The effect of intravenous hyoscine butylbromide on slow progress in labor (BUSCLAB): A double-blind randomized placebo-controlled trial.

BACKGROUND: Prolonged labor is a common condition associated with maternal and perinatal complications. The standard treatment with oxytocin for augmentation of labor increases the risk of adverse outcomes. Hyoscine butylbromide is a spasmolytic drug with few side effects shown to shorten labor when used in a general population of laboring women. However, research on its effect on preventing prolonged labor is lacking. We aimed to assess the effect of hyoscine butylbromide on the duration of labor in nulliparous women showing early signs of slow labor. METHODS AND FINDINGS: In this double-blind randomized placebo-controlled trial, we included 249 nulliparous women at term with 1 fetus in cephalic presentation and spontaneous start of labor, showing early signs of prolonged labor by crossing the alert line of the World Health Organization (WHO) partograph. The trial was conducted at Oslo University Hospital in Norway from May 2019 to December 2021. One hundred and twenty-five participants were randomized to receive 1 ml hyoscine butylbromide (Buscopan) (20 mg/ml), while 124 received 1 ml sodium chloride intravenously. Randomization was computer-generated, with allocation concealment by opaque sequentially numbered sealed envelopes. The primary outcome was duration of labor from administration of the investigational medicinal product (IMP) to vaginal delivery, which was analyzed by Weibull regression to estimate the cause-specific hazard ratio (HR) of vaginal delivery between the 2 treatment groups, with associated 95% confidence interval (CI). A wide range of secondary maternal and perinatal outcomes were also evaluated. Time-to-event outcomes were analyzed by Weibull regression, whereas continuous and dichotomous outcomes were analyzed by median regression and logistic regression, respectively. All main analyses were based on the modified intention-to-treat (ITT) set of eligible women with signed informed consent receiving either of the 2 treatments. The follow-up period lasted during the postpartum hospital stay. All personnel, participants, and researchers were blinded to the treatment allocation. Median (mean) labor duration from IMP administration to vaginal delivery was 401 (440.8) min in the hyoscine butylbromide group versus 432.5 (453.6) min in the placebo group. We found no statistically significant association between IMP and duration of labor from IMP administration to vaginal delivery: cause-specific HR of 1.00 (95% CI [0.77, 1.29]; p = 0.993). Among 255 randomized women having received 1 dose of IMP, 169 women (66.3%) reported a mild adverse event: 75.2% in the hyoscine butylbromide group and 57.1% in the placebo group (Pearson's chi-square test: p = 0.002). More than half of eligible women were not included in the study because they did not wish to participate or were not included upon admission. The participants might have represented a selected group of women reducing the external validity of the study. CONCLUSIONS: One intravenous dose of 20 mg hyoscine butylbromide was not found to be superior to placebo in preventing slow labor progress in a population of first-time mothers at risk of prolonged labor. Further research is warranted to answer whether increased and/or repeated doses of hyoscine butylbromide might have an effect on duration of labor. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03961165) EudraCT (2018-002338-19).

Hyoscine butylbromide in pain reduction associated with ultrasound-guided manual vacuum aspiration: a randomized placebo-controlled trial.

RESEARCH QUESTION: What is the effect of adding an anti-spasmodic drug to an existing ultrasound-guided manual vacuum aspiration (USG-MVA) protocol to alleviate immediate post-procedure abdominal cramping pain in women treated for early pregnancy loss? DESIGN: Double-blind, placebo-controlled, randomized controlled trial conducted between February 2018 and January 2020. Participants were assigned to receive a 1-ml intravenous injection containing 20-mg hyoscine butylbromide (HBB) (n=55) or saline (n =56) as a control immediately before USG-MVA. Primary outcome was reduced abdominal pain after adding a 20-mg dose of HBB to the current pain control regimen. Secondary outcomes were vaginal pain, complications and side-effects, women's pre- and post-procedure psychological state, physiological stress (saliva alpha-amylase) and procedure pain control satisfaction. Two-way mixed ANOVA was used to evaluate the main effects and interactions. RESULTS: VAS abdominal pain scores in the HBB group were 16% lower immediately after and 21% lower 2 h after surgery (not statistically significant). Two-way ANOVA indicated that time (F[1108] = 83.41, P < 0.001) was the only significant main effect for reduced abdominal pain after the procedure and vaginal pain score (F[1108] = 180.1, P < 0.0001) but not drug received. No adverse events were reported. No significant difference was found for psychological state, physiological stress and procedure pain control satisfaction between the two groups. CONCLUSIONS: Anti-spasmodic drugs can help to reduce abdominal cramping pain associated with USG-MVA; HBB produced an insignificant decrease in abdominal pain score. Further studies with longer acting or larger doses of anti-spasmodic drugs are warranted.

A randomized controlled study of the effect of hyoscine butylbromide on duration of labor in primigravida women with prolonged labor.

OBJECTIVE: To assess the safety and efficacy of hyoscine butyl bromide (HBB) in primipara with prolonged 1st stage of labor. MATERIALS AND METHODS: A double-blinded randomized controlled trial included 100 primiparas diagnosed with prolonged labor. They were randomly divided two equal groups. Group I received 40 mg HBB intravenously. Group II received 2 ml of normal saline. The primary outcome was the duration of the 1st stage of labor. Secondary outcomes included success of vaginal delivery, rate of cervical dilation, duration of 2nd and 3rd stages of labor, causes of CS, neonatal outcome and drug side effects. RESULTS: The duration of the 1st stage was 322.3 ± 89.8 min in women who received HBB compared with 451.3 ± 198.3 min in the control women (P < 0.001). The rate of cervical dilation was increased from 0.4 ± 0.2 to 1.5 ± 0.6 in women who received HBB compared with its increase from 0.4 ± 0.1 to 0.9 ± 0.2 in other women (P < 0.001). The rate of CS were significantly higher in control women when compared to those received HBB (34 vs. 20%, P < 0.001). The commonest indication for the operation was arrest of cervical dilatation (28 and 16%, respectively). CONCLUSION: HBB is associated with shortening of the 1st stage, lowered rate of CS without any side effects. GOV ID: NCT03430362 date of registration 6 February 2018. Synopsis Hyoscine butyl bromide is associated with shortening of the 1st stage, lowered rate of CS in primiparas with prolonged labor.

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.

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.

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.

Abuse of the over-the-counter antispasmodic butylscopolamine for the home synthesis of psychoactive scopolamine.

UNLABELLED: We report on two patients who ingested psychoactive scopolamine that was synthesized at home from butylscopolamine (Buscopan®), which is available as over-the-counter antispasmodic in nearly 100 countries worldwide. Patient 1 presented with severe central anticholinergic toxidrome, while patient 2 suffered from minor symptoms. An empty blister of Buscopan® was found in the patients' home, but initially was not suspected to be causative for the observed central anticholinergic symptoms, as Buscopan® is not able to pass the blood-brain barrier in its native form. Only later, the information by third parties and a Google search helped to identify homemade scopolamine derived from Buscopan® as the responsible agent in these two cases. Retrospectively, scopolamine could be detected in serum and urine of both patients, while it was absent in one control after ingestion of native Buscopan®. CONCLUSION: Over-the-counter drugs can be used to synthesize psychoactives with means that are available in every household. Such knowledge can spread via social media and internet discussion boards long before appearing in medical literature. While typical clinical presentation often enables clinicians to adequately identify and treat specific toxidromes, these sources of information need to be increasingly taken into account by medical professionals for identification of its causative agent. This potential of Buscopan® might gain importance as an easily accessible source of psychoactive scopolamine. WHAT IS KNOWN: • Substances with central anticholinergic effects are known for their hallucinogenic potential and may be used as psychoactives. What is New: • The over-the-counter antispasmodic butylscopolamine (Buscopan®) can be abused to synthesize anticholinergic, psychoactive scopolamine at home with means that are available in every household.

Hyoscine N-butylbromide (Buscopan®) in the treatment of acute ureteral colic: what is the evidence?

OBJECTIVE: To investigate the evidence for the use of hyoscine N-butylbromide (HBB) in the treatment of acute renal colic. METHODS: A literature search was performed using the keywords 'hyoscine N-butylbromide', 'ureteral colic', 'spasmolytic', 'anticholinergic' and 'analgesia'. The articles were given the appropriate level of evidence according to the Oxford Centre for Evidence-Based Medicine Levels of Evidence guidelines. RESULTS: The analgesic effect of HBB as monotherapy is inferior to that of opioids and/or non-steroidal anti-inflammatory drugs (NSAIDs). It does provide an analgesic and antispasmodic effect, but not as long-lasting as NSAIDs. HBB does not serve as an adjunct to opioids. Furthermore, it does not facilitate passage of ureteral stones and has no effect on expulsion rate. CONCLUSIONS: HBB is often used where urinary tract smooth muscle spasm is thought to be part of the pathophysiological process. According to the evidence, administration of HBB follows non-peer-reviewed protocols which are based on empiric recommendations. Its role is still unclear, as it appears to have no advantage when used as monotherapy over established forms of analgesia. There appears to be a time-dependent relation to pain reduction following parenteral administration, but this needs to be confirmed by more prospective randomized cohorts.

Efficacy of butylscopolamine for the treatment of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study.

BACKGROUND: Catheter-related bladder discomfort (CRBD) secondary to intraoperative catheterization of urinary bladder is one of the most distressing symptoms during recovery from anaesthesia. Butylscopolamine, a peripheral antimuscarinic agent, is effective for relieving the pain, which is because of smooth muscle contraction. The aim of this study was to assess the efficacy and safety profiles of butylscopolamine in treating CRBD after urological surgeries. METHODS: Adult male patients undergoing urological surgery requiring urinary bladder catheterization intraoperatively were enrolled. Induction and maintenance of anaesthesia were standardized. Patients were randomized into two groups after complaining of CRBD in the post-anaesthesia care unit. The control group (n=29) received normal saline and the butylscopolamine group (n=28) was administered butylscopolamine 20 mg i.v. The severity of CRBD, postoperative pain, and adverse effects were assessed at baseline, 20 min, 1, 2, and 6 h after administration of the study drug. RESULTS: The severity of CRBD observed in the butylscopolamine group was significantly lower than that of the control group at 1, 2, and 6 h after administration of the study drug [59 (12), 50 (16), 40 (21) in the control group vs 41 (22), 32 (25), 23 (18) in the butylscopolamine group, P<0.01]. Rescue analgesics were required less in the butylscopolamine group than in the control group (P=0.001). Adverse events were comparable between the two groups. CONCLUSION: Butylscopolamine 20 mg administered i.v. after complaining CRBD during recovery reduced both the severity of CRBD and the need for rescue analgesics without adverse effects in patients undergoing urologic surgeries.

Cardiovascular effects of hyoscine butylbromide in patients under general anaesthesia.

BACKGROUND: Cardiovascular effects for drugs such as hyoscine butylbromide are poorly documented in the literature, unlike atropine, which is considered the antimuscarinic of choice in the presence of intraoperative bradycardia. AIM: The aim of the study was to describe the dose-related cardiovascular effect of hyoscine butylbromide in patients between 18 and 65 years of age, with low perioperative risk undergoing elective surgery under general anaesthesia on an outpatient basis or hospitalised at our institution between 1 January and 31 May 2019. METHODS: Descriptive, cross-sectional, retrospective study; 28 patients with low perioperative risk who underwent general anaesthesia were selected. Changes in heart rate and blood pressure were analysed during the first 6 minutes after the administration of hyoscine butylbromide. The data obtained was recorded in a Microsoft Excel database and analysed using the Excel analysis tool and IBM SPSS. RESULTS: The average dose of 0.15mg/kg of hyoscine butylbromide achieved an increase in heart rate and mean arterial pressure in 96% and 92.8%, respectively, in the first 6 minutes after the administration. Significant changes in heart rate and blood pressure were obtained during the first 6 minutes at doses between 0.05mg/kg and 0.15mg/kg. CONCLUSION: Hyoscine butylbromide generates positive effects on the heart rate and blood pressure of patients under general anaesthesia, representing a possible alternative in the management of intraoperative bradycardia.

[Pharmacological treatment of malignant bowel obstruction in severely ill and dying patients : a systematic literature review]. / Medikamentöse therapie der gastrointestinalen obstruktion bei schwerkranken und sterbenden patienten : eine systematische literaturübersicht.

BACKGROUND: Malignant bowel obstruction (MBO) occurs in 3-6% of patients suffering from advanced cancer. The incidence of MBO is highest in patients with gynaecological and colorectal malignancies. Typical symptoms include nausea, vomiting, abdominal pain and constipation. Initially, these symptoms may be isolated and sporadic, becoming more and more intense later on. The suggested treatment includes surgical, interventional and pharmacological strategies depending on the symptom pattern and the performance status of the patient. This study investigates the current evidence of pharmacological treatment for MBO during the last days of life. MATERIALS AND METHODS: A systematic literature search of the electronic databases PubMed/Medline and Embase from 1966-2011 was conducted. All retrieved publications were screened for relevance with regard to content and methodology on the basis of title and abstract. The full text was obtained for all relevant articles and for those articles where classification was unsure. RESULTS: The systematic literature search identified 5,431 papers. After screening, 90 publications were analyzed in detail. A total of 69 publications were excluded due to content or methodology. Finally, 21 manuscripts were considered for review. Only a few studies used high quality methodology and they all had rather small sample sizes. In summary, they show weak positive signs of efficacy for the use of somatostatin analogues or anticholinergics in the pharmacological treatment of MBO. CONCLUSION: These results do not lead to a clear evidence base for the pharmacological treatment of MBO in the last days of life. As adverse events were infrequent and clinical studies suggest efficient symptom relief, the authors recommend the use of octreotide as the first line medication. Butylscopolamine may be an alternative, where octreotide is not available. Higher costs for octreotide compared with butylscopolamine have to be considered. Available data do not allow assessing the effect of corticosteroids on symptoms caused by MBO when given during the last days of life. The English full text version of this article will be available in SpringerLink as of November 2012 (under "Supplemental").

[Recommendations for death rattle]. / Empfehlung bei Rasselatmung.

Noisy breathing during the terminal stages of life (death rattle) is one of the most common and most difficult symptoms to treat. In palliative medicine there are still no accepted guidelines for the treatment of death rattle in the final phase of life. In the first part of this article a description of death rattle is presented and in the second part a systematic literature review gives an insight into the effectiveness of interventions for death rattle. Two databases (Embase and Medline) were searched up to 2010 which identified 134 studies but only 6 met the inclusion criteria (2 cohort and 4 experimental studies) in which scopolamine, glycopyrrolate, butyl scopolamine, atropine and octreotide were tested. There is a lack of conclusive studies which investigated the effectiveness of treatment of death rattle. Furthermore, the identified studies revealed methodical problems. In general non-drug therapy is recommended as first choice. If anticholinergics are considered the selection also depends on whether simultaneous sedation is desired or not. The English full text version of this article will be available in SpringerLink as of November 2012 (under "Supplemental").

Efficacy and tolerability of two oral hyoscine butylbromide formulations in Chinese patients with recurrent episodes of self-reported gastric or intestinal spasm-like pain.

AIM: To compare the efficacy and tolerability of oral hyoscine butylbromide tablets and capsules in Chinese patients with recurrent episodes of self-reported gastric or intestinal spasm-like pain and to show non-inferiority of both formulations. METHODS: 302 patients were entered into a randomized, double-blind, double-dummy, active-controlled 2-arm parallel group study. They were randomized to 3 days of treatment with hyoscine butylbromide tablets or capsules. In patient diaries the pain intensity was assessed on 10 cm visual analogue scales on Day 1 (0, 30, 60, 90, 120, and 180 minutes after first dose), Days 2, and 3 (maximum pain intensity once daily). Pain frequency, overall efficacy, and tolerability were assessed on verbal rating scales. RESULTS: In the per-protocol dataset 281 patients were analyzed. The change from baseline after 180 minutes was 59% in both treatment groups; the adjusted means of pain intensity on Day 1 were reduced by -2.36 cm (tablets) and -2.31 cm (capsules). Pain intensity decreased within 30 minutes by approximately 20%. The decrease of the peak pain intensity was approximately 55% after 3 days in both treatment groups; the adjusted means after 3 days were reduced by -2.48 cm (tablets) and by -2.45 cm (capsules). Abdominal pain frequency decreased by 50% (tablets) and 42% (capsules). Both treatments were well tolerated. Drug-related adverse events were infrequent (3.5%). No serious adverse event occurred. CONCLUSIONS: Hyoscine butylbromide is effective in the treatment of recurrent gastric or intestinal spasm-like pain and well tolerated. Non-inferiority of tablets and capsules was demonstrated.

[Chronic myelogenous leukemia complicated by drug-induced agranulocytosis].

We describe a patient with chronic myelogenous leukemia (CML) who developed drug-induced agranulocytosis. A 75-year-old female was diagnosed with CML in December 2001. She had been receiving imatinib therapy for more than five years. In August 2007, she was hospitalized due to a severe neutropenia 10 days after colonoscopy. She was diagnosed as having agranulocytosis induced by colonoscopy premedication including scopolamine butylbromide and flumazenil. Severe neutropenia was resolved by G-CSF treatment without CML progression. Agranulocytosis in patients with CML is rare, but potentially lethal. Here, we report the clinical course in this patient.

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).

Impetigo herpetiformis occurring during N-butyl-scopolammonium bromide therapy in pregnancy: case report.

Impetigo herpetiformis (IH) is a rare dermatosis arising during the third trimester of pregnancy which is generally considered as a form of pustular psoriasis of unknown aetiology. Clinically it is characterized by erythematous plaques surrounded by sterile pustules associated with fever, diarrhea, sweating and increasing risk of stillbirth for placental insufficiency. We describe a case of developed erythematous plaques surrounded by pustules localised initially to the trunk of a 35-year-old woman at the 34th week of gestation after 5 days of treatment with N-Butyl-Scopolammonium, and which later involved the upper and lower limbs. Skin histology confirmed the diagnosis of generalised pregnancy pustular psoriasis (impetigo herpetiformis). IH is reported to be associated with hypocalcemia, hypoparathyroidism, use of oral contraceptives and bacterial infections. This is the first report suggesting the potential role of drugs other than oral contraceptives in the pathogenetic mechanism of this disease. In this case an adverse cutaneous reaction to BB could be the cause of the development of Koebner isomorphism.

Drotaverine hydrochloride versus hyoscine-N-butylbromide in augmentation of labor.

OBJECTIVES: To study and compare the efficacy and side effects of drotaverine hydrochloride and hyoscine-N-butylbromide in the augmentation of labor. METHODS: A prospective randomized trial of 150 women in active labor included 50 women given drotaverine (group 1), 50 women given hyoscine-N-butylbromide (group 2), and 50 women given no medication (group 3). Duration of labor, rate of cervical dilation, mode of delivery, side effects, and neonatal outcome were compared among the groups. RESULTS: The mean duration of the active phase of labor was 4.48+/-2.26 h, 3.9+/-2.42 h, and 3.6+/-2.07 h in groups 1, 2, and 3, respectively. The mean rate of cervical dilation was 2.6 cm/h, 2.4 cm/h, and 2.5 cm/h, respectively. The differences were not statistically significant. There was no difference in the duration of the second and third stages of labor. No adverse maternal or fetal outcomes were noted. CONCLUSION: Drotaverine hydrochloride and hyoscine-N-butylbromide do not have a role in augmentation of labor.

Drug induced linear IgA disease with unusual features: Koebner phenomenon, local insulin sensitivity and annular blister of the nipples.

Linear IgA disease is an autoimmune subepidermal bullous disease in which linear IgA deposits are found at the basement membrane zone. It is classically idiopathic but may be drug induced. We report on a patient with drug induced linear IgA disease who exhibited certain unusual and interesting clinical features including isomorphic Koebner response, annular blister of the nipples and local insulin sensitivity. To the best of our knowledge, these clinical features have not yet been reported in linear IgA disease.

Butil bromuro de hioscina: ¿Una opción para el manejo de bradicardia intraoperatoria? / Hyoscine butyl bromide useful in the management of perioperative bradycardia?

INTRODUCTION: Hyoscine butyl bromide, better known as buscapine, widely used in medicine, is a muscarinic antagonist that shares properties with atropine. OBJECTIVE: To review the pharmacology, mechanism of action, systemic effects, interactions, toxicity, and side effects of hyoscine butyl bromide to understand why it may be useful in the management of perioperative bradycardia. MATERIALS AND METHODS: A bibliographic review was carried out in the main databases with the search of the scientific literature according to the key words defined. CONCLUSIONS: Butyl bromide hyoscine may be an option in the management of intraoperative bradyarrhythmias with a rapid onset of action, more controlled increased heart rate and low penetration to the central nervous system.

INTRODUCCIÓN: El butilbromuro de hioscina más conocido como buscapina, ampliamente utilizado en medicina, es un antagonista muscarínico que comparte propiedades con la atropina. OBJETIVO: Realizar una revisión de la farmacología, mecanismo de acción, efectos sistémicos, interacciones, toxicidad y efectos secundarios del butil bromuro de hioscina para poder entender por qué puede ser útil en el manejo de bradicardia perioperatoria. MATERIALES Y MÉTODOS: Se realizó una revisión bibliográfica en las principales bases de datos como PubMed, con la búsqueda de la literatura científica de acuerdo a las palabras claves definidas. CONCLUSIONES: El butil bromuro de hioscina puede ser una opción en el manejo de bradiarritmias intraoperatorias con un rápido inicio de acción, aumento de la frecuencia cardíaca más controlado y baja penetración al sistema nervioso central.

Hyoscine butylbromide: a review of its use in the treatment of abdominal cramping and pain.

Abdominal cramping and pain is a frequent problem in the adult population of Western countries, with an estimated prevalence of < or =30%. Hyoscine butylbromide (scopolamine butylbromide) [Buscopan/Buscapina] is an antispasmodic drug indicated for the treatment of abdominal pain associated with cramps induced by gastrointestinal (GI) spasms. It was first registered in Germany in 1951 and marketed in 1952, and has since become available worldwide both as a prescription drug and as an over-the-counter medicine in many countries. This article reviews the pharmacology and pharmacokinetic profile of hyoscine butylbromide, and summarises efficacy and safety data from clinical trials of this drug for abdominal cramping and pain. Pharmacological studies have revealed that hyoscine butylbromide is an anticholinergic drug with high affinity for muscarinic receptors located on the smooth-muscle cells of the GI tract. Its anticholinergic action exerts a smooth-muscle relaxing/spasmolytic effect. Blockade of the muscarinic receptors in the GI tract is the basis for its use in the treatment of abdominal pain secondary to cramping. Hyoscine butylbromide also binds to nicotinic receptors, which induces a ganglion-blocking effect. Several pharmacokinetic studies in humans have consistently demonstrated the low systemic availability of hyoscine butylbromide after oral administration, with plasma concentrations of the drug generally being below the limit of quantitation. The bioavailability of hyoscine butylbromide, estimated from renal excretion, was generally <1%. However, because of its high tissue affinity for muscarinic receptors, hyoscine butylbromide remains available at the site of action in the intestine and exerts a local spasmolytic effect.Ten placebo-controlled studies have evaluated the efficacy and safety of oral or rectal hyoscine butylbromide. Hyoscine butylbromide was considered beneficial in all of these trials, which supports its use in the treatment of abdominal pain caused by cramping. Hyoscine butylbromide is barely absorbed and detectable in the blood and does not penetrate the blood-brain barrier, and is, therefore, generally well tolerated. Few adverse events have been reported; in particular, no significant increases in the incidence of anticholinergic-related adverse effects have been observed. In summary, hyoscine butylbromide appears to be a valuable treatment option for patients with symptoms of abdominal pain or discomfort associated with cramping.