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Table 2

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


2 Years
4 Years
ALA
Placebo
ALA
Placebo
n 214 207 215 207 
Composite score     
 NIS-LL+7 (nds) −0.40 ± 4.92 0.19 ± 4.74 −0.37 ± 5.59* 0.29 ± 5.37 
NIS and subscores     
 NIS −0.54 ± 6.62 0.12 ± 6.13 −0.68 ± 6.44 0.61 ± 6.61 
 NIS pinprick −0.06 ± 1.48 −0.05 ± 1.44 −0.07 ± 1.60 0.05 ± 1.43 
 NIS-LL −0.38 ± 4.52 0.03 ± 4.22 −0.34 ± 4.48§ 0.43 ± 4.49 
 NIS-LL sensory function −0.34 ± 3.02 −0.09 ± 2.92 −0.12 ± 3.01 0.10 ± 2.89 
 NIS-LL muscular weakness −0.15 ± 1.66 0.05 ± 1.85 −0.21 ± 1.57 0.17 ± 2.12 
 NIS-LL reflexes 0.10 ± 1.63 0.07 ± 1.57 0.03 ± 1.75 0.16 ± 1.80 
 NIS responders 37.9 35.2 41.1 30.0 
 NIS unchanged 35.6 32.4 29.7 31.9 
 NIS progressors 26.5 32.4 29.2 38.1 
 NIS-LL responders 34.7 34.8 35.6 29.0 
 NIS-LL unchanged 42.0 35.2 40.2 36.2 
 NIS-LL progressors 23.3 30.0 24.2 34.8 
Nerve function tests     
 Peroneal MNCV (m/s) 0.04 ± 3.89 0.18 ± 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 ± 2.12 0.58 ± 2.11 0.87 ± 2.35 0.76 ± 2.38 
 Cold detection threshold (JND) 0.65 ± 3.56 0.87 ± 3.33 1.12 ± 3.96 1.28 ± 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 ± 0.30 0.04 ± 0.42 −0.04 ± 0.26 0.04 ± 0.42 
 NSC weakness (severity) −0.03 ± 0.40 0.03 ± 0.48 −0.05 ± 0.39 0.04 ± 0.50 
 TSS −0.27 ± 2.46 −0.04 ± 2.16 −0.22 ± 2.42 −0.21 ± 2.45 

2 Years
4 Years
ALA
Placebo
ALA
Placebo
n 214 207 215 207 
Composite score     
 NIS-LL+7 (nds) −0.40 ± 4.92 0.19 ± 4.74 −0.37 ± 5.59* 0.29 ± 5.37 
NIS and subscores     
 NIS −0.54 ± 6.62 0.12 ± 6.13 −0.68 ± 6.44 0.61 ± 6.61 
 NIS pinprick −0.06 ± 1.48 −0.05 ± 1.44 −0.07 ± 1.60 0.05 ± 1.43 
 NIS-LL −0.38 ± 4.52 0.03 ± 4.22 −0.34 ± 4.48§ 0.43 ± 4.49 
 NIS-LL sensory function −0.34 ± 3.02 −0.09 ± 2.92 −0.12 ± 3.01 0.10 ± 2.89 
 NIS-LL muscular weakness −0.15 ± 1.66 0.05 ± 1.85 −0.21 ± 1.57 0.17 ± 2.12 
 NIS-LL reflexes 0.10 ± 1.63 0.07 ± 1.57 0.03 ± 1.75 0.16 ± 1.80 
 NIS responders 37.9 35.2 41.1 30.0 
 NIS unchanged 35.6 32.4 29.7 31.9 
 NIS progressors 26.5 32.4 29.2 38.1 
 NIS-LL responders 34.7 34.8 35.6 29.0 
 NIS-LL unchanged 42.0 35.2 40.2 36.2 
 NIS-LL progressors 23.3 30.0 24.2 34.8 
Nerve function tests     
 Peroneal MNCV (m/s) 0.04 ± 3.89 0.18 ± 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 ± 2.12 0.58 ± 2.11 0.87 ± 2.35 0.76 ± 2.38 
 Cold detection threshold (JND) 0.65 ± 3.56 0.87 ± 3.33 1.12 ± 3.96 1.28 ± 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 ± 0.30 0.04 ± 0.42 −0.04 ± 0.26 0.04 ± 0.42 
 NSC weakness (severity) −0.03 ± 0.40 0.03 ± 0.48 −0.05 ± 0.39 0.04 ± 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.

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