Table 2 Outcomes
Mesalazine arm | Placebo arm | P | ||
|---|---|---|---|---|
Safety and compliance | ||||
Deaths | 0 | 1 | 0.32 | |
Hospitalizationsa | 0 | 2 | 0.15 | |
Total adverse events | 35 | 27 | 0.53 | |
Acute watery diarrhea | 7 | 8 | 0.53 | |
Bloody diarrhea | 0 | 2 | 0.32 | |
Chronic diarrhea | 1 | 1 | 1.00 | |
μgastroenteritis (with vomiting) | 5 | 1 | 0.15 | |
μgiardiasis | 6 | 6 | 1.00 | |
Oral candidiasis | 3 | 0 | 0.08 | |
Upper respiratory tract infection | 3 | 5 | 0.64 | |
Lower respiratory tract infection | 3 | 1 | 0.30 | |
Tuberculosis | 1 | 1 | 1.00 | |
Malaria/non-specific febrile illness | 4 | 3 | 0.43 | |
Rash | 2 | 2 | 1.00 | |
Total gastrointestinal adverse events | 23 | 16 | 0.27 | |
Total diarrheal adverse events | 8 | 11 | 0.65 | |
Unable to dose-escalate at day 7 | 1 (5) | 7 (32) | 0.05 | |
Compliance (%) | 93 (71 to 98) | 97 (82 to 99) | 0.44 | |
Anthropometry and recovery | ||||
Recovery: nutritionally cured at day 56 | 13 | 12 | 1.00 | |
Recovery: RUTF-free days at day 56 | 9 (0 to 21) | 9.5 (0 to 21) | 0.94 | |
Nutritional edema | Baseline | 15/22 (68) | 17/22 (77) | 0.72 |
Day 28 | 7/22 (32) | 6/22 (27) | 1.00 | |
Day 56b | 3/20 (15) | 2/19 (11) | 1.00 | |
MUAC (mm) | Baseline | 12.9 (11.2 to 14.4) | 12.7 (11.2 to 13.8) | 0.56 |
Day 28 | 13.7 (11.8 to 14.7) | 13.2 (12.2 to 14.6) | 0.82 | |
Day 56 | 13.9 (12.5 to 14.8) | 13.6 (13.0 to 15.1) | 0.59 | |
MUAC growth rate (mm/day) | To day 28 | 0.23 (0.06 to 0.37) | 0.31 (0.18 to 0.61) | 0.15 |
To day 56 | 0.12 (0.08 to 0.21) | 0.23 (0.14 to 0.33) | 0.01 | |
Height growth rate (mm/day) to day 56 | 0.31 (0.19 to 0.38) | 0.32 (0.21 to 0.38) | 0.94 | |
Height-for-age z-score | Baseline | -3.13 (-3.83 to -2.71) | -3.73 (-4.60 to -2.71) | 0.29 |
Day 28 | -3.17 (-4.04 to -2.61) | -3.70 (-4.20 to -2.73) | 0.42 | |
Day56 | -3.24 (-4.10 to -2.68) | -3.46 (-4.14 to -2.68) | 0.79 | |