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).

MATERIAL AND

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.