|
1
|
Sharma E, Dugg P, Rani N, Pahuja V, Mittal SK, Rekhi HS. Comparative Evaluation of Effects of Oral Diltiazem and Topical Diltiazem (2%) Ointment in the Treatment of Chronic Anal Fissure: A Prospective Randomized Study. Middle East J Dig Dis 2024; 16:160-165. [PMID: 39386341 PMCID: PMC11459288 DOI: 10.34172/mejdd.2024.383] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/09/2023] [Accepted: 06/08/2024] [Indexed: 10/12/2024] Open
Abstract
Background Fissure-in-Ano is a common condition of the anorectal region. Most of the time, it is managed non-surgically. There are various drugs used for the treatment of anal fissures. Calcium channel blockers are one of them that reduce the tone of sphincter muscles. The present study compares the efficacy of oral diltiazem and topical 2% diltiazem ointment in patients with chronic anal fissures. Methods Patients were randomized into two groups. Group A (n=25) received treatment in the form of oral diltiazem, while group B (n=25) received treatment in the form of 2% (weight/volume) diltiazem ointment for local application in addition to other conservative methods like sitz bath and stool softeners. Outcomes in the form of success of treatment and complications were assessed. Statistical analysis was done using MedCalc software version 14.0. P value of<0.05 was considered significant. Results The mean age of patients was 32.00±10.67 years in group A and 30.64±9.53 years in group B. Pain relief was significantly better in group B than in group A at the end of the first week (P=0.00018), but at the end of 6th week, no significant difference was observed. Fissure healing was more significant in group B than in group A after 6 weeks (P=0.0152). Conclusion Local diltiazem ointment is a better option than oral diltiazem for anal fissures with respect to better outcomes and lesser complications.
Collapse
Affiliation(s)
- Ekta Sharma
- Department of General Surgery, Government Medical College and Hospital, Sec-32, Chandigarh, India
| | - Pankaj Dugg
- Department of General Surgery, Government Medical College, Amritsar, India
| | - Nisha Rani
- Civil Hospital, SAS Nagar, Punjab, India
| | - Vivek Pahuja
- Department of General Surgery, Adesh Medical College and Hospital, Vill Mohri, Tehsil- Shahbad, India
| | - Sushil Kumar Mittal
- Department of General Surgery, Adesh Medical College and Hospital, Vill Mohri, Tehsil- Shahbad, India
| | - Harnam Singh Rekhi
- Department of General Surgery, Government Medical College, Amritsar, India
| |
Collapse
|
|
2
|
Burtic SR, Castiglione L, Murariu M, Rosca O, Dumitru C, Neagoe O. Assessment of Quality of Life in Patients with Chronic Anal Fissures: A 1-Year Follow-Up Study before and after Botulinum Toxin (Botox) Injection. J Clin Med 2024; 13:316. [PMID: 38256449 PMCID: PMC10816032 DOI: 10.3390/jcm13020316] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/26/2023] [Revised: 01/02/2024] [Accepted: 01/03/2024] [Indexed: 01/24/2024] Open
Abstract
This longitudinal study aimed to assess the quality of life in patients with anal fissures treated with botulinum toxin (Botox) injections over a one-year period. The study hypothesized that Botox injections would significantly improve quality of life and that these improvements would be sustained over a year. Conducted as a cross-sectional study, it assessed adults diagnosed with chronic anal fissures unresponsive to conventional treatments. Participants received 25 U of Botox in two sessions and their quality of life was assessed using the WHOQOL-BREF, COPE-60, Hospital Anxiety and Depression Scale (HADS), and SF-36 surveys. Data were collected at baseline six months and one year post-treatment. The study involved 113 patients, with a mean age of 38.1 years. Significant improvements were observed in the WHOQOL-BREF scores across all domains from baseline to 12 months (physical domain: 49.4 ± 10.5 to 70.2 ± 10.6, p < 0.001; mental domain: 34.8 ± 11.2 to 61.9 ± 11.5, p < 0.001). SF-36 scores also showed significant enhancements in physical and mental health components (physical: 44.3 ± 7.5 to 56.9 ± 5.9, p < 0.001; mental: 41.1 ± 7.2 to 54.4 ± 6.3, p < 0.001). Additionally, significant improvements were noted in patient perception on quality of life from the perspective of various aspects including physical discomfort, pain management, and mood and emotional well-being. The study demonstrated that Botox injections significantly improved the quality of life in patients with chronic anal fissures, with sustained benefits observed over a year. These findings suggest Botox as an effective treatment modality for enhancing life quality in patients with this condition, highlighting the potential for broader applications in managing chronic anal fissures.
Collapse
Affiliation(s)
- Sonia-Roxana Burtic
- Doctoral School, “Victor Babes” University of Medicine and Pharmacy Timisoara, Eftimie Murgu Square 2, 300041 Timisoara, Romania;
- Department II, Discipline of Medical Communication, “Victor Babes” University of Medicine and Pharmacy Timisoara, Eftimie Murgu Square 2, 300041 Timisoara, Romania
| | - Luca Castiglione
- Doctoral School, “Victor Babes” University of Medicine and Pharmacy Timisoara, Eftimie Murgu Square 2, 300041 Timisoara, Romania;
- Department of General Surgery, “Victor Babes” University of Medicine and Pharmacy Timisoara, Eftimie Murgu Square 2, 300041 Timisoara, Romania;
| | - Marius Murariu
- Department of General Surgery, “Victor Babes” University of Medicine and Pharmacy Timisoara, Eftimie Murgu Square 2, 300041 Timisoara, Romania;
| | - Ovidiu Rosca
- Department of Infectious Diseases, “Victor Babes” University of Medicine and Pharmacy Timisoara, Eftimie Murgu Square 2, 300041 Timisoara, Romania;
| | - Catalin Dumitru
- Department of Obstetrics and Gynecology, “Victor Babes” University of Medicine and Pharmacy Timisoara, Eftimie Murgu Square 2, 300041 Timisoara, Romania;
| | - Octavian Neagoe
- Second Discipline of Surgical Semiology, First Department of Surgery, “Victor Babes” University of Medicine and Pharmacy Timisoara, Eftimie Murgu Square 2, 300041 Timisoara, Romania
| |
Collapse
|
|
3
|
Sierra-Arango F, de la Hoz-Valle J, Espinosa JP, Moreno-Montoya J, Vásquez Roldan M, Pérez-Riveros ED. Clinical Outcomes of Medical Management Options for Chronic Anal Fissures in a Long-Term Follow-up: Systematic Review and Meta-Analysis. Dig Dis 2023; 41:822-832. [PMID: 36646066 DOI: 10.1159/000528222] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/16/2021] [Accepted: 10/31/2022] [Indexed: 01/18/2023]
Abstract
BACKGROUND Topical treatments and botulinum toxin injections are valid options for the management of patients with chronic anal fissures (CAF), but little is known about the efficacy of these techniques in long-term follow-up. The aim of this meta-analysis was to evaluate the effectiveness, given to clinical outcomes, of medical treatments with calcium antagonists, nitroglycerin, and botulinum toxin on CAF treatment in adults. METHOD A systemic review and meta-analysis developed according to PRISMA [PLoS Med. 2009 Jul 21;6(7):e1000100; BMJ. 2010 Mar 23;340:c332] and registered in PROSPERO (Registration number: CRD42020120386). A systematic literature search was conducted through MEDLINE, EMBASE, Web of Science, and Cochrane Library databases. Randomized control trials that compared medical treatment were identified; publications had to have a clinical definition of CAF with at least one of the following signs or symptoms: visible sphincter fibers at the base of the fissure, anal papillae, sentinel piles, and indurated margins. The symptoms had to be chronic for at least 4 weeks. Data were independently extracted for each study, and a meta-analysis was drawn using fixed- and random-effects models. RESULTS 17 randomized trials met the inclusion criteria. Diltiazem showed a superior effect compared with glycerin (RR = 1.16 [95% CI = 1.05-1.30]; I2 = 18%) and with fewer adverse effects (RR = 0.13 [95% CI = 0.04-0.042]; I2 = 87%). Similar results were evidenced with the use of nifedipine compared with lidocaine (RR = 4.53 [95% CI = 2.99-6.86]; I2 = 28%). Botulinum toxin did not show statistically significant differences compared to glycerin (RR = 0.81 [95% CI = 0.02-29.36]; I2 = 93%) or isosorbide dinitrate (RR = 1.45 [95% CI = 0.32-6.54]; I2 = 85%). Regarding recurrence, nifedipine was superior to lidocaine (RR = 0.18 [95% CI = 0.08-0.44]; I2 = 31%). CONCLUSIONS Calcium channel blockers performed well regarding the healing of CAF when compared to others in long-term follow-up. The superiority of botulinum toxin was not evidenced compared to topical treatments. More studies are needed to better assess recurrence rates.
Collapse
Affiliation(s)
- Fernando Sierra-Arango
- Director of Clinical Studies and Clinical Epidemiology Division, Fundación Santa Fé de Bogotá, Bogotá D.C., Colombia
| | - José de la Hoz-Valle
- Head of Clinical Studies and Clinical Epidemiology Division, Fundación Santa Fé de Bogotá, Bogotá D.C., Colombia
| | | | - José Moreno-Montoya
- Statistics and Mathematics, Epidemiologist of Clinical Studies and Clinical Epidemiology Division, Fundación Santa Fé de Bogotá, Bogotá D.C., Colombia
| | | | | |
Collapse
|
|
4
|
Jin JZ, Hardy MO, Unasa H, Mauiliu-Wallis M, Weston M, Connolly A, Singh PP, Hill AG. A systematic review and meta-analysis of the efficacy of topical sphincterotomy treatments for anal fissure. Int J Colorectal Dis 2022; 37:1-15. [PMID: 34608561 DOI: 10.1007/s00384-021-04040-3] [Citation(s) in RCA: 9] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 09/25/2021] [Indexed: 02/04/2023]
Abstract
BACKGROUND Anal fissure is a common condition that can be treated medically or surgically. Chemical sphincterotomy is often used before surgical intervention. This study aims to evaluate the effectiveness of topical agents for chemical sphincterotomy on healing of anal fissures and side-effects. METHODS A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) compliant systematic review was performed using MEDLINE, EMBASE, Scopus, and CENTRAL databases. Eligible studies included randomized controlled trials which compared topical sphincterotomy agents with topical placebo agents or each other. Studies that included surgical treatments were excluded. Overall evidence was synthesized according to the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. RESULTS Thirty-seven studies met the study selection criteria. Seventeen studies show that glyceryl trinitrate (GTN) was significantly more likely to heal anal fissure than placebo (relative risk (RR) = 1.96, 95% confidence interval (95%CI) = 1.35-2.84, I2 = 80%). Eleven studies showed a marginally significant difference between healing rates for diltiazem vs GTN, RR = 1.16, (1.01-1.33) I2 = 48%. There was no significant difference in healing between diltiazem and placebo, RR = 1.65, (0.64-4.23), I2 = 92%. GTN significantly reduced pain on the visual analog scale compared to the placebo group, MD-0.97 (-1.64 to -0.29) I2 = 92%. There was high certainty of evidence that GTN was significantly more likely to cause headache than placebo (RR = 2.73 (1.82-4.10) I2 = 58%) and diltiazem RR = 6.88 (2.19-21.63) I2 = 17%. CONCLUSION There is low certainty evidence topical nitrates are an effective treatment for anal fissure healing and pain reduction compared to placebo. Despite widespread use of topical diltiazem, more evidence is required to establish the effectiveness of calcium channel blockers compared to placebo.
Collapse
Affiliation(s)
- James Z Jin
- Department of Surgery, South Auckland Clinical Campus, The University of Auckland, Auckland, New Zealand.
| | - Molly-Olivia Hardy
- Department of Surgery, South Auckland Clinical Campus, The University of Auckland, Auckland, New Zealand
| | - Hanson Unasa
- Department of Surgery, South Auckland Clinical Campus, The University of Auckland, Auckland, New Zealand.,Department of Surgery, Counties Manukau District Health Board, Manukau, New Zealand
| | - Melbourne Mauiliu-Wallis
- Department of Surgery, South Auckland Clinical Campus, The University of Auckland, Auckland, New Zealand.,Department of Surgery, Counties Manukau District Health Board, Manukau, New Zealand
| | - Maree Weston
- Department of Surgery, Counties Manukau District Health Board, Manukau, New Zealand
| | - Andrew Connolly
- Department of Surgery, Counties Manukau District Health Board, Manukau, New Zealand
| | - Primal Parry Singh
- Department of Surgery, Counties Manukau District Health Board, Manukau, New Zealand
| | - Andrew G Hill
- Department of Surgery, South Auckland Clinical Campus, The University of Auckland, Auckland, New Zealand.,Department of Surgery, Counties Manukau District Health Board, Manukau, New Zealand
| |
Collapse
|
|
5
|
Botulinum Toxin Injection Plus Topical Diltiazem for Chronic Anal Fissure: A Randomized Double-Blind Clinical Trial and Long-term Outcome. Dis Colon Rectum 2021; 64:1521-1530. [PMID: 34747917 DOI: 10.1097/dcr.0000000000001983] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/29/2023]
Abstract
BACKGROUND Chemical sphincterotomy avoids the risk of permanent incontinence in the treatment of chronic anal fissure, but it does not reach the efficacy of surgery and recurrence is high. Drug combination has been proposed to overcome these drawbacks. OBJECTIVE This study aimed to compare the clinical, morphological, and functional effects of combined therapy with botulinum toxin injection and topical diltiazem in chronic anal fissure and to assess the long-term outcome after healing. DESIGN This is a randomized, controlled, double-blind, 2-arm, parallel-group trial with a long-term follow-up. SETTINGS This study was conducted at a tertiary care center. PATIENTS A total of 70 consecutive patients were referred to the gastroenterology department of a hospital in Valencia, Spain. INTERVENTION After botulinum toxin injection (20 IU), patients were randomly assigned to local diltiazem (diltiazem group) or placebo gel (placebo group) for 12 weeks. MAIN OUTCOME MEASURES The primary outcome was fissure healing (evaluated by video register by 3 independent physicians). Secondary outcomes included symptomatic relief (30-day diary), effect on anal sphincters (manometry), safety, and long-term recurrence (24 months and 10 years). RESULTS Healing was achieved per protocol in 13 of 25 (52%) patients of the diltiazem group and 11 of 30 (36.7%) patients of the placebo group (p = 0.25); on an intention-to-treat basis in 37.1% and 31.4% (p = 0.61). Both groups displayed significant reduction of anal pressures. Thirty percent reported minor and transitory incontinence, without differences between groups. Nine (69.2%) of the diltiazem group and 6 (54.5%) of the placebo group experienced a relapse at 24 months (p = 0.67). The overall recurrence rate at 10 years was 83.3% (20/24 patients). LIMITATIONS This study was limited by the loss of patients during the trial. The low healing rate led to a small cohort to assess recurrence. CONCLUSIONS Combined botulinum toxin injection and topical diltiazem is not superior to botulinum toxin injection in the treatment of chronic anal fissure. Both options offer suboptimal healing rates. Long-term recurrence is high (>80% at 10 years) and might appear at any time after healing. See Video Abstract at http://links.lww.com/DCR/B527. INYECCIN DE TOXINA BOTULNICA MS DILTIAZEM TPICO EN FISURA ANAL CRNICA UN ENSAYO CLNICO ALEATORIZADO DOBLE CIEGO Y RESULTADOS A LARGO PLAZO ANTECEDENTES:La esfinterotomía química evita el riesgo de incontinencia permanente en el tratamiento de la fisura anal crónica, pero no alcanza la eficacia de la cirugía y la recurrencia es alta. Se ha propuesto la combinación de fármacos para superar estos inconvenientes.OBJETIVO:Comparar los efectos clínicos, morfológicos y funcionales de la terapia combinada con inyección de toxina botulínica y diltiazem tópico en fisura anal crónica y evaluar el resultado a largo plazo después de la cicatrización.DISEÑO:Ensayo aleatorizado, controlado, doble ciego, de dos brazos, de grupos paralelos con un seguimiento a largo plazo.ESCENARIO:Estudio realizado en un centro de atención terciaria.PACIENTES:Un total de 70 pacientes consecutivos referidos al servicio de gastroenterología de un hospital de Valencia, España.INTERVENCIÓN:Después de la inyección de toxina botulínica (20UI), los pacientes fueron asignados al azar a diltiazem local (grupo de diltiazem) o gel de placebo (grupo de placebo) durante 12 semanas.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue la cicatrización de la fisura (evaluado por registro de video por tres médicos independientes). Los resultados secundarios incluyeron alivio sintomático (diario de 30 días), efecto sobre los esfínteres anales (manometría), seguridad y recurrencia a largo plazo (24 meses y 10 años).RESULTADOS:La curación se logró por protocolo en 13/25 (52%) en el grupo de Diltiazem y 11/30 (36,7%) en el grupo de Placebo (p = 0.25); por intención de tratar en el 37.1% y el 31.4%, respectivamente (p = 0.61). Ambos grupos mostraron una reducción significativa de las presiones anales. El 30% refirió incontinencia leve y transitoria, sin diferencias entre grupos. 9 (69.2%) del grupo de Diltiazem y 6 (54.5%) del grupo de placebo recurrieron a los 24 meses (p = 0.67). La tasa global de recurrencia a los 10 años fue del 83.3% (20/24 pacientes).LIMITACIONES:La pérdida de pacientes a lo largo del ensayo. La baja tasa de curación llevó a una pequeña cohorte para evaluar la recurrencia.CONCLUSIONES:La inyección combinada de toxina botulínica y diltiazem tópico no es superior a la inyección de TB en el tratamiento de la fisura anal crónica. Ambas opciones ofrecen tasas de curación subóptimas. La recurrencia a largo plazo es alta (> 80% a los 10 años) y puede aparecer en cualquier momento después de la curación. Consulte Video Resumen en http://links.lww.com/DCR/B527.
Collapse
|
|
6
|
Nevins EJ, Kanakala V. Topical diltiazem and glyceryl-trinitrate for chronic anal fissure: A meta-analysis of randomised controlled trials. Turk J Surg 2020; 36:347-352. [PMID: 33778393 DOI: 10.47717/turkjsurg.2020.4895] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/31/2020] [Accepted: 09/19/2020] [Indexed: 11/23/2022]
Abstract
Objectives Surgical management of chronic anal fissure can result in permanent fecal incontinence. Topical treatments have a lower risk of severe complication and are less expensive than surgical intervention. Rates of healing and compliance with topical agents vary in the reported literature. The aim of this study was to compare healing rates, incidence of headaches, and recurrence rates of chronic anal fissure in patients treated with topical diltiazem (DTZ) and topical glyceryl-trinitrate (GTN), with a view of identifying which agent should be used as first line non-operative therapy. Material and Methods Randomized controlled trials (RCTs), published since January 2000, comparing topical DTZ and GTN for treatment of chronic anal fissure were identified and compared. End points included healing rates, headache due to treatment, and late recurrence (>12 weeks). A random effects meta-analysis model was used to compare outcomes. Results All studies used 2% DTZ and 0.2% or 0.5% GTN, and treatment was continued twice daily for between 6-12 weeks. Nine RCTs compared rates of healing with topical DTZ (n= 379) and GTN (n= 351), there was no difference between the two groups [RR 1.04 (0.93-1.16), p= 0.48]. Eight RCTs reviewed incidence of headaches, DTZ was better tolerated [RR 0.15 (0.07-0.34), p <0.00001]. Four RCTs reported late recurrence rates, DTZ was superior [RR 0.51 (0.27-0.96), p= 0.04]. Conclusion Topical DTZ and GTN result in comparable healing rates; however, DTZ is superior with regards to headaches and late recurrence rates. DTZ should therefore be considered as first line non-operative treatment for chronic anal fissure.
Collapse
Affiliation(s)
- Edward J Nevins
- South Tees Hospitals Nhs Foundation Trust, Clinic of General Surgery, Middlesbrough, United Kingdom
| | - Venkatesh Kanakala
- South Tees Hospitals Nhs Foundation Trust, Clinic of General Surgery, Middlesbrough, United Kingdom
| |
Collapse
|
|
7
|
Chiarello MM, Cariati M, Brisinda G. Botulinum toxin versus other therapies for treatment of chronic anal fissure. COLOPROCTOLOGY 2020; 42:457-463. [DOI: 10.1007/s00053-020-00497-y] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
|
|
8
|
Mosleh G, Hosseini SV, Azadi A, Bahrami F, Ghahramani L, Badr P, Zaeri M, Abolhassanzadeh Z, Mohagheghzadeh A. Erysimum cheiri and Rosa × damascena cerate vs. Diltiazem 2% gel in the treatment of acute anal fissure: A randomized, controlled clinical trial. Eur J Integr Med 2020. [DOI: 10.1016/j.eujim.2020.101230] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/23/2022]
|
|
9
|
Abstract
ZusammenfassungDie Analfissur ist eine der häufigsten Pathologien, welche sich dem Proktologen präsentiert. Entsprechend ist es wichtig, verlässliche Leitlinien dazu zu entwickeln. Die aktuelle Leitlinie wurde anhand eines systematischen Literaturreview von einem interdisziplinären Expertengremium diskutiert und verabschiedet.Die akute Analfissur, soll auf Grund ihrer hohen Selbstheilungstendenz konservativ behandelt werden. Die Heilung wird am besten durch die Einnahme von Ballaststoff reicher Ernährung und einer medikamentösen Relaxation durch Kalziumkanal-Antagonisten (CCA) unterstützt. Zur Behandlung der chronischen Analfissur (CAF), soll den Patienten eine medikamentöse Behandlung zur „chemischen Sphinkterotomie“ mittels topischer CCA oder Nitraten angeboten werden. Bei Versagen dieser Therapie, kann zur Relaxation des inneren Analsphinkters Botulinumtoxin injiziert werden. Es ist belegt, dass die operativen Therapien effektiver sind. Deshalb kann eine Operation schon als primäre Therapie oder nach erfolgloser medikamentöser Therapie erfolgen. Die Fissurektomie, evtl. mit zusätzlicher Botulinumtoxin Injektion oder Lappendeckung, ist die Operation der Wahl. Obwohl die laterale Internus Sphinkterotomie die CAF effektiver heilt, bleibt diese wegen dem höheren Risiko für eine postoperative Stuhlinkontinenz eine Option für Einzelfälle.
Collapse
|
|
10
|
Nordholm-Carstensen A, Perregaard H, Wahlstrøm KL, Hagen KB, Hougaard HT, Krarup PM. Treatment of chronic anal fissure: a feasibility study on Levorag® Emulgel versus Diltiazem gel 2. Int J Colorectal Dis 2020; 35:615-621. [PMID: 31980871 DOI: 10.1007/s00384-020-03515-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 01/20/2020] [Indexed: 02/04/2023]
Abstract
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.
Collapse
Affiliation(s)
- Andreas Nordholm-Carstensen
- Digestive Disease Center K, Bispebjerg Hospital, University of Copenhagen, Bispebjerg Bakke 23, 2400, Copenhagen NV, Denmark.
| | - Helene Perregaard
- Digestive Disease Center K, Bispebjerg Hospital, University of Copenhagen, Bispebjerg Bakke 23, 2400, Copenhagen NV, Denmark
| | | | - Kikke Bartholin Hagen
- Digestive Disease Center K, Bispebjerg Hospital, University of Copenhagen, Bispebjerg Bakke 23, 2400, Copenhagen NV, Denmark
| | | | - Peter-Martin Krarup
- Digestive Disease Center K, Bispebjerg Hospital, University of Copenhagen, Bispebjerg Bakke 23, 2400, Copenhagen NV, Denmark
| |
Collapse
|
|
11
|
Gardner IH, Siddharthan RV, Tsikitis VL. Benign anorectal disease: hemorrhoids, fissures, and fistulas. Ann Gastroenterol 2019; 33:9-18. [PMID: 31892792 PMCID: PMC6928486 DOI: 10.20524/aog.2019.0438] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/18/2020] [Accepted: 10/04/2020] [Indexed: 12/20/2022] Open
Abstract
Hemorrhoids, anal fissures, and fistulas are common benign anorectal diseases that have a significant impact on patients’ lives. They are primarily encountered by primary care providers, including internists, gastroenterologists, pediatricians, gynecologists, and emergency care providers. Most complex anorectal disease cases are referred to colorectal surgeons. Knowledge of these disease processes is essential for proper treatment and follow up. Hemorrhoids and fissures frequently benefit from non-operative treatment; they may, however, require surgical procedures. The treatment of anorectal abscess and fistulas is mainly surgical. The aim of this review is to examine the etiology, diagnosis, medical, and surgical treatment for these benign anorectal diseases.
Collapse
Affiliation(s)
- Ivy H Gardner
- Department of General Surgery, Division of Gastrointestinal and General Surgery Portland, Oregon Health and Science University, OR, USA
| | - Ragavan V Siddharthan
- Department of General Surgery, Division of Gastrointestinal and General Surgery Portland, Oregon Health and Science University, OR, USA
| | - Vassiliki Liana Tsikitis
- Department of General Surgery, Division of Gastrointestinal and General Surgery Portland, Oregon Health and Science University, OR, USA
| |
Collapse
|
|
12
|
Topical Analgesia with Lidocaine Plus Diclofenac Decreases Pain in Benign Anorectal Surgery: Randomized, Double-blind, and Controlled Clinical Trial. Clin Transl Gastroenterol 2018; 9:210. [PMID: 30467335 PMCID: PMC6250696 DOI: 10.1038/s41424-018-0075-7] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/31/2018] [Revised: 10/05/2018] [Accepted: 10/13/2018] [Indexed: 12/27/2022] Open
Abstract
OBJECTIVE The aim of this study is to evaluate the efficacy and safety of a topical formulation containing lidocaine plus diclofenac (CLIFE1) compared to lidocaine (CLIFE2), to decrease pain in benign anorectal surgery (BARS) to date not evaluated. More than 50% of patients undergoing BARS, especially hemorrhoidectomy, suffer from moderate and severe postoperative pain. This remains an unresolved problem that could be addressed with the new CLIFE1 topical treatment. METHODS A multicenter, randomized double-blind, active-controlled parallel-group superiority trial, was conducted in two Spanish hospitals. Patients undergoing BARS (hemorrhoids, anal fistula and anal fissure) were randomized at the end of surgery at a 1:1 ratio to receive first dose either CLIFE1 (n = 60) or CLIFE2 (n = 60) anorectal topical treatment, and after every 12 h for the first three postoperative days and once a day from the fourth to sixth. The primary outcome was average of pain decrease after topical treatment, measured with visual analogue scale (VAS) by the patients themselves, the evening in the surgery day and four times daily for the first three postoperative days. RESULTS The results of 120 patients included out of 150 selected undergoing BARS show a decrease in pain after CLIFE1 topical treatment (7.47 ± 13.09) greater than with CLIFE2 (4.38 ± 6.75), difference -3.21 95% CI (-5.75; -0.68), p = 0.008, decreasing significantly postoperative pain ( ≥ 9 mm, VAS) in 35% of patients undergoing benign anorectal surgery, compared to 18.33 % treated with lidocaine. CONCLUSIONS The CLIFE1 topical treatment shows better analgesic efficacy than CLIFE2 in BARS.
Collapse
|
|
13
|
Alvandipour M, Ala S, Khalvati M, Yazdanicharati J, Koulaeinejad N. Topical Minoxidil Versus Topical Diltiazem for Chemical Sphincterotomy of Chronic Anal Fissure: A Prospective, Randomized, Double-Blind, Clinical Trial. World J Surg 2018; 42:2252-2258. [PMID: 29290068 DOI: 10.1007/s00268-017-4449-x] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/03/2023]
Abstract
BACKGROUND Anal fissure is a common anorectal problem causing severe pain and discomfort to the patients. Chemical sphincterotomy has emerged as a noninvasive alternative to the surgical methods of fissure treatment. The objective of this study was evaluation of the efficacy and the adverse effects of topically applied minoxidil in chemical sphincterotomy of chronic anal fissure in comparison with topical diltiazem. METHODS A total of 88 patients with chronic anal fissure aged between 15 and 65 years were included in this double-blind, randomized clinical trial and were randomly assigned to either 0.5% minoxidil cream or 2% diltiazem cream twice daily for 2 weeks. The pain intensity, bleeding, wound healing, itching, headache, dizziness, significant drop in blood pressure, allergy and fissure relapse were assessed on a monthly basis for 2 months. RESULTS Both diltiazem and minoxidil reduced the pain, bleeding and improved fissure healing with no significant difference. There were no between-groups differences in the frequencies of adverse effects, except for itching which was slightly higher with minoxidil during the first month. Allergy occurred in two patients in the minoxidil group, which was not severe and did not lead to discontinuation of the trial. CONCLUSION Topically administered minoxidil is of equal efficacy as diltiazem in the treatment of chronic anal fissure with low frequency of adverse effects. Thus, it can be considered as an agent for chemical sphincterotomy of anal fissure, but the itching at the beginning of the treatment can affect the adherence of the patient to treatment. Trial registration number IRCT2015041414483N6 (the full trial protocol could be accessed online at www.irct.ir ).
Collapse
Affiliation(s)
- Mina Alvandipour
- Department of Surgery, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Mazandaran Province, Iran
| | - Shahram Ala
- Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, 18th Km Farahabad Boulevard, Sari, Mazandaran Province, 48175861, Iran.
| | - Mehdi Khalvati
- Department of Surgery, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Mazandaran Province, Iran
| | - Jamshid Yazdanicharati
- Department of Health, Biostatistics and Medical Research, Mazandaran University of Medical Sciences, Sari, Mazandaran Province, Iran
| | - Neda Koulaeinejad
- Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, 18th Km Farahabad Boulevard, Sari, Mazandaran Province, 48175861, Iran
| |
Collapse
|
|
14
|
Nelson RL, Manuel D, Gumienny C, Spencer B, Patel K, Schmitt K, Castillo D, Bravo A, Yeboah-Sampong A. A systematic review and meta-analysis of the treatment of anal fissure. Tech Coloproctol 2017; 21:605-625. [PMID: 28795245 DOI: 10.1007/s10151-017-1664-2] [Citation(s) in RCA: 60] [Impact Index Per Article: 7.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/31/2017] [Accepted: 06/14/2017] [Indexed: 02/06/2023]
Abstract
BACKGROUND Anal fissure has a very large number of treatment options. The choice is difficult. In an effort to assist in that, choice presented here is a systematic review and meta-analysis of all published treatments for anal fissure that have been studied in randomized controlled trials. METHODS Randomized trials were sought in the Cochrane Controlled Trials Register, Medline, EMBASE and the trials registry sites clinicaltrials.gov and who/int/ictrp/search/en. Abstracts were screened, full-text studies chosen, and finally eligible studies selected and abstracted. The review was then divided into those studies that compared two or more surgical procedures and those that had at least one arm that was non-surgical. Studies were further categorized by the specific interventions and comparisons. The outcome assessed was treatment failure. Negative effects of treatment assessed were headache and anal incontinence. Risk of bias was assessed for each study, and the strength of the evidence of each comparison was assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. RESULTS One hundred and forty-eight eligible trials were found and assessed, 31 in the surgical group and 117 in the non-surgical group. There were 14 different operations described in the surgical group and 29 different non-surgical treatments in the non-surgical group along with partial lateral internal sphincterotomy (LIS). There were 61 different comparisons. Of these, 47 were reported in 2 or fewer studies, usually with quite small patient samples. The largest single comparison was glyceryl trinitrate (GTN) versus control with 19 studies. GTN was more effective than control in sustained cure (OR 0.68; 95% CI 0.63-0.77), but the quality of evidence was very poor because of severe heterogeneity, and risk of bias due to inadequate clinical follow-up. The only comparison to have a GRADE quality of evidence of high was a subgroup analysis of LIS versus any medical therapy (OR 0.12; CI 0.07-0.21). Most of the other studies were downgraded in GRADE due to imprecision. CONCLUSIONS LIS is superior to non-surgical therapies in achieving sustained cure of fissure. Calcium channel blockers were more effective than GTN and with less risk of headache, but with only a low quality of evidence. Anal incontinence, once thought to be a frequent risk with LIS, was found in various subgroups in this review to have a risk between 3.4 and 4.4%. Among the surgical studies, manual anal stretch performed worse than LIS in the treatment of chronic anal fissure in adults. For those patients requiring surgery for anal fissure, open LIS and closed LIS appear to be equally efficacious, with a moderate GRADE quality of evidence. All other GRADE evaluations of procedures were low to very low due mostly to imprecision.
Collapse
Affiliation(s)
- R L Nelson
- Epidemiology/Biometry Division, University of Illinois School of Public Health, 1603 West Taylor Room 956, Chicago, IL, 60612, USA.
| | - D Manuel
- Honors College, University of Illinois at Chicago, Chicago, IL, USA
| | - C Gumienny
- Honors College, University of Illinois at Chicago, Chicago, IL, USA
| | - B Spencer
- Honors College, University of Illinois at Chicago, Chicago, IL, USA
| | - K Patel
- Honors College, University of Illinois at Chicago, Chicago, IL, USA
| | - K Schmitt
- Honors College, University of Illinois at Chicago, Chicago, IL, USA
| | - D Castillo
- Honors College, University of Illinois at Chicago, Chicago, IL, USA
| | - A Bravo
- Honors College, University of Illinois at Chicago, Chicago, IL, USA
| | - A Yeboah-Sampong
- Honors College, University of Illinois at Chicago, Chicago, IL, USA
| |
Collapse
|
|
15
|
Affiliation(s)
- Joyce Generali
- Drug Information Center, Kansas University Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160
| | - Dennis J. Cada
- Drug Information Center, Kansas University Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160
| |
Collapse
|
|
16
|
Gaj F, Biviano I, Candeloro L, Andreuccetti J. Anal self-massage in the treatment of acute anal fissure: a randomized prospective study. Ann Gastroenterol 2017; 30:438-441. [PMID: 28655981 PMCID: PMC5479997 DOI: 10.20524/aog.2017.0154] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/17/2017] [Accepted: 04/06/2017] [Indexed: 01/22/2023] Open
Abstract
Background An anal fissure (AF) is a tear in the epithelial lining of the anal canal. This is a very common condition, but the choice of treatment is unclear. The use of anal dilators is effective, economic, and safe. The aim of the study was to compare the efficacy of two conservative treatments, the use of anal dilators or a finger for anal dilatation, in reducing anal pressure and resolving anal fissures. Methods Fifty patients with a clinical diagnosis of AF were randomly assigned to one of the treatments, self-massage of the anal sphincter (group A, 25 patients) or passive dilatation using dilators (group B, 25 patients). All patients were evaluated at baseline, at the end of treatment, and after 12 weeks and 6 months. Pain was measured using a visual analog scale. Results After the treatment, 60% of patients treated with dilators and 80% of patients treated with anal self-massage using a finger showed disappearance of their anal fissures. A comparison between signs and symptoms reported by the patients in the two groups showed a statistically significant reduction in anal pain (group A, P=0.0001; group B, P=0.0001) and bleeding after defecation (group A, P=0.001, group B, P=0.001). At 6 months after treatment, a significantly greater reduction in anal pain was observed in Group A compared to Group B (P=0.02). Conclusion The use of anal self-massage with a finger appears to induce a better resolution of acute anal fissure than do anal dilators, and in a shorter time.
Collapse
Affiliation(s)
- Fabio Gaj
- Department of General Surgery and Organ Transplant, Umberto I Policlinic of Rome, Sapienza University, Rome (Fabio Gaj)
| | - Ivano Biviano
- Department of Medicine and Medical Specialties, Umberto I Policlinic of Rome, Sapienza University of Rome (Ivano Biviano, Laura Candeloro)
| | - Laura Candeloro
- Department of Medicine and Medical Specialties, Umberto I Policlinic of Rome, Sapienza University of Rome (Ivano Biviano, Laura Candeloro)
| | - Jacopo Andreuccetti
- General and Mini-Invasive Surgery, "San Camillo" Hospital, Trento (Jacopo Andreuccetti), Italy
| |
Collapse
|
|
17
|
Sahebally SM, Ahmed K, Cerneveciute R, Iqbal A, Walsh SR, Joyce MR. Oral versus topical calcium channel blockers for chronic anal fissure-a systematic review and meta-analysis of randomized controlled trials. Int J Surg 2017. [PMID: 28629764 DOI: 10.1016/j.ijsu.2017.06.039] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
BACKGROUND Chemical sphincterotomy with pharmacological agents is recommended as first line therapy for chronic anal fissures (CAF). Calcium channel blockers (CCB) are associated with similar efficacy but fewer side effects compared to nitrates. However, the optimal formulation (oral versus topical) is unknown. We aimed to perform a systematic review and meta-analysis to compare the effectiveness of oral and topical CCB in the treatment of CAF. METHODS PubMed and Embase online databases were searched for relevant articles. Two independent reviewers performed methodological assessment and data extraction. Random effects models were used to calculate pooled effect size estimates. A sensitivity analysis was also carried out. RESULTS Four randomized controlled trials describing 279 patients (138 in oral, 141 in topical group) were examined. There was significant heterogeneity among studies. On random effects analysis, topical CCB were associated with a significantly lower rate of unhealed fissure (21.3% vs. 38.4%; OR = 2.65, 95% CI = 1.50 to 4.69, p = 0.0008) when compared to oral therapy. However, there were no significant differences in fissure recurrence (5.4% vs. 5.5%; OR = 1.01, 95% CI = 0.31 to 3.33, p = 0.98) or side effects (15.6% vs. 39.1%; OR = 4.54, 95% CI = 0.46 to 44.3, p = 0.19) between topical and oral CCB. On sensitivity analysis, having excluded the most heavily biased trial, topical CCB were associated with significantly fewer side effects compared to oral therapy (4.3% vs. 38.0%; OR = 13.16, 95% CI = 5.05 to 34.3, p < 0.00001). CONCLUSIONS Topical CCB are associated with better healing and fewer side effects when compared to oral therapy but there is no difference in recurrence rates.
Collapse
Affiliation(s)
- Shaheel M Sahebally
- Department of Surgery, Lambe Institute, National University of Ireland, Galway, Ireland; Department of Colorectal Surgery, University Hospital Galway, Galway, Ireland.
| | - Khalid Ahmed
- Department of Surgery, Lambe Institute, National University of Ireland, Galway, Ireland
| | - Raminta Cerneveciute
- Department of Surgery, Lambe Institute, National University of Ireland, Galway, Ireland
| | - Asif Iqbal
- Department of Colorectal Surgery, University Hospital Galway, Galway, Ireland
| | - Stewart R Walsh
- Department of Surgery, Lambe Institute, National University of Ireland, Galway, Ireland
| | - Myles R Joyce
- Department of Colorectal Surgery, University Hospital Galway, Galway, Ireland
| |
Collapse
|
|
18
|
Ala S, Enayatifard R, Alvandipour M, Qobadighadikolaei R. Comparison of captopril (0.5%) cream with diltiazem (2%) cream for chronic anal fissure: a prospective randomized double-blind two-centre clinical trial. Colorectal Dis 2016; 18:510-6. [PMID: 26456162 DOI: 10.1111/codi.13147] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/18/2015] [Accepted: 07/17/2015] [Indexed: 02/08/2023]
Abstract
AIM This study compared the efficacy of topical captopril with topical diltiazem in the treatment of chronic anal fissure (CAF). METHOD Fifty patients aged between 15 and 75 years with CAF were included in a prospective randomized, double-blind clinical trial. They were randomly allocated to either captopril (0.5%) cream or diltiazem (2%) cream in a dose of 2 cm of cream on the perianal skin every 12 h for 8 weeks. The intensity of pain upon defaecation was evaluated every 10 days using a visual analogue scale. Bleeding on defaecation, pruritus and the presence of perianal irritation were also recorded before and during the trial. RESULTS The average pain scores were lower in the diltiazem group on the 20th and 30th days. From day 40 to the end of the trial the average pain scores of the two groups did not differ significantly. There were no significant differences in bleeding or perianal irritation between the groups, but the incidence of pruritus was considerably higher in the captopril group, and at the end of the trial 45.8% of the patients in this group still suffered from pruritus. CONCLUSION Topical captopril and diltiazem were found to be equally effective in the management of pain, bleeding and perianal irritation due to CAF, but due to the high incidence of pruritus observed with topical captopril this medication is not recommended for the treatment of CAF.
Collapse
Affiliation(s)
- S Ala
- Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
| | - R Enayatifard
- Department of Pharmaceutical Sciences, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
| | - M Alvandipour
- Department of Surgery, Imam Khomeini General Hospital affiliated to Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
| | - R Qobadighadikolaei
- Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
| |
Collapse
|
|
19
|
Bansal AR, Kumar Yadav P, Godara R, Pal N, Tripura R, Jaikaran. Comparative evaluation of 0.2% glyceryl trinitrate vs. 2% diltiazem ointment in treatment of chronic anal fissure treatment - a randomized trial. ACTA ACUST UNITED AC 2016. [DOI: 10.1007/s13126-016-0278-x] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/30/2022]
|
|
20
|
Bibi S, Zutshi M, Gurland B, Hull T. Is Botox for anal pain an effective treatment option? Postgrad Med 2015; 128:41-5. [DOI: 10.1080/00325481.2015.1081047] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/23/2022]
|
|
21
|
Vershenya S, Klotz J, Joos A, Bussen D, Herold A. Combined approach in the treatment of chronic anal fissures. Updates Surg 2015; 67:83-9. [DOI: 10.1007/s13304-015-0290-7] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/05/2014] [Accepted: 03/07/2015] [Indexed: 10/23/2022]
|
|
22
|
|
|
23
|
Gandomkar H, Zeinoddini A, Heidari R, Amoli HA. Partial lateral internal sphincterotomy versus combined botulinum toxin A injection and topical diltiazem in the treatment of chronic anal fissure: a randomized clinical trial. Dis Colon Rectum 2015; 58:228-34. [PMID: 25585082 DOI: 10.1097/dcr.0000000000000307] [Citation(s) in RCA: 38] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
OBJECTIVES The aim of this study is to evaluate the effectiveness and complications associated with combined topical diltiazem cream and botulinum toxin A injection versus partial lateral internal sphincterotomy in chronic anal fissure. DESIGN This study is a parallel, randomized controlled trial (using the block randomization method). SETTING This study was performed at a university hospital in Iran. PARTICIPANTS Ninety-nine patients who had chronic anal fissures were included. INTERVENTION A total of 99 patients were randomly assigned to 2 groups; the first group received combined topical diltiazem ointment (for 6 weeks) and botulinum toxin A injection (once) (n = 49), and the second group received partial lateral internal sphincterotomy (n = 50). All the patients were followed up for 1 year. MAIN OUTCOME MEASURES The primary outcomes measured were the healing of the anal fissure and the development of incontinence as the major adverse event during the 1-year follow-up period. RESULTS The overall healing rate was 65% and 94% in the botulinum toxin A-diltiazem and partial lateral internal sphincterotomy groups (p < 0.001). The patients in the partial lateral internal sphincterotomy group experienced significantly higher incontinence scores (p = 0.04) according to the Cleveland Clinic Florida-Fecal Incontinence scoring system. In patients who had chronic anal fissure for ≤12 months, no statistical difference was observed in the healing rate between the botulinum toxin A-diltiazem and partial lateral internal sphincterotomy groups (100% vs 100%). However, in the patients with longer chronic fissures, the healing rate was significantly higher in the partial lateral internal sphincterotomy group (86% [18/21] vs 23% [5/21], p < 0.001). LIMITATIONS The 1-year follow-up period, subjective definitions of itching, and lack of anorectal manometry examinations and data regarding the effect of each treatment on anal sphincter pressure at rest and contraction are the key limitations of this study. CONCLUSION Combined botulinum toxin A injection with a topical application of diltiazem could be as effective as partial lateral internal sphincterotomy in the treatment of chronic anal fissure in patients who have chronic anal fissure for ≤12 months. However, in chronic anal fissures of longer duration, partial lateral internal sphincterotomy is associated with a significantly higher cure rate.
Collapse
Affiliation(s)
- Hossein Gandomkar
- Sina Trauma and Surgery Research Center, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran
| | | | | | | |
Collapse
|
|
24
|
Topical diltiazem in management of chronic anal fissure: a review of the literature. ACTA ACUST UNITED AC 2014. [DOI: 10.4155/cli.14.86] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
|
|
25
|
Brisinda G, Bianco G, Silvestrini N, Maria G. Cost considerations in the treatment of anal fissures. Expert Rev Pharmacoecon Outcomes Res 2014; 14:511-525. [PMID: 24867398 DOI: 10.1586/14737167.2014.924398] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
Anal fissure is a split in the lining of the distal anal canal. Lateral internal sphincterotomy remains the gold standard for treatment of anal fissure. Although technique is simple and effective, a drawback of this surgical procedure is its potential to cause minor but some times permanent alteration in rectal continence. Conservative approaches (such as topical application of ointment or botulinum toxin injections) have been proposed in order to treat this condition without any risk of permanent injury of the internal anal sphincter. These treatments are effective in a large number of patients. Furthermore, with the ready availability of medical therapies to induce healing of anal fissure, the risk of a first-line surgical approach is difficult to justify. The conservative treatments have a lower cost than surgery. Moreover, evaluation of the actual costs of each therapeutic option is important especially in times of economic crisis and downsizing of health spending.
Collapse
Affiliation(s)
- Giuseppe Brisinda
- Department of Surgery, Catholic School of Medicine, University Hospital "Agostino Gemelli", Largo Agostino Gemelli 8, 00168, Rome, Italy
| | | | | | | |
Collapse
|
|
26
|
Latif A, Ansar A, Butt MQ. Morbidity associated with treatment of chronic anal fissure. Pak J Med Sci 2013; 29:1230-5. [PMID: 24353726 PMCID: PMC3858918 DOI: 10.12669/pjms.295.3623] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/15/2013] [Revised: 06/14/2013] [Accepted: 07/21/2013] [Indexed: 01/27/2023] Open
Abstract
OBJECTIVE To assess the effectiveness of different modes of treatment of chronic anal fissure as regards improvement of symptoms and complications. METHODS This prospective study included 129 consecutive patients with chronic anal fissures presented to the Surgical Outpatients' Department of Islam Teaching Hospital Sialkot, Pakistan; from September 2010 to November 2012. Patients were distributed in three groups. In "OBG group", patients had attended Gynae/Obs OPD and got treated and were then referred to surgical OPD for failure of treatment or recurrence. Patients who presented with history of treatment by GPs were included in "GP Group" "SGR Group" included those who directly reported to surgical OPD for treatment. Patients were managed both pharmacologically as OPD patients and surgically as admitted patients. Patients were instructed to apply small amounts of 0.2% GTN paste in soft white paraffin, to the anoderm with finger tips three times a day. Patients were evaluated at two-week intervals and at each visit the symptoms control, adverse effects and fissure status were recorded. If there was symptomatic relief or the fissure healing was in progress, the treatment was continued for a total duration of eight weeks. Operated patients were nursed in wards after surgery i.e Internal Anal Sphicterotomy. They were advised to report to OPD weekly for one month or earlier if they experienced any symptoms suggestive of complications. Patients were declared cured in case of complete symptomatic relief with fissure healing. Success, failure and associated problems were recorded and analysed to get results. RESULTS This study included 129 patients who could be followed up for a minimum of three months. These patients were referred by gynaecologist i.e. 22 (17%) for treatment failure while 5 patients with wrong diagnosis were not included in statistical analysis; similarly 41 (32%) patients were referred by general practitioners and 9 patients with wrong diagnosis were excluded. Sixty six patients i.e. 51% were those who directly reported to surgical OPD and had no previous treatment. With surgical treatment, pain, bleeding per rectum and constipation showed significant improvement as compared to GTN ointment application. Fissure healing was 100% in surgical group as compared to 74% in medical group. Complications were recorded and were found to be headache with medical treatment; while the most feared complication with surgical treatment i.e. permanent incontinence was not encountered in our study. CONCLUSION Topical glyceryl trinitrate is economical, has a good healing rate, and faecal incontinence has not been reported. Its effectiveness, however, depends on patients' compliance which may be poor in view of associated headaches and a local burning sensation. It is first line of treatment for anal fissure but lateral internal sphincterotomy is superior, more effective and curative than the chemical sphincterotomy. Surgery is reserved for people with anal fissure who have tried medical therapy for at least one to three months but failed.
Collapse
Affiliation(s)
- Ansar Latif
- Dr. Ansar Latif, MBBS, FCPS, Assistant Professor, Department of Surgery, Islam Medical College, Sialkot, Pakistan
| | - Anila Ansar
- Dr. Anila Ansar, MBBS, MCPS, FCPS, Assistant Professor, Department of Obstetrics and Gynaecology, Islam Medical College, Sialkot, Pakistan
| | - Muhammad Qasim Butt
- Dr. Muhammad Qasim Butt, MBBS, FCPS, Department of Surgery, Combined Military Hospital, Kohat, Pakistan
| |
Collapse
|
|
27
|
Abstract
Anal fissure is a common anorectal disorder resulting in anal pain and bleeding. Fissures can either heal spontaneously and be classified as acute, or persist for 6 or more weeks and be classified as chronic, ultimately necessitating treatment. Anal stenosis is a challenging problem most commonly resulting from trauma, such as excisional hemorrhoidectomy. This frustrating issue for the patient is equally as challenging to the surgeon. This article reviews these 2 anorectal disorders, covering their etiology, mechanism of disease, diagnosis, and algorithm of management.
Collapse
Affiliation(s)
- Sherief Shawki
- Department of Colorectal Surgery, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA
| | | |
Collapse
|
|
28
|
Bulus H, Varol N, Tas A, Coskun A. Comparison of topical isosorbide mononitrate, topical diltiazem, and their combination in the treatment of chronic anal fissure. Asian J Surg 2013; 36:165-9. [PMID: 24054756 DOI: 10.1016/j.asjsur.2013.01.010] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/23/2012] [Revised: 11/05/2012] [Accepted: 01/15/2013] [Indexed: 11/29/2022] Open
|
|
29
|
Centkowska K, Sznitowska M. Modified-release ointment with nitroglycerin β-cyclodextrin inclusion complex for treatment of anal fissures. J Pharm Pharmacol 2013; 65:1463-72. [DOI: 10.1111/jphp.12120] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/23/2013] [Accepted: 06/20/2013] [Indexed: 11/30/2022]
Abstract
Abstract
Objectives
The aim was to evaluate ointments for local treatment of anal fissures. Nitroglycerin (NTG) was complexed with β-cyclodextrin (β-CD) to provide prolonged NTG release, with the intention of decreasing systemic drug absorption and thus reducing side effects.
Methods
Gels, creams and anhydrous water-emulsifying (AWE) ointment with NTG-CD were compared with preparations containing uncomplexed NTG (diluted with crospovidone, NTG-cP). The in-vitro NTG release and ex-vivo skin absorption were studied.
Key findings
The prolonged-release ointment with the NTG-CD complex was formulated using AWE base or w/o cream (20% water); release of NTG from a hydrogel was very fast with both the complexed and uncomplexed forms. From the AWE ointment base, 16.4% or 4.5% of the total NTG dose was released after 6 h when NTG-cP or NTG-CD was incorporated, respectively. With the complexed form, NTG absorption to the skin after a 5-h application was 18.1 or 11.1 μg/g from AWE ointment or cream, respectively; absorption of the uncomplexed NTG was higher: 52.3 or 21.9 μg/g from AWE ointment and cream, respectively.
Conclusions
Complexation with β-CD results in prolonged release of NTG from AWE ointment and w/o cream, which was confirmed by the ex-vivo skin absorption results.
Collapse
Affiliation(s)
- Katarzyna Centkowska
- Department of Pharmaceutical Technology, Medical University of Gdansk, Gdansk, Poland
| | - Malgorzata Sznitowska
- Department of Pharmaceutical Technology, Medical University of Gdansk, Gdansk, Poland
| |
Collapse
|
|
30
|
Sajid MS, Whitehouse PA, Sains P, Baig MK. Systematic review of the use of topical diltiazem compared with glyceryltrinitrate for the nonoperative management of chronic anal fissure. Colorectal Dis 2013; 15:19-26. [PMID: 22487078 DOI: 10.1111/j.1463-1318.2012.03042.x] [Citation(s) in RCA: 49] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/26/2022]
Abstract
AIM The study analyzed clinical trials investigating the effectiveness of diltiazem (DTZ) and glyceryltrinitrate (GTN) for the nonsurgical management of chronic anal fissure (CAF). METHOD Randomized trials on the effectiveness of DTZ and GTN were analyzed systematically using RevMan(®) where combined outcome was expressed as risk ratio (RR). RESULTS Seven randomized controlled trials that included 481 patients were analyzed. Two-hundred and thirty-eight patients were treated with DTZ and 243 patients were treated with GTN. There was significant heterogeneity [Tau(2) = 0.24, χ2 = 13.16, d.f. = 6 (P < 0.05); I(2) = 54%] among the included trials. In the random-effects model, DTZ was associated with a lower incidence of side effects (RR = 0.48; 95% CI = 0.27, 0.86; z = 2.46; P < 0.01), headache (RR = 0.39; 95% CI = 0.24, 0.66; z = 3.54; P < 0.004) and recurrence (RR = 0.68; 95% CI = 0.52, 0.89; z = 2.77; P < 0.006) of CAF. Both GTN and DTZ were equally effective (RR = 1.10; 95% CI = 0.90, 1.34; z = 0.92; P = 0.36) in the nonsurgical management of CAF. CONCLUSION This systematic review of seven trials validates and strengthens the finding of a previously published meta-analysis of two randomized trials. Both DTZ and GTN are equally effective in the management of CAF. However, DTZ is associated with a lower incidence of headache and recurrent fissure. Therefore DTZ should be the preferred first line of treatment for CAF.
Collapse
Affiliation(s)
- M S Sajid
- Department of Colorectal Surgery, Worthing Hospital, Worthing, UK.
| | | | | | | |
Collapse
|
|
31
|
Tsunoda A, Kashiwagura Y, Hirose KI, Sasaki T, Kano N. Quality of life in patients with chronic anal fissure after topical treatment with diltiazem. World J Gastrointest Surg 2012; 4:251-5. [PMID: 23494072 PMCID: PMC3596506 DOI: 10.4240/wjgs.v4.i11.251] [Citation(s) in RCA: 23] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/04/2012] [Revised: 08/27/2012] [Accepted: 11/01/2012] [Indexed: 02/06/2023] Open
Abstract
AIM: To assess the physical and mental health of fissure patients before and after topical treatment with diltiazem.
METHODS: Consecutive patients were enrolled prospectively into the study. Quality of life was measured with the short-forum 36 health survey (SF-36) before and after 6-wk treatment with diltiazem. Patients scored symptoms of pain, bleeding, and irritation using numeral rating scales at the initial and follow-up visits. Fissure healing was assessed and side effects were noted.
RESULTS: Fissures healed in 21 of 30 (70%) patients. There were significant reductions in the scores of pain, bleeding, and irritation after 1 wk of treatment, respectively. Four patients experienced perianal itching and one patient reported headache. When measured at baseline, pain and irritation showed a negative impact on two of the eight subscales on the SF-36, respectively (bodily pain and social functioning for pain; vitality and mental health for irritation). Repeating the SF-36 showed an improvement in bodily pain (P = 0.001). Patients whose fissures healed reported an improvement in bodily pain, health-perception, vitality, and mental health (P < 0.05).
CONCLUSION: Successful treatment of chronic anal fissure with topical diltiazem leads to improvement in health-related quality of life.
Collapse
Affiliation(s)
- Akira Tsunoda
- Akira Tsunoda, Nobuyasu Kano, Department of Surgery, Kameda Medical Center, Chiba 296-8602, Japan
| | | | | | | | | |
Collapse
|
|
32
|
Abstract
Anal fissure is one of the most common anorectal problems. Anal fissure is largely associated with high anal sphincter pressures and most treatment options are based on reducing anal pressures. Conservative management, using increased fiber and warm baths, results in healing of approximately half of all anal fissures. In fissures that fail conservative care, various pharmacologic and surgical options offer satisfactory cure rates. Lateral internal sphincterotomy remains the gold standard for definitive management of anal fissure. This review outlines the key points in the presentation, pathophysiology, and management of anal fissure.
Collapse
|
|
33
|
Jindal T, Mandal SN, Mukherjee S, Karmakar D. Comparison of the efficacy and safety of topical diltiazem and nitroglycerine for pain relief during transrectal ultrasound guided biopsy of the prostate. Int Braz J Urol 2012; 38:405-10. [PMID: 22765856 DOI: 10.1590/s1677-55382012000300014] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 05/25/2012] [Indexed: 11/22/2022] Open
Abstract
INTRODUCTION AND OBJECTIVE Transrectal ultrasound biopsy of prostate is a painful procedure. The introduction of the rectal probe is one of the major contributors to the pain associated with this procedure. Drugs that relax the anal sphincter should theoretically decrease this pain. This study was done to compare the efficacy and safety of two topical medications that relax the anal sphincter, diltiazem and nitroglycerine, in decreasing the pain associated with transrectal ultrasound guided prostate biopsy. MATERIALS AND METHODS 66 patients who were to undergo their first prostate biopsy were randomized to receive either 2 mL of 2 % topical diltiazem or 2 mL of 0.2 % topical nitroglycerine or placebo 20 minutes before prostate biopsy. All patients also received 15 mL of intrarectal lignocaine. A 10-point visual analogue score was used to record the pain immediately after the insertion of the probe, during biopsy and at the end of the procedure. RESULTS The pain scores due to probe insertion, during biopsy and at the end of the procedure in patients who received topical diltiazem or nitroglycerine were significantly lower compared to the placebo group (p < 0.001). There were no significant differences in the pain scores between the patients receiving diltiazem compared to those receiving nitroglycerine. Higher incidence of headache and fall in blood pressure was noted in patients who received nitroglycerine compared to those receiving diltiazem. CONCLUSION Topical diltiazem and nitroglycerine are equally effective in reducing the pain associated with transrectal prostatic biopsy. Diltiazem is safer compared to nitroglycerine.
Collapse
Affiliation(s)
- Tarun Jindal
- Department of Urology, Calcutta National Medical College, Kolkata, India.
| | | | | | | |
Collapse
|
|
34
|
Abstract
BACKGROUND Lateral internal sphincterotomy is the most effective treatment for chronic anal fissure (CAF), but carries a risk of faecal incontinence. We aimed to analyse efficacy and acceptance of a treatment algorithm in reducing the rate of necessary sphincterotomies. METHOD Patients with CAF seen from 2001 to 2010 were retrospectively analysed. All patients were offered all steps of the algorithm nitroglycerine (NTG) → Botox (BTX) → surgery, unless symptoms or patient preference demanded a more aggressive treatment. Patients were followed up in clinic, and treatment was advanced if a step either failed or caused intolerable side effects. RESULTS Two hundred and nine patients were included in the analysis. Mean duration of symptoms was 25.6 months and mean follow up 16 months. One hundred and 41 patients started on NTG, 36 on BTX, and 31 went straight to surgery. One patient opted for no treatment. Symptoms persisted in 58 (41.1%) of 141 NTG patients. Forty-five (31.9% of NTG subset) were advanced to BTX and 13 (9.2% of subset) to surgery. Of the 81 (36 primary + 45 secondary) BTX patients (38.8% of the total), only 11 (13.6% of subset) required surgery. A total of 55 (31 primary + 24 secondary; 26.3%) patients needed surgery: two (3.6%) fissures did not heal, one patient developed an abscess, 14 (25.5%) had prolonged wound healing and two (3.6%) developed a recurrent fissure after the sphincterotomy had healed. CONCLUSION Our algorithm is effective in CAF and the majority of patients respond to conservative management. Only 26.3% of all patients require surgery, which is effective but also carries some temporary morbidity.
Collapse
Affiliation(s)
- R Sinha
- Department of Colorectal Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California 90033, USA
| | | |
Collapse
|
|
35
|
Abstract
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.
Collapse
Affiliation(s)
- Richard L Nelson
- Department of General Surgery, Northern General Hospital, Sheffield, UK.
| | | | | | | |
Collapse
|
|
36
|
Topical diltiazem cream versus botulinum toxin a for the treatment of chronic anal fissure: a double-blind randomized clinical trial. Ann Surg 2012; 255:18-22. [PMID: 21685792 DOI: 10.1097/sla.0b013e318225178a] [Citation(s) in RCA: 44] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/21/2023]
Abstract
OBJECTIVE A double-blind randomized clinical trial to compare topical diltiazem with botulinum toxin A (BTA) in the treatment of chronic anal fissure. BACKGROUND Chronic anal fissures remain a challenging condition. Topical diltiazem and BTA are promising agents in the treatment of anal fissure. As to date diltiazem and BTA were never compared in a solid randomized trial, which is the purpose of this study. METHODS One hundred thirty-four patients were randomized to receive either diltiazem cream and placebo injection or BTA injection and placebo cream. The primary end point was fissure healing after 3 months. RESULTS After 3 months healing of the fissure was noted in 32 of 74 (43%) patients in the diltiazem group and 26 of 60 (43%) patients in the BTA group. Reduction >50% in mean pain score was noted in 58 of 74 (78%) patients in the diltiazem group and 49 of 60 (82%) patients in the BTA group. Perianal itching was the only side effect reported and was noted in 15% of patients in the diltiazem group, and this difference was statistically significant (P = 0.012). CONCLUSIONS BTA yields higher healing rates in the short term, though after 3 months diltiazem and BTA resulted in equal healing rates. Also no significant difference in pain reduction was observed for both treatments. This study shows no significant advantage of one treatment compared to the other. This randomized clinical trial is registered by the Dutch Trial Register as NTR1012.
Collapse
|
|
37
|
Medhi B, Prakash A, Upadhyay S, Xess D, Yadav TD, Kaman L. Comparison of observational and controlled clinical trials of diltiazem in the treatment of chronic anal fissure. Indian J Surg 2011. [PMID: 23204700 DOI: 10.1007/s12262-011-0340-4] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022] Open
Abstract
Diltiazem has been extensively studied in the treatment of chronic anal fissures, but efficacy in clinical practice is not fully established. The aim of the present study was to evaluate the safety and efficacy of topical application diltiazem in observational studies as well as in controlled clinical trials in the treatment of chronic anal fissures. A systematic literature search was carried out from 1966 to 31 December, 2007 on PubMed, Medline, Embase and Cochrane database, using the appropriate search words. We found six observational studies with 392 patients and five controlled clinical trials with 289 patients in which topical diltiazem treatment was given. Efficacy was found to be very high in observational studies (56.88%), whereas it was found to be modest in controlled clinical trials (29.41%). In observational studies, most of the patients reported complete healing of fissures within 6-12 weeks, whereas in controlled trials healing was reported within 8 weeks, with tolerable adverse effects of diltiazem. On the basis of the above studies, it can be concluded that topical application of diltiazem is useful in the treatment of chronic anal fissure, but to fully establish its efficacy, larger prospective double-blind study is required in the near future.
Collapse
Affiliation(s)
- Bikash Medhi
- Department of Pharmacology and General Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India ; Department of Clinical Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh, India
| | | | | | | | | | | |
Collapse
|
|
38
|
Amoli HA, Notash AY, Shahandashti FJ, Kenari AY, Ashraf H. A randomized, prospective, double-blind, placebo-controlled trial of the effect of topical diltiazem on posthaemorrhoidectomy pain. Colorectal Dis 2011; 13:328-32. [PMID: 19912283 DOI: 10.1111/j.1463-1318.2009.02138.x] [Citation(s) in RCA: 32] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/31/2022]
Abstract
AIM Spasm of the internal anal sphincter plays a role in haemorrhoidal disease and may be a source of anal pain after haemorrhoid surgery. In this study, we investigated the effect of topical diltiazem (DTZ) on postoperative pain following Milligan-Morgan haemorrhoidectomy. METHOD After haemorrhoidectomy, 33 patients were randomly assigned to receive DTZ ointment (2%; n = 16) or a placebo ointment (n = 17). Ointments were applied to the perianal region three times daily for 7 days. A Visual Analogue Scale was used to assess postoperative pain. The primary end-point was reduction in postoperative pain. RESULTS Patients using the DTZ cream had significantly less pain and greater benefit than those in the placebo group throughout the first postoperative week, and total and daily narcotic analgesic use was higher in the placebo group. There were no differences in morbidity between the two groups. CONCLUSION Perianal application of DTZ cream after haemorrhoidectomy significantly reduces postoperative pain and is perceived as beneficial, with no increase in associated morbidity.
Collapse
Affiliation(s)
- H A Amoli
- Sina Trauma and Surgery Research Center, Tehran University of Medical Sciences Sina Hospital, Tehran University of Medical Sciences Sina Research Development Center, Tehran University of Medical Sciences, Tehran, Iran
| | | | | | | | | |
Collapse
|
|
39
|
Appalaneni V, Fanelli RD, Sharaf RN, Anderson MA, Banerjee S, Ben-Menachem T, Decker GA, Fisher L, Fukami N, Harrison ME, Strohmeyer L, Friis C, Ikenberry SO, Jain R, Jue TL, Khan KM, Krinsky ML, Malpas PM, Maple JT, Dominitz JA. The role of endoscopy in patients with anorectal disorders. Gastrointest Endosc 2010; 72:1117-23. [PMID: 21111864 DOI: 10.1016/j.gie.2010.04.022] [Citation(s) in RCA: 14] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/14/2010] [Accepted: 04/14/2010] [Indexed: 02/08/2023]
|
|
40
|
Perry WB, Dykes SL, Buie WD, Rafferty JF. Practice parameters for the management of anal fissures (3rd revision). Dis Colon Rectum 2010; 53:1110-5. [PMID: 20628272 DOI: 10.1007/dcr.0b013e3181e23dfe] [Citation(s) in RCA: 65] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
|
|
41
|
Poh A, Tan KY, Seow-Choen F. Innovations in chronic anal fissure treatment: A systematic review. World J Gastrointest Surg 2010; 2:231-241. [PMID: 21160880 PMCID: PMC2999245 DOI: 10.4240/wjgs.v2.i7.231] [Citation(s) in RCA: 44] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/03/2010] [Revised: 07/15/2010] [Accepted: 07/22/2010] [Indexed: 02/07/2023] Open
Abstract
A chronic anal fissure is a common perianal condition. This review aims to evaluate both existing and new therapies in the treatment of chronic fissures. Pharmacological therapies such as glyceryl trinitrate (GTN), Diltiazem ointment and Botulinum toxin provide a relatively non-invasive option, but with higher recurrence rates. Lateral sphincterotomy remains the gold standard for treatment. Anal dilatation has no role in treatment. New therapies include perineal support devices, Gonyautoxin injection, fissurectomy, fissurotomy, sphincterolysis, and flap procedures. Further research is required comparing these new therapies with existing established therapies. This paper recommends initial pharmacological therapy with GTN or Diltiazem ointment with Botulinum toxin as a possible second line pharmacological therapy. Perineal support may offer a new dimension in improving healing rates. Lateral sphincterotomy should be offered if pharmacological therapy fails. New therapies are not suitable as first line treatments, though they can be considered if conventional treatment fails.
Collapse
Affiliation(s)
- Aaron Poh
- Aaron Poh, Kok-Yang Tan, Department of Surgery, Khoo Teck Puat Hospital, Singapore 768828, Singapore
| | | | | |
Collapse
|
|
42
|
Abstract
Anal fissure is a common problem, vexing to both patients and physicians. The historical mainstay of therapy has been some method of partial division of the internal anal sphincter with the serious potential complication of fecal incontinence. Nonsurgical treatment methods were therefore pursued, producing healing rates less than that seen after surgical therapy but none of the morbidity of surgery. This article summarizes accepted methods of modern medical and surgical therapy for anal fissure and offers a rationale for treatment type selection.
Collapse
Affiliation(s)
- Jan Rakinic
- Department of Surgery, Southern Illinois University School of Medicine, Springfield, IL 62794-9638, USA.
| |
Collapse
|
|
43
|
Puche JJ, García-Coret MJ, Villalba FL, Ali-Mahmoud I, Roig JV. Tratamiento local de la fisura anal crónica con diltiazem vs. nitroglicerina. Estudio comparativo. Cir Esp 2010; 87:224-30. [DOI: 10.1016/j.ciresp.2009.12.013] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/14/2009] [Revised: 11/26/2009] [Accepted: 12/06/2009] [Indexed: 10/19/2022]
|
|
44
|
Abstract
Anal fissure is a common disorder that is effectively treated and prevented with conservative measures in its acute form, whereas chronic fissures may require medical or surgical therapy. This article discusses the nonoperative and operative management strategies, reviews the current literature on expected outcomes, and provides guidance on dealing with fissures in special situations, such as patients with inflammatory bowel disease or hypotonic sphincters.
Collapse
Affiliation(s)
- Daniel O Herzig
- Department of Surgery, Oregon Health and Science University, 3181 SW Sam Jackson Park Road, Mail Code L-223A, Portland, OR 97239, USA.
| | | |
Collapse
|
|
45
|
Puche JJ, José García-Coret M, Villalba FL, Ali-Mahmoud I, Roig JV. Local treatment of a chronic anal fissure with diltiazem vs. nitroglycerin. A comparative study. ACTA ACUST UNITED AC 2010. [DOI: 10.1016/s2173-5077(10)70052-1] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
|
|
46
|
Festen S, Gisbertz SS, van Schaagen F, Gerhards MF. Blinded randomized clinical trial of botulinum toxin versus isosorbide dinitrate ointment for treatment of anal fissure. Br J Surg 2009; 96:1393-9. [PMID: 19918859 DOI: 10.1002/bjs.6747] [Citation(s) in RCA: 34] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/07/2022]
Abstract
BACKGROUND Nitric oxide donors such as isosorbide dinitrate (ISDN) are considered the first choice of treatment for anal fissure. After reports of the successful treatment of such fissures with botulinum toxin, this randomized blinded trial compared botulinum toxin with ISDN in the treatment of chronic anal fissure. METHODS Patients were randomized to receive an injection of botulinum in the internal anal sphincter and a placebo ointment, or a placebo injection and ISDN ointment. The primary endpoint was macroscopic fissure healing after 4 months. RESULTS After 4 months macroscopic healing of the fissures was noted in 14 of 37 patients in the botulinum group and 21 of 36 in the ISDN group. Pain scores were lower among patients who received ISDN, although the difference was not significant. Side-effects were similar in the two groups. CONCLUSION In contrast with previous reports on botulinum toxin as a therapeutic agent for anal fissure, this study found no advantage over treatment with a nitric oxide donor as regards fissure healing and fissure-related pain.
Collapse
Affiliation(s)
- S Festen
- Department of Surgery, Onze Lieve Vrouwe Gasthuis, Oosterpark 9, 1091 AC Amsterdam, The Netherlands.
| | | | | | | |
Collapse
|
|
47
|
Aivaz O, Rayhanabad J, Nguyen V, Haigh PI, Abbas M. Botulinum Toxin A with Fissurectomy is a Viable Alternative to Lateral Internal Sphincterotomy for Chronic Anal Fissure. Am Surg 2009. [DOI: 10.1177/000313480907501013] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Lateral internal sphincterotomy (LIS) is the gold standard surgical treatment for anal fissure. However, it carries potential complications, including fecal incontinence. The goal of this retrospective study was to compare the outcome of botulinum toxin A injection coupled with fissurectomy ([BTX + FIS) versus LIS. There were 59 patients who underwent BTX + FIS or LIS over a 5-year period. LIS was performed in the standard fashion without fissurectomy. BTX + FIS entailed internal sphincter injection with 80 units of botulinum toxin A coupled with fissurectomy. Forty patients underwent LIS and 19 had BTX + FIS. The choice of operation was based on the patient's preference. Primary healing rate was 90 and 74 per cent in the LIS and BTX + FIS groups, respectively ( P = 0.13). The complication rate was 10 per cent in the LIS vs 0 per cent in the BTX + FIS groups ( P = 0.29). Complications of LIS included anal sepsis in one patient and flatal and/or fecal incontinence in three patients. During a mean follow up of 19 months; recurrence rate was 0 and 5 per cent in the LIS and BTX+FIS groups, respectively ( P = 0.32). The results of this study demonstrate that BTX + FIS is a viable alternative to LIS for patients with chronic anal fissure and should be considered as an alternative first-line surgical therapy.
Collapse
Affiliation(s)
- Ohara Aivaz
- From Department of Surgery, Kaiser Permanente, Los Angeles, California
| | | | - Vincent Nguyen
- From Department of Surgery, Kaiser Permanente, Los Angeles, California
| | - Philip I. Haigh
- From Department of Surgery, Kaiser Permanente, Los Angeles, California
| | - Maher Abbas
- From Department of Surgery, Kaiser Permanente, Los Angeles, California
| |
Collapse
|
|
48
|
Schubert MC, Sridhar S, Schade RR, Wexner SD. What every gastroenterologist needs to know about common anorectal disorders. World J Gastroenterol 2009; 15:3201-9. [PMID: 19598294 PMCID: PMC2710774 DOI: 10.3748/wjg.15.3201] [Citation(s) in RCA: 49] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
Anorectal complaints are very common and are caused by a variety of mostly benign anorectal disorders. Many anorectal conditions may be successfully treated by primary care physicians in the outpatient setting, but patients tend not to seek medical attention due to embarrassment or fear of cancer. As a result, patients frequently present with advanced disease after experiencing significant decreases in quality of life. A number of patients with anorectal complaints are referred to gastroenterologists. However, gastroenterologists’ knowledge and experience in approaching these conditions may not be sufficient. This article can serve as a guide to gastroenterologists to recognize, evaluate, and manage medically or non-surgically common benign anorectal disorders, and to identify when surgical referrals are most prudent. A review of the current literature is performed to evaluate comprehensive clinical pearls and management guidelines for each topic. Topics reviewed include hemorrhoids, anal fissures, anorectal fistulas and abscesses, and pruritus ani.
Collapse
|
|
49
|
Cross KLR, Massey EJD, Fowler AL, Monson JRT. The management of anal fissure: ACPGBI position statement. Colorectal Dis 2008; 10 Suppl 3:1-7. [PMID: 18954306 DOI: 10.1111/j.1463-1318.2008.01681.x] [Citation(s) in RCA: 62] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/21/2023]
Affiliation(s)
- K L R Cross
- North Devon General Hospital, Barnstaple, UK
| | | | | | | | | |
Collapse
|
|
50
|
Abstract
Hemorrhoids and anal fissures are common benign anorectal conditions that form a significant part of a colorectal surgeon's workload. This review summarizes and evaluates the current techniques available in their management.
Collapse
Affiliation(s)
- Peter S Chong
- Department of Colorectal Surgery, Western General Hospital, Edinburgh EH4 2XU, UK.
| | | |
Collapse
|