Botulinum toxin injection versus lateral internal sphincterotomy for the treatment of chronic anal fissure: randomized prospective controlled trial

Purpose

Lateral internal sphincterotomy has been the gold standard treatment for chronic anal fissure, but it still carries the risk of permanent damage of the anal sphincter, which has led to the implementation of alternative treatment like botulinum toxin injection. The aim of this randomized prospective controlled trial was to compare the efficacy and morbidity of botulinum toxin injection and lateral internal sphincterotomy in the treatment of chronic anal fissure.

Methods

Fifty consecutive adults with chronic anal fissure were randomly treated with either lateral internal sphincterotomy or botulinum toxin (BT) injection with 50 U BT into the internal sphincter. The complications, healing and recurrence rate, and incontinence score were assessed 2, 3, 6, 12 months after the procedure.

Results

Inspection at the 2-month visit revealed complete healing of the fissure in 11 (44?%) of the patients in the BT group and 22 (88?%) of the patients in the lateral internal sphincterotomy (LIS) group (p?=?0.001). At the 3-month visit, there was no significant difference between the two groups in healing. The overall recurrence rate after 6 months in the BT group was higher than in the LIS group (p?<?0.05). In the 3-month follow-up, the LIS group had a higher rate of anal incontinence compared to the BT group (p?<?0.05). The final percentage of incontinence was 4?% in the LIS group (p?>?0.05).

Conclusions

The treatment of chronic anal fissure must be individualized depending on the different clinical profiles of patients. Botulinum toxin injection has a higher recurrence rate than LIS, and LIS provides rapid and permanent recovery. However, LIS carries a higher risk of anal incontinence in patients.     

Botulinum toxin injections in the internal anal sphincter for the treatment of chronic anal fissure: long-term results after two different dosage regimens.

OBJECTIVE: To investigate the effects of two different dosage regimens of botulinum toxin to induce healing in patients with idiopathic anal fissure. SUMMARY BACKGROUND DATA: Chronic anal fissure is maintained by contraction of the internal anal sphincter. Sphincterotomy, which is successful in 85% to 95% of patients, permanently weakens the sphincter and therefore might be associated with anal deformity and incontinence. METHODS: Fifty-seven consecutive outpatients were evaluated. Type A botulinum toxin was injected into the internal anal sphincter. RESULTS: Patients were divided into two treatment groups based on the number of botulinum toxin units injected. Patients in the first group were treated with 15 units and retreated with 20 units. Patients in the second group were treated with 20 units and retreated with 25 units. Two months after treatment, 10 patients in the first group and 23 patients in the second group had a healing scar. Symptomatic improvement was observed in 13 patients in the first group and in 24 patients in the second group. Statistical analysis showed that resting anal pressure varied from baseline values as a function of treatment; in contrast, the treatment had no effect on maximum voluntary pressure. Long-term healing was achieved in 13 patients in the first group and in all patients in the second group who underwent a complete treatment. CONCLUSIONS: Botulinum toxin is safe and effective in the treatment of anal fissure. It is less expensive and easier to perform than surgical treatment. No adverse effects resulted from injections of the toxin. The higher dosage is effective in producing long-term healing without complications.     

Botulinum toxin vs glyceryltrinitrate for the medical management of chronic anal fissure: a meta‐analysis

Objective The objective of this review was to analyse systematically the prospective randomized controlled trials on the effectiveness of botulinum toxin (BTX) and glyceryltrinitrate (GTN) for the pharmacological management of chronic anal fissure (CAF). Method A systematic review of the literature was undertaken. Prospective randomized controlled trials on the effectiveness of BTX and GTN for the management of CAF were selected according to specific criteria and analysed to generate summative data. Results Six studies encompassing 355 patients with CAF were retrieved from electronic databases. Only three randomized controlled trials on 180 patients qualified for the meta‐analysis according to inclusion criteria. There were 90 patients in BTX and 90 in the GTN group. BTX and GTN were equally effective in healing/improving the CAF. There was no statistically significant difference between the two pharmacotherapies [RR 1.29 (0.98–1.70) 95% CI, z = ?1.83, P = 1.93, Fig. 1 ]. However, there was statistically significant heterogeneity among the trials (Q = 4.03, df = 1, P = 0.042). On fixed effect model, GTN was associated with higher incidence of total side effects [fixed effect model RR 0.14 (0.05–0.40) 95% CI, z = ?3.71, P = 0.0002] and headache [RR 0.07 (0.02–0.20) 95% CI, z = ?5.05, P = 0.0007] among patients of CAF.

Figure 1 Open in figure viewer PowerPoint Healing.     

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Ambulatory treatment of anal fissure

Not a long time ago, the standard treatment for anal fissure was surgical, inpatient care; this concept failed in the last years, ambulatory treatment becoming the rule and the inpatient care the exception. We wish to present here our results in 125 ambulatory patients, who were referred to our proctologic office with anal fissure. We used two methods: a conservative one, by applying topical 0.2% nitroglycerine, similar to other proctology practitioners, and one method of our own which is a minimal surgical procedure consisting of sphincterotomy. The average follow-up period was 6 months. Symptom-free and anatomic-free states were obtained in 61.2% for conservative treated patients and in 91.4% for operated patients, respectively. We had no postoperative complications, rebounds or sequelae. We consider the results at least equal in effectiveness to those of standard surgical treatment. This is why we underline that ambulatory treatment for anal fissure reaches the goal to be of a first line option.     

Botulinum toxin treatment for bladder dysfunction

Botulinum toxin A is available under three different protein complexes that are not interchangeable until appropriate comparative studies are undertaken. The best studied for the treatment of urinary incontinence as a result of neurogenic detrusor overactivity and overactive bladder/idiopathic detrusor overactivity is onabotulinum toxin A. This brand is only approved for the treatment of urinary incontinence as a result of neurogenic detrusor overactivity at a dose of 200 U and idiopathic detrusor overactivity at a dose of 100 U. In patients with detrusor overactivity as a result of spinal cord injury or multiple sclerosis, 200 U of onabotulinum toxin A should be injected in 30 different sites above the trigone. It was shown to be highly effective in curing or decreasing urinary symptoms of incontinence, increasing quality of life, increasing bladder capacity and decreasing maximal detrusor pressure. This effect was independent of the concomitant use of oral anticholinergic drugs. Adverse events were mild, mainly urinary tract infections and high postvoid residual requiring clean intermittent catheterization. In patients with overactive bladder/idiopathic detrusor overactivity, 100 U of onabotulinum toxin A should be injected in 20 sites above the trigone. It markedly decreases urinary incontinence and improves quality of life. Frequency and urgency episodes are also decreased. Adverse events are mild, mainly urinary tract infections and urinary retention. The latter occurred in just 5% of the patients. Candidates for onabotulinum toxin A treatment should be warned that the effect of the toxin is transient and that repeated injections will be required to maintain the effect in the long term. There is no evidence that repeated injections will have a decreased efficacy.     

A contraction response of the internal anal sphincter to Botulinum toxin: does low‐pressure chronic anal fissure have a different pathophysiology?

Aim A subset of low‐pressure fissures is not associated with typical internal anal sphincter hypertonia and may involve a different pathophysiological mechanism. We aimed to assess the manometric response of the internal anal sphincter to botulinum toxin in low‐pressure fissures compared to high‐pressure fissures. Method Twenty five units of botulinum toxin (Botox^TM) were injected directly into the internal anal sphincter. Maximum resting pressure (MRP) and maximum squeeze increment (MSI) were documented at baseline and four weeks after injection. Results Nine (31%) of 29 patients had a low‐pressure fissure. Those with an anterior fissure had a significantly lower median baseline MRP than those with a posterior fissure (66 vs 83 mmHg, P = 0.009). Significantly more patients with low‐pressure fissures developed a contraction or no response (78%vs 30%, difference 48%, 95% CI 14–82%, P = 0.006). Those developing a contraction response had a lower mean baseline MRP than those developing a relaxation response (56 vs 86 mmHg, difference 30 mmHg, 95% CI 17–43%, P < 0.001). Conclusion Botulinum toxin appears to have an atypical contraction effect on the internal anal sphincter in low‐pressure (usually anterior) fissures. This may be accounted for by blockade of acetylcholine released at parasympathetic nerve terminals and the sympathetic ganglion (relaxation). Low pressure fissures may be physiologically different from high‐pressure fissures.     

Botulinum toxin for the treatment of essential blepharospasm

Twenty-six patients with essential blepharospasm were treated with botulinum toxin by injection. The onset of protractor weakness in all patients ranged from one to five days following treatment. Maximal weakness developed within 12 days. There was a variable and gradual return of protractor strength over eight to 29 weeks in most patients and, with it, a return of spasm. Twenty-five patients received some degree of functional relief following initial injection. In most patients, however, the post-injection result could not be stabilized and repeat injections have been necessary to control recurrent spasms. There was one treatment failure. Three patients treated by injection following previous neurectomy and myectomy appeared to have a reduced requirement for subsequent injections. Complications included transient ptosis in six patients and mild exposure symptoms in four patients. Extraocular muscle paresis did not occur. There were no systemic side effects from the botulinum toxin injections.     

What predicts successful nonoperative management with botulinum toxin for anal fissure?

BackgroundBotulinum toxin has been established as a non-surgical alternative for chronic anal fissures. There is a paucity of data regarding which patients benefit most from this intervention. Methods: We retrospectively collected data from all cases of chronic anal fissures treated with botulinum toxin over seven years to identify predictors of success. Non-responders were defined as any subsequent surgery or reporting satisfaction as poor or fair. Results: Of 91 patients, 60% (n = 55) were responders and 26% (n = 25) underwent subsequent surgery. There were significantly more females among responders (78% vs. 55%, p = 0.02). A higher body mass index tended towards significance among non-responders (30 ± 7 vs. 27 ± 6, p = 0.08). High satisfaction at the first visit was associated with no subsequent surgery (18% vs. 45%, p = 0.002). Conclusions: Botulinum toxin can be successfully used to treat anal fissures in a majority of patients. Primary predictors of success were female sex, satisfaction at the first post-procedure visit and there was a tendency towards a lower body mass index.     

Changing patterns of treatment for chronic anal fissure.

To assess changing patterns of treatment for chronic anal fissure, a retrospective analysis of treatment for chronic anal fissure within one hospital between January 1990 and December 1996 was undertaken. A total of 221 patients received treatment for a chronic anal fissure in this period, of whom 209 had a surgical procedure. Manual dilatation of the anus was performed in 21 patients (10%) and has not been performed since 1995. Lateral internal sphincterotomy was performed in 183 patients (88%) and continues to be the mainstay of treatment. Five female patients (2%) were identified as having a sphincter defect by anal manometry combined with endoanal ultrasound and were treated by an anal advancement flap. From 1996 onwards, 15 patients (7%) were treated by topical glyceryl trinitrate (GTN) paste as the first line of treatment. Of these patients, nine have experienced healing of their fissure, and three have had relief of pain without healing of the fissure. Three have gone on to have a lateral internal sphincterotomy. Lateral internal sphincterotomy remains the primary form of treatment for chronic anal fissure. GTN cream has increasingly been offered as preliminary treatment over the last 12 months. Perioperative use of endoanal ultrasound allowed identification of patients who may be at high risk of postoperative incontinence from a sphincterotomy. An anal advancement flap has been used as an alternative surgical approach for these patients.     

New approaches to the treatment of anal fissure

According to Antropoli, pathologies of the anal canal are extremely common. About 30 to 40 percent of the population suffers from proctologic pathologies at least once in their lives. In most cases they are more annoying than dangerous. Anal fissure (AF) was recognized as a clinical entity in 1934. It is a longitudinal defect of the anal canal mucosa and anoderm extending usually from the dentate line to the external verge of the anal canal. This defect exposes the lower half or even most of the fibres of internal anal sphincter. AF is almost always accompanied by extensive tension of this muscle. Anal fissures affect all age groups but predominantly occur in the 3rd and 4th decades of life (2, 8, 23). Gathright states that fissure disease causes from 6 to 15% of office visits and 10% of operative procedures in a colorectal practice. The etiology of anal fissure has only been partially explained and remains controversial although spasm of the internal anal sphincter has been recognized to play a main role in the pathogenesis of this disease. Recent studies have cast new light on the pathogenesis of anal fissures.