Comparative efficacy and tolerability of 5-Loxin and Aflapin against osteoarthritis of the knee: a double blind, randomized, placebo controlled clinical study

Sengupta K, Krishnaraju AV, Vishal AA, et al. · International Journal of Medical Sciences

Against placebo at day 90, Aflapin improved every score tested: VAS 47.3% (p<0.0001), Lequesne 35.8% (p=0.0004), WOMAC pain 61.7% (p<0.0001), stiffness 60.1% (p=0.0001) and function 49.4% (p=0.0001). 5-Loxin separated from placebo on VAS (31.6%, p=0.006), WOMAC pain (30.3%, p=0.009) and WOMAC stiffness (42.2%, p=0.006), but not on Lequesne (18.35%, p=0.060) or WOMAC function (21.25%, p=0.078). The day-7 improvements both extracts showed are changes from their own baselines, not comparisons with placebo. The two extracts were never tested against each other: the authors' conclusion that Aflapin is superior rests on Aflapin clearing significance against placebo on all five scores where 5-Loxin cleared it on three.

Population

Adults with knee osteoarthritis, India

Intervention

5-Loxin 100 mg/day or Aflapin 100 mg/day (Boswellia extracts) for 90 days

Comparator

Placebo

Limitations

Manufacturer-run trial (Laila Nutraceuticals authors, Laila-funded); 19 subjects per arm completed, from the same research group as the prior 5-Loxin trial. No head-to-head statistical comparison between the two extracts was performed, so the superiority claim is a difference in significance rather than a tested difference. The placebo group improved from baseline too, which the authors attribute partly to heavier ibuprofen rescue use in that arm.