Background
Methods
Study design
Participants
Randomization and blinding
Outcome measurements
Specimen collection and laboratory methods
Determination of nitrite concentrations [21]
Determination of MDA concentration
Determination of vitamin E concentration by reverse-phase high-performance liquid chromatography
Determination of total antioxidant capacity by FRAP
Determination of total antioxidant capacity by TEAC assay [25, 26]
Determination of tissue nitrotyrosine concentration [27]
Determination of inflammatory infiltration of synovial tissue
Statistical analysis
Results
Baseline characteristics
Group A | Group B |
p value | |
---|---|---|---|
Number of patients | 35 | 31 | – |
Age, years | 69.20 ± 1.30 | 69.50 ± 1.30 | 0.87 |
Sex | |||
Male/female | 9/26 | 2/29 | – |
Weight, kg | 63.90 ± 1.60 | 60.10 ± 2.00 | 0.13 |
Height, cm | 155.10 ± 1.30 | 154.80 ± 1.20 | 0.90 |
Body mass index, kg/m2
| 26.60 ± 0.60 | 25.00 ± 0.40 | 0.09 |
Kellgren–Lawrence grading | |||
Grade 3 | 10 | 9 | – |
Grade 4 | 25 | 22 | – |
Group A (placebo) | Group B (vitamin E) |
p value | |
---|---|---|---|
Pain (50 points) | |||
Pre-intervention | 25.20 ± 1.19 | 23.77 ± 1.69 | 0.49 |
Post-intervention | 27.26 ± 0.89 | 19.19 ± 1.43 | <0.01a
|
∆ (post −pre) | 2.06 ± 0.88 | −4.581 ± 1.11 | <0.01a
|
Stiffness (20 points) | |||
Pre-intervention | 7.80 ± 0.87 | 8.94 ± 1.02 | 0.39 |
Post-intervention | 8.23 ± 0.79 | 5.45 ± 0.73 | 0.01a
|
∆ (post − pre) | 0.43 ± 0.73 | −3.48 ± 0.77 | <0.01a
|
Function (170 points) | |||
Pre-intervention | 90.06 ± 4.72 | 90.55 ± 7.12 | 0.95 |
Post-intervention | 94.77 ± 4.22 | 72.74 ± 6.55 | <0.01a
|
∆ (post − pre) | 4.71 ± 3.81 | −17.81 ± 4.23 | <0.01a
|
Group A (placebo) | Group B (vitamin E) |
p value | |
---|---|---|---|
Clinical | |||
Pre-intervention | 23.20 ± 14.52 | 22.48 ± 16.66 | 0.85 |
Post-intervention | 25.31 ± 14.33 | 33.52 ± 16.96 | <0.01a
|
∆ (post − pre) | 2.11 ± 7.26 | 11.03 ± 8.561 | <0.01a
|
Functional | |||
Pre-intervention | 41.14 ± 16.05 | 41.94 ± 18.20 | 0.85 |
Post-intervention | 41.43 ± 16.11 | 51.61 ± 19.60 | 0.02a
|
∆ (post − pre) | 0.29 ± 1.312 | 9.68 ± 1.99 | <0.01a
|
Oxidative stress, vitamin E, and antioxidant capacity in plasma and synovial fluid
Group A (placebo) | Group B (vitamin E) |
p value | |
---|---|---|---|
Oxidative agents and products | |||
- Nitrite (μM) | |||
Pre-intervention | 5.55 ± 0.57 | 5.60 ± 1.09 | 0.96 |
Post-intervention | 5.63 ± 0.58 | 3.89 ± 1.25 | 0.19 |
∆ (post − pre) | 0.08 ± 0.03 | −1.70 ± 1.2 | 0.12 |
- Malondialdehyde (μM) | |||
Pre-intervention | 1.32 ± 0.11 | 1.43 ± 0.07 | 0.43 |
Post-intervention | 1.34 ± 0.10 | 1.00 ± 0.09 | 0.02a
|
∆ (post − pre) | 0.01 ± 0.02 | −0.79 ± 0.39 | 0.03a
|
Antioxidative agents | |||
- Alpha-tocophorol (μg/ml) | |||
Pre-intervention | 15.50 ± 0.98 | 16.24 ± 0.99 | 0.59 |
Post-intervention | 15.92 ± 1.08 | 24.65 ± 1.47 | <0.01a
|
∆ (post − pre) | 0.43 ± 0.33 | 8.41 ± 1.18 | <0.01a
|
- FRAP (mM) | |||
Pre-intervention | 923.30 ± 29.46 | 905.20 ± 35.16 | 0.69 |
Post-intervention | 951.30 ± 29.03 | 1020 ± 40.22 | 0.17 |
∆ (post − pre) | 28.01 ± 9.11 | 114.4 ± 35.19 | 0.01a
|
- TEAC (mM) | |||
Pre-intervention | 4.26 ± 0.10 | 4.56 ± 0.14 | 0.08 |
Post-intervention | 4.22 ± 0.10 | 5.04 ± 0.10 | <0.01a
|
∆ (post − pre) | −0.04 ± 0.05 | 0.89 ± 0.45 | 0.03a
|
Group A (placebo) | Group B (vitamin E) |
P value | |
---|---|---|---|
Oxidative agents and products | |||
- Nitrite (μM) - Malondialdehyde (μM) | 5.94 ± 1.09 1.42 ± 0.12 | 5.24 ± 0.91 1.06 ± 1.08 | 0.63 0.01a
|
Antioxidative agents | |||
- Alpha-tocopherol (μg/ml) - FRAP (mM) - TEAC (mM) | 4.51 ± 0.31 999.10 ± 39.51 1.89 ± 0.06 | 7.03 ± 0.86 1103 ± 44.77 2.19 ± 0.1 | <0.01a
0.09 0.01a
|
Δ WOMAC | Δ KSS | Δ MDA | Δ TEAC | Δ Vit E | Δ Nitrite | ||
---|---|---|---|---|---|---|---|
Δ WOMAC | C* | 1 | −0.08 | 0.31 | −0.40 | −0.09 | −0.02 |
P** | - | 0.69 | 0.09 | 0.03* | 0.62 | 0.91 | |
Δ KSS | C* | −0.08 | 1 | −0.16 | 0.21 | −0.10 | −0.17 |
P** | 0.69 | - | 0.40 | 0.26 | 0.96 | 0.35 | |
Δ MDA | C* | 0.31 | −0.16 | 1 | −0.38 | −0.22 | −0.03 |
P** | 0.09 | 0.40 | - | 0.04* | 0.24 | 0.89 | |
Δ TEAC | C* | −0.40 | 0.21 | −0.38 | 1 | 0.10 | 0.25 |
P** | 0.03 | 0.26 | 0.04 | - | 0.58 | 0.18 | |
Δ Vit. E | C* | −0.09 | −0.10 | −2.2 | 0.10 | 1 | 0.09 |
P** | 0.62 | 0.96 | 0.24 | 0.58 | - | 0.61 | |
Δ Nitrite | C* | −0.02 | −0.17 | −0.03 | 0.25 | 0.09 | 1 |
P** | 0.91 | 0.35 | 0.89 | 0.18 | 0.61 | - |