A double blind, randomized, placebo controlled study of the efficacy and safety of 5-Loxin for treatment of osteoarthritis of the knee

Sengupta K, Alluri KV, Satish AR, et al. · Arthritis Research & Therapy

Against placebo at day 90, the 250 mg dose improved every score measured: VAS by 65.94% (p<0.001), Lequesne index 31.34% (p=0.017), WOMAC pain 52.05% (p<0.001), WOMAC stiffness 62.22% (p=0.014) and WOMAC function 49.34% (p=0.002). The 100 mg dose separated from placebo on VAS (48.83%, p<0.001), Lequesne (23.79%, p=0.036) and WOMAC pain (39.61%, p=0.009), but not on WOMAC stiffness (42.5%, p=0.120) or WOMAC function (28.62%, p=0.100). Both doses moved VAS by day 7 — 10.09% (p=0.05) on the low dose and 12.18% (p=0.02) on the high. Synovial-fluid MMP-3 fell 31.37% (p=0.002) and 46.4% (p<0.001) against placebo, measured in 45 of the 70 patients analysed.

Population

Adults with knee osteoarthritis, India

Intervention

5-Loxin (AKBA-enriched Boswellia serrata extract) 100 or 250 mg/day for 90 days

Comparator

Placebo

Limitations

Funded and co-authored by the extract's manufacturer (Laila Nutraceuticals); 25 patients per arm, 70 analysed. The paper's own account of the MMP-3 dose-response contradicts itself: the text reports the high dose significantly below the low dose (p<0.0001) while the figure legend gives the same comparison as p=0.213.