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Empirical Trial (empirical + trial)

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Medical Sciences100%

Selected Abstracts

The effect of an empirical trial of high-dose lansoprazole on symptom response of patients with non-cardiac chest pain , a randomized, double-blind, placebo-controlled, crossover trial

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 10 2004
J. Bautista
Summary Background :,Empirical trial with high-dose omeprazole has been shown to be a sensitive tool for diagnosing patients with gastro-oesophageal reflux disease-related non-cardiac chest pain. Aim :,To determine the clinical value of an empirical trial of high-dose lansoprazole in detecting patients with gastro-oesophageal reflux disease-related non-cardiac chest pain. Methods :,Patients who were referred by a cardiologist after a comprehensive evaluation, with at least three episodes per week of unexplained chest pain as the predominant symptom, were enrolled into the study. Oesophageal mucosal disease was determined by upper endoscopy followed by 24-h oesophageal pH monitoring to assess acid exposure. Patients were then randomized to either placebo or lansoprazole 60 mg am and 30 mg pm for 7 days. After a washout period of 1 week, patients crossed over to the other arm of the study for an additional 7 days. Patients completed a daily diary assessing severity and frequency of chest pain as the predominant symptom throughout the baseline treatment and washout periods. The lansoprazole empirical trial was considered diagnostic if chest pain score improved ,50% than baseline. Results :,Of the 40 patients with non-cardiac chest pain that were enrolled, 18 (45%) had erosive oesophagitis and/or abnormal pH test (gastro-oesophageal reflux disease-positive) and 22 (55%) had both tests negative (gastro-oesophageal reflux disease-negative). Of the gastro-oesophageal reflux disease-positive patients, 14 (78%) had significantly higher symptom improvement on lansoprazole than on placebo (22%) (P = 0.0143). Of the gastro-oesophageal reflux disease-negative group, two (9.1%) markedly improved on the medication and eight (36.3%) on placebo (P = 0.75). The sensitivity and specificity of the lansoprazole empirical trial was 78 and 80%, respectively. By day 2, 12 (85.7%) of the gastro-oesophageal reflux disease-related non-cardiac chest pain responders had either complete or almost complete symptom resolution. Conclusions :,The lansoprazole empirical trial is highly sensitive and specific for diagnosing gastro-oesophageal reflux disease-related non-cardiac chest pain patients. The trial enables diagnosing most of the responders within the first 2 days and thus a shorter duration of therapy may be considered in a subset of non-cardiac chest pain patients. [source]

Comparison of one-week and two-week empirical trial with a high-dose rabeprazole in non-cardiac chest pain patients

JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 9 2009
Jeong Hwan Kim
Abstract Background:, In patients with non-cardiac chest pain (NCCP), the optimal duration of an empirical trial with a high-dose proton pump inhibitor (PPI) is unclear. We aimed to compare the efficacy of one-week and two-week PPI trial in patients with weekly or more than weekly NCCP and to determine its optimal duration for diagnosing gastroesophageal reflux disease (GERD)-related NCCP. Methods:, Forty-two patients with at least weekly NCCP were enrolled. The baseline symptoms were assessed using a daily symptom diary for seven days. Also, esophago-gastro-duodenoscopy and 24 h esophageal pH monitoring were performed for the diagnosis of GERD. Then, patients were treated with rabeprazole 20 mg twice daily for 14 days. To assess NCCP improvement during the PPI trial, the first week and the second week symptom diary were kept for 1,7 and 8,14 days. The PPI test was considered positive if a symptom score improved (50% compared to the baseline. Results:, There was no significant difference for a positive PPI test between GERD-related NCCP group (n = 8, 50%) and non GERD-related NCCP group (n = 6, 23%) during the first week of the PPI test. However, during the second week, GERD-related NCCP had a higher positive PPI test (n = 13, 81%) than non GERD-related NCCP (n = 7, 27%) (P = 0.001) with a sensitivity and specificity of 81% and 62%, respectively. Conclusions:, The rabeprazole empirical trial was diagnostic for patients with GERD-related NCCP, and its optimal duration was determined to be at least two weeks. [source]

Response rate and predictors of response in a short-term empirical trial of high-dose rabeprazole in patients with globus

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 12 2008
D. H. SINN
Summary Background, Although the aetiology of globus (the sensation of a lump in the throat) remains unclear, gastro-oesophageal reflux disease is associated with globus. A short-term trial with a high-dose proton pump inhibitor has been shown to be a sensitive tool for diagnosing gastro-oesophageal reflux disease. Aim, To see whether patients with globus symptom responded to short-term high-dose rabeprazole trial and assess predictors of symptom response. Methods, Sixty-four patients with globus symptom were analysed. Patients received rabeprazole 20 mg b.d. for 14 days. Patients completed a daily diary assessing the severity and frequency of globus. Results, Forty-one patients (64%) were diagnosed clinically with gastro-oesophageal reflux disease. Based on the pH testing and endoscopy, the prevalence of gastro-oesophageal reflux disease was 22% (14 of 64). The globus symptom score was significantly higher in patients with gastro-oesophageal reflux disease compared with patients without gastro-oesophageal reflux disease (P = 0.004). Two patients (3%) had complete resolution and 22 (34%) had more than a 50% improvement in the globus symptom score. Endoscopic findings (P = 0.714), pathological acid exposure on pH testing (P = 0.741) or baseline gastro-oesophageal reflux disease symptoms (P = 0.606) were not associated with improvement of globus symptom. Conclusion, While gastro-oesophageal reflux disease may be an aggravating factor in patients with globus, it does not appear to be the sole cause of globus symptom. [source]

The effect of an empirical trial of high-dose lansoprazole on symptom response of patients with non-cardiac chest pain , a randomized, double-blind, placebo-controlled, crossover trial

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 10 2004
J. Bautista
Summary Background :,Empirical trial with high-dose omeprazole has been shown to be a sensitive tool for diagnosing patients with gastro-oesophageal reflux disease-related non-cardiac chest pain. Aim :,To determine the clinical value of an empirical trial of high-dose lansoprazole in detecting patients with gastro-oesophageal reflux disease-related non-cardiac chest pain. Methods :,Patients who were referred by a cardiologist after a comprehensive evaluation, with at least three episodes per week of unexplained chest pain as the predominant symptom, were enrolled into the study. Oesophageal mucosal disease was determined by upper endoscopy followed by 24-h oesophageal pH monitoring to assess acid exposure. Patients were then randomized to either placebo or lansoprazole 60 mg am and 30 mg pm for 7 days. After a washout period of 1 week, patients crossed over to the other arm of the study for an additional 7 days. Patients completed a daily diary assessing severity and frequency of chest pain as the predominant symptom throughout the baseline treatment and washout periods. The lansoprazole empirical trial was considered diagnostic if chest pain score improved ,50% than baseline. Results :,Of the 40 patients with non-cardiac chest pain that were enrolled, 18 (45%) had erosive oesophagitis and/or abnormal pH test (gastro-oesophageal reflux disease-positive) and 22 (55%) had both tests negative (gastro-oesophageal reflux disease-negative). Of the gastro-oesophageal reflux disease-positive patients, 14 (78%) had significantly higher symptom improvement on lansoprazole than on placebo (22%) (P = 0.0143). Of the gastro-oesophageal reflux disease-negative group, two (9.1%) markedly improved on the medication and eight (36.3%) on placebo (P = 0.75). The sensitivity and specificity of the lansoprazole empirical trial was 78 and 80%, respectively. By day 2, 12 (85.7%) of the gastro-oesophageal reflux disease-related non-cardiac chest pain responders had either complete or almost complete symptom resolution. Conclusions :,The lansoprazole empirical trial is highly sensitive and specific for diagnosing gastro-oesophageal reflux disease-related non-cardiac chest pain patients. The trial enables diagnosing most of the responders within the first 2 days and thus a shorter duration of therapy may be considered in a subset of non-cardiac chest pain patients. [source]