Efficacy of Turmeric-Boswellia Formulation for Acute Low Back Pain: A Double-blind, Randomized, Placebo-controlled Trial

Objectives To evaluate the efficiency of the turmeric-Boswellia formulation (TBF, Rhuleave-K) in reducing acute low back pain (LBP) among healthy subjects. Materials and Methods This research aimed to assess the effectiveness of TBF compared to a placebo through a single dose of 1,000 mg, administered in a randomized, double-blinded, placebo-controlled trial with 76 participants experiencing acute low back pain. Efficacy was evaluated using objective outcome measures, namely the numerical rating scale (NRS), categorical pain relief scale (PRS), the onset of analgesia, and the short-form McGill questionnaire. NRS and PRS measurements were taken 30 minutes post-dose at rest, during movement, and under pressure application at the afflicted area. The onset of analgesia was assessed 6 hours post-dose. Quantitative analysis of the Sum of Pain intensity Difference (SPID) and Total Pain Relief (TOTPAR) values was conducted based on the NRS and PRS scores, respectively. Results Pain relief began quickly and all participants in the TBF group reported a significantly noticeable reduction in pain at about 76.4 minutes, compared to the 190 minutes in the placebo group. Similarly, 92.7% of participants in the TBF group experienced mean meaningful pain relief (MPR) as early as 224.1 minutes, compared to the zero MPR responders in the placebo group. There was a statistically significant difference in the time to pain relief between the TBF and placebo groups, with significant improvement in the TBF group (log-rank hazard ratio, p < 0.001). None of the individuals in the placebo group demonstrated a minimum of 50% maximum TOTPAR in rest, movement, and pressure. Whereas, 75.71% of the TBF group experienced at least 50% maximum TOTPAR in rest, 88.09% in movement, and 90.48% in pressure. The effectiveness of the treatment, as measured by the number needed to treat (NNT) for achieving at least 50% of MPR in the TBF group, was 1.2 at rest and 1.1 during both movement and pressure. Conclusion Oral administration of TBF (Rhuleave-K) to individuals with acute low back pain significantly reduces pain, providing meaningful relief within 4 hours of administration. This highlights the substantial analgesic effectiveness of TBF in the context of acute LBP.