Table 1.
Clinical trial in patients with peripheral neuropathy
| Author/year | Study type | Neuropathy | Sample Size | Study duration (months) | ALC daily dose (mg) | Outcome Measures | Findings | Class |
|---|---|---|---|---|---|---|---|---|
| Sima et al United Stated, Canadian study (UC), 2005 | RCT | Diabetic peripheral neuropathy | 1257 | 13 | 500 or 1000 | VAS scale, NCS | VAS reduction: −25.53±28.75 mm | II |
| Sima et alUnited Stated, Canadian and European study (UCE), 2005 | VAS reduction: −21.75±34.58 mm | |||||||
| De Grandis et al, 2002 | RCT | Diabetic peripheral neuropathy | 333 | 12 | 2000 | VAS scale, NCS | VAS reduction: −39% compared to baseline NCS improvement: +5.7 m/sec compared to baseline |
II |
| Sheyu et al, 2016 | RCT | Diabetic peripheral neuropathy | 232 | 6 | 500 | NCS and neuropathy symptom score | NCS improvement: 5.03±10.78 m/sec NSS improvement: 4.01±3.25 |
II |
| Youle et al, 2007 | RCT | Antiretroviral toxic neuropathy | 90 | 0.5 | 1000 | VAS scale | VAS reduction: −0.89+/0.75 mm | II |
| Hart et al, 2004 | Open-label uncontrolled trial | Antiretroviral toxic neuropathy | 21 | 33 | 3000 | Skin innervation | Epidermal, dermal and sweat gland innervation reached 92%, 80% and 69%, respectively, after 6-month treatment |
IV |
| Valcour et al, 2009 | Open-label uncontrolled study | Antiretroviral toxic neuropathy | 21 | 6 | 3000 | GPIS, skin innervation, mtDNA copies/cell | GPIS improvement: −0.079 compared to baseline No changes in skin innervation and mtDNA copies/cell |
IV |
| Osio et al, 2006 | Open-label uncontrolled study | Antiretroviral toxic neuropathy | 20 | 1 | 2000 | Short-form McGill Pain Questionnaire | Pain reduction: −21% compared to baseline | IV |
| Scarpini et al, 1997 | Open-label uncontrolled study | Antiretroviral toxic neuropathy | 16 | 0.75 | 500 or 1000 | Huskisson’s analogic scale | Pain reduction in 62.5% of subjects | IV |
| Sun et al, 2016 | RCT | Chemotherapy induced neuropathy | 239 | 2 | 3000 | Peripheral neuropathy grade (NCI-CTC), NCS | Reduced neurotoxicity: 50.5% of patients NCV improvement: 60.7% of patients |
II |
| Maestri et al, 2005 | Open-label uncontrolled study | Chemotherapy induced neuropathy | 27 | 0.25 | 1000 | Peripheral neuropathy grade (WHO) | At least one WHO grade improvement in 73% of patients | IV |
| Bianchi et al, 2005 | Open-label uncontrolled study | Chemotherapy induced neuropathy | 25 | 2 | 3000 | Total neuropathy score | TNS improvement: 92% of patients | IV |
| Cruccu et al, 2018 | Open-label uncontrolled study | Carpal tunnel syndrome | 82 | 4 | 1000 | NCS, BCTQ, NPSI | SCV changed from 34.7±5.6 m/s at t0 to 36.7±6.6 m/s at t120 Symptom and functional BCTQ decrease: −39% and 18% compared to baseline NPSI decrease: −38% to −56% compared to baseline |
IV |
| De Grandis et al, 1995 | RCT | Peripheral neuropathy of different etiologies | 426 | 1 | 2000 | NCS | NCV improvement in patients with mononeuropathies and in sensory nerve neuropathies, compared to placebo | II |
Abbreviations: ALC, acetyl-L-carnitine; RCT, randomized controlled trial; NCS, nerve conduction study; NSS, neuropathy symptom score; NCI-CTC, National Cancer Institute-Common Toxicity Criteria; GPIS, gracely pain intensity scale; NCV, nerve conduction velocity; TNS, total neuropathy score; SCV, sensory conduction velocity; BCTQ, Boston Carpal tunnel questionnaire; NPSI, neuropathic pain symptom inventory.