Table 2

Changes in clinical neuropathy scores and nerve function tests from baseline to 2 and 4 years

2 Years4 Years
ALAPlaceboALAPlacebo
n214207215207
Composite score
 NIS-LL+7 (nds)−0.40 ± 4.920.19 ± 4.74−0.37 ± 5.59*0.29 ± 5.37
NIS and subscores
 NIS−0.54 ± 6.620.12 ± 6.13−0.68 ± 6.440.61 ± 6.61
 NIS pinprick−0.06 ± 1.48−0.05 ± 1.44−0.07 ± 1.600.05 ± 1.43
 NIS-LL−0.38 ± 4.520.03 ± 4.22−0.34 ± 4.48§0.43 ± 4.49
 NIS-LL sensory function−0.34 ± 3.02−0.09 ± 2.92−0.12 ± 3.010.10 ± 2.89
 NIS-LL muscular weakness−0.15 ± 1.660.05 ± 1.85−0.21 ± 1.570.17 ± 2.12
 NIS-LL reflexes0.10 ± 1.630.07 ± 1.570.03 ± 1.750.16 ± 1.80
 NIS responders37.935.241.130.0
 NIS unchanged35.632.429.731.9
 NIS progressors26.532.429.238.1
 NIS-LL responders34.734.835.629.0
 NIS-LL unchanged42.035.240.236.2
 NIS-LL progressors23.330.024.234.8
Nerve function tests
 Peroneal MNCV (m/s)0.04 ± 3.890.18 ± 3.99−0.35 ± 4.23−0.06 ± 4.07
 Sural SNAP (µV)−0.00 ± 2.17−0.07 ± 1.96−0.20 ± 2.34−0.15 ± 2.43
 Foot VPT (JND)0.47 ± 2.120.58 ± 2.110.87 ± 2.350.76 ± 2.38
 Cold detection threshold (JND)0.65 ± 3.560.87 ± 3.331.12 ± 3.961.28 ± 3.43
 Heart rate deep breathing (bpm)−0.68 ± 3.39−1.06 ± 3.23−0.67 ± 4.44−1.35 ± 3.72
Neuropathic symptoms
 NSC weakness (number)−0.02 ± 0.300.04 ± 0.42−0.04 ± 0.260.04 ± 0.42
 NSC weakness (severity)−0.03 ± 0.400.03 ± 0.48−0.05 ± 0.390.04 ± 0.50
 TSS−0.27 ± 2.46−0.04 ± 2.16−0.22 ± 2.42−0.21 ± 2.45
  • Data are means ± SD or %. All P values calculated vs. placebo, with two-way ANOVA for NIS-LL+7 and Wilcoxon Mann-Whitney tests otherwise. JND, just noticeable difference; SNAP, sensory nerve action potential; VPT, vibration perception threshold.

  • *P = 0.105.

  • P < 0.05.

  • P = 0.074.

  • §P = 0.0505.

  • P = 0.087.