Regulatory restrictions in prokinetic drugs: Phytotherapy to fill the gap left by cisapride, metoclopramide and domperidone in the therapy of functional gastrointestinal diseases

After the prokinetic cisaprid, an important therapeutic option in functional gastrointestinal (GI) diseases, had been withdrawn from the market due to rare severe side effects earlier, in 2014 metoclopramid (MCP) and domperidone have likewise been restricted from the use in these indication, so leaving a therapeutic gap. A systematic review was conducted for identifying herbal medicinal products with therapeutic equivalence to MCP. A herbal medicinal combination product, STW 5, was shown to be a therapeutically equivalent therapeutic option, with efficacy proven by several RCTs and a very benign safety profile, due to a multi-target effect on multiple etiological factors. This allows a long term treatment of functional dyspepsia and irritable bowel syndrome also in the future.