Fibroset™ and neuromuscular pain: a multicentric, real world, observational, post-marketing surveillance study in Indian patients suffering from neuromuscular pain
DOI:
https://doi.org/10.18203/issn.2455-4510.IntJResOrthop20232615Keywords:
Fibroset™, Boscurin®, Palmitoylethanolamide, Acetyl-L-carnitine, Pain, SafetyAbstract
Background: Neuromuscular disease (NMD) is a condition due to abnormality or damage to muscles and nerves causing painful symptoms. Symptomatic management involves use of conventional painkillers, but desirable relief is not achieved due to multimodal pathophysiology of disease. This study evaluated the efficacy and safety of Fibroset™ tablets in subjects with neuromuscular pain.
Methods: Subjects with neuromuscular pain, previously unsatisfied with standard therapies, were enrolled. Subjects were advised to take Fibroset™ one tablet BID for 2 weeks with their standard therapy. Efficacy was evaluated on pain, stiffness, swelling, weakness, tenderness, and difficulty in activity of daily living (ADL) as per the visit schedule. Tolerability of therapy was also evaluated.
Results: 59 patients were enrolled in study and 46 patients were included in the final analysis. Fibroset™ supplementation significantly reduced all evaluated parameters (p<0.05 vs baseline). The mean pain score from 2.50 to 0.89, while mean stiffness score was reduced to 0.55 from 1.87 at end of study. The mean swelling score was reduced to 0.81 from 2.04, while the mean weakness score was reduced to 0.64 from baseline score of 1.79. The mean tenderness score was reduced from baseline score of 1.90 to 0.65 and the mean ADL score was reduced to 0.63 from baseline score of 2.00. No treatment related side effects were observed.
Conclusions: Fibroset™ is a potentially effective and safe therapy for subjects with neuromuscular pain. It can be used to reduce symptoms in patients with unsatisfactory results with conventionally standard care therapy.
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