Open AccessEfficacy of a New Nutraceutical Formulation in Patients with Symptomatic Uncomplicated Diverticular Disease (SUDD): a Prospective Observational Study
Author(s) -
Ferdinando D’Amico,
Giulia Fiorini,
Tursi Antonio,
Ilaria Maria Saracino,
Matteo Pavoni,
Silvio Danese,
Dino Vaira
Publication year - 2020
Publication title -
journal of gastrointestinal and liver diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.641
H-Index - 48
eISSN - 1842-1121
pISSN - 1841-8724
DOI - 10.15403/jgld-560
Subject(s) - medicine , bloating , abdominal pain , constipation , clinical endpoint , adverse effect , diverticular disease , irritable bowel syndrome , prospective cohort study , gastroenterology , population , diarrhea , observational study , randomized controlled trial , environmental health
Background and Aim: Symptomatic uncomplicated diverticular disease (SUDD) is characterized by abdominal pain, bloating and altered bowel habits (constipation or diarrhea) attributed to diverticula in the absence of macroscopic mucosal alterations. There is no consensus about management of these patients. DIVER-100®, an association of natural active ingredients may be effective in the treatment of patients with SUDD. The aim was to evaluate the efficacy and safety of DIVER-100® in patients with SUDD.
Methods: We conducted a prospective observational study to evaluate the efficacy of DIVER-100® in consecutive patients with SUDD, confirmed by radiology or endoscopy. All patients were treated with DIVER-100® 2 capsules/day 10 days per month, for 3 months. The primary endpoint was the clinical remission rate, defined as the reduction of abdominal pain and bloating, improvement of bowel habits and prevention of acute diverticulitis (AD). The secondary endpoint was the rate of adverse events.
Results: One hundred and one patients were consecutively enrolled at the Internal Medicine and Gastroenterology Unit, Sant’Orsola Hospital, Bologna, Italy. DIVER-100® was effective in inducing remission of symptoms in 12 patients (11.9%) at 3 months and in 10 patients (9.9%) at 6 months. DIVER-100® significantly reduced abdominal pain and bloating in 45.5% and 57.4% of patients respectively (p <0.001) after 3 months. No episodes of AD and no adverse events related to DIVER--100® were recorded at month 6 in the study population.
Conclusions: DIVER-100® is a safe and effective nutraceutical compound in obtaining remission and symptom relief in SUDD patients. Further randomized, placebo-controlled clinical trials are needed to confirm these preliminary data.