Background:
Functional dyspepsia is one of the commonest digestive disorders. The pathophysiology of
functional dyspepsia is uncertain. Proton pump inhibitor (PPI) has been recommended as the
first line treatment for functional dyspepsia. However, the results on effectiveness of PPI
are conflicting and it has been suggested that PPI is only effective for acid-related
symptoms.
The investigators plan to use a wireless pH monitoring system positioned at the junction of
esophagus and stomach to evaluate the chronological relationship between acid exposure at
this region and symptoms of dyspepsia as well as its impact on the efficacy of acid
suppressive therapy in treatment of functional dyspepsia.
Indication:
Functional dyspepsia patients
Study center(s):
Prince of Wales Hospital, Hong Kong
Aims:
1. To evaluate the chronological relationship between acid exposure at squamo-columnar
junction (SCJ) and dyspeptic symptom in different subtypes of functional dyspepsia
2. To evaluate the relationship between acid exposure at squamo-columnar junction and
dyspeptic symptom response to PPI
3. To compare the efficacy of PPI and placebo in treating functional dyspepsia patients
Study medication:
Esomeprazole 20mg vs Placebo o.d.
Study design:
Double-blind randomized placebo-controlled trial
Number of subjects: 130
Patient population:
Functional dyspepsia patients without concomitant gastroesophageal reflux disease (GERD)
Duration of study:
1 June 2010 - 30 May 2012
Primary variable(s):
Proportion of patients who report positive response to adequate relief of dyspeptic symptoms
at week 8
Secondary variable(s):
Dyspeptic symptom scores, symptom association probability of dyspeptic symptoms in relation
to esophageal pH of less than 4 as measured at 1 cm above SCJ.
Number of visits: 2
Hypothesis:
Increased acid exposure at SCJ contributes to dyspeptic symptom and predicts treatment
response to PPI in FD patients without concomitant GERD