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Indexed/Abstracted in: BIOSIS Previews, EMBASE, Scopus, Emerging Sources Citation Index
Online ISSN 1827-1812
Capanni M., Surrenti E., Biagini M. R., Milani S., Surrenti C., Galli A.
Unità di Gastroenterologia, Dipartimento di Fisiopatologia Clinica, Università di Firenze, Firenze
Aim. Irritable bowel syndrome (IBS) is a common gastroenteric, functional disease, characterized by abdominal pain, meteorism, and bowel habit alterations. A possible treatment is peppermint oil, having carminative and antispasmodic properties. We aimed to analyse the efficacy of enteric-coated peppermint oil formulation (Mintoil) in a randomized, controlled, double-blind study.
Methods. We enrolled 178 consecutive patients affected by IBS, according to the Rome II diagnostic criteria. They were randomized by computer-generated lists to receive either Mintoil 2 capsules t.i.d. before meals for 3 months, or a placebo. A validated questionnaire was administered every 3 weeks to measure the outcome. Data were analysed by χ2 test.
Results. Ninety-one patients (22 M, 69 F; mean age 41 yrs; range 18-72 yrs) received Mintoil, and 87 patients (23 M, 64 F; mean age 44 yrs; range 21-74 yrs) assumed the placebo. Three patients withdrew from the study because of non IBS-related diseases, and two patients because of pyrosis. No other adverse events were recorded. Peppermint oil, compared to placebo, improved IBS overall symptoms in 73/91 (80%) vs 31/87 (36%) patients (p<0.02). Particularly, significant improvements were achieved for gastroenteric symptoms, in 88/91 (97%) vs 29/87 (33%) patients (p<0.01), psychical discomfort, in 34/91 (37%) vs 16/87 (18%) patients (p<0.05), and socio-familiar impact, in 69/91 (76%) vs 37/87 (43%) patients (p<0.04).
Conclusion. Three-month therapy by Mintoil is effective and safe in patients with IBS. The proven questionnaire is useful for monitoring gastroenteric symptoms and quality of life.