3 - Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Controlled, Double-Blind Pilot Study

Monday, October 24, 2022

8:24 AM – 8:36 AM ET

Location: Hall C2

Presenting Author(s)

David Cangemi, MD

Mayo Clinic
Jacksonville, FL

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Award: ACG Governors Award for Excellence in Clinical Research

Cangemi David, MD¹, Marilia Montenegro, MD¹, Brennan Spiegel, MD², Brian E. Lacy, MD, PhD, FACG¹
¹Mayo Clinic, Jacksonville, FL; ²Cedars-Sinai Medical Center, Los Angeles, CA

Introduction: Functional dyspepsia (FD) is a common functional GI disorder, characterized by symptoms of abdominal pain, nausea, and/or early satiety. Virtual reality (VR) is a promising intervention which has been shown to alleviate pain in various clinical settings. There are currently no studies assessing VR for the treatment of FD. The aim of this study was to investigate the effectiveness and safety of VR for the treatment of FD.

Methods: This is a prospective, single-center, randomized, controlled, double-blinded study of adult patients with FD (Rome IV criteria). Enrolled patients were randomized 2:1 (experimental to control). Experimental patients were given a VR headset with software consisting of immersive audiovisual programs. Control patients were given an identical headset with 2-D nature videos. Patients were asked to use their headset at least daily and completed Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) and Nepean Dyspepsia Index (NDI) questionnaires at their initial visit, after 1 week of use, and at the conclusion of the 2-week study. Paired sample t-tests were used to compare questionnaire scores.

Results: Thirty-seven patients were enrolled in the study (27 experimental, 10 controls); demographic data are shown in Table 1. Patients used the VR headset an average of 1.3 times/day for a mean of 23.2 minutes/day. Total PAGI-SYM scores significantly decreased for all patients [2.51 (baseline) to 0.62 (week 2); p=0.000]. Notably, patients in the experimental group had greater improvement in mean total PAGI-SYM scores [2.51 baseline) to 1.83 (week 2); mean difference -0.68; p=0.000], compared to the control group [2.50 (baseline) to 2.04 (week 2); mean difference -0.46; p=0.046]. Further, quality of life (QoL) significantly improved for all patients, as the total NDI QoL score increased from 40.97 (baseline) to 57.14 (week 2), p=0.000, though experimental patients saw greater improvement in QoL, compared to control patients (Figure 1). Seventeen patients (45.9%; 11 experimental, 6 controls) reported non-serious adverse effects (AE), with headache and dizziness being the most common; 1 experimental patient withdrew due to AEs (migraines).

Discussion: In the first randomized, controlled, double-blind study to assess VR for the treatment of FD, VR was shown to be safe and result in statistically significant overall improvement in symptoms and QoL in FD patients. We propose VR as a novel treatment for FD worthy of further investigation.

Figure: Total PAGI-SYM and NDI Quality of Life Scores

Mean Age	45 years (± 14)
Mean BMI	24.56 (± 6.79)
Sex Female Male	30 (81.1%) 7
FD subtype EPS PDS Mixed EPS/PDS	12 (32.4%) 20 (54.1%) 5 (13.5%)
Anxiety	17 (45.9%)
Depression	9 (24.3%)
PTSD	2 (5.4%)
Fibromyalgia	4 (10.8%)
Prior H. pylori infection	5 (13.5%)
Medications PPI Antidepressants Gabapentin Opioids NSAIDs	16 (43.2%) 11 (29.7%) 4 (10.8%) 2 (5.4%) 0
Alcohol Use	7 (18.9%)
Marijuana Use	4 (10.8%)

Table: Study Population Demographic Data

Disclosures:

Cangemi David indicated no relevant financial relationships.

Marilia Montenegro indicated no relevant financial relationships.

Brennan Spiegel: Ironwood Pharmaceuticals – Advisory Committee/Board Member, Grant/Research Support. Pfizer – Grant/Research Support. Takeda Pharmaceuticals – Advisory Committee/Board Member, Grant/Research Support.

Brian Lacy: Allakos – Advisory Committee/Board Member. Allergan Pharmaceuticals – Advisory Committee/Board Member. Arena Pharmaceuticals, Inc. – Advisory Committee/Board Member. Cosmos – Advisory Committee/Board Member. Ironwood Pharmaceuticals, Inc. – Advisory Committee/Board Member. Salix Pharmaceuticals, Inc. – Advisory Committee/Board Member. Viver Health – Consultant.

Cangemi David, MD¹, Marilia Montenegro, MD¹, Brennan Spiegel, MD², Brian E. Lacy, MD, PhD, FACG¹, 3, Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Controlled, Double-Blind Pilot Study, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.