Articles on Hemorrhoids Drugs & Pain Management

Management of acute bleeding per rectum.

Tan BK, Tsang CB, Nyam DC, Ho YH.

Department of General Surgery, Singapore General Hospital, 169608. gsutkt@sgh.com.sg

Asian J Surg. 2004 Jan; 27(1): 32-8.

BACKGROUND: Bleeding per rectum is a common indication for acute hospital admissions to the colorectal department. The frequencies of aetiologies in Singapore are different from those in Western populations. A retrospective analysis of the demography, pathology and management of acute bleeding per rectum was performed to determine the outcome and difference in aetiology from the West. METHODS: During the 1-year period from 1 October 1995 to 30 September 1996, 547 patients were admitted to Singapore General Hospital form the emergency department for acute bleeding per rectum. There were 377 males and 170 females; the mean age was 42 years (range, 15-97 years). RESULTS: Of the patients admitted, 87% wer admitted due to perianal conditions diagnosed at bedside proctoscopy, where haemorrhoids mad up 94%. One percent bled from the upper gastrointestinal tract, while 12% bled from colorectal pathology. Massive bleeding form the colorectum was uncommon. Less than one third of the 47 patients required blood transfusions. Colonoscopy was the most useful diagnostic tool for bleeding from the colorectum. The more common colonic pathologies were diverticular disease (33%), adenomas (18%), and malignancy (26%), accounting for the majority of acute patient admissions. Colonic causes of bleeding were less common and were most stable. There were differences in the frequencies of aetiologies in our population compared ot Western populations. Understanding the common pathologies and outcomes guides the management fo our patients.

Management options for symptomatic hemorrhoids.

Balasubramaniam S, Kaiser AM.

Department of Colorectal Surgery, Keck School of Medicine, University of Southern California, 1450 San Pablo Street, Suite 5400, Los Angeles, CA 90033, USA. akaiser@surgery.usc.edu

Curr Gastroenterol Rep. 2003 Oct; 5(5): 431-7.

Hemorrhoids remain one of the most common colorectal complaints. They are defined as a pathologic engorgement of the submucosal vascular plexus. Although they are often asymptomatic, hemorrhoids may cause bleeding, prolapse and, less commonly, pain. This review gives an update on various treatment options for symptomatic hemorrhoids, which include conservative treatments, office interventions, and surgical procedures, depending on the individual constellation of symptoms. Objective findings and expectations are also addressed. Recent advances (eg, stapled hemorrhoidectomy and use of alternate energy sources) are emphasized, and treatment under special circumstances (HIV, pregnancy, inflammatory bowel disease, and liver disease) is outlined.

Botulinum toxin (botox) reduces pain after hemorrhoidectomy: results of a double-blind, randomized study.

Davies J, Duffy D, Boyt N, Aghahoseini A, Alexander D, Leveson S.

Department of Colorectal Surgery, York District Hospital, York, United Kingdom.

Dis Colon Rectum. 2003 Aug; 46(8): 1097-102.

PURPOSE: Pain after hemorrhoidectomy appears to be multifactorial and dependent on individual pain tolerance, mode of anesthesia, postoperative analgesia, and surgical technique. Spasm of the internal sphincter is believed to play an important role. The aim of this study was to assess the role of botulinum toxin in reducing pain after Milligan-Morgan hemorrhoidectomy. METHODS: This was a double-blind study of 50 consecutive patients undergoing Milligan-Morgan hemorrhoidectomy and assigned to an internal sphincter injection of 0.4 ml of solution containing either botulinum toxin (20 U; Botox) or normal saline. Patients were managed according to standardized perioperative analgesic and laxative regimens. Pain was assessed by use of daily visual analog scores and analgesia requirements for the first seven postoperative days. RESULTS: Patients randomized to receive botulinum toxin had lower daily average and maximal visual analog scores throughout the study period. The difference reached significance on both Day 6 (P < 0.05) and Day 7 (P < 0.05). There was no significant difference (P = 0.12) in morphine requirements in the first 24 hours (botulinum group, 16 (range, 6-27) mg; placebo arm, 22 (range, 13-41) mg). Patients who received Botox used 19 (range, 8-36) coproxamol tablets in the first seven days after surgery compared with 23 (range, 10-40) in the placebo arm (P = 0.63). CONCLUSIONS: Those patients who had botulinum toxin had significantly less pain toward the end of the first week after surgery. Reduction in spasm within the internal sphincter is the presumed mechanism of action. This is the first reported randomized, controlled trial using botulinum toxin in hemorrhoidectomy.

Prospective study of factors affecting postoperative pain and symptom persistence after stapled rectal mucosectomy for hemorrhoids: a need for preservation of squamous epithelium.

Correa-Rovelo JM, Tellez O, Obregon L, Duque-Lopez X, Miranda-Gomez A, Pichardo-Bahena R, Mendez M, Moran S.

Colon and Rectum Clinic, Medica Sur Hospital, Mexico City, Mexico.

Dis Colon Rectum. 2003 Jul; 46(7): 955-62.

PURPOSE The purpose of the study was to determine the variables associated with postoperative pain and the clinical response of patients with uncomplicated hemorrhoidal disease treated with stapled rectal mucosectomy in the medium term.METHODS Patients with Grade II to IV, uncomplicated hemorrhoidal disease who underwent stapled rectal mucosectomy were prospectively included. The basal characteristics of the population were evaluated and level of stapling and placement of hemostatic suture determined. Histologically, the type of resected epithelium and presence of muscle fibers was evaluated. Postoperative pain was evaluated by means of a visual analog scale. Complications and clinical response were evaluated.RESULTS One hundred patients with a mean age of 43.9 years were included. Only columnar epithelium was resected in 48, transitional epithelium in 47, and squamous epithelium in 5 patients. Smooth muscle fragments were found in 55 patients, and, in 12 of these, fibers from the external muscular layer of rectum were also seen. Follow-up was 12.6 +/- 3.4 (range, 7-24) months. A total of 79 patients were completely asymptomatic at the end of follow-up. Resected squamous epithelium was associated with a higher postoperative pain level in the multivariate analysis (coefficient beta = 1.16 (95 percent confidence interval, 0.08-2.24); P = 0.035).CONCLUSIONS Rectal mucosectomy with stapler is an effective method for the treatment of uncomplicated prolapsing hemorrhoidal disease. Intensity of postoperative pain was associated with the type of resected epithelium. This suggests that low transection of hemorrhoids must be avoided.

Effect of 0.2 percent glyceryl trinitrate ointment on wound healing after a hemorrhoidectomy: results of a randomized, prospective, double-blind, placebo-controlled trial.

Hwang do Y, Yoon SG, Kim HS, Lee JK, Kim KY.

Department of Surgery, Song Do Colorectal Hospital, Seoul, Korea.

Dis Colon Rectum. 2003 Jul; 46(7): 950-4.

PURPOSE: Glyceryl trinitrate ointment acts as a dilator of the internal anal sphincter. It has been used as a treatment modality that replaces the lateral sphincterotomy in chronic anal fissures. When glyceryl trinitrate ointment is applied to the wound from a hemorrhoidectomy, it is thought that it will shorten the healing time and decrease postoperative pain. Our study focused on the efficacy of using 0.2 percent glyceryl trinitrate ointment to shorten the healing time after a hemorrhoidectomy. METHODS: A randomized, prospective, double-blind, and placebo-controlled study was designed. The power test indicated that 55 patients should be in each group to give a 90 percent chance of finding a 30 percent difference in healing time. The selection criteria for inclusion in this study were patients with third-degree or fourth-degree hemorrhoids and patients undergoing hemorrhoidectomies for three or more piles. From November 2000 to July 2001, the first 110 patients to meet our criteria were selected, 55 in the nitroglycerin group and 55 in the placebo group. The same physician performed all of the hemorrhoidectomies, and intravenous patient-controlled analgesia was not used. Cases involving other procedures for fissures or fistulas were excluded. The patients randomly received glyceryl trinitrate and placebo ointments from the pharmacologist. The pain score was checked using a visual analog scale (minimum = 0, maximum = 10) during the hospital stay, and complete wound healing was checked at three weeks after the operation. Demands for analgesics and the frequency of postoperative complications were recorded. RESULTS: When the trial was completed, 49 patients remained in the nitroglycerin group and 53 patients in the placebo group. No significant differences in the gender and the age distributions, the number of excised piles, the time for the procedures, the length of hospital stay, and the consumed amounts of analgesics existed between the two groups. The pain score in the nitroglycerin group showed a significant difference with the repeated measures analysis (P < 0.001). The wound healing rates at three weeks postoperative were 74.5 percent in the nitroglycerin group and 42 percent in the placebo group (P = 0.002). There was no significant increase in complications in the nitroglycerin group. CONCLUSION: More rapid healing of hemorrhoidectomy wounds without any specific complications was effected by 0.2 percent glyceryl trinitrate ointment.

The dose response of the internal anal sphincter to topical application of glyceryl trinitrate ointment.

Cundall JD, Gunn J, Easterbrook JR, Tilsed JV, Duthie GS.

The University of Hull, Academic Surgical Unit, Castle Hill Hospital, Cottingham, East Yorkshire, UK.

Colorectal Dis. 2001 Jul; 3(4): 259-62.

INTRODUCTION: Glyceryl trinitrate (GTN) ointment has been used for the treatment of chronic anal fissure based on the assumed pathophysiology that the fissure is due to internal anal sphincter hypertonia and that GTN causes relaxation. METHOD: 48 patients, with a diagnosis of haemorrhoids, underwent 24 h anal manometry following application of different concentrations (placebo, 0.1%, 0.2%, 0.4%) of GTN ointment. RESULTS: We have found that there was a progressive relaxation with increasing doses (placebo -8.8%, 0.1% GTN -21.9%, 0.2% GTN -27.2%, 0.4% GTN -33.1%). One way ANOVA showed this progression was significant (P=0.020), with the difference lying between placebo and 0.4% GTN (Tukey multiple comparisons, P=0.017). Only 3 patients experienced headaches and these were split evenly between the treatment arms. CONCLUSION: The internal anal sphincter has a dose related response to GTN and when dose application is strictly applied higher doses may be used without an increase in side-effects.

[Favorable results of conservative treatment with isosorbide dinitrate in 25 patients with fourth-degree hemorrhoids: a pilot study]

van den Berg M, Stroeken HJ, Hoofwijk AG.
Maaslandziekenhuis Sittard, afd. Heelkunde, Postbus 5500, 6130 MB Sittard.

Ned Tijdschr Geneeskd. 2003 May 17; 147(20): 971-3. [Article in Dutch]
Comment in:
Ned Tijdschr Geneeskd. 2003 Jul 19;147(29):1434-5; author reply 1435.

OBJECTIVE: To evaluate application of isosorbide dinitrate 1% ointment in the treatment of fourth-degree haemorrhoids. DESIGN: Prospective pilot study. METHOD: Twenty-five consecutive patients, 12 men and 13 women, with a median age of 48 years (range: 30-78), presenting in the period October 1999-December 2001 with fourth-degree haemorrhoids, were treated with isosorbide dinitrate 1% ointment. RESULTS: In 24 out of 25 patients (96%) the objective, reduction of the stangulated haemorrhoids and relief of pain, was achieved. In one patient the haemorrhoids were not reduced. This patient was cured after classic haemorrhoidectomy. Two patients interrupted the treatment because of severe headache, but after renewed instructions they continued the therapy and were cured. CONCLUSION: Isosorbide dinitrate 1% ointment gave good results in the treatment of fourth-degree haemorrhoids, with only few side effects.

Posterior perineal block with ropivacaine 0.75% for pain control during and after hemorrhoidectomy.

Brunat G, Pouzeratte Y, Mann C, Didelot JM, Rochon JC, Eledjam JJ.

Department of Anesthesiology B, University of Montpellier, Montpellier, France.

Reg Anesth Pain Med. 2003 May-Jun; 28(3): 228-32.

BACKGROUND AND OBJECTIVES: As perioperative pain management is a difficult challenge during hemorrhoidectomy, we tested the hypothesis that posterior perineal block (PPB) with local anesthetics alone is able to provide adequate pain control during and after surgery. METHODS: In a prospective, blinded, randomized study, we studied analgesic conditions and side effects of PPB in American Society of Anesthesiologists (ASA) I-II patients undergoing hemorrhoidectomy. Patients received general anesthesia (GA) either with PPB (0.75% ropivacaine, 40 mL (PPB group) or without PPB (control group). All patients received intravenous morphine patient-controlled analgesia (PCA) for postoperative pain control (morphine, 1.5 mg-boluses, 8-minute lockout interval). Intra- and postoperative opioids consumption was recorded, and pain assessments were performed at 1, 2, 4, 8, 12, and 24 hours using a visual analog scale (VAS). RESULTS: VAS scores were significantly lower during the first 8 postoperative hours in the PPB group as compared with the control group (P <.001). The PPB group required significantly less opioids during anesthesia (P <.001) and during the first postoperative day (P <.001) as compared with the control group. Time to first defecation and duration of hospitalization were identical in both groups. CONCLUSIONS: The present study shows that PPB with 40 mL 0.75% ropivacaine (300 mg) was a simple, effective, and safe method to provide better postoperative analgesia than PCA alone following surgical hemorrhoidectomy. In addition, PPB was shown to significantly reduce opioid consumption intraoperatively and during the first postoperative day.

Initial study to assess the effects of topical glyceryl trinitrate for pain after haemorrhoidectomy.

Elton C, Sen P, Montgomery AC.

Department of Surgery, Greenwich District Hospital, Vanbrugh Hill, Greenwich, London, England.

Int J Surg Investig. 2001; 2(5): 353-7.

BACKGROUND: Postoperative pain remains the most dreaded part of haemorrhoidectomy in the minds of both patients and doctors. It may delay patient discharge, recovery, and return to work. Glyceryl trinitrate has been used successfully in the treatment of anal fissures. We investigated its topical use in the management of pain after haemorrhoidectomy. METHOD: Twenty patients were entered into a double-blind trial and randomised into two groups. Group A (n = 10) applied glyceryl trinitrate ointment (0.2% twice daily) to the perianal area following surgery, and Group B applied a placebo ointment. They applied the ointment for up to 42 days after surgery, or until they felt it necessary to stop the treatment. Patients scored their daily anal pain using a visual analogue scale. Six weeks after surgery, patients were reviewed by an independent observer. RESULTS: The total pain score was calculated for each patient. The median score for Group A was 50.65; the median score for Group B was 73.50. There was no significant difference in pain scores between both groups, even when aberrant results were ignored. 20% of patients in each group complained that the ointment caused headache. CONCLUSION: The results suggest that topical glyceryl trinitrate ointment may not significantly reduce postoperative pain following haemorrhoidectomy. Meta-analysis would provide a more definitive answer.

Double-blind, randomized, placebo-controlled trial to determine the efficacy of eutectic lidocaine/prilocaine (EMLA) cream for decreasing pain during local anaesthetic infiltration for out-patient haemorrhoidectomy.

Roxas MF, Talip BN, Crisostomo AC.

Division of Colon and Rectal Surgery, Department of Surgery, Philippine General Hospital, University of the Philippines College of Medicine, Manila, The Philippines. ramroxas_md@yahoo.com

Asian J Surg. 2003 Jan; 26(1): 26-30.

OBJECTIVE: The study was undertaken to evaluate the efficacy of eutectic lidocaine/prilocaine (EMLA) cream for decreasing pain during local anaesthetic infiltration for outpatient haemorrhoidectomy. METHODS: Ninety-eight patients were randomly assigned either to receive EMLA or placebo. The creams were applied 45 minutes prior to injection of a lidocaine/bupivacaine mixture using a diamond-shaped perianal block. All participants were blinded to the specific medication received. They were asked to rate pain and levels of acceptability using a pre-validated pain scale and questionnaire. RESULTS: There were 49 patients in each group. The baseline characteristics between the two groups were similar. Forty patients (82%) in the EMLA group and 42 patients (86%) in the placebo group reported only mild pain during injection and infiltration of the lidocaine/bupivacaine mixture. The mean rank pain scores were 49.11 and 48.89, respectively (p = 0.886, not significant). CONCLUSION: While outpatient haemorrhoidectomy under local anaesthesia was generally well tolerated, there was no statistically significant difference between EMLA cream and placebo for decreasing pain during anaesthetic infiltration.

Efficacy of Daflon in the treatment of hemorrhoids.

Meshikhes AW.

Department of Surgery, PO Box 18418, Qatif 31911, Kingdom of Saudi Arabia. Tel./Fax. +966 (3) 8551019. E-mail: meshikhes@doctor.com

Saudi Med J. 2002 Dec; 23(12): 1496-8.

OBJECTIVE: To demonstrate the value of Daflon in the management of hemorrhoidal symptoms in Saudi patients attending the Surgical clinic. METHODS: This is a prospective clinical study of 105 consecutive patients suffering from hemorrhoidal problems including thrombosed piles. Detailed history and proctoscopic examination to determine position, size, and degree of hemorrhoids was conducted in all patients attending the Surgical Clinic at Dammam Central Hospital, Dammam, Kingdom of Saudi Arabia (KSA). The study was conducted over a 6-months period (December 2000 to May 2001). All were started on Daflon; 2 tablets twice daily for 4 weeks and were followed up weekly during the study period and proctoscopic examination was conducted at each consultation. RESULTS: The mean age was 35 (range 19-70) years. The majority (77%) suffered congested hemorrhoidal disease and only 8% had thrombosed piles. Previous surgery for piles was noted in 11%. Concomitant medical diseases were present in 10%. The degrees of piles were first degree (23 patients), 2nd degree (73), 3rd degree (9) and 4th degree (0). There was a statistically significant (p<0.001) improvement in pain, heaviness, bleeding, pruritus, and mucosal discharge from baseline to last visit. There was also a significant (p<0.001) improvement on the proctoscopic appearance. Five patients failed to improve on Daflon; therefore, they underwent surgery. The side effects of Daflon (mainly gastrointestinal symptoms) were encountered in 5 patients but did not force interruption of the medication. CONCLUSION: Daflon is a very safe and effective drug in the treatment of all hemorrhoidal symptoms in the population of Eastern KSA.

Micronised purified flavonoid fraction: a review of its use in chronic venous insufficiency, venous ulcers and haemorrhoids.

Lyseng-Williamson KA, Perry CM.

Adis International Limited, Mairangi Bay, Auckland, New Zealand. demail@adis.co.nz

Drugs. 2003; 63(1): 71-100.

Micronised purified flavonoid fraction (MPFF) [Daflon 500 mg], an oral phlebotropic drug consisting of 90% micronised diosmin and 10% flavonoids expressed as hesperidin, improves venous tone and lymphatic drainage, and reduces capillary hyperpermeability by protecting the microcirculation from inflammatory processes. The absorption of diosmin is improved by its micronisation to particles with a diameter <2 microm. Compared with placebo, MPFF 500 mg twice daily significantly decreased ankle or calf circumference, and improved many symptoms of chronic venous insufficiency (CVI) and plethysmographic parameters in two randomised, double-blind, 2-month studies. Improvement in symptoms was parallelled by an improvement in health-related quality of life in a nonblind, 6-month trial. Significantly more venous leg ulcers </=10 cm in diameter completely healed with MPFF 500 mg twice daily plus standard management (compression and local treatment) for 2-6 months than with standard management alone or with placebo in a nonblind and a double-blind trial. The addition of MPFF to standard management was cost effective in a retrospective pharmacoeconomic analysis of the 6-month trial. Compared with placebo, the duration and/or intensity of individual symptoms of grade 1 or 2 acute internal haemorrhoids improved significantly with 3 tablets of MPFF 500 mg twice daily for 4 days then 2 tablets of MPFF 500 mg twice daily for 3 days. Two tablets of MPFF 500 mg daily for 60 or 83 days reduced the frequency, duration and/or severity of acute haemorrhoidal symptoms and improved the overall signs and symptoms of chronic (recurrent) haemorrhoids compared with placebo. Compared with a control group, MPFF significantly reduced the risk of secondary bleeding after elective haemorrhoidectomy. In clinical trials, MPFF had a tolerability profile similar to that of placebo; the most frequently reported adverse events were gastrointestinal and autonomic in nature. In conclusion, MPFF is a well established and well tolerated treatment option in patients with CVI, venous ulcers, or acute or chronic internal haemorrhoids. MPFF is indicated as a first-line treatment of oedema and the symptoms of CVI in patients in any stage of the disease. In more advanced disease stages, MPFF may be used in conjunction with sclerotherapy, surgery and/or compression therapy, or as an alternative treatment when surgery is not indicated or is unfeasible. The healing of venous ulcers </=10 cm in diameter is accelerated by the addition of MPFF to standard venous ulcer management. MPFF may reduce the frequency, duration and/or intensity of symptoms of grade 1 or 2 acute internal haemorrhoids, and also the severity of the signs and symptoms of chronic haemorrhoids.

Healing potential of Datura alba on burn wounds in albino rats.

Priya KS, Gnanamani A, Radhakrishnan N, Babu M.

Department of Biomaterials, Central Leather Research Institute, Adyar Chennai 600020, India.

J Ethnopharmacol. 2002 Dec; 83(3): 193-9.

Datura alba Nees (Solanaccae) is popular all over the world for its medicinal uses in asthma, muscle spasm, whooping cough, hemorrhoids, skin ulcers, etc. In India, it is widely used traditionally for the relief of rheumatism and other painful affections. Ayurveda and Siddha practitioners use oil based preparations of this plant from ancient days to till date for all types of wounds. Hence, the present study was chosen to evaluate its scientific validity. The alcohol extract of the D. alba leaves were investigated for the evaluation of its healing efficiency on burn wound models in rats. The crude alcohol extract and one of the fractions exhibited antimicrobial effect against all the pathogens studied. A 10% (w/w) formulation of alcoholic extract was topically applied on thermal wounds. Complete wound closure was observed within 12 days in treated rats. The effect produced by the ointment, in terms of wound contracting ability, wound closure time, tissue regeneration at the wound site and histopathological characteristics were significant in treated rats. Collagen, hexosamine and gelatinase expressions were also well correlative with the healing pattern observed. The present study thus provides a scientific rationale for the traditional use of this plant in the management of wounds.

Use of enzyme and heparin paste in acute haemorrhoids.

Gupta PJ.

Gupta Nursing Home, Nagpur, India.

Rom J Gastroenterol. 2002 Sep; 11(3): 191-5.

BACKGROUND: While treating acutely inflammed piles, surgeons in general prefer to stick to the conservative method of treatment. This includes bed rest in a Trendelenburg's or jack-knife position, administration of liquid diet, stool softeners, antibiotics, and anti-inflammatory drugs along with warm Sitz baths and local application of glycerin and magnesium sulphate paste. We introduced an additional method in treating acutely inflammed piles. Ten tablets of trypsin and chymotrypsin (Chymoral forte, Elder Pharmaceuticals India) were powdered and were mixed with 30 grams of heparin (Thrombophobe, German Remedies Ltd, Germany) ointment. This paste was applied to the inflammed pile mass. In all, 67 received this in patient treatment with an average hospital stay of 2 days. The results were compared using chi2 test with similarly placed 22 patients who were treated with the conventional method only. RESULTS: In the patients receiving the application of the enzyme paste, local pain was reduced to a great extent, the defecation was comfortable, there was negligible local pruritus, and the routine body movements of the patient were painless. Local signs observed in the form of the size of the piles, perianal edema, and tenderness, were also found to be significantly reduced. CONCLUSION: The results of this study demonstrate that the additional use of a heparin-enzyme paste applied directly over the pile masses significantly improves the healing and resolution of acutely inflammed hemorrhoids. The effectiveness of the traditional conservative method of treatment could be gainfully supplemented by use of the pharmaceutical preparation suggested in this study.

A randomized, double-blind trial of the effect of metronidazole on pain after closed hemorrhoidectomy.

Balfour L, Stojkovic SG, Botterill ID, Burke DA, Finan PJ, Sagar PM.

Department of Surgery and Centre for Digestive Diseases, The General Infirmary at Leeds, United Kingdom.

Dis Colon Rectum. 2002 Sep; 45(9): 1186-90; discussion 1190-1.

PURPOSE: Patients consider hemorrhoidectomy to be a painful operation. Attempts to reduce the length of inpatient stay have concentrated mainly on a reduction in postoperative pain. Metronidazole has been shown to reduce pain after open hemorrhoidectomy. The aim of this study was to evaluate the effect of metronidazole after closed hemorrhoidectomy. METHODS: Thirty-eight patients undergoing closed hemorrhoidectomy were randomly allocated to receive metronidazole 400 mg (n = 18) or placebo (n = 20) three times daily for seven postoperative days. All patients received a stool softener and analgesics perioperatively. Linear analog scales were used to assess expected pain, actual pain and patient satisfaction. Time to first bowel movement, return to normal activity, complications, and use of additional analgesics were recorded. RESULTS: Both groups of patients experienced less pain than expected. Patients in the metronidazole group required fewer additional analgesics postoperatively (6.3 vs. 26.3 percent), and satisfaction scores in the placebo group were higher at one week (0.5 vs. 2.5), although these differences were not statistically significant. There were no differences in pain actually experienced, time to first bowel movement, return to normal activity, or complications between the two groups. Satisfaction scores at six weeks for all patients were relatively high, with no significant difference between the groups. CONCLUSION: Closed hemorrhoidectomy results in high patient satisfaction and low pain scores. The use of postoperative metronidazole did not reduce postoperative pain.

Local treatment of hemorrhoidal disease and perianal eczema. Meta-analysis of the efficacy and safety of an Escherichia coli culture suspension alone or in combination with hydrocortisone.

Wienert V, Heusinger JH.

University Hospital, Aachen, Germany. anvowie@aol.com

Arzneimittelforschung. 2002; 52(7): 515-23.

The objective of this paper was to assess the available clinical data on the efficacy and safety of ointments containing either a bacterial culture suspension (BCS) from Escherichia coli or a combination of BCS with hydrocortisone (CAS 50-23-7) (BCS: Posterisan, and BCS + HC: Posterisan forte). The BCS is assumed to act by immunomodulation in hemorrhoidal disease and perianal eczema. Six randomized, double-blind trials are reported: three of them using BCS ointment and one using BCS + HC, against ointment base, and two trials using BCS + HC against hydrocortisone ointment alone. Patients with hemorrhoids and/or perianal eczema were included and treated over 2 weeks with weekly assessments. Efficacy parameters included score changes for burning, itching, redness and soiling as well as the investigators' overall efficacy rating. Safety was assessed from adverse drug reactions and an overall safety rating. Out of 1,070 patients (mean age 50 years), 273 received BCS and 229 BCS + HC; 568 patients were given the various controls. In the overall efficacy rating, BCS ointment was significantly superior to the ointment base in all three studies (p = 0.028, p = 0.016, and p = 0.045). Moreover, BCS + HC was superior to the ointment base (p < 0.001) and to hydrocortisone alone (p = 0.156 and p = 0.021), confirming the distinct effect of the E. coli suspension. Satisfactory results were achieved in 83% of patients after the BCS + HC combination, 77% after BCS-containing ointment, 75% after hydrocortisone ointment and 52% after ointment base. Symptom scores decreased consistently more after administration of BCS than after the ointment base (p = 0.095, p = 0.006, and p = 0.029), and likewise, the combination of BCS + HC was significantly superior to the ointment base (p < 0.001) and to hydrocortisone alone (p = 0.036 and p = 0.019). Adverse events were less frequent for BCS and BCS + HC than for the ointment base. It can therefore be concluded that ointments containing either only E. coli BCS or a combination of BCS and hydrocortisone provide significant relief in perianal eczema as well as in early stages of hemorrhoidal disease.