Identifying response to acid suppressive therapy in functional dyspepsia using a random starting day trial--is gastro-oesophageal reflux important?
BACKGROUND
Single subject trials offer an alternative approach to identify and characterize responders to a specific treatment.


OBJECTIVE
To test a new single subject trials design, called random starting day trial, to identify acid-related symptoms in dyspepsia.


METHODS
A total of 119 patients with functional dyspepsia entered a 12-day, double-blind random starting day trial. All patients started on placebo and switched to omeprazole 80 mg/day at a randomized and blinded day between day 5 and day 9, with active treatment continuing for the rest of the trial. Based on changes of a daily symptom score, response was defined as a sustained > or =50% reduction of symptoms within 3 days of active treatment.


RESULTS
Thirteen of 119 patients (11%) were classified as spontaneous responders because of complete symptom relief before switching to omeprazole. Of the remaining 106 patients, 15 (15.6%) were classified as responders. Five of six (83%) responders compared with 28 of 53 (53%) non-responders had pathological reflux. Multivariate testing identified symptoms suggestive of gastro-oesophageal reflux predictive of response.


CONCLUSIONS
The random starting day trial design could identify a subset of dyspeptic patients with a uniform symptomatic response to acid-suppressive therapy. Response seems to be associated with gastro-oesophageal reflux. The random starting day trial needs to be further validated to be considered as a reliable instrument in clinical research.
Madsen
L G
LG
Department of Medical Gastroenterology, Glostrup University Hospital, Glostrup, Denmark.
Wallin
L
L
Bytzer
P
P
D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy*; D005260:Female; D005744:Gastric Acid / Q000378:metabolism*; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D009853:Omeprazole