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Table 2 Intention-to-treat (ITT) and per-protocol (PP) analysis of the Efficacy of the Sufficient Improvementa of Reflux symptoms between the Two Groups

From: Efficacy of a high-dose proton pump inhibitor in patients with gastroesophageal reflux disease: a single center, randomized, open-label trial

 

Standard-dose groupb

High-dose groupc

P-value

n/N (%)

95% CI

n/N (%)

95% CI

ITT analysis

 Total symptoms

  All gender

27/40 (67.5)

60.0–75.0

39/44 (88.6)

83.8–93.4

0.018

  Male

7/12 (58.3)

43.4–73.2

14/15 (93.3)

86.6–100.0

0.060

  Female

20/28 (71.4)

62.7–80.1

25/29 (86.2)

79.7–92.7

0.171

 Typical symptomsd

  All gender

24/29 (82.8)

75.7–89.9

33/33 (100.0)

100.0–100.0

0.018

  Male

6/8 (75.0)

58.6–91.4

10/10 (100.0)

100.0–100.0

0.183

  Female

18/21 (85.7)

77.9–93.5

23/23 (100.0)

100.0–100.0

0.100

 Atypical symptomse

  All gender

20/31 (64.5)

55.8–73.2

31/39 (79.5)

72.9–86.1

0.162

  Male

5/9 (55.6)

38.0–73.2

14/15 (93.3)

86.6–100.0

0.047

  Female

15/22 (68.2)

58.0–78.4

17/24 (70.8)

61.3–80.3

0.845

PP analysis

 Total symptoms

  All gender

24/35 (68.6)

60.6–76.6

35/38 (92.1)

87.7–96.5

0.011

  Male

7/11 (63.6)

48.4–78.8

13/14 (92.9)

85.8–100.0

0.133

  Female

17/24 (70.8)

61.3–80.3

22/24 (91.7)

87.1–98.7

0.137

 Typical symptomsd

  All gender

21/25 (84.0)

76.5–91.5

29/29 (100.0)

100.0–100.0

0.040

  Male

6/8 (75.0)

58.6–91.4

10/10 (100.0)

100.0–100.0

0.183

  Female

15/17 (88.2)

80.1–96.3

19/19 (100.0)

100.0–100.0

0.216

 Atypical symptomse

  All gender

17/27 (63.0)

53.5–72.5

28/34 (82.4)

75.8–89.0

0.087

  Male

5/8 (62.5)

44.2–80.8

13/14 (92.9)

85.8–100.0

0.117

  Female

12/19 (63.2)

51.8–74.6

15/20 (75.0)

65.1–84.9

0.423