Table 1
Basic characteristic of the included studies.
Study Arm Randomized
sample size: I/C
Age: mean (SD) years, I/C Gender: M/F Diagnostic
instrument
Duration of insomnia history:
mean (SD), I/C
Outcomes Follow-up
Niu ZZ 2014
[87] 2 48/48 41.32 (7.46) /40.12 (8.66) 38/58 CCMD-3 28.36 (11.51) m/26.89 (13.65)
m
PSQI 10 d
Li ZJ 2014
[79] 2 50/50 43.32 (11.31)/42.13 (12.41) 47/54 CCMD-3 28.36 (8.38) m/27.62 (7.68) m PSQI No
Cai TR 2013
[43] 2 98/49 46.2 (6.5)/47 (6.2) 56/91 CCMD-3 5.6 (1.2) y/5.9 (1) y PSQI 3 m
Hou N 2013
[60] 2 54/54 42.3 (5.3)/43.5 (4.3) NS CCMD-3 NS PSQI No
Wang SM 2013
[94] 2 48/48 45.12 (11.51)/44.58 (12.17) 34/62 CCMD-3 27.16 (35.05) m/25.99 (32.17)
m
PSQI and PSG No
A M 2013
[39] 2 41/41 44.45 (8.33)/45.12 (7.76) 55/27 CCMD-3 6.32 (2.43) y/6.76 (2.01) y PSQI No
Gan JG 2013
[54] 2 60/60 67.2 (5)/66.5 (9.2) 46/74 CCMD-3 19.4 (6.1) m/20.6 (8.7) m PSQI No
Zhang XZ 2013
[112] 2 110/55 40.5 (8.6)/41.3 (9.2) 65/100 CCMD-3 16.5 (2.7) m/15.5 (2.8) m Patient-rated sleep
parameters
No
Huang HB 2013
[63] 2 33/33 28 (2.14)/30 (2.21) 32/34 CCMD-3 1.6 (0.61) y/1.4 (0.47) y PSQI 30 d
Huang WM 2013
[97] 2 39/35 41.7 (10.5)/40.8 (9.8) 31/43 ICSD-2 19.2 (5.5) m/17.7 (4.7) m AIS No
Li GX 2013
[75] 2 35/35 49.93 (11.54)/52.7 (10.54) 27/34 WHO ICD-10 10.13 (13.42) y/11.94 (10.31) y PSQI No
Sun XA 2013
[91] 2 50/50 40.34 (12.6)/41.15 (12.7) 51/49 CCMD-3 2.64 (5.11) y/2.15 (4.18) y PSQI No
Yuan CX 2013
[108] 2 30/30 39.57 (12.38)/34.53 (11.73) 11/49 CCMD-3 2.18 (2.08) y/2.18 (1.98) y PSQI 7 d
Lin YY 2013
[82] 2 30/30 70.85 (3.06)/71.14 (3.24) 27/33 CCMD-3 6.43 (3.88) y/6.55 (3.12) y PSQI No
Han YC 2013
[57] 2 32/32 45.2 (19.3)/40.7 (16) 26/38 WHO ICD-10 7.8 (3.4) m/8.3 (3.9) m PSQI No
Pan BX 2013
[88] 2 40/40 40.25 (11.71)/41.25 (15.3) 36/44 DSM-4 3.30 (5.29) y/3.22 (4.14) y PSQI No
Qian C 2012
[41] 2 158/52 44.97 (13.55)/42.75 (13.81) 74/136 ICSD-2 108.32 (44.12) d/111.79 (44.96)
d
PSQI and patient-
rated sleep
parameters
No
Chen WM 2012b
[46] 2 60/30 39.8 (12.77)/37.3 (12.39) 53/37 CCMD-3 28.2 (11.9) m/24.9 (12.3) m PSQI No
Zhang CL 2012
[51] 2 48/30 50/49 49/29 CCMD-3 1.9 y/1.8 y PSQI No
Sheng CJ 2012
[50] 2 25/21 56.1 (6.5)/57.3 (7.1) 18/28 CCMD-3 NS PSQI and patient-
rated sleep
parameters
No
Yang YL 2012
[117] 2 60/60 73.15 (10.19)/73.18 (10.15) 81/39 CCMD-3 4.97 (2.11) y/4.95 (2.15) y PSQI 6 m
Yang XC 2012
[99] 2 30/30 41 (12)/43 (13) 28/32 CCMD-3 7 m–1 y/6 m–21 y PSQI No
Chen WM 2012a
[47] 2 50/30 38.95 (10.57)/38.35 (11.58) 43/37 CCMD-3 26.5 (10.8) m/25.9 (11.2) m PSQI No
Wang LH 2012
[93] 2 38/38 61 (12.4)/61 (12.8) 34/36 ICSD-2 NS PSQI No
Lou YY 2012
[109] 2 30/30 72.83 (6.18)/74.1 (7.33) 31/29 CCMD-3 4.13 (2.11) y/5.34 (4.2) y PSQI No
Li Y 2012 & Li Y 2013
[77,78] 3 30/30/30 NS NS CCMD-3 NS PSQI No
Li GR 2012
[74] 2 30/30 37.8/37.4 28/32 CCMD-3 NS PSQI No
Zhang HM 2012
[59] 2 32/34 34.32 (1.45)/32.34 (1.67) 27/39 CCMD-3 7.34 (0.65) m/9.13 (0.15) m AIS No
Li XL 2012
[102] 2 96/90 43 (2)/43.5 (1) 73/113 CCMD-3 1.5 (0.5) y/1.8 (0.2) y PSQI No
Miao WH 2012
[96] 2 30/29 44.46 (12.34)/43.51 (12.81) 18/41 CCMD-3 24.70 (29.74) m/17.48 (15.63)
m
PSQI No
Kuang JG 2012
[69] 2 40/40 73.8/74.1 43/37 CCMD-3 3.7 y/4.1 y Patient-rated sleep
parameters
No
Li DY 2012
[73] 2 52/52 45.9 (11.3)/44.54 (10.6) 41/63 CCMD-3 9.3 (4.7) m/10.7 (5.3) m PSQI No
Luo HO 2012
[84] 2 60/59 NS 46/71 CCMD-3 NS PSQI No
Zhu GQ 2012
[114] 2 34/34 NS 32/36 CCMD-3 NS PSQI No
Cai Y 2011
[44] 2 21/21 40.17 (11.26)/41.36 (11.48) 19/23 CCMD-3 15.92 (11.55) m/16.39 (12.21)
m
Patient-rated sleep
parameters
No
Qi GF 2011
[55] 2 40/40 51.2 (10.3)/53.5 (12.42) 36/44 CCMD-3 5.62 (2.35) y/6.30 (3.12) y PSQI No
Sun P 2011
[90] 2 40/40 66.7 (5.8)/67.1 (6.2) 25/55 CCMD-3 12.8 (6.4) m/13.28 (6.9) m PSQI No
Zhu WH 2011
[115] 2 31/30 NS 20/40 CCMD-3 NS AIS No
Huang XY 2011
[64] 2 50/50 44.58 (10.25)/44.2 (7.83) 40/60 CCMD-3 5.3 (1.5) y/5.1 (1.8) y PSQI No
Jia B 2011
[40] 2 39/39 50.63 (10.56)/47.76 (10.58) 37/41 CCMD-3 18 m/16 m PSQI No
Wang C 2011
[42] 2 60/60 39.3/37.6 54/66 CCMD-3 2.9 y/3.1 y PSQI No
Yang XH 2011
[105] 2 50/50 46.1/45 50/50 CCMD-3 9.78 m/9.44 m Patient-rated sleep
parameters
No
Jing XW 2011
[104] 2 21/27 41.82 (12.88)/42.37 (11.64) 12/35 CCMD-3 7.9 (3.84) y/5.7 (2.53) y PSQI No
(continued on next page)
1466 X. Ni et al./Sleep Medicine 16 (2015) 1462–1481
Table 1 (continued)
Study Arm Randomized
sample size: I/C
Age: mean (SD) years, I/C Gender: M/F Diagnostic
instrument
Duration of insomnia history:
mean (SD), I/C
Outcomes Follow-up
Chen YY 2011
[49] 2 32/20 46.6 (1.5)/59.2 (0.9) 20/32 WHO ICD-10 3.2 (0.3) y/3.3 (0.4) y PSQI No
Xiao LG 2010
[72] 2 33/32 68.2 (18.3)/67.5 (19) 38/27 WHO ICD-10 38 (18.5) m/45 (16.2) m PSQI No
Jiang HQ 2010
[61] 2 183/183 71.9/70.8 176/188 CCMD-3 33.1(5.7) m/31.4 (7.1) m PSQI No
Wang ZT 2010
[95] 2 41/39 NS NS CCMD-3 NS Patient-rated sleep
parameters
No
Liao RD 2010
[116] 2 22/18 48.95 (1.468)/50.6 (1.911) 31/9 CCMD-3 NS PSQI 3m
Huang D 2010
[62] 2 42/38 50.2 (9.2)/53.6 (8.7) 47/33 CCMD-3 9.56 (5.42) y/10.37 (6.63) y PSQI No
Wang F 2010
[53] 2 59/60 40.23 (10.79)/39.92 (11.47) 36/83 CCMD-3 37.49 (7.36) m/35.81 (9.92) m PSQI No
Tian J 2010
[66] 2 30/30 70 (7)/67 (5) 26/34 CCMD-3 NS AIS No
Huang Y 2010
[65] 2 62/62 47 (9)/48 (10) 60/64 CCMD-3 4.8 (1.2) y/4.16 (1.6) y PSQI 4w
Song XH 2010
[81,101] 2 106/106 NS 54/147 WHO ICD-10 NS CGI-S 2w
Lian FM 2009
[80] 2 71/36 43.14 (13.91)/44.73 (13.92) 39/68 CCMD-3 19.83 (27.13) m/20.92 (45.12)
m
Patient-rated sleep
parameters
1w
Xia CY 2009
[52] 2 60/60 42.18 (9.82)/42.75 (10.72) 33/87 CCMD-3 11.09 (14.27) m/11.84 (14.29)
m
AIS No
Zhang XP 2009
[111] 2 82/80 71.14 (3.24)/70.85 (3.07) 89/73 ICSD-2 6.51 (3.27) y/6.02 (3.45) y PSQI No
Xu HK 2009
[58] 2 42/40 56 (7)/58 (7) 36/46 CCMD-3 56 (7) m/92 (8) m PSQI No
Nie ZH 2009
[86] 2 50/45 37.81(10.42)/41.24 (9.14) 39/53 Chinese
guideline
NS PSQI No
She YQ 2009
[106] 2 60/59 36.68 (8.53)/35.32 (9.13) 0/119 CCMD-3 3.22 (3.37) y/3.51 (3.67) y PSQI No
Li X 2008
[98] 2 68/52 36.64 (4.51)/37.26 (4.79) 60/60 CCMD-3 9 (4.85) m/8.89 (4.52) m PSQI No
Jiang LP 2008
[70] 2 34/34 44.8 (14.1)/39.26 (12.38) 31/37 CCMD-3 6.27 (4.18) m/5.91 (4.31) m CGI-S No
Feng XD 2008
[100] 2 25/23 NS 20/28 CCMD-3 NS PSQI Unclear
Zhang XM 2008
[103] 2 43/41 NS 38/46 ICSD-2 NS PSQI and patient-
rated sleep
parameters
3m
Zhang JP 2008
[71] 2 30/30 41.26 (10.25)/40.3 (13.62) 36/24 CCMD-3 2.35 (5.22) y/2.25 (4.27) y PSQI and patient-
rated sleep
parameters
No
Sun Y 2008
[118] 2 52/50 3836 44/58 WHO ICD-10 1.56 (1.04) y/1.61 (1.03) y PSQI No
Ren YJ 2007
[89] 2 50/50 NS 48/62 CCMD-3 NS CGI-S 7d
Chang C 2006
[119] 2 19/18 18-65 12/25 CCMD-3 51.32 (73.32) m/60.14 (92.3) m PSQI No
Chen JF 2006
[67] 2 30/30 NS 28/32 CCMD-3 NS PSQI No
Zheng SY 2006
[113] 2 34/34 38.67 (15.42)/39.26 (12.38) 28/40 CCMD-3 6.27 (4.18) m/5.92 (4.33) m CGI-S No
Luo LC 2006
[85] 2 52/30 51.2/50.5 32/50 CCMD-3 2.6 y/2.5 y AIS No
Chen FQ 2005
[45] 2 180/90 42 (15.4)/41 (14.9) 100/170 CCMD-3 NS Patient-rated sleep
parameters
3m
Yu HT 2005
[107] 2 48/45 32.6 (8.9)/30.6 (8.4) 45/48 CCMD-3 2.2 (0.6) y/2.8 (4.6) y CGI-S No
Zhang JF 2003
[68] 2 113/114 44.09 (13.29)/44.97 (13.11) 68/159 CCMD-3 79.64 (102.66) m/71.89 (93.5)
m
PSQI and patient-
rated sleep
parameters
No
Zhu T 2013
[92] 3 60/60/60 NS 71/109 CCMD-3 NS PSQI No
Chen H 2012
[56] 3 30/30/30 NS 75/15 CCMD-3 NS AIS No
Liu Y 2009
[83] 3 30/30/30 36.9 (11.48)/37.2 (11.36)/
37.8 (11.38)
38/52 WHO ICD-10 8.9 (2.89) m/9.3 (2.18) m/9.8
(2.28) m
PSQI No
Chen WQ 2008
[48] 3 68/72/76 62.19 (6.09)/64.32 (6.71)/
66.19 (5.81)
108/108 CCMD-3 NS PSQI No
Zhan SQ 2008
[110] 3 39/21/40 43.8 (12.8)/47.1 (10.8)/44.6
(14.4)
35/65 CCMD-3 NS AIS No
Li Y 2009
[76] 4 NS 32.7 (9.2)/37.6 (10.3)/38.4
(13.8)/30 (9.7)
8/25 ICSD-2 56.1 (36.4) d/39 (37.7) d/51.1
(32.9) d/ 47.7 (33.2) d
PSQI and PSG No
Abbreviations: AIS: Athens Insomnia Scale; BZDs: benzodiazepine drugs; C: control; CBT-i: Cognitive and behavioral therapy for insomnia; CHM: Chinese herbal medicine; CGI-S: Clinician Global Impression-Severity; CCMD-3:
Chinese Classification and Diagnosis of Mental Disease, Third Edition; CGDTAI: Chinese Guideline on Diagnosis and Treatment for Adult Insomnia; DSM-4: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition;
d: day/days; F: female; M: male; m: month/months; I: intervention; ISCD-2: International Classification of Sleep Disorders, Second Edition; NS: not stated; PSQI: Pittsburgh Sleep Quality Index; PSG: polysomnography; WHO
ICD-10: World Health Organization International Classification of Diseases, 10th Version; w: week/weeks; y: year/years.
1467X. Ni et al./Sleep Medicine 16 (2015) 1462–1481
Table 2
Details of the treatment in the included studies.
Study Formula
d
Herbal ingredients
c
IM Preparation Dosage Frequency Comparator Treatment
duration
Niu ZZ 2014
[87] Bu Shen Shu Gan Tang shu di, gou qi zi,sheng di, xuan shen, mai dong, dang gui,
chuan xiong, chai hu, zhi ke, huang qin, huang lian, gan cao,
ye jiao teng, bai he, zhen zhu mu
N decoction 1 pack decocted
twice
bid clonazepam tablet,
2–4 mg, qn
30 d
Li ZJ 2014
[79] Jia Wei Chang Pu Yu Jin
Tang
shi chang pu, yu jin, huang lian, rou gui, yun fu shen, yuan
zhi,bai zi ren
Y decoction 1 pack decocted 3
times
tid estazolam tablet,
2 mg, qn
30 d
Cai TR 2013
[43] Tiao Zhong Hua Tan An
Shen He Ji
suan zao ren, fu ling, chai hu, huang qin, zhi mu, fa ban xia,
chuan xiong, chen pi, zhu ru, shou wu teng, zhen zhu mu, zhi
shi,zhi gan cao
N decoction 1 pack decocted
twice
bid estazolam tablet,
1–2 mg qn
2w
Hou N 2013
[60] Mian An Ning Ke Li dan shen, shu di huang, shou wu teng, bai zhu, chen pi, yuan
zhi,da zao
N granule 1 bag bid alprazolam tablet
,0.4 mg qn
3w
Wang SM 2013
[94] Zao Ren An Shen Pian he shou wu, suan zao ren, sang shen,he huan hua, bai zi ren,
dang gui, shu di huang, yuan zhi,chai hu
N tablet 4 tablets tid Placebo 4 w
A M 2013
[39] Zi Ni Yang Xin An Shen
Tang
sheng di huang ,mai men dong, dang gui, dan shen, ren shen,
fu shen, bai zi ren, suan zao ren,ye jiao teng,zhi gan cao
N decoction 1 pack decocted 3
times
tid zolpidem tablet,
5 mg, qn
4w
Gan JG 2013
[54] Zao Ren An Shen Jiao
Nang
suan zao ren, dan shen,wu wei zi N capsule 5 tablets qn alprazolam tablet
,0.8 mg, qn
4w
Zhang XZ 2013
[112] Yang Yin An Shen Jiao
Nang
suan zao ren, wu wei zi, ye jiao teng, zhi mu, fu shen, he huan
hua, dan shen, hu po,ling ci shi
N capsule 3 mg bid alprazolam tablet,
0.4–0.8 mg, qn
4w
Huang HB 2013
[63] Xie Cao xie cao N powder 3 g tid Placebo 150d
Huang WM 2013
[97] Wen Dan Tang plus
Xue Fu Zhu Yu Tang Jia
Jian
fa ban xia, chen pi, zhu ru, zhi shi, fu ling, tao ren, hong hua,
chi shao, chuan xiong, niu xi, sheng di huang,dang gui, ,jie
geng,gan cao
N decoction 1 pack decocted
twice
bid estazolam tablet,
2 mg, qn
30 d
Li GX 2013
[75] Wen Dan Ning Xin Ke
Li
suan zao ren, dang shen, ban xia, chen pi, zhu ru, zhi shi, fu
ling,shi chang pu, yuan zhi, shu di huang, long gu, mu li,zhi
gan cao
N granule 6 g tid estazolam tablet,
1–2 mg, qn
4w
Sun XA 2013
[91] Shui Mian Ling ren shen, huang qi, wu wei zi, bai he, zhi yu cao,chao suan
zao ren, ye jiao teng, dan shen, yuan zhi,fu ling, sheng di,nv
zhen zi, chai hu, yu jin, he huan pi, shen qu, shan zha, you
dong, bai zhu, zhi ke,ban xia
Y pill 10 g tid zopiclone tablet,
3.75 mg qn
4w
Yuan CX 2013
[108] Mei An Ke Li suan zao ren ,ren shen ,ci wu jia ,fu ling ,dang gui ,chuan
xiong
Y granule 4.0 g qn placebo + estazolam,
1 mg, qn
2w
Lin YY 2013
[82] Jian Nao Ning Shen Ke
Li
suan zao ren ,bai zi ren ,huang lian ,zhi zi ,bai shao ,mai dong
,dan shen ,long gu ,zhen zhu mu ,yuan zhi ,bai he ,shou wu
teng
N granule 1 bag bid estazolam tablet,
1 mg, qn
4w
Han YC 2013
[57] Tian Wang Bu Xin Dan bai shao ,dan shen ,chao zao ren ,bai zi ren ,bai he ,shou wu
teng ,chao bai zhu ,fu ling ,sha ren ,ji nei jin ,zhen zhu mu
,duan long chi ,rou gui ,bai dou kou ,zhi gan cao ,zhi zi
N decoction 1 pack decocted 4
times
qid alprazolam tablet
,0.4–0.8 mg,qn
4w
Pan BX 2013
[88] Jian Pi Shu Gan Tang
plus Fu Fang Zao Ren
Jiao Nang
tang ji :dang shen ,fu chao bai zhu ,fu ling ,chen pi ,fa ban xia
,chao chai hu ,bai shao ,dang gui ,bo he ,yi yi ren ,shan yao
,zhi yuan zhi ,shou wu ,shen qu ,sha ren ,chao gu ya ,gan cao
Y Decoction + capsule 1 bag decocted
twice;0.4g
bid; qn estazolam tablet,
0.5–1 mg, qn
2w
Qian C 2012
[41] Nan Wu Wei Zi Jiao
Nang
nan wu wei zi Y capsule 2 capsules qn Placebo 4 w
Chen WM 2012b
[46] Tian Wang Bu Xin Dan suan zao ren ,bai zi ren ,dang gui ,tian men dong ,mai men
dong ,sheng di huang ,dang shen ,dan shen ,xuan shen ,fu ling
,wu wei zi ,yuan zhi ,ju geng
N decoction 1 pack decocted
twice
bid estazolam tablet,
1mgqn
8w
Zhang CL 2012
[51] Zi Ni Yi Shen An Mei
Tang
shu di huang ,yin yang huo ,huang jing ,nv zhen zi ,wu wei zi
,bai shao ,suan zao ren ,sheng long gu,sheng mu li ,fo shou
,gan song
N decoction 1 pack decocted
twice
bid diazepam tablet,
5mgqn
1m
(continued on next page)
1468 X. Ni et al./Sleep Medicine 16 (2015) 1462–1481
Table 2 (continued)
Study Formula
d
Herbal ingredients
c
IM Preparation Dosage Frequency Comparator Treatment
duration
Sheng CJ 2012
[50] Jian Pi He Wei Zhong
Yao
yi yi ren ,huai shan yao ,fu ling ,ze xie ,zhu ling ,chen pi ,jiao
san xian ,pu gong ying ,suan zao ren ,gan cao
N decoction NS NS diazepam tablet,
5–10 mg, qn
10 d
Yang YL 2012
[117] Suan Zao Ren Shui suan zao ren N decoction 1 pack decocted
once
qn benzodiazepine
drugs without
details
1w
Yang XC 2012
[99] Jie Yu Wan zi shao ,chai hu ,dang gui ,fu ling ,gan cao ,xiao mai ,da zao
,yu jin ,he huan pi
N pill 4 g bid estazolam tablet,
1–2 mg, qn
4w
Chen WM 2012a
[47] Gui Pi Tang huang qi ,dang shen ,bai zhu ,dang gui ,fu shen ,suan zao ren
,yuan zhi ,mu xiang ,gan cao ,long yan rou
N decoction 1 pack decocted
twice
bid estazolam tablet,
1 mg, qn
8w
Wang LH 2012
[93] Er Dong Yang Xin Kou
Fu Ye
di huang,tian dong,mai dong,huang qi,dang shen,bai zhu N oral solution 20 ml bid estazolam tablet,
1mgqn
4w
Lou YY 2012
[109] Wen Yang Huo Xue
Ning Xin Fang
dang gui ,zhi fu pian ,tao ren ,hong hua ,chuan xiong ,gua lou
ke ,chi shao ,sheng di ,shi chang pu ,jiu yuan zhi ,suan zao ren
,ye jiao teng ,zhen zhu mu
Y decoction 1 pack decocted
once
qd estazolam tablet,
1 mg, qn
4w
Li Y 2012 & Li Y 2013
[77,78]
1.Qing Zhen Tang; 2.Jia
Wei Wen Dan Tang
1. huang lian ,sha shen ,bai he ,dan shen ,yuan zhi ,niu xi ,shi
ju pu ,gan cao ,rou gui ,fu ling ,zhu ru ,yan huang bai ,long gu
,mu li, zhu ye,ge gen ,yu jin; 2. chen pi ,fa ban xia ,fu ling ,zhi
shi ,zhu ru ,shi chang pu ,dan nan xing ,zhi mu ,yuan zhi ,zhen
zhu mu ,ye jiao teng ,chuan xiong ,bai he ,chao zao ren ,gan
cao
Y decoction 1 pack decocted
once
qd CBT 8 w
Li GR 2012
[74] Zao Ren An Shen Jiao
Nang
chao suan zao ren ,dan shen ,cu zhi wu wei zi N capsule 5 capsules estazolam tablet,
1 mg, qn
2w
Zhang HM 2012
[59] Xue Fu Zhu Yu Tang chai hu ,zhi ke ,chi shao ,tao ren ,chuan hong hua ,dang gui
,chuan xiong ,sheng di ,niu xi ,ju geng
N decoction 1 pack decocted 3
times
tid estazolam tablet,
1 mg, qn
4w
Li XL 2012
[102] Xue Fu Zhu Yu Tang tao ren ,hong hua ,dang gui ,sheng di huang ,chuan xiong ,chi
shao ,niu xi ,ju geng ,chai hu ,zhi ke ,gan cao
N decoction 1 pack decocted
twice
bid estazolam tablet,
1 mg, qn
4w
Miao WH 2012
[96] Xin Ren Shen An Jiao
Nang
sheng di huang,suan zao ren,lian zi xin,yuan zhi,chen pi,gan
cao
N capsule 1.35 g tid Placebo 4 w
Kuang JG 2012
[69] Tian Ma Gou Teng Yin tian ma ,gou teng ,shi jue ming ,du zhong ,niu xi ,shan zhi
,huang qin ,ye jiao teng ,fu shen
N decoction 1 pack decocted
twice
bid diazepam tablet,
2.5 mg, qn
4w
Li DY 2012
[73] He Wei An Shen Fang ban xia ,yi yi ren ,shi chang pu ,fu ling ,bai zhu ,he huan pi ,ye
jiao teng ,chao zao ren ,
N decoction 1 pack decocted
twice
bid estazolam tablet,
1 mg, qn
4w
Luo HO 2012
[84] He Wei An Shen Fang ban xia ,sheng yi ren ,chen pi ,fu ling ,bai zhu ,chai hu ,chao
huang qin ,ye jiao teng ,zhi gan cao
N decoction 1 pack decocted
twice
bid zolpidem tablet,
10 mg, qn
4w
Zhu GQ 2012
[114] Gan Cao Xie Xin Tang gan cao ,dang shen ,huang qin ,huang lian ,gan jiang ,ban xia
,da zao
N decoction 1 pack decocted
twice
bid alprazolam tablet
,0.4–0.8 mg, qn
12 w
Cai Y 2011
[44] Zi Ni Shu Gan Qing Xin
Tang
chai hu ,yu jin ,fo shou ,zhi zi ,he huan pi ,ye jiao teng ,suan
zao ren ,bai shao ,chuan lian zi ,fu shen ,an mu xiang ,zhi mu
,gan cao
N decoction 1 pack decocted
twice
bid diazepam tablet,
2.5–5.0 mg, qn
2w
Qi GF 2011
[55] Zi Ni Qing Hua Zi Yin
Fang
ban xia ,xia ku cao ,jiang can ,yu jin ,huang lian ,bai he ,zhi
mu ,fu ling ,yuan zhi ,chao zao ren ,sheng di huang ,dang gui
,dan shen ,ye jiao teng ,sheng long chi
N decoction 1 pack decocted
twice
bid estazolam tablet,
1 mg, qn
28 d
Sun P 2011
[90] Zi Ni Jie Yu Hua Tan An
Shen Tang
huang lian ,dan nan xing ,chai hu ,bai shao ,zhi ke ,xiang fu
,zhu ru ,ban xia ,chang pu ,yu jin ,fu ling ,ye jiao teng ,yuan
zhi ,sheng gan cao
N decoction 1 pack decocted
twice
bid estazolam tablet,
2 mg, qn
30 d
Zhu WH 2011
[115] Wu Ling Jiao plus Nang
Zao Ren An Shen Jiao
Nang
wu ling jun N capsule 3capsules tid, qn estazolam tablet,
1 mg, qn
30 d
Huang XY 2011
[64] Wu Ling Jiao Nang wu ling jun N capsule 3 capsules tid diazepam tablet,
5 mg, qn
4w
(continued on next page)
1469X. Ni et al./Sleep Medicine 16 (2015) 1462–1481
Table 2 (continued)
Study Formula
d
Herbal ingredients
c
IM Preparation Dosage Frequency Comparator Treatment
duration
Jia B 2011
[40] Wen Bu Zhen She Fang zhi fu zi ,rou gui ,yin yang huo ,ling ci shi ,long chi ,zhen zhu
mu ,wu wei zi ,chang pu ,yuan zhi ,zhi gan cao
N decoction 1 pack decocted
twice
bid diazepam tablet,
5 mg, qn
30 d
Wang C 2011
[42] Qing Xin Ning Shen
Fang
lian zi xin ,jiu huang lian ,shui niu jiao ,lian qiao ,shan zhi
,zhu ye ,wu wei zi ,mai dong ,yuan zhi ,chang pu ,yu jin ,suan
zao ren ,bai zi ren
N decoction 1 pack decocted
twice
bid estazolam tablet,
1 mg, qn
4w
Yang XH 2011
[105] Gui Pi Tang huang qi ,fu ling ,bai zhu ,dang shen ,suan zao ren ,mu xiang
,yuan zhi ,zhi gan cao ,long yan rou ,dang gui ,bai zi ren ,ye
jiao teng ,he huan pi
N decoction 1 pack decocted 3
times
tid estazolam tablet,
1 mg, qn
4w
Jing XW 2011
[104] Xin Shen Ning Pian suan zao ren ,fu ling ,shou wu teng ,shen qu ,wei zi Y tablet 6 tablets tid placebo + estazolam
tablet, 1 mg, qn
3w
Chen YY 2011
[49] Chai Hu Jia Long Mu
Tang plus Ban Xia Xie
Xin Tang
chai hu ,huang qin ,huang lian ,ban xia ,dang shen ,gui zhi
,bai shao ,gan jiang ,sheng long gu ,sheng mu li ,ye jiao teng
,gan cao ,da zao
N decoction 1 pack decocted
twice
bid estazolam tablet,
2 mg, qn
8w
Xiao LG 2010
[72] Bu Xin An Shen Hua
Tan Fang
shu di huang ,bai shao yao ,e jiao ,suan zao ren ,fu shen ,bai zi
ren ,chen pi ,fa ban xia ,zhu ru ,he huan pi
N decoction 1 pack decocted
twice
bid estazolam tablet,
1.3 mg, qn
6w
Jiang HQ 2010
[61] Fu Zha Zao Ren Tang fu ling ,shan zha ,suan zao ren N decoction 1 pack decocted
twice
bid alprazolam tablet ,
0.4–0.8 mg, qn
3w
Wang ZT 2010
[95] San Qi Ke Li suan zao ren ,ji xue teng ,san qi ,xiao ji N granule 1 bag qd Placebo 4 w
Liao RD 2010
[116] No Name Formula sang ye ,ju hua ,tian ma ,gou teng ,chai hu ,long gu ,mu li ,yu
jin ,shi chang pu ,chi bai shao ,dan shen ,he huan pi
N decoction 1 pack decocted
once
qd estazolam tablet,
1–2 mg, qn
2w
Huang D 2010
[62] Xue Fu Zhu Yu Tang tao ren ,hong hua ,dang gui ,chuan xiong ,sheng di huang ,chi
shao ,chai hu ,zhi ke ,niu xi ,ju geng ,gan cao
N decoction 1 pack decocted
twice
bid alprazolam tablet,
0.8 mg, qn
4w
Wang F 2010
[53] Jie Yu Ning Shen Fang chai hu ,yu jin ,bai zi ren ,dang shen ,bai zhu ,shan yao ,suan
zao ren ,shan yu rou ,yuan zhi ,fu shen ,bai he ,sheng long mu
,zhen zhu mu ,hu po ,tao ren
N decoction 1 pack decocted
twice
bid diazepam tablet,
5mgqn
28 d
Tian J 2010
[66] Shen Qi Wu Wei Zi
Pian
wu wei zi ,dang shen ,huang qi ,suan zao ren N tablet 3 tablets tid estazolam tablet,
1 mg, qn
8w
Huang Y 2010
[65] An Shen Gao lian zi ,qian shi ,fu ling ,hei zhi ma ,mi zao ren ,bai zi ren ,ye
jiao teng ,yuan zhi ,e jiao
N soft extracts 15 ml qn zopiclone tablet,
7.5 mg, qn
6w
Song XH 2010
[81,101]
Wu Ling Jiao Nang wu ling jun N capsule 0.99 g tid Placebo 4 w
Lian FM 2009
[80] Chan Ye An Shen Jiao
Nang
tian zhu huang ,can tui ,shou wu teng ,jiang can ,di long ,bai
shao ,gou teng ,fa ban xia ,suan zao ren ,yuan zhi
N capsule 2 g qd Placebo 3 w
Xia CY 2009
[52] Xia’s No.1 Sleep
Prescription
huang qi, bai zhu, suan zao ren,ye jiao teng, he huang pi, dan
shen, huai xiao mai, fu ling, zhi yuan zhi, long gu, e jiao
N decoction 1 pack decocted
twice
bid Estazolam, 1 mg,
qn
6w
Zhang XP 2009
[111] Shen Song Yang Xin
Jiao Nang
ren shen ,mai dong ,wu wei zi ,sang ji sheng, shan zhu
yu,suan zao ren ,dan shen ,chi shao ,tu bie chong ,gan song
,huang lian ,long gu
Y capsule 1.6g qn to tid CBT 12w
Xu HK 2009
[58] Yin Dan Xin Nao Tong
Ruan Jiao Nang
yin xing ye ,deng zhan xi xin ,dan shen ,jiao gu lan ,san qi
,bing pian ,shan zha ,da suan
Y capsule 0.8g bid estazolam tablet,
2 mg, qn
4w
Nie ZH 2009
[86] Rou Gan Ning Shen
Tang
suan zao ren ,long chi ,bai shao ,ye jiao teng ,he huan pi ,yu
jin ,dan pi ,chao zhi zi ,gua lou pi ,fu ling ,
N decoction 1 pack decocted
twice
bid alprazolam tablet,
0.4–0.8 mg, qn
2w
She YQ 2009
[106] No Name Formula suan zao ren ,chuan xiong ,fu ling ,zhi mu ,gan cao N decoction 1 pack decocted
twice
bid diazepam tablet,
5 mg, qn
4w
Li X 2008
[98] Zhu Mian Tang ye jiao teng ,chao zao ren ,wu wei zi ,lian zi rou ,bai zi ren ,shi
chang pu ,yuan zhi ,fu ling ,zhi mu ,zhu ru ,ban xia ,gan cao
N decoction 1 pack decocted
twice
bid alprazolam tablet ,
0.4–0.8 mg, qn
20 d
Jiang LP 2008
[70] Jie Yu Wan bai shao ,chai hu ,dang gui ,yu jin ,fu ling ,bai he ,he huan pi
,gan cao ,xiao mai ,da zao ,
N pill 12 g tid estazolam tablet,
2–12 mg, bid
6w
Feng XD 2008
[100] Wu Ling Jiao Nang wu ling jun N capsule 3 capsules tid alprazolam tablet,
0.4–0.8 mg, qn
60 d
(continued on next page)
1470 X. Ni et al./Sleep Medicine 16 (2015) 1462–1481
Table 2 (continued)
Study Formula
d
Herbal ingredients
c
IM Preparation Dosage Frequency Comparator Treatment
duration
Zhang XM 2008
[103]
An Shen Jiao Nang suan zao ren ,zhi mu ,dan shen ,fu ling ,chuan xiong ,mai
dong ,zhi shou wu ,wu wei zi
N capsule 4 capsules tid alprazolam tablet,
0.4–0.8 mg, qn
8w
Zhang JP 2008
[71] Ye He Jian Nao Pian ye jiao xi ,he huan pi ,wu wei zi ,yuan zhi Y tablet 5 capsules tid zopiclone tablet,
7.5 mg, qn
4w
Sun Y 2008
[118] Zi Ni Wu Hua Shu Gan
Tang
fo shou hua ,dai dai hua ,lv e mei ,chuan piao hua ,mei gui
hua ,shou di ,dang gui ,bai shao ,chao bai zhu ,zhi gan cao
N decoction 1 pack decocted
twice
bid alprazolam tablet,
0.4–0.8 mg, qn
4w
Ren YJ 2007
[89] Zao Ren An Shen Jiao
Nang
suan zao ren ,dan shen ,wu wei zi N capsule 5 capsules qn estazolam tablet,
1 mg, qn
16 d
Chang C 2006
[119] Xin Ren Shen An Jiao
Nang
sheng di huang ,suan zao ren ,lian zi xin ,yuan zhi ,chen pi
,gan cao
Y capsule 3 capsules tid Placebo + sleep
hygiene education
4w
Chen JF 2006
[67] Tian Meng Jiao Nang huang jing ,huang qi ,dang shen ,ci wu jia ,yin yang huo (zhi
),shan yao ,ze xie ,fu ling ,gou qi zi ,shu di huang ,ma qian zi
(zhi )
N capsule 3 capsules bid alprazolam tablet,
0.4–0.8 mg, qn
1m
Zheng SY 2006
[113] Bai Lian Tang bai he ,lian zi xin ,chao zao ren ,shan yu rou ,sheng mu li ,fu
shen ,mai dong ,wu wei zi ,shi chang pu ,chuan bei mu ,he
huan pi
N decoction 1 pack decocted
twice
bid estazolam tablet,
2–12 mg, bid
6w
Luo LC 2006
[85] Yi Shen Qiang Shen Yin rou cong rong ,huang jing ,huang qi ,shan zha ,jue ming zi N granule 4.5g qd diazepam tablet,
5 mg, qn
1m
Chen FQ 2005
[45] An Shui Chong Ji chai hu ,dang gui ,xia ku cao ,gou teng ,dan shen ,sheng di
,long yan rou ,bai he ,zhen zhu mu ,ye jiao teng
N granule 9–18 g tid diazepam tablet,
2.5–5.0 mg, qn
1m
Yu HT 2005
[107] Jia Wei Suan Zao Ren
Tang
suan zao ren ,zhi mu ,chuan xiong ,fu ling ,long gu ,chi shao
,wu wei zi ,yuan zhi ,gan cao
Y decoction 1 pack decocted
once
qd lorazepam tablet,
0.5–1.5 mg, qn
4w
Zhang JF 2003
[68] Suan Zao Ren Gao suan zao ren ,zhi mu ,fu ling ,chuan xiong N soft extracts 20 g bid Placebo 4 w
Zhu T 2013
[92] Yang Xin An Shen Tang bai zi ren ,ye jiao teng ,he huan pi hua,fu shen ,chao zao ren
,dang gui ,bai shao ,hu po mo ,wu wei zi ,chen pi ,zhi ke
N + Y decoction 1 pack decocted
twice
bid CBT 4 w
Chen H 2012
[56] Bai Le Mian Jiao Nang bai he ,ci wu jia ,shou wu teng ,suan zao ren ,he huan hua
,zhen zhu mu ,shi gao ,fu ling ,yuan zhi ,dang can ,sheng di
huang ,mai dong ,wu wei zi ,deng xin cao ,dan can
N + Y capsule 4 capsules bid zolpidem, 10 mg,
qn
8w
Liu Y 2009
[83] Zao Ren An Shen Jiao
Nang
zao ren ,dan can ,wu mei zi N capsule 5 capsules qn
a
1: estazolam
tablet, 1 mg, qn; 2:
placebo, 5 capsule,
bid
3w
Chen WQ 2008
[48] Nao Kang II zhi shou wu ,shou di ,san qi ,chang pu N + Y oral solution 50 ml bid diazepam tablet,
2.5 mg, qn
4w
Zhan SQ 2008
[110] Huo Li Su Kou Fu Ye zhi shou nia ,gou qi zi ,zhi huang jing ,huang qi ,yin yang huo
,dan can
N + Y oral solution 10 ml bid zolpidem,
5–10 mg, qn
4w
Li Y 2009
[76] Jia Wei Xiao Yao San suan zao ren, fu shen, chai hu, dang gui,bai shao, bai shu, gan
cao,bao he ,wei sheng jiang
N + Y decoction 1 pack decocted
twice
bid 1. Estazolam 1 mg,
qn + placebo of
CHM; 2.placebo of
CHM + placebo of
estazolam
b
6w
Notes: Abbreviations: CBT-i: cognitive behavior therapy for insomnia; CHM: Chinese herbal medicine; IM: integrative medicine; N: no, stating Chinese herbal medicine is used alone; Y: yes, stating Chinese herbal medicine is
used as an adjunct to conventional medicine; N + Y: stating there are two intervention groups, one for Chinese herbal medicine and the other for integrative medicine; d: day/days; m: month/months; w:week/weeks; y:year/years.
a
There are two groups of control: pharmacotherapy and placebo.
b
This is a study including four groups: Chinese herbal medicine plus placebo of pharmacotherapy, Chinese herbal medicine plus pharmacotherapy, pharmacotherapy plus placebo of Chinese herbal medicine, and placebo of
Chinese herbal medicine plus placebo of pharmacotherapy.
c
When Chinese herbal medicine is used as an adjunct to conventional medicine, the control is the same as the conventional medicine in intervention group.
d
The herbal ingredients are presented as Chinese pinyin. The correspondent scientific names are specified in the book “Dan Bensky, editor. Chinese Herbal Medicine: Materia Medica, Third Edition. Seattle, WA: Eastland
Press, Inc; 2004.”
1471X. Ni et al./Sleep Medicine 16 (2015) 1462–1481
