The Value of Injection Therapy with Botulinum Toxin in Pain Treatment of Primary Chronic Anal Fissures Compared to Anal Dilation, and Local Nifedipine in Combination with Lidocaine.

Introduction: Anal fissure is a longitudinal tear of the mucosa of the anal canal extending from the outer anal orifice in the direction of the dentate line of the inner anal opening. Fissures are divided into primary and secondary, and acute or chronic. Besides minimal rectal bleeding, itching and soiling, primary chronic anal fissures (PCAF) manifest with anal pain as theirs main determinant. It is described as the most troubling symptom. Aim: To compare the effect of injection therapy with botulinum toxin A (ITBT) vs. anal dilation (AD), and local nifedipine with lidocaine (LNL) in pain treatment of PCAF. Materials and Methods: This controlled retrospective prospective longitudinal study covered 94 patients, divided in 3 groups. The first was treated with ITBT, the second with AD and third using LNL (31, 33 and 30 patients respectively). Clostridium botulinum toxin A was used, dissolved with saline to concentration of 200 U/ml. The solution was applied to both sides of PCAF at dose of 40U. Modified technique of AD was done using 3 fingers of a single hand, progressively introduced into the anal canal, followed by gradual lateral distraction during 1 min. LNL therapy was conducted using nifedipine (0.3%) with lidocaine (1.5%) ointment, applied twice daily for 3 weeks. To measure pain, a visual analog scale (VAS) was used. The follow-up period was 12 weeks with checkup at week 4. Results: The median age of participants was 46.6±13.9 years (50 males vs. 44 females). The type of therapy had a significantly different effect on pain at week 4 (p=0.0003). Severe pain was present in only 2 ITBT patients, 16 AD, and 6 LNL patients. Post hoc analyses showed different pain disappearance time by week 12 (p <0.0001). The mean time was shortest in ITBT group (6.1±1.5 weeks). Anal pain intensity significantly differed among the 3 groups (Fisher exact, p=0.002). Namely, 71% in ITBT group rated the pain as weakest (VAS score 1) compared to 18.2% in AD and 30% of patients in LNL group. The overall pain reduction significance was in favor of ITBT, due to the differences between the ITBT and AD groups (p=0.00024) and ITBT compared to LNL group (p=0.018). Conclusion: ITBT is superior to AD and LNL in reducing pain in PCAF.

L-Arginine is a feasible supplement to heal chronic anal fissure via reducing internal anal sphincter pressure: a randomized clinical trial study.

The hypertonicity of internal anal sphincter resting pressure is one of the main causes of chronic anal fissure. Therefore, the aim of this study was to assess the effect of oral administration of L-arginine on the improvement of the anal fissures by relaxing the internal anal sphincter. Seventy-six chronic anal fissure patients (aged 18-65 years) who were referred to Rasoul-e-Akram Hospital, Tehran, Iran from February 2019 to October 2020 participated in this randomized, double-blind, placebo-controlled trial. Participants were allocated into treatment (L-arginine) and placebo groups. They took a 1000 mg capsule three times a day for 1 month, and then we followed them at the end of the first and third months after the intervention. Clinical symptoms, anal sphincter resting pressure, and quality of life (QoL) were completed at baseline and the end of the study. The analysis of data showed a significant decrease in bleeding, fissure size, and pain for each group; however, in the L-arginine group was more than the control group at the end of the study (P values < 0.001). Following that, a significant increase in QoL was seen just in patients treated with L-arginine (P value = 0.006). In addition, the comparison of anal pressures at baseline and, between groups at the end of the study showed a significant reduction in sphincter pressure in patients treated with L-arginine (P value < 0.001, = 0.049; respectively). The oral administration of 3000 mg L-arginine can heal chronic anal fissures by reducing internal anal sphincter pressure with more negligible side effects. However, we recommend long-term study with more extended follow-up.Clinical trial registry: IRCT20190712044182N1 at Iranian clinical trials, date: 2019-08-27.

Analgesic effectiveness and improvement in quality of life after using topical sevoflurane for an extremely painful anal fissure / Eficácia analgésica e melhoria da qualidade de vida com o uso tópico de sevoflurano em fissura anal extremamente dolorosa

Painful anal fissures could be distressing conditions that severely impair the patients' quality of life. The analgesic effectiveness of topical drugs, such as calcium-antagonists and nitrates is quite variable. The inhalational anesthetic sevoflurane is being repurposed as a topical analgesic for painful chronic wounds.We report a pioneer experience treating a painful chronic anal fissure with topical sevoflurane. A young adult male was suffering from an extremely painful chronic anal fissure, which severely affected his quality of life. The topical treatment with nitroglycerine and diltiazem gels failed. The patient agreed to the treatement with topical sevoflurane as an off-label medication, and it produced an immediate, intense, and long-lasting analgesic effect. An intense but rapidly transient burning sensation, as well as persistent but well-tolerated flatulence were the only adverse effects. The quality of life was greatly improved, and the cost of the treatment was affordable. Therefore, the off-label use of topical sevoflurane appears to be an effective alternative for the symptomatic treatment of painful anal fissures (AU)

As fissuras anais dolorosas podem ser condições angustiantes que prejudicam gravemente a qualidade de vida dos pacientes. A eficácia analgésica de medicamentos tópicos, como antagonistas de cálcio e nitratos, é bastante variável. O anestésico inalatório sevoflurano está sendo reaproveitado como analgésico tópico para feridas crônicas dolorosas. Relatamos uma experiência pioneira de tratamento com sevoflurano tópico em fissura anal crônica dolorosa. Umjovemadulto do sexomasculino sofria de uma fissura anal crônica extremamente dolorosa, que afetava gravemente sua qualidade de vida. O tratamento tópico com nitroglicerina e géis de diltiazem foi ineficaz. O paciente concordou com o tratamento com sevoflurano tópico como medicamento off-label, ou seja, com uso diferente do aprovado embula. O sevoflurano tópico produziu um efeito analgésico imediato, intenso e duradouro. Uma sensação de ardência intensa, mas transitória, e flatulência persistente, embora bem tolerada, foram os únicos efeitos adversos. A qualidade de vidamelhorou significativamente, e o custo do tratamento revelou-se acessível. Portanto, o uso off-label de sevoflurano tópico pode ser uma alternativa analgésica eficaz em casos de fissuras anais dolorosas. (AU)

Role of micronize purified flavonoid fraction and ethanol Graptophyllum pictum extract on experimental anal ulcer healing. Study on Wistar rat / Papel da fração flavonoica purificada micronizada e do extrato etanólico de Graptophyllum Pictum em experimento de cicatrização de úlcera anal. Estudo com ratos Wistar

ABSTRACT Aim of the study To evaluate the role of micronized purified flavanoid fraction and ethanol Graptophyllum pictum extract in the treatment of anal ulcer. Method Twenty-eight Wistar rats were randomly allocated into four groups. Groups 2, 3 and 4 the anus were induced with croton oil, but was not induced on group 1. Groups 1 and 2 were treated with normal saline, while groups 3 and 4 were treated with micronized purified flavanoid fraction, and ethanol G. pictum extract, respectively. On 9th days blood sample were taken from the retro-orbital region, and Wistar was killed by cervical dislocation under ether anesthesia. The anal canal was resected up 2 cm from anal opening, weighted, photographically taken to measure the percentage of residual ulcer, and then prepared for microscopic examination. Elisa methods were done for superoxide dismutase and malondialdedhyde. The total leukocyte in the anal specimen was counted under 400 magnification power. superoxide dismutase, anal coefficient, and total leukocyte for statistical analysis were using ANOVA and LSD, while malondialdedhyde and percentage of ulcers were using Kruskal-Wallis and Mann-Whitney. Result Treatment with ethanol G. pictum extract dose of 100 mg/kg BW significantly reduces the percentage of anal ulcer, the edema, leukocyte infiltration, and malondialdedhyde, and increase the superoxide dismutase in comparison without treatment. Treatment with micronized purified flavanoid fraction did not reduce the leukocyte, anal coefficient, and percentage of anal ulcer, only increase malondialdedhyde and decrease superoxide dismutase significantly.

RESUMO Objetivo do estudo Avaliar o papel da Fração Flavonoica Purificada Micronizada e do Extrato Etanólico de Graptophyllum pictum no tratamento de úlcera anal. Método Vinte e oito ratos Wistar foram randomicamente alocados em quatro grupos. Nos grupos 2, 3 e 4, indução com óleo de cróton foi realizada no ânus, excetuando-se o Grupo 1. Os grupos 1 e 2 foram tratados com solução salina normal, enquanto os grupos 3 e 4 foram tratados com fração flavonoica purificada micronizada e extrato etanólico de Graptophyllum pictum, respectivamente. No nono dia, amostras de sangue foram colhidas da região retroorbital, e o rato Wistar sofreu eutanásia por deslocamento cervical sob anestesia com éter. O canal anal foi ressecado até 2 cm da abertura anal, ponderado e fotografado para medir a porcentagem de úlcera residual e, em seguida, preparado para exame microscópico. Os métodos superoxide dismutase e malondialdedhyde do ensaio Elisa foram realizados. A contagem total de leucócitos foi realizada na amostra anal com ampliação de 400 vezes. ANOVA e LSD foram utilizados para a análise estatística de superoxide dismutase, coeficiente anal e número total de leucócitos, enquanto os testes de Kruskal-Wallis e Mann-Whitney foram utilizados para a análise de malondialdedhyde e porcentagem de úlceras. Resultado O tratamento com o extrato etanólico de Graptophyllum pictum (100 mg/kg de peso corporal) reduz de modo significativo a porcentagem de úlceras anais, o edema, a infiltração de leucócitos e o malondialdedhyde e aumenta a superoxide dismutase, comparado ao não tratamento. O tratamento com a fração flavonoica purificada micronizada não reduziu os leucócitos, o coeficiente anal e a porcentagem de úlceras anais, apenas aumentou o malondialdedhyde e diminuiu significativamente a superoxide dismutase.

Treatment of chronic anal fissure: a feasibility study on Levorag® Emulgel versus Diltiazem gel 2.

PURPOSE: To compare the standard treatment, diltiazem gel 2%, with Levorag® Emulgel for chronic anal fissures. METHODS: This was a single-blinded, randomised, controlled, clinical trial with a non-inferiority design. Patients with a chronic anal fissure were randomised to treatment with diltiazem or Levorag® Emulgel twice daily for 8 weeks. Primary endpoint was complete healing of the anal fissure after 12 weeks. Secondary endpoints included incidence of adverse events and efficacy on pain relief. RESULTS: In total, 55 patients were included. Inclusion was terminated prematurely due to a slow inclusion rate. Complete fissure healing at 12 weeks follow-up was overall achieved in 31 of 55 (56%) patients, 18 of 29 (62%) in the diltiazem group compared with 13 of 26 (50%) in the Levorag® Emulgel group (P = 0.424). Pain relief was significantly better at day seven in patients treated with diltiazem (P = 0.040) compared with Levorag® Emulgel, whereas there were no differences in early (3 days) or late (12 weeks) pain relief. Three patients (10.3%) developed severe perianal exanthema during diltiazem treatment, whereas no side effects were observed in the Levorag® Emulgel group. CONCLUSION: The study demonstrated statistical non-inferiority of Levorag® Emulgel compared with diltiazem in the treatment of chronic anal fissure. Diltiazem resulted in a more prompt pain relief and also in a substantial number of local allergic reactions. Levorag® Emulgel may therefore be an alternative in these patients. TRIAL REGISTRATION: Clinicaltrials.gov no. NCT02158013.

Potential combination topical therapy of anal fissure: development, evaluation, and clinical study†.

To treat anal fissure, internal anal sphincterotomy may be associated with surgical risks and incidence of incontinence. Botulinum toxin injection into the anal sphincter is invasive and expensive. Headache and hypotension hindered topical treatment with glyceryl trinitrate. Greater patient compliance, potentiated efficacy, reduced side effects, and lower cost are the major advantages offered by the combination therapy. Therefore, combination topical gels of nifedipine (NIF), lidocaine hydrochloride (LDH) and betamethasone valerate (BMV) were prepared and evaluated regarding viscosity, pH, drug content, and in vitro release. Compatibility study of drug-drug and drug-excipient mixtures preceded the formulation. Stability study was performed. A prospective randomized clinical trial was conducted for six weeks to assess the efficacy of the optimized formula in the treatment of anal fissure either acute (AAF, 37 patients) or chronic (CAF, 34 patients) in comparison with three single drug market products. The compatibility was indicated except in case of LDH with each of poloxamer 407 (P407), methylparaben, and propylparaben as well as BMV with P407. The gels showed acceptable viscosity ranges, tolerated pH values, and drugs content limits complying with the pharmacopeial limit. The gel containing 10% Transcutol® (F2) was selected as optimized formula due to the significant (p < 0.05) enhancement in NIF release. The recommended storage temperature was 8 °C. In comparison with the market products, the optimized gel can be represented as a potential combination therapy of acute and chronic anal fissures as suggested by significantly increased healing% and significantly reduced pain, bleeding, anal discharge and itching without side effects.

The Effect of Nonoperative Management of Chronic Anal Fissure and Hemorrhoid Disease on Bowel Function Patient-Reported Outcomes.

BACKGROUND: Nonoperative management has been reported to decrease symptoms from common anorectal conditions such as chronic anal fissures and hemorrhoids. The effects of these interventions on bowel function are unknown. OBJECTIVE: This study aims to perform a prospective evaluation of patient-reported outcomes of bowel function on nonoperative management for chronic anal fissures and hemorrhoid disease. DESIGN: This is a prospective, observational study. SETTINGS: Patient-reported outcome measures were collected from the clinical practice of the division of colon and rectal surgery at a tertiary colon and rectal surgery referral center. INTERVENTION: All patients received standardized dietary counseling including fiber supplementation as well as toileting strategies. Those with chronic anal fissures were also prescribed topical calcium channel blockers. The Colorectal Functional Outcome questionnaire was administered at baseline and at first follow-up visit. MAIN OUTCOME MEASURES: The primary outcomes measured were the mean change in patient-reported bowel function scores after nonoperative management for each disease and in aggregate. RESULTS: A cohort of 64 patients was included, 37 patients (58%) with chronic anal fissure and 27 patients with hemorrhoid disease. Incontinence, social impact, stool-related aspects, and the global score were observed to have statistically significant improvement in the aggregate group. When analyzed by diagnosis, hemorrhoid disease demonstrated a statistically significant improvement in incontinence and stool-related aspects, whereas chronic anal fissure was associated with a statistically significant change in social impact, stool-related aspects, and the global score. LIMITATIONS: This study was limited by the small cohort size and unclear patient adherence to medical management. CONCLUSIONS: Nonoperative management of chronic anal fissures and hemorrhoid disease is associated with significant improvement in patient-reported outcome scores in several domains, suggesting that dietary counseling and medical therapy should be the first-line outpatient therapy for these diseases. See Video Abstract at http://links.lww.com/DCR/A726.

Comparison of Flavonoids and Centella asiatica for the treatment of chronic anal fissure. A randomized clinical trial.

AIMS: We aim to test and compare the effects of Flavonoids (Fs) and Centella asiatica (Ca), and the traditional treatment to find out which best deals with healing time, bleeding and pain in the treatment of chronic Anal Fissure (AF). Materials of Study: 98 outpatients were divided randomly into treated (either Fs or Ca) and control group. The control group (Group C, n=32) received the traditional treatment along with the other two subgroups which were treated, additionally, with Fs (Group A, n=30) or Ca (Group B, n=36). Patients were observed once weekly over 8 consecutive weeks. RESULTS: The median time to stop bleeding in the group A was 1 week, in the Group B was 3 weeks and in the group C was 4 weeks. There were significant differences between Groups in terms of time to end bleeding (A vs B: p-value= 0.022; A vs C: p-value<0.001; B vs C: p-value=0.070). As for pain score from baseline to the 2nd week were statistically different between Groups A and B on the one hand and Group C on the other hand (A vs C: p-value=0.004; B vs C: p-value 0.035). All patients healed within 8th week. DISCUSSION: Either patients treated with Fs or Ca experienced early pain disappearance. Fs and Ca did not show side effects CONCLUSIONS: The treatment with Fs is the most effective for bleeding. Patients additionally treated with either Fs or Ca experienced an earlier healing and disappearance of pain in comparison with patients underwent to the traditional treatment. KEY WORDS: Anal bleeding, Anal fissure, Defecation pain.

Preparation and characterization of textile-based carrier systems for anal fissure treatment.

Anal fissure is common and painful disease of anorectum. In this study, microparticles containing nifedipine and lidocaine HCl were prepared by spray drying and applied to bio-degradable and bio-stable tampons. Characterization of microparticles was determined by visual analyses, mass yield, particle size measurement, encapsulation efficiency, drug loading and in vitro drug release. Mass yield was between 5.5 and 45.9%. The particle size was between 15.1 and 26.8 µm. Encapsulation efficiency were 96.142 ± 5.931 and 85.571 ± 3.301; drug loading were 65.261 ± 3.914% and 37.844 ± 4.339% of L2 and N1, respectively. Well-separated, mainly spherical microparticles with suitable properties were obtained. Optimum microparticles were applied to tampons. Physical properties and visual characteristics of tampons were investigated before and after binder application. In vitro drug release from tampons were also examined. According to the results, textile-based carrier systems loaded microparticles containing nifedipine and lidocaine HCl will be an effective and promising alternative for current anal fissure treatment.

Effectiveness of 0.2% Glyceryl Trinitrate and 0.5% Nifedipine in the Treatment of Chronic Anal Fissure.

INTRODUCTION: Anal fissure is an ischemic ulcer caused by combination of spasm of internal anal sphincter and poor blood supply to the posterior midline of anal canal. This study aimed to assess the efficacy of Glyceryl Trinitrate and Nifedipine in the treatment of chronic anal fissure. METHODS: Ninety patients with symptomatic anal fissure in Kathmandu Medical College Teaching Hospital are allocated for study in two groups of 45 each from March 2013 to April 2014. The patients are assigned alternatively to GTN group and Nifedipine group. All patients were assessed every week till 8 weeks in regards to headache, compliance, healing and recurrence. The patients who had complete healing in 8 weeks were further followed up for 6 weeks to detect recurrence. RESULTS: Patients in the two groups were comparable in regard to demographic data (age and sex) as well as clinical factors. Headache was main complaint of patients using GTN in high percentage (16.6%) than complained by patients using topical Nifedipine (6.9%). This factor led to poor compliance with GTN compared with Nifedipine. Nifedipine showed better healing rate 82.5% compared with GTN 60%. Recurrence was comparable among the two groups. CONCLUSIONS: Nifedipine ointment showed better results than GTN ointment in chronic anal fissure regarding headache, compliance, healing and recurrence in 6 weeks of follow up period after complete healing of fissure in 8 weeks.

Myoxinol ointment for the treatment of acute fissure.

Myoxinol is a complex of oligopeptides obtained from the seeds of Hibiscus esculentus used in cosmetic as natural alternative to botulin toxin. The aim of the study was to evaluate the safety and effectiveness of local myoxinol for the treatment of acute anal fissure. All the consecutive patients with acute fissure treated from January to June 2014 underwent 30 days of topical treatment (twice/day) with a mioxinol based ointment. Pain, symptomatic relief, fissure healing and re-epithelization, 1-year recurrence rate, subjective satisfaction and need for further treatments were evaluated. During the study period 157 patients were eligible for data analysis (91 males: 58%; mean age 38 years: range 17-83). Median anal pain score was 7.1 pre-treatment and 1.7 and 0.9 after 30 days and 12 months from treatment, respectively (p: 0.0001). After the treatment period complete healing was achieved in 103 patients (65.5%), relevant improvement in 31 (20%) and no improvement in 21 patients (13.5%). Overall efficacy rate was 85.5%. A significant difference was reported considering patients with pre-treatment VAS between 1-5 and 6-10 (p: 0.004). Twenty-nine patients (18.5%) required further treatments. Hydrolyzed Hibiscus esculentus extract was proven to be an effective and well-tolerated topical treatment for acute fissure, with a high healing rate, a significant reduction of pain and a low 1-year recurrence rate.

Efficacy of nitroglycerine ointment in the treatment of pediatric anal fissure.

BACKGROUND: Anal fissure is the most common anal disease in children. In the past few decades, the understanding of its pathophysiology has led to a progressive reduction in invasive procedures in favor of conservative treatment based on stool softeners and the relaxation of the anal sphincter. This randomized controlled study assessed the safety and efficacy of nitroglycerine (NTG) ointment in the treatment of pediatric anal fissure, which had not yet been proved. PATIENTS AND METHODS: An unequal randomized controlled study included 105 pediatric patients with anal fissure who had presented to the private and outpatient clinics of the Central Teaching Hospital of Pediatrics during the period from February 2015 to May 2016. The control group consisted of 70 patients. Both groups were treated with classical conservative therapy of sitz bath, stool softener, and local anesthetic. In the second group, chemical sphincterotomy with 0.2% NTG ointment was used in 35 patients, and was applied at the anal canal twice daily for 8weeks. The primary outcomes of symptomatic improvement and healed fissure, as well as side effects, were analyzed. RESULTS: The average age of patients was 2years (range, 4months to 5years). Patients in the NTG group had 77% symptomatic relief and 60% healed fissure compared to the control group, which had 54% and 32.8% respectively. All were statistically significant. No serious adverse effects were noticed during the treatment period. CONCLUSION: The use of 0.2% NTG ointment is an effective therapy for anal fissure in children in terms of good healing rate and rapid symptom relief, but it has the drawback of a long treatment period, making patient compliance more difficult, in addition to the problems of tolerance and recurrence. TYPE OF STUDY: Prospective randomized controlled study (treatment study). LEVEL OF EVIDENCE: Type 2.

Topical application of LEVORAG® as first-line treatment for chronic anal fissures: a preliminary multicentric study.

AIM: The aim of the present study was to assess the safety and efficacy of this new topical agent as a first line treatment in patients with chronic anal fissures. METHODS: Nine centres were involved in the study. Patients with chronic anal fissures were recruited and received Levorag® for 40 days. Follow-up visits were conducted at 10, 20 and 40 days from the recruitment. Primary outcome was the healing rate, secondary outcome the reduction of pain at the end of the treatment measured with a VAS scale. RESULTS: Fifty patients completed the treatment. No adverse events were recorded. 60% of patients healed completely at the end of the treatment. In those that did not heal the reduction of mean VAS values was 60%. CONCLUSION: The use of Levorag® on patients affected by chronic anal fissures achieved in the short term results similar to those experienced by more classic local treatments without any side effect.

Maintenance therapy with partially hydrolyzed guar gum in the conservative treatment of chronic anal fissure: results of a prospective, randomized study.

PURPOSE: This study was designed to evaluate the role of maintenance therapy with partially hydrolyzed guar gum (PHGG) after topical application of glyceryl trinitrate (GTN) in the conservative treatment of chronic anal fissure (CAF). METHODS: From all the patients with CAF observed during the study period, 165 subjects with healed CAF after standard therapy with topical GTN 0.4% ointment were randomized to receive (group II) or not (group I) maintenance therapy with PHGG for 10 months. Clinical and manometric followup was carried out 6 and 12 months after treatment. RESULTS: At six-month followup, median visual analogue scale score was significantly higher in group I if compared with group II. The success and recurrence rate at 12-month followup were, respectively, 38.3% (28/73) in group I versus 58.5% (41/70) in group II (P = 0.019; Fisher's exact test) and 30.2% (13/43) in group I versus 14.5% (7/48) in group II (P = 0.0047; Fisher's exact test). CONCLUSION: The maintenance therapy with PHGG in patients with healed CAF after chemical sphincterotomy by topical application of GTN 0.4% ointment seems associated with a significant reduction of recurrence rate and with a significant increase of success rate at 12-month followup.

Effects of Aloe vera cream on chronic anal fissure pain, wound healing and hemorrhaging upon defection: a prospective double blind clinical trial.

Aloe vera is a medicinal plant that promotes wound healing in burn injuries. A prospective clinical trial was conducted to evaluate the effects of a topical cream containing 0.5% Aloe vera juice powder in the treatment of chronic anal fissures. The aloe cream was applied by the patients to the wound site 3 times per day for 6 weeks following the instructions of a physician. Pain was assessed with a visual analog scale before treatment and at the end of each week of treatment. Wound healing and the amount and severity of bleeding were examined and evaluated before and at the end of each week of treatment. There were statistically significant differences in chronic anal fissure pain, hemorrhaging upon defection and wound healing before and at the end of the first week of treatment also in comparison with control group (p < 0.0001). In this study, a topical cream containing aloe vera juice was an effective treatment for chronic anal fissures. This is a promising result indicating that further comparative studies are justified.

Non surgical therapy for anal fissure.

BACKGROUND: Because of the disability associated with surgery for anal fissure and the risk of incontinence, medical alternatives for surgery have been sought. Most recently, pharmacologic methods that relax the anal smooth muscle, to accomplish reversibly what occurs in surgery, have been used to obtain fissure healing. OBJECTIVES: To assess the efficacy and morbidity of various medical therapies for anal fissure. SEARCH METHODS: Search terms include "anal fissure randomized". Timing from 1966 to August 2010. Further details of the search below. SELECTION CRITERIA: Studies in which participants were randomized to a non-surgical therapy for anal fissure. Comparison groups may include an operative procedure, an alternate medical therapy or placebo. Chronic fissure, acute fissure and fissure in children are included in the review. Atypical fissures associated with inflammatory bowel disease or cancer or anal infection are excluded. DATA COLLECTION AND ANALYSIS: Data were abstracted from published reports and meeting abstracts, assessing method of randomization, blinding, "intention to treat" and drop-outs, therapies, supportive measures (applied to both groups), dosing and frequency and cross-overs. Dichotomous outcome measures included Non-healing of the fissure (a combination of persistence and recurrence), and Adverse events (including incontinence, headache, infection, anaphylaxis). Continuous outcome measures included measures of pain relief and anorectal manometry. MAIN RESULTS: In this update 23 studies including 1236 participants is added to the 54 studies and 3904 participants in the 2008 publication, however 2 studies were from the last version reclassified as un included, so the final number of participants is 5031.49 different comparisons of the ability of medical therapies to heal anal fissure have been reported in 75 RCTs. Seventeen agents were used (nitroglycerin ointment (GTN), isosorbide mono & dinitrate, Botulinum toxin (Botox), diltiazem, nifedipine (Calcium channel blockers or CCBs), hydrocortisone, lignocaine, bran, minoxidil, indoramin, clove oil, L-arginine, sitz baths, sildenafil, "healer cream" and placebo) as well as Sitz baths, anal dilators and surgical sphincterotomy. GTN was found to be marginally but significantly better than placebo in healing anal fissure (48.9% vs. 35.5%, p < 0.0009), but late recurrence of fissure was common, in the range of 50% of those initially cured. Botox and CCBs were equivalent to GTN in efficacy with fewer adverse events. No medical therapy came close to the efficacy of surgical sphincterotomy, though none of the medical therapies in these RCTs were associated with the risk of incontinence. AUTHORS' CONCLUSIONS: Medical therapy for chronic anal fissure, currently consisting of topical glyceryl trinitrate, botulinum toxin injection or the topical calcium channel blockers nifedipine or diltiazem in acute and chronic fissure and fissure in children may be applied with a chance of cure that is marginally better than placebo. For chronic fissure in adults all medical therapies are far less effective than surgery. A few of the newer agents investigated show promise based only upon single studies (clove oil, sildenifil and a "healer cream") but lack comparison to more established medications.

[Mucosa advancement flap anoplasty in treatment of chronic anal fissures: a prospective, multicenter, randomized controlled trial].

BACKGROUND: Anal fissure is one of the most common anal-rectum diseases, and approximately 10 percent patients with chronic anal fissure ultimately receive surgery. Relieving postoperative pain and protecting functions of the sphincter are central issues for coloproctologists. OBJECTIVE: To evaluate the efficacy and safety of anoplasty in the treatment of chronic anal fissures. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: In this prospective, multicenter, randomized controlled trial, 120 adult patients with chronic anal fissure were referred from Department of Coloproctology of Yueyang Hospital of Integrated Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and Shanghai Municipal Hospital of Traditional Chinese Medicine. The patients were enrolled from January 2009 to April 2010 and randomly divided into study (mucosa advancement flap anoplasty, abbreviated as anoplasty) group and control (fissurectomy) group. The two groups were assessed separately, and the main outcome measures were observed for 2 weeks, with a short-term follow-up for 6 weeks. MAIN OUTCOME MEASURES: Degree of pain, haemorrhage and anal canal pressure were observed and recorded preoperatively, and on the third day, the fourteenth day and the sixth week postoperatively. The wound healing time was also recorded. Surgical complications of the two groups were recorded and compared on the third day and the sixth week postoperatively. The curative effects associated with the surgery were analyzed on the fourteenth day and the sixth week after surgery and the therapeutic results were evaluated. RESULTS: Three patients were dropped out due to the early discharge from hospital and losing connection (1 in study group and 2 in control group). Overall the surgery showed that the anoplasty group had better results than the fissurectomy group in the curative effect on the sixth week after operation (P<0.05). Time of wound healing in the anoplasty group was (17.22 ± 4.41) d and was better than (21.24 ± 7.44) d of the fissurectomy group (P<0.05). Concerning the relief of wound pain, the anoplasty group achieved better results than the fissurectomy group at the third day, the fourteenth day and the sixth week after operation (P<0.05). Anoplasty reduced bleeding and had better efficacy than the fissurectomy at the third day and the fourteenth day after operation (P<0.05), however, there was no statistical difference at the sixth week after operation (P>0.05). There were no significant differences in relieving the anal canal pressure (P>0.05) and the surgical complications (dysuria, edema of anal margin, fever, infection, anal incontinence and anal deformation) between the two groups (P>0.05). None of the patients suffered postoperative complications by the sixth week after operation. Furthermore, there was no recurrence in either of the two groups at six weeks after operation. CONCLUSION: The results indicate that anoplasty for chronic anal fissures has advantages such as better therapeutic effects, less postoperative pain, a shorter healing time and no incidence of anal incontinence.

Anorectal fissures: an under-recognized cause of low back pain? Case report.

INTRODUCTION: Low back pain is one of the most common complaints for which patients seek medical attention. The differential for such a complaint is wide and therefore requires a thoughtful and thorough work-up. Anorectal disorders are an often-overlooked cause of low back pain. CASE PRESENTATION: We discuss the case of a 46-year-old male with history of dull aching back pain in the midline at the lumbosacral junction. The pain extended to the left of midline, into the region of the sacroiliac joint. There was no radiation into the buttock or leg. Physical exam was unremarkable. Upon soliciting further history, the patient reported a long history of anal pruritus and occasional hematochezia. Colonoscopy subsequently revealed anal fissures in various stages of healing. He was treated with Metamucil capsules and oral nifedipine with significant improvement of his symptoms. CONCLUSION: Low back pain is a challenging chief complaint to the primary care diagnostician due to its wide differential. In a careful and thorough work-up of this complaint, disorders of the anus and rectum should not be overlooked as possible culprits.