Table 2. Baseline characteristics of participants (per-protocol analysis).
| YH1 Group (n = 21) |
Placebo Group (n = 20) |
p value | ||
|---|---|---|---|---|
| median (min, max) | median (min, max) | |||
| Demographic characteristics | ||||
| Age (yr) | 50.0 (33.0, 69.0) | 56.0 (40.0, 66.0) | .44 | |
| Sex, male / female | 13 / 8 | 8 / 12 | .22 | |
| Diabetes duration (yr) | 10.0 (1.0, 23.0) | 11.5 (4.0, 20.0) | .24 | |
| Number of OHAs | .60 | |||
| Three | 14 | 16 | ||
| Four | 6 | 4 | ||
| Five | 1 | 0 | ||
| Anthropometric characteristics | ||||
| Weight (kg) | 73.5 (59.6, 107.0) | 72.2 (60.9, 88.1) | .67 | |
| Body mass index (kg/m2) | 26.1 (23.4, 35.4) | 28.0 (23.0, 36.0) | .48 | |
| Waist circumference (cm) | 90.5 (80.5, 110.5) | 93.0 (81.0, 105.0) | .19 | |
| Blood pressure and heart rate | ||||
| Systolic BP (mmHg) | 131.0 (107.0, 157.0) | 123.5 (110.0, 153.0) | .16 | |
| Diastolic BP (mmHg) | 76.0 (64.0, 92.0) | 73.5 (65.0, 93.0) | .73 | |
| Heart rate (beat/min) | 82.0 (63.0, 104.0) | 82.0 (65.0, 117.0) | .78 | |
| Antihypertensive drug, no. (%) | 10 (47.6) | 8 (40.0) | .76 | |
| Laboratory data | ||||
| HbA1c (%) | 8.1 (7.5, 11.3) | 8.7 (7.6, 11.8) | .19 | |
| FPG (mg/dL) | 159.0 (85.0, 243.0) | 159.0 (105.0, 283.0) | .77 | |
| 2hPG (mg/dL) | 220.2 (117.0, 371.0) | 216.5 (120.0, 357.0) | .95 | |
| Fasting insulin (μU/mL) | 8.0 (2.9, 15.7) | 6.9 (2.9, 11.9) | .25 | |
| HOMA-IR | 3.3 (0.8, 6.1) | 3.1 (0.8, 5.5) | .51 | |
| HOMA-β | 31.7 (8.0, 152.8) | 25.6 (10.3, 48.7) | .27 | |
| ALT (U/L) | 24.0 (8.0, 68.0) | 25.0 (8.0, 53.0) | .38 | |
| Creatinine (mg/dL) | 0.7 (0.4, 1.1) | 0.6 (0.4, 1.0) | .55 | |
| Total cholesterol (mg/dL) | 176.0 (139.0, 232.0) | 187.0 (114.0, 254.0) | .41 | |
| HDL-C (mg/dL) | 43.0 (31.0, 66.0) | 42.5 (28.0, 61.0) | .44 | |
| LDL-C (mg/dL) | 103.0 (58.0, 164.0) | 117.0 (60.0, 192.0) | .25 | |
| Triglyceride (mg/dL) | 151.0 (75.0, 446.0) | 161.0 (53.0, 596.0) | .99 | |
| Hypolipidemic drug, no. (%) | 10 (47.6) | 8 (40.0) | .76 | |
| Score of TCM symptoms of diabetes |
5.0 (1.0, 14.0) | 6.0 (2.0, 13.0) | .43 | |
Statistics were evaluated by using the Mann–Whitney U test for continuous variables and Fisher’s exact test for categorical variables. No significant differences were observed between the two groups at baseline. Because of the small sample sizes, the data are presented as the median (min, max). OHAs, oral hypoglycemic agents; BP, blood pressure; HbA1c, glycated hemoglobin; FPG, fasting plasma glucose; 2hPG, 2-hour postprandial glucose; HOMA-IR, homeostatic model assessment of insulin resistance; HOMA-β, homeostatic model assessment of β cell function; ALT, alanine aminotransferase; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; TCM, traditional Chinese medicine.