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. 2017 Mar 14;7(3):e1056. doi: 10.1038/tp.2017.10

Table 2. Efficacy outcomes.

  Bumetanide 0.5 mg (N=20) Bumetanide 1.0 mg (N=23) Bumetanide 2.0 mg (N=22) Placebo (N=23) P-value
CARS (full analysis set)
Screening
  N 20 23 22 23  
  Mean (s.d.) 42.45 (4.18) 41.43 (6.01) 41.30 (5.44) 40.41 (4.89)  
 
Day 90
  N 20 23 22 23  
  Mean (s.d.) 37.48 (5.59) 38.04 (6.13) 38.14 (6.19) 38.78 (4.58)  
 
Change
  Mean (s.d.) −4.98 (4.33) −3.09 (3.30) −3.16 (3.98) −1.63 (2.34)  
  Median [range] −5.00 [−11.0/3.0] −2.50 [−10.0/1.0] −2.00 [−12.0/3.0] −1.00 [−8.5/2.0]  
           
 Kruskal–Wallis test         0.069
Steel–Dwass pair-wise comparisons
  0.5 mg b.i.d. vs placebo         0.049
           
CARS (completers)
Screening
  N 20 23 22 23  
  Mean (s.d.) 42.45 (4.18) 41.13 (6.01) 41.30 (5.44) 40.41 (4.89)  
 
Day 90
  N 20 19 13 21  
  Mean (s.d.) 37.48 (5.59) 37.00 (5.31) 37.73 (7.14) 38.62 (4.60)  
 
Change
  Mean (s.d.) −4.98 (4.33) −3.74 (3.28) −5.35 (3.88) −1.79 (2.39)  
  Median [range] −5.00 [−11.0/3.0] −4.00 [−10.0/1.0] −6.00 [−12.0/3.0] −1.00 [−8.5/2.0]  
           
 Kruskal–Wallis test         0.015
Steel–Dwass pair-wise comparisons
  2.0 mg b.i.d. vs placebo         0.017
           
SRS (total score)
Screening
  N 20 23 22 22  
  Mean (s.d.) 113.35 (17.48) 106.42 (23.95) 106.58 (25.09) 112.68 (20.65)  
 
Day 90
  N 20 18 13 21  
  Mean (s.d.) 100.99 (23.70) 87.96 (19.89) 87.03 (22.03) 109.47 (26.07)  
 
Change
  Mean (s.d.) −12.36 (23.57) −13.17 (20.45) −21.83 (19.78) −1.55 (20.38)  
  Median [range] −13.00 [−86.0/14.0] −6.00 [−52.0/18.0] −27.00 [−47.0/8.0] 3.5 [−68.0/27.0]  
           
 Kruskal–Wallis test         0.020
           
CGI-I
CGI-I at day 90
  Very much improved 0 0 1 (7.7%) 0  
  Much improved 7 (35.0%) 5 (26.3%) 5 (38.5%) 1 (4.8%)  
  Minimally improved 7 (35.0%) 10 (52.6%) 7 (53.8%) 10 (47.6%)  
  No change 4 (20.0%) 4 (21.1%) 0 9 (42.9%)  
  Minimally worse 1 (5.0%) 0 0 1 (4.8%)  
  Not assessed/missing 0 4 9 2  
           
 Kruskal–Wallis test         0.004

Abbreviations: CARS, Childhood Autism Rating Scale; CGI-I, Clinical Global Impressions Improvement scale; SRS, Social Responsive Scale.

Efficacy outcomes, N is number of patients. For CARS and SRS scales, change from screening to day 90. A reduction in CARS and SRS score corresponds to an improvement.