Transcutaneous vagal nerve stimulation for treating gastrointestinal symptoms in individuals with diabetes: a randomised, double-blind, sham-controlled, multicentre trial
Authors' conclusion
Cervical tVNS, compared with sham stimulation, does not improve gastrointestinal symptoms among individuals with diabetes and autonomic neuropathy.
Study context
- Population
- Adults (aged 20–86) with T1D or T2D, gastrointestinal symptoms and autonomic neuropathy, three Steno Diabetes Centres in Denmarkrandomised 1:1
- Participants
- 68 vs 77
- Comparison
- Active cervical transcutaneous vagal nerve stimulation (tVNS) vs sham stimulation
- Activen = 68
- Shamn = 77reference
- Primary endpoint
- Gastrointestinal symptom changes measured by gastroparesis cardinal symptom index (GCSI) and gastrointestinal symptom rating scale (GSRS)
Methodological detailssham-controlled, double-blind, multicentre
- Sham-controlled
- Double-blind
- Multicentre
Primary result
As reported in the abstract
GCSI change (co-primary) · study period 1 (1 week)
Active
−0.26
mean · SD 0.64
Sham
−0.17
mean · SD 0.62
P = 0.44
Secondary outcomes
| Outcome | Active | Sham | P value |
|---|---|---|---|
| GSRS change (co-primary) · study period 1 (1 week)Mean | −0.35 (SD 0.62) | −0.32 (SD 0.59) | P = 0.77 |
| GCSI change (co-primary) · study period 2 (8 weeks)Mean | −0.47 (SD 0.78) | −0.33 (SD 0.75) | P = 0.34 |
| GSRS change (co-primary) · study period 2 (8 weeks)Mean | −0.46 (SD 0.90) | −0.35 (SD 0.79) | P = 0.50 |
| Gastric emptying time changeIncreased with Active | 23 min | −19 min | P = 0.04 |
- Segmental intestinal transit times and cardiovascular autonomic measurements
- all p>0.05
- Gastroparesis cardinal symptom index (GCSI) change (co-primary): 62 in each group analysed in study period 2
Segmental intestinal transit times and cardiovascular autonomic measurements
- Did not differ between treatment groups
Safety
Tolerability
- tVNS was well-tolerated
Original publication
Transcutaneous vagal nerve stimulation for treating gastrointestinal symptoms in individuals with diabetes: a randomised, double-blind, sham-controlled, multicentre trial. Diabetologia. Published 28 March 2024. doi:10.
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