Knee osteoarthritis: honey bee venom found safe, effective in phase 3 trial

  • Conrad VJ & al.
  • J Altern Complement Med
  • 08/07/2019

  • Miriam Davis, PhD
  • Clinical Essentials
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Takeaway

  • Dermal injections of honey bee venom at prespecified acupuncture points were more efficacious than control injections, and were of comparable safety in patients with knee osteoarthritis (KOA).

Why this matters

  • Honey bee venom may become a new treatment option for KOA.

Study design

  • Phase 3 double-blind, randomized, controlled trial of 538 patients receiving 15 honey bee venom (100 μg) or histamine control (2.75 μg) dermal injections per week at prespecified acupuncture sites, given for 12 weeks after a 3-week dose-escalation period.
  • All had Kellgren/Lawrence grade 1-3 radiographic KOA and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score ≥2.
  • Funding: Apimeds, Inc.

Key results

  • Honey bee venom showed superior efficacy for:
    • WOMAC pain score, 1.1 unit mean difference; analysis of covariance (ANCOVA), P=.0010 with baseline as covariate, which was maintained 4 weeks posttreatment.
    • WOMAC physical function, 3.1 unit mean difference; ANCOVA, P=.0046, which was maintained 4 weeks posttreatment.
    • Visual analog scale (P=.0010).
    • Patient Global Assessment, "very good" improvement, 20.9% vs 23.3%; "good" improvement, 61.1% vs 39.1% (each P=.0001).
  • Honey bee venom had a comparable safety profile vs histamine, with the exception of more injection site reactions (
  • Rescue acetaminophen utilization was similar across groups (78.2% vs 76.7% of controls; P=.7946).

Limitations

  • Combination therapy not assessed.