Introduction
Methods
Search Strategy
Selection Criteria
Outcome Measures
Data Extraction and Quality Assessment
Assessment of Evidence Quality
Data Synthesis
Results
First author year | Sample size (randomized/dropouts); Sex: M/F | Age (years) | BMI (kg/m2) | Diagnostic criteria | Intervention | Intervention period (months) | Follow-up duration (months) | Outcome measure | |
---|---|---|---|---|---|---|---|---|---|
Treatment group (T) | Control group (C) | ||||||||
Lian 2014 [18] | 420/31 T: 210 (98/112) C: 210 (106/104) | T: 52.95 ± 10.06 C: 51.86 ± 10.16 | T: 25.15 ± 3.07 C: 25.50 ± 2.66 | WHO 1999 | Tianqi capsule (5 capsules, po, tid) + LM | Placebo (5 capsules, po, tid) + LM | 12 | 12 | A–D, G |
Sun 2011 [19] | 216/2 T: 110 (64/46) C: 106 (59/47) | T: 51.0 ± 9.3 C: 51.4 ± 9.5 | T: 24.8 ± 3.0 C: 23.9 ± 3.0 | WHO 1999 | Tianqi capsule (5 capsules, po, tid) + LM | Placebo (5 capsules, po, tid) + LM | 12 | 12 | A–C, E–G |
Wang 2011 [20] | 168/9 T: 94 (40/54) C: 74 (34/40) | T: 51.46 ± 8.77 C: 51.73 ± 9.35 | T: 25.33 ± 2.65 C: 25.02 ± 2.45 | WHO 1999 | Tianqi capsule (5 capsules, po, tid) + LM | Placebo (5 capsules, po, tid) + LM | 12 | 12 | A–G |
Hong 2013 [21] | 60/0 T: 29 (10/19) C: 31 (10/21) | T: 44 ± 9.3 C: 43 ± 10.1 | – | WHO 1999 | Tianqi capsule (5 capsules, po, tid) + LM | LM | 24 | 24 | A–C, E–F, H |
Wei 2009 [22] | 60/0 T: 30 (15/15) C: 30 (14/16) | T: 51.7 ± 5.69 C: 52.6 ± 6.10 | T: 25.9 ± 1.23 C: 25.8 ± 1.25 | WHO 1999 | Tianqi capsule (5 capsules, po, tid) + LM | Placebo (5 capsules, po, tid) + LM | 6 | 6 | A–G |
Wang 2010 [23] | 103/0 T: 53 (28/25) C: 50 (20/30) | T: 44/(29–69) C: 43/(29–72) | T: 26.75 ± 7.93 C: 25.77 ± 3.30 | WHO 1999 | Tianqi capsule (5 capsules, po, tid) + LM | Placebo (5 capsules, po, tid) + LM | 12 | 12 | A–C, E, F |
Study Characteristics
Methodological Quality Assessment
Primary Outcomes
Incidence of Diabetes
Regression Towards Normoglycemia
Secondary Outcomes
IGT Stabilized Incidence
Fasting Blood Glucose and Two-Hour Postprandial Blood Glucose
Body Mass Index
Adverse Events
Total events/total number | Risk ratio (95% CI) | ||
---|---|---|---|
Tianqi capsule + LM | Placebo + LM | ||
Gastrointestinal reactions | 7/240 | 9/240 | 0.78 (0.29, 2.05) |
Rash | 1/210 | 0/210 | 3.00 (0.12, 73.22) |
Weakness | 1/210 | 0/210 | 3.00 (0.12, 73.22) |
Weight loss | 1/210 | 0/210 | 3.00 (0.12, 73.22) |
Frequently urination | 1/210 | 0/210 | 3.00 (0.12, 73.22) |
Tinnitus | 1/210 | 0/210 | 3.00 (0.12, 73.22) |
Genital swelling | 0/210 | 1/210 | 0.33 (0.01, 8.14) |
Elevated blood white blood cell | 1/210 | 0/210 | 3.00 (0.12, 73.22) |
Decreased hemoglobin | 1/210 | 0/210 | 3.00 (0.12, 73.22) |
Elevated urine white blood cell | 2/210 | 0/210 | 5.00 (0.24, 103.52) |
Elevated urine protein | 0/210 | 1/210 | 0.33 (0.01, 8.14) |
Total events | 16 | 11 | |
Incidence of any adverse event | – | – | Pooled rate ratio: 1.31 (0.69, 2.50) |
Sensitivity Analysis
Subgroup Analysis
Group | No. of studies | No. of participants | RR | 95% CI |
Z
|
P (effect) |
I
2
| χ2
|
P (het) | |
---|---|---|---|---|---|---|---|---|---|---|
Treatment duration | ≥ 12 months | 5 | 967 | 0.56 | [0.45, 0.69] | 5.23 | < 0.00001 | 0% | 1.62 | 0.81 |
< 12 months | 1 | 60 | 0.25 | [0.03, 2.11] | 1.27 | 0.20 | – | – | – | |
Sample size | ≥ 100 | 4 | 907 | 0.57 | [0.45, 0.71] | 4.85 | < 0.00001 | 0% | 1.37 | 0.71 |
< 100 | 2 | 120 | 0.42 | [0.21, 0.85] | 2.42 | 0.02 | 0% | 0.31 | 0.58 | |
Use of placebo | Used | 5 | 967 | 0.56 | [0.44, 0.70] | 5.00 | < 0.00001 | 0% | 1.94 | 0.75 |
Not used | 1 | 60 | 0.47 | [0.23, 0.97] | 2.04 | 0.04 | – | – | – | |
Publication language | English | 1 | 420 | 0.64 | [0.44, 0.93] | 2.33 | 0.02 | – | – | – |
Chinese | 5 | 607 | 0.50 | [0.39, 0.66] | 4.99 | < 0.00001 | 0% | 1.25 | 0.87 |
Group | No. of studies | No. of participants | RR | 95% CI |
Z
|
P (effect) |
I
2
| χ2
|
P (het) | |
---|---|---|---|---|---|---|---|---|---|---|
Treatment duration | ≥ 12 months | 5 | 967 | 0.71 | [0.63, 0.80] | 5.43 | < 0.00001 | 0% | 1.04 | 0.90 |
< 12 months | 1 | 60 | 0.50 | [0.30, 0.84] | 2.63 | 0.009 | – | – | – | |
Sample size | ≥ 100 | 4 | 907 | 0.71 | [0.62, 0.80] | 5.29 | < 0.00001 | 0% | 1.02 | 0.80 |
< 100 | 2 | 120 | 0.61 | [0.42, 0.86] | 2.77 | 0.006 | 9% | 1.09 | 0.30 | |
Use of placebo | Used | 5 | 967 | 0.69 | [0.61, 0.78] | 5.80 | < 0.00001 | 0% | 2.62 | 0.62 |
Not used | 1 | 60 | 0.73 | [0.45, 1.20] | 1.25 | 0.21 | – | – | – | |
Publication language | English | 1 | 420 | 0.70 | [0.57, 0.86] | 3.45 | 0.0006 | – | – | – |
Chinese | 5 | 607 | 0.69 | [0.59, 0.80] | 4.85 | < 0.00001 | 0% | 2.65 | 0.62 |