Hyoscine butylbromide for colorectal polyp detection: prospective, randomized, placebo-controlled trial

OBJECTIVES: The removal of pre-malignant colorectal lesions prevents cancer. Hyoscine has been proposed as a means of improving diagnosis by reducing colonic movements. The aim of this study was to analyze whether this anti-spasmodic enhances the detection of pre-malignant colorectal lesions. METHODS: In a randomized, double-blinded fashion patients received hyoscine or a saline solution in all consecutive colonoscopies in which the cecum was reached. Lesions were analysed with respect to number, size, location, histology and capillary pattern. RESULTS: A total of 440 colonoscopies were randomized. The overall polyp detection rate (PDR) and the adenoma detection rate (ADR) were 65.2% and 49.3%, respectively. In the hyoscine group, non-polypoid lesions were detected significantly more often (p=0.01). In the placebo group 281 lesions were diagnosed (202 adenomas) and in the hyoscine group 282 lesions were detected (189 adenomas) (p=0.23). The PDR and ADR were similar between the placebo and hyoscine groups (64% vs 66% and 50% vs 47%, respectively). No differences were observed between the two groups in the advanced-ADR or advanced neoplasia detection rate, as well the mean numbers of polyps, adenomas, advanced adenomas and advanced neoplasias detected per patient. The administration of hyoscine also did not improve the diagnostic accuracy of digital chromoendoscopy. The presence of adenomatous polyps in the right colon was detected significantly more frequently in the hyoscine group (OR 5.41 95% CI 2.7 - 11; p<0.01 vs OR 2.3 95% CI 1.1 - 4.6; p=0.02). CONCLUSION: The use of hyoscine before beginning the withdrawal of the colonoscope does not seem to enhance the PDR and the ADR.

Simultaneous Determination of Hyoscine N- Butyl Bromide and Paracetamol by RP-TLC Spectrodensitometric Method.

Aims: A simple RP-TLC Spectrodensitometric method was developed for determination of Hyoscine N-Butyl Bromide (HBB) and Paracetamol (PAR) either in bulk powder or in their pharmaceutical preparation. Study Design: Validation study. Methodology: In this method, HBB and PAR were separated on RP-18 W/ UV254 TLC plates using developing mobile phase consisting of methanol: citrate buffer (pH=1.5): triflouroacetic acid (70:30:0.1, by volume) at room temperature. Experimental conditions such as band size, slit width, different developing systems and scanning wavelength were carefully studied and the optimum conditions were selected. The obtained bands were then scanned at 210 nm. The two drugs were satisfactorily resolved with RF 0.60 ± 0.02 for HBB and 0.81 ± 0.02 for PAR. The validation of spectrodensitometric method was done regarding linearity, accuracy, precision, and specificity. Results: Linearity of the proposed methods was evaluated and it was found to lie within the concentration range of 2.0-12.0 μg.band-1 for HBB and 2.0-14.0 μg.band-1 for PAR. Conclusion: The proposed method was successfully applied for determination of HBB and PAR in pure form and in their different pharmaceutical formulations. The method proved to be specific, accurate and selective.

Efficacy of three different alpha 1-adrenergic blockers and hyoscine N-butylbromide for distal ureteral stones

PURPOSE: To evaluate hyoscine N-butyl bromide (HBB) and three different alpha-1 blockers in the treatment of distal ureteral stones. MATERIALS AND METHODS: A total of 140 patients with stones located in the distal tract of the ureter with stone diameters of 5 to 10mm were enrolled in the present study and were randomized into 4 equal groups. Group 1 received HBB, Group 2 received alfuzosin, Group 3 received doxazosin and Group 4 received terazosin. The subjects were prescribed diclofenac injection (75 mg) intramuscularly on demand for pain relief and were followed-up after two weeks with x-rays of the kidneys, ureters, bladder and urinary ultrasonography every week. The number of pain episodes, analgesic dosage and the number of days of spontaneous passage of the calculi through the ureter were also recorded. RESULTS: The average stone size for groups 1, 2, 3 and 4 was comparable (6.13, 5.83, 5.59 and 5.48 mm respectively). Stone expulsion was observed in 11 percent, 52.9 percent, 62 percent, and 46 percent in groups 1, 2, 3 and 4 respectively. The average time to expulsion was 10.55 ± 6.21 days in group 1, 7.38 ± 5.55 days in group 2, 7.85 ± 5.11 days in group 3 and 7.45 ± 5.32 days in group 4. Alpha blockers were found to be superior to HBB (p < 0.05). CONCLUSIONS: Medical treatment of distal ureteral calculi with alfuzosin, doxazosin and terazosin resulted in a signi?cantly increased stone-expulsion rate and decreased expulsion time when compared with HBB. HBB seems to have a negative effect on stone-expulsion rate.

Relief of renal colic using tramadol, tramadol/hyoscine-N-butylbromide or tramadol/alfuzosine combination therapy

OBJECTIVES: To compare the effect of Tramadol, Tramadol/HNBB combination and Tramadol/Alfuzosine combination in the relief of renal colic. MATERIALS AND METHODS: A total of 82 patients diagnosed with renal colic from May to October 2009 were included in the study. The patients were divided into three groups: Group I (n=27) was given Tramadol (50 mg/capsule orally) only, Group II (n=28) was given Tramadol and Hyoscine-N-Butylbromide (10 mg/tablet orally) and Group III was given Tramadol and Alfuzosine (10 mg/tablet orally). Pain was evaluated using the Visual Analog Scale pre-treatment and post-treatment. RESULTS: The Visual Analog Scale scores for all groups showed improvement after treatment. The average difference in Visual Analog Scale for Group I was 3.148, Group II was 3.444, and Group III was 3.429. A significant difference was seen in all treatment groups. ANOVA was used to compare the differences between the three treatments. All treatments had comparable results, therefore, no significant difference was seen in the effect of the three treatments. CONCLUSION: Relief of renal colic was achieved in all groups as seen in a decrease in the Visual Analog Scale Score after giving of treatment, however, the differences for each treatment group was not statistically significant.

Eficácia da N-butilescopolamina e dipirona sódica associadas ao cetoprofeno no alívio da dor pós-operatória de pacientes submetidas a duas técnicas diferentes de laqueadura por laparoscopia / Efficacy of N-butylscopolamine and sodium dipirone associated to ketoprofen for postoperative pain relief of patients submitted to two different laparoscopic sterilization techniques

JUSTIFICATIVA E OBJETIVOS: A laqueadura laparoscópica (LL) é um dos procedimentos mais dolorosos e a intensidade da dor varia com a técnica selecionada, sendo mais intensa com a técnica de oclusão das tubas uterinas com anel. As pacientes submetidas à LL referem dor em cólica no período PO e a N-butilescopolamina e a dipirona sódica, por suas propriedades anti-espasmódicas e analgésicas, associadas às propriedades antiinflamatórias do cetoprofeno, podem ser opção para profilaxia e tratamento de dor. O objetivo deste foi estudar a eficácia da N-butilescopolamina e da dipirona sódica associadas ao cetoprofeno, na prevenção de dor PO em pacientes submetidas à LL, com duas técnicas diferentes - diatermia e pinçamento com anel. MÉTODO: Participaram do estudo 50 pacientes, estado físico ASA I e II, com idade entre 23 e 47 anos. As pacientes foram distribuídas aleatoriamente em dois grupos: G1 - oclusão das tubas uterinas com anéis, G2 - oclusão das tubas uterinas com diatermia. Todas as pacientes receberam N-butilescopolamina (20 mg) e dipirona sódica (2500 mg) e cetoprofeno (100 mg), por via venosa, imediatamente antes da indução da anestesia. A dor foi avaliada pelo critério de escala numérica verbal, variando de 0 a 10, sendo 0 ausência de dor e 10 o máximo de dor, a cada 10 minutos na primeira hora, na sala de recuperação pós-anestésica (SRPA) e na 1ª, 2ª, 3ª e 4ª horas após a alta da SRPA. Dor com intensidade maior que 3 era tratada com tramadol (100 mg), por via venosa. A avaliação da dor foi realizada sem que se soubesse a que grupo pertencia a paciente. Para análise estatística, testes t de Student, Mann-Whitney e Friedman. RESULTADOS: Ambos os grupos foram idênticos com relação à idade, ao peso, à altura, à duração da cirurgia e anestesia. As pacientes do G1 apresentaram maior escore de dor que as do G2, em todos os momentos do estudo. Valores estatisticamente significativos: 80 por cento das pacientes de G1 e 16 por cento de G2 necessitaram de tramadol em algum momento do estudo. CONCLUSÕES: A N-butilescopolamina e a dipirona sódica associadas ao cetoprofeno mostraram ser alternativa de analgesia pós-operatória quando a laqueadura é realizada com a técnica de diatermia.

Determination and quantification of cetirizine HCL in dosage formulations by RP-HPLC

A simple, sensitive, reliable and rapid HPLC method for the determination of cetirizine hydrochloride using hyoscine butyl bromide as an internal standard has been developed. The chromatographic system consisted of Shimadzu LC-10 AT VP pump, SPD-10 AV VP with UV/visible detector and a CBM-102 Bus Module integrator. Separation was achieved on the U Bondapak 125 A C18 10um column at room temperature. The samples were introduced through an injector valve with a 10 ul sample loop. Acetonitrile-water [1:1 v/v] was used as mobile phase, with flow rate 2 ml/minutes. pH was adjusted to 2.9 with phosphoric acid. UV detection was performed at 205 nm. The results obtained showed a good agreement with the declared content. Recovery values for cetirizine hydrochloride were 99.19 - 100.82%. The proposed method is reliable rapid, precise, selective and may be used for the quantitative analysis of cetirizine HCl, in presence of hyoscine butyl bromide as internal standard. The method was valid was for the determination in raw materials, bulk drug and formulations. The limit of quantification was 5 - 30 nano grams, while the limit of detection was 0.4 nano grams

Valor terapêutico da associaçäo de espasmolítico com analgésico contendo brometo de N-butilescopolamina com dipirona / Therapeutic value of the combination between an spasmolithic with an analgesic: scopolamine-N-butyl bromide and dipirone

A grande mioria das combinaçöes de fármacos säo irracionais e perigosas. Por outro lado, existem algumas associaçöes medicamentosas que apresentam bases farmacológicas racionais ao lado de uma adequada relaçäo benefício/risco. A associaçäo entre o brometo de N-butilescopolamina com a dipirona é aprovada pelas autoridades sanitárias em vários países apresentando claras indicações terapêuticas, No Brasil particularmente, essa combinaçäo foi aprovada há mais de trinta anos, estando mesmo padronizada em muitos hospitais, principalmente na emergência. A classe médica considera essa combinaçäo fixa como uma associação analgésica de primeira escolha, prática, de baixo custo e muito eficaz

Non-operative management of intestinal obstruction due to Ascaris lumbricoides

To compare, evaluate and analyze three different non-operative modalities of treatment of intestinal obstruction due to ascaris lumbricoides. Design: A non-randomized, cohort and comparative study. Place and Duration of Study: Department of Pediatric Surgery, National Institute of Child Health, Karachi from March 2001 to October 2002. Patients and A total of 45 patients with the diagnosis of intestinal obstruction due to ascaris lumbricoides were included in the study. They were divided in 3 groups of 15 patients each. Group I patients were given I/V fluids only, group II patients were given hyoscinbutylbromide in infusion and group III patients were given hypertonic saline enema. The outcome of all groups was compared in terms of improvement in obstruction and hospital stay. The data was analyzed by SPSS 11.0 by using ANOVA and HSD Tuckey test for multiple comparisons. The non-operative treatment was successful in all of the patients. In group III improvement of intestinal obstruction occurred in 1.6 +/- 1.11 days [p value=0.001], whereas it was 2.6 +/- 1.11 days in group II and 3.4 +/- 1.35 days in group I. The mean hospital stay in group III was 4 +/- 1.69 days [p value=0.003], whereas it was 6.27 +/- 2.31 days in group II and 5.87 +/- 1.25 days in group I. We recommend that hypertonic saline enema is a better non-operative treatment modality of intestinal obstruction, due to ascaris lumbricoides, in patients who do not have peritonitis. It is associated with early improvement of obstruction coupled with reduced hospital stay

Antispasmodic action of propinox on the isolated human gallbladder: possible mechanism of action

Propinox is an antispasmodic drug frequently used in the treatment of disorders of the gastrointestinal tract, the uterus and the galbladder, but little is known about its relaxing activity in gallbladder tissue. The main objective of this study was to determine the antispasmodic activity of propinox, compared to other antispasmodics, in the gallblader and to assess its binding affinity to receptor sites which may be involved in its mechanism of action. Antispasmodic activity of propinox, (-) scopolamine-n-butyl bromide, atropine and verapamil was determined in human gallbladders to reduce the risk of interspecies variability. Inhibitory activities (ED50) of carbachol-induced contraction were: atropine 5.03x10(-8) M>propinox 1.25x10(-7) M> verapamil 6.63x10(-6)M> (-) scopolamine-n-butyl1 bromide 5.4x10(-5) M. pD'2 for propinox was 6.94, indicating non competitive inhibition of carbachol action. Radioligand binding studies were performed to determine if the antisplasmodic action of the drug involved binding to muscarinic receptors or calciumatagonist sites. The inhibition constant (Ki) of proponix for muscarinic receptors of guinea pig ileum smoth muscle, which contains a mixed M2-M3 receptor population, was 1.6x10(-6) M. Ki for brain muscarinic receptors (M1) was 1.0x10(-4) M, for cardiac receptors (M1) was 1.0x10(-4)M, for receptors (M2) 1.2x10(-6)M and from salivary gland receptors (M3) 1.5x10(-6)M. For binding to the dihidropiridine calcium antagonist binding sites, Ki were: 4.9x10(-5)M for propinox and 2.2x10(-7)M for verapamil. For the phenylakylamine binding sites Ki were: 5.0x10(-6)M for propinox and 3.5x10(-8)M for verapamil. For the benzothiacepine binding sites, Ki for propinox was 5.2x10(-6)M. The following may be concluded: 1- The antispasmodic activity of propinox in isolated human galbladder was was comparatively less potent than of atropine and more potent than those verapamil and (-) scopolamine-n-butyl bromide. 2- Propinox showed binding to muscarinic and calcium receptors that can be related to its antisplasmodic activity; suggesting that the drug is an antispasmodic with anticholinergic and musculotropic activity. 3.- The dual mechanism of action, anticholinergic and calcium-blocking, would induce synergism of pharmacodynamic effects and minimize adverse events of pure antimuscarinic drugs or calcium antagonists.

Effect of hyoscine butylbromide and atropine on heart rate during nocturnal sleep.

This is a single blind crossover study designed to test the effects of hyoscine butylbromide (HBB), an anticholinergic which does not cross the blood brain barrier (BBB), on the temporal changes in heart rate during nocturnal sleep. The effects were compared with atropine sulphate which is known to cross the BBB. Ten healthy male volunteers slept in the JIPMER sleep disorders laboratory for three nights and received either saline, atropine sulphate (0.4 mg, i.v.) or HBB (10 mg, i.v.) just prior to sleep onset. All night polysomnography recording was done to monitor heart rate during the specific stages of sleep. The normal physiological fall in heart rate is blunted by both drugs during slow wave sleep whereas only HBB prevented the fall in rapid eye movement sleep. Therefore, HBB may be a better choice as pre-anaesthetic medication for patients with cardiac abnormalities since it does not alter heart rate during both slow wave sleep and rapid eye movement sleep.

Comparative effects of hyoscine butylbromide and atropine sulphate on sleep architecture in healthy human volunteers.

The changes in sleep architecture, heart rate and respiratory rate to hyoscine butylbromide (HBB), a peripherally acting anticholinergic was studied. These effects were compared with that of atropine sulphate, a drug known to cross the blood brain barrier. The study followed a single blind cross over design with a one week washout period. Atropine sulphate (0.4 mg) and HBB (10 mg) were given intravenously to ten adult healthy male volunteers before sleep onset. Normal saline was used as control. All night sleep polysomnography was done with the standard montage for sleep staging. Respiration and airflow were also monitored. Rapid eye movement (REM) latency was significantly increased with both the drugs whereas the duration of REM sleep was decreased only with atropine. Slow wave sleep (SWS) was also increased significantly by atropine. There was no change in heart rate, or respiratory rate during any of the sleep stages. HBB affects the initiation of REM sleep whereas atropine affects both its initiation and maintenance.

Efecto analgésico antiespasmódico y seguridad del clonixinato de lisina y bromuro de L-Butilhioscina en el tratamiento oral de la dismenorrea / Antispasmodic-analgesic effect and safety of Lysene clonixinate and Butylhioscine broide for dysmenorrhea oral treatment

Fue realizado un estudio clínico longitudinal abierto, no comparativo, en 30 mujeres con diagnóstico de dismenorrea primaria o secundaria a dispositivo intrauterino. El objetivo del estudio fue evaluar la eficacia y seguridad del compuesto terapéutico, Clonixinato de lisina y Bromuro de butihioscina 125 y 10 mg respectivamente, en cápsulas, durante un periodo de observación de tres ciclos menstruales. El tiempo de evolución de la dismenorrea primaria fue de 4.46 años; para la secundaria fue de 1.77 años. A la dismenorrea le acompañaron síntomas asociados como: náusea 92 por ciento, vómito 92 por ciento, malestar general 82.1 por ciento, pesantez abdominales 85.7 por ciento y cefalea 46.4 por ciento. Respecto a la intensidad del dolor menstrual, al inicio fue muy severo en el 10.7 por ciento, severo en 42.9 por ciento y moderado 46.4 por ciento. Al final del estudio sólo una paciente de las 28, presentó dolor menstrual de intensidad moderada. Encontramos sólo tres menciones de efectos secundarios de intensidad leve y que no requirieron tratamiento; que correspondieron a dos menciones de gastralgía y una de somnolencia. La conclusión del estudio es que la asociación analgésica espasmolítica del Clonixinato de lisina y Bromuro de butilhioscina en el tratamiento de la dismenorrea primaria o secundaria, reduce y previene el dolor menstrual, así como las manifestaciones asociadas con pocos efectos secundarios. Esta asociación analgésica espasmolítica, es eficaz y segura

Effect of Low - Dose Midazolam for Colonoscopy / 대한소화기내시경학회지

BACKGROUND/AIMS: Because colonoscopy is a painful procedure, analgesics and sedatives may be necessary as premedication. Midazolam reacts quicker, has a more excellent amnesic effect and fewer complications compared to diazepam. The effects of midazolam depend on dose, age, and rapidity of injection. According to several studies, side effects of midazolam were more common in high-dose injections (more than 5 mg) compared to low dose injections (0.03-0.05 rng/kg). Moreover, low dose injections were found to be as effective as high dose injections. However, there was no report about the effect and the side effects of midazolam in Korea. Therefore, we performed this study to determine the effect of low dose midazolam as premedication for colonoscopy. METHODS: We performed colonoscopy in 99 consecutive patients who were randomly selected (midazolam group: 50, placebo group: 49) prospectively from July 1996 to September 1996. Premedication was administered through intravenous injection of midazolam or saline 0.03 mg/kg, combined with intramuscular injections of meperidine 50 mg, and intravenous injections of Buscopan 20 mg in all patients. Blood pressure, puise rate, and O2 saturation by oxymeter were checked before, during, and 30 minutes after colonoscopy. The degree of amnesia, discomfort, cooperation and acceptance of the re-examination were checked.

Compatibility Studies on some Commercially Available Gentamicin Sulphate Injections with Commonly Co-Administered Parenterals

Compatibility of four brands of gentamicin sulphate injection with five parenteral drugs-dexamethasone; diazepam; hyoscine butylbromide; furosemide and promethazine were studied. These drugs are commonly used together in pre-anaesthetic or post-anaesthetic medications among others. For the different test situations; solutions of varying concentrations of gentamicin sulphate were prepared and mixed with the test drugs. After the test period; all the admixtures were evaluated for gentamicin potency; Ph changes; clarity and extent of interaction. Potency changes were determined by microbial assays while the extend of interaction was determined by chromatographic techniques. No significant changes in pH were observed in all the admixture studied. A significant reduction in potency was observed in all the admixtures of Gentarad. No significant interactions were observed based on the chromatographic studies

Dynamic MR Imaging in gastric Cancer: Comparison Between Precontrast and Postcontrast Images

PURPOSE: To analyze contrast-enhancement pattern of stomach cancer on dynamic MRI and to verify the efficacy of intravenous contrast agent in the evaluation of stomach cancer. MATERIALS AND METHODS: Twelve patients with proven stomach cancer underwent dynamic MRI, By using 1.0T scanner, we obtained precontrast FLASH images, and 30, 60, 90 second delay FLASH images after intravenous contrast injection. All patients ingested on liter of water and had intramuscluar injection of Buscopan just before MR study. For quantitative analysis we measured signal to noise ratio (S/N) of stomach cancer on each image, and signal difference to noise ratio (SD/N) between cancer and intraluminal fluid, cancer and the pancreas. For qualitative analysis two radiologists evaluated lesion conspicuity on each image by grading system(grade 0, 1, 2, 3: poor, fair, good, excellent). RESULTS: S/N of stomach cancer increased gradually by time(precontrast, 30, 60, 90 second delay:38.7, 42.5, 57.4, 65.7). SD/N between cancer and intraluminal fluid significantly increased after contrast enhancement(1.24, 25.01, 39.30, 45.89). SD/Ns between cancer and the pancreas were 10.5, 9.33, 9.99, 10.66 respectively. In qualitative analysis, precontrast images were better than postcontrast images for delineation of stomach cancer, Postcontrast images showed clear endo-luminal side of stomach cancer, but outer margin of stomach cancer was more distinct on precontrast images. CONCLUSION: Precontrast MR images are better than postcontrast MR images in the depiction of stomach cancer. Intravenous contrast agent is not imperative in the evaluation of stomach cancer.

A Clinical Usefulness of Premedication with Hyoscine-N-butyl bromide (Buscopan(R)) in Colonoscopy: A Randomized, Double Blinded, Prospective Study / 대한소화기내시경학회지

BACKGROUND: Use of antispasmodic medication prior to colonoscopy is controversial but someone believes antispasmodic may improve visualization of colonic mucosa and ease colonoscope insertion. So, we designed a study to assess the effect of premedication with the antispasmodic, hyoscine-N-butyl bromide(Buscopan(R)) on the performance of colonoscopy. METHODS: This study was prospective, double blinded, randomized, controlled study, One hundred three consecutive patients were randomized to receive intravenous buscopan lml(n=52) or placebo(n=51) combined with our standard initial medication(me-peridine 50 mg and midazolam 2 mg). Insertion of colonoscopy was timed, and 100 mm visual analogue scales (VAS) were used for asscssing difficulty of procedure, colonic motility, frequency of positional change, frequency of external compression, difficulty of assistance and degree of discomfort experienced by the patients. RESULTS: There were no significant differences of intubation time between buscopan group(mean time, 7.23 min., range 2~15) and placebo group(7.07 min., range 3~25), (p=0.83) and withdrawal time between buscopan group (6.46 min., range 2-22) and placebo group(6.76 min., range 2 25), (p=0.69). Also, there was no significant differences in intubation time between males and females(buscopan; males 7.00 min., females 7.60 min., p=0.34, placebo; males 7.0~5 min., females 7.08 min., p 0.44). The VAS scores checked by endoscopist(p=0.29), assistant(p=0.32) and patient (p=0.15) were not significantly different in both groups. There were no significant differences in intubation time, VAS scores nf endoscopist, assistant, and patients. CONCLUSION: Premedication with intravenous bu.opan has no advantage on colonoscopy procedure. Use of antispasmodic medication prior to colonoscopy was not considered as recommendable agent.