Vagal nerve stimulation reduces need for rescue medication in gastroparesis, dyspepsia
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Key takeaways:
- Noninvasive vagal nerve stimulation reduced the number of rescue medications used by half.
- Stimulation also reduced reflux pain, constipation, depression and some autonomic symptoms.
VANCOUVER, British Columbia — As-needed vagal nerve stimulation reduced rescue mediation use among patients with nausea related to gastroparesis or functional dyspepsia, according to data presented at the ACG Annual Scientific Meeting.
“Chronic nausea and vomiting are key symptoms of gastroparesis and functional dyspepsia, particularly of the postprandial distress type,” Pankaj Jay Pasricha, MD, MBBS, of Mayo Clinic Arizona, said. “These sensations are relayed to the brain via the vagus nerve, and therefore, modulation of its function via [non-invasive] VNS offers a novel therapeutic approach.”
Pasricha continued: “In fact, previous studies using scheduled nVNS two to three times a day have shown promise in reducing gastroparesis symptoms, even if they are drug refractory, and one study at least showed improvement in gastric emptying.”
To evaluate the effectiveness of noninvasive vagal nerve stimulation (nVNS) on an “as needed” basis and as an alternative to rescue mediation, Pasricha and colleagues conducted a single center pilot study of 41 patients (38 women; mean age, 35.5 years) with ongoing symptoms of gastroparesis (GP) or functional dyspepsia (FD), who were on as-needed rescue medications.
The primary endpoint was reduced use of anti-nausea mediation, while the secondary endpoint was type and incidence of adverse events. Additional exploratory endpoints included nVNS effects on the efficacy of right vs. left side, other gastrointestinal symptoms, depression and anxiety, frequency of migraines and headaches, and autonomic symptoms.
According to Pasricha, patients were trained to self-administer nVNS at home using the handheld Gammacore device, with instructions to perform two 2-minute stimulations for severe nausea, wait and repeat, no more than eight times per day. Rescue medications could be used if there was no improvement.
Patients were randomized to perform as-needed stimulations to one side of the neck for 4 weeks, followed by a 2-week washout period, then repeat on the other side of the neck for 4 weeks. Data was collected via email questionnaires.
According to results, 35 patients were included in analysis, nine of whom met criteria for gastroparesis and 26 who had gastroparesis-like syndrome.
Pasricha noted an “overall significant decline” in the use of anti-nausea rescue medication from approximately 1.5 per day at baseline to approximately 0.5 per day, which persisted during washout periods. There was no difference in stimulation results on the left vs. right side of the neck.
Exploratory endpoints analysis of the entire study population revealed improved symptom scores from baseline to final washout in nausea (2.29 vs. 1.95), fullness (3.18 vs. 2.97), bloating (2.94 vs. 2.53), abdominal pain (4.13 vs. 3.52), reflux (3.01 vs. 2.35), indigestion (3.58 vs. 3.18) and constipation (4.07 vs. 3.3).
Further, depression “decreased significantly” (17.54 vs. 12.17), as did COMPASS secretomotor (4.6 vs. 4.52) and GI (13.18 vs. 11.3) scores. Migraine scores also declined (4.98 vs. 4.24) and the average number of pills used per headache or migraine dropped as well (0.81 vs. 0.367). There were no device-related adverse events.
“As needed nVNS can reduce the use for rescue medications for exacerbations of nausea due to GP or FD providing an attractive option to patients,” Pasricha said. “There appears to be several relatively unexpected benefits in a variety of symptoms including reflux pain, constipation, depression and some autonomic symptoms.”
He added, “These results should inform larger randomized sham-controlled trials in these disorders for which there are a few therapeutic alternatives.”
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Pasricha P, et al. Noninvasive vagal nerve stimulation reduces nausea rescue medication in patients with gastroparesis and related disorders, with additional benefits on multiple other associated symptoms. Presented at: ACG Annual Scientific Meeting; Oct. 20-25, 2023; Vancouver, British Columbia (hybrid meeting).
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