How we can improve patients' comfort after Milligan-Morgan open haemorrhoidectomy. Experimental comparative study of the efficacy and side effects of Cissus quadrangularis L. (Vitaceae) to Daflon (Servier) and placebo in the treatment of acute hemorrhoids. Randomized clinical trial of micronized flavonoids in the early control of bleeding from acute internal haemorrhoids. [Treatment of acute symptoms of hemorrhoid disease with high-dose oral O-(beta-hydroxyethyl)-rutosides]. Flavonoids to reduce bleeding and pain after stapled hemorrhoidopexy: a randomized controlled trial. A clinical trial of hydroxyethylrutosides in the treatment of haemorrhoids of pregnancy. Prospective randomized controlled trial of a micronized flavonidic fraction to reduce bleeding after haemorrhoidectomy. Trihydroxyethylrutosides in the treatment of hemorrhoids of pregnancy: a double-blind placebo-controlled trial. Prospective randomized multicentre trial comparing stapled with open haemorrhoidectomy.
To demonstrate the value of Diosmin (flavonidic fraction) in the management of post-haemorhoidectomic symptoms.
                Eighty-six consecutive patients with grades III and IV acute mixed hemorrhoids admitted to the Anorectal Surgical Department of First Affiliated Hospital, Xinjiang Medical University from April 2009 to April 2010, were enrolled in this study. An observer-blinded, randomized trial was conducted to compare post-haemorhoidectomic symptoms with use of Diosmin flavonidic fraction vs placebo. Eighty-six patients were randomly allocated to receive Diosmin flavonidic fraction 500 mg for 1 wk (n = 43) or placebo (n = 43). The Milligan-Morgan open haemorrhoidectomy was performed by a standardized diathermy excision method. Pain, bleeding, heaviness, pruritus, wound edema and mucosal discharge were observed after surgery. The postoperative symptoms and hospitalization time were recorded.
                The mean age of the Diosmin group and controls was 53.2 and 51.3 years, respectively. In Diosmin group, haemorrhoid piles were of the third degree in 33 patients and the fourth degree in 10; and in the control group, 29 were of the third degree and 14 were of the fourth degree. There was no statistically significance in age, gender distribution, degree and number of excised haemorrhoid piles, and the mean duration of haemorrhoidal disease between the two groups. There was a statistically significant improvement in pain, heaviness, bleeding, pruritus from baseline to the 8th week after operation (P < 0.05). Patients taking Diosmin had a shorter hospitalization stay after surgery (P < 0.05). There was also a significant improvement on the proctoscopic appearance (P < 0.001). However, there was no statistical difference between the two groups in terms of wound mucosal discharge. Two patients experienced minor bleeding at the 8th week in Diosmin group, and underwent surgery.
                Diosmin is effective in alleviating postoperational symptoms of haemorrhoids. Therefore, it should be considered for the initial treatment after haemorrhoid surgery. However, further prospective randomized trials are needed to confirm the findings of this study. To investigate efficacy and side effects of Cissus quadrangularis L. and micronised purified flavanoid fraction (MPFF) in treatment of hemorrhoids.
                A prospective double blind randomized study was designed in acute hemorrhoidal patients from three hospitals. In each hospital, eighty patients received the flavanoid mixture, C. quadrangularis, or placebo (3 x 2 p.c. for 4 days and then 2 x 2 p.c. for 3 days). Patients were evaluated on bleeding, pain, discharge, pruritis, erythema, and direct patient interviews. Each symptom was scored on a graded severity scale from 0 to 3 on the first day and the seventh day. Blood tests and monitoring of treatment-related side effects were conducted.
                Five hundred seventy patients (299 females, 271 males) were enrolled. No significant difference regarding age, gender, occupation, and history of disease was recorded. Mostly acute bleeding ceased at the second day in all groups. Analysis on all groups revealed improvement in all symptoms with non-significant difference. No adverse events, no blood chemistry changes were reported.
                The therapeutic efficacy of flavanoid mixture, C. quadrangularis L. and placebo are not different indicating that they play no role in improving early hemorrhoidal symptoms. Long-term studies should be conducted for effects in preventive and curative action. Patients with acute bleeding from internal haemorrhoids often have to be referred by the general practitioner to the surgeon for definitive treatment with invasive outpatient procedures. At the initial consultation, patients frequently seek postponement of immediate surgery to a more convenient time. Effective and rapid non-invasive control of acute bleeding could be of practical use in scheduling surgery to a time convenient to both patient and surgeon.
                In a 90-day randomized, double-blind study treatment with a micronized purified flavonoid fraction (MPFF) was compared with placebo, in 100 outpatients who presented for treatment of acute internal haemorrhoids of less than 3 days' duration. The primary endpoint was cessation of bleeding on the third day of treatment.
                Of 50 patients randomized to each group, acute bleeding ceased by the third day in 40 (80 per cent) who received MPFF compared with 19 (38 per cent) who had placebo (P < 0.01). Mean(s.d. ) duration of acute bleeding from onset to cessation of 4.9(1.6) days was 2.1 (95 per cent confidence interval 1.2-2.9) days less than that in patients receiving placebo (P < 0.01). Continued treatment in patients with no bleeding prevented a relapse in 30 of 47 patients, compared with 12 of 30 receiving placebo (P < 0.05).
                Patients with acute internal haemorrhoids treated with MPFF had rapid cessation of bleeding and a reduced risk of relapse. This could be of value in the more convenient timing of treatment with invasive outpatient procedures. The pharmacological treatment is widely used in the therapy of haemorrhoids. An efficient treatment is particularly useful in case of haemorrhoids of 2nd, 3rd and 4th degree, when phlogosis, oedema and pain are present. Forty patients were treated with either O-(beta-hydroxyethyl)-rutosides (4 g/day orally) or placebo in a double blind randomized comparative trial. The groups of treatment were homogeneous. O-(beta-hydroxyethyl)-rutosides induced a statistically significant reduction of pain and bleeding; placebo did not induce any significant improvement. Tolerability was good and similar for both treatments. It has never been necessary to stop treatment for side effects. The results obtained in this study confirm the usefulness on administering an oral treatment, and not only a local treatment, to patients with acute symptoms of haemorrhoids, both in case of intermittent treatment and in case it is used to prepare quickly the patient for surgery. 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. The safety and efficacy of 500 mg O-(beta-hydroxyethyl)rutosides given orally twice daily in the treatment of 97 patients with first-, second-, or third-degree haemorrhoids were investigated in a double-blind, randomized placebo-controlled trial. The rutosides produced a significant (P less than 0.001) improvement in patient-assessed subjective symptoms (pain, bleeding, exudation and pruritus) compared with placebo. There was also a significant (P less than 0.001) improvement in clinician-assessed subjective and objective signs (bleeding, inflammation and dilatation of the haemorrhoidal plexus) after 2 and 4 weeks' treatment compared with placebo. There were three mild, transient side-effects reported in the active treatment group and no drug-related problems in the pregnancy or delivery were observed. The results suggest that O-(beta-hydroxyethyl)rutosides provide a safe and effective treatment for women with haemorrhoids of pregnancy. 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. The safety and efficacy of Trihydroxyethylrutosides (HR) in the treatment of 53 patients with 1st-2nd degree hemorrhoids of pregnancy (16th-34th week) was investigated in a double-blind randomised, placebo controlled trial. The dosage of Trihydroxyethylrutosides was 1 tablet of 300 milligrams twice daily for the first 2 weeks. If the treatment was successful, the treatment was stopped. If the clinical signs or symptoms still persisted, the treatment was continued for another two weeks using the same dosage and re-evaluated at the end of the fourth week after initial treatment. The parameters for efficacy were symptoms (pain, bleeding, exudation and pruritus) and the objective signs on proctoscopy (bleeding, inflammation and dilatation of the hemorrhoidal venous plexus). The study revealed improvement of symptoms in the study group which was better than in the control group after 2 weeks of treatment but the clinical signs were not different. After a further 2 weeks of treatment, the result showed improvement of both clinical signs and symptoms in this study. Only one mild transient side effect was reported in the HR group and there were no drug-related problems in the pregnancies, delivery or the babies. The aim of this study was to compare the results of conventional open haemorrhoidectomy as currently practised in Italy (group 1) with stapled haemorrhoidectomy using a 33-mm circular stapling device (group 2).
                One hundred patients with symptomatic third- and fourth-degree haemorrhoids were enrolled by five hospitals. Patients were allocated to the two groups according to a centralized randomization scheme featuring five permutated blocks of 20. Preoperative clinical examination and anorectal manometry demonstrated no features of anal incontinence. Patients had a clinical and manometric re-evaluation after operation and were asked to complete a clinical diary. After a median of 16 (range 8-19) months patients were administered a standardized questionnaire by telephone.
                Postoperative bleeding requiring haemostatic procedures occurred in three patients in each group. Patients in group 1 complained of moderate pain for a median of 5.3 (range 0-19) days compared with 3.1 (range 0-10) days in group 2 (P = 0.01), while severe pain was present for 2.3 (range 0-24) days in group 1 but only for 1 (range 0-14) day in group 2 (P = 0.03). The median hospital stay was 2 days in group 1 compared with 1 day in group 2 (P = 0.01). In the early days after operation, patients in group 2 had greater difficulty in maintaining normal continence to liquid stools (P = 0.01), but after 30 days the continence score was better in group 2 (P = 0.04).
                Stapled haemorrhoidectomy is as effective as conventional haemorrhoidectomy. Reduced postoperative pain, shorter hospital stay and a trend toward earlier return to work suggest short-term advantages for the stapled technique.
This review did not provide strong evidence concerning the effectiveness of TCMHs for stopping bleeding from haemorrhoids. Most of the included studies were of low quality and there was a scarcity of eligible trials and numbers of participants. Limited, weak evidence showed that some herbal formulae, when including Radix Sanguisorbae, Radix Rehmanniae, Fructus Sophorae, Radix Angelicae Sinensis, Radix Scutellariae, etc., may alleviate some symptoms caused by haemorrhoids. These include hematochezia, congestive haemorrhoidal cushions and inflammation of perianal mucosa in the short term. Well-designed clinical trials are required urgently before any confident conclusions can be drawn about the value of TCMHs for stopping bleeding from haemorrhoids.
At present, the evidence is not enough that clinical practice should be changed immediately on the basis of these results.