Functional dyspepsia is characterized by abdominal pain that is not caused by structural gastrointestinal conditions such as gallbladder disease, peptic ulcer disease, or gastroesophageal reflux disease. The condition causes pain, discomfort and bloating in the upper abdomen above the belly button. Early fullness during or after a meal, nausea and belching are also common symptoms associated with functional dyspepsia.
Dr. Brooks Cash, professor of internal medicine at the USA College of Medicine and a gastroenterologist with USA Physicians Group, said functional dyspepsia is very common, affecting between 5-10 percent of the population. Currently, no medications are approved to treat the symptoms of functional dyspepsia.
The purpose of the functional dyspepsia clinical study is to evaluate the effectiveness of the new medication FDgard. The unique capsule contains a combination of caraway seed oil and peppermint oil.
“Both of these natural products have been used for centuries to treat chronic abdominal symptoms due to their antispasmodic and pain relieving qualities,” Dr. Cash said. “Each capsule contains a formulation of specially coated micro pellets that release the therapy into the small intestine, as opposed the stomach, to reduce the common side effect of heartburn that is common with peppermint oil.”
Dr. Cash said there are at least 10 published randomized clinical trials of combinations of peppermint and caraway for the treatment of functional dyspepsia. In one trial with 120 patients, an herbal preparation containing peppermint leaves, caraway fruit and other plant extracts, 43 percent of adults meeting clinical criteria for functional dyspepsia had complete symptom relief at eight weeks, as compared to 3 percent of those treated with placebo. In another trial, 96 patients with functional dyspepsia were treated with either placebo or an enteric-coated capsule containing peppermint and caraway oils for four weeks. In this trial the herbal preparation was more likely than placebo to reduce both abdominal pain intensity and global dyspeptic symptoms.
Adults diagnosed with functional dyspepsia between the ages of 19 and 65 may qualify to participate in the clinical study. Eligible participants will receive study-related care at no cost and up to $275 in compensation for time and travel.
For more information, call the University of South Alabama Digestive Health Center at 251-660-5555.
Dr. Cash - Functional Dyspepsia clinical trial from USA Health System on Vimeo.