Evidence-Based Complementary and Alternative Medicine

Research Article

Effect of Transcutaneous Vagus Nerve Stimulation at Auricular Concha for Insomnia: A Randomized Clinical Trial

Table 2

Primary and secondary outcome comparison between groups.


Variable	ta-VNS (n = 31)	tn-VNS (n = 32)	Differences	value^a

Primary outcome^b
PSQI score at wk4, mean (95% CI)	8.8 (4.1 to 14.0)	10.0 (5.0 to 18.9)	−1.2 (−3.1 to 0.8)	0.25
Change at wk 4, PSQI score, mean (95% CI)	−5.7 (−7.5 to −4.0)	−4.6 (−6.4 to 2.8)	−1.8 (−3.3 to 0.9)	0.27
Sleep quality^c	−0.7 (−1.1 to −0.3)	−0.8 (−1.4 to −0.2)	0.1 (−0.4 to 0.7)	0.65
Sleep latency^c	−0.9 (−1.3 to −0.5)	−0.8 (−1.2 to −0.4)	−0.1 (−0.5 to 0.3)	0.66
Sleep duration^c	−0.7 (−1.2 to −0.3)	−0.8 (−1.2 to −0.3)	0 (−0.5 to 0.5)	0.98
Sleep efficiency^c	−0.9 (−1.4 to −0.3)	−0.2 (−0.8 to 0.3)	−0.7 (−1.3 to 0.0)	0.06
Sleep disturbances^c	−0.3 (−0.5 to 0)	−0.2 (−0.5 to 0)	0 (−0.3 to 0.2)	0.76
Hypnotic use^c	−1.0 (−1.5 to −0.5)	−0.8 (−1.3 to −0.2)	−0.3 (−0.9 to 0.4)	0.45
Daytime dysfunction^c	−1.2 (−1.6 to −0.9)	−0.9 (−1.3 to −0.6)	−0.3 (−0.7 to 0.1)	0.18
Secondary outcome^b
ESS score at wk4, mean (95% CI)	4.4 (0 to 10.0)	4.6 (0 to 10.0)	−0.2 (−1.8 to 1.5)	0.86
Change at wk 4, ESS score, mean (95% CI)	−1.1 (−3.0 to 0.8)	−1.5 (−3.6 to 0.6)	0.4 (−1.4 to 2.2)	0.65
FFS score at wk4, mean (95% CI)	10.9 (4.1 to 19.9)	11.1 (5.1 to 18.9)	−0.2 (−2.5 to 2.0)	0.85
Change at wk 4, FFS score, mean (95%CI)	−3.4 (−5.8 to −1.0)	−3.6 (−6.0 to −1.3)	0.3 (−2.1 to 2.7)	0.82
SF-36 score at wk4, mean (95% CI)	576.8 (417.2 to 730.8)	520.8 (290.0 to 728.9)	60.0 (−8.9 to 120.9)	0.09
Change at wk 4, SF-36 score, mean (95% CI)	67.7 (14.1 to 121.2)	85.3 (14.3 to 156.2)	−17.6 (−70.2 to 35.0)	0.51
Physical function^c	4.2 (−1.1 to 9.5)	5.0 (−3.2 to 13.2)	−0.8 (−7.0 to 5.4)	0.80
Role physical^c	9.7 (−9.9 to 29.3)	10.2 (−12.9 to 33.2)	−0.5 (−22.5 to 21.6)	0.97
Bodily pain^c	7.5 (−13.5 to 28.6)	13.5 (−8.3 to 35.4)	−6.0 (−25.6 to 13.6)	0.54
General health^c	11.1 (1.9 to 20.4)	14.7 (5.5 to 23.9)	−3.6 (−11.8 to 4.6)	0.39
Vitality^c	10.5 (1.6 to 19.3)	15.0 (5.8 to 24.2)	−4.5 (−11.9 to 2.8)	0.22
Social functioning^c	2.9 (−8.2 to 14.0)	7.5 (−3.2 to 18.3)	−4.5 (−19.7 to 10.5)	0.55
Role emotional^c	12.3 (3.5 to 21.1)	7.0 (−3.3 to 17.3)	5.2 (−3.8 to 12.2)	0.25
Mental health^c	9.5 (1.1 to 17.9)	12.3 (1.9 to 22.8)	−2.8 (−10.4 to 4.7)	0.46
HAMD score at wk4, mean (95% CI)	6.1 (2.9 to 1.1)	7.6 (1 to 18.0)	−1.5 (−3.6 to 0.8)	0.20
Change at wk 4, HAMD score, mean (95% CI)	−5.8 (−8.0 to −3.6)	−7.7 (−10.5 to −4.8)	1.9 (−1.1 to 4.9)	0.21
HAMA score at wk4, mean (95% CI)	5.4 (0 to 11.0)	6.3 (0.1 to 15)	−0.9 (−3.1 to 1.3)	0.42
Change at wk 4, HAMA score, mean (95% CI)	−5.6 (−8.1 to −3.2)	−8.1 (−11.0 to −5.1)	2.4 (−0.2 to 5.1)	0.07

^aAll tests were 2-sided value of less than 0.05 was considered significant. ^bMissing data not imputed for outcomes analyses. ^cChange at week 4 to baseline mean (95% CI).