Discussion
Dizziness, pain, dizziness, muscle spasms, adverse drug reactions, LBP
ADVERSE DRUG REACTIONS
This phase III, prospective, single-blind, parallel-group trial evaluated the efficacy of the single IM administration of FDC diclofenac-thiocolchicoside compared to diclofenac IM injection alone for the symptomatic relief of Greek patients in non-specific moderate to severe acute LBP. The trial population was representative of the typical patients with non-specific moderate-to-severe LBP, with the mean age and sex ratio of participants being similar to those observed in other clinical and real-life studies [Population-based studies have reported that the overall prevalence of LBP is higher in women compared to men across all age groups with a prevalence ratio of female:male ranging from 1.185 to 1.360 across all age groups [The effect of a single IM administration of the test and reference treatment resulted in acute LBP relief, based on VAS assessments, both at 1 h and 3 h post-administration. This was anticipated due to the potency of diclofenac IM administration [The results of our trial support the findings of a recent phase 3, randomized, controlled trial which evaluated the efficacy of IM diclofenac and thiocolchicoside, administered either as FDC or free combination, in the treatment of patients with acute non-specific moderate-to-severe LBP. Following once-daily treatment for 5 days, both the FDC and the free combination of diclofenac and thiocolchicoside resulted in similar marked improvements in the VAS score and muscle spasms. Especially on the first day of treatment, the mean VAS score (~ 73 mm) improved approximately by 10 mm [Both treatments were overall well-tolerated in the 24 h post-injection follow-up. No adverse drug reactions were observed in patients receiving the combination treatment, whereas dizziness was reported in two patients who were administered diclofenac. Dizziness is commonly reported following the IM administration of diclofenac [According to the approved labelling for diclofenac IM injection, it is not to administered more than 2 days and if necessary, treatment can be continued with diclofenac tablets or suppositories. Although the guidelines for acute LBP management per country, nevertheless, it is reported that pharmacological treatments for which efficacy has been demonstrated, such as NSAIDs, only have small to moderate effects at best at the immediate term and short term [Τhe potential of reporting bias in patient-reported pain intensity cannot be ruled out. Τhe non-balanced baseline pain intensity VAS score between the two treatment groups may have influenced subsequent assessments [