Piero Portincasa1, Leonilde Bonfrate2, Maria Lia Lia Scribano3, Anna Kohn3, Nicola Caporaso4, Davide Festi5, Maria Chiara Campanale6, Teresa Di Rienzo6, Maria Guarino4, Martina Taddia5, Maria Vittoria Fogli7, Maria Grimaldi7, Antonio Gasbarrini6. 1. Department of Biomedical Sciences and Human Oncology, University Medical School, Bari, Italy. piero.portincasa@uniba.it. 2. Department of Biomedical Sciences and Human Oncology, University Medical School, Bari, Italy. 3. Gastroenterology Operative Unit, Azienda Ospedaliera San Camillo-Forlanini, Rome, Italy. 4. Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy. 5. Department of Medical and Surgical Sciences, University of Bologna-Alma Mater Studiorum, Bologna, Italy. 6. Department of Internal Medicine, Gastroenterology Division, Catholic University of Sacred Heart, Policlinico A. Gemelli Hospital, Rome, Italy. 7. Department of Clinical Research, Alfa Wassermann SpA, Bologna, Italy.
Abstract
BACKGROUND AND AIMS: Irritable Bowel Syndrome (IBS) patients still require effective treatment. The anti-inflammatory property of curcumin and the antispasmodic and carminative effect of fennel suggests that combination of these nutraceutical compounds would be useful in functional bowel disorders including IBS. We assessed the efficacy 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 defined 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). The 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 significant decrease in the mean relative IBS-SSS was observed after 30 days of treatment (50.05 +/- 28.85% vs 26.12 +/- 30.62%, P<0.001). This result matched the reduction of abdominal pain and all the other symptoms of IBS-SSS. The percentage of symptom-free patients was significantly 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 significantly improved symptoms and quality of life in IBS patients over 30 days.
RCT Entities:
BACKGROUND AND AIMS: Irritable Bowel Syndrome (IBS) patients still require effective treatment. The anti-inflammatory property of curcumin and the antispasmodic and carminative effect of fennel suggests that combination of these nutraceutical compounds would be useful in functional bowel disorders including IBS. We assessed the efficacy 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 defined 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). The 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 significant decrease in the mean relative IBS-SSS was observed after 30 days of treatment (50.05 +/- 28.85% vs 26.12 +/- 30.62%, P<0.001). This result matched the reduction of abdominal pain and all the other symptoms of IBS-SSS. The percentage of symptom-free patients was significantly 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 significantly improved symptoms and quality of life in IBSpatients over 30 days.
Authors: Maura Di Vito; Maria Grazia Bellardi; Maurizio Sanguinetti; Francesca Mondello; Antonietta Girolamo; Lorenzo Barbanti; Stefania Garzoli; Manuela Sabatino; Rino Ragno; Alberto Vitali; Ivana Palucci; Brunella Posteraro; Antonio Gasbarrini; Gian Maria Prati; Giovanni Aragona; Paola Mattarelli; Francesca Bugli Journal: Nutrients Date: 2020-05-07 Impact factor: 5.717