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Incontro Nazionale Neurofisiologia: Nuove Strategie   “ Controversie sulla diagnosi e terapia del dolore neuropatico ” Opinioni a confronto. NO. Acido lipoico e dolore neuropatico diabetico. Domenico A. Restivo U.O. di Neurologia P.O. “Nuovo Garibaldi”, Catania.

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Incontro Nazionale Neurofisiologia:

Nuove Strategie  

“Controversie sulla diagnosi e terapia del dolore neuropatico”

Opinioni a confronto

NO

Acido lipoico e dolore

neuropatico diabetico

Domenico A. Restivo

U.O. di Neurologia

P.O. “Nuovo Garibaldi”,

Catania


AANEM GUIDELINES - 2011

There is insufficient evidence to support or refute the usefulness of vitamins and alpha-lipoic acid in the treatment of PDN (Level U).

BRIL ET AL., 2011


ALA AND NEUROPATHIC PAIN

Golbidi et al., 2011


ALA RCTs

  • ALADIN I

  • ALADIN III

  • SYDNEY

  • NATHAN II

  • SYDNEY 2

  • NATHAN I

Misure di outcome inappropriate per valutare il dolore neuropatico


OUTCOME MEASURES IN ALA RCTs

  • TSS (Total symptoms Score: points: 0-14.64): Sensory symptoms

  • (Ziegler et al., 2004)

  • Neuropathy TSS: Sensory symptoms (Bastyr et al., 2002)

  • TNS (Total Neuropathy Score): Sensory, motor, and autonomic symptoms;

    Sensory and motor signs; reflexes; QST (vibration); sensory and motor NCS.

    (Cornblath et al., 1999)

  • NSS (Neuropathy Symptoms Score): Sensory, motor, and autonomic

    Symptoms (Dyck et al., 1988)

  • NIS (Neuropathy Impairment Score): NIS LL:Sensory and motor signs;

  • Reflexes in the lower limbs; NIS LL + 4: Sensory and motor signs; Reflexes

  • in the lower limbs+ motor NCS; NIS LL + 5: Sensory and motor signs; Reflexes

  • in the lower limbs+ motor NCS + QST (vibration); NIS LL + 7: Sensory and motor

  • signs; Reflexes in the lower limbs+ sensory and motor NCS + QST (vibration) +

  • AFT (Dyck et al., 1997)


TSS

  • Patients: 328

  • Outcome primario: TSS

  • Outcome secondario: NSS,

  • Neuropathy Disability Score

  • Results: improvement in TSS


ALADIN

TSS

Significant changes in TSS score


Patienti: 509

Outcome primario: TSS

Outcome secondario:NIS, NIS-LL

Risuatati: No miglioramento in

TSS; SI NIS


NO IMPROVEMENT

IN QST

Pazienti: 60 vs 60 controlli

Outcome primario: TSS

Outcome secondario: NIS, NSC, NCS, QST, AF test

Risultati: miglioramento significativo in TTS, NIS, NCS


  • Patients: 181

  • Primary Outcome: TSS

  • Secondary Outcome :individual symptoms of TSS, NIS, NSC, Patient’s

  • Global Assessment (PGA)

  • Results: improvement in TSS, individual symptoms of TSS, NSC, PGA


Primary outcome

Secondary outcomes


Results: no significant improvement in

the primary endpoints

Patients: 460

Primary outcome: NIS-LL 7

Secondary outcome: NIS, NIS-LL, NCS, QST


EFFECTS OF ALA ON DIFFERENT OUTCOME MEASURES

20 DPNP PTS

Restivo et al., unpublished data


ALA

NPSI

20 DPNP PTS

NPSI: SIGNIFICANT IMPROVEMENT ONLY FOR

DEEP SPONTANEOUS PAIN (PRESSING) AND

PARESTHESIA/DYSESTHESIA

QUESTO DATO POTREBBE IN QUALCHE MODO SPIEGARE

L’ASSENZA DI MIGLIORAMENTO DEL QST DOPO ALA


Neuropatie dolorose in corso di diabete

Neuropatie Dolorose in corso di Diabete

PoliNPT sensitiva dolorosa associata a ridotta tolleranza al Glc

NPT da iperglicemia o funzionale

NPT acuta dolorosa precipitata dal controllo glicemico

PoliNPT prevalentemente sensitiva distale e simmetrica

NPT delle fibre di piccolo calibro

NPT cachettica o NPT dolorosa acuta

Anoressia con neuropatia dolorosa acuta

Mononeuropatie singole o multiple

Radicolopatia toracica multipla dolorosa

Radicolo-plessopatia lombosacrale dolorosa acuta

Mononeuropatie da intrappolamento

NPT oftalmoplegica


POTREBBE L’EFFETTO DELL’ALA DIPENDERE DAL TIPO DI NEUROPATIA ?

BPI

ALA

15 SFDN PTS; 22 DSP PTS

Risposta migliore nei pz con polineuropatia simmetrica

sensitiva distale

Scarsa risposta in pz con neuropatia prevalentemente a carico

delle piccole fibre


Stimulation of distal sensory axons to study the neural impulse generation in individual nerve fibers by-passing the receptor organ

The absolute refractory periods (ARP) of single sensory axons is

significantly shorter in diabetic patients (Mackel and Brink 2003)

The shorter ARP in diabetic nerves may be consistent with reduced

nodal Na+ currents (Quasthoff, 1998), which is a consequence of

reduction of Na+-K+ ATPase activity, which play an important role in

the pathophysiology of DN (Distal Simmetric Polyneuropathy)


The absolute refractory period is the shortest interpulse interval at which

an action potential is generated and propagated in response to a second

stimulus

ALA INCREASE ARP IN DISTAL SIMMETRIC POLYNEUROPATHY

ARP

No correlation between ARP increase and BPI changes

in patients with diabetic distal sensory neuropathy and pain

12 PTS


COSTI interval at which

IN ITALIA LA TERAPIA PER UN MESE CON ACIDO LIPOICO

COSTA CIRCA 20 EURO…

HA UN SENSO SOTTOPORRE IL PAZIENTE AD UNA SPESA,

NON SEMPRE DA TUTTI SOSTENIBILE, IN ASSENZA DI SICURI

BENEFICI E/O SOLO SULLA BASE DEL PRESUPPOSTO CHE:

“TANTO NON FA MALE…”

???


CONCLUSIONI interval at which

NON VI SONO SUFFICIENTI EVIDENZE CHE L’ACIDO LIPOICO

POSSA MIGLIORARE IL DOLORE NEUROPATICO ASSOCIATO

A DIABETE MELLITO

ULTERIORI STUDI RANDOMIZZATI-CONTROLLATI CHE UTILIZZINO

MISURE DI OUTCOME PIU’ “SPECIFICHE” SONO NECESSARI

PRIMA DI UN SICURO E DEFINITIVO UTILIZZO DELL’ALA SUL DPNP


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