Table 3

QOLRAD scores at baseline and end of treatment (full-analysis set, N=146)*

QOLRAD score (mean (SD))Verum (n=72)Placebo (n=74)ANCOVA† Results (estimate (95% CI), p value)
Food/drink problems
 Baseline4.12 (1.07)4.51 (1.14)0.38 (0.08 to 0.68), 0.0125
 After 6 weeks5.76 (1.21)5.50 (1.21)
 Change from baseline1.62 (1.27)0.96 (1.25)
Emotional distress
 Baseline4.90 (1.25)5.10 (1.48)0.35 (0.07 to 0.63), 0.0147
 After 6 weeks6.24 (1.07)5.93 (1.02)
 Change from baseline1.32 (1.25)0.79 (1.22)
Vitality
 Baseline4.29 (1.27)4.37 (1.34)0.33 (0.02 to 0.64), 0.0393
 After 6 weeks5.90 (1.23)5.50 (1.30)
 Change from baseline1.59 (1.45)1.13 (1.44)
Sleep disturbance
 Baseline4.94 (1.21)4.99 (1.48)0.21 (–0.09 to 0.51), 0.1604
 After 6 weeks6.10 (1.06)5.94 (1.16)
 Change from baseline1.15 (1.43)0.92 (1.30)
Physical/social functioning
 Baseline5.38 (1.12)5.42 (1.21)0.19 (–0.04 to 0.42), 0.1048
 After 6 weeks6.34 (0.92)6.16 (0.97)
 Change from baseline0.96 (1.01)0.73 (1.09)
  • *The full-analysis set includes all randomised patients who received the study drug at least once, and who provided any postbaseline data for the RDQ score used for responder analysis, and who did not violate against inclusion criteria.

  • †ANCOVA (baseline as covariate) verum versus placebo for change from baseline.

  • ANCOVA, analysis of covariance; CI, confidence interval; n/N, number of patients; QOLRAD, Quality Of Life in Reflux and Dyspepsia; RDQ, Reflux Disease Questionnaire.