By Feyza Sancar, Ph.D.: For More Info, Go Here…
The FDA has authorized marketing of the first medical device for adolescents with abdominal pain associated with irritable bowel syndrome (IBS). The device, which is available by prescription only, is indicated for patients aged 11 through 18 years.
Research suggests abnormal communication between the brain and gut is involved in IBS-related functional abdominal pain. The approved IB-Stim device targets the brain-gut axis by modulating pain pathways in the central nervous system with low-frequency electrical stimulation of peripheral cranial nerves beneath the skin. Worn behind the ear, the single-use, battery-powered stimulator is replaced after 5 days of continuous use. Patients can use the device for up to 3 consecutive weeks.
The agency reviewed data from a clinical trial involving 115 adolescents with abdominal pain related to functional gastrointestinal tract disorders. Participants were randomized to 4 weeks of active therapy with the device or sham treatment without stimulation. In a subgroup analysis of 50 patients with IBS, at 3 weeks, 59% in the active treatment group compared with 26% in the sham group had a 30% or greater reduction in worst pain. Patients in the active treatment group also showed significantly greater improvements in the frequency, severity, and duration of pain compared with those in the sham group. No serious adverse events were reported.
Similar devices have been authorized for electroacupuncture therapies or to treat opioid withdrawal symptoms.