Table 3.
Details of Secondary Objectives at Baseline and Day 42
| Variables (Mean (SD)) | IP (n=27) | Placebo (n=32) | P-value | ||||
|---|---|---|---|---|---|---|---|
| Day 0 | Day 42 | Change | Day 0 | Day 42 | Change | ||
| Vit B12 | 131.43 (94.80) | 162.48 (88.99) | 37.62 (54.87) | 103.22 (78.50) | 83.80 (54.25) | −14.35 (52.69) | 0.001 |
| Brief Pain Inventory | 6.01 (0.90) | 2.55 (1.34) | −3.46 (1.55) | 5.84 (0.98) | 6.05 (1.05) | 0.21 (0.42) | <0.0001 |
| Moderate Treatment Response, n (%) | – | 25 (92.59%) | – | – | 0 (0.00%) | – | <0.0001 |
| Excellent Treatment Response, n (%) | – | 23 (85.19%) | – | – | 0 (0.00%) | – | <0.0001 |
| NTTS-6 | 10.44 (3.22) | 3.34 (2.17) | −7.22 (2.37) | 10.11 (3.80) | 10.99 (4.05) | 0.81 (0.85) | <0.0001 |
| Insomnia Severity Index | 12.85 (5.50) | 4.48 (2.67) | −8.37 (5.38) | 12.63 (4.04) | 13.84 (4.65) | 1.22 (2.39) | <0.0001 |
| Nerve Conduction Velocity Test (m/s) | |||||||
| Ankle Peroneal Amp (mV) | 5.31 (3.59) | 5.35 (2.52) | 0.17 (2.27) | 5.09 (2.93) | 5.18 (3.06) | 0.33 (1.13) | 0.85 |
| Ankle Tibial Amp (mV) | 9.63 (5.74) | 10.56 (5.63) | 0.67 (1.86) | 9.63 (5.71) | 10.09 (6.31) | 0.20 (2.62) | 0.78 |
| Knee Peroneal Amp (mV) | 4.37 (2.79) | 4.36 (1.72) | 0.07 (1.97) | 4.16 (2.30) | 4.20 (2.55) | 0.29 (1.51) | 0.97 |
| Knee Tibial Amp (mV) | 7.30 (4.61) | 7.66 (4.16) | 0.04 (1.77) | 6.61 (3.91) | 7.41 (4.51) | 0.66 (1.95) | 0.83 |
| Ankle Peroneal NCV (m/s) | 45.94 (5.67) | 45.44 (5.29) | −0.89 (4.28) | 42.70 (4.89) | 43.99 (3.81) | 0.62 (4.74) | 0.26 |
| Ankle Tibial NCV (m/s) | 41.89 (5.34) | 42.79 (3.88) | 0.28 (3.53) | 40.85 (5.66) | 42.65 (5.64) | 1.02 (4.96) | 0.95 |
| Sural NCV (m/s) | 53.81 (8.58) | 55.17 (8.84) | 2.01 (10.09) | 50.68 (6.36) | 53.70 (7.78) | 4.24 (8.11) | 0.50 |
| Blood flow velocity – Femoral artery (cm/sec) | |||||||
| Right common | 95.11 (24.26) | 93.32 (30.23) | −2.10 (29.21) | 94.45 (35.24) | 92.89 (36.92) | −3.29 (30.71) | 0.85 |
| Left common | 90.44 (26.88) | 95.08 (35.20) | 2.99 (27.98) | 90.29 (30.46) | 92.98 (32.10) | 3.41 (21.83) | 0.87 |
| Proximal right superficial | 73.52 (16.69) | 73.72 (17.08) | 0.44 (16.12) | 74.17 (21.59) | 79.06 (21.79) | 2.57 (17.13) | 0.32 |
| Proximal left superficial | 69.91 (18.44) | 74.60 (18.85) | 3.70 (18.25) | 78.22 (22.62) | 78.31 (21.81) | −0.50 (17.40) | 0.51 |
| Mid right superficial | 69.60 (20.34) | 66.42 (17.59) | −0.85 (−1.40) | 71.14 (21.53) | 71.72 (19.39) | 0.33 (18.74) | 0.26 |
| Mid left superficial | 64.98 (16.13) | 66.41 (21.38) | 2.70 (18.12) | 69.89 (20.86) | 65.98 (20.46) | −4.59 (12.05) | 0.85 |
| Distal right superficial | 60.17 (20.21) | 61.38 (16.61) | 1.84 (15.45) | 65.94 (25.23) | 68.08 (19.17) | −0.34 (21.75) | 0.18 |
| Distal left superficial | 56.50 (16.34) | 53.52 (13.76) | −1.84 (17.46) | 62.46 (23.22) | 62.75 (19.60) | −1.36 (19.13) | 0.06 |
Notes: p-value was calculated using two sample t-test (T)/Mann Whitney-U test (U).
Abbreviations: SD, Standard deviation; n, Number of participants.