Background:The need for safe, effective pain management for osteoarthritis (OA) is important as the number of australian people with OA is expected to grow by 30% from year 2015 to year 2030. Extracts from Boswellia serrata and Curcuma longa are described to have anti-inflammatory and analgesic properties. Clinical studies have also reported efficacy for improving joint pain and stiffness and tolerability. A combination of Boswellia serrata and Curcuma longa formulated extracts might provide benefits in OA pain management.Objectives:To review the literature describing the efficacy, safety and bioavailability of a formulated Boswellia serrata extract enriched with boswellic acids and a Curcuma longa extract formulated with piperine for OA pain management.Methods:PubMed searches for studies reporting efficacy, safety, and/or bioavailability data for Boswellia and Curcumin formulations were conducted on 4 December 2020 with no publication date limitations.Results:For the enriched Boswellia formulation, two clinical studies in OA assessing efficacy and one preclinical bioavailability study were identified1,2,3. For the curcumin formulation, 2 clinical studies were identified4,5. Two double-blind, randomized, parallel, placebo-controlled studies (each N=60) demonstrated significant improvement in Western Ontario and McMaster Universities OA index (WOMAC) pain and stiffness subscale scores in patients with knee OA receiving the enriched Boswellia formulation (100mg/d): In the first study1, a 30-day treatment with enriched Boswellia, compared with placebo, significantly reduced WOMAC pain (−23.6; placebo, −5.6; P<0.0001) and stiffness (−18.8; placebo, −3.4; P=0.0014) scores. Improvement in pain visual analog scale (VAS) score was significant versus placebo at day 5 (P<0.05). In the second study2, A 90-day treatment with enriched Boswellia also significantly improved WOMAC pain (−31.1; placebo, −8.4; P<0.0001) and stiffness (−27.7; placebo, −9.9; P<0.0001) scores versus placebo; Of note, a significant reduction in pain score and functional ability was observed as early as day 7. For the curcumin/piperine formulation, piperine was added to increase the bioavailability of curcumin in humans as established in a comparative bioavailability and pharmacokinetic study4. The results obtained in his study demonstrates that piperine enhances the oral bioavailability of curcumin without side effects. Curcumin/piperine monotherapy (350-400mg curcumin TID) was also shown to significantly reduce WOMAC, VAS and Lequesne’s pain functional index (LPFI) compared to placebo in a randomized double-blind placebo-controlled parallel-group study (N=40)5. In a sub-study that measured inflammatory biomarkers (N=40), there is no significant difference in the magnitude of changes in the inflammatory biomarkers (IL-4, IL-6, hs-CRP, TNF-α, TGF-β and mean ESR between the curcuminoid treatment group and the placebo group (p>0.05)6.Conclusion:Enriched boswellic acid and curcumin/piperine formulations demonstrate efficacy and safety for suitable treatment option: both ingredients, often cited as natural alternatives to address OA pain and stiffness could be evaluated to explore the potential benefit as a formulated combination.References:[1]Vishal et al. Int. J. Med. Sci. 2011, 8[2]Sengupta et al. Int. J. Med. Sci. 2010, 7[3]Sengupta et al. Mol Cell Biochem. 2011, 354:189-197.[4]Shoba et al. Planta Med. 1998 May;64(4):353-6[5]Panahi et al. Phytother. Res. 28: 1625–1631 (2014).[6]Rahimnia A-R et al. Drug Res 2015; 65: 521–525.Disclosure of Interests:Vidhu Sethi Employee of: Employee of GSK Consumer Healthcare, Kamran Siddiqui Employee of: Employee of GSK Consumer Healthcare, Manohar Garg: None declared.
Acute and Chronic Toxicity, Cytochrome P450 Enzyme Inhibition, and hERG Channel Blockade Studies with a Polyherbal, Ayurvedic Formulation for Inflammation
