Safety and Efficacy of Proctosoll Allevia in the Management of Haemorrhoidal Disease in Adults: A Prospective Randomized Clinical Trial

Sturiale, Alessandro; Gallo, Gaetano; Brusciano, Luigi; Cacace, Concetta; Cafaro, Danilo; Porzio, Felipe Celedon; Naldini, Gabriele

doi:10.2174/1574887115666200421110107

Cited by 6 publications

(4 citation statements)

References 22 publications

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“…It has been involved in several processes as tissue regeneration and matrix organization. It has been observed that local administration is effective helping wounds healing due to the barrier effect protecting the injured epithelium [16,17] .…”

Section: Discussionmentioning

confidence: 99%

Topical Treatment with Bergamot Flavonoid-Based Gel in Post-Surgical Wounds after Hemorrhoidectomy: Preliminary Results

Cafaro

Sturiale

Sinicropi

et al. 2022

ijirms

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Background: Haemorrhoidal Disease (HD) is a very diffuse anorectal condition that involves a large part of the population, both male and female of every age. Among the several procedures proposed to treat HD, conventional excisional surgery remains one of the most performed, it is characterized by important post-operative pain whose historical knowledge often scare the patients. The pain is mainly related to the anal wounds and the healing speed surely influence the post-operative course. The aim of this study was to evaluate the effect of using Benebeo Gel® on post-operative wound healing after open haemorrhoidectomy. Methods and Results: This was an observational prospective study conducted in the Proctological and Pelvic Floor Clinical Centre (PPFCC) of the University Hospital of Pisa. From April 2019 to January 2020 all the 175 patients aged between 18 and 75 undergone to open hemorrhoidectomy were enrolled. The post-operative follow-up was scheduled as follows: 7 day, 15 day, 22 days and 30 days after surgery. The primary end point was: time taken to get complete wound healing with a re-epithelized tissue. Secondary endpoints were: evaluate post-operative pain using VAS scale, bleeding, discharge and overall patients satisfaction about the procedure and the topical gel. All the patients were instructed to take topical gel by using the cannula provided with the product put it into the finger phalanx and then upon injured area twice a day (once in the morning after defecation and once before sleeping) for 25 days after. The administration of the product begins in 4th post-operative day. The mean post-operative pain at 7 days was 6±2, at 15 days 4±1 at 22 day 3 and at 30 days was 2±1. The mean time to get complete wound healing was 23±4 days. Conclusions: He present study aimed to evaluate the efficacy of a new topical gel mainly composed by bergamot-derived flavonoids and hyaluronic acid in patients treated with excisional hemorrhoidectomy. The results after 2 weeks of treatment seems to be promising with a very good clinical outcome and patient satisfaction within 1 month.

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Section: Discussionmentioning

confidence: 99%

Topical Treatment with Bergamot Flavonoid-Based Gel in Post-Surgical Wounds after Hemorrhoidectomy: Preliminary Results

Cafaro

Sturiale

Sinicropi

et al. 2022

ijirms

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“…Furthermore, non-surgical treatments such as topical and pharmacological approaches have not been fully effective. Treatment with Proctosoll Allevia ® was proven effective against I–II degree symptomatic hemorrhoids with a good profile of tolerability and safety ( 42 ). A clinical study by our group suggested that treatment with Anoac-H polyherbal formulation exhibited efficacy and safety in patients with bleeding hemorrhoids ( 25 ).…”

Section: Discussionmentioning

confidence: 99%

Polyherbal formulation Anoac‑H suppresses the expression of RANTES and VEGF for the management of bleeding hemorrhoids and fistula

Porwal¹,

Kundu

Bhagwat³

et al. 2021

Mol Med Rep

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Hemorrhoids and fistula are considered the most common anorectal conditions in the general population. These conditions affect the quality of a patient's life by causing pain and bleeding during defecation or even in the resting state. Lower grades of hemorrhoids may be controlled by traditional measures. However, surgery is an effective treatment option in recurrent-lower and higher-grade hemorrhoids. Surgical procedures are associated with various complications, including pain and delayed wound healing. Recurrence of hemorrhoids is also a major concern in the post-operative period. An anal fistula is the connection between the anus and the skin and causes severe pain, swelling, as well as blood and pus discharge. Fistula has serious social and economic consequences. Hence, it is important to understand the pathophysiology and molecular pathology of hemorrhoids and fistula, to identify the molecular targets and to develop pharmacological-interventions. In a previous study by our group, the polyherbal formulation Anoac-H was developed for the treatment of different stages of hemorrhoids and fistula, and it was demonstrated that Anoac-H is an effective formulation for treating hemorrhoids. However, the molecular mode of action of Anoac-H on hemorrhoids and fistula had remained elusive. In the present study, it was determined that this formulation reduces the migration of mesenchymal (fibroblasts) and immune (RAW 264.7) cells without affecting their viability. It was also observed that Anoac-H suppresses the expression of regulated upon activation, normal T cell expressed and presumably secreted (RANTES) and VEGF in fibroblasts and macrophages. Inflammation and elevated expression of RANTES and VEGF were observed in hemorrhoids and fistula. However, inflammation, as well as the expression of RANTES and VEGF, were significantly reduced in treated human hemorrhoid and fistula tissues as compared to untreated ones, confirming the in vitro results.

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“…Foram avaliados 45 indivíduos distribuídos em grupo 1 (tratado com Proctosoll Allevia® + dieta controlada) e grupo 2 (sem tratamento + dieta controlada). Aqueles tratados com o extrato apresentaram melhora dos sintomas num período 14 dias antes do grupo controle (Sturiale et al, 2020).…”

Section: Estudos Clínicos Randomizados Com Fitoterápicosunclassified

Uso de fitoterápicos na Doença Hemorroidária

Momm

Torresilha²,

Santos³

2023

RSD

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O presente estudo trata-se de uma revisão da literatura sobre o uso de fitoterápicos no tratamento da Doença Hemorroidária (DH), um tipo de patologia anorretal, cujo quadro clínico inclui sangramento ao evacuar, desconforto anal, prurido, dor e protrusão anal. Buscou-se reunir dados de ensaios clínicos, guidelines, estudos experimentais e revisões sistemáticas com o objetivo de apresentar os fitoterápicos que demonstraram eficácia no tratamento da DH, haja visto que seu manejo padrão apresenta diversos efeitos colaterais e complicações. Dentre fitoterápicos avaliados (ex.: Terminalia chebula Retz, Allium iranicum e Centella asiatica L.) mostraram melhora significativa, principalmente, nos parâmetros como: sangramento, diminuição da atividade inflamatória, e nos padrões clínicos e endoscópicos da doença. Portanto, há uma grande necessidade de introduzí-los como terapia alternativa ou coadjuvante ao tratamento convencional, e incentivar a realização de mais pesquisas que explorem sua eficácia clínica, assim cooperando para o aperfeiçoamento da qualidade de vida dos indivíduos acometidos.

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Safety and Efficacy of Proctosoll Allevia in the Management of Haemorrhoidal Disease in Adults: A Prospective Randomized Clinical Trial

Cited by 6 publications

References 22 publications

Topical Treatment with Bergamot Flavonoid-Based Gel in Post-Surgical Wounds after Hemorrhoidectomy: Preliminary Results

Topical Treatment with Bergamot Flavonoid-Based Gel in Post-Surgical Wounds after Hemorrhoidectomy: Preliminary Results

Polyherbal formulation Anoac‑H suppresses the expression of RANTES and VEGF for the management of bleeding hemorrhoids and fistula

Uso de fitoterápicos na Doença Hemorroidária

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