No other pharmacological treatment known to influence the gastrointestinal tract was allowed during the study. A final evaluation was performed at day 60. At day 30, if the compliance with treatment was adequate, the treatment was reduced to two capsules q.d. All patients continued the follow up and were included in the analysis only if they confirmed that they were taking the treatment regularly on a daily basis. The compliance of patients with therapy was checked by interview at the follow-up visits. For the first 30 days, the dose consisted of two capsules b.i.d., before meals. The IBS severity index, intestinal habits and locations of pain were checked at each time point, whereas the QoL was assessed at baseline and after 60 days.Īfter baseline evaluation, the therapy consisted of Enterofytol®, containing bio-optimized turmeric extract standardized to 42 mg of curcumin and 25 mg fennel essential oil (trans-anethole). QoL was assessed according to a validated questionnaire (IBS QoL) with scores ranging from 0-100 (the higher the score, the better the QoL). The number of pain locations was recorded for each patient. Patients were also asked to mark all the locations where they felt abdominal pain on a body graph with the abdomen divided into 9 numbered quadrants. The features of intestinal habits depended on another 5 questions ( Table 2). Since each response varied from 0-100, the final score ranged from 0-400 and was proportional to the severity of the syndrome (the higher the index, the greater the IBS severity). The final score was calculated by summing the scores for each answer. The evaluation of the IBS severity index was based on the answers to 4 questions ( Table 1). At baseline, patients underwent a complete clinical examination and completed questionnaires related to IBS severity index, QoL, intestinal habits and the location of pain (see below). Patients were scheduled for three visits at time 0 (baseline), 30 and 60 days. All subjects were fully informed about the aims of the protocol and had to sign a written informed consent document. Also excluded were patients with IBD, anatomical gastrointestinal abnormalities, symptoms lasting for more than 10 years, gallstones, positive stool culture, drug or alcohol abuse, concomitant immunological, hematological or neoplastic disease, liver diseases, heart failure with New York Heart Association class III-IV, or a history of abdominal surgery in the previous six months. Exclusion criteria were the presence of “alarm” features (i.e., age of symptom onset after 50 years rectal bleeding or melena nocturnal diarrhea progressive abdominal pain, unexplained weight loss laboratory abnormalities with iron deficiency anemia, elevated C-reactive protein or fecal calprotectin or family history of inflammatory bowel disease or colorectal cancer). Seventy GPs enrolled a total of 211 patients who fulfilled the Rome III criteria diagnostic criteria for IBS. This observational, prospective, non-controlled, non-randomized pilot study was conducted in the setting of general practice between October 2015 and August 2016. The aim of this study, therefore, was to verify the “real-life” efficacy of bio-optimized extracts of turmeric and essential oil of fennel in a larger group of IBS subjects diagnosed and recruited by general practitioners (GPs) in Belgium, a geographical area where dietary habits are quite different from those in southern Europe. A potential limitation in that context was the role of dietary habits in the modulation of symptoms, since results were collected in a geographical area where subjects consume a typical Mediterranean diet, which might have been responsible for their milder clinical presentation. In that study a limited number of subjects (n=60) were randomized to nutraceuticals and enrolled in tertiary referral centers. The combination of curcumin (derived from the turmeric herb Curcuma longa) and fennel essential oil improved symptoms and QoL in an Italian short-term double-blind, placebo-controlled multicenter study involving 120 IBS patients. Conventional therapies often have poor outcomes and herbal products are currently being proposed as a useful alternative, although their efficacy is still under evaluation. Irritable bowel syndrome (IBS) is a chronic functional disease that significantly affects the quality of life (QoL).
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