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World Journal of Surgical Oncology Feb 2015The aim of this randomized controlled study was to determine whether octreotide (OCT) or scopolamine butylbromide (SB) was the more effective antisecretive drug... (Comparative Study)
Comparative Study Randomized Controlled Trial
Randomized clinical trial comparing octreotide and scopolamine butylbromide in symptom control of patients with inoperable bowel obstruction due to advanced ovarian cancer.
BACKGROUND
The aim of this randomized controlled study was to determine whether octreotide (OCT) or scopolamine butylbromide (SB) was the more effective antisecretive drug controlling gastrointestinal (GI) symptoms due to malignant bowel obstruction (MBO) caused by advanced ovarian cancer.
METHODS
Ninety-seven advanced ovarian cancer patients with inoperable MBO were randomized to OCT 0.3 mg/day (OCT group, n = 48) or SB 60 mg/day (SB group, n = 49) for 3 days through a continuous subcutaneous infusion. The following parameters were measured: episodes of vomiting, nausea, dry mouth, drowsiness, and continuous and colicky pain, using a Likert scale corresponding to a numerical value (none 0, slight 1, moderate 2, severe 3) recorded before starting the treatment (T0) and 24 h (T1), 48 h (T2), and 72 h after (T3) and the daily quantity of GI secretions through the Nasogastric tube (NGT) during the period of study. One patient in the SB group is not included in any assessments since she withdrew consent prior to receiving any treatment because of rapidly progressing cancer.
RESULTS
OCT significantly reduced the amount of GI secretions at T1, T2, and T3 (P < 0.05) compared with SB. NGT secretions significantly reduced at T1, T2, and T3 compared with T0 (P < 0.05) in the OCT group, while in the SB group, only at T3, NGT secretions significantly reduced compared with T0. OCT treatment induced a significantly rapid reduction in the number of daily episodes of vomiting and intensity of nausea compared with SB treatment. No significant changes were observed in dry mouth, drowsiness, and colicky pain after either drug. Continuous pain values were significantly lower in the OCT group than in the SB group at T2 and T3 (P < 0.05).
CONCLUSIONS
At the doses used in this study, OCT was more effective than SB in controlling gastrointestinal symptoms of bowel obstruction. Further studies are necessary to understand the role of hydration more clearly in such a clinical situation.
Topics: Butylscopolammonium Bromide; Female; Follow-Up Studies; Gastrointestinal Agents; Humans; Intestinal Obstruction; Liver Neoplasms; Middle Aged; Neoplasm Staging; Octreotide; Ovarian Neoplasms; Parasympatholytics; Peritoneal Neoplasms; Pleural Neoplasms; Prognosis; Prospective Studies; Severity of Illness Index
PubMed: 25889313
DOI: 10.1186/s12957-015-0455-3 -
World Journal of Gastroenterology Jun 2014To investigate the benefits of hyoscine butylbromide in polyp detection during colonoscopy by a meta-analysis of available randomized controlled trials (RCTs). (Meta-Analysis)
Meta-Analysis Review
AIM
To investigate the benefits of hyoscine butylbromide in polyp detection during colonoscopy by a meta-analysis of available randomized controlled trials (RCTs).
METHODS
Databases, including PubMed, EMBASE, the Cochrane Library, and the Science Citation Index up to September 2013, were searched. The primary outcome was polyp detection rate, and the secondary outcome was adenoma detection rate. The meta-analysis was performed using the free software Review Manager. Differences observed between the treated and the control groups were expressed as odds ratio (OR) with a 95% confidence interval (CI). A fixed-effects model was used to pool data when statistical heterogeneity was absent. If statistical heterogeneity was present (P < 0.05), a random-effects model was used.
RESULTS
The initial search identified nine articles. After screening, five RCTs with a total of 1998 patients were included in this meta-analysis. Of the five studies, all described a comparison of baseline patient characteristics and showed that there was no statistically significant difference between the two groups. Among the 1998 patients, 1006 received hyoscine butylbromide and 992 were allocated to the control group, and the polyp detection rate was reported. There were no significant differences between the treated and the control group (OR = 1.09, 95%CI: 0.91-1.31, P = 0.33). Four RCTs included 1882 patients, of whom 948 received hyoscine butylbromide, and the adenoma detection rate was reported. There were no significant differences between the treated and the control group (OR = 1.13, 95%CI: 0.92-1.38, P = 0.24).
CONCLUSION
The use of hyoscine butylbromide did not significantly improve the polyp detection rate during colonoscopy.
Topics: Adenoma; Butylscopolammonium Bromide; Chi-Square Distribution; Colonic Neoplasms; Colonic Polyps; Colonoscopy; Humans; Odds Ratio; Parasympatholytics; Predictive Value of Tests; Randomized Controlled Trials as Topic
PubMed: 24944499
DOI: 10.3748/wjg.v20.i22.7034 -
Urologia Internationalis 2014To investigate the evidence for the use of hyoscine N-butylbromide (HBB) in the treatment of acute renal colic. (Review)
Review
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.
Topics: Acute Disease; Analgesics; Butylscopolammonium Bromide; Evidence-Based Medicine; Humans; Muscarinic Antagonists; Renal Colic; Treatment Outcome
PubMed: 24576895
DOI: 10.1159/000358015 -
American Journal of Veterinary Research Nov 2013To evaluate the ability of atropine sulfate, butylscopolammonium bromide combined with metamizole sodium, and flunixin meglumine to ameliorate the clinical adverse... (Randomized Controlled Trial)
Randomized Controlled Trial
Evaluation of the use of atropine sulfate, a combination of butylscopolammonium bromide and metamizole sodium, and flunixin meglumine to ameliorate clinical adverse effects of imidocarb dipropionate in horses.
OBJECTIVE
To evaluate the ability of atropine sulfate, butylscopolammonium bromide combined with metamizole sodium, and flunixin meglumine to ameliorate the clinical adverse effects of imidocarb dipropionate in horses.
ANIMALS
28 horses with piroplasmosis.
PROCEDURES
28 horses were randomly assigned to 4 equal groups according to the pretreatment administered. Fifteen minutes before administration of 2.4 mg of imidocarb dipropionate/kg IM, horses in the first group were pretreated with 0.02 mg of atropine sulfate/kg IV, the second group with a combination of 0.2 mg of butylscopolammonium bromide/kg IV and 25 mg of metamizole sodium/kg IV, the third group with 1.1 mg of flunixin meglumine/kg IV, and the fourth (control) group with 1 mL of saline (0.9% NaCl) solution/50 kg IV. Physical examination, including evaluation of rectal temperature, heart and respiratory rates, capillary refill time, mucous membrane color, hydration status, abdominal sounds, signs of abdominal pain, salivation, diarrhea, and number of defecations, was performed.
RESULTS
Imidocarb dipropionate use in the control group was associated with serious adverse effects including signs of abdominal pain (4/7 horses) and diarrhea (2/7). Horses pretreated with atropine had no diarrhea, but 6 had signs of abdominal pain. Only 1 horse that received butylscopolammonium-metamizole pretreatment had signs of abdominal pain and 3 had diarrhea, which was numerically but not significantly different than the control group. Of horses pretreated with flunixin, 3 had signs of abdominal pain and 3 had diarrhea.
CONCLUSIONS AND CLINICAL RELEVANCE
A combination of butylscopolammonium bromide and metamizole sodium may be useful to ameliorate the adverse effects of imidocarb dipropionate in horses, although group size was small and significant differences from the control group were not found.
Topics: Abdominal Pain; Administration, Intravenous; Animals; Anti-Inflammatory Agents, Non-Steroidal; Antiprotozoal Agents; Atropine; Babesiosis; Butylscopolammonium Bromide; Clonixin; Diarrhea; Dipyrone; Female; Horse Diseases; Horses; Imidocarb; Male; Muscarinic Antagonists
PubMed: 24168305
DOI: 10.2460/ajvr.74.11.1404 -
World Journal of Radiology Jul 2013To evaluate the value of administration of hyoscine-N-butyl-bromide (HBB) for image quality magnetic resonance imaging (MRI) of the prostate.
AIM
To evaluate the value of administration of hyoscine-N-butyl-bromide (HBB) for image quality magnetic resonance imaging (MRI) of the prostate.
METHODS
Seventy patients were retrospectively included in the study. Thirty-five patients were examined with administration of 40 milligrams of HBB (Buscopan(®); Boehringer, Ingelheim, Germany); 35 patients were examined without HBB. A multiparametric MRI protocol was performed on a 3.0 Tesla scanner without using an endorectal coil. The following criteria were evaluated independently by two experienced radiologists on a five-point Likert scale: anatomical details (delineation between peripheral and transitional zone of the prostate, visualisation of the capsule, depiction of the neurovascular bundles); visualisation of lymph nodes; motion related artefacts; and overall image quality.
RESULTS
Comparison of anatomical details between the two cohorts showed no statistically significant difference (3.9 ± 0.7 vs 4.0 ± 0.9, P = 0.54, and 3.8 ± 0.7 vs 4.2 ± 0.6, P = 0.07) for both readers. There was no significant advantage regarding depiction of local and iliac lymph nodes (3.9 ± 0.6 vs 4.2 ± 0.6, P = 0.07, and 3.8 ± 0.9 vs 4.1 ± 0.8, P = 0.19). Motion artefacts were rated as "none" to "few" in both groups and showed no statistical difference (2.3 ± 1.0 vs 1.9 ± 0.9, P = 0.19, and 2.3 ± 1.1 vs 1.9 ± 0.7, P = 0.22). Overall image quality was rated "good" in average for both cohorts without significant difference (4.0 ± 0.6 vs 4.0 ± 0.9, P = 0.78, and 3.8 ± 0.8 vs 4.2 ± 0.6, P = 0.09).
CONCLUSION
The results demonstrated no significant effect of HBB administration on image quality. The study suggests that use of HBB is not mandatory for MRI of the prostate at 3.0 Tesla.
PubMed: 23908696
DOI: 10.4329/wjr.v5.i7.259 -
British Journal of Anaesthesia Dec 2013Catheter-related bladder discomfort (CRBD) secondary to intraoperative catheterization of urinary bladder is one of the most distressing symptoms during recovery from... (Randomized Controlled Trial)
Randomized Controlled Trial
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.
Topics: Adult; Aged; Blood Pressure; Butylscopolammonium Bromide; Double-Blind Method; Dysuria; Heart Rate; Humans; Intraoperative Care; Male; Middle Aged; Muscarinic Antagonists; Pain Measurement; Pain, Postoperative; Postoperative Care; Prospective Studies; Treatment Outcome; Urinary Catheterization; Urologic Surgical Procedures, Male; Young Adult
PubMed: 23869107
DOI: 10.1093/bja/aet249 -
African Health Sciences Dec 2012Prolonged labor is one of the most important risk factors for perinatal compromise and, if caused by obstructed labor, it carries the risk of uterine rupture, postpartum... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Prolonged labor is one of the most important risk factors for perinatal compromise and, if caused by obstructed labor, it carries the risk of uterine rupture, postpartum hemorrhage (PPH), puerperal sepsis, and maternal death.
OBJECTIVE
To determine whether or not hyoscine butylbromide shortens the stages of labor, without an increase in maternal or neonatal complications.
METHOD
In single-blinded randomized clinical trial study, 188 multiparas women in active phase of labor who were admitted to Shahid Sadoughi Hospital from October 2006 to April 2007 in Yazd - Iran, were evaluated. They were divided hyoscine group (n = 94) received 20mg (1ml) of hyoscine and control group (n = 94) received 1 ml of normal saline was given as placebo, intravenously. The effects of hyoscine in shortening labor time; and neonatal Apgar score was compared.
RESULTS
Duration of the first (mean± SD: 186.8 ± 125.6 minutes vs. 260.4 ± 120.9 minutes, p= 0.00 1) and second stage of labor (mean± SD: 20.0 ± 8.1minutes vs. 25.8 ± 9.4 minutes, p= 0.03) was shorter in hyoscine group. Frequency of cesarean section and mean of neonatal Apgar score at minutes of one and 5 were not different in both groups. No serious adverse events were seen in the two groups.
CONCLUSION
Injection of hyoscine in active phase of labor can be effective in shortening of labor without any adverse effect on mother and fetus.
Topics: Administration, Oral; Adult; Apgar Score; Butylscopolammonium Bromide; Cesarean Section; Female; Gestational Age; Humans; Infant, Newborn; Iran; Labor Stage, First; Labor, Induced; Maternal Age; Parasympatholytics; Parity; Pregnancy; Pregnancy Outcome; Single-Blind Method; Socioeconomic Factors; Time Factors
PubMed: 23515202
DOI: 10.4314/ahs.v12i4.1 -
Preoperative multidetector-row computed tomography scan staging for lymphatic gastric cancer spread.World Journal of Surgical Oncology Sep 2012Multidetector-row computed tomography (MDCT) is commonly used to stage patients with gastric cancer, even though the technique often shows low specificity for lymph-node...
BACKGROUND
Multidetector-row computed tomography (MDCT) is commonly used to stage patients with gastric cancer, even though the technique often shows low specificity for lymph-node involvement.
METHODS
In this study, 111 patients with gastric cancer who consecutively underwent MDCT scan followed by radical surgical treatment at our hospital were retrospectively evaluated.
RESULTS
In total, 3632 lymph nodes from 643 lymphatic stations were studied and then correlated with radiological features. Lymph-node size was not always associated with infiltration. Of the 261 lymph-node stations that were not radiologically detected, 60 (22.9%) were infiltrated. There were 108 stations with lymph nodes larger than 10 mm seen on MDCT, of which 67 (62%) had lymphatic invasion. The sensitivity was 32.6%, specificity 90.6%, positive predictive value 62.0%, negative predictive value 74.2%, and accuracy 72.1%. When three lymph nodes, at least one of which was larger than 10 mm, were detected in the same station, infiltration was confirmed with 99% specificity in 93.8% of patients. Moreover, all of the 13 patients in whom three lymph nodes larger than 10 mm were detected in different neighboring stations had lymphatic invasion.
CONCLUSIONS
Although presence of lymph nodes greater than 10 mm in size is not, in itself, sufficient to confirm lymphatic invasion, nodal involvement can be hypothesized when associated images are detected by MDCT.
Topics: Butylscopolammonium Bromide; Female; Gastrectomy; Humans; Lymph Nodes; Lymphatic Metastasis; Male; Multidetector Computed Tomography; Muscarinic Antagonists; Neoplasm Staging; Preoperative Period; Sensitivity and Specificity; Stomach Neoplasms
PubMed: 23006343
DOI: 10.1186/1477-7819-10-197 -
Journal of Veterinary Internal Medicine 2012Equine recurrent airway obstruction (RAO) is characterized by airway inflammation, bronchoconstriction, and increased mucus production in the airways. Anticholinergic... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Equine recurrent airway obstruction (RAO) is characterized by airway inflammation, bronchoconstriction, and increased mucus production in the airways. Anticholinergic drugs like atropine induce bronchodilatation and rapid improvement in lung function. N-butylscopolammonium bromide (NBB) is an anticholinergic drug used to relieve spasmodic colic in horses, but its effect on airway smooth muscle is unknown.
OBJECTIVE
To evaluate the effect of NBB on clinical signs and lung function of RAO-affected horses.
ANIMALS
Nine horses diagnosed with RAO.
METHODS
Double-blind, placebo-controlled, randomized crossover trial. Horses were challenged with moldy hay until a maximum change in transpulmonary pressure (∆P(L) (max) ) > 15 cm H(2) O was achieved. NBB (0.3 mg/kg) or placebo (0.9% saline) was administered IV. Clinical scores and lung function were recorded at baseline and then periodically after treatment administration. Horses were allowed a 6-week washout before administration of opposite treatments.
RESULTS
Clinical score at 10 and 30 minutes (8.7 ± 2.8 and 8.7 ± 3.2, respectively) after NBB administration was significantly lower than baseline (10.8 ± 2.4). NBB administration resulted in a significant decrease in ∆P(L) (max) (baseline: 35.1 ± 6.9 cm H(2) O) starting 2 minutes after administration (16.3 ± 6.6 cmH(2) O) with a maximum decline observed at 10 minutes (13.5 ± 7.1 cm H(2) O). ∆P(L) (max) values between 60 and 120 minutes after NBB administration were not different from placebo.
CONCLUSION AND CLINICAL IMPORTANCE
N-butylscopolammonium bromide is a potent bronchodilator, reaching maximum effect 10 minutes after intravenous administration. This effect dissipates within 1 hour of drug administration.
Topics: Animals; Butylscopolammonium Bromide; Cross-Over Studies; Double-Blind Method; Horse Diseases; Horses; Lung Diseases, Obstructive; Parasympatholytics
PubMed: 22925156
DOI: 10.1111/j.1939-1676.2012.00992.x -
Yakugaku Zasshi : Journal of the... 2011Marketing authorization holders do not disclose any information on the pharmaceutical properties of over-the-counter drugs (OTC). When a drug is switched from a... (Comparative Study)
Comparative Study
Marketing authorization holders do not disclose any information on the pharmaceutical properties of over-the-counter drugs (OTC). When a drug is switched from a prescription drug to OTC, pharmacists can acquire that information from the corresponding ethical drug (ED) through the package insert, interview form, and so on. However, the pharmaceutical equivalence between ED and OTC is unclear. In this study, we examined the drug dissolution behavior of both ED and OTCs containing scopolamine butylbromide. Dissolution tests were performed by the paddle method using Japanese Pharmacopeia (JP) XV test fluids at pH 1.2, 4.0 and 6.8 and water based on the guidelines for bioequivalence studies of generic products. The dissolution profiles of OTCs differed significantly from ED showing a similarity factor (f2) value ranging from 8.9 to 42.9. Time until 85% dissolution ranged from 23 to 95 min and from 17 to 174 min at pH 1.2 and pH 6.8, respectively. Then JP XV disintegration tests were conducted to investigate differences in the disintegration process. The disintegration time of preparations showing delayed dissolution was prolonged compared to that of others, suggesting that the disintegration of the tablet or capsule is one of the important factors affecting the drug dissolution. These differences in the disintegration and drug dissolution might cause differences in the bioavailability of the drug. For patient safety, more detailed product information of OTCs should be supplied by the manufacturer, and not be assumed from that of corresponding ED.
Topics: Biological Availability; Butylscopolammonium Bromide; Drug Substitution; Nonprescription Drugs; Patient Safety; Prescription Drugs; Solubility; Therapeutic Equivalency; Water
PubMed: 22041704
DOI: 10.1248/yakushi.131.1645