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International Journal of Surgery... Aug 2017Chemical sphincterotomy with pharmacological agents is recommended as first line therapy for chronic anal fissures (CAF). Calcium channel blockers (CCB) are associated... (Comparative Study)
Comparative Study Review
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.
Topics: Administration, Oral; Administration, Topical; Calcium Channel Blockers; Fissure in Ano; Humans; Randomized Controlled Trials as Topic; Recurrence; Wound Healing
PubMed: 28629764
DOI: 10.1016/j.ijsu.2017.06.039 -
BMJ Clinical Evidence Nov 2014Anal fissures are a common cause of anal pain during, and for 1 to 2 hours after, defecation. The cause is not fully understood, but low intake of dietary fibre may be a... (Review)
Review
INTRODUCTION
Anal fissures are a common cause of anal pain during, and for 1 to 2 hours after, defecation. The cause is not fully understood, but low intake of dietary fibre may be a risk factor.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of surgical treatments for chronic anal fissure? We searched: Medline, Embase, The Cochrane Library, and other important databases up to January 2014 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found nine studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: anal advancement flap, anal stretch/dilation, and internal anal sphincterotomy.
Topics: Anal Canal; Fissure in Ano; Humans; Risk Factors; United States
PubMed: 25391392
DOI: No ID Found -
The Cochrane Database of Systematic... Feb 2012Because of the disability associated with surgery for anal fissure and the risk of incontinence, medical alternatives for surgery have been sought. Most recently,... (Meta-Analysis)
Meta-Analysis Review
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.
Topics: Adult; Anal Canal; Child; Dilatation; Fissure in Ano; Humans; Hydrotherapy; Randomized Controlled Trials as Topic
PubMed: 22336789
DOI: 10.1002/14651858.CD003431.pub3 -
The Cochrane Database of Systematic... Nov 2011Reports of direct comparisons between operative techniques for anal fissure are variable in their results. These reports are either subject to selection bias (in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Reports of direct comparisons between operative techniques for anal fissure are variable in their results. These reports are either subject to selection bias (in non-randomized studies) or observer bias (in all studies) or have inadequate numbers of patients enrolled to answer the question of efficacy.
OBJECTIVES
To determine the best technique for fissure surgery.
SEARCH METHODS
The Cochrane Central Register of Controlled Trials and MEDLINE (1965-2011), Medline (Pubmed) and Embase were searched March to 2011. The list of cited references in all included reports and several study authors also were helpful in finding additional comparative studies.A total of four new trials were included in this update of the review.
SELECTION CRITERIA
All reports in which there was a direct comparison between at least two operative techniques were reviewed and when more than one report existed for any given pair, that report was included. All studies must also be randomised. If crude data were not presented in the report, the authors were contacted and crude data obtained.
DATA COLLECTION AND ANALYSIS
The two most commonly used end points in all reported studies were treatment failure and post-operative incontinence both to flatus and faeces. These are the only two endpoints included in the meta-analysis.
MAIN RESULTS
Four trials, encompassing 406 patients were included in this update, with now a total of 2056 patients in the review from 27 studies that describe and analyze 13 different operative procedures. These operative techniques used by these studies include closed lateral sphincterotomy, open lateral internal sphincterotomy, anal stretch, balloon dilation, wound closure, perineoplasty, length of sphincterotomy and fissurectomy. Two new procedures in the update, similar to anal stretch were described- sphincterolysis and controlled intermittent anal dilatation. A new comparison was described, comparing the effects of unilateral internal sphincterotomy and bilateral internal sphincterotomy.Manual Anal stretch has a higher risk of fissure persistence than internal sphincterotomy and also a significantly higher risk of minor incontinence than sphincterotomy. The combined analyses of open versus closed partial lateral internal sphincterotomy show little difference between the two procedures both in fissure persistence and risk of incontinence Unilateral internal sphincterotomy was shown to be more likely to result in treatment failure compared to bilateral internal sphincterotomy, but there is no significant difference in the risk of incontinence.Sphincterotomy was less likely to result in treatment failure when compared to fissurectomy, but there was no significant difference when considering post-operative incontinence.When comparing sphincterotomy to sphincterolysis, there was no significant difference between the two procedures both in treatment failure and risk of incontinence; the same is the case when comparing sphincterotomy with controlled anal dilation.
AUTHORS' CONCLUSIONS
Manual anal stretch should probably be abandoned in the treatment of chronic anal fissure in adults. For those patients requiring surgery for anal fissure, open and closed partial lateral internal sphincterotomy appear to be equally efficacious. More data are needed to assess the effectiveness of posterior internal sphincterotomy, anterior levatorplasty, wound suture or papilla excision. Bilateral internal sphincterotomy shows promise, but needs further research into its efficacy.
Topics: Anal Canal; Catheterization; Fecal Incontinence; Fissure in Ano; Flatulence; Humans; Postoperative Complications; Randomized Controlled Trials as Topic; Treatment Failure
PubMed: 22071803
DOI: 10.1002/14651858.CD002199.pub4 -
World Journal of Gastrointestinal... Jul 2010A 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...
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.
PubMed: 21160880
DOI: 10.4240/wjgs.v2.i7.231 -
BMJ Clinical Evidence Mar 2010Anal fissures are a common cause of anal pain during, and for 1 to 2 hours after, defecation. The cause is not fully understood, but low intake of dietary fibre may be a... (Review)
Review
INTRODUCTION
Anal fissures are a common cause of anal pain during, and for 1 to 2 hours after, defecation. The cause is not fully understood, but low intake of dietary fibre may be a risk factor.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of non-surgical treatments for chronic anal fissure? What are the effects of surgical treatments for chronic anal fissure? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2009 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 28 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: anal advancement flap, anal stretch/dilation, botulinum A toxin-haemagglutinin complex alone or with nitrates, calcium channel blockers, internal anal sphincterotomy, and nitric oxide donors.
Topics: Administration, Oral; Anal Canal; Fissure in Ano; Humans; Nitric Oxide Donors; Nitroglycerin; Treatment Outcome
PubMed: 21718564
DOI: No ID Found -
Alimentary Pharmacology & Therapeutics Jul 2006Anal fissure is one of the most common anorectal conditions encountered in clinical practice. Most patients experience anal pain with defecation and minor bright red... (Review)
Review
BACKGROUND
Anal fissure is one of the most common anorectal conditions encountered in clinical practice. Most patients experience anal pain with defecation and minor bright red rectal bleeding, allowing a focused history to direct the evaluation.
METHODS
A systematic medical literature search of NIH, Pubmed, and MEDLINE using the search terms anal fissure, sphincterotomy, anal surgery and anal fissure medical therapy. English language was not a restriction. Cited references were used to find additional studies.
RESULTS
No single treatment is the best choice for all patients. Because pharmacological therapy is not associated with permanent alterations in continence, a trial of either a topical sphincter relaxant or botulin toxin injection, along with adequate fluid and fibre intake, is a reasonable option. However, because pharmacological therapy has lower healing and higher relapse rates, surgery can be offered in the first instance to patients without incontinence risk factors who have severe, unrelenting pain and are willing to accept a small risk of incontinence, for the highest likelihood of prompt healing and the lowest risk of recurrence.
CONCLUSIONS
Both non-operative and operative approaches currently exist for the management of anal fissure. Improved non-surgical therapies may continue to lessen the role of sphincter-dividing surgery in future.
Topics: Administration, Oral; Administration, Topical; Botulinum Toxins, Type A; Diet; Dilatation; Fissure in Ano; Gastrointestinal Agents; Humans; Injections, Intralesional
PubMed: 16842451
DOI: 10.1111/j.1365-2036.2006.02990.x