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1.
Gastroenterology ; 2016 Feb 19.
Article in English | MEDLINE | ID: mdl-27144629

ABSTRACT

The concept that motor disorders of the gallbladder, cystic duct and sphincter of Oddi can cause painful syndromes is attractive and popular, at least in the USA. However, the results of commonly performed ablative treatments (cholecystectomy and sphincterotomy) are not uniformly good. The predictive value of tests that are often used to diagnose dysfunction (dynamic gallbladder scintigraphy and sphincter manometry) is controversial. Evaluation and management of these patients is made difficult by the fluctuating symptoms and the placebo effect of invasive interventions. A recent stringent study has shown that sphincterotomy is no better than sham treatment in patients with post-cholecystectomy pain and little or no objective abnormalities on investigation, so that the old concept of sphincter of Oddi dysfunction (SOD) type III is discarded. ERCP approaches are no longer appropriate in that context. There is a pressing need for similar prospective studies to provide better guidance for clinicians dealing with these patients. We need to clarify the indications for cholecystectomy in patients with Functional Gallbladder Disorder (FGBD) and the relevance of sphincter dysfunction in patients with some evidence for biliary obstruction (previously SOD type II, now called "Functional Biliary Sphincter Disorder - FBSD") and with idiopathic acute recurrent pancreatitis.

2.
Endoscopy ; 43(4): 325-30, 2011 Apr.
Article in English | MEDLINE | ID: mdl-21455872

ABSTRACT

BACKGROUND: Temporary prophylactic pancreatic duct stenting effectively reduces post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk patients, but the optimal stent remains unclear. We compared rate of spontaneous passage, and technical difficulty of placement for 3-Fr and 5-Fr stents. METHODS: A randomized controlled trial at a single academic medical center. Patients deemed high risk for PEP randomly received 5-Fr or 3-Fr pancreatic duct stents. Primary outcome was spontaneous stent passage by 2 weeks. Secondary outcomes were ease and time for stent placement, and number of guide wires required for the entire procedure. RESULTS: Patients (69 female [89 %]; mean age 44.9 years, standard deviation [SD] 16.8) were randomly assigned to receive 5-Fr (n = 38) and 3-Fr (n = 40) stents. Indications for stenting were similar. Seven patients in the 3-Fr group actually received a 5-Fr stent, and two in the 5-Fr group had a 3-Fr stent. Spontaneous passage or non-passage was confirmed in 64 (83 %). No statistically significant difference in spontaneous passage rates was seen (5-Fr group, 68.4 %; 3-Fr group 75.0 %; P = 0.617). Non-passage rates were 10.5 % (5-Fr group) and 10.0 % (3-Fr group) ( P = 1.00). The study was stopped after a futility analysis for the primary end point. Placement of 5-Fr stents was rated easier, at a mean score of 1.8 (5-Fr) vs. 3.4 (3-Fr), P < 0.001, with a trend towards being faster, 9.2 vs. 11.1 minutes ( P = 0.355). Fewer guide wires were required for 5-Fr stent placement, 1.5 vs. 1.9 ( P = 0.002). PEP rates did not differ ( P = 0.519). CONCLUSION: Placement of 5-Fr compared to 3-Fr pancreatic duct stents for PEP prophylaxis is easier, faster, and requires fewer wires. No statistically significant difference in spontaneous passage was found between the two sizes.


Subject(s)
Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Pancreatic Ducts/surgery , Pancreatitis/etiology , Pancreatitis/prevention & control , Stents , Adult , Female , Humans , Male , Middle Aged , Risk Factors , Stents/adverse effects
3.
Gut ; 57(9): 1262-7, 2008 Sep.
Article in English | MEDLINE | ID: mdl-18375470

ABSTRACT

BACKGROUND: Several pharmacological agents for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) have been studied. Clinical trials evaluating the protective effect of non-steroidal anti-inflammatory drugs (NSAIDs) have yielded inconclusive results. AIM: To perform a meta-analysis of studies evaluating the effect of prophylactic rectal NSAIDs on PEP. METHODS: By searching Medline, Embase, meeting abstracts and bibliographies, two independent reviewers systematically identified prospective randomised controlled trials (RCTs) examining the effect of rectally administered prophylactic NSAIDs on the incidence of PEP pancreatitis. A meta-analysis of these clinical trials was performed. RESULTS: Four RCTs, enrolling a total of 912 patients, have been published. Meta-analysis of these studies demonstrates a pooled relative risk for PEP after prophylactic administration of NSAIDs of 0.36 (95% CI 0.22 to 0.60); patients who received NSAIDs in the periprocedural period were 64% less likely to develop pancreatitis and 90% less likely to develop moderate to severe pancreatitis. The pooled number needed to treat with NSAIDs to prevent one episode of pancreatitis is 15 patients. No adverse events attributable to the use of NSAIDs were reported in any of the clinical trials. CONCLUSION: In this meta-analysis, prophylactic NSAIDs were effective in preventing PEP. Widespread prophylactic administration of these agents may significantly reduce the incidence of PEP, resulting in major clinical and economic benefit. Given current scepticism regarding the efficacy of any prophylactic medication for ERCP, additional multicentre studies are needed for confirmation prior to widespread adoption of this strategy.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Pancreatitis/prevention & control , Acute Disease , Administration, Rectal , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Humans , Pancreatitis/etiology , Randomized Controlled Trials as Topic
4.
Am J Gastroenterol ; 96(10): 2900-4, 2001 Oct.
Article in English | MEDLINE | ID: mdl-11693324

ABSTRACT

OBJECTIVES: ERCP is the gold standard for pancreaticobiliary evaluation but is associated with complications. Less invasive diagnostic alternatives with similar capabilities may be cost-effective, particularly in situations involving low prevalence of disease. The aim of this study was to compare the performance of endoscopic ultrasound (EUS) with magnetic resonance cholangiopancreatography (MRCP) and ERCP in the same patients with suspected extrahepatic biliary disease. The economic outcomes of EUS-, MRCP-, and ERCP-based diagnostic strategies were evaluated. METHODS: Prospective cohort study of patients referred for ERCP with suspected biliary disease. MRCP and EUS were performed within 24 h before ERCP. The investigators were blinded to the results of the alternative imaging studies. A cost-utility analysis was performed for initial ERCP, MRCP, and EUS strategies for these patients. RESULTS: A total of 30 patients were studied. ERCP cholangiogram failed in one patient, and another patient did not complete MRCP because of claustrophobia. The final diagnoses (N = 28) were CBD stone (mean = 4 mm; range = 3-6 mm) in five patients; biliary stricture in three patients, and normal biliary tree in 20. Two patients had pancreatitis after therapeutic ERCP, one after precut sphincterotomy followed by a normal cholangiogram. EUS was more sensitive than MRCP in the detection of choledocolithiasis (80% vs 40%), with similar specificity. MRCP had a poor specificity and positive predictive value for the diagnosis of biliary stricture (76%/25%) compared to EUS (100%/100%), with similar sensitivity. The overall accuracy of MRCP for any abnormality was 61% (95% CI = 0.41-0.78) compared to 89% (CI = 0.72-0.98) for EUS. Among those patients with a normal biliary tree, the proportion correctly identified with each test was 95% for EUS and 65% for MRCP (p < 0.02). The cost for each strategy per patient evaluated was $1346 for ERCP, $1111 for EUS, and $1145 for MRCP. CONCLUSIONS: In this patient population with a low disease prevalence, EUS was superior to MRCP for choledocholithiasis. EUS was most useful for confirming a normal biliary tree and should be considered a low-risk alternative to ERCP. Although MRCP had the lowest procedural reimbursement, the initial EUS strategy had the greatest cost-utility by avoiding unnecessary ERCP examinations.


Subject(s)
Biliary Tract Diseases/diagnosis , Cholangiography/methods , Endosonography , Magnetic Resonance Imaging/methods , Adult , Aged , Cholangiography/economics , Cholangiopancreatography, Endoscopic Retrograde/economics , Costs and Cost Analysis , Endosonography/economics , Female , Humans , Magnetic Resonance Imaging/economics , Male , Middle Aged , Prospective Studies , Ultrasonography, Interventional/economics
5.
J Low Genit Tract Dis ; 5(2): 105-8, 2001 Apr.
Article in English | MEDLINE | ID: mdl-17043586

ABSTRACT

OBJECTIVE: The Home Study Course is intended for the practicing colposcopist or practitioner who is seeking to develop or enhance his or her colposcopic skills. The goal of the course is to present colposcopic cases that are unusual or instructive in terms of appearance, presentation, or management or that demonstrate new and important knowledge in the area of colposcopy or pathology. Participants may benefit from reading and studying the material or from testing their knowledge by answering the questions. ACCME ACCREDITATION: The American Society for Colposcopy and Cervical Pathology (ASCCP) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to sponsor continuing medical education for physicians. The ASCCP designates this continuing medical education activity for 1 credit hour in Category 1 of the Physician's Recognition Award of the American Medical Association. Credit is available for those who choose to apply. The Home Study Course is planned and produced in accordance with the ACCME's Essential Areas and Elements.

6.
Am J Gastroenterol ; 95(9): 2271-7, 2000 Sep.
Article in English | MEDLINE | ID: mdl-11007228

ABSTRACT

UNLABELLED: Preoperative localization of pancreatic neuroendocrine tumors with traditional imaging fails in 40-60% of patients. Endoscopic ultrasound (EUS) is highly sensitive in the detection of these tumors. Previous reports included relatively few patients or required the collaboration of multiple centers. We report the results of EUS evaluation of 82 patients with pancreatic neuroendocrine tumors. METHODS: We prospectively used EUS early in the diagnostic evaluation of patients with biochemical or clinical evidence of neuroendocrine tumors. Patients had surgical confirmation of tumor localization or clinical follow-up of >1 yr. RESULTS: Eighty-two patients underwent 91 examinations (cases). Thirty patients had multiple endocrine neoplasia syndrome type 1. One hundred pancreatic tumors were visualized by EUS in 54 different patients. The remaining 28 patients had no pancreatic tumor or an extrapancreatic tumor. Surgical/pathological confirmation was obtained in 75 patients. The mean tumor diameter was 1.51 cm and 71% of the tumors were < or =2.0 cm in diameter. Of the 54 explorations with surgical confirmation of a pancreatic tumor, EUS correctly localized the tumor in 50 patients (93%). Twenty-nine insulinomas, 18 gastrinomas, as well as one glucagonoma, one carcinoid tumor, and one somatostatinoma were localized. The most common site for tumor localization was the pancreatic head (46 patients). Most tumors were hypoechoic, homogenous, and had distinct margins. EUS of the pancreas was correctly negative in 20 of 21 patients (specificity, 95%). EUS was more accurate than angiography with or without stimulation testing (secretin for gastrinoma, calcium for insulinoma), transcutaneous ultrasound, and CT in those patients undergoing further imaging procedures. EUS was not reliable in localizing extrapancreatic tumors. CONCLUSIONS: In this series, the largest single center experience reported to date, EUS had an overall sensitivity and accuracy of 93% for pancreatic neuroendocrine tumors. Our results support the use of EUS as a primary diagnostic modality in the evaluation and management of patients with neuroendocrine tumors of the pancreas.


Subject(s)
Adenoma, Islet Cell/diagnostic imaging , Carcinoid Tumor/diagnostic imaging , Pancreatic Neoplasms/diagnostic imaging , Somatostatinoma/diagnostic imaging , Adenoma, Islet Cell/pathology , Adenoma, Islet Cell/surgery , Adolescent , Adult , Aged , Carcinoid Tumor/pathology , Carcinoid Tumor/surgery , Diagnosis, Differential , Female , Humans , Male , Middle Aged , Pancreatectomy , Pancreatic Neoplasms/pathology , Pancreatic Neoplasms/surgery , Prospective Studies , Reproducibility of Results , Sensitivity and Specificity , Somatostatinoma/pathology , Somatostatinoma/surgery , Ultrasonography
7.
Gastrointest Endosc ; 52(3): 362-6, 2000 Sep.
Article in English | MEDLINE | ID: mdl-10968851

ABSTRACT

BACKGROUND: Pre-medication with droperidol has been used to improve sedation during endoscopy, especially in patients with a history of alcohol or narcotic abuse. We studied whether routine use of droperidol pre-endoscopic retrograde cholangiopancreatography (ERCP) could improve patient and physician satisfaction with sedation. METHODS: Sixty-seven patients undergoing routine ERCP were enrolled in this double-blind placebo-controlled study. Patients were given either parenteral normal saline solution or 5 mg of droperidol 15 minutes before the procedure. After the ERCP, several parameters of procedural sedation were scored on an ordinal scale by the endoscopist, the endoscopy nurse, and the recovered patient. In addition, a follow-up telephone call was made to the patient after 24 hours. RESULTS: The mean procedural room time was similar in the two groups. Nearly 25% less meperidine and diazepam was used in the droperidol-treated patients, making the overall medication cost similar in both groups. The mean recovery room time was 113 minutes for the placebo group and 106 minutes for the droperidol group. Droperidol premedication significantly decreased post-procedure nausea and vomiting, reduced gagging at intubation, and decreased retching during the procedure. Droperidol also improved physician (p = 0.001), nurse (p = 0.001), and patient (p = 0.0001) impressions of overall sedation and decreased the need for physical restraint during the procedure. Droperidol significantly increased the number of patients with no memory of the procedure. CONCLUSION: Droperidol improved overall patient, physician, and nurse satisfaction with sedation during ERCP. It also reduced post-ERCP nausea and vomiting without increasing recovery time or medication cost. Droperidol is recommended for routine pre-ERCP sedation. (Gastrointest Endosc 2000;52:362-6).


Subject(s)
Antipsychotic Agents/administration & dosage , Cholangiopancreatography, Endoscopic Retrograde , Conscious Sedation/methods , Droperidol/administration & dosage , Premedication/methods , Adolescent , Adult , Aged , Aged, 80 and over , Double-Blind Method , Humans , Injections, Intravenous , Middle Aged , Pain Measurement , Patient Satisfaction , Surveys and Questionnaires
8.
Gastrointest Endosc ; 51(3): 282-7, 2000 Mar.
Article in English | MEDLINE | ID: mdl-10699772

ABSTRACT

BACKGROUND: Flumazenil is a benzodiazepine antagonist indicated for reversal of the sedative effects of benzodiazepines. Previous studies suggest that flumazenil may shorten recovery time after endoscopy, but there are few data on actual recovery room times and charges. METHODS: Fifty patients undergoing routine upper endoscopy were sedated with midazolam alone in the usual titrated manner. Patients were randomized in a double-blind fashion to receive either flumazenil or saline immediately after procedure. Assessments of responsiveness, speech, facial expression, and ptosis (Observer's Assessment of Alertness/Sedation [OAA/S] scale) were made before procedure, immediately after procedure and every 15 minutes thereafter. The patient was discharged from the recovery room when vital signs and OAA/S scale reached preprocedure levels. Recovery room times and charges were recorded. RESULTS: The flumazenil group demonstrated shorter recovery room times and recovery room charges than the placebo group (p < 0.001). The difference in recovery room charges was not statistically different when flumazenil charges were included (p = 0.09). CONCLUSIONS: The routine use of flumazenil after midazolam sedation for upper endoscopy significantly shortened recovery time and charges but did not statistically reduce overall charges.


Subject(s)
Endoscopy, Gastrointestinal , Flumazenil , Adult , Ambulatory Care , Anesthesia Recovery Period , Attitude of Health Personnel , Cost-Benefit Analysis , Double-Blind Method , Female , Flumazenil/administration & dosage , Flumazenil/economics , Hospital Charges , Humans , Hypnotics and Sedatives , Male , Midazolam , Middle Aged , Patient Satisfaction , Recovery Room/economics , Time Factors
9.
Gastrointest Endosc ; 50(1): 27-33, 1999 Jul.
Article in English | MEDLINE | ID: mdl-10385718

ABSTRACT

BACKGROUND: Computerized tomography (CT), magnetic resonance imaging (MRI), and transabdominal ultrasound frequently fail to detect ampullary lesions. Endoscopic ultrasound (EUS) is a sensitive modality for detecting and staging ampullary tumors. Accurate staging may be affected by biliary stenting, which is frequently performed in these patients with obstructive jaundice. The present study assessed the accuracy of ampullary tumor staging with multiple imaging modalities in patients with and those without endobiliary stents. METHODS: Fifty consecutive patients with ampullary neoplasms from two endosonography centers were preoperatively staged by EUS plus CT (37 patients), MRI (13 patients), or angiography (10 patients) over a 3(1/2) year period. Twenty-five of the 50 patients had a transpapillary endobiliary stent present at the time of endosonographic examination. Accuracy of EUS, CT, MRI, and angiography was assessed with the TNM classification system and compared with surgical-pathologic staging. The influence of an endobiliary stent present at the time of EUS on staging accuracy of EUS was also evaluated. RESULTS: EUS was more accurate than CT and MRI in the overall assessment of the T stage of ampullary neoplasms (EUS 78%, CT 24%, MRI 46%). No significant difference in N stage accuracy was noted between the three imaging modalities (EUS 68%, CT 59%, MRI 77%). EUS T stage accuracy was reduced from 84% to 72% in the presence of a transpapillary endobiliary stent. This was most prominent in the understaging of T2/T3 carcinomas. CONCLUSIONS: EUS is superior to CT and MRI in assessing T stage but not N stage of ampullary lesions. The presence of an endobiliary stent at EUS may result in underestimating the need for a Whipple resection because of tumor understaging.


Subject(s)
Ampulla of Vater/pathology , Common Bile Duct Neoplasms/pathology , Common Bile Duct/diagnostic imaging , Endosonography , Magnetic Resonance Imaging , Pancreatic Ducts/diagnostic imaging , Stents , Tomography, X-Ray Computed , Adult , Aged , Aged, 80 and over , Ampulla of Vater/diagnostic imaging , Angiography , Chi-Square Distribution , Common Bile Duct/pathology , Common Bile Duct Neoplasms/diagnosis , Endosonography/instrumentation , Endosonography/methods , Endosonography/statistics & numerical data , Female , Humans , Lymphatic Metastasis , Male , Middle Aged , Neoplasm Staging , Pancreatic Ducts/pathology
10.
J Gastrointest Surg ; 2(3): 217-22, 1998.
Article in English | MEDLINE | ID: mdl-9841977

ABSTRACT

Endoscopic ultrasonography (EUS) is currently being used to evaluate and stage pancreaticobiliary malignancies and neuroendocrine tumors, and to perform aspiration for cytologic diagnosis. There are currently two different commercially available EUS systems for clinical use. One system uses a mechanical radial sector scanner oriented in a plane perpendicular to the long axis of the endoscope, and the other uses an electronic convex scanner that is oriented in the long axis of the endoscope. The vast majority of the current literature reports experience using the radial scanning device in the evaluation of pancreaticobiliary abnormalities. We prospectively evaluated the linear probe as the sole instrument for EUS in 26 patients with suspected pancreatic disease. The results of the endoscopic ultrasound examination were compared with the results of surgery or long-term clinical follow-up. The sensitivity and specificity of linear array EUS for benign pancreatic disease were 93.8% and 88.2%, respectively. The sensitivity and specificity for malignant disease of the pancreas were 80.0% and 88.9%, respectively. The linear array echoendoscope, employed as the only instrument for evaluation of the pancreas, is accurate in the evaluation of pancreatic disease. The addition of EUS-guided pancreatic biopsy would be anticipated to improve the sensitivity of the linear array instrument for detecting malignancy.


Subject(s)
Endosonography/instrumentation , Pancreatic Diseases/diagnostic imaging , Endoscopes , Equipment Design , Evaluation Studies as Topic , Female , Follow-Up Studies , Humans , Male , Middle Aged , Pancreatic Diseases/epidemiology , Pancreatic Neoplasms/diagnostic imaging , Pancreatic Neoplasms/epidemiology , Prospective Studies , Sensitivity and Specificity , Time Factors
11.
Gastrointest Endosc ; 47(2): 149-53, 1998 Feb.
Article in English | MEDLINE | ID: mdl-9512280

ABSTRACT

BACKGROUND: Complications after endoscopic biliary sphincterotomy occur in 8% to 10% of patients when studied prospectively. It is not known whether the type of electrocautery current affects this rate. Theoretically, less edema of the ampulla after a pure cutting current sphincterotomy could decrease the risk of pancreatitis although the risk of postsphincterotomy hemorrhage might be greater. METHODS: One hundred seventy patients undergoing sphincterotomy were prospectively randomized to either a blended or pure cut current on the Valleylab electrosurgical unit. The settings were a blended three current at a power setting of 30 watts/sec for both the cut and coagulation currents or a pure cut current at a power setting of 30 watts/sec. The individual determining whether a complication occurred was blinded to the type of current used, and all patients were hospitalized for 24 hours post-procedure. Pancreatitis was defined as mild if fewer than 5 days, moderate if 5 to 14 days, and severe if more than 14 days of hospitalization were required. RESULTS: Indications for sphincterotomy were choledocholithiasis in 111 patients, sphincter of Oddi dysfunction in 36 patients, stent placement in 15 patients, and miscellaneous in 8 patients. There were a total of 16 complications in 170 patients (9%); 4 (5%) were in the pure cut current group of 86 patients (one episode of bleeding that required transfusion of 4 U and three episodes of mild pancreatitis), and 12 (14%) were in the blended current group of 84 patients (7 mild, 2 moderate, and 1 severe pancreatitis; 1 case of cholangitis; and one episode of bleeding that required transfusion of 2 U). There were significantly fewer complications in the pure cut group (p < 0.05 by chi-square). CONCLUSION: The use of pure cut current is associated with a lower incidence of pancreatitis, the most common ERCP complication, than with blended current sphincterotomy. An insufficient number of patients were studied to comment on the relative risk of hemorrhage. However, because the complication of hemorrhage is much less common than pancreatitis, pure cut current is safer overall.


Subject(s)
Cholangiopancreatography, Endoscopic Retrograde/methods , Electrocoagulation/methods , Pancreatitis/etiology , Postoperative Complications/etiology , Sphincterotomy, Endoscopic/adverse effects , Sphincterotomy, Endoscopic/methods , Acute Disease , Adult , Aged , Aged, 80 and over , Female , Hemorrhage/complications , Humans , Male , Middle Aged , Single-Blind Method
12.
Aliment Pharmacol Ther ; 12(12): 1263-7, 1998 Dec.
Article in English | MEDLINE | ID: mdl-9882036

ABSTRACT

BACKGROUND: We report a clinical trial which evaluated the effectiveness of triple therapy containing low- and high-dose azithromycin to treat Helicobacter pylori infection. METHODS: From March 1997 to March 1998, patients infected with H. pylori were assigned to receive either: Treatment 1: ranitidine bismuth citrate (RBC) (400 mg b.d.) and amoxycillin (1 g b.d.) for 10 days with azithromycin 500 mg o.m. for 3 days: or Treatment 2: RBC and amoxycillin for 10 days with azithromycin 1 g o.m. for 3 days. H. pylori eradication was established by a urea breath test at least 4 weeks after therapy. Side-effects and compliance were assessed using a diary. RESULTS: Sixty-eight patients were enrolled. Fifty-seven per cent of patients were treated for active peptic ulcer disease or a history of peptic ulcer disease. Treatment 1 cured H. pylori in 44% and 44% by per protocol and intention-to-treat analysis, respectively. The corresponding eradication rates for Treatment 2 were 79% and 75%. Two patients taking Treatment 2 dropped out of the study because of side-effects. CONCLUSIONS: With RBC and amoxycillin for 10 days, azithromycin at a dose of 1 g/day for 3 days was significantly better at curing H. pylori infection than azithromycin 500 mg/day for 3 days.


Subject(s)
Amoxicillin/therapeutic use , Anti-Ulcer Agents/therapeutic use , Azithromycin/administration & dosage , Bismuth/therapeutic use , Drug Therapy, Combination/administration & dosage , Helicobacter Infections/drug therapy , Helicobacter pylori , Ranitidine/analogs & derivatives , Adult , Aged , Amoxicillin/adverse effects , Azithromycin/adverse effects , Bismuth/adverse effects , Clinical Trials as Topic , Dose-Response Relationship, Drug , Female , Humans , Male , Middle Aged , Ranitidine/adverse effects , Ranitidine/therapeutic use
13.
Am J Gastroenterol ; 92(9): 1483-6, 1997 Sep.
Article in English | MEDLINE | ID: mdl-9317068

ABSTRACT

OBJECTIVE: We evaluated the efficacy of lansoprazole, clarithromycin, and metronidazole (LCM) administered twice daily for 7 days. Because there is growing concern about the development of metronidazole-resistant H. pylori (HP) strains, we also tested a novel regimen consisting of lansoprazole, clarithromycin, and bismuth subsalicylate (LCB). METHODS: Patients with active HP infection and peptic ulcer, a history of peptic ulcer, or nonulcer dyspepsia were randomized to either lansoprazole 30 mg b.i.d., clarithromycin 500 mg b.i.d., and metronidazole 500 mg b.i.d. or lansoprazole 30 mg b.i.d., clarithromycin 500 mg b.i.d., and bismuth subsalicylate 524 mg b.i.d. (LCB) for 7 days. Compliance and side effects were recorded by using a diary. RESULTS: "Per protocol" eradication with LCM was achieved in 41 of 47 (87%). By using "intention to treat" analysis, LCM eradicated HP infection in 43 of 53 patients (81%). By using "per protocol" analysis, LCB eradicated HP infection in 40 of 47 patients (85%). On an "intention to treat" basis, LCB led to HP eradication in 42 of 52 (81%). The most common significant side effects observed with LCM were altered taste (39%) and abdominal pain (19%). With LCB, the most common significant side effects were altered taste (23%) and dark stools (23%). CONCLUSIONS: LCB for 7 days was as effective in eradicating HP infection as a 7-day course of LCM. Further studies evaluating the role of bismuth compounds in proton-pump inhibitor based triple therapy are warranted. Such therapy may have particular importance in areas where high metronidazole resistance is a concern.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Anti-Ulcer Agents/therapeutic use , Bismuth/therapeutic use , Clarithromycin/therapeutic use , Helicobacter Infections/drug therapy , Helicobacter pylori , Metronidazole/therapeutic use , Omeprazole/analogs & derivatives , Organometallic Compounds/therapeutic use , Proton Pump Inhibitors , Salicylates/therapeutic use , 2-Pyridinylmethylsulfinylbenzimidazoles , Abdominal Pain/chemically induced , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/adverse effects , Anti-Ulcer Agents/administration & dosage , Anti-Ulcer Agents/adverse effects , Bismuth/administration & dosage , Bismuth/adverse effects , Clarithromycin/administration & dosage , Clarithromycin/adverse effects , Drug Administration Schedule , Drug Combinations , Drug Resistance, Microbial , Dyspepsia/drug therapy , Evaluation Studies as Topic , Feces , Humans , Lansoprazole , Medical Records , Metronidazole/administration & dosage , Metronidazole/adverse effects , Middle Aged , Omeprazole/administration & dosage , Omeprazole/adverse effects , Omeprazole/therapeutic use , Organometallic Compounds/administration & dosage , Organometallic Compounds/adverse effects , Patient Compliance , Peptic Ulcer/drug therapy , Salicylates/administration & dosage , Salicylates/adverse effects , Taste Disorders/chemically induced
14.
J Clin Gastroenterol ; 23(3): 170-3, 1996 Oct.
Article in English | MEDLINE | ID: mdl-8899495

ABSTRACT

In clinical practice, eradication of Helicobacter pylori infection may be difficult due to medication side effects and the need for 2 weeks of therapy. Because therapies of shorter duration may improve patient compliance and reduce treatment side effects, we compared the efficacy and tolerability of two anti-H. pylori treatments of 1 week's duration. Patients with H. pylori infection were randomized to treatment with either (a) short-course triple therapy, composed-of bismuth subsalicylate (Pepto-Bismol, Procter & Gamble, Cincinnati, OH, U.S.A.) two tablets four times daily, amoxicillin 1 g (two 500-mg tablets) twice daily, and metronidazole 500 mg four times daily on days 5-7 or (b) omeprazole 40 mg twice a day with amoxicillin 1 g twice a day for 1 week. At least 4 weeks posttreatment, efficacy was evaluated with either histological evaluation of antral biopsies for H. pylori or 14C urea breath testing. Patients who failed initial therapy were allowed to cross over to the alternative treatment regimen after a minimum "wash-out" period of 5 weeks. Patients completed a diary during therapy to monitor both compliance and side effects. Thirty-four patients completed the study, 10 receiving both treatment regimens. Treatment with the shortcourse triple therapy eradicated H. pylori in 78.3% of treatments compared with 38% with the high-dose omeprazole/ amoxicillin combination (p < 0.05). Patients were highly compliant with both treatments, and mild side effects, such as transient loose stools or abdominal pain, were common in both groups. This is the first report from North America confirming the success of the short-course triple therapy for the eradication of H. pylori. The high-dose omeprazole/ amoxicillin regimen's eradication rate was markedly inferior to that achieved by the short-course triple therapy regimen and should not be used. Comparative studies of the short-course triple therapy regimen with other 7-day anti-H. pylori treatment regimen therapies are indicated.


Subject(s)
Amoxicillin/administration & dosage , Anti-Ulcer Agents/administration & dosage , Bismuth/administration & dosage , Helicobacter Infections/drug therapy , Helicobacter pylori , Metronidazole/administration & dosage , Omeprazole/administration & dosage , Organometallic Compounds/administration & dosage , Penicillins/administration & dosage , Salicylates/administration & dosage , Drug Administration Schedule , Drug Therapy, Combination , Female , Humans , Male , Middle Aged
15.
Dig Dis Sci ; 41(3): 512-5, 1996 Mar.
Article in English | MEDLINE | ID: mdl-8617124

ABSTRACT

Chiari malformation, also called Arnold-Chiari deformities, are rare hindbrain herniations that may present in children or adults. The most common symptoms include headache, syncope, disordered eye movement, sensory loss, weakness, and cerebellar features such as ataxia. Dysphagia occurs in 5-15% of patients, although only a few reports describe dysphagia as the only presenting symptom. We report a case of a 27-year-old woman who presented with a three-year history of dysphagia, chest pain, and weight loss. Esophageal manometrics revealed markedly disordered esophageal motility and gastroesophageal reflux. Her symptoms failed to respond to high doses of omeprazole, prokinetics, and eventually surgical fundoplication. The subsequent onset of neurological symptoms led to the diagnosis of Chiari type I malformation. Following posterior craniotomy with decompression, her dysphagia and chest discomfort completely resolved. Repeat esophageal manometrics revealed complete resolution of prior abnormalities.


Subject(s)
Arnold-Chiari Malformation/diagnosis , Deglutition Disorders/diagnosis , Adult , Arnold-Chiari Malformation/complications , Arnold-Chiari Malformation/surgery , Chronic Disease , Deglutition Disorders/etiology , Deglutition Disorders/surgery , Diagnosis, Differential , Esophagus/physiopathology , Female , Fundoplication , Humans , Manometry , Recurrence
16.
Am J Gastroenterol ; 91(1): 89-92, 1996 Jan.
Article in English | MEDLINE | ID: mdl-8561151

ABSTRACT

OBJECTIVES: We investigated omeprazole's effect on 14C-urea breath testing. We also determined the duration of omeprazole's effect on the breath test. Finally, we studied whether effects on breath testing were dose dependent. METHODS: Fifty-seven employees and outpatients were screened for Helicobactor infection. Those positive for serology, CLO, or histology were asked to undergo baseline breath testing. Those with a positive breath test took omeprazole 20 mg/day for 14 days followed by repeat breath testing, 1, 3, and 5 days after therapy. Subjects with persistently positive breath tests despite omeprazole 20 mg/day were asked to take omeprazole 20 mg b.i.d. for 14 days. Repeat breath tests were performed as above. RESULTS: Thirteen of 57 had HP infection. Ten of 13 underwent a baseline breath test. Eight of 10 with baseline breath test experienced a significant decrease in expired 14CO2 after omeprazole 20 mg/day. Five of 13 with active HP infection developed a negative breath test after omeprazole. All subjects had a positive breath test within 5 days of stopping omeprazole 20 mg/day. Five of eight with persistently positive breath tests despite omeprazole 20 mg/day took omeprazole 40 mg/day. Four of five developed a significant decrease in 14CO2 excretion after omeprazole. All subjects had a positive breath test within 5 days of stopping omeprazole 40 mg/day. CONCLUSIONS: Recent treatment with omeprazole 20 mg/day led to a false-negative breath tests in 38.5%. This effect appeared to be dose dependent and lasted up to 5 days after cessation of omeprazole.


Subject(s)
Anti-Bacterial Agents/pharmacology , Breath Tests , Omeprazole/pharmacology , Urea/analysis , Anti-Bacterial Agents/administration & dosage , Breath Tests/methods , Carbon Radioisotopes , Dose-Response Relationship, Drug , False Negative Reactions , False Positive Reactions , Female , Helicobacter Infections/diagnosis , Helicobacter Infections/drug therapy , Helicobacter pylori , Humans , Male , Middle Aged , Omeprazole/administration & dosage , Sensitivity and Specificity , Time Factors
17.
Gastrointest Endosc ; 42(3): 238-43, 1995 Sep.
Article in English | MEDLINE | ID: mdl-7498689

ABSTRACT

Polyethylene glycol-electrolyte lavage solutions are widely used to prepare the colon for colonoscopy. Unfortunately, some patients find this preparation difficult to complete. Recent studies of a sodium phosphate-based laxative have shown both good patient tolerance and good bowel preparation. In these studies, the laxative has generally been prescribed in two doses, with the second dose taken early the morning of colonoscopy. Because the morning dose is inconvenient for many patients, we compared giving a common polyethylene glycol-based electrolyte lavage solution the day before colonoscopy with our method of giving both doses of sodium phosphate-based laxative the day before colonoscopy: one dose at 4 PM and the second dose at 8 PM. We judged efficacy by an assessment of residual liquid and fecal matter in the colon and judged tolerance by the results of a symptom questionnaire completed by each patient immediately before the procedure. Our results in more than 200 patients showed similar efficacy ratings and similar symptom scores for both preparations, but patients rated the sodium phosphate-based preparation as easier to tolerate. In conclusion, in selected patients this new dosing method for sodium phosphate is preferable to large-volume, whole-gut lavage solutions.


Subject(s)
Cathartics/administration & dosage , Colonoscopy , Phosphates/administration & dosage , Polyethylene Glycols/administration & dosage , Administration, Oral , Humans , Patient Satisfaction , Prospective Studies , Single-Blind Method , Therapeutic Irrigation
18.
Am J Gastroenterol ; 90(7): 1089-93, 1995 Jul.
Article in English | MEDLINE | ID: mdl-7611203

ABSTRACT

BACKGROUND/AIMS: It remains controversial whether Helicobacter pylori infection causes symptoms in non-ulcer dyspepsia. One hundred non-ulcer dyspepsia patients were screened for H. pylori infection between November 1989 and February 1994. Forty patients entered a trial where both infected and uninfected patients were treated with H. pylori therapy, with the uninfected group serving as controls. METHODS: Non-ulcer dyspepsia was defined as unexplained epigastric discomfort lasting for at least 4 wk. From November 1989 until February 1992, all patients, regardless of H. pylori status, were treated with bismuth subsalicylate tablets (524 mg q.i.d.) for 4 wk and metronidazole (250 mg q.i.d.) for the first 2 of the 4 wk. From March 1992 until February 1994, only infected patients were treated in an attempt to obtain equal numbers in each group. H. pylori infection was diagnosed histologically at the index endoscopy and 1 month after completion of therapy. Symptoms were scored on a 0-5 scale for both frequency and severity. RESULTS: Of 100 patients screened, 33 were infected with H. pylori (mean age, 42; 10 men, 23 women), and 67 were uninfected (mean age, 38; 16 men, 51 women). Thirty-six uninfected patients were not offered treatment during the latter part of the trial. Of the remaining 31 uninfected patients, 10 dropped out; of the 33 infected patients, 14 dropped out. Twenty-one uninfected patients and 19 H. pylori-infected patients completed treatment; in 13 of 19 patients (68%), H. pylori was eradicated. Symptoms improved in eight of 13 (61%) H. pylori-eradicated patients and in four of six (66%) H. pylori-persistent patients, compared with 14 of 21 (66%) uninfected patients. Long-term follow-up (mean, 34 months) showed similar symptom outcome in the two treatment groups. CONCLUSIONS: Thirty-three percent of our non-ulcer dyspepsia patients were infected with H. pylori, a number similar to the percentage of infected age-matched controls in the U.S. Treatment with bismuth subsalicylate and metronidazole resulted in symptomatic improvement in 61-66% of non-ulcer dyspepsia patients regardless of initial or post-treatment H. pylori status. Long-term symptom follow-up in both the control and infected groups gave similar results. H. pylori infection is not related to the symptoms of non-ulcer dyspepsia.


Subject(s)
Dyspepsia/complications , Helicobacter Infections/drug therapy , Helicobacter pylori , Adult , Bismuth/administration & dosage , Drug Therapy, Combination , Female , Follow-Up Studies , Helicobacter Infections/complications , Humans , Male , Metronidazole/administration & dosage , Organometallic Compounds/administration & dosage , Salicylates/administration & dosage , Time Factors
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