Table 2 Efficacy of the treatment measured by endpoint symptoms (the response rates, odds ratios (OR), and 95% confidence interval (CI)) in the intention-to-treat population).

From: Assessing the post-treatment therapeutic effect of pinaverium in irritable bowel syndrome: a randomized controlled trial

 

Primary endpoints

Secondary endpoints

Pain

Stool consistency

Pain frequency

Stool frequency

Res%

OR (95% Cl) P (X22)

Res%

OR (95% Cl) P (X22)

Res%

OR (95% Cl) P (X22)

Res%

OR (95% Cl) P (X22)

TREATMENT

Day 1

 Pinaverium

52.3

5.19

28.8

2.73

44.7

3.46

28.0

1.97

 Placebo

17.4

(2.5–9.13)

12.9

(1.45–5.15)

18.9

(1.99–6.02)

16.5

(1.08–3.57)

  

< 0.001 (35.3)

 

< 0.005 (10.1)

 

< 0.001 (20.2)

 

< 0.05 (5.0)

Day 2

 Pinaverium

54.5

3.91

31.8

2.68

50.8

2.75

42.4

2.86

 Placebo

23.5

(2.30–6.63)

14.4

(1.46–4.93)

27.3

(1.65–4.59)

20.5

(1.66–4.94)

  

< 0.001 (26.8)

 

< 0.005 (10.4)

 

< 0.001 (15.3)

 

< 0.001 (14.8)

Day 3

 Pinaverium

60.6

3.67

37.9

3.22

56.8

3.95

42.4

2.10

 Placebo

29.5

(2.20–6.12)

15.9

(1.80–5.78)

25.0

(2.34–6.66)

26.0

(1.25–3.53)

  

< 0.001 (25.7)

 

< 0.001 (16.2)

 

< 0.001 (27.6)

 

< 0.005 (7.9)

Week 1

 Pinaverium

53.8

2.68

47.7

2.26

60.6

2.88

47.0

2.07

 Placebo

30.3

(1.62–4.44)

28.8

(1.36–3.76)

34.8

(1.74–4.74)

29.9

(1.25–3.44)

  

< 0.001 (14.9)

 

< 0.005 (10.0)

 

< 0.001 (17.6)

 

< 0.005 (8.1)

Week 4

 Pinaverium

64.4

3.88

54.5

2.57

66.7

3.87

54.5

1.91

 Placebo

31.8

(2.32–6.46)

31.8

(1.56–4.25)

34.1

(2.32–6.44)

38.6

(1.17–3.12)

  

< 0.001 (28.1)

 

< 0.001 (13.9)

 

< 0.001 (28.0)

 

< 0.010 (6.8)

POST-TREATMENT

 Day 1

  Pinaverium

62.3

4.04

58.3

3.11

65.2

4.15

58.3

2.09

  Placebo

29.5

(2.42–6.76)

31.1

(1.87–5.15)

31.1

(2.48–6.94)

40.2

(1.28–3.41)

  

< 0.001 (29.5)

 

< 0.001 (19.9)

 

< 0.001 (30.7)

 

< 0.005 (8.7)

 Day 2

  Pinaverium

62.1

4.37

56.8

3.25

63.6

4.33

59.1

2.22

  Placebo

27.3

(2.60–7.36)

28.8

(1.95–5.42)

28.8

(2.58–7.26)

39.4

(1.36–3.64)

  

< 0.001 (32.4)

 

< 0.001 (21.1)

 

< 0.001 (32.2)

 

< 0.005 (10.3)

 Day 3

  Pinaverium

62.1

4.21

54.5

2.66

63.6

4.03

55.3

2.11

  Placebo

28.0

(2.51–7.07)

31.1

(1.61–4.41)

30.3

(2.41–6.73)

37.0

(1.29–3.45)

  

< 0.001 (31.0)

 

< 0.001 (14.9)

 

< 0.001 (29.4)

 

< 0.005 (8.9)

 Week 4

  Pinaverium

56.8

2.63

47.0

1.71

59.8

3.31

53.0

2.21

  Placebo

33.3

(1.60–4.34)

34.1

(1.04–2.81)

31.1

(1.99–5.49)

33.9

(1.34–3.62)

  

< 0.001 (14.7)

 

< 0.05 (4.5)

 

< 0.001 (22.1)

 

< 0.005 (9.9)

 Week 9

  Pinaverium

50.8

1.69

50.0

1.69

49.2

1.64

49.2

1.77

  Placebo

37.9

(1.04–2.76)

37.1

(1.04–2.77)

37.1

(1.01–2.69)

35.4

(1.08–2.90)

  

< 0.05 (4.5)

 

< 0.05 (4.5)

 

< 0.05 (4.0)

 

< 0.05 (5.2)

 Week 17

  Pinaverium

43.9

1.47

47.0

1.55

47.0

1.55

45.5

1.37

  Placebo

34.8

(0.89–2.41)

36.4

(0.95–2.54)

36.4

(0.95–2.54)

37.8

(0.84–2.24)

  

> 0.05 (2.3)

 

> 0.05 (3.1)

 

> 0.05 (3.1)

 

> 0.05 (1.6)

 Week 25

  Pinaverium

45.5

1.56

43.9

1.47

46.2

1.55

41.7

1.30

  Placebo

34.8

(0.95–2.56)

34.8

(0.89–2.41)

35.6

(0.95–2.55)

35.4

(0.79–2.14)

  

> 0.05 (3.1)

 

> 0.05 (2.3)

 

> 0.05 (3.1)

 

> 0.05 (1.1)

 Week 33

  Pinaverium

40.2

1.34

41.7

1.59

43.2

1.57

42.4

1.44

  Placebo

33.3

(0.81–2.22)

31.1

(0.96–2.63)

32.6

(0.95–2.60)

33.9

(0.87–2.37)

  

> 0.05 (1.3)

 

> 0.05 (3.2)

 

> 0.05 (3.2)

 

> 0.05 (2.1)

 Week 45

  Pinaverium

38.6

1.07

43.9

1.57

40.9

1.38

40.9

1.31

  Placebo

37.1

(0.65–1.75)

33.3

(0.95–2.58)

33.3

(0.84–2.29)

34.6

(0.79–2.15)

  

> 0.05 (0.1)

 

> 0.05 (3.1)

 

> 0.05 (1.6)

 

> 0.05 (1.1)

 Week 57

  Pinaverium

37.1

1.10

40.9

1.29

39.4

1.30

42.4

1.30

  Placebo

34.8

(0.67–1.82)

34.8

(0.76–2.13)

33.3

(0.79–2.15)

36.2

(0.79–2.13)

  

> 0.05 (0.1)

 

> 0.05 (1.0)

 

> 0.05 (1.0)

 

> 0.05 (1.1)

  1. Res% response rates.
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