Research Article

Efficiency and Safety of Chinese Herbal Medicine in the Treatment of Prediabetes: A Systemic Review and Meta-Analysis of Randomized Controlled Trials

Table 1

Characteristics of the included 22 studies.

Study IDDiagnosis criteriaSample sizeAge (mean ± SD)Sex (male/female)LossExperiment groupControl groupDurationOutcome measuresAdverse effect

Fang et al. [18]WHO 1999Total: 514
I: 257/C: 257
I: 54.95 ± 9.50;
C: 54.61 ± 10.51
I: 136/121
C: 142/115
I: 34/C: 41CHM + LMLM12 months①②③④⑤⑥⑦⑧⑨AEs 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 1999Total: 510
I: 255/C: 255
I: 49.3 ± 1.2;
C: 51.12 ± 1.3
I: 110/145
C: 112/143
I: 25/C: 27CHM + LMLM3 years②③④⑤⑥⑦⑧⑨4 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 1999Total: 127
I: 64/C: 63
I: 52.02 ± 8.60;
C: 51.05 ± 9.25
I: 31/29
C: 35/25
I: 4/C: 3CHM + LMLM12 weeks①②③④⑤⑥⑦⑧⑨No AEs occurred.
Karimi-Nazari et al. [32]ADATotal: 80
I: 40/C: 40
I: 57.95 ± 8.12
C: 57.9 ± 8.7
I: 13/23
C: 14/25
I: 4/C: 1CHMPlacebo8 weeks③④⑥⑦⑧No AEs occurred.
Ke et al. [33]WHO 1999Total: 85
I: 45/C: 40
I: 46.5 ± 7.3
C: 45.7 ± 7.5
I: 23/22
C: 20/20
I: 2/C: 2CHM + LMLM6 months②③④⑤⑥⑦⑧⑨5 patients in the treated group felt fatigue, hunger, and dizziness, which were recovered after giving normal diets.
Lian et al. [34]WHO 1999Total: 420
I: 210/C: 210
I: 52.95 ± 10.06
C: 51.86 ± 10.16
I: 98/112
C: 106/104
I: 10/C: 18CHMPlacebo12 months①②③15 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]ADATotal:34
I:17/C:17
I: 49.6 ± 1.5
C: 55.1 ± 2.0
I: 13/4
C: 13/4
I: 0/C: 0CHMPlacebo8 weeks③④⑤No AEs occurred.
Shi et al. [36]WHO 2003Total: 65
I: 34/C: 31
I: 47.1 ± 7.1
C: 49.9 ± 7.2
I: 17/17;
C: 14/17
I:2/C:2CHM + LMLM12 weeks①②③④⑤⑥⑨1 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 2008Total: 362
I: 182/C: 180
I: 55.49 ± 8.61
C: 53.49 ± 8.85
I: 90/92
C: 82/98
I: 12/C: 16CHM + LMPlacebo + LM12 months①②③AEs 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 1999Total: 140
I: 70/C: 70
I: 51.3 ± 8.8
C: 50.7 ± 8.1
I: 31/39
C: 32/38
I: 6/C: 2CHMNo treatment6 months①②③④⑤⑥⑦⑧⑨No AEs occurred.
He [39]WHO 1999Total: 253
I: 126/C: 127
I: 29–70
C: 25–75
I: 64/62
C: 66/61
I: 0/C: 0CHM + LMLM3 months①②③④⑤⑨No AEs occurred.
Liu et al. [41]WHO 2008Total: 150
I: 75/C: 75
No statistically significant differenceNo statistically significant differenceI: 3/C: 6CHM + LMPlacebo + LM12 months①②③④⑦⑧No AEs occurred.
Zhuo et al. [40]WHO 1999Total: 136
I: 66/C: 70
I: 57.4 ± 10.2
C: 56.7 ± 10.9
I: 30/36
C: 34/36
I: 0/C: 0CHM + LMLM12 weeks②③④⑤⑥⑦⑧⑨No AEs occurred.
An et al. [42]ADA 2008Total: 216
I: 108/C: 108
I: 41.8 ± 7.7
C: 39.6 ± 7.5
I: 70/38
C: 72/36
I: 13/C: 11CHM + LMLM12 months①②③④⑤⑥In 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]GPTDCTotal: 64
I: 31/C: 33
I: 55.7 ± 12.8
C: 56.93 ± 10.34
I: 5/21
C: 6/22
I: 5/C: 5CHM + LMLM12 months①②③④⑤⑥⑦⑧⑨No AEs occurred.
Fan et al. [43]WHO 1999Total: 51
I: 25/C: 26
I: 54.60 ± 9.09;
C: 57.45 ± 8.76
I: 10/13
C: 11/11
I: 2/C: 4CHM + LMLM6 months①②④⑤⑥⑦⑧⑨No records.
Ge et al. [44]ADA 2009Total: 234
I: 117/C: 117
60.7 ± 8.1141/93I: 10/C: 17CHM + LMLM12 months①②③④⑤⑥⑦⑧8 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 1999Total: 122
I: 63/C: 59
I: 52.87 ± 10. 57
C:52.97 ± 10. 94
I: 27/36
C: 32/27
I: /C:CHM + LMplacebo + LM12 months①③④⑤⑦⑧No AEs occurred.
Wang and Xu [46]GPTDCTotal: 140
I: 70/C: 70
I: 43.7 ± 5.8
C: 42.9 ± 6.1
I: 27/36
C: 32/27
I: 1/C: 2CHM + LMMetformin + LM3 months①②③④⑥⑦⑧⑨⑩1 patient in the CHM group withdrew due to nausea and bloating.
Hong et al. [47]WHO 1999Total: 60
I: 29/C: 31
I: 44 ± 9.3
C: 43 ± 10.1
I: 10/19
C: 10/21
I: 0/C: 0CHM + LMLM3 months①②③④⑤⑩No AEs occurred.
Gao and Li [48]WHO 1999Total: 60
I: 30/C: 30
I: 49.0 ± 5.3
C: 50.2 ± 6.3
I: 20/10
C: 18/12
I: 0/C: 0CHM + LMLM6 months④⑤No records.
Li et al. [49]ADA 2010Total: 100
I: 50/C: 50
I: 52.70 ± 7.28
C:50.80 ± 7.05
I: 24/26
C: 13/27
I: 0/C: 0CHM + LMMetformin + LM3 months③④⑥⑦⑨No AEs occurred.

① Incidence of type 2 diabetes mellitus; ② incidence of the normalization of blood glucose; ③ AEs; ④ FPG; ⑤ 2hPG; ⑥ HbA1c; ⑦ TG; ⑧ TC; ⑨ BMI.