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. 2019 Sep 2;46(11):1105–1115. doi: 10.1111/jcpe.13175

Table 2.

Change from baseline and between‐treatment comparisons for change in Schiff sensitivity score and tactile threshold (intent‐to‐treat population)

  Test Control Test versus controlc
Schiff sensitivity scorea
Study 1
Baseline 2.82 (0.031) 2.80 (0.031)  
Immediate

−0.41 (−0.54, −0.27)

p < .0001

−0.31 (−0.44, −0.18)

p < .0001

−0.09 (−0.280, 0.092)

p = .3226

Day 3

−0.96 (−1.14, −0.78)

p < .0001

−0.77 (−0.95, −0.59)

p < .0001

−0.18 (−0.442, 0.072)

p = .1575

Study 2
Baseline 2.12 (0.028) 2.12 (0.028)  
Immediate

−0.89 (−0.97, −0.81)

p < .0001

−0.17 (−0.25, −0.09)

p < .0001

−0.72 (−0.839, −0.610)

p < .0001

Day 3

−1.40 (−1.49, −1.30)

p < .0001

−0.38 (−0.48, 0.28)

p < .0001

−1.02 (−1.150, −0.882)

p < .0001

Study 3
Baseline 2.18 (0.033) 2.18 (0.033)  
Immediate

−0.63 (−0.73, −0.54)

p < .0001

−0.38 (−0.47, 0.28)

p < .0001

−0.26 (−0.387, −0.123)

p = .0002

Day 3

−1.37 (−1.46, −1.28)

p < .0001

−0.45 (−0.54, 0.35)

p < .0001

−0.92 (−1.055, −0.793)

p < .0001

Tactile threshold (g)b
Study 1
Baseline 10 (10, 20) 10 (10, 20)  
Immediate 0 (−5, 65)d 0 (−10, 40)d p = .3372
Day 3 10 (−10, 80)d 5 (−10, 80)d p = .3719
Study 2
Baseline 10.85 (0.229) 10.69 (0.193)  
Immediate

19.42 (17.16, 21.68)

p < .0001

3.74 (1.47, 6.01)

p = .0014

15.68 (12.476, 18.883)

p < .0001

Day 3

35.48 (32.40, 38.55)

p < .0001

6.55 (3.47, 9.62)

p < .0001

28.93 (24.576, 33.277)

p < .0001

Study 3
Baseline 12.35 (0.373) 11.76 (0.346)  
Immediate

15.19 (12.81, 17.56)

p < .0001

8.05 (5.67, 10.43)

p < .0001

7.14 (3.768, 10.506)

p < .0001

Day 3

32.87 (30.03, 35.71)

p < .0001

10.37 (7.50, 13.24)

p < .0001

22.50 (18.458, 26.541)

p < .0001

a

Baseline values are raw mean scores (± standard error); post‐baseline values are adjusted mean changes from baseline (± 95% confidence interval).

b

Baseline values are raw median scores (minimum, maximum) for Study 1, raw mean scores (± standard error) for Studies 2 and 3; post‐baseline values are adjusted median change from baseline scores (minimum, maximum) for Study 1, adjusted mean change from baseline scores (± 95% confidence interval) for Studies 2 and 3.

c

Difference (95% confidence) p‐value from ANCOVA model: first‐named minus second‐named group. For Schiff sensitivity score, a negative difference favours the first‐named group. For Study 1 tactile threshold, p‐value is from a van Elteren nonparametric test. For tactile threshold (Studies 2 and 3 only), a positive difference favours the first‐named group.

d

The analysis of the statistical significance of change from baseline in Tactile threshold was not performed for Study 1.