Table 7.
12- and 24-week change in questionnaire data: appetite, food cravings, and health-related quality of life in the modified intention-to-treat population of a randomised clinical trial of Tesomet for hypopituitary patients with hypothalamic obesity. Data presented as least squares mean (95% CI) change from baseline to week 12 and 24 in the mITT population. Last observation carried forward imputation was used for missing data. Inferential tests were performed using a baseline adjusted ANCOVA model with treatment as factor and change from baseline as dependent variable.
∆Week 0–12 | ∆Week 0–24 | |||||
---|---|---|---|---|---|---|
Tesomet (n = 13) | Placebo (n = 8) | P | Tesomet (n = 13) | Placebo (n = 8) | P | |
Composite satiety score (mm) | 12.7 (1.7; 23.8) | 1.7 (−12.4; 15.7) | 0.21 | 3.6 (−6.1; 13.4) | 3.8 (8.7; 16.2) | 0.99 |
How much do you think you can you eat? | −15.7 (−29.2; −2.2) | −10.2 (−27.5; 7.0) | 0.60 | −8.3 (−18.1; 1.6) | −12.5 (−25.1; 0.1) | 0.59 |
How full do you feel? | 10.1 (−2.1; 22.3) | −1.7 (−17.2; 13.8) | 0.22 | 0.5 (−11.7; 12.6) | 8.4 (−7.1; 23.9) | 0.41 |
How hungry do you feel? | −11.7 (−26.4; 3.0) | −2.1 (−20.8; 16.6) | 0.41 | −5.8 (−18.9; 7.3) | 10.1 (−6.6; 26.8) | 0.13 |
How satisfied do you feel? | 13.5 (1.5; 25.6) | −4.4 (−19.8; 11.1) | 0.07 | 0.6 (−11.8; 12.9) | 3.2 (−12.5; 19.0) | 0.78 |
How comfortable do you feel? | 1.5 (−10.7; 13.7) | −4.8 (−20.4; 10.8) | 0.52 | 1.4 (−12.0; 14.8) | −0.7 (−17.8; 16.5) | 0.85 |
Food cravings (mm)a | ||||||
Like to eat something savoury | 12.2 (−3.0; 27.4) | 9.2 (−10.3; 28.7) | 0.80 | 14.3 (−1.2; 29.8) | 1.5 (−18.4; 21.4) | 0.31 |
Like to eat something fatty | 19.1 (11.1; 27.1) | 20.5 (10.2; 30.7) | 0.83 | 17.1 (5.8; 28.4) | 8.8 (−5.6; 23.2) | 0.35 |
Like to eat something sweet | 17.9 (6.9; 28.9) | 14.9 (0.8; 29.1) | 0.74 | 12.4 (−4.7; 29.5) | 16.5 (−5.5; 38.5) | 0.77 |
Like to eat something salty | 7.7 (−8.10; 23.4) | 12.7 (−7.4; 32.8) | 0.69 | 2.0 (−11.1; 15.1) | 10.7 (−6.0; 27.4) | 0.40 |
Health-related Quality of Life | ||||||
Physical component score | 3.1 (1.2; 4.9) | −0.3 (−2.7; 2.0) | 0.03 | 1.2 (−2.6; 4.9) | 0.6 (−4.2; 5.4) | 0.84 |
Mental component score | −1.9 (−4.9; 1.1) | −0.3 (−4.1; 3.5) | 0.50 | −2.9 (−8.1; 2.3) | −1.2 (−7.8; 5.4) | 0.67 |
aAn increase in score represents a decrease in perceived desire.
ANCOVA, analysis of covariance; Mitt, modified intention-to-treat.