Treatment with α-Lipoic Acid over 16 Weeks in Type 2 Diabetic Patients with Symptomatic Polyneuropathy Who Responded to Initial 4-Week High-Dose Loading.
Effective treatment of diabetic sensorimotor polyneuropathy remains a challenge. To assess the efficacy and safety of α-lipoic acid (ALA) over 20 weeks, we conducted a multicenter randomized withdrawal open-label study, in which 45 patients with type 2 diabetes and symptomatic polyneuropathy were initially treated with ALA (600 mg tid) for 4 weeks (phase 1). Subsequently, responders were randomized to receive ALA (600 mg qd; n = 16) or to ALA withdrawal (n = 17) for 16 weeks (phase 2). During phase 1, the Total Symptom Score (TSS) decreased from 8.9 ± 1.8 points to 3.46 ± 2.0 points. During phase 2, TSS improved from 3.7 ± 1.9 points to 2.5 ± 2.5 points in the ALA treated group (p < 0.05) and remained unchanged in the ALA withdrawal group. The use of analgesic rescue medication was higher in the ALA withdrawal group than ALA treated group (p < 0.05). In conclusion, in type 2 diabetic patients with symptomatic polyneuropathy who responded to initial 4-week high-dose (600 mg tid) administration of ALA, subsequent treatment with ALA (600 mg qd) over 16 weeks improved neuropathic symptoms, whereas ALA withdrawal was associated with a higher use of rescue analgesic drugs. This trial is registered with ClinicalTrials.gov Identifier: NCT02439879.
Departamento de Ciencias de Salud, Facultad de Medicina, Universidad Popular Autónoma del Estado de Puebla, Calle 21 Sur 1103, Barrio de Santiago, 72410 Puebla, Mexico.
Hector
H
Garcia-Alcala
Outpatient Diabetes Clinic PEMEX, Calle 46 Poniente 1502, Colonia Cleotilde Torres, 72050 Puebla, Mexico.
Celia Isabel
CI
Santos Vichido
Hospital Universitario de Puebla, Benemerita Universidad Autonoma de Puebla, Avenida 25 Poniente 1301, Colonia Los Volcanes, 72410 Puebla, Mexico.
Silverio
S
Islas Macedo
Departamento de Ciencias de Salud, Facultad de Medicina, Universidad Popular Autónoma del Estado de Puebla, Calle 21 Sur 1103, Barrio de Santiago, 72410 Puebla, Mexico.
Christelle Nathalie
CN
Genestier-Tamborero
Departamento de Ciencias de Salud, Facultad de Medicina, Universidad Popular Autónoma del Estado de Puebla, Calle 21 Sur 1103, Barrio de Santiago, 72410 Puebla, Mexico.
Marissa
M
Minutti-Palacios
Departamento de Ciencias de Salud, Facultad de Medicina, Universidad Popular Autónoma del Estado de Puebla, Calle 21 Sur 1103, Barrio de Santiago, 72410 Puebla, Mexico.
Omara
O
Hirales Tamez
Departamento de Ciencias de Salud, Facultad de Medicina, Universidad Popular Autónoma del Estado de Puebla, Calle 21 Sur 1103, Barrio de Santiago, 72410 Puebla, Mexico.
Carlos
C
García
Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University, Auf'm Hennekamp 65, 40225 Düsseldorf, Germany ; Department of Endocrinology and Diabetology, Medical Faculty, Heinrich Heine University, Moorenstraße 5, 40225 Düsseldorf, Germany.
Dan
D
Ziegler
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage; D000975:Antioxidants / Q000627:therapeutic use; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D003929:Diabetic Neuropathies / Q000503:physiopathology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011115:Polyneuropathies / Q000188:drug therapy*; D063189:Symptom Assessment; D008063:Thioctic Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
D000700:Analgesics; D000975:Antioxidants; D008063:Thioctic Acid