s-5682 and Hemorrhoids

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Clinical Trials as Topic; Diosmin; Double-Blind Method; Drug Combinations; Female; Flavonoids; Hemorrhoids; Hesperidin; Humans; Lymphedema; Male; Middle Aged; Placebos; Platelet Aggregation Inhibitors; Pregnancy; Thrombophlebitis; Time Factors

Control of postoperative symptoms is of paramount importance in ambulatory surgery. This trial was conducted to evaluate whether a micronized purified flavonoid fraction (MPFF) (Detralex((R))) reduces postoperative bleeding, pain and consumption of analgesics after ambulatory stapled hemorrhoidopexy, as reported in trials after classic hemorrhoidectomy. Phlebotropic activity, protective effect on the capillaries and anti-inflammatory properties of this drug have been reported in several studies.. Sixty-three patients with third-degree hemorrhoids had ambulatory stapled hemorrhoidopexy under spinal anesthesia in the period of one year. The patients were randomized, with 30 receiving Detralex 500 mg (2 tablets 3 times daily for 5 days after the operation) and 33 forming the control group. The patients were asked to daily self-assess the presence of blood on defecation, degree of pain and consumption of analgesics for the first week after the operation.. There was no significant difference between the two groups in duration of presence of blood, degree of pain or analgesics requirement. No major complications, such as bleeding requiring transfusion or hospitalization, sepsis, anal stenosis or urgent defecation, were noted in the follow-up period. There were no side effects from Detralex treatment.. In our study we could not demonstrate any positive effect of prescribing flavonoids after stapler hemorrhoidopexy. This procedure may not be sufficiently aggressive and is associated with too few postoperative complications to show any protective influence of flavonoids.

Topics: Analgesics; Anti-Inflammatory Agents; Diosmin; Drug Combinations; Female; Flavonoids; Hemorrhoids; Hesperidin; Humans; Intestinal Mucosa; Male; Melena; Middle Aged; Pain, Postoperative; Pelvic Pain; Surgical Stapling; Treatment Outcome

A prospective randomized controlled trial was carried out on the effects of Daflon 500 mg (a micronized flavonidic fraction containing diosmin 450 mg and hesperidin 50 mg) on bleeding after haemorrhoidectomy. In all, 228 consecutive patients with prolapsed irreducible piles were recruited. Elective haemorrhoidectomy was performed with a standardized diathermy excision method. Some 114 patients were randomized to receive Daflon 500 mg for 1 week after operation (group 1), and there were 114 controls (group 2). Postoperative analgesia and laxative prescription as well as hospital stay were otherwise the same. One patient (0.9 per cent) from group 1 and seven (6.1 per cent) from group 2 had postoperative bleeding (P = 0.03). All bleeding occurred from 6 to 15 days after haemorrhoidectomy. There were no side-effects from the use of Daflon 500 mg. The risk of secondary bleeding from haemorrhoidectomy is reduced with postoperative Daflon.

Topics: Adult; Diosmin; Drug Combinations; Female; Flavonoids; Hemorrhage; Hemorrhoids; Hesperidin; Humans; Male; Postoperative Complications; Prospective Studies

One hundred patients with a history of hemorrhoidal disease and suffering from an acute hemorrhoidal attack were randomized into two parallel groups and treated with Daflon 500 mg* (D500) or placebo (PL) under double-blind conditions. Daflon 500 mg was administered at the dosage of three tablets bid the first four days and two tablets bid the following three days. Overall improvement of symptoms was greater in the D500 group than in the PL group, from D2 up to D7. The clinical severity of proctorrhagia, anal discomfort, pain, and anal discharge diminished in both groups but to a greater extent in the D500 group (P < 0.001 for all parameters except protorrhagia, P = 0.006). Inflammation, congestion, edema, and prolapse were more markedly improved in the D500 group than in the PL group. Duration and severity of the current hemorrhoidal episode, as assessed by patient self-evaluation, were less important in the D500 group as compared with previous episodes. Use of analgesics and topical medications diminished in both groups, with a major reduction in the D500 group from D4 (P < 0.001). Acceptability was good in both groups: no patient experienced major side effects. In summary, treatment with D500 resulted in a quicker and more pronounced relief of signs and symptoms of acute hemorrhoids than with the placebo.

Topics: Acute Disease; Adult; Aged; Diosmin; Double-Blind Method; Drug Combinations; Female; Flavonoids; Hemorrhoids; Hesperidin; Humans; Male; Middle Aged

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.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Chronic Disease; Diosmin; Double-Blind Method; Drug Combinations; Female; Flavonoids; Hemorrhoids; Hesperidin; Humans; Male; Middle Aged

This study was conducted to determine the frequency of complaints in a cohort of patients with symptomatic hemorrhoidal disease (HD) treated with micronized purified flavonoid fraction (MPFF, Detralex). MPFF was selected for conservative treatment in this population owing to its proven effects on hemorrhoidal symptoms in a large number of patients.. This multicenter, non-interventional study was part of the international CHORUS survey (Chronic venous and HemORrhoidal diseases evalUation for improvement of Scientific knowledge), conducted in nine centers in different regions of Russia with the participation of 80 coloproctologists. The study enrolled consecutive patients with complaints of hemorrhoids. All were prescribed MPFF-based conservative treatment. The effect of treatment on HD clinical signs and symptoms was assessed at two follow-up visits performed 5-7 days and 25-30 days after enrollment. Surgical and minimally invasive treatment could be performed from day 7 onwards if required.. A total of 1952 patients were enrolled. Over the entire period of observation, MPFF-based conservative treatment was effective in 1489 (76.3%) patients in eliminating the main clinical manifestations of disease, i.e., bleeding and prolapse of internal nodes. Invasive treatment was performed in 68 (3.5%) patients with grade IV hemorrhoids and was combined with MPFF conservative treatment in 395 (20.2%) patients with grades I-III hemorrhoids.. Conservative therapy with MPFF was beneficial for relieving hemorrhoidal symptoms in the majority of patients. MPFF-based treatment was most effective in patients with grade I and II hemorrhoids before irreversible degenerative changes in ligaments of the hemorrhoidal plexuses have occurred. It was also beneficial in preventing disease relapse in patients with more advanced HD and for promoting optimal conditions in the postoperative period.. Servier.

Topics: Adult; Chronic Disease; Conservative Treatment; Diosmin; Drug Combinations; Female; Flavonoids; Hemorrhage; Hemorrhoids; Hesperidin; Humans; Male; Middle Aged; Russia; Secondary Prevention; Severity of Illness Index; Symptom Assessment; Treatment Outcome

Topics: Diosmin; Drug Combinations; Flavonoids; Hemorrhoids; Hesperidin; Humans; Venous Insufficiency

Daflon 500 mg is a new flavonoid vasoprotector venotonic agent whose active principle is micronized and contains 90% diosmin and 10% flavonoids expressed as hesperidin. In animal studies, the safety of Daflon 500 mg is shown by an LD50 (lethal dose 50) of more than 3 g/kg, ie, 180 times the daily therapeutic dose, as well as by the absence of any toxic effect after repeated oral dosing for thirteen and twenty-six weeks, using a dose representing 35 times the daily dosage, in the rate and primate. Daflon 500 mg has no mutagenic action nor any significant effect on reproductive function. Gastrointestinal tolerance is good when administered orally in the rat. Transplacental passage and passage into breast milk are minimal. In the rat, 0.003% of the administered dose has been found in each fetus and 1% in breast milk. Clinical trials fulfill international scientific requirements and have collected more than 2850 patients treated with Daflon 500 mg at the dosage of two tablets per day for six weeks to one year. The proportion of patients with side effects (10% of those treated), essentially of a gastrointestinal or autonomic nature and leading to a rate of only 1.1% trial dropouts, is less than described in 225 patients given a placebo (13.9%) in controlled trials. Satisfactory clinical acceptability already confirmed in the short term was equally found in long-term treatment. Hemodynamic parameters (systolic and diastolic blood pressure) as well as laboratory parameters (hematology, liver and renal function, metabolic) were uninfluenced even by prolonged treatment for one year at the dosage of two tablets per day.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Animals; Clinical Trials as Topic; Diosmin; Drug Combinations; Flavonoids; Hemorrhoids; Hesperidin; Humans; Mice; Rats; Rats, Wistar; Venous Insufficiency