Table 1.
Characteristics of 14 Included Randomized Controlled Trials of Zusanli (ST36) Injection for Diabetic Peripheral Neuropathy
| Study ID | Sample | Diagnostic criteria | Age (years) | Sex (M/F) | Disease course (years) | ST36 injection | Control | Outcome |
|---|---|---|---|---|---|---|---|---|
| Chen (2012)39 | I: 20 C: 20 Total: 40 |
Type 2 diabetes prevention and treatment guidelines released in China (2010) | NR | NR | NR | Mecobalamin, bilateral, 0.5 mL for each point, once a day, for 2 weeks | Mecobalamin 1 mL, intramuscular injection, once a day, for 2 weeks | NCV |
| Guo (2011)40 | I: 30 C: 30 Total: 60 |
Diagnosis and treatment of diabetic neuropathy | I: 56.8 ± 5.6 C: 56.8 ± 5.8 |
I: 13/17 C: 14/16 |
I: 4.75 ± 2.16 C: 4.5 ± 2.67 |
Mecobalamin 0.5 mg and normal saline 2 mL, once a day, for 4 weeks | Mecobalamin 0.5 mg and normal saline 2 mL, intramuscular injection, once a day, for 4 weeks | Adverse event; pain score |
| He (2011)41 | I: 35 C: 35 Total: 70 |
Practical of internal medicine | I: 55.4 C: 54.8 |
I: 19/16 C: 17/18 |
I: 6.2 ± 3.4 C: 6.3 ± 3.6 |
Anisodamine, bilateral, 5 mg, once a day, for 2 weeks | NCV | |
| Li (2015)42 | I: 30 C: 30 Total: 60 |
Contemporary diabetes mellitus | I: 51.7 ± 3.4 C: 51.6 ± 3.5 |
I: 16/14 C: 17/13 |
I: 2.5 ± 0.8 C: 2.3 ± 0.7 |
Danshen injection, bilateral alternate, 1.0 mL, once a day, for 4 weeks plus control treatment | Thioctic acid injection 600 mg and normal saline 250 mL, intravenous injection, once a day, for 4 weeks | NCV |
| Shan (2009)43 | I: 34 C: 33 Total: 67 |
Self-defined diagnostic criterion | I: 47 ± 11 C: 46 ± 12 |
I: 19/15 C: 18/15 |
I: 0.25–6 C: 0.33–6 |
Vitamin B12 500 μg, alternatively right and left point injection, once a day, for 3 weeks | Mecobalamin, 500 μg, intramuscular injection, once a day, for 3 weeks | Adverse event |
| Su (2015)44 | I: 60 C: 60 Total: 120 |
WHO | I: 52.29 ± 5.45 C: 53.12 ± 4.99 |
I: 28/32 C: 31/29 |
I: 6.17 ± 2.42 C: 5.89 ± 2.33 |
Mecobalamin, 500 μg, intramuscular injection Danhong injection, 2 mL, for 4 weeks |
Mecobalamin, 500 μg, intramuscular injection, for 4 weeks | TCSS; NCV |
| Wang (2011)45 | I: 30 C: 30 Total: 60 |
Self-defined diagnostic criterion | I: 59.6 (45–69) C: 57.8 (43–67) |
I: 17/13 C: 15/15 |
I: 0.25–9 C: 0.33–10 |
Vitamin B1 0.1 g, B12 500 μg, alternatively right and left point injection, once a day, for 3 weeks | Mecobalamin, 500 μg, intramuscular injection, once a day, for 3 weeks | Adverse event |
| Wang (2013)46 | I1: 25 I2: 34 C: 21 Total: 80 |
Diagnosis and treatment of diabetic neuropathy | I1: 56.8 ± 4.2 I2: 56.5 ± 4.6 C: 56.6 ± 4.4 |
I1: 13/12 I2: 21/13 C: 10/11 |
I1: 3.8 ± 1.4 I2: 3.5 ± 1.2 C: 3.6 ± 1.3 |
I1: cobamamide 1 mg (0.5 mg for each side), once a day, for 4 weeks I2: cobamamide 1 mg (0.5 mg for each side), once a day, plus Sanqi Tongshu capsule, one grain three times a day, for 4 weeks |
Cobamamide 1 mL, intramuscular injection, once a day, for 4 weeks | NCV |
| Xiao (2007)47 | I: 40 C: 36 Total: 76 |
Practical of internal medicine | I: 72.5 (65–80) C: 71 (60–82) |
I: 22/18 C: 20/16 |
I: 17 (4–30) C: 11 (2–20) |
Mecobalamin 500 μg, once a day, for 2 weeks | Mecobalamin 1 mg and normal saline 250 mL, intravenous injection, for 2 weeks | NCV |
| Xu (2010)48 | I: 37 C: 35 Total: 72 |
Self-defined diagnostic criterion | NR | I: 20/17 C: 21/14 |
NR | Fufang Danggui injection, 2 mL, 1 mL for each side, once 2 days, for 6 weeks | Vitamin B12, intramuscular injection, once 2 days, for 6 weeks | Effective rate (TCSS) |
| Xu (2011)49 | I1: 20 I2: 38 C: 16 Total: 74 |
Self-defined diagnostic criterion | I1: 60.4 (52–74) I2: 62.1 (50–75) C: 59.4 (50–73) |
I1: 12/8 I2: 24/14 C: 10/6 |
I1: 0.16–6.5 I2: 0.08–7 C: 0.04–6 |
I1: mecobalamin 0.5 mg (0.25 mg for each side), once a day, for 2 weeks I2: mecobalamin 0.5 mg (0.25 mg for each side), once a day, plus Fufang Danshen injection 800 mg and normal saline 250 mL, intravenous injection, for 2 weeks |
Mecobalamin 0.5 mg, intramuscular injection, once a day, for 2 weeks | Effective rate (TCSS) |
| Zhang (2014)50 | I: 70 C: 70 Total: 140 |
Self-defined diagnostic criterion | 49–75 | 65/75 | NR | Mecobalamin 0.25 mg and normal saline 1 mL, once 2 days, for 6 weeks plus control treatment | Improve circulation, trophic nerve, for 6 weeks | Effective rate (TCSS) |
| Zhan (2009)51 | I: 40 C: 40 Total: 80 |
Self-defined diagnostic criterion | I: 49 ± 12 C: 46 ± 11 |
I: 22/18 C: 23/17 |
I: 0.25–6 C: 0.33–5.5 |
Vitamin B12 500 μg, alternatively right and left point injection, once a day, for 3 weeks plus control treatment | Mecobalamin 500 μg plus normal saline 100 mL, intravenous injection, once a day, for 3 weeks | Adverse event |
| Zhao (2009)52 | I: 36 C: 36 Total: 72 |
Self-defined diagnostic criterion | I: 52.13 ± 7.92 C: 50.24 ± 8.85 |
I: 16/20 C: 17/19 |
I: 4.85 ± 2.93 C: 4.65 ± 2.87 |
Cobamamide 1 mg, once a day, for 4 weeks | Cobamamide 1 mL, intramuscular injection, once a day, for 4 weeks | NCV; pain score |
All randomized controlled trials reported incorporating additional treatments for diabetes such as diet control, exercise, oral insulin, or antidiabetic medications for all treatment groups.
C, control; I, intervention; NCV, nerve conduction velocity; NR, not reporting; TCSS, Toronto clinical scoring system.