A randomised placebo-controlled trial of a herbal preparation in functional dyspepsia: cost effectiveness and mechanisms

INTERVENTION: This study is designed to compare the effects of 4 different intervention groups with a double dummy technique. Intervention group 1: Iberogast, herbal medication, 20 drops orally 3 times a day for 4 week. Intervention group 2: Esomeprazole, Proton Pump Inhibitor (PPI), 20mg orally daily for 4 weeks. Intervention group 3:Oral Esomeprazole 20mg daily and oral Iberogast 20 drops 3 times a day for 4 weeks. Intervention group 4: oral placebo tablet daily and oral placebo liquid 20 drops 3 times a day for 4 weeks. All Responders to the treatments will continue with intervention group 4 (placebo) for week 6 and week 8. All intervention groups will have Endoscopy with biopsies, pregnancy urine test and Laboratory values only at screening. Questionnaires, nutrients challenge drink and blood for immune activation will be obtained at visits CONDITION: Functional Gastrointestinal Disorders PRIMARY OUTCOME: Cost‐ effectiveness will be assessed with a questionnaire regarding their on going costs relating to Irritable Bowel Symptoms or Functional Dyspesia whilst study participation. Validated questionnnaires such as Leeds Dyspepsia Questionnaire (LDQ), Gastointestinal Syptoms (GIS), Hospital Anxiety and Depression scale (HADS) and Nepean Dyspepsia Index (NDI) will be used. Nutrients challenge drink and bloods immune activation will assist in clinical efficacy. SECONDARY OUTCOME: From a blood sample the role of markers of immune activation (cytokine production, and presence of activated, gut homing inflammatory cells) and/or genectic variables in predicting the response to therapy are obtained. If a patient reports complete resolution of symptoms or near complete resolution of symptoms at week 4 they will be considered a responder and continue with placebo treatment until week 6. If at week 6 their symptoms have deteriorated they are considered relapsers. Relapsers do not require to complete week 8. Responders at week 6 continue with placebo treatment until week 8. If at week 8 they maintain complete resolution or near complete resolution of symptoms they are considered a placebo withdraw relapser otherwise they will be called a sustained responder. The association between the clinical response (complete resolution or substantial improvement of symptoms) and changes of visceral sencory function before and during treatment as assessed with a nutrient challenge INCLUSION CRITERIA: Patient meeting diagnostic criteria for Functional Dyspesia. Outpatients with a suspected diagnosis of functional dyspepsia based upon modified Rome III criteria.Sufficient understanding of English. Non Pregnant.