V S Groshilin, V K Shvetsov, A A Kolesnichenko, A B Alnikin, M I Sultanmuradov, V E Bardakhchyan, V D Kuznecov, A S Arkhipov
{"title":"[Treatment of acute hemorrhoids according to the results of a multicenter observational study].","authors":"V S Groshilin, V K Shvetsov, A A Kolesnichenko, A B Alnikin, M I Sultanmuradov, V E Bardakhchyan, V D Kuznecov, A S Arkhipov","doi":"10.17116/hirurgia2025031112","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The issue of improving hemorrhoid treatment outcomes in outpatient practice is one of the most pressing in the daily work of coloproctologists today. Advances in the treatment of hemorrhoidal disease, the most common pathological condition in general proctology, in recent decades have been associated not only with the adoption of minimally invasive surgical techniques but also with the enhancement of pharmacological therapy. A key component of systemic pharmacotherapy for chronic and acute hemorrhoids is the use of venotonic drugs, including flavonoids which are included in the clinical guidelines. Therefore, a comprehensive and reliable evaluation of the clinical efficacy of diosmin is an important area of research, especially in cases of acute hemorrhoids.</p><p><strong>Objective: </strong>The study aimed to assess the effectiveness of using Phlebodia 600 and evaluate the dynamics of patients' quality of life with acute hemorrhoids of grades I-II in outpatient practice without employing minimally invasive surgical methods.</p><p><strong>Material and methods: </strong>A Russian multicenter prospective observational study was conducted involving an adult population of patients with grade I-II acute hemorrhoids in the city of Rostov-on-Don and the Rostov region. Outpatients (both men and women) aged 18 to 64 with a confirmed diagnosis of grade I-II acute hemorrhoids (thrombosis of external or internal hemorrhoidal nodes, including those with bleeding) established through standardized clinical examination were included. Therapy with Phlebodia 600 (diosmin) commenced no later than three days after the onset of clinical symptoms, which included a dominant set of symptoms such as enlarged hemorrhoidal nodes, pain, bleeding, anal itching, burning, or discomfort. The total sample size analyzed was 220 patients, and the medication was administered for at least 36 days.</p><p><strong>Results: </strong>The use of Phlebodia 600 for grade I-II acute hemorrhoids allowed for the resolution of complaints and stabilization of all key clinical parameters within the timeframes set by the study design. Following the proposed treatment regimen, early resolution and reduction of complaints such as pain, discomfort, itching, and blood streaks during defecation were observed by the control visit after seven days of therapy, compared to baseline. In 73% of cases, a reduction in the size of hemorrhoidal nodes was noted within this period. The proposed treatment regimen can be considered rational since, after 30 days, not only was there consistent resolution of complaints in the majority of patients, but there was also a significant improvement in quality of life (SF-36). No cases of intolerance to Phlebodia 600 or adverse reactions associated with its use were identified, indicating a high safety profile.</p><p><strong>Conclusions: </strong>A 35-40 day course of Phlebodia 600 administered continuously according to the manufacturer's recommended regimen effectively reduces the severity and frequency of major complaints in patients with grade I-II acute hemorrhoids. This is achieved through improved microcirculation, venotonic, anti-inflammatory, and anti-edema effects. Diosmin (Phlebodia 600) favourable safety profile has been demonstrated. in acute hemorrhoids.</p>","PeriodicalId":35986,"journal":{"name":"Khirurgiya","volume":" 3","pages":"112-123"},"PeriodicalIF":0.0000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Khirurgiya","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.17116/hirurgia2025031112","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
[Treatment of acute hemorrhoids according to the results of a multicenter observational study].
Background: The issue of improving hemorrhoid treatment outcomes in outpatient practice is one of the most pressing in the daily work of coloproctologists today. Advances in the treatment of hemorrhoidal disease, the most common pathological condition in general proctology, in recent decades have been associated not only with the adoption of minimally invasive surgical techniques but also with the enhancement of pharmacological therapy. A key component of systemic pharmacotherapy for chronic and acute hemorrhoids is the use of venotonic drugs, including flavonoids which are included in the clinical guidelines. Therefore, a comprehensive and reliable evaluation of the clinical efficacy of diosmin is an important area of research, especially in cases of acute hemorrhoids.
Objective: The study aimed to assess the effectiveness of using Phlebodia 600 and evaluate the dynamics of patients' quality of life with acute hemorrhoids of grades I-II in outpatient practice without employing minimally invasive surgical methods.
Material and methods: A Russian multicenter prospective observational study was conducted involving an adult population of patients with grade I-II acute hemorrhoids in the city of Rostov-on-Don and the Rostov region. Outpatients (both men and women) aged 18 to 64 with a confirmed diagnosis of grade I-II acute hemorrhoids (thrombosis of external or internal hemorrhoidal nodes, including those with bleeding) established through standardized clinical examination were included. Therapy with Phlebodia 600 (diosmin) commenced no later than three days after the onset of clinical symptoms, which included a dominant set of symptoms such as enlarged hemorrhoidal nodes, pain, bleeding, anal itching, burning, or discomfort. The total sample size analyzed was 220 patients, and the medication was administered for at least 36 days.
Results: The use of Phlebodia 600 for grade I-II acute hemorrhoids allowed for the resolution of complaints and stabilization of all key clinical parameters within the timeframes set by the study design. Following the proposed treatment regimen, early resolution and reduction of complaints such as pain, discomfort, itching, and blood streaks during defecation were observed by the control visit after seven days of therapy, compared to baseline. In 73% of cases, a reduction in the size of hemorrhoidal nodes was noted within this period. The proposed treatment regimen can be considered rational since, after 30 days, not only was there consistent resolution of complaints in the majority of patients, but there was also a significant improvement in quality of life (SF-36). No cases of intolerance to Phlebodia 600 or adverse reactions associated with its use were identified, indicating a high safety profile.
Conclusions: A 35-40 day course of Phlebodia 600 administered continuously according to the manufacturer's recommended regimen effectively reduces the severity and frequency of major complaints in patients with grade I-II acute hemorrhoids. This is achieved through improved microcirculation, venotonic, anti-inflammatory, and anti-edema effects. Diosmin (Phlebodia 600) favourable safety profile has been demonstrated. in acute hemorrhoids.