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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