Skip to main content
SpringerLink
Log in

Thioctic Acid and Acetyl-L-Carnitine in the Treatment of Sciatic Pain Caused by a Herniated Disc

A Randomized Double-Blind Comparative Study

  • Original Research Article
  • Published:
Clinical Drug Investigation Aims and scope Submit manuscript

Abstract

Background and objective: Sciatica is a painful condition characterized by radiating leg pain that most commonly originates from a herniated disc in the lumbar or sacral spine. Although sciatic pain is typically self-limiting, pharmacological analgesic therapy forms the mainstay of treatment. Acetyl-L-carnitine (levacecarnine; ALC) is a naturally occurring substance that promotes peripheral nerve regeneration and has been shown to have analgesic effects in patients with peripheral neuropathies of diabetic, HIV-related or chemotherapeutic origin. Thioctic acid, a key compound in oxidative metabolism, has antioxidant properties that may help the recovery of nerve functionality and decrease neuropathic pain. This study aimed to compare, for the first time, the efficacy of oral treatment with ALC or thioctic acid in patients with peripheral neuropathic (sciatic) pain associated with a herniated disc.

Methods: This was a randomized, double-blind trial conducted in a hospital setting. A total of 64 consecutive patients (mean age 61 years; range 29–85) with acute backache and moderate sciatica were recruited. Patients in group 1 (n = 33) received ALC 1180 mg/day; patients in group 2 (n = 31) received thioctic acid 600 mg/day. The study period was 60 days. The primary efficacy endpoint was change in clinical signs and symptoms of sciatica, as measured on the Neuropathy Impairment Score in the Lower Limbs (NIS-LL) questionnaire, the Neuropathy Symptoms and Change in the Lower Limbs (NSC-LL) questionnaire, and the Total Symptom Score (TSS) questionnaire. The secondary efficacy endpoint was improvement in neurological deficit (as measured by electromyography) compared with baseline.

Results: Both treatments produced significant improvements from baseline in neuropathy on electromyography at day 60, and greater mean improvements were observed with thioctic acid (−0.19 ± 0.29 vs baseline) than with ALC (−0.09 ± 0.40 vs baseline), although the between-group difference was not statistically significant. Thioctic acid produced significantly greater mean improvements than ALC from baseline for NIS-LL (−2.52 ± 1.50 vs −1.48 ± 1.37, respectively), NSC-LL (−2.16 ± 1.37 vs 1.42 ± 1.37, respectively) and TSS (−1.90 ± 1.08 vs 1.18 ± 1.01, respectively) scores (p < 0.05 for all comparisons). More patients receiving thioctic acid than ALC reported a decreased need for analgesia (71.0% vs 45.5%, respectively; p < 0.05) and neither treatment impacted significantly on sleep quality.

Conclusions: Thioctic acid 600 mg/day appears to be at least as effective as ALC in the treatment of sciatic pain caused by a herniated disc and may be associated with an improvement in symptom scores and reduced need for analgesia. However, because of the limited number of patients evaluated and the lack of a placebo control in this trial, further studies are warranted in order to provide more definitive results.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

Notes

  1. The use of trade names is for product identification purposes only and does not imply endorsement.

References

  1. Cherkin DC, Deyo RA, Loeser JD, et al. An international comparison of back surgery rates. Spine 1994; 19: 1201–6

    PubMed  CAS  Google Scholar 

  2. Hart LG, Deyo RA, Cherkin DC, et al. Physician office visits for low back pain: frequency, clinical evaluation, and treatment patterns from a US national survey. Spine 1995; 20: 11–9

    Article  PubMed  CAS  Google Scholar 

  3. Kinkade S. Evaluation and treatment of acute low back pain. Am Family Physician 2007; 75(8): 1190–2

    Google Scholar 

  4. Peul WC, van Houwelingen HC, van den Hout WB, et al. Surgery versus prolonged conservative treatment for sciatica. N Engl J Med 2007; 356(22): 2245–56

    Article  PubMed  CAS  Google Scholar 

  5. Chiechio A, Copani A, Gereau RW, et al. Acetyl-L-carnitine in neuropathic pain: experimental data. CNS Drugs 2007; 21Suppl. 1: 31–8

    Article  PubMed  CAS  Google Scholar 

  6. Vanotti A, Osio M, Mailland E, et al. Overview on pathophysiology and newer approaches to treatment of peripheral neuropathies. CNS Drugs 2007; 21Suppl. 1: 3–12

    Article  PubMed  CAS  Google Scholar 

  7. Youle M. Acetyl-L-carnitine in HIV-associated antiretroviral toxic neuropathy. CNS Drugs 2007; 21Suppl. 1: 25–30

    Article  PubMed  CAS  Google Scholar 

  8. Hart AM, Wiberg M, Terenghi G. Pharmacological enhancement of peripheral nerve regeneration in the rat by systemic acetyl-L-carnitine treatment. Neurosci Lett 2002; 334: 181–5

    Article  Google Scholar 

  9. Hart AM, Wiberg M, Youle M, et al. Systemic acetyl-L-carnitine eliminates sensory neuronal loss after peripheral axotomy: a new clinical approach in the management of peripheral nerve trauma. Exp Brain Res 2002; 145: 182–9

    Article  PubMed  CAS  Google Scholar 

  10. Onofrj M, Fulgente T, Melchionda D, et al. L-acetyl-carnitine as a new therapeutic approach for peripheral neuropathies with pain. Int J Clin Pharmacol Res 1995; 15: 9–15

    PubMed  CAS  Google Scholar 

  11. Quatarao A, Roca P, Donzella C, et al. Acetyl-L-carnitine for symptomatic diabetic neuropathy [letter]. Diabetologia 1995; 38: 123

    Article  Google Scholar 

  12. Scarpini E, Sacilotto G, Baron P, et al. Effect of acetyl-L-carnitine in the treatment of painful peripheral neuropathies in HIV+ patients. J Peripher Nerv Syst 1997; 2: 250–2

    PubMed  CAS  Google Scholar 

  13. Sima AAF, Calvani M, Mehra M, et al. Acetyl-L-carnitine improves pain, nerve regeneration, and vibratory perception in patients with chronic diabetic neuropathy. Diabetes Care 2005; 28(1): 89–94

    Article  PubMed  CAS  Google Scholar 

  14. De Grandis D. Tolerability and efficacy of L-acetylcarnitine in patients with peripheral neuropathies: a short-term, open multicentre study. Clin Drug Invest 1998; 15(2): 73–9

    Article  CAS  Google Scholar 

  15. De Grandis D, Minardi C. Acetyl-L-carnitine (levacecarnine) in the treatment of diabetic neuropathy: a long-term, randomized, double-blind, placebo-controlled trial. Drugs R D 2002; 3(4): 223–31

    Article  Google Scholar 

  16. Bilska A, Wlodek L. Lipoic acid: the drug of the future? Pharm Rep 2005; 57: 570–7

    CAS  Google Scholar 

  17. Kagan VE, Shvedova A, Serbinova E, et al. Dihydrolipoic acid: a universal antioxidant both in the membrane and in the aqueous phase. Reduction of peroxyl, ascorbyl, and chromanoxyl radicals. Biochem Pharmacol 1992; 44: 1637–49

    Article  PubMed  CAS  Google Scholar 

  18. Matsugo S, Yan LJ, Han D, et al. Elucidation of antioxidant activity of alpha-lipoic acid towards hydroxyl radical. Biochem Biophys Res Commun 1995; 208: 161–7

    Article  PubMed  CAS  Google Scholar 

  19. Dyck PJ, Davies JL, Litchy WJ, et al. Longitudinal assessment of diabetic polyneuropathy using a composite score in the Rochester Diabetic Neuropathy Study cohort. Neurology 1997 Jul; 49(1): 229–39

    Article  PubMed  CAS  Google Scholar 

  20. Ad Hoc Panel on Endpoints for Diabetic Neuropathy Trials. Positive neuropathic sensory symptoms as endpoints in diabetic neuropathy trials. J Neurol Sci 2001; 189: 3–6

    Article  Google Scholar 

  21. Bastyr 3rd EJ, Price KL, Bril V. Development and validity testing of the neuropathy total symptom score-6: questionnaire for the study of sensory symptoms of diabetic peripheral neuropathy. Clin Ther 2005 Aug; 27(8): 1278–94

    Article  PubMed  Google Scholar 

  22. Peripheral Nerve Society. Diabetic polyneuropathy in controlled clinical trials: consensus report of the Peripheral Nerve Society. Ann Neurol 1995; 38: 472–82

    Article  Google Scholar 

  23. Ametov AS, Barinov A, Dyck PJ, et al. The sensory symptoms of diabetic polyneuropathy are improved with alpha-lipoic acid. Diabetes Care 2003; 26(3): 770–6

    Article  PubMed  CAS  Google Scholar 

  24. Ziegler D, Ametov AS, Barinov A, et al. Oral treatment with alpha-lipoic acid improves symptomatic diabetic polyneuropathy. Diabetes Care 2006; 29(11): 2365–70

    Article  PubMed  CAS  Google Scholar 

  25. Ziegler D, Hanefeld M, Ruhnau K-J, et al. Treatment of symptomatic diabetic peripheral neuropathy with the anti-oxidant alpha-lipoic acid: a 3-week multicentre randomized controlled trial (ALADIN Study). Diabetologia 1995; 38: 1425–33

    Article  PubMed  CAS  Google Scholar 

Download references

Acknowledgements

This study was sponsored by MDM SpA, Monza, Italy. English language assistance for the preparation of this manuscript was provided by Vicki Oldfield, Wolters Kluwer Health, Medical Communications. This assistance was supported by MDM SpA, Monza, Italy. The authors have no conflicts of interest that are directly relevant to the content of this study.

Author information

Authors and Affiliations

  1. Ortopedia Pediatrica, Istituto Ortopedico Gaetano Pini, Piazza A. Ferrari 1, 20122, Milan, Italy

    Antonio Memeo

  2. Unità Operativa di Neurologia, Istituto Ortopedico Gaetano Pini, Milan, Italy

    Mario Loiero

Authors
  1. Antonio Memeo
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Mario Loiero
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Antonio Memeo.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Memeo, A., Loiero, M. Thioctic Acid and Acetyl-L-Carnitine in the Treatment of Sciatic Pain Caused by a Herniated Disc. Clin. Drug Investig. 28, 495–500 (2008). https://doi.org/10.2165/00044011-200828080-00004

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/00044011-200828080-00004

Keywords

Search

Navigation