Table 1.
Basic demographic data and intervention of studies includes in the review.
| Included Study (Reference) |
Type of Diabetes/Diagnosis Criteria | Trial Design/Randomization Method | Number of Participants (Male/Female); Age (Mean ± SD) | Interventions | Morbidity Period (Mean ± SD or Range) | Outcome Index (Intergroup Differencies p-Value) | Course of Treatment | Adverse Event (Case/Symptom) | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Trial | Control | Trial | Control | Trial | Control | ||||||
| Jin 2004 [59] | T1DM and T2DM/ WHO criteria, 1999 |
Randomized; Single center; Parallel/NR | 103 (54/49) 59.4 ± 5.61 y |
99 (51/48) 58.81 ± 6.01 y |
Tangmaitong tablets (0.5 g × 4 t, t.i.d.) | Mecobalamin tablets (500 mg, t.i.d.) |
3.31 ± 1.25 y | 3.82 ± 1.17 y | 1. MMNCV (p > 0.05) 2. MSNCV (p < 0.01) 3. PMNCV (p < 0.05) 4. PSNCV (p < 0.01) |
8 w | Trial: 1 AE/diarrhea Control: 3 AEs/abdomnial pain with diarrhea |
| Sun 2008 [60] | T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/NR | 30 (18/12) 40~70 y |
30 (16/14) 43~69 y |
1. Ziyinbushenhuoxuetonglou fang decoction (300 mL, b.i.d.) 2. Mecobalamin tablets (500 mg, t.i.d.) |
Mecobalamin tablets (500 mg, t.i.d.) |
1~33 m | 1~34 m | 1. Response rate (p < 0.05) |
4 w | NR |
| Shen 2009 [61] | T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/Block randomization method | 50 (21/29) 60 ± 4.2 y |
50 (27/23) 58.81 ± 6.01 y |
Tangmaining capsule (4.5 g × 5 c, b.i.d.) |
Mecobalamin tablets (500 mg, t.i.d.) |
8.5 y | 7.9 y | 1. Response rate (p < 0.05) 2. MMNCV (p < 0.05) 3. MSNCV (p < 0.05) 4. UMNCV (p < 0.01) 5. USNCV (p < 0.01) 6. PMNCV (p < 0.05) 7. PSNCV (p > 0.05) 8. TMNCV (p > 0.05) 9. TSNCV (p < 0.01) |
8 w | Trial: No AE Control: No AE |
| Lin 2010 [62] | T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/NR | 40 (22/18) median 55.6 y |
40 (23/19) median 54.2 y |
1. Tongxinluo capsule (3c, t.i.d.) 2. Mecobalamin tablets (500 mg, t.i.d.) |
Mecobalamin tablets (500 mg, t.i.d.) |
NR | NR | 1. Response rate (p < 0.05) 2. PMNCV (p < 0.01) 3. PSNCV (p < 0.01) 4. TMNCV (p < 0.01) 5. TSNCV (p < 0.01) |
4 w | NR |
| Wang 2010 [63] | T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/Simple randomization using random number table | 80 (45/35) 62.68 ± 7.35 y |
79 (43/36) 62.78 ± 7.57 y |
1. Huangqiguizhiwuwu decoction (300 mL, b.i.d.) 2. Mecobalamin injection (0.5 mg, q.d., i.m.) |
Mecobalamin injection (0.5 mg, q.d., i.m.) | 7.12 ± 4.25 y | 6.98 ± 4.62 y | 1. Response rate (p < 0.01) 2. MMNCV (p < 0.01) 3. MNSCV (p < 0.01) 4. PMNCV (p < 0.01) 5. PSNCV (p < 0.01) |
12 w | NR |
| Yan 2010 [64] | T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/NR | 14 (7/7) 57.79 ± 6.73 y |
15 (6/9) 52.53 ± 8.0 y |
Shutangluofang granule (b.i.d.) |
Methylcobalamine (500 mg, t.i.d.) |
13.14 ± 10.58 m | 10.67 ± 11.14 m | 1. Response rate (p < 0.05) |
12 w | NR |
| Wu 2011 [65] | T1DM and T2DM/Guidelines for the Prevention and Treatment of Diabetes in China, 2004 | Randomized; Single center; Parallel/NR | 30 (16/14) mean 49.9 y |
27 (15/12) mean 48 y |
Modified yiqihuoxue decoction (300 mL, b.i.d.) |
Vitamin B1 (20 mg, t.i.d.) Vitamin B6 (20 mg, t.i.d.) |
mean 12 m | mean 11.4 m | 1. Response rate (p < 0.01) 2. PMNCV (p < 0.01) 3. PSNCV (p < 0.01) |
6 w | NR |
| Gao 2012 [66] | T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/NR | 30 (16/14) NR |
30 (17/13) NR |
1. Nourishing the liver to stop the wind and tongluo decoction 2. Methylcobalamine (0.5 mg, t.i.d.) |
Methylcobalamine (0.5 mg, t.i.d.) |
NR | NR | 1. Response rate (p < 0.05) 2. MMNCV (p < 0.01) 3. MSNCV (p < 0.01) 4. PMNCV (p < 0.01) 5. PSNCV (p < 0.01) |
8 w | Trial: 2 AEs/ nausea, upper abdominal discomfort Control: No AE |
| Gong 2013 [67] | T1DM and T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/NR | 60 (32/28) 56.42 ± 5.28 y |
60 (33/27) 57.16 ± 5.34 y | 1. Modified aconiti decoction (400 mL, b.i.d.) 2. Methylcobalamine (500 mg, t.i.d.) |
Methylcobalamine (500 mg t.i.d.) |
7.65 ± 3.84 m | 7.83 ± 3.29 m | 1. Response rate (p < 0.05) 2. PMNCV (p < 0.01) 3. PSNCV (p > 0.05) |
30 d | Trial: No AE Control: No AE |
| Han 2013 [68] | T1DM and T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/Simple randomization using random number table | 31 (17/14) 54.2 ± 9.6 y |
31 (16/15) 55.3 ± 10.1 y |
1. Modified huangqiguizhiwuwu decoction (400 mL, b.i.d.) 2. Methylcobalamine (0.5 mg, t.i.d.) |
Methylcobalamine (0.5 mg, t.i.d.) |
NR | NR | 1. Response rate (p < 0.05) 2. PMNCV (p < 0.01) 3. PSNCV (p < 0.01) 4. MMNCV (p < 0.01) 5. MSNCV (p < 0.01) |
8 w | NR |
| Zhang 2013a [69] | T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/NR | 30 (16/14) 54.32 ± 7.14 y |
30 (15/15) 56.24 ± 7.40 y |
1. Mudan tong luo fang (b.i.d.) 2. α-Lipoic acid injection (600 mg, q.d., i.v. drip) |
α-Lipoic acid injection (600 mg, q.d., i.v. drip) | 8.3 ± 1.67 y | 8.5 ± 1.54 y | 1. Response rate (p < 0.05) 2. MMNCV (p < 0.05) 3. MSNCV (p < 0.05) 4. PMNCV (p < 0.05) 5. PSNCV (p < 0.05) |
3 w | NR |
| Zhang 2013b [70] | T1DM and T2DM/Only diagnostic criteria are presented without reference. | Randomized; Single center; Parallel/NR | 30 Total 60 (36/14) 56 ± 8 y |
30 Total 60 (36/14) 56 ± 8 y |
Tang bao kang (20 pills, t.i.d.) |
1. Methylcobalamine (500 mg, t.i.d.) 2. Vitamin B1 (30 mg, t.i.d.) 3. Vitamin B6 (30 mg, t.i.d.) |
Total 5~10 y |
Total 5~10 y |
1. Response rate (p < 0.01) 2. MMNCV (p < 0.01) 3. MSNCV (p < 0.01) 4. UMNCV (p < 0.01) 5. USNCV (p < 0.01) 6. PMNCV (p < 0.01) 7. PSNCV (p < 0.01) |
24 w | Trial: No AE Control: 1 AE/skin rash |
| Guo 2014 [71] | T1DM and T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/NR | 32 (19/13) 64.78 ± 8.90 y |
32 (15/17) 65.59 ± 8.35 y |
1. Modified huangqiguizhiwuwu decoction (b.i.d.) 2. Mecobalamin tablets (0.5 mg, t.i.d.) 3. Gabapentin (600 mg, t.i.d.) |
1. Mecobalamin tablets (0.5 mg, t.i.d.) 2. Gabapentin (600 mg, t.i.d.) |
NR | NR | 1. Response rate (p < 0.01) |
8 w | NR |
| Yang 2014a [73] | T2DM/Diagnostic criteria of Chinese guidelines for the prevention and treatment of type 2 diabetes, 2008 | Randomized; Single center; Parallel/NR | 60 (35/25) 51.30 ± 6.03 y |
60 (37/23) 51.26 ± 5.38 y |
1. Shenqixuebi feng (b.i.d.) 2. α-Lipoic acid injection (0.3 g, q.d., i.v. drip) 3. Mecobalamin injection (0.5 mg, q.d., i.v. drip) |
1. α-Lipoic acid injection (0.3 g, q.d., i.v. drip) 2. Mecobalamin injection (0.5 mg, q.d., i.v. drip) |
3.65 ± 1.12 y | 3.36 ± 1.18 y | 1. Response rate (p < 0.05) |
4 w | NR |
| Yang 2014b [72] | T1DM and T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/NR | 36 (23/13) 47.8 ± 8.3 y |
36 (20/16) 46.5 ± 8.1 y |
1. Modified huangqiguizhiwuwu decoction (200 mL, q.d.) 2. Methylcobalamine injection (500 mg, q.d., i.m.) |
1. Methylcobalamine injection (500 mg, q.d., i.m.) | 4.1 ± 1.3 m | 3.9 ± 1.4 m | 1. Response rate (p < 0.05) |
4 w | NR |
| Qi 2015 [74] | T1DM and T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/NR | 32 (17/15) 53.2 ± 7.1 y |
32 (16/16) 52.4 ± 7.0 y |
1. Mudan granule (7 g, t.i.d.) 2. 0.9% Sodium chloride 200 mL + α-Lipoic acid injection (450 mg, q.d., i.v. drip) |
1. 0.9% Sodium chloride 200 mL + α-Lipoic acid injection (450 mg, q.d., i.v. drip) | 2.3 ± 2.1 y | 2.6 ± 1.9 y | 1. Response rate (p < 0.05) 2. PMNCV (p < 0.01) 3. PSNCV (p < 0.01) |
4 w | Trial: No AE Control: No AE |
| Wang 2015 [75] | T2DM/TCM diagnosis and treatment plan for 95 diseases in 22 specialties | Randomized; Single center; Parallel/NR | 40 (20/20) mean 68.5 y |
40 (23/17) mean 71.2 y |
1. Yinxinshu capsule (3c, t.i.d.) 2. Maixuekang capsule (3c, t.i.d.) |
1. Oryzanol (20 mg, t.i.d.) 2. Vitamin B1 (10 mg, t.i.d.) 3. Adenosylcobalamin (1 mg, t.i.d.) |
10~12 y | 10~12 y | 1. Response rate (p < 0.05) |
4 w | Trial: No AE Control: No AE |
| Xue 2015 [76] | T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/Simple randomization using random number table | 42 (23/19) 36~78 y |
42 (22/20) 35~78 y |
1. Modified liutengshuilushexian decoction (150 mL, q.d.) |
1. Methylcobalamine tablet (0.5 mg, t.i.d.) |
28~73 d | 30~73 d | 1. Response rate (p < 0.01) 2. MSNCV (p < 0.01) 3. TSNCV (p < 0.01) 4. PSNCV (p < 0.01) |
3 w | Trial: No AE Control: No AE |
| Guo 2016 [77] | T1DM and T2DM/Diabetic peripheral neuropathy diagnosis and treatment guidelines of China, 2009 | Randomized; Single center; Parallel/Simple randomization using random number table | 51 (26/25) 69.54 ± 5.06 y |
51 (28/23) 69.78 ± 5.96 y |
1. Qitengtongluo decoction (b.i.d.) 2. Epalrestat (50 mg, 1t, t.i.d.) |
1. Epalrestat (50 mg, 1 t, t.i.d.) | 1.91 ± 2.09 y | 6.59 ± 1.91 y | 1. Response rate (p < 0.05) 2. NCSS (p < 0.05) 3. MSNCV (p < 0.05) 4. TSNCV (p < 0.05) 5. PMNCV (p < 0.05) 6. PSNCV (p < 0.05) |
12 w | NR |
| Han 2016 [78] | TIDM and T2DM/Diagnostic criteria for diabetic peripheral neuropathy formulated by the Chinese Medical Doctor Association | Randomized; Single center; Parallel/NR | 20 (12/8) 54.3 ± 7.2 y |
20 (11/9) 53.7 ± 6.8 y |
1. Zhanjin tongluo Chinese medicine (b.i.d.) 2. Mecobalamin tablets (500 mg, t.i.d.) |
1. Mecobalamin tablets (500 mg, t.i.d.) |
2.4 ± 1.2 y | 2.6 ± 1.3 y | 1. Response rate (p < 0.05) |
4 w | NR |
| Lan 2016 [79] | T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/NR | 54 Other information NR |
54 Other information NR |
Yiqihuoxue tongluo capsule (1.2 g, t.i.d.) | Epalrestat tablets (50 mg, t.i.d.) | NR | NR | 1. Response rate (p < 0.05) 2. PMNCV (p < 0.05) |
12 w | Trial: No AE Control: No AE |
| Mo 2016 [82] | T2DM/Guidelines for the Prevention and Treatment of Type 2 Diabetes in China, 2013 | Randomized; Single center; Parallel/Simple randomization using random number table | 33 (19/14) 65.28 ± 9.098 y |
32 (17/15) 62.34 ± 8.168 y |
Yangyinjiedu decoction (300 mL, b.i.d.) |
Methylcobalamine (0.5 mg t.i.d.) | 2~23 y | 2~19 y | 1. Response rate (p < 0.01) |
8 w | NR |
| Wang 2016 [83] | T2DM/Guidelines for the Prevention and Treatment of Type 2 Diabetes in China, 2013 | Randomized; Single center; Parallel/Simple randomization using random number table | 124 (72/52) 57.3 ± 6.8 y |
103 (58/45) 58.1 ± 7.2 y |
Modified tangbitong feng (150 mL, b.i.d.) |
Lifestyle modification | 22.1 ± 5.4 m | 23.5 ± 4.8 m | 1. Response rate (p < 0.01) |
8 w | Trial: No AE Control: No AE |
| Li 2016a [80] | T1DM and T2DM/Diabetic peripheral neuropathy diagnosis and treatment of China, 2009 | Randomized; Single center; Parallel/Simple randomization using random number table | 30 (18/12) 49.6 ± 5.6 y |
30 (17/13) 50.3 ± 5.4 y |
1. Wenyanghuoxuetongbi feng (b.i.d.) 2. Methylcobalamine (0.5 mg, t.i.d.) |
1. Methylcobalamine (0.5 mg, t.i.d.) | 18.21 ± 12.37 m | 17.97 ± 12.54 m | 1. Response rate (p < 0.01) 2. TSNCV (p < 0.01) 3. PSNCV (p < 0.05) |
8 w | Trial: No AE Control: No AE |
| Zhang 2016a [85] | T1DM and T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/Simple randomization using random number table | 48 (26/22) 54.6 y |
48 (28/20) 55.2 y |
1. Huangichifeng decoction combined Dangguisini decoction (q.d.) 2. Methylcobalamine injection (500 mg, q.d., i.m.) |
1. Methylcobalamine injection (500 mg, q.d., i.v.) | 2.8 y | 3.2 y | 1. Response rate (p < 0.01) 2. MSNCV (p < 0.01) 3. USNCV (p < 0.01) 4. PMNCV (p < 0.01) 5. TMNCV (p < 0.01) |
4 w | NR |
| Li 2016b [81] | T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/NR | 60 (37/23) 57 y |
60 (35/25) 56 y |
Huangzhitongnaoluo capsule (3c, t.i.d.) | Mecobalamin dispersible tablets (500 mg, t.i.d.) | 1~13 y | 1~12 y | 1. Response rate (p < 0.05) 2. MSNCV (p < 0.05) 3. TMNCV (p < 0.05) |
12 w | NR |
| Zhang 2016b [84] | T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/Simple randomization using random number table | 60 (36/24) 55.3 ± 6.4 y |
60 (35/25) 55.6 ± 5.5 y |
1. Qiming granule (4.5 g, t.i.d.) 2. Nimodipine injection (8 mg, q.d., i.v. drip) |
1. Nimodipine injection (8 mg, q.d., i.v. drip) | 2.0 ± 1.1 y | 2.2 ± 1.0 y | 1. Response rate (p < 0.01) 2. MMNCV (p < 0.01) 3. MSNCV (p < 0.01) 4. UMNCV (p < 0.05) 5. USNCV (p < 0.01) 6. TMNCV (p < 0.05) 7. TSNCV (p < 0.01) |
12 w | Trial: No AE Control: 1 AE/mild dizziness |
| Chen 2017 [86] | T2DM/Guidelines for the Prevention and Treatment of Type 2 Diabetes in China, 2013 | Randomized; Single center; Parallel/Simple randomization using random number table | 30 (14/16) 38.72 ± 20.02 y |
30 (13/17) 39.11 ± 19.57 y |
Dagguisini decoction (300 mL, b.i.d.) | Epalrestat capsule (50 mg, t.i.d.) | 4.32 ± 2.05 y | 4.20 ± 2.01 y | 1. Response rate (p < 0.05) |
12 w | Trial: No AE Control: No AE |
| Shi 2017 [87] | T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/NR | 32 (20/12) 38.7 ± 8.1 y |
32 (22/10) 40.3 ± 10.1 y |
1. Fufang danshen dripping pill (10 pill, t.i.d.) | 1. Methylcobalamine (0.5 mg, t.i.d.) 2. Epalrestat (50 mg, t.i.d.) |
3.87 ± 1.5 y | 3.69 ± 1.3 y | 1. TSNCV (p < 0.01) |
15 w | NR |
| Wang 2017 [88] | T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/Simple randomization using random number table | 30 (15/15) 58.76 ± 4.32 y | 30 (16/14) 57.21 ± 3.56 y |
Dangguisini decoction (200 mL, b.i.d.) |
Mecobalamin tablets (500 mg, t.i.d.) |
3.56 ± 1.21 y | 3.84 ± 1.36 y | 1. Response rate (p < 0.05) 2. MMNCV (p > 0.05) 3. MSNCV (p > 0.05) 4. PMNCV (p < 0.05) 5. PSNCV (p < 0.05) 6. TMNCV (p < 0.05) 7. TSNCV (p < 0.05) |
8 w | NR |
| Chen 2018 [89] | T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/Simple randomization using random number table | 40 (19/21) 55.8 ± 4.7 y |
40 (20/20) 56.2 ± 2.8 y |
1. Dangguisinin decoction (b.i.d.) 2. Mecobalamin tablets (500 mg, t.i.d.) |
Mecobalamin tablets (500 mg, t.i.d.) |
3.6 ± 1.8 y | 2.4 ± 2.1 y | 1. Response rate (p < 0.05) |
4 w | Trial: 2 AEs/skin rash, gastrointestinal discomfort Control: 3 AEs/diarrhea (2), skin rash |
| Dai 2018 [90] | T2DM/Guidelines for the Prevention and Treatment of Type 2 Diabetes in China, 2013 | Randomized; Single center; Parallel/NR | 40 45~85 y Other information NR |
40 45~85 y Other information NR |
Modified huangqiguizhiwuwu decoction (500 mL, b.i.d.) |
Epalrestat capsule (50 mg, t.i.d.) | NR | NR | 1. Response rate (p < 0.05) 2. UMNCV (p < 0.05) 3. USNCV (p < 0.05) 4. PMNCV (p < 0.05) 5. PSNCV (p < 0.05) |
3 w | NR |
| Hu 2018 [92] | T2DM/Guidelines for the Prevention and Treatment of Type 2 Diabetes in China, 2013 | Randomized; Single center; Parallel/NR | 31 (13/18) 55.45 ± 11.52 y |
31 (15/16) 53.76 ± 2.03 y |
1. Modified jiajianhuangqiguizhiwuwu decoction (200 mL, b.i.d.) 2. Methylcobalamine (0.5 mg, t.i.d.) |
1. Methylcobalamine tablet (0.5 mg, t.i.d.) | 7.13 ± 2.01 y | 6.52 ± 1.95 y | 1. Response rate (p < 0.05) 2. PMNCV (p < 0.05) |
8 w | NR |
| Huang 2018 [93] | T1DM and T2DM/Diagnostic and therapeutic effect evaluation criteria of diseases and syndromes in traditional Chinese medicine, 1994 | Randomized; Single center; Parallel/Simple randomization using random number table | 120 (52/68) 51.3 ± 11.4 y |
120 (51/69) 50.9 ± 11.6 y |
Matong powder (7 g, t.i.d.) |
Methylcobalamine tablet (0.5 mg, t.i.d.) | 8.92 ± 8.6 m | 8.97 ± 8.5 m | 1. Response rate (p < 0.05) 2. PMNCV (p < 0.05) 3. TSNCV (p < 0.05) |
8 w | Trial: 3 AEs/ Abdominal bloating with anorexia (3) Control: 2 AEs/Abdominal bloating with anorexia (2) |
| She 2018 [94] | T2DM/Guidelines for the Prevention and Treatment of Type 2 Diabetes in China, 2010 | Randomized; Single center; Parallel/Simple randomization using random number table | 30 (18/12) 63.35 ± 7.12 y |
30 (17/13) 65.13 ± 6.21 y |
1. Huangqiguizhiwuwu granule (b.i.d.) 2. Mecobalamin tablet (1 mg, t.i.d.) |
Mecobalamin tablet (1 mg, t.i.d.) | 3.31 ± 2.06 y | 3.82 ± 1.97 y | 1. Response rate (p < 0.05) |
6 w | NR |
| Xin 2018 [95] | T2DM/Diabetic peripheral neuropathy diagnosis and treatment of China, 2009 | Randomized; Single center; Parallel/NR | 30 Total 60 (36/24) 55.3 y |
30 Total 60 (36/24) 55.3 y |
1. Mongolian medicine garidi-13 weiwan (3 g, q.d.) | Mecobalamin tablet (0.5 mg, t.i.d.) | Total 4.2 y |
Total 4.2 y |
1. Response rate (p < 0.05) |
4 w | NR |
| Gao 2019 [91] | T1DM and T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/NR | 50 (26/24) 60.83 ± 5.26 y |
50 (25/25) 61.17 ± 6.05 y |
1. Modified shegmaisan (300 mL, b.i.d.) 2. Mecobalmin tablet (500 mg, t.i.d.) |
Mecobalmin tablet (500 mg, t.i.d.) | 3.82 ± 1.04 y | 3.77 ± 1.12 y | 1. Response rate (p < 0.05) 2. MMNCV (p > 0.05) 3. MSNCV (p > 0.05) 4. PMNCV (p < 0.05) 5. PSNCV (p < 0.05) 6. TMNCV (p < 0.05) 7. TSNCV (p < 0.05) |
8 w | Trial: No AE Control: No AE |
| Wu 2019 [99] | T2DM/Guidelines for the Prevention and Treatment of Type 2 Diabetes in China, 2013 | Randomized; Single center; Parallel/Simple randomization using random number table | 30 (16/14) 57.60 ± 7.20 y |
30 (16/14) 57.03 ± 7.63 y |
Taohongsiwu decoction (t.i.d.) |
Epalrestat tablet (50 mg, t.i.d.) | 4.3 y | 4.3 y | 1. Response rate (p < 0.05) 2. MSNCV (p < 0.05) 3. PSNCV (p < 0.05) |
4 w | Trial: No AE Control: No AE |
| Yi 2019 [100] | T1DM and T2DM/Diabetic neuropathy diagnosis criteria of American Diabetes Association, 2017 | Randomized; Single center; Parallel/Simple randomization using random number table | 60 (31/29) 61.36 ± 4.37 y |
60 (29/31) 61.53 ± 4.64 y |
Mongolian medicine zhenbo pills (0.2 g × 15 p, b.i.d.) | α-Lipoic acid tablet (0.3 g × 2 c, q.d.) | 8.23 ± 3.21 y | 8.23 ± 3.12 y | 1. MMNCV (p < 0.05) 2. MSNCV (p < 0.05) 3. PMNCV (p < 0.05) 4. PSNCV (p < 0.05) |
24 w | Trial: 5 AEs/ nausea (2), anorexia (3) Control: 6 AEs/ nausea (2), gastric pain (2) |
| Ji 2019 [96] | T2DM/Guidelines for the Prevention and Treatment of Type 2 Diabetes in China, 2010 | Randomized; Single center; Parallel/Simple randomization using random number table | 54 (32/22) 54.47 ± 9.81 y |
53 (33/20) 54.81 ± 9.44 y |
1. Yangyinzhuyu decoction (150 mL, b.i.d.) 2. Epalrestat tablet (50 mg, t.i.d.) |
Epalrestat tablet (50 mg, t.i.d.) | 10.24 ± 3.08 y | 10.53 ± 2.66 y | 1. Response rate (p < 0.05) |
90 d | Trial: No AE Control: No AE |
| Liu 2019a [97] | T2DM/Guidelines for the Prevention and Treatment of Type 2 Diabetes in China, 2013 | Randomized; Single center; Parallel/Simple randomization using random number table | 40 Other information NR |
40 Other information NR |
1. Shengjinsan combined Taohongyin (200 mL, b.i.d.) 2. Mecobalamin tablet (500 mg, t.i.d.) |
Mecobalamin tablet (500 mg, t.i.d.) | NR | NR | 1. MMNCV (p < 0.05) 2. MSNCV (p < 0.05) 3. TMNCV (p < 0.05) 4. TSNCV (p < 0.05) |
4 w | NR |
| Liu 2019b [98] | T2DM/Guidelines for the Prevention and Treatment of Type 2 Diabetes in China, 2013 | Randomized; Single center; Parallel/Simple randomization | 45 (27/18) 58.77 ± 4.26 y |
45 (26/19) 59.46 ± 4.77 y |
1. Huangqiguizhiwuwu decoction (400 mL, b.i.d.) 2. Epalrestat tablets (t.i.d.) 3. Mecobalamin tablet (t.i.d.) |
1. Epalrestat tablets (t.i.d.) 2. Mecobalamin tablet (t.i.d.) |
3.28 ± 1.45 m | 3.31 ± 1.13 m | 1. Response rate (p < 0.05) |
8 w | NR |
| Chen 2021 [101] | T2DM/Guidelines for the Prevention and Treatment of Type 2 Diabetes in China, 2013 | Randomized; Single center; Parallel/NR | 28 (15/13) 57.2 ± 8.1 y |
29 (16/13) 56.5 ± 7.6 y |
1. Zicuijuanbi decoction (150 mL, b.i.d.) 2. Normal saline injection (250 mL, i.v.) |
1. gabapentin capsule (0.3 g, t.i.d.) 2. Normal saline injection (250 mL, i.v.) |
15.57 ± 3.68 y | 14.59 ± 4.35 y | 1. Response rate (p < 0.05) |
10 w | NR |
| Hou 2021 [102] | T2DM/WHO criteria, 1999 | Randomized; Single center; Parallel/NR | 39 (24/15) 56.74 ± 11.79 y |
28 (18/10) 55.83 ± 10.60 y |
Jiuchongdan (40 pills, t.i.d.) |
Mecobalamin tablet (500 mg, t.i.d.) |
15.28 ± 11.23 m | 16.72 ± 10.96 m | 1. Response rate (p < 0.05) 2. PSNCV (p < 0.05) 3. MSNCV (p < 0.05) 4. USNCV (p < 0.05) |
12 w | NR |
| Li 2021 [103] | T2DM/Guidelines for the Prevention and Treatment of Diabetic Peripheral Neuropathy by Traditional Chinese Medicine, 2011 | Randomized; Single center; Parallel/Simple randomization using random number table | 41 (22/19) 59.81 ± 5.63 y |
41 (23/18) 60.20 ± 5.62 y |
1. Huangqiguizhiwuwu decoction (200 mL, t.i.d.) combined Mudan granule (7 g, t.i.d.) 2. Mecobalmin tablet (500 mg, t.i.d.) |
1. Mecobalamin tablet (500 mg, t.i.d.) | 3.15 ± 0.45 y | 3.12 ± 0.43 y | 1. Response rate (p < 0.05) 2. MMNCV (p < 0.05) 3. MSNCV (p < 0.05) 4. PMNCV (p < 0.05) 5. PSNCV (p < 0.05) |
8 w | Trial: 5 AEs/diarrhea (1), nausea (1), constipation (2), dizziness (1) Control: 1 AE/ nausea (1) |
| Wang 2021a [105] | T1DM and T2DM/diagnostic criteria are presented without reference | Randomized; Single center; Parallel/Simple randomization using random number table | 30 (16/14) 64.63 ± 4.72 y |
30 (17/13) 64.71 ± 4.68 y |
1. Yiqiyangyintongluo decoction (200 mL, b.i.d.) 2. Epalrestat tablets (50 mg, t.i.d.) |
1. Epalrestat tablets (50 mg, t.i.d.) | 6.14 ± 1.24 y | 6.12 ± 1.22 y | 1. Response rate (p < 0.05) |
12 w | NR |
| Wang 2021b [104] | T2DM/diagnostic criteria are presented without reference | Randomized; Single center; Parallel/Simple randomization using random number table | 50 (34/16) 67.13 ± 6.29 y |
50 (32/18) 67.13 ± 6.29 y |
1. Taohongsiwu decoction (b.i.d.) 2. Mecobalmin capsule (0.5 mg, t.i.d.) |
1. Mecobalamin capsule (0.5 mg, t.i.d.) | 1.57 ± 0.51 y | 1.42 ± 0.83 y | 1. MMNCV (p < 0.05) 2. MSNCV (p < 0.05) 3. PMNCV (p < 0.05) 4. PSNCV (p < 0.05) 5. TMNCV (p < 0.05) 6. TSNCV (p < 0.05) |
4 w | NR |
| Zhang 2021 [106] | T2DM/Guidelines for the Prevention and Treatment of Diabetic Peripheral Neuropathy by Traditional Chinese Medicine, 2011 | Randomized; Single center; Parallel/NR | 74 Total 148 (78/70) 59.64 ± 8.94 y |
74 Total 148 (78/70) 59.64 ± 8.94 y |
1. Buqi Huoxue Zhitong decoction (b.i.d.) 2. α-Lipoic acid injection (0.6 g, q.d.) combined 0.9% Sodium chloride injection (250 mL, q.d.) |
1. α-Lipoic acid injection (0.6 g, q.d.) combined 0.9% Sodium chloride injection (250 mL, q.d.) |
Total 9.33 ± 1.25 y |
Total 9.33 ± 1.25 y |
1. TSNCV (p < 0.05) 2. PSNCV (p < 0.05) |
8 w | NR |
AEs: adverse events; b.i.d.: bis in die; c: capsules; d: days; EAHM: East Asian herbal medicine; g: grams; i.v.: intravenous; m: months; mg: milligrams; MMNCV: median motor nerve conduction velocity; MSNCV: median sensory nerve conduction velocity; NR: not reported; p: packs; p.o.: per os; PMNCV: peroneal motor nerve conduction velocity; PSNCV: peroneal sensory nerve conduction velocity; q.d: quaque die; SD: standard deviation; t: tablets; t.i.d.: ter in die; T1DM: type one diabetes mellitus; T2DM: type two diabetes mellitus; TMNCV: tibial motor nerve conduction velocity; TSNCV: tibial sensory nerve conduction velocity; UMNCV: ulnar motor nerve conduction velocity; USNCV: ulnar sensory nerve conduction velocity; w: weeks; WHO: World Health Organization; y: years; µg: microg.