Table 4.
Active | Placebo | p c | |||||
---|---|---|---|---|---|---|---|
Baseline | 12Months | p a | Baseline | 12Months | p b | ||
HbA1c (%) | 7.14 ± 1.14 | 6.91 ± 0.79 | 0.120 | 6.84 ± 0.83 | 6.88 ± 0.75 | 0.81 | 0.486 |
HbA1c (mmol/L) | 54.6 ± 12.5 | 51.4 ± 9.1 | 0.120 | 52.12 ± 8.67 | 51.75 ± 8.19 | 0.806 | 0.486 |
B12 (pg/mL) | 262.94 ± 106.6 | 335.42 ± 107.59 | 0.000 | 293.47 ± 125.6 | 305.1 ± 145.2 | 0.57 | 0.018 |
MNSIQ | 6.76 ± 1.66 | 6.16 ± 1.7 | 0.000 | 6.16 ± 2.35 | 6.35 ± 2.26 | 0.06 | <0.001 |
MNSIE | 4.26 ± 3.01 | 4.06 ± 2.49 | 0.161 | 3.75 ± 2.5 | 3.86 ± 2.4 | 0.16 | 0.063 |
QL | 39.83 ± 10.82 | 36.2 ± 9.8 | 0.000 | 38.1 ± 10.5 | 38.8 ± 9.7 | 0.21 | <0.001 |
SNAP (IV) | 5.62 ± 5.79 | 7.55 ± 6.58 | 0.031 | 6.93 ± 6.19 | 6.56 ± 6.27 | 0.70 | 0.065 |
SNCV (m/s) | 30.8 ± 23.5 | 39.4 ± 22.8 | 0.027 | 38 ± 21.67 | 38.9 ± 21.4 | 0.87 | 0.031 |
BIO (V) | 33.7 ± 11.6 | 23.3 ± 11.5 | 0.000 | 29.8 ± 11.9 | 28.5 ± 11.5 | 0.78 | <0.001 |
MCR | 17 ± 19.6 | 16.4 ± 13.9 | 0.630 | 19.3 ± 22.4 | 12.5 ± 19.1 | 0.01 | 0.220 |
PI | 3.2 ± 1.5 | 3.4 ± 1.2 | 0.330 | 2.75 ± 1.1 | 2.9 ± 1.1 | 0.18 | 0.494 |
PO (mm/Hg) | 10.5 ± 8.9 | 8,7 ± 7.3 | 0.001 | 10.3 ± 10.3 | 12.9 ± 9.8 | 0.06 | <0.001 |
Valsalva | 1.50 ± 0.29 | 1.55 ± 0.34 | 0.110 | 1.53 ± 0.24 | 1.49 ± 0.29 | 0.220 | 0.393 |
PAIN | 19.5 ± 7.8 | 17.4 ± 7 | 0.000 | 16.6 ± 8.7 | 17.7 ± 9.4 | 0.00 | <0.001 |
a for difference in active group, b for difference in placebo group, c for difference between groups. Abbreviations: HbA1c (glycated hemoglobin), MNSIQ (Michigan Neuropathy Screening Instrument Questionnaire), MNSIE (Michigan Neuropathy Screening Instrument Examination), QL (Diabetes Quality of Life Questionnaire), SNAP (sural nerve action potential (amplitude) in right foot), SNCV (sural sensory nerve conduction velocity in right foot), BIO (Biothesiometer), MCR (Mean Circular Resultant), PI (Postural Index), Postural hypotension PO (orthostatic hypotension), PAIN(Pain Score Questionnaire).