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Minerva Ortopedica e Traumatologica 2018 March;69(1):1-6

DOI: 10.23736/S0394-3410.18.03870-5

Copyright © 2018 EDIZIONI MINERVA MEDICA

language: English

Assessment of the effectiveness of Assonal® in the treatment of lumbosciatalgia: an observational study

Vincenzo MAGLIANI 1, Roberto D’ANGELO 2, Luigi BURRUANO 3, Piermassimo PROTO 4, Antonio VILLAMINAR 5, Roberta RAVENNI 6, Andrea VERONI 7, Fabio ROSSI ESPAGNET 8

1 Renzetti Hospital, Lanciano, Chieti, Italy; 2 Sant’Orsola-Malpighi Policlinic, Bologna, Italy; 3 S. Maria Maddalena Private Hospital, Palermo, Italy; 4 A. Perrino Hospital, Brindisi, Italy; 5 Villa Berica Private Hospital, Vicenza, Italy; 6 Azienda Sanitaria ULSS 18, Rovigo, Italy; 7 Hospital of Suzzara, Mantova, Italy; 8 Santo Spirito General Hospital, Rome, Italy


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BACKGROUND: The aim of this study was to assess the efficacy of the association of acetyl-L-carnitine: 500 mg; alpha lipoic acid: 300 mg; citicoline: 125 mg; vitamin B1:12.5 mg; vitamin B2:12.5 mg; vitamin B5:9 mg; vitamin B6:2.5 mg; vitamin B12:16.5 mcg (Assonal®, Agave Farmaceutici, Casalecchio di Reno, Bologna, Italy) in the supportive management of lumbosciatalgia.
METHODS: A total of 112 patients with lumbosciatalgia were recruited. Informed participants freely decided to follow oral daily supplementation with Assonal® for 60 days at 2 tablets/day. Subjects were allowed to use rescue non-steroidal anti-inflammatory drugs (NSAIDs) and/or cortisone drugs as rescue medications in the acute phase (according to the standard of care of the centers involved). The Visual Analogue Scale (VAS) and DN4 questionnaires were administered to the patients at day 30 and day 60 from the baseline, motor function and consumption of NSAIDs and corticosteroids were evaluated.
RESULTS: Supplementation with Assonal® (2 tablets/day) showed a significant reduction in pain using the VAS at day 30 (Δ vs. baseline - 25.99 mm P<0.001) and at day 60 (Δ vs. baseline - 38.71 P<0.001); after 60 days a significant reduction (P<0.001) was observed in the scores of all items of the DN4 questionnaire, with the exception of itching and painful cold sensation. The percentage of patients with normal motor function increased in a statistically significant way at day 30 (Δ vs. baseline +23.46 percentage points P<0.001) and day 60 (Δ vs. baseline +30.14 percentage points P<0.001). Patients taking NSAIDs and/or steroids decreased after 60 days compared to the 30-day control (from 69 and 57 patients to 39 and 27 patients respectively). Supplementation with Assonal® for 60 days at 2 tablets/day proved to be useful and safe in patients with lumbosciatalgia undergoing treatment with NSAIDs and/or corticosteroids. Moreover, the supplementary use of Assonal® was well-tolerated and devoid of side effects.
CONCLUSIONS: This study highlight the effectiveness of the supplement with Assonal® in reducing neuropathic pain and improving motor function in patients with lumbosciatalgia, being treated with NSAIDs and/or corticosteroids.


KEY WORDS: Neuroprotection - Dietary supplements - Acetylcarnitine - Thioctic acid - Vitamin B complex - Cytidine diphosphate choline

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