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Table 2 Outcomes

From: Mesalazine in the initial management of severely acutely malnourished children with environmental enteric dysfunction: a pilot randomized controlled trial

  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
  1. 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.