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For Irritable Bowel Progress in Nutrition 2018; Vol. 20, N. 3: 526-531 DOI: 10.23751/pn.v20i3.7574 © Mattioli 1885 Original article A mixture of vegetable extracts (chamomile, passionflower, caraway, fennel) and enzymes (beta-galactosidase) for Irritable Bowel Syndrome (IBS): an observational study (“BIOVES”) Giovanni Tomasello1, Vincenzo Davide Palumbo2,3, Emanuele Sinagra2,4, Margherita Mazzola1,2, Agostino Accardo5, Andrea Busalacchi6, Antonio Ciulla7, Benedetto Di Trapani2,7, Paolo Pirrotta2, Simone Tomasini7, Bartolo De Luca8, Simona Cusimano8, Salvatore Sardo8, Giuseppina Di Gaetano8, Claudia Corallo8, Gianluca Bonetti9, Monica Pellerone10, Giulia Tomasello11 Provvidenza Damiani12, Francesco Carini1 1Department of Experimental Biomedicine and Clinical Neurosciences, University of Palermo, Palermo, Italy - E-mail: giovanni. [email protected]; 2Euro-Mediterranean Institute of Science and Technology (IEMEST), Palermo, Italy; 3Department of Surgi- cal, Oncological and Stomatological Disciplines, University of Palermo, Palermo, Italy; 4Digestive Endoscopy Service, “G. Giglio” Hospital, Cefalù, Italy; 5School of Medicine, University of Palermo, Palermo, Italy; 6Department of General Surgery and Medical- Surgical Specialties, University of Catania, Catania, Italy; 7Torina Hospital, Palermo, Italy; 8Azienda Sanitaria Provinciale Palermo, Palermo, Italy; 9School of Medicine, Poland University, Czech Republic; 10Kore University, Enna, Italy; 11School of Human and Society Sciences, Kore University, Enna, Italy; 12A.O.U.P. “P. Giaccone” Hospital University, Palermo, Italy. Summary. Aims: Irritable bowel syndrome (IBS) is a functional intestinal disorder. This syndrome may creates psychological disorders in patients who are affected and severely limits daily activities and lifestyle. Methods: We investigated the effect of the natural product consisting of chamomile, fennel, caraway, passionflower and melissa (Spasmicol®), on IBS patients. For the study, 187 patients with IBS, enrolled by primary care doctors, were treated with Spasmicol® (Aristeia Farmaceutici s.r.l.), two tablets/daily, for 30 days. At the end of the study, patients were re-evaluated to analyse the effects of therapy. Results: After 30 days, patients showed a marked reduction of symptoms (abdominal pain, abdominal distention, stool habit changes). Conclusions: Due to to the combination of chamomile, fennel, caraway, melissa, passionflower and beta-galactosidase, the product Spasmicol® turned out to be remarkedly effective in treating IBS symptoms. Key words: irritable bowel syndrome, gastroenterology, supplements, alternative treatments Introduction - related to a change in stool consistency. These criteria have to be satisfied for at least the previ- Irritable bowel syndrome (IBS) is a functional in- ous 3 months, while the onset of symptoms has to oc- testinal disorder that affects 5% to 15% of the general cur at least 6 months prior to diagnosis (1,2). population, moreso women than men (ratio 2:1). IBS According to Roma IV criteria, IBS can be classified is defined, according to Roma IV criteria, as the pres- as follows: ence of recurrent abdominal pain on average at least - IBS that manifests itself mainly with constipation 1 day per week during the previous 3 months (1-3). (IBS-C); Furthermore, in order to make a correct diagnosis, the - IBS that manifests itself mainly with diarrhoea (IBS- pain should be associated with at least two of the fol- D); lowing symptoms or clinical signs: - Mixed type IBS (IBS-M), in which there is an alter- - related to defecation; nation of diarrhoea and constipation; - related to a change in evacuation frequency; - Unclassified IBS (IBS-U). A mixture of vegetable extracts (chamomile, passionflower, caraway, fennel) and enzymes (beta-galactosidase) for Irritable Bowel Syndrome (IBS) 527 Stool classification is based on the Bristol Stool Scale COX–LOX dependent and antispasmodic, sedative (1,4). and hypnotic effects (7); IBS could be also classified as: − Passionflower and Melissa: they have a sedative effect - sporadic IBS (or not specific IBS); mediated by the GABAergic system (8-10); - post-infectious IBS (PI-IBS); − Melissa: it adjusts the digestive processes thanks to - IBS associated with Inflammatory Bowel Diseases its ability to moderate the frequency and the size of (IBD) (IBD-IBS) (1,3,5). the slow intestinal waves, by doing so it has a myor- The syndrome produces psychological disorders elaxant effect (8,9); in patients who are affected and severely limits their − Caraway and Fennel: they reduce the mobility of the lifestyle, as health-care utilization, and daily activities, smooth intestinal muscle as a result of the release of such as work productivity, intimacy, leisure activities, acetylcholine (10,11); interpersonal relationships, and eating habits. − Beta-galactosidase: it increases the digestibility of lac- Dietary measures may include fibre supplementa- tose. tion in order to improve the symptoms of constipation and diarrhoea; polycarbophil compounds (eg, Citru- cel, FiberCon) to produce less flatulence than psyllium Materials and Methods compounds (eg, Metamucil); judicious water intake, especially for those patients who predominantly expe- Despite the double-masked, randomized, placebo rience constipation; caffeine avoidance in order to lim- controlled, parallel-group trial is the gold standard for it anxiety and symptom exacerbation; legume avoid- testing the efficacy of new treatments, we designed an ance in order to decrease abdominal bloating. Lactose, open label, prospective observational study, due to the fructose, and/or FODMAPs (fermentable oligosac- higher placebo rates found in European randomized charides, disaccharides, monosaccharides, and polyols) controlled trials (RCTs) compared with those con- should be limited or avoided in patients with these ducted in other continents, in trials evaluating anti- contributing disorders. Probiotics are being studied for spasmodics, and in trials using shorter duration of their use in decreasing IBS symptoms (6). therapy. Pharmacologic agents used for the management This prospective observational study involved of symptoms in IBS include the following: primary care physicians (11 in total); each doctor re- • Anticholinergics (eg, dicyclomine, hyoscyamine); cruited a maximum of 20 consecutive patients suffer- • Antidiarrheals (eg, diphenoxylate, loperamide); ing from IBS. In the present study, 183 consecutive • Tricyclic antidepressants (eg, imipramine, amitriptyline); patients were recruited. • Prokinetic agents; The patients were consecutively recruited and • Bulk-forming laxatives; successively classified, according to Rome IV criteria, • Serotonin receptor antagonists (eg, alosetron); in IBS-C, IBS-D, IBS-M and IBS-U. • Chloride channel activators (eg, lubiprostone); We excluded patients: • Guanylate cyclase C (GC-C) agonists (eg, linaclo- − with any alarm symptoms; tide, plecanatide); − with any unexplained weight loss; • Antispasmodics (eg, peppermint oil, pinaverium, tri- − with any uninvestigated rectal bleeding; mebutine, cimetropium/dicyclomine); − with past or present disease likely to complicate the • Altering bacterial flora and gas formation (eg, rifaximin). evaluation of the study; In this open-label prospective observational study we − with abdominal pain relieved by acid-inhibiting aimed to investigate the clinical efficacy of Spasmicol®,, drugs; a nature-derived dietary supplement which acts effec- − with pregnancy or lactation; tively in IBS patients, thanks to the synergistic combi- − with inability to complete the questionnaire; nation of the following constituents: − with family history of bowel cancer in a first or sec- − Chamomile: it has an anti-inflammatory effect ond-degree relative; 528 G. Tomasello, V. D. Palumbo, E. Sinagra, et al. − with a recent (12 month) history of assumption of − an assessment of stool consistency, by using the Bris- benzodiazepines, antidepressants, barbiturates, psy- tol Stool Form Scale (a type 3 or 4 score was con- chotropics, analgesics, prokinetics (cisapride, me- sidered as a normalized consistency, with a baseline toclopramide), bulk laxatives, antispasmodics, an- type 5, 6 or 7 score); tidiarrhoeal agents, alternative medicines as herbal − if they have a complete spontaneous bowel move- compounds. ments (CSBM) per week greater than 3/week. We identified, accordingly: All the patients were treated with a daily oral in- − 76/183 patients with IBS-M; take of Spasmicol® 500 mg (Aristeia farmaceutici s.r.l., − 40 patients with IBS-C; Valguarnera, Italy). The chewable tablets were admin- − 40 patients with IBS-D; istered two times daily, before the main meals, for 30 − 24 patients with IBS-U. days. All the patients were re-evaluated at the end of In IBS-C patients, we evaluated, with a binary re- the study (t1). Four patients (2.1%, 2 females) were dis- sponse (yes/no), if they have a satisfactory relief of their carded due to their scarce adherence to therapy (they IBS symptoms during the past week (with particular did not take the drug constantly). attention to abdominal pain and altered bowel habits, Finally, safety was also assessed, while quality of considering in this case a complete spontaneous bowel life was not assessed. movements (CSBM) per week superior to 3/week). Table 1 and 2 shows bowel habits variations and pain In IBS-D patients, we evaluated, with a binary relief, respectively, after 30 days of treatment with response (yes/no): Spasmicol®. − an assessment of stool consistency, by using the Bris- Data
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