Psychological factors as a predictor of treatment response in patients with heartburn: a pooled analysis of clinical trials.
OBJECTIVE
A pooled analysis, using data from three prospective, randomized, double-blind, placebo-controlled, clinical studies, was undertaken to determine the relationship between well-being and subsequent clinical response to acid suppressant therapy in 1887 adult patients with reflux symptoms (with/without endoscopically verified erosive esophagitis).


METHODS
Well-being was assessed at study entry using the Psychological General Well-Being (PGWB) Index. Patients were assessed for complete relief of heartburn (absence of symptoms in the preceding 7 days) after 4 weeks' treatment (omeprazole 10 or 20 mg once daily; ranitidine 150 mg twice daily).


RESULTS
Multiple logistic regression analysis identified baseline PGWB Index total score and anxiety score as independent prognostic indicators of treatment response in endoscopy-positive patients (n=1333). Thus, the likelihood of achieving complete heartburn relief was impaired by high baseline levels of anxiety or a low total well-being score. In the endoscopy-negative group, high levels of depression and low vitality scores affected treatment response adversely. Furthermore, age (for endoscopy-positive patients only) and body mass index (for endoscopy-negative patients only) showed an association with treatment outcome. Gender seemed to have no prognostic value on treatment outcome.


CONCLUSIONS
Patient well-being may be a useful prognostic indicator in patients presenting with reflux symptoms, with a high level of anxiety predicating against a response to acid suppressant therapy, particularly in those with normal endoscopic findings.
Wiklund
Ingela
I
AstraZeneca R and D Mölndal, Mölndal, Sweden. ingela.wiklund@astrazeneca.com
Carlsson
Rolf
R
Carlsson
Jonas
J
Glise
Hans
H
D000293:Adolescent; D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001007:Anxiety / Q000209:etiology* / Q000523:psychology; D002648:Child; D002675:Child, Preschool; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005500:Follow-Up Studies; D006356:Heartburn / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D011788:Quality of Life / Q000523:psychology*; D016032:Randomized Controlled Trials as Topic; D011899:Ranitidine / Q000627:therapeutic use*; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D011899:Ranitidine; D009853:Omeprazole