EFFICACY OF DICLOFENAC VERSUS COMBINATION OF IBUPROFEN AND PARACETAMOL, IN ACUTE LOW BACK PAIN WITH SCIATICA
Sunil Nikose*, Sohael Khan, Mahendra Gudhe, Bhushan Patil and Pradeep K. Singh
Sciatica is a leading cause of low back pain. It is very common in young population of rural India. Paracetamol, non-steroidal anti-inflammatory drugs and muscle relaxants are commonly prescribed alone or in combination for the treatment of back pain. Various clinical trials were and are being conducted for the preferred NSAIDs for its efficacy, safety and tolerability in treatment of acute low back pain due to disc prolapsed. We conducted a double bind randomized controlled trial to compare the efficacy of diclofenac Sodium versus Ibuprofen and Paracetamol combination in acute disc prolapsed with sciatica. Post medication mean pain score (VAS) was 3.4 ± 1.73 for Diclofenac Sodium where as it was 2.7±0.63 for Ibuprofen+ Paracetamol combination. Mean TOPAR 8 hrs and 24hrs was 17.3±3and 58.4 ±12.4 respectively for Diclofenac Sodium where as it was 24.5 ±3 and 72.7 ±8.54 for Ibuprofen + Paracetamol combination. Mean SPID at 8 hrs was 10.0±3.55 with Diclofenac Sodium and 15.1±4.18 with combination. Adverse events in terms of nausea, gastritis, epigastric pain, flatulence, indigestion, hypersensitivity reaction, dizziness and discontinuation due to adverse reaction occurred in 237 patients on combined drug therapy where the number was 688 patients for Diclofenac Sodium. So it was concluded that on final assessment 70.8% of Ibuprofen + Paracetamol group rated their tolerability as “VERY GOOD” as compared to 50.89% of those in Diclofenac Sodium group. Moreover, Ibuprofen + Paracetamol shows a trend towards superiority in its efficacy and tolerability compared to diclofenac sodium.
Keywords: Diclofenac Sodium, Ibuprofen, Paracetamol, Sciatica, Summed pain intensity difference (SPID), Visual analogue scale (VAS), Total pain relief (TOPAR).
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