Validation of a symptom diary for patients with gastro-oesophageal reflux disease.

BACKGROUND: Symptom diaries are potentially attractive but, because of concerns about patient compliance, they have had limited use in clinical trials. We assessed the validity and responsiveness of a symptom diary for patients with gastro-oesophageal reflux disease. METHODS: We included 215 patients with gastro-oesophageal reflux disease after starting treatment for 4 weeks with 40 mg esomeprazole once daily. Patients recorded whether they experienced night-time heartburn (yes/no), the severity of daytime heartburn on a scale from 1 (no heartburn) to 4 (severe heartburn) and their antacid use. Patients also completed a number of disease-specific and preference-based Health-related Quality of Life questionnaires at baseline and follow-up. RESULTS: Consistent with a priori predictions, daytime heartburn showed moderate to strong correlations with the Quality of Life in Reflux and Dyspepsia questionnaire (0.36-0.67) and four scales of symptom severity (0.36-0.70) for baseline, follow-up and change scores, but low correlations with the Standard Gamble. Responsiveness of the daytime heartburn item was excellent with a mean change from baseline to follow-up of -1.3 (95% CI -1.4 to -1.1) and a standardized response mean of 1.33 while responsiveness of the daily antacid use item was moderate (mean change scores -1.8 tablets taken, 95% CI -2.3 to -1.3 and standardized response mean of 0.64). CONCLUSIONS: The excellent psychometric properties of this simple gastro-oesophageal reflux disease diary make it an attractive measure for future trials.

Do physicians correctly assess patient symptom severity in gastro-oesophageal reflux disease?

BACKGROUND: The accuracy of physicians' assessment of the severity of gastro-oesophageal reflux disease is unclear. AIM: To correlate physician and patient assessment of gastro-oesophageal reflux disease severity and its response to treatment. METHODS: Adult uninvestigated gastro-oesophageal reflux disease patients (n = 217) completed symptom and health-related quality of life questionnaires at baseline and after treatment with esomeprazole 40 mg p.o. daily. Pearson coefficients quantified correlations between physician assessments and patient responses. RESULTS: At baseline, the strongest correlations were heartburn severity (0.31), overall symptom severity (0.44) and a domain of the quality of life in reflux and dyspepsia questionnaire (0.31) (P < 0.001). Correlations of change with treatment were greater than baseline correlations: heartburn (0.39), overall symptoms (0.50) and global rate of change -- stomach problems (0.72, all P < 0.001). The mean difference between the physicians' assessment of change and the patients' global rating of change was 0.20 (95% confidence intervals: 0.10-0.29) with physicians overestimating benefit. CONCLUSIONS: Correlations were often significant, although weak to moderate and better with symptom severity than with health-related quality of life instruments as well as with change after therapy than at baseline. Increasing attention to health-related quality of life may help physicians better understand patients' experience. In clinical trials, treatment success should be assessed by the patient as well as the physician.

Oral esomeprazole vs. intravenous pantoprazole: a comparison of the effect on intragastric pH in healthy subjects.

BACKGROUND: Intravenous (IV) proton-pump inhibitor therapy is used in patients who cannot take oral medications or require greater acid suppression. Oral esomeprazole produces greater acid suppression than oral pantoprazole; however, no comparative data exist for oral esomeprazole and i.v. pantoprazole. AIM: To compare acid suppression (time with pH>3.0, 4.0, 5.0 and 6.0) produced by standard doses of oral esomeprazole and i.v. pantoprazole in healthy subjects. METHODS: A randomized, two-way crossover study in 30 subjects receiving oral esomeprazole (40 mg o.d.) or i.v. pantoprazole (40 mg o.d.) for 5 days followed by a 2-week washout period before the second 5-day drug administration period using the crossover drug regimen. RESULTS: Oral esomeprazole produced greater acid suppression than i.v. pantoprazole on day 1 [pH>3.0 (56.9%, 35.8%; P<0.001), pH>4.0 (43.4%, 25.0%; P<0.001) and pH>5.0 (28.7%, 15.6%; P<0.001)] and on day 5 [pH>3.0 (70.4%, 45.9%; P<0.001), pH>4.0 (59.2%, 33.9%; P<0.001), pH>5.0 (45.5%, 23.9%; P<0.001) and pH>6.0 (19.6%, 12.6%; P=0.045)]. The adverse event profiles indicated both treatments to be safe and well tolerated. CONCLUSIONS: In healthy subjects, esomeprazole, 40 mg o.d. dispersed in water, produces greater acid suppression than pantoprazole 40 mg i.v. o.d. after 1 and 5 days of medication.