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 ORIGINAL ARTICLE
Year : 2011  |  Volume : 57  |  Issue : 4  |  Page : 278-285

Evaluation of eperisone hydrochloride in the treatment of acute musculoskeletal spasm associated with low back pain: A randomized, double-blind, placebo-controlled trial


1 Department of Orthopedics, Grant Medical College and Sir J. J. Group of Hospitals, Mumbai, India
2 Consultant Physician and Rheumatologist, Centre for Rheumatic Diseases, Arthritis Research and Core Foundation, Hermes House, Pune, Maharashtra, India
3 Department of Orthopedics, L.T.M. Medical College and General Hospital, Mumbai, Maharashtra, India
4 Department of Clinical Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, Punjab and Haryana, India
5 Department of Orthopedics, Mahadevappa Rampure Medical College, Gulbarga, Karnataka, India
6 Department of Pharmacology, Grant Medical College and Sir J. J. Group of Hospitals, Mumbai, India
7 Department of Pharmacology and Unit of Clinical Pharmacology, L.T.M. Medical College and General Hospital, Mumbai, Maharashtra, India
8 Department of Medical Services, Eisai Pharmaceuticals India Private Limited, Marwah Centre, Mumbai, Maharashtra, India
9 Department of Pharmacology, Mahadevappa Rampure Medical College, Gulbarga, Karnataka, India

Correspondence Address:
S C Mehta
Department of Medical Services, Eisai Pharmaceuticals India Private Limited, Marwah Centre, Mumbai, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0022-3859.90076

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Background : Eperisone hydrochloride is a centrally acting muscle relaxant inhibiting the pain reflex pathway, having a vasodilator effect. Aims : To evaluate the efficacy and tolerability of eperisone in patients with acute musculoskeletal spasm associated with low back pain. Settings and Design : Prospective, randomized, double-blind, placebo-controlled, multicentric trial conducted at five tertiary care orthopedic centers across India. Materials and Methods : It was planned to enroll 240 patients of either sex between 18-60 years with acute musculoskeletal spasm (AMSP) with low back pain (LBP) due to spondylosis deformans, prolapsed disc or muscle sprain. Patients with other associated unrelated spasm conditions were excluded. Assessments were done for finger-to-floor distance (FFD), lumbar pain, Lasegue's sign, tenderness of vertebral muscles, need for rescue medication and response to therapy for efficacy and tolerability. Statistical Analysis : Parametric data were analyzed by 't' test and ANOVA, and non-parametric data were analyzed using Mann-Whitney 'U' test and Kruskall-Wallis test. Proportions were compared using Fischer's (Chi-square) test. Results : Two hundred and forty patients were randomized to receive eperisone 150 mg/day in three divided doses (n=120) or placebo (n=120) for 14 days, of which 15 patients did not complete and 225 patients completed the study (eperisone, 112 and placebo, 113). Significantly greater improvement in FFD (P<0.001) from baseline on Day 14 was seen with eperisone (150.66 to 41.75) compared to placebo (138.51 to 101.60). Improvements in other parameters were greater with the eperisone group. For 89 (79.46%) patients the therapy was rated as good-excellent with eperisone compared to 43 (38.05%) patients with placebo. Nausea, abdominal pain, headache and dizziness were the common adverse events with both therapies. Rescue drug was needed by 40 (35.71%) eperisone patients and 83 (73.45%) placebo patients. Conclusions : Eperisone hydrochloride was effective and well tolerated for the treatment of patients with AMSP with LBP.






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Online since 12th February '04
2004 - Journal of Postgraduate Medicine
Official Publication of the Staff Society of the Seth GS Medical College and KEM Hospital, Mumbai, India
Published by Wolters Kluwer - Medknow