Perceived Changes in Symptom Burden and Physiological Effects of a Proprietary Phyto-therapeutic Preparation (Amara) in Patients With Functional Dyspepsia: Prospective Study as Investigator Initiated Trial (IIT)

Functional dyspepsia (FD) with postprandial distress is a common functional gastrointestinal (GI) disorder characterized by the occurrence of epigastric symptoms such as early satiety (fullness), nausea and upper abdominal pain after meals at least twice a week over at least six months (Rome IV criteria). By definition, no structural disease is found on routine endoscopy or imaging studies. Instead, symptoms are thought to be related to abnormal gastrointestinal motility (e.g., impaired gastric relaxation, abnormal emptying) and increased sensitivity to gastric distension and the digestive process.

Epidemiological studies report a 10-30% prevalence of functional dyspepsia (FD) worldwide. When dyspeptic symptoms are short in duration and relatively mild, many patients wish to self-manage with dietary adaptation and /or over the counter (OTC) preparations. Others report high rates of intolerance to prescription medications. In these patients complementary and alternative medicines (CAM) based on natural products, such as plant-based "phytotherapy", are particularly appealing. Several herbal therapies for functional dyspepsia have been tested in randomized clinical studies. These include phytochemicals such as peppermint oil that inhibits smooth muscle contraction by direct blockade of calcium channels and other effects, deglycyrrhizinated licorice that increases gastric mucus secretion and may enhance mucosal protection and other preparations that combine multiple herbal products with the intention of inducing synergistic effects that promote normal digestive function. For example, a meta-analysis of 3 double blind RCTs provided evidence that STW-5 (Iberogast, Bayer) is more effective than placebo in the Treatment of dyspeptic symptoms.

Amara tincture (Weleda, Arlesheim, Switzerland) is a proprietary preparation used for many decades in complementary medicine that is marketed for the treatment of functional digestive disorders. Patients take 10-20 drops before meals to relieve loss of appetite, bloating, nausea, and other dyspeptic symptoms. These bitter substances are thought to promote digestion and relieve symptoms by stimulating the secretion of gastric and pancreatic enzymes, upper gastrointestinal motility and gastric emptying. These prokinetic effects may be therapeutic in patients with functional dyspepsia because there is an association between optimally measured delayed gastric emptying (GE) and upper gastrointestinal symptoms. To date, the effect of Amara has not been subjected to pre-clinical or clinical studies.

The primary aim of this investigator-initiated, prospective, open-label pilot therapeutic study is to assess perceived changes in symptom burden reported by in patients with functional dyspepsia treated with Amara. Additionally, the physiological effects of Amara on gastric motor and sensory function will be assessed using validated methods (Nutrient drink test followed by 13C gastric emptying study using the 400ml Nottingham Test Meal)

A prospective, open label, non-randomized study will assess (i) Perceived changes in symptom burden reported by patients during regular intake of 10-20 Amara Drops before main meals using the validated Leuven Dyspepsia Score.