J Gastrointestin Liver Dis, June 2016 Vol. 25 No 2: 151-157 1) Department of Biomedical Sciences and Human Oncology, University Medical School, Bari; 2) Gastroenterology Operative Unit, Azienda Ospedaliera San Camillo-Forlanini, Rome; 3) Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples; 4) Department of Medical and Surgical Sciences, University of Bologna-Alma Mater Studiorum, Bologna; 5) Department of Internal Medicine, Gastroenterology Division, Catholic University of Sacred Heart, Policlinico A. Gemelli Hospital, Rome; 6) Department of Clinical Research, Alfa Wassermann SpA, Bologna; Italy Address for correspondence: Prof. Piero Portincasa Department of Biomedical Sciences and Human Oncology University of Bari Medical School, Piazza Giulio Cesare 11 70124 Bari, Italy piero.portincasa@uniba.it Received: 18.02.2016 Accepted: 01.04.2016 *equally contributed to the study Curcumin and Fennel Essential Oil Improve Symptoms and Quality of Life in Patients with Irritable Bowel Syndrome Piero Portincasa 1* , Leonilde Bonfrate 1* , Maria Lia Scribano 2 , Anna Kohn 2 , Nicola Caporaso 3 , Davide Festi 4 , Maria Chiara Campanale 5 , Teresa Di Rienzo 5 , Maria Guarino 3 , Martina Taddia 4 , Maria Vittoria Fogli 6 , Maria Grimaldi 6 , Antonio Gasbarrini 5 INTRODUCTION Irritable bowel syndrome (IBS) is a frequent functional gastrointestinal disorder and one of the most common diagnoses for gastroenterologists and family practitioners. Cardinal symptoms of IBS are episodes of abdominal pain, bloating, and altered bowel habits in the absence of organic abnormalities. Quality of life (QoL) can be strongly afected in IBS patients leading to poor work productivity, and high access to medical health care [1]. ORIGINAL PAPER ABSTRACT Background & Aims: Irritable Bowel Syndrome (IBS) patients still require efective treatment. Te anti- infammatory property of curcumin and the antispasmodic and carminative efect of fennel suggests that combination of these nutraceutical compounds would be useful in functional bowel disorders including IBS. We assessed the efcacy and tolerability of a combination of curcumin and fennel essential oil (CU-FEO) in IBS symptoms relief. Methods: 121 patients with mild-to-moderate symptoms of IBS defned by an Irritable Bowel Syndrome- symptom severity score (IBS-SSS) 100-300 and abdominal pain score 30-70 on a 100 mm Visual Analogue Scale (VAS), were randomly assigned to CU-FEO or placebo (2 capsules b.d. for 30 days). Primary endpoint was the mean decrease of IBS-SSS at the end of the treatment corrected for the mean baseline score (relative decrease). Te impact of the treatment on quality of life was assessed through IBS-QoL questionnaire. Results: CU-FEO was safe, well-tolerated and induced symptom relief in patients with IBS; a signifcant decrease in the mean relative IBS-SSS was observed afer 30 days of treatment (50.05 ± 28.85% vs 26.12 ± 30.62%, P<0.001). Tis result matched the reduction of abdominal pain and all the other symptoms of IBS- SSS. Te percentage of symptom-free patients was signifcantly higher in the CU-FEO than in the placebo group (25.9% vs. 6.8%, P = 0.005). All domains of IBS-QoL improved consistently. Conclusion: CU-FEO signifcantly improved symptoms and quality of life in IBS patients over 30 days. Key words: abdominal pain – bloating – irritable bowel syndrome – randomized placebo-controlled study. Abbreviations: AEs: adverse events; CU-FEO: Curcumin-Fennel Essential Oil; GI: gastrointestinal; IBS: irritable bowel syndrome; IBS-D: irritable bowel syndrome-diarrhea; IBS-C: irritable bowel syndrome- constipation; IBS-SSS: Irritable Bowel Syndrome - symptom severity score; NF-kB: nuclear factor-κB; QoL: quality of life; UC: ulcerative colitis; VAS, Visual Analogue Scale. Available from: http://www.jgld.ro/wp/archive/y2016/n2/a6 DOI: http://dx.doi.org/10.15403/jgld.2014.1121.252.ccm Defnitive treatment options are still missing in IBS patients with either diarrhea or constipation and might include from time to time dietary modification, laxatives, lubiproston, linaclotide, antidiarrhoeals, alosetron, rifaximin, eluxadoline [2-5]. Further therapies including herbal products have been evaluated in IBS patients but their ultimate role remains elusive [6, 7]. Curcumin-Fennel Essential Oil (CU-FEO) is a nutraceutical product consisting of a combination of two phytonutrients: curcumin, derived from the rhizome (turmeric) of the herb Curcuma longa and fennel essential oil. In vitro, curcumin displays an anti-infammatory activity [8], while in the animal model of colitis curcumin reduces mucosal injuries [9-15]. Mechanisms include the modulation of I-kappa B kinase activity, driven by inhibition of nuclear factor- κB (NF-kB) and pro-infammatory cytokines (tumor necrosis