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Table 4 Outcome of clonidine intervention – cardiovascular variables

From: Effects of low-dose clonidine on cardiovascular and autonomic variables in adolescents with chronic fatigue: a randomized controlled trial

 

Baseline

Week 8 (during treatment)

Supine

  

Heart rate - beats/min

  

 Clonidine group, mean

70

67

 Placebo group, mean

72

69

 Difference (95 % CI)

 

−2.0 (−4.1 to 0.1)

 p-value (clonidine vs. placebo)

 

0.06

SBP – mmHg

  

 Clonidine group, mean

103

104

 Placebo group, mean

107

103

 Difference (95 % CI)

 

1.4 (−1.0 to 3.9)

 p-value (clonidine vs. placebo)

 

0.25

MBP – mmHg

  

 Clonidine group, mean

77

78

 Placebo group, mean

80

77

 Difference (95 % CI)

 

1.3 (−0.7 to 3.4)

 p-value (clonidine vs. placebo)

 

0.19

DBP – mmHg

  

 Clonidine group, mean

65

64

 Placebo group, mean

66

63

 Difference (95 % CI)

 

0.8 (−1.0 to 2.7)

 p-value (clonidine vs. placebo)

 

0.37

SI - ml/m2

  

 Clonidine group, mean

47

46

 Placebo group, mean

46

46

 Difference (95 % CI)

 

0.2 (−2.1 to 2.4)

 p-value (clonidine vs. placebo)

 

0.86

TPRI - mmHg/L/min/m2

  

 Clonidine group, mean

9.1

9.4

 Placebo group, mean

8.9

8.9

 Difference (95 % CI)

 

0.5 (−0.1 to 1.1)

 p-value (clonidine vs. placebo)

 

0.11

SDNN – ms

  

 Clonidine group, mean

74

78

 Placebo group, mean

66

66

 Difference (95 % CI)

 

12.0 (−0.2 to 23.7)

 p-value (clonidine vs. placebo)

 

0.05

r-MSSD – ms

  

 Clonidine group, mean

79

83

 Placebo group, mean

65

70

 Difference (95 % CI)

 

13.1 (−3.2 to 29.5)

 p-value (clonidine vs. placebo)

 

0.11

pNN50 - %

  

 Clonidine group, mean

40

40

 Placebo group, mean

31

38

 Difference (95 % CI)

 

2.2 (−3.0 to 7.3)

 p-value (clonidine vs. placebo)

 

0.40

LF-HRV – nu

  

 Clonidine group, mean

40

42

 Placebo group, mean

43

38

 Difference (95 % CI)

 

3.7 (−0.5 to 8.0)

 p-value (clonidine vs. placebo)

 

0.08

HF-HRV – nu

  

 Clonidine group, mean

60

58

 Placebo group, mean

57

62

 Difference (95 % CI)

 

−3.7 (−8.0 to 0.5)

 p-value (clonidine vs. placebo)

 

0.08

LF-HRV* - ms2

  

 Clonidine group, mean

628

679

 Placebo group, mean

451

487

 Ratio (95 % CI)

 

1.4 (1.1 to 1.8)

 p-value (clonidine vs. placebo)

 

0.007

HF-HRV* - ms2

  

 Clonidine group, mean

962

961

 Placebo group, mean

600

825

 Ratio (95 % CI)

 

1.2 (0.9 to 1.5)

 p-value (clonidine vs. placebo)

 

0.28

Total Power-HRV* - ms2

  

 Clonidine group, mean

1991

2053

 Placebo group, mean

1352

1638

 Ratio (95 % CI)

 

1.3 (1.0 to 1.6)

 p-value (clonidine vs. placebo)

 

0.06

LF/HF-ratio*

  

 Clonidine group, mean

0.65

0.70

 Placebo group, mean

0.75

0.59

 Ratio (95 % CI)

 

1.2 (1.0 to 1.4)

 p-value (clonidine vs. placebo)

 

0.09

LF-SBP – nu

  

 Clonidine group, mean

39.3

38.0

 Placebo group, mean

38.1

36.9

 Difference (95 % CI)

 

1.1 (−3.0 to 5.2)

 p-value (clonidine vs. placebo)

 

0.60

LF-SBP* - mmHgs2

  

 Clonidine group, mean

3.8

3.7

 Placebo group, mean

3.0

3.2

 Ratio (95 % CI)

 

1.1 (0.9 to 1.5)

 p-value (clonidine vs. placebo)

 

0.34

Response to 20° head-up tilt

  

Heart rate - beats/min

  

 Clonidine group, mean

5.2

4.9

 Placebo group, mean

4.8

4.9

 Difference (95 % CI)

 

0.0 (−1.1 to 1.2)

 p-value (clonidine vs. placebo)

 

0.97

SBP – mmHg

  

 Clonidine group, mean

0.74

−0.59

 Placebo group, mean

0.15

−0.01

 Difference (95 % CI)

 

−0.58 (−2.2 to 1.0)

 p-value (clonidine vs. placebo)

 

0.48

MBP - mmHg

  

 Clonidine group, mean

1.19

0.61

 Placebo group, mean

0.94

1.23

 Difference (95 % CI)

 

−0.63 (−2.1 to 0.8)

 p-value (clonidine vs. placebo)

 

0.39

DBP - mmHg

  

 Clonidine group, mean

1.13

1.2

 Placebo group, mean

1.58

1.8

 Difference (95 % CI)

 

−0.59 (−2.0 to 0.8)

 p-value (clonidine vs. placebo)

 

0.40

SI - ml/m2

  

 Clonidine group, mean

−5.9

−4.5

 Placebo group, mean

−5.1

−5.3

 Difference (95 % CI)

 

0.9 (−0.4 to 2.1)

 p-value (clonidine vs. placebo)

 

0.17

TPRI - mmHg/L/min/m2

  

 Clonidine group, mean

0.66

0.44

 Placebo group, mean

0.60

0.62

 Difference (95 % CI)

 

−0.18 (−0.47 to 0.11)

 p-value (clonidine vs. placebo)

 

0.22

SDNN - ms

  

 Clonidine group, mean

−5.1

−7.9

 Placebo group, mean

−4.4

−0.7

 Difference (95 % CI)

 

−7.2 (−16.0 to 1.6)

 p-value (clonidine vs. placebo)

 

0.11

r-MSSD - ms

  

 Clonidine group, mean

−18

−24

 Placebo group, mean

−16

−17

 Difference (95 % CI)

 

−7.6 (−19.6 to 4.4)

 p-value (clonidine vs. placebo)

 

0.11

pNN50 - %

  

 Clonidine group, mean

−14

−11

 Placebo group, mean

−9

−13

 Difference (95 % CI)

 

1.2 (−3.1 to 5.4)

 p-value (clonidine vs. placebo)

 

0.59

LF-HRV - nu

  

 Clonidine group, mean

8.3

6.1

 Placebo group, mean

6.7

9.2

 Difference (95 % CI)

 

−3.1 (−7.4 to 1.1)

 p-value (clonidine vs. placebo)

 

0.15

HF-HRV - nu

  

 Clonidine group, mean

−8.3

−6.1

 Placebo group, mean

−6.7

−9.2

 Difference (95 % CI)

 

3.1 (−1.1 to 7.4)

 p-value (clonidine vs. placebo)

 

0.15

LF-HRV# - ms2

  

 Clonidine group, mean

−320

−161

 Placebo group, mean

−176

−171

 n.a.

 

n.a.

 p-value (clonidine vs. placebo)

 

0.87

HF-HRV# - ms2

  

 Clonidine group, mean

−828

−640

 Placebo group, mean

−523

−629

 n.a.

 

n.a.

 p-value (clonidine vs. placebo)

 

0.99

Total Power-HRV# - ms2

  

 Clonidine group, mean

−1107

−790

 Placebo group, mean

−668

−736

 n.a.

 

n.a.

 p-value (clonidine vs. placebo)

 

0.78

LF/HF-ratio

  

 Clonidine group, mean

0.35

0.34

 Placebo group, mean

0.44

0.55

 Difference (95 % CI)

 

−0.21 (−0.46 to 0.04)

 p-value (clonidine vs. placebo)

 

0.09

LF-SBP - nu

  

 Clonidine group, mean

2.5

4.4

 Placebo group, mean

3.2

3.7

 Difference (95 % CI)

 

0.7 (−2.4 to 3.8)

 p-value (clonidine vs. placebo)

 

0.66

LF-SBP - mmHgs2

  

 Clonidine group, mean

−2.6

−1.0

 Placebo group, mean

−0.6

−0.2

 Difference (95 % CI)

 

−0.7 (−1.7 to 0.3)

 p-value (clonidine vs. placebo)

 

0.17

  1. Missing values were imputed based on the principle of last observation carried forwards. Thus, all calculations are based on 120 individuals (60 in each intervention group). Means and differences at week 8 are estimated from the parameters of the general linear model
  2. For variables annotated with a *, modeling was performed on ln-transformed variables; all means are based on back-transformation of the variables, and ratios instead of differences are reported. For variables annotated with a #, modeling was performed on square root-transformed variables; all means are based on back-transformation of the variables, but neither differences nor ratios can be computed, as indicated with the label n.a. (not applicable). CI = Confidence Interval; SBP = Systolic Blood Pressure; MBP = Mean arterial Blood Pressure; DBP = Diastolic Blood Pressure; SI = Stroke Index; TPRI = Total Periferal Resistance Index; RRI = R-R Interval; HRV = heart rate variability; HF = High Frequency; LF = Low Frequency; SDNN = standard deviation of all RR-intervals; pNN50 = the proportion of successive RRIs with adifference greater than 50 ms; r-MSSD = the square root of the mean square differences of successive RRIs; nu = normalized units; n.a. = not applicable because of square root transformation of variables; n = number of patients, for most variables equal to 60 because of imputation