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

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.