TABLE 2.
Changes in QOL scales from baseline to week 4
| QOL scale | Subscale | Elo | Pbo | P value* |
|---|---|---|---|---|
| JPAC‐QOL | Physical Discomfort | −0.3 ± 0.8 | 0.1 ± 0.7 | 0.0518 |
| Psychosocial Discomfort | −0.1 ± 0.5 | −0.1 ± 0.4 | 0.8281 | |
| Worries/Concerns | −0.1 ± 0.6 | −0.1 ± 0.5 | 0.8837 | |
| Satisfaction | −0.7 ± 1.2 | 0.0 ± 0.8 | 0.0054 | |
| Total | −0.2 ± 0.6 | 0.0 ± 0.4 | 0.1534 | |
| MDS‐UPDRS | Part I subtotal | −0.9 ± 2.3 | −0.5 ± 2.7 | 0.4378 |
| Part II subtotal | 1.1 ± 2.8 | −0.4 ± 3.3 | 0.0426 | |
| Part III subtotal | −1.1 ± 6.7 | −4.0 ± 6.8 | 0.0701 | |
| Part IV subtotal | 0.1 ± 1.1 | 0.1 ± 0.7 | 0.9027 | |
| Total | −0.9 ± 8.0 | −4.8 ± 8.7 | 0.0485 | |
| PDQ‐39 | Mobility | −0.7 ± 6.4 | −1.5 ± 5.0 | 0.5577 |
| Activity of Daily Living | −0.1 ± 2.3 | −0.6 ± 3.6 | 0.5389 | |
| Emotional Well‐being | −0.6 ± 2.9 | 0.0 ± 3.6 | 0.4420 | |
| Stigma | −0.6 ± 1.9 | 0.4 ± 1.8 | 0.0248 | |
| Communication | −0.2 ± 1.1 | −0.2 ± 0.9 | 1.0000 | |
| Bodily Discomfort | −0.1 ± 1.7 | −0.1 ± 1.4 | 0.9419 | |
| Social Support | −0.1 ± 1.8 | −0.1 ± 1.4 | 0.8857 | |
| Cognition | 0.0 ± 2.5 | 0.3 ± 2.1 | 0.6166 | |
| Total | −2.4 ± 13.0 | −1.8 ± 12.8 | 0.8434 | |
| EQ‐5D | Index Value | −0.0 ± 0.1 | 0.0 ± 0.1 | 0.0598 |
| VAS | −3.8 ± 15.3 | 0.7 ± 14.6 | 0.1961 |
Note: Values in the treatment group columns are expressed as means ± SD.
Abbreviations: Elo, elobixibat; EQ‐5D, Euro‐Qol 5 dimensions; JPAC‐QOL, Japanese version of Patient Assessment of Constipation Quality of Life; MDS‐UPDRS, Movement Disorder Society‐unified Parkinson's Disease Rating Scale; Pbo, placebo; PDQ‐39, Parkinson's Disease Questionnaire‐39; QOL, quality of life; SD, standard deviation; VAS, visual analogue scale.
*
P values were based on the 2‐sample t‐test. The number of patients evaluated was 37 in each group.