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.
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