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      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

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          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.

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          Most cited references33

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          In vitro antioxidant properties of rutin

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            Chemistry and pharmacology of the Citrus bioflavonoid hesperidin.

            Hesperidin, a bioflavonoid, is an abundant and inexpensive by-product of Citrus cultivation. A deficiency of this substance in the diet has been linked with abnormal capillary leakiness as well as pain in the extremities causing aches, weakness and night leg cramps. No signs of toxicity have been observed with the normal intake of hesperidin or related compounds. Both hesperidin and its aglycone hesperetin have been reported to possess a wide range of pharmacological properties. This paper reviews various aspects of hesperidin and its related compounds, including their occurrence, physical and chemical properties, analysis, pharmacokinetics, safety and toxicity and the marketed products available. A special emphasis has been laid on the pharmacological properties and medicinal uses of these compounds. Copyright 2001 John Wiley & Sons, Ltd.
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              Hemorrhoids: from basic pathophysiology to clinical management.

              This review discusses the pathophysiology, epidemiology, risk factors, classification, clinical evaluation, and current non-operative and operative treatment of hemorrhoids. Hemorrhoids are defined as the symptomatic enlargement and distal displacement of the normal anal cushions. The most common symptom of hemorrhoids is rectal bleeding associated with bowel movement. The abnormal dilatation and distortion of the vascular channel, together with destructive changes in the supporting connective tissue within the anal cushion, is a paramount finding of hemorrhoids. It appears that the dysregulation of the vascular tone and vascular hyperplasia might play an important role in hemorrhoidal development, and could be a potential target for medical treatment. In most instances, hemorrhoids are treated conservatively, using many methods such as lifestyle modification, fiber supplement, suppository-delivered anti-inflammatory drugs, and administration of venotonic drugs. Non-operative approaches include sclerotherapy and, preferably, rubber band ligation. An operation is indicated when non-operative approaches have failed or complications have occurred. Several surgical approaches for treating hemorrhoids have been introduced including hemorrhoidectomy and stapled hemorrhoidopexy, but postoperative pain is invariable. Some of the surgical treatments potentially cause appreciable morbidity such as anal stricture and incontinence. The applications and outcomes of each treatment are thoroughly discussed.
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                Author and article information

                Contributors
                Journal
                Front Pharmacol
                Front Pharmacol
                Front. Pharmacol.
                Frontiers in Pharmacology
                Frontiers Media S.A.
                1663-9812
                14 December 2021
                2021
                : 12
                : 773320
                Affiliations
                Department of Precision Medicine, University of Campania Luigi Vanvitelli, Naples, Italy
                Author notes

                Edited by: Angelo A. Izzo, University of Naples Federico II, Italy

                Reviewed by: Giada Maramaldi, Givaudan, France

                Talha Bin Emran, Begum Gulchemonara Trust University, Bangladesh

                Ian James Martins, University of Western Australia, Australia

                Md Munan Shaik, Cedilla Therapeutics, United States

                *Correspondence: Antonietta G. Gravina, antoniettagerarda.gravina@ 123456unicampania.it

                This article was submitted to Gastrointestinal and Hepatic Pharmacology, a section of the journal Frontiers in Pharmacology

                Article
                773320
                10.3389/fphar.2021.773320
                8712720
                ccbdb427-bb78-4a7e-a739-749c47e856c3
                Copyright © 2021 Gravina, Pellegrino, Facchiano, Palladino, Loguercio and Federico.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 09 September 2021
                : 15 November 2021
                Categories
                Pharmacology
                Original Research

                Pharmacology & Pharmaceutical medicine
                hemorrhoidal disease,flavonoids,vitamin c,centella asiatica,vaccinium myrtillus,vitis vinifera

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