A Randomized, Double-blind Clinical Trial, Comparing the Combination of Caffeine, Carisoprodol, Sodium Diclofenac and Paracetamol versus Cyclobenzaprine, to Evaluate Efficacy and Safety in the Treatment of Patients with Acute Low Back Pain and Lumboischialgia

Objective: To evaluate the efficacy and safety of the combination of diclofenac, paracetamol, carisoprodol, and caffeine in the treatment of acute low back pain and lumboischialgia, compared to the efficacy and safety of cyclobenzaprine. Study design: Single-center, comparative, randomized, double-blind clinical trial. Method: Drugs were administered t.i.d. for a period of 7 days. Study population: 108 patients with a diagnosis of acute low back pain and lumboischialgia in the last 7 days were randomized, being included 54 patients in each group. Endpoints: The primary efficacy endpoints selected for the study were the pain visual analog scale and the Roland-Morris questionnaire, the results of which were compared before and after treatment. The secondary endpoints were the patient’s and the investigator’s overall assessment of the treatment, as well as the use of the analgesic rescue medication. The safety criteria were the tolerability analysis, the medication discontinuation due to adverse events, and laboratory tests. Results: There were no statistically significant differences among the groups regarding efficacy in any of the endpoints examined. Both medications have been shown to be safe and tolerable in the treatment of acute low back pain and lumboischialgia. The thorough statistical analysis revealed a difference between the two groups only concerning adverse events, which were more frequent in the group treated with cyclobenzaprine.