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Year : 2012  |  Volume : 7  |  Issue : 3  |  Page : 135-140

Comparative study of efficacy and tolerability of flupirtine versus tramadol in non-steroidal anti-inflammatory drug intolerant mechanical low back pain

1 Department of Pharmacology, Medical College, Kolkata 700073, India
2 Junior Resident, Medical College, Kolkata 700073, India
3 Department of Medicine, Rheumatology Division, Medical College, Kolkata 700073, India

Correspondence Address:
Manasi Banerjee
Department of Pharmacology, Medical College, Kolkata 700073
Rathindra Nath Sarkar
Department of Medicine, Rheumatology Division, Medical College, Kolkata 700073
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Source of Support: None, Conflict of Interest: None

DOI: 10.1016/j.injr.2012.06.002

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Background: Mechanical low back pain (MLBP) is a commonly encountered entity in clinical practice. Pain relief and restoration of functional capacity are management goals. Aims and objectives: To compare the efficacy and tolerability of flupirtine, a selective neuronal potassium channel- opener (SNEPCO), with tramadol, a widely-used opioid analgesic, in MLBP. Methods: This randomized, single-blinded, intention to treat (ITT) trial started with 240 non-steroidal anti-inflam- matory drug (NSAID) intolerant patients who were prescribed either tablet flupirtine (100 mg twice daily) or capsule tramadol (50 mg twice daily), for 4 weeks. Follow-up was done on days 14, 28 and 4 weeks after treatment completion. Assessment of improvements in Indian Health Assessment Questionnaire Disability Index (Indian HAQ- DI), Visual Analogue Scale (VAS), Numerical Rating Scale (NRS) and measurement of Pain Relief Rate (PRR) were performed. Adverse events were recorded. Results: One hundred and seven patients receiving flupirtine and 103 receiving tramadol were analyzed on an ITT basis. Scores in Indian HAQ-DI, VAS and NRS improved significantly in both groups in the last visit, but more so with flupirtine. PRR was reasonably higher with flupirtine, [59 (55.14%)] patients experiencing significant to complete pain relief at the end of the study, compared to tramadol [41 (39.81%)]. Adverse effects were less with flupirtine [26 (24.30%) versus 41 (39.81%), p < 0.05], minimizing drop-outs. Conclusion: Flupirtine has better sustained efficacy and tolerability than tramadol in

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