Treatment of irritable colon with the food additive Appital

Appital is a herbal medicine. The aim was to examine its effect in patients with irritable bowel syndrome (IBS). Other diseases were excluded by physical examination, rectoscopy, blood tests and in patients older than 35 years X-ray of the colon or colonoscopy. The study was designed as a double-blind placebo-controlled trial. The patients were randomized to either Appital or placebo. Following two weeks without medicine, the patient had Appital or placebo for eight weeks. Fifty-nine patients were randomized, 47 completed the study. The results were based on symptom scores registered by the patients. The symptom score was significantly reduced in patients treated with Appital (p = 0.002), but when compared to placebo, the difference was insignificant (p = 0.081). We concluded that Appital has no effect in relieving symptoms of IBS compared to placebo, although due to the possibility of type two error we cannot exclude a small, but hardly clinically relevant effect.