Table 1.
Biochemical indicators of patients (blood lipids, liver function and blood sugar), B-ultrasound, TCM symptom and signs score before treatment (baseline) and after 16 weeks of treatment
| Ros | Sil | DSSG |
P-value among three groups |
DSSG + Sil |
P-value (Sil vs DSSG + Sil) |
P-value (DSSG vs DSSG + Sil) |
||
|---|---|---|---|---|---|---|---|---|
| Number | 30 | 50 | 130 | 50 | ||||
| TC (mmol/L) | Pre- treatment | 6.55 ± 0.19 | 6.56 ± 0.28 | 6.46 ± 0.55 | 0.340 | 6.50 ± 0.46 | > 0.05 | > 0.05 |
| Post treatment | 5.85 ± 0.15 | 6.41 ± 0.23 | 4.97 ± 0.33 | 6.02 ± 0.28 | ||||
| Δ | -0.69 ± 0.29 | -0.15 ± 0.29 | -1.56 ± 0.95 | < 0.05 | -0.48 ± 0.41 | > 0.05 | < 0.05 | |
| TG (mmol/L) | Pre- treatment | 2.83 ± 0.13 | 2.80 ± 0.59 | 2.72 ± 0.90 | 0.695 | 3.03 ± 0.71 | > 0.05 | > 0.05 |
| Post treatment | 2.26 ± 0.09 | 2.32 ± 0.51 | 1.80 ± 0.24 | 2.30 ± 0.41 | ||||
| Δ | -0.57 ± 0.60 | -0.48 ± 0.67 | -0.99 ± 1.09 | < 0.05 | -0.73 ± 0.68 | > 0.05 | > 0.05 | |
| ALT (U/L) | Pre- treatment | 76.84 ± 3.51 | 75.41 ± 6.99 | 74.98 ± 16.39 | 0.792 | 76.47 ± 8.60 | > 0.05 | > 0.05 |
| Post treatment | 71.18 ± 4.12 | 38.96 ± 4.51 | 44.01 ± 6.06 | 36.94 ± 4.01 | ||||
| Δ | -5.66 ± 13.37 | -36.45 ± 5.80 | -32.78 ± 25.42 | < 0.05 | -39.53 ± 8.34 | > 0.05 | > 0.05 | |
| AST (U/L) | Pre- treatment | 72.42 ± 2.69 | 74.21 ± 8.27 | 73.08 ± 16.16 | 0.822 | 76.99 ± 12.02 | > 0.05 | > 0.05 |
| Post treatment | 62.41 ± 2.32 | 54.20 ± 7.73 | 42.24 ± 4.96 | 53.26 ± 8.23 | ||||
| Δ | -10.01 ± 17.60 | -20.01 ± 8.84 | -32.02 ± 19.73 | < 0.05 | -23.73 ± 8.31 | > 0.05 | < 0.05 | |
| GGT (U/L) | Pre- treatment | 71.02 ± 3.28 | 74.99 ± 9.08 | 76.40 ± 10.64 | < 0.05 | 76.43 ± 9.95 | > 0.05 | > 0.05 |
| Post treatment | 47.20 ± 2.54 | 64.26 ± 7.68 | 47.58 ± 6.21 | 60.09 ± 6.30 | ||||
| Δ | -23.82 ± 13.97 | -10.72 ± 10.79 | -31.72 ± 18.89 | < 0.05 | -16.34 ± 8.31 | > 0.05 | > 0.05 | |
| FPG (mmol/L) | Pre- treatment | 6.09 ± 0.14 | 6.03 ± 0.29 | 5.89 ± 0.72 | 0.139 | 6.02 ± 0.36 | > 0.05 | > 0.05 |
| Post treatment | 4.26 ± 0.08 | 5.76 ± 0.29 | 5.52 ± 0.58 | 5.63 ± 0.31 | ||||
| Δ | -1.83 ± 1.19 | -0.27 ± 0.28 | -0.36 ± 0.72 | < 0.05 | -0.39 ± 0.36 | > 0.05 | > 0.05 | |
| B-ultrasonography | Cure | 4 (13.0%) | 1 (2.0%) | 40 (31.0%) | < 0.05 | 5 (10.0%) | > 0.05 | < 0.05 |
| Obviously effective | 12 (40.0%) | 4 (8.0%) | 32 (24.5%) | < 0.05 | 11 (22.0%) | < 0.05 | > 0.05 | |
| Effective | 8 (27.0%) | 24 (48.0%) | 47 (36.0%) | 0.139 | 23 (46.0%) | > 0.05 | > 0.05 | |
| Non-effective | 6 (20.0%) | 21 (42.0%) | 11 (8.5%) | < 0.05 | 11 (22.0%) | < 0.05 | < 0.05 | |
| Effective rate | 24 (80.0%) | 29 (58.0%) | 119 (91.5%) | < 0.05 | 39 (78.0%) | < 0.05 | < 0.05 | |
| TCM symptom and signs score | Pre- treatment | 14.00 ± 0.51 | 13.92 ± 2.39 | 13.72 ± 1.10 | 0.529 | 14.76 ± 2.60 | > 0.05 | < 0.05 |
| Post treatment | 3.00 ± 0.31 | 9.10 ± 1.95 | 2.41 ± 0.43 | < 0.05 | 5.04 ± 2.27 | < 0.05 | < 0.05 | |
| Δ | -11.00 ± 0.20 | -4.82 ± 0.44 | -11.31 ± 0.67 | < 0.05 | -9.72 ± 0.33 | < 0.05 | < 0.05 |
Note: If the measured data were normally distributed, the mean ± standard deviation (SD) was used. Single factor variance analysis was used to make pairwise comparison among multiple groups. The test level was α = 0.05 and a P-value < 0.05 was considered to be statistically significant. Δ, value change before and after the rosiglitazone, Silibinin and DSSG treatments for the TCM symptoms and sign scores to compare the TCM syndrome. Group Ros: Rosiglitazone hydrochloride, 4 mg/time, once a day. Group Sil: Silibinin capsules, orally, 3 × 35 mg containing capsules, 3 times a day. Group DSSG: Patients received DSSG, 12 g/packages, each containing the above dose proportions; 2 packages/time, were administered 3 times a day. Group DSSG + Sil: DSSG (orally, 2 packages, 3 times a day) + Silibinin capsules (orally, 3 tablets, 3 times a day)
ALT alanine aminotransferase, AST aspartate amino transferase, DSSG Danshao Shugan Granules, FPG Fasting plasma glucose, GGT γ-glutamyl transpeptidase, TC total cholesterol, TCM traditional Chinese medicine, TG triacylglycerol