Evaluation of the Efficacy and Safety of a Compound of Micronized Flavonoids in Combination With Vitamin C and Extracts of Centella asiatica, Vaccinium myrtillus, and Vitis vinifera for the Reduction of Hemorrhoidal Symptoms in Patients With Grade II and III Hemorrhoidal Disease: A Retrospective Real-Life Study

Abstract

Background and Aim: Several evidences have shown how, in hemorrhoidal disease, phlebotonic flavonoid agents such as quercetin reduce capillary permeability by increasing vascular walls resistance, how rutin and vitamin C have antioxidant properties, and that Centella asiatica has reparative properties towards the connective tissue. A retrospective study was designed in order to evaluate the efficacy and safety of a compound consisting of micronized flavonoids in combination with vitamin C and extracts of C. asiatica, Vaccinium myrtillus, and Vitis vinifera for grade II and III hemorrhoidal disease. Patients and Methods: Data of 49 patients, over 18, who were following a free diet regimen, not on therapy with other anti-hemorrhoid agents, treated with a compound consisting of 450 mg of micronized diosmin, 300 mg of C. asiatica, 270 mg of micronized hesperidin, 200 mg of V. vinifera, 160 mg of vitamin C, 160 mg of V. myrtillus, 140 mg of micronized quercetin, and 130 mg of micronized rutin (1 sachet or 2 tablets a day) for 7 days were collected. Hemorrhoid grade according to Goligher's scale together with anorectal symptoms (edema, prolapse, itching, thrombosis, burning, pain, tenesmus, and bleeding) both before treatment (T0) and after 7 days of therapy (T7) were collected. Primary outcomes were the reduction of at least one degree of hemorrhoids according to Goligher's scale assessed by proctological examination and compound safety. The secondary outcome was the reduction of anorectal symptoms assessed by questionnaires administered to patients. Results: Forty-four patients (89.8%) presented a reduction in hemorrhoidal grade of at least one grade (p < 0.001). No adverse events with the use of the compound were noted. A significant reduction was observed in all anorectal symptoms evaluated (p < 0.05). No predictors of response to the compound were identified among the clinical and demographic variables collected. Conclusion: The compound analyzed was effective and safe for patients with grade II and III hemorrhoidal disease according to Goligher's scale.

Keywords: Centella asiatica; Vaccinium myrtillus; Vitis vinifera; flavonoids; hemorrhoidal disease; vitamin C.

FIGURE 1

Flowchart describing the selection of patients for inclusion in the study. The number of patients excluded and the reasons for exclusion from the study are shown.

FIGURE 2

Improvement in hemorrhoidal symptoms, in terms of grade, at the different evaluation times, at baseline (T0), and after 7 days of treatment with the study compound (T7). Data in the histogram are presented as medians. Differences in the distribution of the symptom variable, in the interval T0–T7, and found to be statistically significant are highlighted with “*”.