Participants
A total number of 182 patients who participated in this study were divided into four groups: G1 (n = 63 or 34.61%), G2 (n = 32 or 17.58%), G3 (n = 58 or 31.86%), and G4 (n = 29 or 15.93%). Laboratory data showed that the patients had a high level of total cholesterol, triglyceride, and LDL-c in Table 1.
Table 1
Demographic and clinical characteristics of participants
Laboratory | G1 N = 63 (34.61%) | G2 N = 32 (17.58%) | G3 N = 58 (31.86%) | G4 N = 29 (15.93%) | p-value |
Gender | | | | | |
Male (N = 81, 44.50%) | 33 (52.38%) | 11 (34.37%) | 24 (41.37%) | 13 (44.82%) | - |
Female (N = 101, 55.49%) | 30 (47.61%) | 21 (65.62%) | 34 (58.62%) | 16 (55.17%) | - |
Age, mean ± SD | 76.87 ± 8.87 | 76.5 ± 8.96 | 74.13 ± 8.29 | 77.13 ± 9.96 | - |
Smoking (N = 30, 16.48%) | 9 (0.01%) | 2 (6.25%) | 16 (27.58%) | 3 (10.34%) | - |
Alcohol (N = 34, 18.68%) | 11 (17.46%) | 2 (6.25%) | 16 (27.58%) | 5 (17.24%) | - |
Underlying disease (N = 109, 59.89%) | 35 (55.55%) | 8 (25%) | 43 (74%) | 23 (79.31%) | - |
Lipid profile (mean ± SE) | | | | | |
total cholesterol < 200 mg/dL | 163.58 ± 6.03 | 196.60 ± 8.37 | 178.64 ± 6.84 | 172.44 ± 7.04 | 0.50 |
Triglyceride < 150 mg/dL | 115.77 ± 8.63 | 124.53 ± 10.11 | 114.08 ± 7.18 | 139.51 ± 17.22 | 0.18 |
HDL-C F > 40 mg/dL M > 50 mg/dL | 55.41 ± 2.08 | 58.35 ± 3.21 | 56.77 ± 2.00 | 50.59 ± 2.93 | 0.98 |
LDL-C < 100 mg/dL | 89.01 ± 4.56 | 115.39 ± 6.94 | 100.98 ± 5.57 | 96.25 ± 5.25 | 0.36 |
LDL-C/HDL-C ratio < 3.5 | 1.74 ± .11 | 2.09 ± .14 | 1.95 ± 0.14 | 2.02 ± 0.13 | 0.09 |
Blood sugar | | | | | |
FBS 70–100 mg/dL High value 100–125 mg/dL Abnormal value > = 126 mg/dL | 111.27 ± 4.62 | 113.19 ± 8.16 | 111.14 ± 3.21 | 113.24 ± 5.47 | 0.67 |
HbA1c 4.8-6.0% High value > 6.5% | 7.76 ± 1.61 | 5.86 ± 0.15 | 6.15 ± 0.11 | 6.14 ± 0.25 | 0.16 |
Liver function levels | | | | | |
SGOT 0–35 IU/L | 25.74 ± 0.94 | 26.16 ± 2.04 | 29.000 ± 1.44 | 29.80 ± 2.03 | 0.26 |
SGPT 0–48 IU/L | 32.30 ± 1.48 | 33.66 ± 3.90 | 33.50 ± 2.47 | 31.49 ± 6.42 | 0.11 |
Renal function levels | | | | | |
BUN 10–20 mg/dL | 15.77 ± 0.92 | 14.71 ± 0.96 | 14.34 ± 0.63 | 17.02 ± 1.41 | 0.35 |
Creatinine 0.6–1.2 mg/dL | 1.04 ± 0.03 | 0.94 ± 0.06 | 1.02 ± 0.04 | 1.15 ± 0.07 | 0.82 |
GFR 125 ml./s | 68.87 ± 2.64 | 72.02 ± 3.70 | 70.43 ± 2.82 | 58.48 ± 3.96 | 0.90 |
CBC | | | | | |
WBC 4–11 x 103 cell/mm3 | 6.91 ± 0.25 | 6.49 ± 0.46 | 8.03 ± 1.20 | 6.90 ± 0.49 | 0.67 |
RBC 4.5-6.0 x 106 cell/mm3 | 4.32 ± 0.07 | 4.13 ± 0.10 | 4.37 ± 0.07 | 4.38 ± 0.14 | 0.43 |
Hct male 40–54 mg/dL female 37–47 mg/dL | 37.30 ± 0.61 | 35.40 ± 0.82 | 37.78 ± 0.46 | 37.45 ± 0.96 | 0.30 |
N/LP ratio < 4.86 | 1.23 ± 0.12 | 1.54 ± 0.32 | 1.15 ± 0.06 | 1.32 ± 0.28 | 0.02* |
P value to compare between groups by one-way ANOVA
*P value < 0.05 was considered statistically significant.
When the data at baseline and month six were compared in Table 2, the mean lipid profiles in G1, G2, and G3 decreased. In G1, the total cholesterol, LDL-C, and LDL-C/HDL-C ratio showed that the patients' mean total cholesterol values decreased from 163.93 to 151.68 mg/dL (p-value = 0.00) mean values of LDL-C decreased from 88.88 to 77.34 mg/dL. (p-value = 0.02) and the mean LDL-C/HDL-C ratio decreased from 1.73 to 0.24 (p-value = 0.00). The HDL-C values tended to increase in G1, G2, and G4. The mean SGOT values decreased in G1, G2 (p-value = 0.22,0.29) and the mean values increased in G3, G4 (p-value = 0.32, 0.36). The mean SGPT values in G1, G2, and G4 tended to decrease. In Group 1, the mean SGPT values decreased from 32.50 IU/L to 28.09 IU/L statistically significantly (p-value = 0.00) while G3 had higher mean SGPT values. The mean BUN values decreased in G1, but they increased in G2, G3, and G4. Creatinine values decreased in G1, G3, and G4. In G4, the mean values decreased from 1.15 mg/dL to 1.07 mg/dL statistically significantly (p-value = 0.01) while G2 had higher mean values. The mean values of the N/LP ratio decreased in G2 and G4, while those in G1 and G3 increased. In particular, the mean values of the N/LP ratio in G3 increased from 1.13 to 1.47 statistically significantly (p-value = 0.02).
Table 2
Lipid level and laboratory test compare within-group at Baseline-Month 6
parameters | Mean ± SE | Baseline-Month 6 | p-value |
Baseline | Month 6 | Mean ± SE (95% CI) |
Total cholesterol | | | | |
G1 | 163.93 ± 6.12 | 151.68 ± 4.31 | 12.24 ± 4.60 (3.03, 21.45) | 0.00* |
G2 | 196.60 ± 8.37 | 197.60 ± 8.19 | -1.00 ± 1.74 (-4.57, 2.57) | 0.28 |
G3 | 178.64 ± 6.84 | 171.03 ± 6.42 | 7.61 ± 5.37 (-3.15, 18.38) | 0.08 |
G4 | 172.44 ± 7.04 | 181.14 ± 8.63 | -8.70 ± 6.85 (-22.80, 5.39) | 0.10 |
Triglyceride | | | | |
G1 | 115.77 ± 8.63 | 113.48 ± 9.39 | 2.29 ± 7.31 (-12.33, 16.91) | 0.38 |
G2 | 124.53 ± 10.11 | 121.28 ± 11.36 | 3.25 ± 5.75 (-8.55, 15.05) | 0.28 |
G3 | 114.08 ± 7.18 | 114.35 ± 7.02 | -0.26 ± 4.56 (-9.41, 8.88) | 0.47 |
G4 | 139.51 ± 17.22 | 127.70 ± 17.56 | 11.81 ± 4.82 (1.90, 21.72) | 0.01* |
LDL-C | | | | |
G1 | 88.88 ± 4.57 | 77.34 ± 3.01 | 11.54 ± 3.93 (3.68, 19.40) | 0.00* |
G2 | 115.39 ± 6.94 | 114.53 ± 6.79 | 0.85 ± 1.86 (-2.97, 4.68) | 0.32 |
G3 | 100.98 ± 5.57 | 94.24 ± 5.11 | 6.74 ± 4.62 (-2.51, 15.99) | 0.07 |
G4 | 96.25 ± 5.25 | 100.22 ± 6.20 | -3.96 ± 4.73 (-13.69, 5.76) | 0.20 |
HDL-C | | | | |
G1 | 55.62 ± 2.09 | 56.62 ± 2.43 | -1.00 ± 1.19 (-3.39, 1.39) | 0.20 |
G2 | 58.35 ± 3.21 | 58.78 ± 3.38 | -0.42 ± 1.96 (-4.46, 3.61) | 0.41 |
G3 | 56.77 ± 2.00 | 55.06 ± 1.93 | 1.70 ± 0.87 (-0.03, 3.45) | 0.02* |
G4 | 50.59 ± 2.93 | 52.74 ± 2.78 | -2.14 ± 1.07 (-4.36, 0.06) | 0.02* |
LDL-C/HDL-C ratio | | | | |
G1 | 1.73 ± 0.11 | 1.49 ± 0.08 | 0.24 ± 0.08 (0.07, 0.40) | 0.00* |
G2 | 2.09 ± 0.14 | 2.08 ± 0.14 | 0.01 ± 0.07 (-0.13, 0.17) | 0.41 |
G3 | 1.95 ± 0.14 | 1.85 ± 0.12 | 0.09 ± 0.08 (-0.08, 0.27) | 0.14 |
G4 | 2.02 ± 0.13 | 2.00 ± 0.14 | 0.01 ± 0.11 (-0.21, 0.25) | 0.43 |
SGOT | | | | |
G1 | 25.93 ± 0.94 | 25.36 ± 0.89 | 0.56 ± 0.75 (-0.95, 2.08) | 0.22 |
G2 | 26.16 ± 2.04 | 25.56 ± 1.45 | 0.59 ± 1.08 (-1.62, 2.81) | 0.29 |
G3 | 28.91 ± 1.44 | 29.70 ± 2.02 | -0.79 ± 1.74 (-4.29, 2.71) | 0.32 |
G4 | 25.86 ± 2.69 | 26.63 ± 2.83 | -0.76 ± 2.25 (-5.39, 3.87) | 0.36 |
SGPT | | | | |
G1 | 32.50 ± 1.51 | 28.09 ± 1.58 | 4.41 ± 1.19 (2.02, 6.81) | 0.00* |
G2 | 33.66 ± 3.90 | 29.06 ± 2.79 | 4.59 ± 3.26 (-2.05, 11.24) | 0.08 |
G3 | 33.41 ± 2.47 | 34.08 ± 3.08 | -0.67 ± 2.49 (-5.67, 4.33) | 0.39 |
G4 | 30.29 ± 6.24 | 28.75 ± 3.46 | 1.53 ± 3.99 (-6.65, 9.73) | 0.35 |
Creatinine | | | | |
G1 | 1.04 ± 0.02 | 1.00 ± 0.02 | 0.03 ± 0.01 (0.00, 0.05) | 0.01* |
G2 | 0.94 ± 0.06 | 0.94 ± 0.06 | -0.00 ± 0.03 (-0.07, 0.07) | 0.49 |
G3 | 1.02 ± 0.04 | 1.01 ± 0.04 | 0.01 ± 0.02 (-0.03, 0.06) | 0.28 |
G4 | 1.15 ± 0.07 | 1.07 ± 0.07 | 0.08 ± 0.03 (0.00, 0.15) | 0.01* |
RBC | | | | |
G1 | 4.32 ± 0.07 | 4.32 ± 0.07 | -0.00 ± 0.03 (-0.07, 0.05) | 0.41 |
G2 | 4.13 ± 0.10 | 4.16 ± 0.09 | -0.02 ± 0.04 (-0.11, 0.05) | 0.25 |
G3 | 4.37 ± 0.07 | 4.39 ± 0.07 | -0.01 ± 0.02 (-0.07, 0.04) | 0.28 |
G4 | 4.38 ± 0.14 | 4.27 ± 0.14 | 0.10 ± 0.06 (-0.01, 0.23) | 0.04* |
N/LP ratio | | | | |
G1 | 1.23 ± 0.12 | 1.41 ± 0.12 | -0.18 ± 0.13 (-0.45, 0.08) | 0.09 |
G2 | 1.83 ± 0.41 | 1.66 ± 0.37 | 0.16 ± 0.55 (-0.97, 1.30) | 0.38 |
G3 | 1.13 ± 0.06 | 1.47 ± 0.15 | -0.33 ± 0.17 (-0.67, 0.00) | 0.02* |
G4 | 1.29 ± 0.28 | 1.03 ± 0.11 | 0.26 ± 0.30 (-0.35, 0.88) | 0.19 |
HbA1c | | | | |
G1 | 7.76 ± 1.61 | 7.79 ± 1.61 | -0.03 ± 0.06 (-0.17, 0.10) | 0.30 |
G2 | 5.86 ± 0.15 | 5.74 ± 0.09 | 0.11 ± 0.12 (-0.13, 0.36) | 0.17 |
G3 | 6.15 ± 0.11 | 6.25 ± 0.15 | -0.10 ± 0.07 (-0.25, 0.04) | 0.08 |
G4 | 6.14 ± 0.02 | 5.91 ± 0.16 | 0.22 ± 0.11 (-0.00, 0.45) | 0.02* |
P value was determined by paired t-test. *P value < 0.05 was considered statistically significant.
When the mean laboratory results of the patients at baseline and month 6 in each group were analyzed and compared with G4 without statin and perilla oil in Table 3, it was found that total cholesterol values in G4-G1 were significantly different in month 6 (mean diff = 29.93, P = 0.02). Triglyceride values in G1, G2, G3 were lower than G4 in month 6. The LDL-C values in G4-G1 were significantly different in month 6 (mean diff = 22.75, P = 0.01). The HDL-C values in G1, G2, G3 were higher than G4 in month 6. The LDL-C/HDL-C ratio in G4-G1 was significantly different in month 6 (mean diff = 0.50 ± 0.16, P = 0.02) shown in Table 3.
Table 3
Lipid level and laboratory tests between groups at baseline and Month 6
Parameters | Baseline | Month 6 |
(i-j) | Mean ± SE i | Mean ± SE j | Mean diff ± SE (i-j) | P | Mean ± SE i | Mean ± SE j | Mean diff ± SE (i-j) | P |
Total cholesterol |
G4-G1 | 172.44 ± 7.04 | 163.58 ± 6.03 | 8.86 ± 9.27 | 0.91 | 181.14 ± 8.63 | 151.20 ± 4.27 | 29.93 ± 9.63 | 0.02* |
G4-G2 | 172.44 ± 7.04 | 196.60 ± 8.37 | -24.16 ± 10.94 | 0.17 | 181.14 ± 8.63 | 197.60 ± 8.19 | -16.45 ± 11.90 | 0.66 |
G4-G3 | 172.44 ± 7.04 | 178.64 ± 6.84 | -6.20 ± 9.82 | 0.98 | 181.14 ± 8.63 | 171.03 ± 6.42 | 10.11 ± 10.76 | 0.92 |
Triglyceride |
G4-G1 | 139.51 ± 17.22 | 115.77 ± 8.63 | 23.74 ± 19.26 | 0.76 | 127.70 ± 17.56 | 113.32 ± 9.41 | 14.38 ± 19.93 | 0.97 |
G4-G2 | 139.51 ± 17.22 | 124.53 ± 10.11 | 14.98 ± 19.97 | 0.97 | 127.70 ± 17.56 | 121.28 ± 11.36 | 6.41 ± 20.92 | 1.00 |
G4-G3 | 139.51 ± 17.22 | 114.08 ± 7.18 | 25.43 ± 18.66 | 0.68 | 127.70 ± 17.56 | 114.35 ± 7.02 | 13.35 ± 18.92 | 0.97 |
LDL-C |
G4-G1 | 96.25 ± 5.25 | 89.01 ± 4.56 | 7.24 ± 6.95 | 0.87 | 100.22 ± 6.20 | 77.47 ± 3.00 | 22.75 ± 6.89 | 0.01* |
G4-G2 | 96.25 ± 5.25 | 115.39 ± 6.94 | -19.13 ± 8.71 | 0.17 | 100.22 ± 6.20 | 114.53 ± 6.79 | -14.31 ± 9.20 | 0.54 |
G4-G3 | 96.25 ± 5.25 | 100.98 ± 5.57 | -4.72 ± 7.66 | 0.99 | 100.22 ± 6.20 | 94.24 ± 5.11 | 5.98 ± 8.04 | 0.97 |
HDL-C |
G4-G1 | 50.59 ± 2.93 | 55.41 ± 2.08 | -4.82 ± 3.60 | 0.69 | 52.74 ± 2.78 | 56.41 ± 2.43 | -3.67 ± 3.69 | 0.89 |
G4-G2 | 50.59 ± 2.93 | 58.35 ± 3.21 | -7.76 ± 4.35 | 0.38 | 52.74 ± 2.78 | 58.78 ± 3.38 | -6.04 ± 4.37 | 0.66 |
G4-G3 | 50.59 ± 2.93 | 56.77 ± 2.00 | -6.18 ± 3.55 | 0.41 | 52.74 ± 2.78 | 55.06 ± 1.93 | -2.32 ± 3.39 | 0.98 |
LDL-C/HDL-C ratio |
G4-G1 | 2.02 ± 0.13 | 1.74 ± 0.11 | 0.28 ± 0.17 | 0.50 | 2.00 ± 0.14 | 1.50 ± 0.08 | 0.50 ± 0.16 | 0.02* |
G4-G2 | 2.02 ± 0.13 | 2.09 ± 0.14 | -0.07 ± 0.19 | 0.99 | 2.00 ± 0.14 | 2.08 ± 0.14 | -0.07 ± 0.20 | 0.99 |
G4-G3 | 2.02 ± 0.13 | 1.95 ± 0.14 | 0.07 ± 0.19 | 0.99 | 2.00 ± 0.14 | 1.85 ± 0.12 | 0.14 ± 0.19 | 0.97 |
P value for comparison between groups was determined by one-way ANOVA.
*P value < 0.05 was considered statistically significant.