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VenEase

CLINICAL STUDIES ON THE FOLLOWING INGREDIENTS:

Diosmin/ Hesperidin/ MPFF

Diosmin-induced increase in sensitivity to Ca2+ of the smooth muscle contractile apparatus in the rat isolated femoral vein

Abstract

The effect of diosmin, a flavone derivative, on the Ca2+ sensitivity of the venous contractile apparatus was investigated in chemically (beta-escin) skinned strips from the rat isolated femoral vein. Diosmin (0.5-10 microM) shifted to the left the concentration-response curve to Ca2+ (0.05-5 microM). The maximal effect was observed in the presence of 1 microM diosmin which increased the contractile response evoked by 0.15 microM Ca2+ from 26.3% to 78.9% of the maximal Ca(2+)-induced response. This work demonstrates that the venotonic action of diosmin involves an increase in the Ca2+ sensitivity of the contractile apparatus. Such a mechanism of action could represent a new and important means of therapeutic control of vasomotor activity.

Source: Savineau JP, Marthan R. "Diosmin-induced increase in sensitivity to Ca2+ of the smooth muscle contractile apparatus in the rat isolated femoral vein." Br J Pharmacol. (1994);111(4):978-80.

Daflon 500 mg in the management of acute and recurrent hemorrhoidal disease

Abstract

Daflon 500 mg seems to offer a comprehensive pharmacological answer to all the needs of hemorrhoid treatment. Firstly, the flavonoids, including Daflon 500 mg, have been demonstrated to restain lysosome enzymes and interfere with enzymes involved in the flow of arachidonic acid, which causes inflammation.2 Daflon 500 mg has also demonstrated an antioxidant activity, which allows it to oppose free radicals,3 as well as a decreasing effect on the synthesis of PGE-2 and TXA-2 by the macrophage.4 All these effects result in a reduction of the pericapillar permeability,5 and an increase in the capillary resistance to blood extravasation in the interstitium. The hemodynamic effect manifests itself through an increase in venous tone demonstrated both experimentally6 and clinically.7 Regarding clinical benefits, two recent studies have demonstrated the outstanding efficacy of Daflon 500 mg, both in acute and recurrent attacks.

Source: Referenced online 6/23/2022: https://www.phlebolymphology.org/daflon-500-mg-in-the-management-of-acute-and-recurrent-hemorrhoidal-disease/

Daflon 500 mg in the treatment of hemorrhoidal disease: a demonstrated efficacy in comparison with placebo

Abstract

Hemorrhoidal disease (HD) is a trophic disorder of the anal canal characterized by recurrent, self-resolving acute episodes. The author reports the results of a double-blind, placebo-controlled trial of the efficacy of Daflon 500 mg in the treatment of acute and chronic symptoms of hemorrhoids. One hundred and twenty outpatients (54 men, 66 women) suffering from an acute episode of HD during the previous two months were included. They received Daflon 500 mg (group D, n = 60) or placebo (group P, n = 60) two tablets daily for two months. The patients were examined at entry (T0) and at two months (T2). At T0, the two groups did not differ in terms of age, sex, weight, height, history of symptoms of HD; 7 patients were excluded from analysis because of treatment failure (group D, n = 2; group P, n = 3), or lost to follow-up (group P, n = 2). In group D, 40% of patients had an attack during the trial with a mean duration of 2.6 days and a mean severity of 1.1 scored on a scale from 1 to 3. These values were significantly different (P < 0.01) from the corresponding values in the P group: 70%, 4.6 days and 1.6 respectively. Each symptom and sign was scored on a scale of severity. The overall symptom score, scored from 0 to 15, decreased from 6.6 (group D) and 6.1 (group P) (NS) to 1.1 and 4.0 respectively (P < 0.01) at the end of treatment.

Source: Godeberge P. "Daflon 500 mg in the treatment of hemorrhoidal disease: a demonstrated efficacy in comparison with placebo." Angiology. (1994);45(6 Pt 2):574-8.

Phlebotonics for haemorrhoids

Abstract

Background: Haemorrhoids are variceal dilatations of the anal and perianal venous plexus and often develop secondary to the persistently elevated venous pressure within the haemorrhoidal plexus (Kumar 2005). Phlebotonics are a heterogenous class of drugs consisting of plant extracts (i.e. flavonoids) and synthetic compounds (i.e. calcium dobesilate). Although their precise mechanism of action has not been fully established, they are known to improve venous tone, stabilize capillary permeability and increase lymphatic drainage. They have been used to treat a variety of conditions including chronic venous insufficiency, lymphoedema and haemorrhoids.Numerous trials assessing the effect of phlebotonics in treating the symptoms and signs of haemorrhoidal disease suggest that there is a potential benefit.

Objectives: The aim of this review was to investigate the efficacy of phlebotonics in alleviating the signs, symptoms and severity of haemorrhoidal disease and verify their effect post-haemorrhoidectomy.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library 2011 issue 9 , MEDLINE (1950 to September 2011) and EMBASE (1974 to September 2011).

Selection criteria: Only randomised controlled trials evaluating the use of phlebotonics in treating haemorrhoidal disease were used. No cross-over or cluster-randomized trials were included for analysis and any trial which had a quasi-random method of allocation was excluded.

Data collection and analysis: Two authors independently extracted the data and analysed the eligibility of the data for inclusion. Disagreements were resolved by meaningful discussion.

Main results: We considered twenty-four studies for inclusion in the final analysis. Twenty of these studies (enrolling a total of 2344 participants) evaluated the use of phlebotonics versus a control intervention. One of these twenty studies evaluated the use of phlebotonics with a medical intervention and another study with rubber band ligation.The remaining four studies included two which compared different forms of phlebotonics with each other, one study which evaluated phlebotonics with a medical intervention and one study which compared the use of phlebotonics with infrared photocoagulation. Eight studies were excluded for various reasons including poor methodological quality.Phlebotonics demonstrated a statistically significant beneficial effect for the outcomes of pruritus (OR 0.23; 95% CI 0.07 to 0.79) (P=0.02), bleeding (OR 0.12; 95% CI 0.04 to 0.37) (P=0.0002), bleeding post-haemorrhoidectomy (OR 0.18; 95% 0.06 to 0.58)(P=0.004), discharge and leakage (OR 0.12; 95% CI 0.04 to 0.42) (P=0.0008) and overall symptom improvement (OR 15.99 95% CI 5.97 to 42.84) (P< 0.00001), in comparison with a control intervention. Although beneficial they did not show a statistically significant effect compared with a control intervention for pain (OR 0.11; 95% CI 0.01 to 1.11) (P=0.06), pain scores post-haemorrhoidectomy (SMD -1.04; 95% CI -3.21 to 1.12 ) (P= 0.35) or post-operative analgesic consumption (OR 0.54; 95% CI 0.30 to 0.99)(P=0.05).

Authors' conclusions: The evidence suggests that there is a potential benefit in using phlebotonics in treating haemorrhoidal disease as well as a benefit in alleviating post-haemorrhoidectomy symptoms. Outcomes such as bleeding and overall symptom improvement show a statistically significant beneficial effect and there were few concerns regarding their overall safety from the evidence presented in the clinical trials.However methodological limitations were encountered. In order to enhance our conclusion further, more robust clinical trials which take into account these limitations will need to be performed in the future.

Source: Perera N, Liolitsa D, Iype S, Croxford A, Yassin M, Lang P, Ukaegbu O, van Issum C. "Phlebotonics for haemorrhoids."Cochrane Database Syst Rev. (2012);(8):CD004322.

Horse Chestnut

Hemorrhoids and varicose veins: a review of treatment options

Abstract

Hemorrhoids and varicose veins are common conditions seen by general practitioners. Both conditions have several treatment modalities for the physician to choose from. Varicose veins are treated with mechanical compression stockings. There are several over-the-counter topical agents available for hemorrhoids. Conservative therapies for both conditions include diet, lifestyle changes, and hydrotherapy which require a high degree of patient compliance to be effective. When conservative hemorrhoid therapy is ineffective, many physicians may choose other non-surgical modalities: injection sclerotherapy, cryotherapy, manual dilation of the anus, infrared photocoagulation, bipolar diathermy, direct current electrocoagulation, or rubber band ligation. Injection sclerotherapy is the non-surgical treatment for primary varicose veins. Non-surgical modalities require physicians to be specially trained, own specialized equipment, and assume associated risks. If a non-surgical approach fails, the patient is often referred to a surgeon. The costly and uncomfortable nature of treatment options often lead a patient to postpone evaluation until aggressive intervention is necessary. Oral dietary supplementation is an attractive addition to the traditional treatment of hemorrhoids and varicose veins. The loss of vascular integrity is associated with the pathogenesis of both hemorrhoids and varicose veins. Several botanical extracts have been shown to improve microcirculation, capillary flow, and vascular tone, and to strengthen the connective tissue of the perivascular amorphous substrate. Oral supplementation with Aesculus hippocastanum, Ruscus aculeatus, Centella asiatica, Hamamelis virginiana, and bioflavonoids may prevent time-consuming, painful, and expensive complications of varicose veins and hemorrhoids.

Source: MacKay D. "Hemorrhoids and varicose veins: a review of treatment options." Altern Med Rev. (2001);6(2):126-40.

Escin: a review of its anti-edematous, anti-inflammatory, and venotonic properties

Abstract

This review discusses historical and recent pharmacological and clinical data on the anti-edematous, anti-inflammatory, and venotonic properties of escin (Reparil®). Escin, the active component of Aesculus hippocastanum, or horse chestnut, is available as orally absorbable dragées and as a transdermal gel. The anti-inflammatory and anti-edematous effects of escin have been studied over many years in pre-clinical models. More recent data confirm the anti-inflammatory properties of escin in reducing vascular permeability in inflamed tissues, thereby inhibiting edema formation. The venotonic effects of escin have been demonstrated primarily by in vitro studies of isolated human saphenous veins. The ability of escin to prevent hypoxia-induced disruption to the normal expression and distribution of platelet endothelial cell-adhesion molecule-1 may help explain its protective effect on blood vessel permeability. Escin oral dragées and transdermal gel have both demonstrated efficacy in blunt trauma injuries and in chronic venous insufficiency. Both oral escin and the transdermal gel are well tolerated.

Source: Gallelli L. "Escin: a review of its anti-edematous, anti-inflammatory, and venotonic properties." Drug Des Devel Ther. (2019);13:3425-3437.

Rutin

Clinical study for the evaluation of the tolerability of O-(beta-hydroxy-ethyl)-rutoside in the treatment of hemorrhoids during the 3d trimester of pregnancy and in the postpartum period

Abstract

Hemorrhoidal disease is particularly frequent in the last trimester of pregnancy and immediately after birth. The aim of the present study was to evaluate the efficacy and tolerability of high doses of O-(beta-hydroxyethyl)-rutoside in patients affected by this pathology. Forty-two women with hemorrhoid varices of varying severity which had appeared during the last trimester of pregnancy or immediately post-partum were treated by administering 3 g/day of the substance in question for 14 consecutive days. At the start and end of treatment a series of clinical and objective parameters were measured and at the end of treatment efficacy and tolerability were assessed. The latter was found to be excellent; in fact, it was not necessary to suspend treatment in any of the subjects treated. Clinical efficacy, assessed by the researcher, was judged to be positive in 95% of cases treated. Clinical improvements in the parameters examined were statistically significant (p < 0.01). The results obtained confirm the value of oral therapy using O-(beta-hydroxyethyl)-rutoside in pregnant or puerperal patients since the preparation was found to be efficacious and easily managed, above all significantly reducing pain, subjectively the most urgent symptom to be treated.

Source: Benzi G, Vanzulli A, Pozzi E, Acerboni S. "Clinical study for the evaluation of the tolerability of O-(beta-hydroxy-ethyl)-rutoside in the treatment of hemorrhoids during the 3d trimester of pregnancy and in the postpartum period." Minerva Ginecol. (1992);44(11):591-7.

 

References:
  1. https://www.phlebolymphology.org/daflon-500-mg-in-the-management-of-acute-and-recurrent-hemorrhoidal-disease/
  2. https://www.researchgate.net/figure/Harvest-of-small-immature-fruits-10-to-20-mm-in-diameter-to-produce-MPFF_fig2_309768797
  3. https://emedicine.medscape.com/article/775407-overview
  4. https://www.healthline.com/health/pregnancy/pregnancy-hemorrhoids#causes
  5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3342598/
  6. https://pubmed.ncbi.nlm.nih.gov/11141716/
  7. https://www.cvphysiology.com/Blood%20Flow/BF002
  8. https://totalhealthmagazine.com/Ingredient-Spotlight/The-ORANGE-is-for-More-Than-Juice-DIOSMIN-Protects-the-Veins-and-Beyond.html
  9. https://pubmed.ncbi.nlm.nih.gov/8032624/
  10. https://pubmed.ncbi.nlm.nih.gov/22895941/
  11. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6824339/
  12. https://www.colonrectalsurgeryassoc.com/2-painful-reasons-your-hemorrhoids-won-t-go-away
  13. https://www.medicinenet.com/hemorrhoids_piles/article.htm
  14. https://www.healthline.com/nutrition/horse-chestnut-benefits
  15. https://pubmed.ncbi.nlm.nih.gov/11302778/
  16. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6776292/
  17. https://pubmed.ncbi.nlm.nih.gov/1480309/
  18. https://my.clevelandclinic.org/health/diseases/21882-poor-circulation