TABLE 2.
Questionnaires (absolute changes from baseline to week 26)
| EMP16‐120/40 (n = 44) | Estimated difference (95% CI), EMP16‐120/40 vs. placebo | p value, EMP16‐120/40 vs. placebo | EMP16‐150/50 (n = 44) | Estimated difference (95% CI), EMP16‐150/50 vs. placebo | p value, EMP16‐150/50 vs. placebo | Placebo (n = 46) | |
|---|---|---|---|---|---|---|---|
| Satiety and craving total score | 8.1 (35.4) | 9.00 (−5.74 to 23.74) | 0.229 | −0.8 (29.7) | 0.10 (−13.50 to 13.70) | 0.919 | −0.9 (35.2) |
| RAND‐36 | |||||||
| Physical functioning | 9.0 (14.9) | 7.00 (1.48 to 12.52) | 0.008 | 11.5 (15.3) | 9.50 (3.88 to 15.12) | 0.002 | 2.0 (11.3) |
| Role functioning/physical | 7.7 (36.0) | 7.70 (−5.95 to 21.35) | 0.181 | 12.2 (35.8) | 12.20 (−1.40 to 25.80) | 0.075 | 0.0 (29.0) |
| Pain (bodily pain) | 1.3 (17.4) | 1.50 (−5.68 to 8.68) | 0.877 | 11.8 (21.0) | 12.00 (4.02 to 19.98) | 0.013 | −0.2 (17.0) |
| General health | 3.3 (17.1) | 8.00 (1.68 to 14.32) | 0.017 | 6.0 (12.6) | 10.70 (5.38 to 16.02) | < 0.001 | −4.7 (±12.9) |
| Energy/fatigue (vitality) | −1.4 (19.9) | 1.70 (−6.01 to 9.41 | 0.437 | 7.2 (20.0) | 10.30 (2.57 to 18.03) | 0.022 | −3.1 (16.9) |
| Social functioning | 1.2 (20.3) | 3.90 (−4.37 to 12.17) | 0.468 | 6.4 (26.8) | 9.10 (−0.65 to 18.85) | 0.089 | −2.7 (19.3) |
| Role functioning/emotional | −2.4 (38.5) | 8.90 (−5.75 to 23.55) | 0.286 | 3.3 (43.3 | 14.60 (−1.17 to 30.37) | 0.145 | −11.3 (31.3) |
| Emotional well‐being (mental) | −3.8 (16.6) | 0.50 (−5.41 to 6.41) | 0.302 | 1.7 (17.8) | 6.00 (−0.21 to 12.21) | 0.036 | −4.3 (11.2) |
| Health transition score | 18.5 (29.8) | 12.60 (2.05 to 23.15) | 0.006 | 16.5 (20.6) | 10.60 (2.18 to 19.02) | 0.011 | 5.9 (19.7) |
| GSRS | |||||||
| Diarrhea syndrome | 1.3 (1.5) | 1.00 (0.50 to 1.50) | < 0.001 | 1.8 (1.4) | 1.50 (1.02 to 1.98) | < 0.001 | 0.3 (0.8) |
| Indigestion syndrome | 0.8 (1.0) | 0.70 (0.34 to 1.06) | < 0.001 | 1.0 (1.1) | 0.90 (0.52 to 1.28) | < 0.001 | 0.1 (0.7) |
| Constipation syndrome | 0.2 (1.0) | 0.10 (−0.23 to 0.43) | 0.831 | 0.3 (0.6) | 0.20 (−0.03 to 0.43) | 0.404 | 0.1 (0.5) |
| Abdominal pain syndrome | 0.2 (0.7) | 0.30 (0.03 to 0.57) | 0.079 | 0.1 (0.8) | 0.20 (−0.10 to 0.50) | 0.284 | −0.1 (0.6) |
| Reflux syndrome | 0.0 (0.9) | −0.20 (−0.50 to 0.10) | 0.717 | −0.1 (0.4) | −0.30 (−0.49 to −0.11) | 0.110 | 0.2 (0.5) |
Note: Observed mean data (SD) and estimated difference (95% CI) are presented for the intention‐to‐treat analysis set without imputations. ANCOVA was performed with imputations using last‐observation‐carried‐forward. Changes at weeks 7 and 14 during the trial are presented in online Supporting Information.
Abbreviations: GSRS, gastrointestinal symptoms rating scale, where higher scores indicate increased intensity; RAND‐36, 36‐item short form health survey where higher score indicates better quality of life.