Table 1
Basic characteristics of the included studies
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

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.

Xie et al. BMC Complementary and Alternative Medicine 2013 13:18   doi:10.1186/1472-6882-13-18

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