Assessing the effectiveness and safety of virtual reality in treating functional dyspepsia

Oct. 22, 2024

Functional dyspepsia (FD) is one of the most common disorders of gut-brain interaction (DGBI), with an estimated prevalence of approximately 10%. Symptoms can include abdominal pain, fullness, nausea and bloating.

FD can negatively impact patients' quality of life (QOL) and the healthcare system. Currently, there is no medication approved by the Food and Drug Administration (FDA) for the treatment of FD. Guidelines from the American College of Gastroenterology recommend treatment with proton pump inhibitors, tricyclic antidepressants or prokinetic agents, and with psychological-based therapies, such as cognitive behavioral therapy, for patients whose symptoms fail to respond to medications.

The limited array of effective treatments for FD has prompted researchers to explore the therapeutic potential of virtual reality (VR). Using 3D, multisensory information, VR allows patients to immerse themselves into a simulated virtual world and limits their ability to sense or process negative stimuli and sensations outside of the virtual world.

Proponents of VR believe that it could provide benefits similar to psychological-based therapies, with few side effects. Researchers have demonstrated that VR is effective at reducing acute pain in various settings, when compared with other forms of distraction, standard care or no treatment.

There is currently a lack of data regarding the use of VR for treating gastrointestinal symptoms. Noting this, a group of researchers from Mayo Clinic in Florida and Cedars-Sinai Health System conducted the first randomized, controlled pilot study assessing the effectiveness and safety of VR for the treatment of FD. Results from the pilot study were published in The American Journal of Gastroenterology in 2024.

"There is a great deal of excitement about the therapeutic potential for virtual reality, not only within the field of gastroenterology, but in medicine as a whole," explains David J. Cangemi, M.D., a gastroenterologist at Mayo Clinic in Florida and the publication's first author. "This technology provides the unique opportunity to deliver personalized treatment in the privacy of the patient's home to help manage a variety of chronic conditions — particularly those associated with pain."

Study methods

Study participants included 40 adults diagnosed with FD (using Rome IV criteria) who were randomized into two groups — the active VR group (N = 29) and the sham VR group (n = 11). The researchers assessed participant symptoms using the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) over a two-week period.

Both study groups received identical-appearing headsets. The active VR group used headsets equipped with software that delivered 3D immersive audiovisual programs designed to alleviate pain. The sham VR group used headsets equipped with 2D nature videos. Participants were instructed to use their headsets at least daily and to keep a log of the headset use and any potential adverse effects. They also were asked to complete PAGI-SYM and Nepean Dyspepsia Index (NDI) questionnaires at the initial visit, after one week of headset use and at the conclusion of the two-week study.

"Although this is a small pilot study, our findings demonstrate that virtual reality can safely and effectively reduce symptoms of functional dyspepsia. We think that VR is particularly well suited to treat symptoms of DGBIs like functional dyspepsia, and we anticipate that VR will become more commonplace as a treatment for DGBIs moving forward."

— David J. Cangemi, M.D.

Results

  • Although there was no statistically significant difference in improvement in PAGI-SYM and NDI QOL scores between the active VR and sham VR groups, PAGI-SYM scores from the active VR group participants (mean difference = -0.7; P < 0.001) showed greater numerical improvement compared with scores from the sham VR group participants (mean difference = -0.4; P = 0.032).
  • Participants in the active VR group had significant improvements in all PAGI-SYM subscales, except in scores for lower abdominal pain and bloating. In contrast, participants in the sham VR group showed improvements in only heartburn/regurgitation and nausea/vomiting subscales.
  • Half of all participants reported nonserious adverse effects, although only one patient withdrew from the study because of adverse effects, due to migraines.

"Although this is a small pilot study, our findings demonstrate that virtual reality can safely and effectively reduce symptoms of functional dyspepsia," explains Dr. Cangemi. "Because there are currently no FDA-approved medications for FD, we desperately need novel, safe and effective treatment options for this common, frequently bothersome condition. We think that VR is particularly well suited to treat symptoms of DGBIs like functional dyspepsia, and we anticipate that VR will become more commonplace as a treatment for DGBIs moving forward."

Next steps

Dr. Cangemi notes that to validate and build on the team's initial findings, they need to conduct larger and longer clinical trials. "We also need to assess the durability of treatment response in these patients," says Dr. Cangemi. "We are conducting a similar study utilizing an improved VR software that is tailored specifically for functional dyspepsia, over an eight-week time period, and we are collecting follow-up data for four weeks after treatment ends to assess the durability of VR treatment."

For more information

Cangemi DJ, et al. Virtual reality improves symptoms of functional dyspepsia: Results of a randomized, double-blind, sham-controlled, pilot study. The American Journal of Gastroenterology. 2024;119:210.

Refer a patient to Mayo Clinic.