Evaluating the Efficacy of GCSB-5 in Lumbar Disc Herniation: A Randomized Controlled Trial

Abstract

Background: GCSB-5 has demonstrated a favorable safety profile and promising efficacy in reducing pain, exerting anti-inflammatory effects, and improving joint function in patients with osteoarthritis. Objectives: To evaluate the clinical effectiveness and safety of GCSB-5, a botanical formulation known for its anti-inflammatory and analgesic properties, in patients with lumbar disc herniation. Study Design: Double-blinded, placebo-controlled design. Setting: Two university hospitals in the Republic of Korea. Methods: This prospective, multicenter, double-blinded, randomized, placebo-controlled clinical trial was conducted over 16 weeks. In total, 46 patients with lumbar disc herniation were enrolled and randomly assigned to either the GCSB-5 group (n = 23) or the placebo group (n = 23). The GCSB-5 and placebo tablets were administered for 12 weeks. The primary outcome was the change in Numeric Rating Scale (NRS-11) scores for back pain from baseline to post treatment commencement week 16. Secondary outcomes included NRS-11 changes in radiating leg pain, Oswestry Disability Index scores, Short Form-36 scores, and magnetic resonance imaging-based structural assessments. Adverse events were monitored throughout the study. Results: One patient in the GCSB-5 group and 4 patients in the placebo group dropped out. The GCSB-5 group showed a statistically significant greater reduction in NRS-11 scores for back pain compared to the placebo group at post treatment commencement weeks 4, 8, and 16. Additionally, leg pain was statistically improved more significantly in the GCSB-5 group at post treatment commencement weeks 4, 8, 12, and 16. Functional outcomes, as assessed by the Oswestry Disability Index, had a statistically significant greater reduction in the GCSB-5 group at post treatment commencement week 16. However, magnetic resonance imaging analyses revealed no statistically significant difference between the 2 groups. No serious adverse events were reported, and the safety profile of GCSB-5 was comparable to that of the placebo. Limitations: The short study duration. Conclusion: Our study suggests that GCSB-5 may reduce pain in patients with lumbar disc herniation, with potential improvement in functional ability and mental well-being. Further largescale studies are needed to validate these findings.