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Protocol Analysis (protocol + analysis)

Distribution by Scientific Domains

Medical Sciences	89%
Business, Economics, Finance and Accounting	10%

Selected Abstracts

Focusing failures in competitive environments: explaining decision errors in the Monty Hall game, the Acquiring a Company problem, and multiparty ultimatums

JOURNAL OF BEHAVIORAL DECISION MAKING, Issue 5 2003
Avishalom Tor
Abstract This paper offers a unifying conceptual explanation for failures in competitive decision making across three seemingly unrelated tasks: the Monty Hall game (Nalebuff, 1987), the Acquiring a Company problem (Samuelson & Bazerman, 1985), and multiparty ultimatums (Messick, Moore, & Bazerman, 1997). We argue that the failures observed in these three tasks have a common root. Specifically, due to a limited focus of attention, competitive decision makers fail properly to consider all of the information needed to solve the problem correctly. Using protocol analyses, we show that competitive decision makers tend to focus on their own goals, often to the exclusion of the decisions of the other parties, the rules of the game, and the interaction among the parties in light of these rules. In addition, we show that the failure to consider these effects explains common decision failures across all three games. Finally, we suggest that this systematic focusing error in competitive contexts can serve to explain and improve our understanding of many additional, seemingly disparate, competitive decision-making failures. Copyright © 2003 John Wiley & Sons, Ltd. [source]

Moxifloxacin-based strategies for first-line treatment of Helicobacter pylori infection

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 10 2005
E. C. Nista
Summary Background :,Standard anti- Helicobacter pylori therapy may not achieve a satisfactory eradication rate. Fluoroquinolones, such as moxifloxacin, are safe and promising agents for H. pylori eradication. Aim :,To compare the efficacy of two 1-week moxifloxacin-based H. pylori eradication regimens with two standard treatments. Methods :,Three hundred and twenty H. pylori -positive subjects were randomized into four groups to receive: moxifloxacin, amoxicillin, esomeprazole (Group MAE); moxifloxacin, tinidazole and esomeprazole (Group MTE); standard triple therapies with clarithromycin, amoxicillin and esomeprazole (Group CAE) or tinidazole (Group CTE) for 7 days. H. pylori status was re-assessed 6 weeks after the end of therapy by 13C urea breath test. Results :,Three hundred and twenty patients completed the efficacy analysis per protocol; H. pylori eradication rate in group MTE was 90% (72 of 80) and 92% (72 of 78), in group MAE was 88% (70 of 80) and 89%, (70 of 79) in Group CAE was 73% (58 of 80) and 78% (58 of 74), and in Group CTE was 75% (60 of 80) and 79% (60 of 76), respectively, in intention-to-treat and in per protocol analyses. Eradication rates of moxifloxacin-based triple therapies were significantly higher than that observed using standard triple schemes. The incidence of side effects was significantly lower in moxifloxacin groups than in control groups. Conclusions :,Seven-day moxifloxacin-based triple therapies provide optimal eradication rates with a good compliance when compared with the standard triple therapy schemes. [source]

Furazolidone-based triple ,rescue therapy' vs. quadruple ,rescue therapy' for the eradication of Helicobacter pylori resistant to metronidazole,

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 7 2002
V. Isakov
Summary Background : The optimal treatment of patients with Helicobacter pylori resistant to metronidazole has not been established. Aim : To compare the efficacy of quadruple and furazolidone-based triple therapy in the eradication of H. pylori resistant to metronidazole. Methods : Duodenal ulcer patients (n = 70) in whom initial eradication therapy failed and who harboured H. pylori strains resistant to metronidazole were randomized to receive one of the following 7-day regimens: colloidal bismuth subcitrate, 240 mg, tetracycline, 750 mg, and furazolidone, 200 mg, each given twice daily (BTF), or omeprazole, 20 mg b.d., colloidal bismuth subcitrate, 240 mg b.d., tetracycline, 500 mg q.d.s., and metronidazole, 500 mg b.d. (OBTM). H.pylori status was assessed by culture, histology and rapid urease test before treatment and 4,6 weeks after therapy. Susceptibility to metronidazole was assessed by the agar dilution method. Results : H. pylori eradication rates with intention-to-treat/per protocol analyses were: BTF, 85.7%/90.9%; OBTM, 74.2%/89.6%. Duodenal ulcers were healed in nine of 10 (90%) patients in the BTF group and in all patients (12/12) (100%) in the OBTM group (P = N.S.). A significantly lower rate of adverse events was observed in the BTF group than in the OBTM group (31.4% vs. 60%, P = 0.03), but there was no difference in terms of discontinuation of treatment (2/35 vs. 6/35, P = N.S.). Conclusions : The 1-week BTF regimen was as effective as the OBTM regimen, and produced less adverse events. Thus, it may be used in patients in whom resistance of H. pylori to metronidazole is suspected. [source]

A Community-Based Study of Helicobacter pylori Therapy Using the Strategy of Test, Treat, Retest, and Re-treat Initial Treatment Failures

HELICOBACTER, Issue 5 2006
Yi-Chia Lee
Abstract Background:, Although eradication of Helicobacter pylori infection can decrease the risk of gastric cancer, the optimal regimen for treating the general population remains unclear. We report the eradication rate (intention-to-treat and per protocol) of a community-based H. pylori therapy using the strategy of test, treat, retest, and re-treat initial treatment failures. Materials and methods:, In 2004, a total of 2658 residents were recruited for 13C-urea breath testing. Participants with positive results for infection received a standard 7-day triple therapy (esomeprazole 40 mg once daily, amoxicillin 1 g twice daily, and clarithromycin 500 mg twice daily), and a 10-day re-treatment (esomeprazole 40 mg once daily, amoxicillin 1 g twice daily, and levofloxacin 500 mg once daily) if the follow-up tests remained positive. Both H. pylori status and side-effects were assessed 6 weeks after treatment. Results:, Among 886 valid reporters, eradication rates with initial therapy were 86.9% (95% confidence interval [CI]: 84.7,89.1%) and 88.7% (95%CI: 86.5,90.9%) by intention-to-treat and per protocol analysis, respectively. Re-treatment eradicated infection in 91.4% (95%CI: 86,96.8%) of 105 nonresponders. Adequate compliance was achieved in 798 (90.1%) of 886 subjects receiving the initial treatment and in all 105 re-treated subjects. Mild side-effects occurred in 24% of subjects. Overall intention-to-treat and per protocol eradication rates were 97.7% (95%CI: 96.7,98.7%) and 98.8% (95%CI: 98.5,99.3%), respectively, which were only affected by poor compliance (odds ratio, 3.3; 95%CI, 1.99,5.48; p < .0001). Conclusions:, A comprehensive plan using drugs in which the resistance rate is low in a population combined with the strategy of test, treat, retest, and re-treat of needed can result in virtual eradication of H. pylori from a population. This provides a model for planning country- or region-wide eradication programs. [source]

Role of Chronic Infection and Inflammation in the Gastrointestinal Tract in the Etiology and Pathogenesis of Idiopathic Parkinsonism

HELICOBACTER, Issue 4 2005
Part 2: Response of Facets of Clinical Idiopathic Parkinsonism to Helicobacter pylori Eradication.
ABSTRACT Background., Links between etiology/pathogenesis of neuropsychiatric disease and infection are increasingly recognized. Aim., Proof-of-principle that infection contributes to idiopathic parkinsonism. Methods., Randomized, double-blind, placebo-controlled efficacy study of proven Helicobacter pylori eradication on the time course of facets of parkinsonism. Intervention was 1 week's triple eradication therapy/placebos. Routine deblinding at 1 year (those still infected received open-active), with follow-up to 5 years post-eradication. Primary outcome was mean stride length at free-walking speed, sample size 56 for a difference, active vs. placebo, of 3/4 (between-subject standard deviation). Recruitment of subjects with idiopathic parkinsonism and H. pylori infection was stopped at 31, because of marked deterioration with eradication failure. Interim analysis was made in the 20 who had reached deblinding, seven of whom were receiving antiparkinsonian medication (long- t1/2, evenly spaced) which remained unchanged. Results., Improvement in stride-length, on active (n = 9) vs. placebo (11), exceeded size of effect on which the sample size was calculated when analyzed on intention-to-treat basis (p = .02), and on protocol analysis of six weekly assessments, including (p = .02) and excluding (p = .05) those on antiparkinsonian medication. Active eradication (blind or open) failed in 4/20, in whom B-lymphocyte count was lower. Their mean time course was: for stride-length, ,243 (95% CI ,427, ,60) vs. 45 (,10, 100) mm/year in the remainder (p = .001); for the ratio, torque to extend to flex relaxed arm, 349 (146, 718) vs. 58 (27, 96)%/ year (p < .001); and for independently rated, visual-analog scale of stance,walk videos (worst,best per individual , 0,100 mm), ,64 vs. ,3 mm from anterior and ,50 vs. 11 lateral (p = .004 and .02). Conclusions., Interim analysis points to a direct or surrogate (not necessarily unique) role of a particular infection in the pathogenesis of parkinsonism. With eradication failure, bolus release of antigen from killed bacteria could aggravate an effect of ongoing infection. [source]

Galantamine: a randomized, double-blind, dose comparison in patients with Alzheimer's disease,

INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 9 2001
D. Wilkinson
Abstract Objectives To investigate whether Galantamine significantly improves the core symptoms of Alzheimer's disease (AD). Background Galantamine is a reversible, competitive, selective inhibitor of acetylcholinesterase (AChE) that also allosterically modulates nicotinic acetylcholine receptors. This dual mechanism of action provided the rationale for a phase II trial of galantamine in AD. Method A multicentre, randomized, parallel, double-blind, placebo-controlled trial was carried out to evaluate the efficacy and tolerability of galantamine 18, 24 and 36,mg/day administered for 3 months in 285 patients with mild-to-moderate probable AD. The primary outcome measure was the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog); secondary outcome measures were the Clinical Global Impression of Change (CGIC) and the Progressive Deterioration Scale (PDS). Results Patients treated with galantamine 24,mg/day had a significantly better outcome than placebo on ADAS-cog; the treatment difference was 3 points on the intention-to-treat (ITT) analysis ( p,=,0.01) and 4.2 points on per protocol analysis ( p,=,0.001). Per protocol analysis showed that galantamine had a significantly better outcome than placebo on PDS ( 24-mg/day dose, p,<,0.05) and CGIC (36-mg/day dose, p,<,0.05). Galantamine was well tolerated at the lower doses of 18 and 24,mg/day where it produced mild, transient effects typical of cholinomimetic agents. Conclusion This study shows that, relative to placebo, galantamine significantly improves the core symptoms of Alzheimer's disease. Copyright © 2001 John Wiley & Sons, Ltd. [source]

Outcome of self-expandable metallic stents in low-grade versus advanced hilar obstruction

JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 11 2008
Rungsun Rerknimitr
Abstract Background:, Self-expandable metallic stents (SEMS) are known to provide a longer patency time than plastic stents for malignant biliary obstructions including hilar obstruction. However, studies that focus on the efficacy of SEMS in low-grade and advanced hilar obstructions are still scanty. Methods:, Ninety four patients with malignant hilar obstructions were enrolled (six were later excluded). Patients were divided into two groups according to their Bismuth levels. Group A were patients with Bismuth I (n = 53). Group B were patients with Bismuth II, III and IV (n = 35). Technical success, complications, jaundice resolution, stent patency time, and patients' survival were analyzed. Results:, Our intention-to-treat analysis showed that group A had a significant lower rate of post-endoscopic retrograde cholangiopancreatography (ERCP) cholangitis than group B; 16.1% versus 44.7%, (P < 0.01). Four patients from group B still had persistent jaundice. Our per protocol analysis demonstrated that median stent patency time in groups A and B were not statistically different (74 vs 60 days). Median survival time in groups A and B were also not statistically different (90 vs 75 days). In both groups, those without liver metastasis had significantly better patency and survival time than those with liver metastasis (P = 0.010 and 0.027, respectively). Conclusions:, In patients with hilar obstruction, liver metastasis is one of the main factors that determine survival of the patient. Patency times of SEMS in both low-grade and advanced obstructions are comparable. However, in the advanced group, there is a significant risk of post-ERCP cholangitis. [source]

Clinical trial: the safety and short-term efficacy of recombinant cholera toxin B subunit in the treatment of active Crohn's disease

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 3 2010
P. STÅL
Aliment Pharmacol Ther,31, 387,395 Summary Background, The cholera toxin B subunit ameliorates experimentally induced colitis in mice. In humans, cholera toxin B subunit has never been tested in the treatment of Crohn's disease (CD). Aim, To evaluate the safety and efficacy of treatment with recombinant cholera toxin B subunit of patients with CD. Methods, An open-label, multicentre, nonrandomized trial including 15 patients with mild/moderate CD. Patients received an oral solution of 5 mg recombinant cholera toxin B subunit three times weekly for 2 weeks. Reduction in CD Activity Index (CDAI) with >100 between baseline and days 15, 29, 42 and 70 defined clinical response. Patients with CDAI score ,150 were defined as being in remission. Results, A significant decrease in CDAI score was observed. Response rates were 40% in the full analysis set and 42% in the per protocol analysis. Two patients receiving adjuvant treatment after day 29 were excluded, after which 40% were in remission at 4 weeks and 30% at 8 weeks post-treatment. Mild side effects (arthralgia, headache and pruritus) were seen in 33% of patients. Conclusions, Treatment with recombinant cholera toxin B subunit was safe. Approximately 40% of patients with active CD responded to treatment. Randomized studies are needed to establish the clinical efficacy of recombinant cholera toxin B subunit. [source]

One-week ranitidine bismuth citrate, amoxicillin and metronidazole triple therapy for the treatment of Helicobacter pylori infection in Chinese

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 12 2002
W. K. Hung
Summary Background : We have previously shown that ranitidine bismuth citrate-based, clarithromycin-containing triple therapy achieves a higher eradication rate than proton pump inhibitor-based regimens in areas with a high prevalence of metronidazole resistance. Aim : To evaluate whether this higher efficacy of ranitidine bismuth citrate over proton pump inhibitor can be extended to non-clarithromycin-containing regimens. Methods : Helicobacter pylori -positive dyspeptic patients were randomized to receive either ranitidine bismuth citrate, 400 mg, amoxicillin, 1000 mg, and metronidazole, 400 mg, or omeprazole, 20 mg, amoxicillin, 1000 mg, and metronidazole, 400 mg, each given twice daily for 1 week. H. pylori eradication was confirmed by 13C-urea breath test 5 weeks later. The side-effects of the treatments were documented. Results : Two hundred and twenty-nine patients were eligible for analysis. By intention-to-treat and per protocol analysis, the eradication rates were 77% and 79%, respectively, in the ranitidine bismuth citrate,amoxicillin,metronidazole group and 77% and 82%, respectively, in the omeprazole,amoxicillin,metronidazole group (P = 0.58 and P = 0.65). However, patients in the omeprazole,amoxicillin,metronidazole group reported a significantly higher incidence of minor side-effects when compared to those in the ranitidine bismuth citrate,amoxicillin,metronidazole group (P = 0.001). Conclusions : Ranitidine bismuth citrate,amoxicillin,metronidazole was equally as effective as omeprazole,amoxicillin,metronidazole triple therapy, and may be considered as an alternative non-clarithromycin-based regimen in the Chinese population. [source]

Low-dose lansoprazole and clarithromycin plus metronidazole vs. full-dose lansoprazole and clarithromycin plus amoxicillin for eradication of Helicobacter pylori infection

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 1 2002
F. Bazzoli
To compare, in a randomized controlled trial, the efficacy and tolerability of two 1-week triple therapies for Helicobacter pylori eradication. Methods: One hundred and thirty-four consecutive patients with non-ulcer dyspepsia and H. pylori infection were randomized to receive lansoprazole 30 mg once daily, clarithromycin 250 mg twice daily, and metronidazole 500 mg twice daily (LCM group), or lansoprazole 30 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1000 mg twice daily (LCA group). H. pylori status was assessed by rapid urease test, histology and 13C-urea breath test before and after therapy. Results: At 3 months, H. pylori eradication (intention- to-treat/per protocol analysis) was 92.4%/93.8% in the LCM group and 83.1%/85.7% in the LCA group (P=N.S.). Side-effects were more frequently reported in the LCA group (37.9%) than in the LCM group (19.7%) (P < 0.05). Conclusions: In this open, randomized controlled trial, eradication of H. pylori by low-dose lansoprazole and clarithromycin plus metronidazole was higher with significantly less side-effects than by full-dose lansoprazole and clarithromycin plus amoxicillin. This finding may be related to the stronger synergism of clarithromycin plus metronidazole, even at lower doses, than of clarithromycin plus amoxicillin. Considering the lower cost as well, LCM should be preferred to LCA in the eradication of H. pylori. [source]

Is a one-week course of triple anti- Helicobacter pylori therapy sufficient to control active duodenal ulcer?

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 7 2001
B. Tepe
Background: Triple therapy currently forms the cornerstone of the treatment of patients with Helicobacter pylori -positive duodenal ulcer. Aim: To establish whether prolonged antisecretory therapy is necessary in patients with active duodenal ulcer. Methods: A total of 77 patients with H. pylori -positive duodenal ulcer were included in a prospective, controlled, double-blind study. All patients received a 7-day treatment with omeprazole 20 mg b.d., clarithromycin 500 mg b.d. and amoxicillin 1000 mg b.d. Patients in the omeprazole group underwent an additional 14-day therapy with omeprazole 20 mg; patients in placebo group received placebo. Endoscopy was performed upon inclusion in the study and after 3 and 8 weeks. Results: Seventy-four patients were eligible for a per protocol analysis after 3 weeks, and 65 after 8 weeks. After 3 weeks, the healing rate was 89% in the omeprazole group and 81% in the placebo group (P=0.51). After 8 weeks, the ulcer healed in 97% of the patients in the total group (95% CI: 92.7,100%). H. pylori was eradicated in 88% of patients in the omeprazole group and in 91% in the placebo group (P=1.0). No statistically significant differences between the groups were found in ulcer-related symptoms or in ulcer healing. Conclusion: In patients with H. pylori -positive duodenal ulcer, a 7-day triple therapy alone is sufficient to control the disease. [source]

A multicentre study on eradication of Helicobacter pylori using four 1-week triple therapies in China

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 1 2001
CHINESE NATIONAL COOPERATIVE STUDY GROUP FOR HELICOBACTER PYLORI
Background: Short-term proton pump inhibitor-based triple therapies for the eradication of Helicobacter pylori are used widely. The eradication rates vary greatly from country to country and from region to region. Aim: To assess the efficacy at eradicating H. pylori of 1-week regimens containing three medications: omeprazole (O) or colloidal bismuth subcitrate (B), furazolidone (F) or metronidazole (M), and amoxicillin (A) or clarithromycin (C). Methods: A multicentre study involving 20 hospitals in different regions of China. A total of 892 patients with H. pylori- positive non-ulcer dyspepsia or healed duodenal ulcer confirmed by endoscopy were recruited to receive, randomly, one of four regimens: OMC, OFC, OFA, and BFC, b.d. for 7 days. 13C-urea breath test was performed 4,8 weeks after completion of treatment. Results: The eradication rates with per protocol/intention-to-treat analyses were: OMC (n=217/219) 66%/65%; OFC (n=227/229) 69%/69%; OFA (n=223/225) 87%/86%; and BFC (n=214/219) 80%/78%. The eradication rate (per protocol analysis) in duodenal ulcer (79%) was higher than that in non-ulcer dyspepsia (73%, P=0.033). Patient compliance was good. The adverse events of the four regimens were mild, and mainly gastrointestinal. Conclusions: The omeprazole, furazolidine and amoxicillin regimen achieves a high H. pylori eradication rate in different geographical regions of China. [source]

Triple therapy with clarithromycin, omeprazole, and amoxicillin for eradication of Helicobacter pylori in duodenal ulcer patients in Asia and Africa

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 11 2000
B. C. Y. Wong
Background: Studies assessing the efficacy of triple therapy containing clarithromycin and amoxicillin for the eradication of Helicobacter pylori infection and healing of duodenal ulcers in Asian and African countries are limited. Aim: To determine the efficacy and safety of 1-week triple therapy with omeprazole, amoxicillin and clarithromycin for eradicating H. pylori infection in patients with active duodenal ulcer living in Asian and African regions. Methods: This was an open-label, multicentre study in 11 centres in Asia and Africa. Patients with endoscopy-proven duodenal ulcer and who were H. pylori -positive were treated with clarithromycin 500 mg, omeprazole 20 mg, and amoxicillin 1000 mg, all given twice daily for 7 days. Upper endoscopy was repeated at week 6 to check for ulcer healing and H. pylori status. Results: A total of 117 patients were recruited. H. pylori eradication rates were 85% by per protocol analysis and 80% by intention-to-treat analysis. Ulcer healing was found in 94% of subjects (per protocol analysis). Clinical success, measured by change of pre-treatment ulcer symptoms, was strongly supported by complete resolution or improvement in 100% of the evaluable patients (per protocol analysis). Since treatment-related adverse events, when present, were largely mild or moderate, the triple therapy regimen was considered safe. Conclusion: Seven-day triple therapy with omeprazole, amoxicillin, and clarithromycin was efficacious for treating Asian and African patients with duodenal ulcer disease associated with H. pylori infection, and the treatment regimen was well-tolerated. [source]

Efficacy of sucralfate for Helicobacter pylori eradication triple therapy in comparison with a lansoprazole-based regimen

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 7 2000
Adachi
Background: Sucralfate has an inhibitory action against Helicobacter pylori and enhances the anti- H. pylori activity of antimicrobials. Aim: To evaluate the efficacy and safety of sucralfate-based eradication therapy for H. pylori infection, compared with that based on lansoprazole, in a randomized multicentre study. Subjects and methods: The subjects were 150 H. pylori -positive patients. They were randomly assigned to one of two regimens for 2 weeks: sucralfate 1 g t.d.s., amoxycillin 500 mg t.d.s., and clarithromycin 400 mg b.d. (SAC regimen: 75 patients); or lansoprazole 30 mg o.m. with the same antimicrobial medications (LAC regimen: 75 patients). Cure of infection was assessed by a 13C urea breath test 1 month after completion of treatment. Results: Eight patients (four in the SAC group and four in LAC group) could not continue therapy because of severe diarrhoea, and three did not take the 13C urea breath test after therapy. Cure rates for intention-to-treat, all-patients-treated, and per protocol analysis in the SAC group were 80%, 83%, and 88%, respectively, and those in the LAC group were 87%, 87%, and 92%, respectively. There were no significant differences in cure rate or adverse effects between the two regimens. Conclusion: Sucralfate in combination with amoxycillin and clarithromycin is as effective as lansoprazole-based eradication therapy for H. pylori. [source]

Randomized study comparing omeprazole with ranitidine as anti-secretory agents combined in quadruple second-line Helicobacter pylori eradication regimens

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 6 2000
Michopoulos
Background: Few data are available on the efficacy of second-line H. pylori eradication regimens. Aim: To compare the efficacy of either omeprazole or ranitidine in a second-line quadruple regimen in patients with duodenal ulcer or erosive duodenitis. Patients and methods: A total of 37 patients with erosive duodenitis and 119 with duodenal ulcer who have failed eradication of H. pylori with double or triple regimens, without metronidazole, were randomly assigned to receive tripotassium dicitrato bismuthate 600 mg t.d.s. + metronidazole 500 mg t.d.s. + tetracycline hydrochloride 500 mg t.d.s. combined with either omeprazole 20 mg b.d. (group O, 78 patients) or ranitidine 300 mg b.d. (group R, 78 patients) for 14 days. H. pylori eradication was verified by histology, rapid urease test and 13C-urea breath test. Statistics: t -test, ,2 -test. Results: A total of 143 patients had a post-treatment endoscopy. Eradication rates were: intention-to-treat: group O 77% (67,87), group R 76% (66,85), P=0.85; per protocol analysis: group O 86% (77,95), group R 82 (71,93), P=0.58. Side-effects were frequent but mild. Conclusions: Omeprazole 20 mg b.d. and ranitidine 300 mg b.d. were equally effective as antisecretory agents combined in a second-line quadruple eradication regimen. [source]

Pharmacokinetics of clarithromycin in Helicobacter pylori eradication therapy in patients with liver cirrhosis

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 2000
T. Azuma
Summary Background: Proton pump inhibitor triple therapy with clarithromycin and metronidazole has been widely used for Helicobacter pylori eradication. However, the efficacy and the safety of this therapy in patients with liver cirrhosis have not been established. Aim: To evaluate the effect of hepatic dysfunction on metabolism of clarithromycin as it is used for H. pylori eradication therapy in patients with liver cirrhosis, and the efficacy of eradication therapy in those patients. Methods: Serum levels of clarithromycin and its meta-bolite, 14-(R)-hydroxyclarithromycin, were examined in 18 subjects (five normal controls and 13 hospitalized patients with liver cirrhosis) on a selected day between days 7 and 10 of a 2-week course of eradication therapy. This therapy consisted of lansoprazole (30 mg, once a day) together with clarithromycin (200 mg, twice a day) and metronidazole (250 mg, twice a day). In addition, 118 H. pylori -positive out-patients, 88 with peptic ulcer and 30 with liver cirrhosis, underwent the same eradication therapy. Results: Values for the area under the 0,6 h concentration,time curve (AUC) for clarithromycin were not significantly different among the groups. However, the AUC (0,6 h) values of 14-(R)-hydroxyclarithromycin were significantly lower in the Child-Pugh C group than in either the normal controls or the Child-Pugh A/B group. The cure rate for the peptic ulcer patients was 84% on a per protocol analysis (95% CI: 80%,88%) and 81% on an intention-to-treat analysis (95% CI: 77%,85%), while in the liver cirrhosis patients it was 89% in a per protocol analysis (95% CI: 78%,99%) and 83% in an intention-to-treat analysis (95% CI: 70%,97%). Mild adverse effects were observed in 10% of the peptic ulcer patients and 13% of the liver cirrhosis patients, with none leading to premature withdrawal from the study. Conclusion: The 2-week low-dose lansoprazole-based triple therapy tested is a simple, effective and well-tolerated regimen for H. pylori eradication in patients with liver cirrhosis. [source]

Cognitive insights into the highly skilled or expert salesperson

PSYCHOLOGY & MARKETING, Issue 2 2006
C. David Shepherd
A cognitive psychology based approach is used to investigate the highly skilled or expert salesperson. The study utilized verbal protocol analysis to identify differences in the decision processes of expert and less-skilled salespeople as they progressed through a difficult selling situation. The results of this study indicate that experts in sales share several similarities with experts in such diverse fields as chess, medicine, physics, and teaching. For example, expert salespeople were shown to reach better decisions in a faster and more confident manner than their less-skilled contemporaries. Further, in resolving current problems, experts were shown to be more likely to utilize their memory of previous selling situations, as well as to employ different strategies for customer interactions than less-skilled salespeople. © 2006 Wiley Periodicals, Inc. [source]

ORIGINAL RESEARCH,FSD PHARMACOTHERAPY: Tibolone and Transdermal E2/NETA for the Treatment of Female Sexual Dysfunction in Naturally Menopausal Women: Results of a Randomized Active-Controlled Trial

THE JOURNAL OF SEXUAL MEDICINE, Issue 3 2008
Esme A. Nijland MD
ABSTRACT Introduction., There are some data to suggest that tibolone improves sexual function in postmenopausal women. However, evidence about the effects of tibolone on female sexual dysfunction is lacking. Aim., To compare the efficacy on sexual function of tibolone 2.5 mg to continuous combined transdermal estradiol (E2)/norethisterone acetate (NETA) (50 µg/140 µg) in naturally postmenopausal women with sexual dysfunction. Main Outcome Measure., Differences between treatment groups in the change from baseline for the composite subscore of the arousal, desire, and satisfaction domains of the self-reported Female Sexual Function Index (FSFI). Methods., A multicenter, double-blind, randomized, clinical trial was performed. Sexual function was assessed with the FSFI at baseline, week 12, and week 24. The outcomes of the Female Sexual Distress Scale (FSDS) and the frequency of satisfying sexual events (daily diaries) were secondary end points. Results., Four hundred three women, mean age 56, were included. Both therapies improved sexual function assessed by the FSFI. In the per protocol analysis, but not in the intent-to-treat analysis, the increase in FSFI scores was significantly larger in the tibolone group when compared with the E2/NETA patch group at week 24 (P = 0.036 and P = 0.025 for the composite subscore and total FSFI score, respectively). The satisfying sexual event rate increased from three to four times per 28 days at week 24 (P < 0.001 from baseline for both groups), with no difference between groups. The FSDS showed a significant decrease from baseline (P < 0.001), which was comparable for both treatment groups. Conclusions., Both treatments resulted to improved overall sexual function, as determined by scores on the FSFI, an increase in the frequency of sexual events, and a reduction in sexuality-related personal distress. The statistically significant higher FSFI scores in the tibolone group, when compared to the E2/NETA group, may be because of tibolone's combined estrogenic and androgenic properties. Nijland EA, Schultz WCMW, Nathorst-Boös J, Helmond FA, Van Lunsen RHW, Palacios S, Norman RJ, Mulder RJ, and Davis SR for the LISA study investigators. Tibolone and transdermal E2/NETA for the treatment of female sexual dysfunction in naturally menopausal women: Results of a randomized active-controlled trial. J Sex Med 2008;5:646,656. [source]