A clinical trial of hydroxyethylrutosides in the treatment of haemorrhoids of pregnancy. Trihydroxyethylrutosides in the treatment of hemorrhoids of pregnancy: a double-blind placebo-controlled trial. [Anemia in puerperium; parenteral iron substitution renders erythropoietin therapy dispensable]. The treatment of second degree haemorrhoids by injection, rubber band ligation, maximal anal dilatation, and haemorrhoidectomy: a prospective clinical trial. [Treatment of acute symptoms of hemorrhoid disease with high-dose oral O-(beta-hydroxyethyl)-rutosides]. How we can improve patients' comfort after Milligan-Morgan open haemorrhoidectomy. Clinical use of micronized purified flavonoid fraction for treatment of symptoms after hemorrhoidectomy: results of a randomized, controlled, clinical trial. Maintenance bran therapy for prevention of symptoms after rubber band ligation of third-degree haemorrhoids. The efficiency of prostaglandin E2 vaginal suppositories versus intracervical prostaglandin gel for induction of labor in patients with unfavorable inducibility prospects.
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. 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. In a double-blind, randomised study we treated 36 women in the puerperium with haemoglobin concentration below 9 g/dl with 400 mg Fe . 20 women received 20,000 IE erythropoietin (rHuEPO) i.v. in addition, 12 women received placebos. In both groups there were no differences in the haematological and iron parameters in the first 4 weeks after delivery. The results show that the additional therapy with rHuEPO in postpartum anaemia is not justified. The limiting factor in a quick correction of the postpartum anaemia is the insufficient presence of iron at the end of pregnancy. The therapy of choice for quick and safe correction of p.p. anaemia is the effective intravenous iron supplementation. One hundred and twenty patients with confirmed second degree haemorrhoids were randomly allocated to four treatment groups; injection, rubber band ligation, maximal anal dilatation, and haemorrhoidectomy. Each groups consisted of 30 patients. All patients were regularly followed up for at least one year. Assessment at one year showed that haemorrhoidectomy "cured" the haemorrhoids in 29 out of 30 patients. Rubber band ligation relieved 25 out of 30 and maximal anal dilatation 24 out of 30. Injection was the least effective treatment, and relieved 18 of the 30 patients, with a cure rate of 60% only. Haemorrhoidectomy caused pain in all cases, anal stenosis in two, postoperative haemorrhage in two, and the patients required an average hospital stay of 11.5 days and an average of a further 15.5 days off work. Rubber band ligation was painless in 26 patients out of 30, and maximal anal dilatation was painless in 25 our of 30. There were no postoperative complications in the latter two treatment groups. Haemorrhoidectomy is good in "curing" the disease, but the higher possibility of postoperative pain and complications and longer hospital stay would not justify its use in the treatment of second degree haemorrhoids. Both rubber band ligation and maximal anal dilatation are effective and relatively free from complications. Rubber band ligation has the additional advantage of not requiring hospital stay or anaesthesia and is therefore considered to be the most appropriate method of treatment for second degree haemorrhoids. 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. 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. The aim of this study was to evaluate if the combination of micronized purified flavonoid fraction with short-term routine antibiotic and anti-inflammatory therapy was better at reducing the intensity of postoperative symptoms and wound bleeding after a Milligan-Morgan's open hemorrhoidectomy than antibiotic and anti-inflammatory treatment alone.
                Fifty patients were randomly assigned to receive routine antibiotic and anti-inflammatory treatment alone (control patients) or a combination of micronized purified flavonoid fraction with identical antibiotic and anti-inflammatory treatment (micronized purified flavonoid fraction patients). The evolution of symptoms (pain, tenesmus, pruritus, and bleeding) during the postoperative period was assessed by means of patients' self-questionnaires. Each symptom was scored on a graded severity scale from 0 to 3, daily during the first three days of the immediate postoperative period, then at regular intervals (about every 14 days) until postoperative day 60. A global score for evaluation of each postoperative symptom and bleeding was used. The global score for each symptom was the sum of scores for each patient over the study period. The global score for each symptom was compared between the two groups with the Mann-Whitney U test.
                No significant differences in age, gender distribution, and stage of disease between the two groups were noticed at baseline. Posthemorrhoidectomy symptoms were relieved more rapidly in the micronized purified flavonoid fraction group; during the first three postoperative days, the global score for each symptom was significantly more reduced in the micronized purified flavonoid fraction group. The global scores for each symptom are as follows: pain after 3 days, 6.16 (SD = 1.9) in the control group vs. 3.48 (SD = 1.8) in the micronized purified flavonoid fraction group (P < 0.0001); tenesmus, 5.36 (SD = 1.8) in the control group vs. 1.48 (SD = 1.5) in the micronized purified flavonoid fraction group (P < 0.0001); pruritus, 4.04 (SD = 1.9) in the control group vs. 1.84 (SD = 1.4) in the micronized purified flavonoid fraction group (P < 0.0001); bleeding, 4.4 (SD = 2.1) in the control group vs. 2.0 (SD = 1.3) in the micronized purified flavonoid fraction group (P < 0.0001). A significant difference (P < 0.0001) between groups was also shown in favor of micronized purified flavonoid fraction patients when global scores were calculated over the entire study period (60 days).
                Micronized purified flavonoid fraction used in combination with short-term antibiotic and anti-inflammatory treatment can reduce both the duration and extent of postoperative symptoms and wound bleeding following hemorrhoidectomy. Proctoscopically diagnosed third-degree haemorrhoids were treated with rubber band ligation (RBL) in 92 patients, who were randomly assigned to management with or without twice-daily intake of unprocessed bran for 18 months. RBL was performed maximally five times at 2-week intervals. Patients who were symptom-free 10 weeks after first banding were considered cured and were enrolled in a follow-up study. The two treatment groups did not differ in regard to clinical or proctoscopic characteristics. The number of RBL required for cure was lower in the bran-treated group (p less than 0.01). The intergroup difference in cure rate 10 weeks after the first treatment was not significant (85% v. 91%). During the follow-up period symptoms recurred in 45% of the RBL group, but in only 15% of the RBL + bran group (p less than 0.01). A high-fiber diet thus increased the long-term cure rate among patients with third-degree haemorrhoids initially cured by RBL. Two different applications of prostaglandin E2 for induction of labor were randomly used in 113 women with an unripe cervix; 57 women were given prostaglandin suppositories each containing 2.5 mg PGE2 in a basis of Witepsol S55 (Dynamit Nobel), another 56 women were treated with intracervical gel containing 1 mg PGE2 in 5 g hydroxypropylmethyl cellulose. The treatment was repeated after 4 h if the cervix was still unripe, and the procedure was repeated the following day if the cervix was still unfavorable. Cesarean sections was performed within 48 h after the start of induction and before the second stage of labor in 8 women in the suppository group and 7 women in the intracervical gel group. Of the remaining 98 women, 73% (34/48 women) in the suppository group and 36% (18/50 women) in the cervical gel group had delivered within 24 h (p less than 0.01). After 48 h, 88% (42/48 women) in the suppository group and 74% of the women (37/50 women) in the cervical gel group had delivered (p greater than 0.05). The induction-delivery interval in the suppository group was half that found in the cervical gel group. There was no significant difference between the two groups in the use of instrumental vaginal deliveries and cesarean sections nor was there any difference with regard to fetal distress. The post-delivery condition of the newborn was similar in the two groups. No side-effects were reported in either of the two groups.
Although the treatment with oral hydroxyethylrutosides looks promising for symptom relief in first and second degree haemorrhoids, its use cannot be recommended until new evidence reassures women and their clinicians about their safety. The most commonly used approaches, such as dietary modifications and local treatments, were not properly evaluated during pregnancy and the puerperium.