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Study ID | Diagnosis criteria | Sample size | Age (mean ± SD) | Sex (male/female) | Loss | Experiment group | Control group | Duration | Outcome measures | Adverse effect |
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Fang et al. [18] | WHO 1999 | Total: 514 I: 257/C: 257 | I: 54.95 ± 9.50; C: 54.61 ± 10.51 | I: 136/121 C: 142/115 | I: 34/C: 41 | CHM + LM | LM | 12 months | ①②③④⑤⑥⑦⑧⑨ | AEs were noted in 14 patients, including 5 in the control group and 9 in the experimental group. 13 patients experienced gastrointestinal reactions, and one patient had pruritus. All reported AEs were mild-moderate; no serious AEs were reported. |
Gao et al. [16] | WHO 1999 | Total: 510 I: 255/C: 255 | I: 49.3 ± 1.2; C: 51.12 ± 1.3 | I: 110/145 C: 112/143 | I: 25/C: 27 | CHM + LM | LM | 3 years | ②③④⑤⑥⑦⑧⑨ | 4 cases in the TCM intervention group showed mild abdominal distension; 3 cases in the control group showed mild abdominal distension. |
Huang et al. [31] | WHO 1999 | Total: 127 I: 64/C: 63 | I: 52.02 ± 8.60; C: 51.05 ± 9.25 | I: 31/29 C: 35/25 | I: 4/C: 3 | CHM + LM | LM | 12 weeks | ①②③④⑤⑥⑦⑧⑨ | No AEs occurred. |
Karimi-Nazari et al. [32] | ADA | Total: 80 I: 40/C: 40 | I: 57.95 ± 8.12 C: 57.9 ± 8.7 | I: 13/23 C: 14/25 | I: 4/C: 1 | CHM | Placebo | 8 weeks | ③④⑥⑦⑧ | No AEs occurred. |
Ke et al. [33] | WHO 1999 | Total: 85 I: 45/C: 40 | I: 46.5 ± 7.3 C: 45.7 ± 7.5 | I: 23/22 C: 20/20 | I: 2/C: 2 | CHM + LM | LM | 6 months | ②③④⑤⑥⑦⑧⑨ | 5 patients in the treated group felt fatigue, hunger, and dizziness, which were recovered after giving normal diets. |
Lian et al. [34] | WHO 1999 | Total: 420 I: 210/C: 210 | I: 52.95 ± 10.06 C: 51.86 ± 10.16 | I: 98/112 C: 106/104 | I: 10/C: 18 | CHM | Placebo | 12 months | ①②③ | 15 patients in the Tianqi group and 11 in the placebo group experienced AEs, all of which were mild adverse reactions (grades 1-2). |
Ogawa et al. [35] | ADA | Total:34 I:17/C:17 | I: 49.6 ± 1.5 C: 55.1 ± 2.0 | I: 13/4 C: 13/4 | I: 0/C: 0 | CHM | Placebo | 8 weeks | ③④⑤ | No AEs occurred. |
Shi et al. [36] | WHO 2003 | Total: 65 I: 34/C: 31 | I: 47.1 ± 7.1 C: 49.9 ± 7.2 | I: 17/17; C: 14/17 | I:2/C:2 | CHM + LM | LM | 12 weeks | ①②③④⑤⑥⑨ | 1 patient in the JLD group experienced diarrhea, and 1 subject in the control group had nausea. No hypoglycemia or other serious AEs were reported. |
Sun et al. [37] | ADA 2008 | Total: 362 I: 182/C: 180 | I: 55.49 ± 8.61 C: 53.49 ± 8.85 | I: 90/92 C: 82/98 | I: 12/C: 16 | CHM + LM | Placebo + LM | 12 months | ①②③ | AEs in the treatment group and the control group occurred in 5 and 3 cases. No statistically significant difference was observed between the two groups. |
Liu et al. [25] | WHO 1999 | Total: 140 I: 70/C: 70 | I: 51.3 ± 8.8 C: 50.7 ± 8.1 | I: 31/39 C: 32/38 | I: 6/C: 2 | CHM | No treatment | 6 months | ①②③④⑤⑥⑦⑧⑨ | No AEs occurred. |
He [39] | WHO 1999 | Total: 253 I: 126/C: 127 | I: 29–70 C: 25–75 | I: 64/62 C: 66/61 | I: 0/C: 0 | CHM + LM | LM | 3 months | ①②③④⑤⑨ | No AEs occurred. |
Liu et al. [41] | WHO 2008 | Total: 150 I: 75/C: 75 | No statistically significant difference | No statistically significant difference | I: 3/C: 6 | CHM + LM | Placebo + LM | 12 months | ①②③④⑦⑧ | No AEs occurred. |
Zhuo et al. [40] | WHO 1999 | Total: 136 I: 66/C: 70 | I: 57.4 ± 10.2 C: 56.7 ± 10.9 | I: 30/36 C: 34/36 | I: 0/C: 0 | CHM + LM | LM | 12 weeks | ②③④⑤⑥⑦⑧⑨ | No AEs occurred. |
An et al. [42] | ADA 2008 | Total: 216 I: 108/C: 108 | I: 41.8 ± 7.7 C: 39.6 ± 7.5 | I: 70/38 C: 72/36 | I: 13/C: 11 | CHM + LM | LM | 12 months | ①②③④⑤⑥ | In the CHM group, drug-related adverse reactions occurred in 5 cases, mostly mild, and the patients could be relieved by themselves. There were 2 cases of nausea and anorexia, 1 case of mild diarrhea, and 1 case of bowel ringing and stool change |
Li et al. [38] | GPTDC | Total: 64 I: 31/C: 33 | I: 55.7 ± 12.8 C: 56.93 ± 10.34 | I: 5/21 C: 6/22 | I: 5/C: 5 | CHM + LM | LM | 12 months | ①②③④⑤⑥⑦⑧⑨ | No AEs occurred. |
Fan et al. [43] | WHO 1999 | Total: 51 I: 25/C: 26 | I: 54.60 ± 9.09; C: 57.45 ± 8.76 | I: 10/13 C: 11/11 | I: 2/C: 4 | CHM + LM | LM | 6 months | ①②④⑤⑥⑦⑧⑨ | No records. |
Ge et al. [44] | ADA 2009 | Total: 234 I: 117/C: 117 | 60.7 ± 8.1 | 141/93 | I: 10/C: 17 | CHM + LM | LM | 12 months | ①②③④⑤⑥⑦⑧ | 8 patients had slight gastrointestinal discomfort within 1 week of medication, and the symptoms disappeared after symptomatic treatment, which did not affect the treatment |
Chen et al. [45] | WHO 1999 | Total: 122 I: 63/C: 59 | I: 52.87 ± 10. 57 C:52.97 ± 10. 94 | I: 27/36 C: 32/27 | I: /C: | CHM + LM | placebo + LM | 12 months | ①③④⑤⑦⑧ | No AEs occurred. |
Wang and Xu [46] | GPTDC | Total: 140 I: 70/C: 70 | I: 43.7 ± 5.8 C: 42.9 ± 6.1 | I: 27/36 C: 32/27 | I: 1/C: 2 | CHM + LM | Metformin + LM | 3 months | ①②③④⑥⑦⑧⑨⑩ | 1 patient in the CHM group withdrew due to nausea and bloating. |
Hong et al. [47] | WHO 1999 | Total: 60 I: 29/C: 31 | I: 44 ± 9.3 C: 43 ± 10.1 | I: 10/19 C: 10/21 | I: 0/C: 0 | CHM + LM | LM | 3 months | ①②③④⑤⑩ | No AEs occurred. |
Gao and Li [48] | WHO 1999 | Total: 60 I: 30/C: 30 | I: 49.0 ± 5.3 C: 50.2 ± 6.3 | I: 20/10 C: 18/12 | I: 0/C: 0 | CHM + LM | LM | 6 months | ④⑤ | No records. |
Li et al. [49] | ADA 2010 | Total: 100 I: 50/C: 50 | I: 52.70 ± 7.28 C:50.80 ± 7.05 | I: 24/26 C: 13/27 | I: 0/C: 0 | CHM + LM | Metformin + LM | 3 months | ③④⑥⑦⑨ | No AEs occurred. |
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