Abstract
BACKGROUND: Acute low back pain is one the leading cause of doctor's visit in our country with innumerable medication for treatment. Finding an ideal analgesic medication with better efficacy and least adverse effects is always a challenging task to the treating doctor. METHODS: In this study we compared the efficacy and safety profile of a fixed dose combination of novel analgesic tramadol 37.5 mg/paracetamol 325 mg/caffeine 30 mg/taurine 250 mg with commonly used tramadol 37.5 mg/paracetamol 325 mg tablet in the treatment of moderate to moderately severe acute low back pain. Patients attending 50 clinics throughout India were enrolled in either of the above group and were asked to take one tablet every 6th hour for five consecutive days. The pain evaluation in both groups was done with verbal pain relief scale and pain intensity scale at end of treatment. RESULTS: Proportion of patients in novel combination group compared to tramadol/paracetamol only group responding to treatment based on treatment satisfaction (good and excellent) and mean pain intensity (no pain or mild pain), were 81% Vs 45%, (p < 0.001) and 83% Vs 66% (p < 0.001) respectively. Common expected adverse drug reaction like nausea, vomiting and dizziness occurred with far less frequency in patients under novel combination group. CONCLUSION: We conclude that significantly more patients in novel combination drug group compared to tramadol/paracetamol only group had a superior analgesic effect with lesser adverse reactions.