|
| Study | Design | Sample and characteristics | Diagnostic criteria | Herbal intervention | Control | Outcome measures | ITT*1 | Drop out*2 | ADR*3 |
|
| 1 | Wan et al. [63], China Monotherapy Unclear center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 2 months duration | 68 VaD patients, age: 58–82; duration: 4.37–15.85 yr | DSM-3-R, HDS, HIS, “TCM dementia differential criteria”*a | Fucong 150 mL,
bid (37) | Piracetam
0.8 g, tid (31) | MMSE, HDS, BEAM, hemodynamic changes | N | N | U |
| 2 | Zhao et al. [74], China Monotherapy Single center | Randomized: method not mentioned; single blind; parallel design; 2 months duration | 46 VaD patients; age: 57–76; duration: 6 m –1 yr | DSM-4, HIS, HDS, MMSE, “Protocol for new herbal drugs study on dementia”* b | Xianlong
2.7 g, bid (24) | Hydergine
3 mg, bid (22) | TCD, hemodynamic changes | N | N | U |
| 3 | Ji [59], China Monotherapy Unclear center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 2 months duration | 68 VaD patients; age: 58–82; duration: 1.45-3.24 yr | DSM-3-R, HDS, HIS, “TCM dementia differential criteria”* a | Dangguishaoy
ao bid (37) | Piracetam
0.8 g, tid (31) | MMSE, HDS | N | N | U |
| 4 | Lu et al. [90], China Monotherapy Unclear center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 60 days duration | 50 VaD patients; age: 56–82; duration: 2–6 yr | DSM-3-R, MMSE, “TCM diagnostic criteria, differentiation and outcome measures on senile dementia”* c | Shentong 10 g,
tid (30) | Hydergine
1 mg, tid (20) | MMSE, BBS | N | N | U |
| 5 | Luo et al. [55], China Monotherapy Multicenter | Randomized: method not mentioned; double blind: method not mentioned; parallel design; 75 days duration | 68 VaD patients; age: 49–79; duration: 0.99–2.07 yr | DSM-4, ICD 10, HIS, “TCM diagnostic criteria, differentiation and outcome measures on senile dementia”* c | Shenmayizhi
1 g, tid (35) | Hydergine
1 mg, tid (33) | MMSE, ADL, BEAM, Neurological deficits | N | N | U |
| 6 | Zhang et al. [51], China Monotherapy Unclear center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 3 months duration | 61 VaD patients; age: 60–77; duration: 6 m–2.5 yr; | NINDS-AIREN, HIS, HDS, “protocol for new herbal drugs study on dementia”* b | Jiannaotongluo
1.6 g, tid (30) | Aniracetam
0.3 g, tid (31) | HDS, hemodynamic changes | N | N | U |
| 7 | Zhou and Yi [64], China Monotherapy Single center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 3 months duration | 46 VaD patients; age: 60–80; duration: 8 m–3 yr | DSM-3, “protocol for new herbal drugs study on dementia,”*b “protocol for new herbal drugs study on stroke”* b | Yinaoling
40 mL, bid (23) | Piracetam
0.8 g tid (23) | HDS, FAQ, CCSE | N | N | U |
| 8 | Cao et al. [82], China Monotherapy Unclear center | Randomized: method not mentioned; double blind: method not mentioned; parallel design; 60 days duration | 53 VaD patients; age: 58–75; duration: 3 m–12 m | DSM-4 | Congsheng
tid (25) | Hydergine
tid (28) | MMSE, BBS, TCD, EKG, SELF | N | N | N |
| 9 | Hong et al. [54], China Monotherapy Single center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 60 days duration | 86 VaD patients; age: 45–76; duration: 5 m–3 yr | DSM-4, MMSE, “TCM diagnostic criteria, differentiation and outcome measures on senile dementia,”* c CORELATION, HIS | Shouxing
tid (48) | Piracetam
tid (38) | MMSE, ADL | N | N | U |
| 10 | Huang et al. [91], China Monotherapy Unclear center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 3 months duration | 58 VaD patients; age: 57–79; duration: 6 m–3 yr | DSM-4, MMSE, ADL, HIS, “TCM diagnostic criteria, differentiation and outcome measures on senile dementia”* c | Naohuandan
62 g/d (28) | Piracetam
tid (28) | MMSE, ADL, E2, T, hemodynamic changes | N | N | U |
| 11 | Liu et al. [65], China Monotherapy Unclear center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 2 months duration | 64 VaD patients; age: 54–81; duration: 0.8–3 yr | DSM-4, HIS, CT, MRI | Tongqiaohuoxue-
buyanghuanwu
bid (36) | Duxil 1 tablet
bid (28) | MMSE, HDS, hemodynamic changes | N | N | U |
| 12 | Wang et al. [52] Monotherapy Single center | Randomized: method not mentioned; single blind: method not mentioned; parallel design; 30 days duration | 300 VaD patients; age: 52–83; duration: 7 m–7 yr | DSM-3-R, DSM-4, MMSE, “TCM diagnostic criteria, differentiation and outcome measures on senile dementia,”* c HIS, CT, MRI | Yizhitongluo
0.9–1.2 g TID (200) | Piracetam
0.8 g tid (100) | MMSE, HDS, GDS, ADL, hemodynamic changes, SELF | N | N | U |
| 13 | Yang et al. [80], China Monotherapy Single center | Randomized: method not mentioned; single blind: method not mentioned; parallel design; 2 months duration | 90 VaD patients; age: 50–81; duration: 3 M–6.5 yr | DSM-4-R, ICD10, CDR, MMSE, HDS-R, CORNELL, “protocol for new herbal drugs study on dementia”* b | Zhinao 1.5 g
tid (60) | Hydergine
2 mg tid (30) | MMSE, HDS, ADL, neurological deficits, hemodynamic changes, TCD, EEG, “TCM diagnostic criteria, differentiation and outcome measures on senile dementia”*c | N | N | U |
| 14 | Cai et al. [72], China Monotherapy Center unclear | Randomized: computer generated sequence; single blind: method not mentioned; parallel design; 3 months duration | 63 VaD patients; age: 65–78; duration: 3 m–94 m | DSM-4-R, MMSE, HIS, CT, MRI | Kangxing
0.9 g tid (33) | Hydergine
2 mg tid (30) | MMSE, ADL, hemodynamic changes, “protocol for new herbal drugs study on stroke” 中藥 新 藥治療
癡呆的 臨
床研究指導原則 | N | Y | N |
| 15 | Guo et al. [53], China
Adjunct therapy
Center unclear | Randomized: method not mentioned; double blinding not mentioned; parallel design; 2 months duration | 53 VaD patients; age: 55–73; duration: 1 yr–5 yr | DSM-4, “protocol for new herbal drugs study on dementia,”* b “protocol for new herbal drugs study on stroke”* b | Bunaotongqiao
+ Duxil 1 tablet
bid (28) | Duxil 1 tablet
bid (25) | MMSE, HDS, hemodynamic changes, | N | N | U |
| 16 | Jia et al. [92], China Monotherapy Single center | Randomized: method not mentioned; single blind: method not mentioned; parallel design; 60 days duration | 162 VaD patients; age: 54–71; duration: 0.8–3 yr | DSM-4, CDR, imaging, HDS | Luoshukang
1.5–2.5 g
tid (108) | Duxil 1 tablet
bid (54) | MMSE, BBS, “protocol for new herbal drugs study on dementia”* b | N | N | N |
| 17 | Cheng et al. [93] Monotherapy Single center | Randomized: method not mentioned; single blind: method not mentioned; parallel design; 2 months duration | 36 VaD patients; age: 62–83; duration: 0.5–9 yr | DSM-4-R, HIS, CT, MMSE, FAQ, HDS-R, ADL | Naozhitong 4
pcs tid (18) | Nimodipine
20 mg tid (18) | MMSE, FAQ, HDS-R, ADL, NO | N | N | U |
| 18 | Liao et al. [73], China Monotherapy Single center | Randomized: computer-generated sequence; single blind: method not mentioned; parallel design; 2 months duration | 60 VaD patients; age: 71–74; duration: 3.2–5.6 hr | DSM-4, CT, MRI, HIS, MMSE, HDS, “TCM diagnostic criteria, differentiation and outcome measures on senile dementia”*c | Shoulingjiannao
0.9 g tid (32) | Hydergine
1 mg tid (28) | MMSE, HDS, “protocol for the selection of anti-aging herbal medicine and the corresponding outcome measures”* d | N | N | N |
| 19 | Shen and Du [94], China Monotherapy Single center | Randomized: method not mentioned; single blind: method not mentioned; parallel design; 3 months duration | 70 VaD patients; age: 65–77; duration: 6 m –3 yr | DSM-4, NINDS-AIREN, CT, MRI, “protocol for new herbal drugs study on dementia”* b | Bushenjianpiy-angxuehuoxue
0.9 g tid (40) | Hydergine
2 mg tid (30) | MMSE, ADL, ET, NO, HCY, E2, T | N | N | U |
| 20 | Wang et al. [95], China Monotherapy Single center | Randomized: method not mentioned; double blind: details given; crossover design; 7 months duration (3 m + 1 m wash out + 3 m) | 18 VaD patients; age: 54–83; duration: 1–7 yr | DSM-4, CT, MRI, HDS, MMSE, ADL-R, “protocol for new herbal drugs study on dementia”* b | Shenlong
180 mL bid (18) | Placebo
180 mL bid (18) | HDS, MMSE-R, ADL-R, “protocol for new herbal drugs study on dementia” *b | N | N | Y (2, mouth dryness, sore throat) |
| 21 | Wang et al. [96], China Monotherapy Single center | Randomized: method not mentioned; single blind: method not mentioned; parallel design; 3 months duration | 100 VaD patients; age: 50–78; duration: 0.7–1.8 hr | DSM-4, HIS, ADL, MMSE, SDS, “TCM diagnostic criteria, differentiation and outcome measures on senile dementia”* c, “protocol for new herbal drugs study on dementia”* b | Huitian 0.8 g
tid (50) | Piracetam
08. g tid (50) | MMSE, ADL, hemodynamic changes, “protocol for new herbal drugs study on dementia” *b | N | N | U |
| 22 | Wu et al. [83], China Monotherapy Center unclear | Randomized: method not mentioned; double blind: method not mentioned; parallel design; 30 days duration | 46 VaD patients; age: 62–77; duration: 0.8–4.7 yr | DSM-4, CCDVD, CDSVD-R, MMSE, HIS | Extract from Herba Cistanches 2 tablets tid (23) | Hydergine 2
tablet tid (23) | MMSE, BBS, ADL, hemodynamic changes | N | 2 | N |
| 23 | Yu et al. [66], China Monotherapy Single center | Randomized: method not mentioned; single blind: method not mentioned; parallel design; 14 days duration | 123 VaD patients; age: 57–74; duration: 0.4–1.4 yr | DSM-4, “TCM diagnostic criteria, differentiation and outcome measures on senile dementia,”* c CT | Fucong 30 mL
od (72) | Piracetam 0.8 g tid + vitamin E 0.1 g tid (51) | SOD, LPO, TG, TCH, HDL, EEG | N | N | Y (2, mouth dryness, sore throat) |
| 24 | Zhao [97], China Monotherapy Center unclear | Randomized: method not mentioned; double blinding not mentioned; Parallel design; 2 months duration | 90 VaD patients; age: 49–81; duration: 0.5–3.5 yr | DSM, CT, MRI, clinical presentation | Jiannaoqingxin
od (50) | Duxil 1 tablet bid (40) | MMSE, MMSE-R, hemodynamic changes, HDS | N | N | N |
| 25 | Feng et al. [86], China Monotherapy Single center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 6 months duration | 50 VaD patients; age: 59–82; duration: 2–5 yr | Portera-sanchey | Yizhi bid (30) | Piracetam
1.6 g tid (20) | MMSE, BBS, ADL | N | N | U |
| 26 | Liu [71], China Monotherapy Single center | Randomized: method not mentioned; no blinding is applied; parallel design; 2 months duration | 142 VaD patients; age: 64–68; duration: 1.9–4.2 yr | DSM-R, CT, MRI, HIS | Bushenyinao
3 g tid (98) | Cerebroprot-ein Hydrolysate iv. 30 mL/day (44) | HDS, hemodynamic changes | N | 46 | Y |
| 27 | Liu et al. [60], China Monotherapy Single center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 2 months duration | 92 VaD patients; age: 45–80; duration: 1–12 yr | DSM, MMSE, ADL, CDR, HIS, “protocol for new herbal drugs study on dementia”* b | Huatuozaizao
8 g tid (52) | Duxil 1 tablet
bid (40) | MMSE, ADL, TC, TG, HDL-C, ET, NO, SELF, “protocol for new herbal drugs study on dementia” *b | N | N | N |
| 28 | Liu and Chen [74], China Monotherapy Single center | Randomized: computer generated sequence; double blinding not mentioned; parallel design, 8 weeks duration | 86 hospitalized VaD patients; age: 60–79; duration: 4 m–6.5 yr | DSM-4, HDS, HIS | Buyanghuanwu
12 g bid (43) | Hydergine
1 mg bid (43) | HDS, FAQ, hemodynamic changes, MQ, “protocol for new herbal drugs study on dementia”*b | N | N | U |
| 29 | Tang et al. [75], China Monotherapy Single center | Randomized: computer generated sequence; double blinding not mentioned; parallel design; 3 months duration | 80 VaD patients; age: 53–80; duration: 6 m–12 yr | DSM-3-R, MMSE, CT, MRI, HIS, “TCM manual for neurological diseases”* e | Bushenhuoxie bid (40) | Duxil 1 tablet bid, Nimodipine 30 mg tid (40) | MMSE, ADL, WBHSV, WBLSV, PV, HCT, “TCM diagnostic criteria, differentiation and outcome measures on senile dementia”* c | N | N | N |
| 30 | Wang et al. [56], China Monotherapy Unclear center | Randomized: method not mentioned; double blind: details given; crossover design; 7 months duration (3 m + 1 m wash out + 3 m) | 36 VaD patients; age: 52–83; duration: 1–7 yr. | DSM-4, ADL-R | Shenlong
180 mL bid (36) | Placebo bid (36) | MMSE-R, BBS, HDS, ADL-R | N | N | Y (4, sore throat, mouth dryness) |
| 31 | Wang et al. [98], China Monotherapy Single center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 3 months duration | 140 VaD patients; age: 50–78; duration: 0.9–1.8 yr | DSM-4, HIS, ADL, MMSE, SDS, “protocol for new herbal drugs study on dementia,”* b “TCM diagnostic criteria, differentiation and outcome measures on senile dementia” *c | Jiannaocongming
100 mL tid (100) | Piracetam
0.8 g tid (40) | MMSE, ADL, hemodynamic changes | N | N | U |
| 32 | Wang et al. [99], China Monotherapy Single center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 6 months duration | 80 hospitalized VaD patients; age: 46–78; duration: 6–122 m | DSM-4, NINDS-AIREN, MMSE, HDS, FAQ, HIS, “protocol for new herbal drugs study on dementia”*b | Tongxinluo
3 pcs tid (40) | Huperzine A
0.1 mg bid (40) | MSME, HDS, FAQ, “TCM diagnostic criteria, differentiation and outcome measures on senile dementia”* c | N | N | Y (nausea, decrease in appetite, etc.) |
| 33 | Wang [100], China, Adjunct therapy Single center | Randomized: method not mentioned; double blinding not mentioned, parallel design; 45 days duration | 66 VaD patients; age: 51–76; duration: 0.5–6 yr | DSM-4-R, MMSE, HDS, CT, MRI | Buyanghuanwu od + Piracetam 1.2 g bid,
Nimodipine 20 mg tid (33) | Piracetam
1.2 g bid, Nimodipine
20 mg tid (33) | HDS-R | N | N | U |
| 34 | Zhou et al. [101], China Monotherapy Single center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 3 months duration | 62 VaD patients; age: 59–76; duration: 0.5–6 yr | CCMD-2-R, DSM-4, MMSE, HDS, HIS | Yiqifuzhi
46 g tid (30) | Piracetam
0.8 g tid (32) | Hemodynamic changes, SOD, MDA, “protocol for new herbal drugs study on dementia”* b | N | N | U |
| 35 | Gao [67], China Monotherapy Single center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 3 months duration | 98 VaD patients; age: 54–75; duration: 0.2–1.8 yr | DSM-4, “TCM diagnostic criteria, differentiation and outcome measures on senile dementia”* c, ADL, MMSE | Shumaiyinao
1.2 g tid (58) | Piracetam
1.2 g tid (40) | MMSE, hemodynamic changes, Vmin, Qmin, RI | N | N | U |
| 36 | Hao et al. [102], China Monotherapy Single center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 6 months duration | 100 VaD patients; age: 48–81; duration: 7–118 m | ICD10, CT, MMSE, IADL, HIS | Tongxinluo
3 pcs tid (50) | Piracetam
0.8 g tid (50) | MMSE, NPI, IADL, HIS | N | N | Y (16, GI discom-fort) |
| 37 | Li et al. [61], China Monotherapy Single center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 3 months duration | 60 VaD patients; age: 45–80; duration: 1–12 yr | DSM-4, ADL, MMSE, HIS, “protocol for new herbal drugs study on dementia”* b | Tongmaiyizhi
8 g tid (30) | Duxil 1 tablet
bid (30) | MMSE, ADL, “protocol for new herbal drugs study on dementia”* b | N | N | U |
| 38 | Mou [68], China Monotherapy Unclear center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 60 days duration | 60 VaD patients; age: 57–89; duration: 2.5–4 yr | DSM-4, HDS | Self-derived
CHM 16 g
100 mL bid (30) | Nimodipine
30 mg tid (30) | MMSE | N | N | U |
| 39 | Shi and Wang [76], China
Adjunct therapy
Single center | Randomized: computer generated sequence; double blind: method not mentioned; parallel design; 3 months duration | 78 VaD patients; age: 50–80+; duration: 5 m–1.5 yr | DSM-4, “TCM diagnostic criteria, differentiation and outcome measures on senile dementia,”* c “Diagnostic manual for geriatrics”* f | Self-derived CHM 2 bid + nimodipine 40 mg tid, hydergine 2 mg tid (46) | nimodipine
40 mg tid,
hydergine
2 mg tid (32) | ADL, MMSE | N | N | U |
| 40 | Zhang and Lu [69], China Monotherapy Unclear center | Randomized: method not mentioned; double blinding not mentoned; parallel design; 3 months duration | 72 VaD patients; age: 57–71; duration: 0.3–5.6 yr | DSM-4, ICD10, HIS, HDL, TC | Bushenjiannao
300 mL bid (39) | Piracetam
800 mg tid +
hydergine
2 tablet bid (34) | MMSE, HDS, hemodynamic changes, “protocol for new herbal drugs study on dementia”*b | N | N | U |
| 41 | Chen et al. [84], China Monotherapy Single center | Randomized: method not mentioned; double blind: method not mentioned; parallel design; 3 months duration | 68 VaD patients; age: 60–86; duration: 1–7 yr | DSM-4, HDS, MMSE, CT, MRI | Shenlong
600 mL/day (36) | Piracetam
1.6 g tid (32) | MMSE, BBS, HDS, “protocol for new herbal drugs study on dementia”*b | N | N | U |
| 42 | Cui et al. [77], China Monotherapy Single center | Randomized: computer generated sequence; double blinding not mentioned; parallel design; 3 months duration | 67 VaD patients; age: 56–83; duration: 2 m–31 m | DSM-4, NINDS-AIREN, HIS, CDR | Shuangshencuzhi
8 g tid (51) | Duxil 1 tablet
bid (16) | MMSE, BBS, HCY, CT, MRI | N | 5 | U |
| 43 | He [57], China Monotherapy Single center | Randomized: method not mentioned; single blind: method not mentioned; parallel design; 8 weeks duration | 90 VaD patients; age: 48–80; duration: 2 m–6.5 yr | NINDS-AIREN, SDSVD, CDR, HIS, “criteria for the diagnosis, the differentiation of syndrome and the evaluation of efficacy of vascular dementia for research studies”* g | Kangnao
6 g tid (60) | Hydergine
2 mg tid (30) | MMSE, hemodynamic changes, SELF | N | N | N |
| 44 | Jin et al. [85], China Monotherapy Unclear center | Randomized: method not mentioned; double blind: details given; crossover design (12 w + 4 w wash out + 12 w); | 72 VaD patients; age: 55–83; duration: 1–7 yr | DSM-4-R, MMSE, ADL, HDS, CT, MRI, “protocol for new herbal drugs study on dementia”* b | Jiannaoyizhi
2 g tid (72) | Placebo tid (72) | MMSE-R, HDS, ADL-R, “protocol for new herbal drugs study on dementia”*b, “protocol for new herbal drugs study on stroke”* b | N | N | Y (2, sore throat, mouth dryness) |
| 45 | Yan [58], China Adjunct therapy Single center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 1 month duration | 79 VaD patients; age: 51–78; duration: 0.5–9 yr. | DSM-4-R, HDS-R, MMSE, CT, MRI | Buyanghuanwu + Cerebroprotein Hydrolysate 10 mL 20 d, Aniracetam 0.12 g tid; Nimodipine 20 mg tid (36) | Cerebroprot-ein Hydrolysate 10 mL 20 d, Aniracetam 0.12 g tid; Nimodipine 20 mg tid (43) | HDS-R | N | N | U |
| 46 | Chang et al. [70], China Monotherapy Single center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 12 weeks duration | 66 VaD patients; age: 60–78; duration: 1.3–3.6 yr | DSM-4, HIS, “TCM diagnostic criteria, differentiation and outcome measures on senile dementia,”*c MMSE, CT, MRI, HDS | Qihong 300 mL
bid (33) | Piracetam 0.4 g bid (33) | HDS, MMSE | N | N | U |
| 47 | Li et al. [103], China Monotherapy Single center | Randomized: method not mentioned; double blinding not mentioned; parallel design; 2 months duration | 120 VaD patients; age: 59–75; duration: 0.6–6.2 yr | DSM-4, MMSE-R, CDR, NINDS-AIREN, SDSVD, HIS, CSDD, “protocol for new herbal drugs study on dementia”* b | Shouwuyizhi
2.4 g tid (80) | Piracetam 0.8 g tid (40) | MMSE, HDS, WMS, SDSVD, TCD, hemodynamic changes, SELF | N | N | N |
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