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Table 1 Basic characteristics of the included studies

From: Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials

Included trials

Eligibility criteria

Study designs

Interventions

Sample and characteristics (male/female; age ;Duration)

Outcome index

Intergroup differences

   

Trial

control

Trial

control

  

WU 2005[31]

GCTNPCM in I993

RCT (method unreported) and controlled nonblind parallel study

Modified suanzaorentang 1dose/d for 2 week

alprazolam 0.4-1.2 mg/p.t qn for 2 week

70 (M:30, F:40) Mean age: Mean age: 48y Disease duration: 6 m-9y

70 (M:32, F:38) Mean age: 47y Disease duration: 6 m-9y

1. Clinical effect

1. p < 0.05

2. adverse effect

2.P < 0.01

Yu 2005[32]

CCMD-III

RCT (Psychological test Numbers) and controlled nonblind parallel study

Modified Suanzaorentang 1dose/d+Lorazepam o.5 mg qn

for 4 weeks

Lorazepam o.5 mg qn for 4 weeks

48 (M:22, F:26) Mean age: Mean age: 32.6±8.9y Disease duration: 1.5 m-10y

45 (M:23, F:22) Mean age: Mean age: 30.6±8.4y Disease duration: 1 m-12y

1. SDRS

1. p < 0.05

2. HAMA

2. p < 0.05

3. CGI

3.P > 0.05

Tan 2006[35]

CCMD-III

RCT (method unreported) and controlled nonblind parallel study

Suanzaorentang 1dose/d (150 ml) + Oxazepam 60 mg/d For 30d

Oxazepam 60 mg/d For 30d

N.R N.R N.R

N.R N.R N.R

Clinical effect

p < 0.05

Yu 2006[36]

CCMD-III

RCT (method unreported) and controlled nonblind parallel study

Baihesuan Zaorentang 1dose/d (300 ml) for 3 week

estazolam 2 mg/p.t qn For 3 weeks

63 (M:34, F:29) 63(M:34, F:29) Mean age: 31.2y Mean disease duration: 2.3y

57 (M:30, F:27) 63(M:34, F:29) Mean age: 31.3y Mean disease duration: 2.4y

1. Clinical effect

1.p < 0.05

2.adverse effect

2.p < 0.01

Wu 2008[42]

CCMD-III+GCTNPCM in I993

RCT (method unreported) and controlled single-blind 3-group design study

Modified Suanzaorentang 1dose/d For 14d

alprazolam 0.2-0.6 mg/pt qn For 14d

70 (M:30, F:40) Mean age: Mean age: 48y Disease duration: 6 m-9y

70 (M:32, F:38) Mean age: Mean age: 47y Disease duration: 6 m-9y

1. Clinical effect

1. P < 0.01

2. PSQI

2. P < 0.01

3. adverse effect

3.P < 0.01

Modified Suanzaorentang 1dose/d + alprazolam 0.2-0.6 mg/pt qn For 14d

alprazolam 0.2-0.6 mg/pt qn For 14d

260 (M:98, F:162) Mean age: Mean age: 48.5y Disease duration: 6 m-10y

70 (M:32, F:38) Mean age: Mean age: 47y Disease duration: 6 m-9y

1. Clinical effect

1. P < 0.01

2. PSQI

2. P < 0.01

3. adverse effect

3. P < 0.01

She 2009[37]

CCMD-III

RCT (random number table) a And controlled nonblind parallel study

Modified Suanzaorentang 1dose/d (300 ml) Divide two time for 4 week

diazepam 5 mg/pt qn For 4 weeks

60 (-,-) Mean age: 36.±8.53y Mean disease duration: 3.22±3.37y

59 (-,-) Mean age: 35.32±9.13y Mean disease duration: 3.51±3.67y

1. Clinical effect

1. P < 0.01

2. PSQ I

2. P < 0.05

Yuan 2009[38]

CCMD-2-R

RCT (random number table) and controlled nonblind parallel study

Modified Suanzaorentang 1dose/d Divide two time for 15d

estazolam 2 mg/pt qn For 15d

69 (M:27, F:42) Mean age: Mean age: 37y Disease duration:

65 (M:23, F:42) Mean age: Mean age: 37y Disease duration:

1. Clinical effect

1. P < 0.05

2. timeliness of drug

2. P < 0.05

Luo 2009[34]

CCMD-III

RCT (method unreported) and controlled nonblind parallel study

Suanzaorentang 1dose/d (250 ml) Divide two time For 15d

diazepam 2.5-5 mg/pt qn For 15d

30 (M:12, F:18) Mean age: Mean age: 60y Mean disease duration: 15y

30 (M:13, F:17) Mean age: 62y Mean disease duration: 16y

Clinical effect

P < 0.05

Zou 2011[40]

GCTNPCM in 1993

RCT (method unreported) and controlled nonblind parallel study

Suanzaorentang 1dose/d + estazolam 2 mg/pt qn For 4 weeks

estazolam 2 mg/pt qn For 4 weeks

25 (M:12, F:13) Mean age: Mean age: 48.82±4.32y Disease duration: 2 m-13 m

25 (M:13, F:12) Mean age: Mean age: 47.74±3.98y Disease duration: 1 m-13 m

Clinical effect

P < 0.05

Cong 2011[41]

GCTNPCM in I993

RCT (method unreported) and controlled nonblind parallel study

Modified Suanzaorentang 1dose/d Divide two time for 4 week

diazepam 2.5-5 mg/pt qn For 4 weeks

59 (M:18, F:41) Mean age: Mean age: 40y Mean disease duration: 3y

59 (M:17, F:42) Mean age: 39y Mean disease duration: 2.6y

Clinical effect

p > 0.05

Feng 2011[39]

CCMD-III

RCT (method unreported) and controlled nonblind parallel study

Modified Suanzaorentang 1dose/d (150 ml) qn for 2 week

estazolam 2 mg/pt qn For 2 weeks

78 (M:31, F:47) Mean age: Mean age: 39.53y Mean disease duration: 5.3mo

69 (M:25, F:44) Mean age: 38.89y Mean disease duration: 5.1mo

1. Clinical effect

1. p > 0.05

2. Spiegel sleep questionnaire

2. P < 0.05

Liu 2012[33]

CCMD-III

RCT (method unreported) and controlled nonblind parallel study

Modified Suanzaorentang 1dose/d for 14d

diazepam 5 mg/pt qn For 14d

50 (M:25, F25) Mean age: Mean age: 48.5±20.3y Disease duration: 1 m-51 m

25 (M:24, F:26) Mean age: Mean age: 46.3±17.8y Disease duration: 2 m-42 m

1. Clinical effect

1. p > 0.05

  1. CCMD-III Chinese classification and diagnostic criteria for mental disorders 3rd edition, CCMD-2-R Chinese classification and diagnostic criteria for mental disorders second edition-revision, GCTNPCM Guideline for Clinical Trials of New Patent Chinese Medicines, RCT, Randomized controlled trial, y year, m month, d day, PSQI, Pittsburgh Sleep Quality Index, SDRS, Sleep Dysfunction Rating Scale, HAMA, Hamilton Anxiety Scale, CGI Clinical general impression scale, N.R non-reported.