A Randomized, Double‐Blind, Sham‐Controlled, Clinical Trial of Auricular Vagus Nerve Stimulation for the Treatment of Active Rheumatoid Arthritis
Primary result · ACR20 responseResult — go to the resultDifference −1.9 95% CI −18.8 to 14.9Authors' conclusion
Auricular VNS did not meaningfully improve RA disease activity.
Study context
- Population
- Patients aged 18 to 75 years with active rheumatoid arthritis (RA) who had failed csDMARDs and were naïve to b/tsDMARDs101 completed week 12
- Participants
- 113 patients
- Comparison
- Active auricular vagus nerve stimulation (VNS) vs sham stimulation
- Primary endpoint
- Proportion achieving ACR20
- Follow-up
- Week 12
Methodological detailsdouble-blind, sham-controlled
- Double-blind
- Sham-controlled
Primary result
ACR20 response
Difference
−1.9
95% CI −18.8 to 14.9
P = 0.823
By group
Active stimulationvs Sham
difference −1.9 (95% CI −18.8 to 14.9); P = 0.823
As reported in the abstract
Secondary outcomes
Least square mean
| Outcome | Active stimulation | Sham | P value |
|---|---|---|---|
| Change in DAS28-CRP | −0.95 (SE 0.16) | −0.66 (SE 0.16) | P = 0.201 |
| Change in HAQ-DI | −0.19 (SE 0.06) | −0.02 (SE 0.06) | P = 0.044 |
Safety
- Adverse events in 17 patients
- 15%
- All were mild or moderate
Original publication
A Randomized, Double‐Blind, Sham‐Controlled, Clinical Trial of Auricular Vagus Nerve Stimulation for the Treatment of Active Rheumatoid Arthritis. Arthritis Rheumatol. Published 9 November 2023. doi:10.
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