Table 2.
Questionnaire outcome scores for compliant intention-to-treat group
| Questionnaires and intervention | No in group | Mean score at follow-up (95% CI) | ||
|---|---|---|---|---|
| Baseline | 16 weeks* | 12 months | ||
| RSI*: | ||||
| Lansoprazole | 102 | 22.0 (20.4 to 23.6) | 17.4 (15.5 to 19.4) | 16.0 (13.6 to 18.4) |
| Placebo | 118 | 21.7 (20.5 to 23.0) | 15.6 (13.8 to 17.3) | 13.6 (11.7 to 15.5) |
| Difference† | 0.3 (−1.7 to 2.3) | 1.8 (−0.8 to 4.4) | 2.4 (−0.6 to 5.4) | |
| RSI-HB: | ||||
| Lansoprazole | 102 | 20.3 (18.8 to 21.7) | 16.3 (14.5 to 18.1) | 14.7 (12.4 to 16.9) |
| Placebo | 118 | 19.8 (18.6 to 21.0) | 13.9 (12.2 to 15.5) | 11.9 (10.1 to 13.7) |
| Difference† | 0.5 (−1.4 to 2.4) | 2.4 (−0.0 to 4.8) | 2.8 (0.5 to 5.1) | |
| CReSS: | ||||
| Lansoprazole | 102 | 50.3 (44.9 to 55.7) | 38.9 (33.4 to 44.3) | 36.6 (29.8 to 43.5) |
| Placebo | 118 | 51.1 (46.4 to 55.8) | 34.7 (29.6 to 39.9) | 31.8 (26.6 to 36.9) |
| Difference† | −0.8 (−7.9 to 6.3) | 4.2 (−3.2 to 11.6) | 4.8 (−3.5 to 13.1) | |
| LPR-HRQL: | ||||
| Lansoprazole | 102 | 28.9 (24.5 to 33.3) | 20.5 (16.1 to 25.0) | 18.8 (13.7 to 23.8 |
| Placebo | 118 | 26.5 (22.5 to 30.5) | 17.1 (13.3 to 21.0) | 13.9 (10.0 to 17.8) |
| Difference† | 2.4 (−3.5 to 8.3) | 3.4 (−2.4 to 9.2) | 4.9 (−1.3 to 11.1) | |
RSI=reflux symptom index; RSI-HB=laryngopharyngeal RSI items without the heartburn score; CReSS=comprehensive reflux symptom score; LPR-HRQL=laryngopharyngeal health related quality of life.
*
Primary outcome measure.
†
Lansoprazole minus placebo is the difference in means (95% confidence intervals).