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Table 3 Change in outcome measures with treatment

From: A pilot dose finding study of pioglitazone in autistic children

  Estimate (95%CL) Estimate (95%CL)
p value
Effect sized pooled sd
Baseline Week 8 Week 16 Week 16–baseline
n 27 25 25   
Social function
 ABC social withdrawal 10.1 (6.6; 13.7) 7.5 (4.8; 10.3) 6.7 (3.8; 9.6) − 3.4 (− 5.3; 1.6) 0.0005* − 0.43 7.96
 SRS totala 88.4 (73.6; 103.2) 88.2 (78.9; 97.5) 85.8 (75.2; 96.4) − 2.6 (− 17.2; 12.0) 0.7 − 0.09 29.29
Externalizing behaviors
 ABC irritability 13.8 (10.2; 17.4) 11.2 (8.3; 14.0) 10.0 (6.9; 13.0) − 3.8 (− 6.3; − 1.3) 0.004* − 0.46 8.27
 ABC hyperactivity 21.7 (17.6; 25.7) 18.7 (14.9; 22.4) 16.5 (13.2; 19.7) − 5.2 (− 7.8; − 2.6) 0.0003* − 0.58 8.96
Anxiety
 BASC-2 anxietyb 8.9 (5.5; 12.2) 8.1 (5.3; 10.8) 8.2 (5.2; 11.3) − 0.6 (− 2.8; 1.5) 0.6 − 0.08 7.76
 CASI-4 generalized anxietyc 6.6 (5.1; 8.0) 5.4 (4.3; 6.6) 5.2 (4.0; 6.3) − 1.4 (− 2.5; − 0.3) 0.02 − 0.44 3.16
 CASI-4 social phobiac 2.4 (1.6; 3.3) 2.2 (1.4; 3.0) 1.6 (1.1; 2.1) − 0.8 (− 1.5; − 0.2) 0.01 − 0.50 1.66
 CASI-4 separation anxietyc 2.4 (1.3; 3.5) 1.8 (1.1; 2.6) 1.6 (0.8; 2.4) − 0.8 (− 1.6; 0.1) 0.08 − 0.33 2.32
Repetitive behaviors
 RBSR total 33.0 (25.7; 40.3) 27.5 (20.6; 34.3) 24.5 (17.4; 31.5) − 8.5 (− 13.3; − 3.7) 0.0009* − 0.48 17.62
 CY-BOCSa 12.6 (11.1; 14.2) 10.7 (9.4; 12.1) 9.4 (8.0; 10.9) − 3.2 (− 4.4; − 2.0) < .0001* − 0.90 3.54
Clinical global impression % Responders: score of 1 or 2 (95%CL)
Week 8 Week 16
n 25 27
CGI social 20.3
(9.4; 38.2)
34.1
(18.6; 54.0)
CGI global 26.0
(11.7; 48.1)
45.8
(27.8; 65.0)
  1. Score (95%CL) at each visit is estimated from a repeated measures linear model controlling for age; a planned contrast is used to estimate the change from baseline to week 16 from the model; model excludes one participant with a placebo response at week 2
  2. an = 26 at baseline and week 16
  3. bn = 24 at week 8
  4. cn = 26 at week 16; * = remains significant using Bonferroni adjusted level for significance of p = 0.005
  5. dWeek 16–baseline/pooled standard deviation where the pooled standard deviation is derived from the baseline and week 16 standard deviations obtained from the repeated measures model