Objectives: A survey of health-related quality of life (HRQOL) in the Japanese general population has suggested that HRQOL is affected by sex and age. We investigated whether there is any effect of baseline patients' characteristics on HRQOL of patients with reflux oesophagitis (RE), and its changes with lansoprazole (LPZ) treatment.
Research design and methods: This was a post hoc analysis of an open-label, multicentre, post-marketing, observational study which investigated the effect of LPZ (15 or 30 mg/day for 8 weeks) on HRQOL in patients with RE. At baseline, and after 4 and 8 weeks of treatment, HRQOL was assessed using a Japanese version of the 8-item Short-Form Health Survey (SF-8) and a newly-developed RE-specific questionnaire (RESQ). Stratified analysis of changes in HRQOL scores according to baseline patient characteristics such as sex, age and baseline severity of typical RE symptoms was performed.
Results: A total of 8,757 patients were included in the efficacy analysis. At baseline, physical component summary scores from the SF-8 were lower in older patients (>/=60 years) than in younger patients (<60 years), and mental component summary scores were lower in younger patients than in older patients. These scores significantly improved after LPZ treatment regardless of sex and age. HRQOL scores were lower in patients with more severe typical RE symptoms at baseline. After LPZ treatment, HRQOL scores significantly improved to similar levels irrespective of the severity of the typical RE symptom at baseline.
Conclusions: This post hoc analysis suggests that sex, age and severity of typical RE symptoms affect HRQOL in patients with RE in Japan, and such factors do not affect the improvement of HRQOL with LPZ treatment. The present study suggests a positive impact of LPZ; however, it is difficult to estimate the degree of improvement in HRQOL that may have arisen from symptomatic relief as part of the natural history of the disease from the study. Our results may overestimate the efficacy of LPZ. Further well-controlled clinical studies are needed to confirm the efficacy of LPZ on HRQOL in patients with RE.