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 | |
| Gastroenteritis (with vomiting) | 5 | 1 | 0.15 | |
| Giardiasis | 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 | |
aIncludes the one child who died in hospital. bExcluding children who were unable to be assessed. Data are medians (inter-quartile range) or numbers (%) unless otherwise stated. MUAC, mid-upper arm circumference; RUTF, ready-to-use therapeutic food.