Clinical Assessment of the Activity and the Tolerability of a Triticum Vulgare Extract-Containing Medical Device in Patients with Haemorrhoids

Abstract

Twenty outpatients suffering from symptomatic haemorrhoids were treated with a medical device in gel form containing watery extract of Triticum Vulgare, glycerine and Mucosave CG, given in three daily applications for 1-2 weeks. Signs and symptoms of haemorrhoids were evaluated at baseline (Visit 1) and after 1 (Visit 2) and 2 (Visit 3) weeks of treatment according to a 4-point rating scale (0 = absent, 1 = mild, 2 = moderate, 3 = intense). The primary variable of the study was the percentage of responder patients at Visit 2, defined as those patients in which the total Symptoms Score (TSS: sum of the scores of all symptoms) decreased at least 50% from the baseline value (V1). Two patients discontinued the treatment, one just before V2, inclusive of symptoms assessments, and another before V2 without evaluations. One patient did not attend V3. A decrease of at least 50% in TSS (i.e. a therapeutic success) was observed in 10 patients at week 1 and in 16 out of 17 patients at week 2. The mean TTS (mean baseline score: 8.47) decreased by 51% at week 1; a mean TTS score of 2 was observed at the end of study (p<0.05 vs baseline). Pain intensity and tenesmus were almost disappeared at the end of treatment. Improvements in burning and pruritus were evident just from week 1. Bleeding was present in almost all patients at baseline and greatly decreased from week 1. Mucorrhoea was present in 6 patients at baseline and disappeared during treatment. Interference with daily activities (mean baseline score: 1.8) significantly decreased at end of treatment (mean score: 0.4). No adverse events were recorded. The results of this study suggest that the device tested may represent an effective and safe method for the treatment of the haemorrhoids in symptomatic phase. (Study DAM/MD/001/12 approved by the Italian Ministry of Health).