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Identifying responders to acid suppression in dyspepsia using a random starting day trial.

Abstract：

BACKGROUND:Functional dyspepsia is a heterogeneous condition and a uniform response to drug treatment is not likely. This may be the reason for the general failure of acid suppression in clinical trials in these patients. It may be more rewarding to identify true responders to drug treatment by a single subject trial. AIM:To develop and to test a novel single subject trial design (random starting day trial) in dyspeptic patients. PATIENTS AND METHODS:A total of 301 dyspeptic patients entered a 16-day trial. All patients received placebo for the first 4 days and switched to omeprazole at a randomized and blinded day between day 5 and day 14. Response was defined as a sustained >/= 50% decrease in symptom score occurring in relation to drug shifting. RESULTS:Spontaneous response varied between 0.3% and 10.6% per day, uniformly distributed over time. Overall, 53-61% of patients with organic dyspepsia had a symptom response in relation to shifting to active treatment, compared to only 23% of patients with functional dyspepsia. The only predictor of response was symptoms suggesting gastro-oesophageal reflux. CONCLUSIONS:A random starting day trial may be a valuable tool to identify response to acid suppression in dyspeptic patients.

journal_name

Aliment Pharmacol Ther

journal_title

Alimentary pharmacology & therapeutics

authors

Bytzer P,Hansen JM,Rune S,Bonnevie O,Breinstrup H,Funch-Jensen P,Matzen P,Meineche-Schmidt V,Schaffalitzky De Muckadell OB

doi

10.1046/j.1365-2036.2000.00866.x

subject

Has Abstract

pub_date

2000-11-01 00:00:00

pages

1485-94

issue

11

eissn

0269-2813

issn

1365-2036

pii

apt866

journal_volume

14

pub_type

临床试验,杂志文章,随机对照试验

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