Double-blind, randomized controlled study to assess the effects of lansoprazole 30 mg and lansoprazole 15 mg on 24-h oesophageal and intragastric pH in Chinese subjects with gastro-oesophageal reflux disease.

BACKGROUND: Previous studies have suggested that the acid secretory capacity of the Chinese population is lower than that of the Western population. AIM: To compare the effect of lansoprazole 30 mg and 15 mg once daily on the 24-h oesophageal and intragastric pH profiles in Chinese patients with gastro-oesophageal reflux disease. METHODS: Forty-four patients (male to female ratio, 27 : 17; mean age, 53 years; 55% with oesophagitis) with gastro-oesophageal reflux disease were randomized to receive lansoprazole 30 mg or 15 mg once daily for 4 weeks. Measurement of the 24-h oesophageal and intragastric pH, gastro-oesophageal reflux disease symptoms and quality of life was performed at baseline and during the last week of each dosing period. RESULTS: Lansoprazole 30 mg maintained an intragastric pH > 4 for 10.5 h vs. 9.6 h for lansoprazole 15 mg (P = 0.44). The percentage total time at oesophageal pH < 4 was similar for lansoprazole 30 mg and 15 mg (2.0% vs. 2.3%, P = 0.30). The proportion of patients with complete cure of heartburn and acid regurgitation and the quality of life assessment were similar for lansoprazole 30 mg and 15 mg. Both dosages of lansoprazole were well tolerated and the compliance was 100% in both groups. CONCLUSION: Lansoprazole dosages of 30 mg and 15 mg once daily provide a satisfactory decrease for oesophageal acid exposure and are equally effective for the treatment of gastro-oesophageal reflux disease in the Chinese population.

A validated symptoms questionnaire (Chinese GERDQ) for the diagnosis of gastro-oesophageal reflux disease in the Chinese population.

BACKGROUND AND AIMS: To develop a validated gastro-oesophageal disease (GERD) symptom questionnaire for the Chinese population. METHODS: One hundred Chinese patients with GERD and 101 healthy Chinese controls were presented with a 20-item GERD questionnaire in the Chinese language (Chinese GERDQ). Quality of life in GERD patients was assessed by SF-36. A standard dose of proton pump inhibitors for 4 weeks was prescribed to 35 patients with newly diagnosed GERD. The Chinese GERDQ was performed before, 4 weeks and 8 weeks after treatment. Concept, content, construct, discriminant validity and reliability of the questionnaire were assessed. RESULTS: Seven items were selected by logistic regression to account for most of the differences between controls and GERD patients with a good reproducibility and internal consistency. A cut-off score of equal or greater than 12 was determined to discriminate between controls and GERD patients with a sensitivity of 82% and a specificity of 84%. The Chinese GERDQ correlated negatively with five domains of the SF-36 and discriminated between GERD patients who reported symptomatic improvement during proton pump inhibitor treatment and symptoms deterioration upon withdrawal of proton pump inhibitor treatment. CONCLUSIONS: The Chinese GERDQ could be used in epidemiological studies to assess the frequency and severity of GERD in patient populations and in interventional studies of GERD.

Symptomatic response to lansoprazole predicts abnormal acid reflux in endoscopy-negative patients with non-cardiac chest pain.

AIM: To determine whether symptomatic response to lansoprazole predicts abnormal acid reflux in endoscopy-negative patients with non-cardiac chest pain. METHODS: Patients who complained of chest pain, but had normal coronary angiography, were asked to undergo upper endoscopy. Those without gastric and oesophageal lesions were recruited for 24-h ambulatory oesophageal pH monitoring, and were randomly given lansoprazole 30 mg or placebo, both daily for 4 weeks. Chest pain symptoms were recorded before and 1 month after treatment on a locally validated questionnaire. The symptom score was calculated by multiplying the severity and frequency of the symptom, and symptom improvement was defined as > 50% reduction in symptom score. RESULTS: Overall, 68 patients, 36 on lansoprazole and 32 on placebo, completed the trial. The symptom score was reduced significantly in both groups (P < 0.001). In the lansoprazole group, more patients with than without abnormal reflux showed symptom improvement (92% vs. 33%; odds ratio = 22; 95% confidence interval, 2.3-201.8; chi2 = 10.9; P = 0.001), giving a sensitivity, specificity, positive predictive value, negative predictive value and accuracy of 92%, 67%, 58%, 94% and 75%, respectively. In the placebo group, the rates of symptom improvement were similar between those with and without abnormal reflux (33% vs. 35%, P = N.S.). CONCLUSIONS: Treatment with lansoprazole is a useful test in diagnosing endoscopy-negative gastro-oesophageal reflux disease in Chinese patients with non-cardiac chest pain.

Normal 24-hour ambulatory proximal and distal gastroesophageal reflux parameters in Chinese.

OBJECTIVE: To quantify normal proximal and distal oesophageal acid parameters in healthy Chinese. DESIGN: Observational study. SETTING: University teaching hospital, Hong Kong. SUBJECTS AND METHODS: Twenty healthy adults who were not on medication and were free from gastrointestinal symptoms were recruited by advertisement. Ambulatory oesophageal acid (pH<4) exposure parameters were recorded at distal and proximal sites, 5 and 20 cm, respectively above the lower oesophageal sphincter. RESULTS: The 95th percentile for reflux parameters assessed in the distal/proximal oesophagus were: percent total time pH<4, 4.6/0.7%; percent upright time pH<4, 7.0/1.1%; percent supine time pH<4, 4.5/0.5%; number of reflux episodes, 73/12; number of reflux episodes with pH<4 for >5 minutes, 4/0; and the longest single acid exposure episode, 11.2/3.0 minutes. CONCLUSION: Physiological gastroesophageal reflux occurs in healthy Chinese. These initial data provide a preliminary reference range that could be utilised by laboratories studying Chinese subjects.