Evaluation of efficacy and tolerability of eperisone and thiocolchicoside in treatment of low back pain associated with muscle spasm: An open label, prospective, randomized controlled trial

Authors

  • Syed H. Maaz Department of Pharmacology, Indian Institute of Medical Science and Research, Jalna, Maharashtra, India
  • Prakash N. Khandelwal Department of Pharmacology, Government Medical College, Aurangabad, Maharashtra, India
  • Shiraz M. Baig Department of Pharmacology, Government Medical College, Aurangabad, Maharashtra, India
  • Sudhakar M. Doifode Department of Pharmacology, Government Medical College, Aurangabad, Maharashtra, India
  • Ulhas M. Ghotkar Department of Pharmacology, Government Medical College, Akola, Maharashtra, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20164144

Keywords:

Eperisone, Low back pain, Thiocolchicoside

Abstract

Background: Low back pain has a high prevalence in adult population. Because of reflex muscle spasm, muscle relaxants are frequently used either alone or in combination with analgesics. Eperisone inhibits voltage gated sodium channels in brain stem and Thiocolchicoside acts via GABA-mediated mechanism to relax muscle spasm and relieves pain.

Methods: This was a prospective; open labeled, randomized, two-arm, parallel group, controlled, clinical trial. 113 patients were randomised to two groups. Patients in group A received Tablet Eperisone 100 mg whereas patients in group B received Tablet Thiocolchicoside 8 mg for seven days along with Tablet Paracetamol 500 mg. The outcome measures of trial were the improvement in finger to floor distance (FFD) and pain in lumbar region, relief of spasm and tenderness of paravertebral muscles on day 4 and 7.

Results: At the end of the study FFD reduced by 18 cm in group A (p < 0.0001*) and 17.36 cm in group B (p<0.0001*) from baseline. Mean score of pain on day 7 reduced by 5.64 scale in group A as compared to 5.42 scale in group B (p<0.0001* in both groups). Paravertebral tenderness reduced by 92.6% in group A and 94.6% in group B at the end of the trial. On day 7, the spasm relief was 87% in group A and 88% in group B.

Conclusions: Eperisone is an effective muscle relaxant with equivalent efficacy compared to Thiocolchicoside, and has a better tolerability in treatment of low back pain with muscle spasm.

References

Prabhoo R, Keny S, Prabhoo T, Singh A, Rana R. A phase IV observational multi-Centre, open-label study on efficacy and safety of Tolperisone 150 mg in patients with painful muscle spasm associated with degenerative or inflammatory diseases of the musculoskeletal system. JAPI. 2011;59:33-7.

Maurits WT, Tony T, Andrea DF, Sherra S, Lex MB. Muscle Relaxants for Nonspecific Low Back Pain. A Systematic Review within the Framework of the Cochrane Collaboration. Spine. 2003;28(17):1978-92.

Nadine EF, Jan H, Peter RC. Taking responsibility for the early assessment and treatment of patients with musculoskeletal pain: a review and critical analysis. Arthritis Research and Therapy. 2012;4(1):205.

Andrew RM, Sebastian SB, Sheena D, Henry JM. Low back pain analgesic studies: A methodological mine field. Pain. 2010;149(3):431-4.

Roger C, Laurie HH. Clinical Guideline for the evaluation and management of low back pain: Evidence Review. American Pain Society, Publisher Glenview, IL; 2009.

Felder M. Medical treatment of muscle spasms and pain. In: Emre M, Mathies H (Eds). Muscle Spasms and Pain. Parthenon Publishing, Carnforth, NJ; 1988:89-96.

Burton AK, Balagué F, Cardon G, Eriksen HR, Henrotin Y, Lahad A. European guideline for prevention in low back pain: Nov 2004. European Spine J. 2006;15(2):136-68.

Ketenci A, Ozcan E, Karamursel S. Assessment of efficacy and psychomotor performances of thiocolchicoside and tizanidine in patients with acute low back pain. Int J Clin Pract. 2005;59(7):764-70.

Pratzel HG, Alken RG, Ramm S. Efficacy and tolerance of repeated oral doses of tolperisone hydrochloride in the treatment of painful reflex muscle spasm: results of a prospective placebo-controlled double-blind trial. Pain.1996;67(2-3):417-25.

Gold MS. Na+ channel blockers for the treatment of pain: context is everything, almost. Exp Neurol. 2008;210(1):1-6.

Cabitza P, Randelli P. Efficacy and safety of eperisone in patients with low back pain: a double blind randomized study. European Review for Medical and Pharmacological Sciences. 2008;12:229-35.

Silvana S, Lucia G. Open experience with a new myorelaxant agent for low back pain. Advances in Therapy. 2008;25(10):1010-8.

Kocsis P, Farkas S, Fodor L, Bielik N, Thán M, Kolok S, Gere A, Csejtei M, Tarnawa I. Tolperisone-type drugs inhibit spinal reflexes via blockade of voltage-gated sodium and calcium channels. J of Pharmacology and Experimental Therapeutics. 2005;315(3):1237-46.

Quasthoff S, Mockel C, Zieglgänsberger W, Schreibmayer W. Tolperisone: a typical representative of a class of centrally acting muscle relaxants with less sedative side effects. CNS Neuroscience and Therapeutics. 2008;4(2):107-19.

Dulin J, Kovács L, Ramm S, Horvath F, Ebeling L, Kohnen R. Evaluation of sedative effects of single and repeated doses of 50mg and 150 mg tolperisone: Results of a prospective, randomized, double-blind, placebo-controlled trial. Pharmacopsychiatry. 1998;31(4):137-42.

Roger C: Pharmacological Management of Low Back Pain, Drugs 2010;70(4):387-402.

Savigny P, Kuntze S, Watson P, Underwood M, Ritchie G, Cotterell M, et al. Low back pain: early management of persistent non-specific low back pain Full guideline. National Collaborating Centre for Primary Care (London): Royal College of General Practitioners; May 2009.

Guideline for the Low Back Pain: Evidence-Informed Primary Care Management of low back pain, 2 Edition 2011.

Berry H, Hutchinson D. Tizanidine and ibuprofen in acute low-back pain: results of a double-blind multicentre study in general practice. J Int Med Res. 1988;16(2):83-91.

Sirdalud Ternelin Asia-Pacific Study Group. Efficacy and gastro protective effects of tizanidine plus diclofenac versus placebo plus diclofenac in patients with painful muscle spasms. Curr Ther Res. 1998;59(1):13-22.

Tanaka K, Kaneko T, Yamatsu K. Effects of 4’-ethyl- 2-methyl-3 piperidinoproprio phenone on experimental rigidity and spinal cord activity. Folia Pharmacol Jpn. 1981;77:511-20.

Chandanwale AS, Chopra A, Goregaonkar A, Medhi B, Shah V, Gaikwad S et al. Evaluation of eperisone hydrochloride in the treatment of acute musculoskeletal spasm associated with low back pain: A randomized, double-blind, placebo-controlled trial. JPGM. 2010;57(4):278-85.

Rao R, Panghate A, Chandanwale A, Sardar I, Ghosh M, Roy M et al. Clinical Comparative Study: Efficacy and Tolerability of Tolperisone and Thiocolchicoside in Acute Low Back Pain and Spinal Muscle Spasticity. ASJ. 2012;6(2):115-22.

Soonawalla DF, Joshi N. Efficacy of thiocolchicoside in Indian patients suffering from low back pain associated with muscle spasm. J Indian Med Assoc. 2008;106(5):331-5.

Frandisco CR, Ramon VP, Enrique RB, Francisco FB. Effect of two different doses of Eperisone in treatment of acute low back pain. The J of Applied Research. 2009;9(1):23-9.

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Published

2016-12-21

How to Cite

Maaz, S. H., Khandelwal, P. N., Baig, S. M., Doifode, S. M., & Ghotkar, U. M. (2016). Evaluation of efficacy and tolerability of eperisone and thiocolchicoside in treatment of low back pain associated with muscle spasm: An open label, prospective, randomized controlled trial. International Journal of Basic & Clinical Pharmacology, 5(6), 2669–2674. https://doi.org/10.18203/2319-2003.ijbcp20164144

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Original Research Articles