Impact of Acupuncture on Sleep and Comorbid Symptoms for Chronic Insomnia: A Randomized Clinical Trial

Figures & data

Figure 1 Acupoints for the acupuncture and sham acupuncture groups.

Figure 2 Flow of subjects randomized to acupuncture or sham acupuncture.

Table 1 Demographic Characteristics of Subjects

Variable	Total Sample (n = 82)	Acupuncture (n = 41)	Sham Acupuncture (n = 41)	Z/χ^2 Value^a	P
Age, y	58(25, 73)	57(25, 72)	58(25, 73)	−0.264	0.791
Gender	–	–	–	0.544	0.461
Male	23(28.0%)	13(31.7%)	10(24.4%)
Female	59(72.0%)	28(69.3%)	31(75.6%)
BMI, kg/m^2	–	–	–	−1.106	0.269
Under weight	2(2.4%)	1(2.4%)	1(2.4%)
Normal weight	68(82.9%)	36(87.8%)	32(78.0%)
Overweight	10(12.3%)	3(7.4%)	7(17.2%)
Obesity	2(2.4%)	1(2.4%)	1(2.4%)
Education	–	–	–	1.352	0.853
Primary school	3(3.8%)	1(2.4%)	2(4.9%)
Junior high school	11(13.6%)	7(17.1%)	4(9.8%)
High school	20(24.4%)	9(21.9%)	11(27.1%)
College degree	40(48.4%)	20(48.8%)	20(48.4%)
Graduate degree	8(9.8%)	4(9.8%)	4(9.8%)
Insomnia duration, y	9.5(0.3, 40.0)	6.0(0.3, 40.0)	10.0(0.5, 40.0)	−1.297	0.195
Concomitant diseases	35(42.7%)	18(43.9%)	17(41.5%)	0.050	0.823
Drug allergy	20(24.4%)	12(29.3%)	8(19.5%)	1.058	0.304
Current hypnotics	–	–	–	−0.603	0.546
Never	38(46.3%)	18(43.9%)	20(48.8%)
Taking one or more	44(53.7%)	23(56.1%)	21(51.2%)

Notes: Data are presented as either M (Min, Max) or number (%). ^aThe measurement data did not conform to normality after the Shapiro–Wilk test. Comparison between the acupuncture and sham acupuncture groups by Mann–Whitney U-test or χ² test.

Table 2 The Mixed Effect Model Analysis of Primary Outcome Measures

	Group	Age	Gender	Time	Comorbidity	Age Group*	Gender Group*	Time Group *	Comorbidity Group*
PSQI
F	2.129	20.486	0.031	71.178	0.261	0.832	1.406	4.756	1.058
P	0.145	<0.001	0.860	<0.001	0.609	0.362	0.236	0.004	0.304
ISI
F	0.440	4.222	6.264	59.901	0.005	0.038	1.682	4.130	0.534
P	0.507	0.040	0.012	<0.001	0.946	0.845	0.195	0.008	0.465

Notes: Data were analyzed using a mixed-effect model for repeated measures (MMRM). *Interaction.

Abbreviations: PSQI, Pittsburgh sleep quality index; ISI, insomnia severity index.

Table 3 Primary Outcome Measures from Baseline to 4-Week Follow-Up

Assessments	Group		Baseline	Post-Treatment	Follow-Up 1	Follow-Up 2	F	P
PSQI score	Acupuncture (n=41)		14.78±2.71	9.74±3.08	10.66±3.43	10.51±3.60	41.694	<0.001
	Sham-acupuncture (n=41)		14.61±3.11	11.69±3.65	11.03±3.40	10.59±3.95	32.217	<0.001
	Between-group	F	0.265	−2.537	−0.472	−0.075	–	–
		P	0.791	0.013	0.638	0.940	–	–
ISI score	Acupuncture (n=41)		18.78±4.68	11.13±3.74	12.05±5.60	12.14±5.03	43.048	<0.001
	Sham-acupuncture (n=41)		20.49±4.65	15.44±5.98	14.49±7.45	13.42±6.58	34.019	<0.001
	Between-group	F	−1.657	−3.796	−1.624	−0.949	–	–
		P	0.101	<0.001	0.109	0.346	–	–

Notes: Data are presented as the mean ± SD. Comparison within-group and between-group by repeated-measures ANOVA.

Abbreviations: PSQI, Pittsburgh sleep quality index; ISI, insomnia severity index.

Figure 3 Mean PSQI scores of the two groups during the study period.

Note: *P<0.05 vs sham-acupuncture group.

Figure 4 Mean ISI scores of the two groups during the study period.

Note: *P<0.05 vs sham-acupuncture group.

Table 4 PSG Measures from Baseline to Post-Treatment

PSG Assessments	Acupuncture			Sham-Acupuncture
	/ M(Min, Max)	Z/F^a	P	/ M(Min, Max)	Z/F^a	P	Z/F^b	P
SOL(minutes)	–			–
Baseline	20.0(5.0, 78.0)	2.273	0.132	13.0(5.0, 100.0)	0.333	0.564	−1.141	0.254
Post-treatment	15.5(10.0, 18.5)			18.5(11.5, 31.0)			−2.065	0.039
TST (minutes)	–			–
Baseline	384.5(226.5, 452.5)	7.364	0.007	353.0(214.5, 443.0)	8.333	0.004	−1.016	0.310
Post-treatment	404.0(318.5, 458.0)			394.0(219.0, 475.0)			−1.046	0.295
WASO (minutes)	–			–
Baseline	74.5(13.0, 242.5)	7.364	0.007	84.5(12.0, 259.0)	5.333	0.021	−1.037	0.300
Post-treatment	41.5(9.5, 109.0)			76.25(1.5, 258.0)			−1.416	0.157
SE (%)	–			–
Baseline	73.66±13.63	2.836	0.018	68.82±12.64	3.399	0.006	1.011	0.321
Post-treatment	80.93±9.25			75.70±12.26			1.147	0.264
Arl	–			–
Baseline	17.38±8.96	−1.789	0.104	16.69±7.72	1.157	0.272	0.224	0.824
Post-treatment	13.38±6.51			18.57±6.03			−1.984	0.060
N1 (%)	–			–
Baseline	31.61±10.38	−4.737	0.001	28.52±9.68	−1.735	0.111	0.844	0.406
Post-treatment	19.65±5.06			24.99±4.60			−2.654	0.015
N2 (%)	–			–
Baseline	35.73±10.82	−1.919	0.084	35.96±11.18	−1.695	0.118	−0.056	0.955
Post-treatment	29.13±9.03			32.83±8.14			−1.035	0.312
N3 (%)	–			–
Baseline	14.37±5.58	6.846	<0.001	17.55±8.34	0.812	0.434	−1.228	0.230
Post-treatment	25.22±5.31			17.88±4.84			3.467	0.002
R (%)	–			–
Baseline	18.30±5.50	4.856	0.001	17.97±5.16	4.407	0.001	0.168	0.868
Post-treatment	26.01±3.30			24.26±5.51			0.914	0.371

Notes: Data are presented as the mean ± SD or median (minimum, maximum). ^aComparison within groups by repeated-measures ANOVA or nonparametric test. ^bPost-treatment comparison between groups by repeated-measures ANOVA or nonparametric test.

Abbreviations: PSG, polysomnography; SOL, sleep onset latency; TST, total sleep time; WASO, wake after sleep onset; SE, sleep efficiency; ArI, arousal index; R, rapid eye movement.

Table 5 Comorbid Symptom Measurements from Baseline to Post-Treatment

Comorbid Assessments	Acupuncture			Sham-Acupuncture
	/ M(Min, Max)	Z/F^a	P	/ M(Min, Max)	Z/F^a	P	Z/F^b	P
BAI score	–			–
Baseline	36 (24, 71)	19.882	<0.001	38 (24, 74)	8.257	0.004	−0.427	0.669
Post-treatment	33 (24, 59)			33 (24, 65)			−0.552	0.581
BDI score	–			–
Baseline	16 (2, 34)	15.114	<0.001	16 (1, 37)	1.000	0.317	−0.251	0.802
Post-treatment	11.5 (0, 39)			13 (0, 31)			−1.031	0.303
FSS score	–			–
Baseline	40.59±14.46	0.685	0.497	43.98±13.40	1.414	0.166	−1.101	0.274
Post-treatment	38.13±13.65			41.54±13.16			−1.115	0.269
ESS score	–			–
Baseline	9 (0, 19)	<0.001	1.000	10 (0, 21)	1.400	0.237	−0.019	0.985
Post-treatment	8.5 (1, 24)			6 (0, 18)			−1.729	0.084

Notes: Data are presented as the mean ± SD or median (minimum, maximum). ^aComparison within groups by repeated-measures ANOVA or nonparametric test. ^bPost-treatment comparison between groups by repeated-measures ANOVA or nonparametric test.

Abbreviations: BAI, Beck anxiety inventory; BDI, Beck depression inventory; FSS, fatigue severity scale; ESS, Epworth sleepiness scale.