Real World Effectiveness of Orphenadrine citrate 50 mg + Paracetamol 650 mg (Norgesic ® Forte ) on Low Back Pain of Filipino Patients

Abstract

Introduction: Low back pain is a common musculoskeletal disorder, estimated to affect up to 84% of adults at some point in their lives. It is one of the leading causes of activity limitation, work absenteeism, and lost productivity, inflicting substantial costs on health, social, and economic systems. Globally, back pain causes more disability than any other condition. The study aimed to determine the effectiveness of a combination drug: Orphenadrine citrate 50 mg + paracetamol 650 mg (Norgesic ® Forte) in alleviating low back pain of adult Filipino patients who are presenting with acute non-specific moderate to severe low back pain. Methods: This is a real-world, uncontrolled, longitudinal, observational study on the effectiveness of a combination drug: Orphenadrine citrate 50 mg + paracetamol 650 mg (Norgesic ® Forte). Patients with acute low back pain were prescribed by participating physicians with said drugs according to local prescribing information and routine clinical practice. The pain was assessed using the Visual Analogue Scale (VAS), and the Roland-Morris Disability Questionnaire (RMDQ) was used to evaluate for self-rated physical disability. Patients were followed up until the total resolution of the low back pain or up to a maximum of ten (10) days. The study also documented any adverse effects for ten (10) days. Results: In the 181 participants, the median onset of pain relief occurred an hour after the first dose; the fastest occurred at 5 minutes, and the slowest at 8 hours. At baseline, the median VAS score was 7, the lowest was 2, and the highest was 10. Generally, a decreasing trend was observed on subsequent time points compared to baseline (p<0.0001). By day 5, VAS scores dropped to 0 until day 10. The mean duration of symptoms before total resolution of low back pain was 4.3 SD ± 2.0 days. As much as 72.4% of the participants’ VAS scores decreased by 2 points from baseline as early as day 1. The highest observed proportion of respondents with at least two 2-point decreases from baseline VAS scores was on day 3. Using the RMDQ with scores ranging from 0 (no disability) to 24 (severe disability), the median physical disability score on day 1 was 9, with a minimum value of 1 and a maximum of 23. On day 11, this significantly decreased to 1, with values ranging from 0 to 11 (p<0.0001). Thirteen participants developed adverse events, which were generally mild. Conclusion: Results indicate that Orphenadrine citrate 50 mg + Paracetamol 650 mg (Norgesic ® Forte) provides pain relief compared to the baseline. In addition to its analgesic effects, there is an improvement in physical function, as evidenced by the significant decrease in the physical disability scores and, subsequently, an improvement in the quality of life (QoL) of these patients.