscine N-Butylbromide for Preventing Propofol Injection Pain: A Randomized, Placebo-Controlled and Double-Blind Study.

OBJECTIVE: In this study, the aim was to investigate the effect of hyoscine N-butylbromide (HnBB) pretreatment on pain during propofol injection. SUBJECTS AND METHODS: In this prospective, randomized, placebo-controlled and double-blind trial, 60 patients scheduled to undergo routine outpatient surgery under general anesthesia were randomly allocated to 2 groups, the HnBB (n = 30) and sodium chloride (n = 30) groups. Twenty seconds after the injection of 20 mg HnBB or 0.9 % sodium chloride, a 50-mg dose of propofol was injected in 2-3 s. Ten seconds later, the pain intensity was assessed using a 4-point scale: no pain (0), mild (1), moderate (2), and severe (3) pain. The Student t test was used for the analysis of parametric data and the Pearson χ2 test for categorical data. RESULTS: The occurrence of pain in the HnBB group (43.3%) was significantly lower than the control group (73.3%) (p < 0.018). Of the 30 patients in each group, 10 in the control group and 3 in the HnBB group experienced severe pain (p = 0.001). CONCLUSIONS: Pretreatment with 20 mg HnBB significantly reduced propofol injection pain compared to placebo.

Risks in the clinical applications of scopolamine butylbromide injections.

OBJECTIVE: To investigate and analyze the clinical application of scopolamine butylbromide injection and promote the rational use of the drug. MATERIALS AND METHODS: We classified and analyzed 3,695 cases of scopolamine butylbromide injection (effective cases only) collected over the period of January 2016 to July 2017, including details on gender, age, course of treatment, high-risk patients with other medications, adverse drug reactions, and drug combinations. RESULTS: Use in high-risk patients is common, occurrence of adverse drug reaction rate in patients with high risk is 8.32 times the incidence of adverse reactions of the drug in general, in high-risk patients with adverse drug reaction the rate is 7.63 times that for lower-risk patients. Combined use of drugs is common, and there are 1.98% of cases with potential drug interactions. CONCLUSION: The findings have importance for other Asian ethnic groups and for Chinese living outside China - Chinese are considered a "moderate-risk" ethnic group in using scopolamine butylbromide injection. We should adhere to the requirements of drug instructions, pay attention to high-risk patients, drug and drug interactions, drug and food interactions, reduce the risk of adverse drug reactions, and ensure drug safety.

Hyoscine butylbromide significantly decreases motion artefacts and allows better delineation of anatomic structures in mp-MRI of the prostate.

OBJECTIVES: To prospectively evaluate the effect of hyoscine butylbromide (HBB) on visualisation of anatomical details and motion-related artefacts in mp-MRI of the prostate at 3.0 Tesla. METHODS: One hundred and three consecutive patients (65 ± 10 years) were included in this trial, powered to demonstrate an improvement of image quality after HBB administration, assessed on a 5-point scale by two blinded readers. All patients received high-spatial resolution axial T2-weighted TSE sequences at 3.0 T without spasmolytic agent, repeated after application of 40 mg HBB and followed by routine mp-MRI. Secondary endpoints were (1) susceptibility to side effects, (2) dependence of spasmolytic effect on patients´ weight, and (3) prostate volume. RESULTS: In 68% of patients, HBB significantly improved the anatomic score (mean 3.4 ± 0.9 before and 4.4 ± 0.7 after HBB for both readers, p = <0.001). In 67%, HBB significantly enhanced the artefact score (mean 3.2 ± 1 before and 4.2 ± 0.8 after HBB for reader 1, p = <0.001; 3.2 ± 1 and 4.1 ± 0.8 for reader 2, p = <0.001). Subgroup analysis revealed no statistically significant difference between patients with different bodyweight or prostate volume. Inter-reader agreement was excellent (k = 0.95-0.98). CONCLUSIONS: Hyoscine butylbromide significantly improves image quality and reduces motion-related artefacts in mp-MRI of the prostate independent of bodyweight or prostate volume. No side effects were reported. KEY POINTS: • Hyoscine butylbromide (HBB) improved image quality in over 2/3 of patients. • Severe artefacts were reduced after HBB in more than 20%. • The number of non-diagnostic MRI was reduced to <1% after HBB. • HBB effect was independent of bodyweight and prostate volume. • No side effects of HBB were reported in this study population.

Effect of hyoscine butyl-bromide on the duration of active phase of labor: A randomized-controlled trial.

OBJECTIVE: Hyoscine butyl bromide (HBB) is known for its antispasmodic action and has been in use for over five decades, there is however no consensus on its effectiveness in the labor process. The aim of this study was to determine the effect of HBB on the duration of the active phase of labor. MATERIALS AND METHODS: A randomized double-blind placebo-controlled clinical trial involving 160 parturient who received either intravenous Hyoscine butyl-bromide (20 mg in 1 ml; n = 80) or intravenous normal saline (1 ml, n = 80). The mean duration of active phase of labor was compared between the two groups. RESULTS: The observed mean duration of the active phase of labor was significantly shorter (P = 0.001) in the Hyoscine butyl-bromide group (365.11 ± 37.32 min, range = 280-490) than in the Placebo group (388.46 ± 51.65 min, range = 280-525). There was no significant difference between the two groups in the mean duration of the second and third stages of labor (20.46 ± 10.46 vs. 23.38 ± 18.95 min, P = 0.43 and 8.96 ± 4.34 vs. 9.23 ± 5.92 min, P = 0.75, respectively). The mean 1-min APGAR scores were also comparable (8.08 ± 1.54 vs. 7.64 ± 1.60, P = 0.08). The mean postpartum blood loss was significantly less in the Hyoscine butyl-bromide group (303 ± 96.52 vs. 368 ± 264.19 ml, P = 0.04). CONCLUSION: Hyoscine butyl-bromide was effective in shortening the duration of the active phase of labor. It was also associated with significantly less postpartum blood loss.

Abdominal pain, cramping or discomfort impairs quality of life in women: An internet-based observational pilot study focussing on impact of treatment.

Background Abdominal pain, cramping, and discomfort (APCD) are experienced by up to 30 % of adults in Europe. Objective To assess the impact of APCD on quality of life (QoL) and to investigate the effectiveness, tolerability, and impact on QoL of hyoscine butylbromide (HBB, Buscopan®) compared with STW 5 (Iberogast®) or analgesics in women with APCD. Methods An internet-based observational pilot study was conducted in Germany in women who had predominantly used HBB, STW 5, or analgesics (n = 240 per treatment) to treat APCD. This online survey included questions on QoL, effectiveness, and tolerability. Results A total of 720 completed questionnaires was evaluated. APCD had a major impact on QoL, with 96 % of women reporting that daily activities were disrupted at least sometimes, and 44 % at least often. Other aspects of QoL, such as quality of work, eating habits, and social activities, were also affected in most women. After taking their medication of choice, 91 % of women in the HBB group reported they could "very often" or "often" continue with their daily activities, compared with 84 % and 85 % in the STW 5 and analgesic groups, respectively (p < 0.05 for both comparisons). HBB was perceived to be the "best solution" to overcome APCD symptoms "very often" or "often" by more women (86 %) than STW 5 (75 %) and analgesics (74 %) (p < 0.05 for both comparisons). Conclusion Women with APCD have impaired QoL. All treatments were considered effective by the majority of participants. Compared with STW 5 or analgesics, HBB was reported to facilitate return to daily activities more frequently.

Diffusion-weighted MR enterography for evaluating Crohn's disease: Effect of anti-peristaltic agent on the diagnosis of bowel inflammation.

OBJECTIVES: To prospectively investigate how Buscopan affects the diagnosis of bowel inflammation by diffusion-weighted imaging MR enterography (DWI-MRE) in Crohn's disease (CD). METHODS: Thirty CD patients without previous bowel surgery underwent DWI-MRE (b = 900 sec/mm2) before and after intravenous Buscopan. The 30 patients were randomly divided into two groups; using a crossover design, interpretations were made regarding the presence of restricted mural diffusion (i.e., bowel inflammation) in nine bowel segments in two separate reading sessions by two readers. The readers also judged restricted mural diffusion extent in each bowel segment on two side-by-side DWI-MRE images with a random right-to-left order. Ileocolonoscopy and conventional MRE interpreted by an expert panel were reference standards. RESULTS: We analyzed 262 bowel segments. DWI-MRE without Buscopan significantly decreased sensitivity for both readers (58.8 % vs. 72.9 %, P = 0.046; 57.6 % vs. 85.9 %, P = 0.001) and did not significantly increase specificity (P = 0.085 and 0.396). Two readers noted that 28.6 % and 23.3 % of 262 bowel segments had greater diffusion restriction extent on DWI-MRE with Buscopan compared with DWI-MRE without Buscopan (P < 0.001) and 68.7 % and 74 %, respectively, had similar extent between them. CONCLUSION: Omitting Buscopan caused a greater loss in sensitivity of DWI-MRE than false-positive reduction for diagnosing bowel inflammation in CD. KEY POINTS: • Omitting Buscopan significantly decreases DWI-MRE sensitivity for diagnosing bowel inflammation in CD. • Increase in the corresponding DWI-MRE specificity by omitting Buscopan is less apparent. • DWI-MRE without Buscopan underestimates the extent of bowel inflammation in CD.

The role of routinely given hyoscine-N-butylbromide in colonoscopy: a double-blind, randomized, placebo-controlled, clinical trial.

OBJECTIVE: Hyoscine-N-butylbromide (HBB) has been proposed to ease colonoscopy and improve mucosal visualization, yet the results from previous studies are conflicting. In our prospective, double-blind, placebo-controlled, randomized study we aimed at evaluating whether routine administration of HBB, before and during colonoscopy, ease the procedure or increase the detection rate for polyps. MATERIAL AND METHODS: One hundred fifty outpatients scheduled for an elective colonoscopy were randomized to receive intravenous injections of either 10 mg hyoscine-N-butylbromide or saline before insertion and at cecum. Patient tolerance and technical ease of colonoscopy were evaluated by visual analogue scale (VAS). Procedure times were recorded. Number of detected polyps per patient was evaluated as well. Heart rate was monitored with a pulse oximetry. RESULTS: HBB did not improve patient tolerance or technically ease the procedure as evaluated by VAS. However, HBB led to faster ileal intubation (1.5 vs 2.0 min, p < 0.001) and shorter total procedure time (22.0 vs 24.0 min, p = 0.03). Patients who received HBB also needed less often external abdominal pressure (48.6 vs 66.7%, p = 0.03). HBB did not improve polyp detection rate (0.89 vs 0.91, p = 0.90). HBB induced a significant rise in heart rate (p < 0.001) and more often tachycardia (17.6 vs 0%, p < 0.001). CONCLUSIONS: Routine administration of HBB before and during colonoscopy yields only limited improvement in the technical performance of the examination compromised by high incidence of tachycardia.

A multicenter pragmatic study of an evidence-based intervention to improve adenoma detection: the Quality Improvement in Colonoscopy (QIC) study.

BACKGROUND AND STUDY AIMS: Low adenoma detection rates (ADRs) at colonoscopy are linked to significantly higher interval cancer rates, and vary between colonoscopists. Studies demonstrate that lesion detection is improved by: withdrawal time of ≥ 6 minutes; use of hyoscine butylbromide; position change; and rectal retroflexion. We evaluated the feasibility of implementing the above "bundle" of interventions into colonoscopy practice, and the effect on ADR. MATERIALS AND METHODS: A longitudinal cohort design was used. Implementation combined central training, local promotion, and feedback. The uptake marker was change in hyoscine butylbromide use. Comparisons were between the 3 months before and the 9 months after the implementation phase, globally, by endoscopy unit and by quartile when colonoscopists were ranked according to baseline ADR. Chi-squared or Fisher's tests were used to evaluate significance. RESULTS: 12 units participated. Global and quartile analyses included data from 118 and 68 colonoscopists and 17 508 and 14 193 procedures respectively. A significant increase in hyoscine butylbromide use was observed globally (54.4 % vs. 15.8 %, P < 0.001), in all endoscopy units (P < 0.001) and quartiles (P < 0.001). A significant increase in ADR was observed globally (18.1 % vs. 16.0 %, P = 0.002) and in the lower two colonoscopist quartiles (P < 0.001), with a nonsignificant increase in the upper middle quartile and a significant fall to 21.5 %. in the upper quartile. The significant variations in ADR among the upper three quartiles disappeared. CONCLUSION: In routine clinical practice, introduction of a simple, inexpensive, evidence-based "bundle" of measures is feasible and is associated with higher global ADR, driven by improvements amongst the poorest performing colonoscopists.