Reliability and validity of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire in dyspepsia: a six-country study.

BACKGROUND: Symptoms of dyspepsia significantly disrupt patients' lives and reliable methods of assessing symptom status are important for patient management. The aim of the current study was to document the psychometric characteristics of the Gastrointestinal Symptom Rating Scale (GSRS) and the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD) in Afrikaans, German, Hungarian, Italian, Polish and Spanish patients with dyspepsia. METHODS: 853 patients with symptoms of dyspepsia completed the GSRS, the QOLRAD, the 36-item Short-Form Health Survey (SF-36) and the Hospital Anxiety and Depression scale. RESULTS: The internal consistency reliability of the GSRS was 0.43-0.87 and of the QOLRAD 0.79-0.95. Test-retest reliability of the GSRS was 0.36-0.75 and of the QOLRAD 0.41-0.82. GSRS Abdominal pain domain correlated significantly with all QOLRAD domains in most language versions, and with SF-36 Bodily pain in all versions. QOLRAD domains correlated significantly with the majority of SF-36 domains in most versions. Both questionnaires were able to differentiate between patients whose health status differed according to symptom frequency and severity. CONCLUSION: The psychometric characteristics of the different language versions of the GSRS and QOLRAD were found to be good, with acceptable reliability and validity. The GSRS and QOLRAD were found to be useful for evaluating dyspeptic symptoms and their impact on patients' daily lives in multinational clinical trials.

Pantoprazole for the treatment of peptic ulcer bleeding and prevention of rebleeding.

Adding proton pump inhibitors (PPIs) to endoscopic therapy has become the mainstay of treatment for peptic ulcer bleeding, with current consensus guidelines recommending high-dose intravenous (IV) PPI therapy (IV bolus followed by continuous therapy). However, whether or not high-dose PPI therapy is more effective than low-dose PPI therapy is still debated. Furthermore, maintaining pH ≥ 4 appears to prevent mucosal bleeding in patients with acute stress ulcers; thus, stress ulcer prophylaxis with acid-suppressing therapy has been increasingly recommended in intensive care units (ICUs). This review evaluates the evidence for the efficacy of IV pantoprazole, a PPI, in preventing ulcer rebleeding after endoscopic hemostasis, and in controlling gastric pH and protecting against upper gastrointestinal (GI) bleeding in high-risk ICU patients. The review concludes that IV pantoprazole provides an effective option in the treatment of upper GI bleeding, the prevention of rebleeding, and for the prophylaxis of acute bleeding stress ulcers.

Intragastric pH during continuous infusion with pantoprazole in patients with bleeding peptic ulcer.

OBJECTIVES: In managing patients with bleeding peptic ulcers, prevention of rebleeding is a particular challenge to hemostasis and fibrinolysis, both of which involve reactions that are impaired in acidic gastric environment. Therefore, such patients are expected to benefit from profound acid suppression. The present investigation aimed to establish a safe and, with regard to pH elevation, effective treatment that, based on in vitro evidence, should provide clinical benefit in this patient population. METHODS: Patients with acute bleeding peptic ulcers (Forrest Ia, Ib, IIa) after successful endoscopic hemostasis were enrolled in two pilot studies (N = 20 each). They were given an intravenous bolus injection of 80 mg of pantoprazole immediately followed by continuous infusion of either 6 mg/h or 8 mg/h pantoprazole for 72 h. Intragastric pH was measured continuously over 24 h and, if possible, for up to 48 h. RESULTS: Intragastric pH increased rapidly to values of about 6 with both treatments. For the 0-24 h period, the median pH values were 6.1 (68% range 4.5-7.4) and 6.1 (68% range 5.2-6.7) in patients receiving 6 mg/h and 8 mg/h continuous infusion, respectively; the values for the 0-48 h period were 5.9 (4.9-6.7) and 6.3 (5.5-7.0), respectively. The median percentage time that pH was > or =6 during the 0-48 h interval was 47% (68% range 28-89) for the 6 mg/h treatment group and 64% (68% range 41-84) for the 8 mg/h treatment group. Both treatment regimens with pantoprazole were well tolerated based on electrocardiographic measurements, vital signs, clinical laboratory values, and adverse events. CONCLUSIONS: Compared with the infusion with 6 mg/h pantoprazole, the continuous infusion of 8 mg/h pantoprazole showed a lower interindividual variability of the intragastric pH and a greater percentage of time that pH was >/ or =6. Thus, with regard to safety and efficacy, an initial 80-mg bolus injection, followed by 8 mg/h continuous infusion, seems to be the adequate treatment in patients with a high risk of rebleeding.