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Botulinum Toxin Injection for Treatment of Chronic Anal Fissure: Is There Any Dose-Dependent Efficiency? A Meta-Analysis

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      Chronic anal fissure (CAF) is a linear split of the anoderm. The minimally invasive management of CAF such as botulinum toxin (BT) injection is recommended. However, the exact efficient dose of BT, number of injections per session and the injection sites are still debatable. The aim of this analysis was to assess the dose-dependent efficiency of botulinum toxin injection for CAF.


      PubMed and Web of Science databases were searched for terms: “anal fissure” AND “botulinum toxin.” Studies published between October 1993 and May 2015 were included and had to meet the following criteria: (1) chronic anal fissure, (2) prospective character of the study, (3) used simple BT injection without any other interventions and (4) no previous treatment with BT.


      A total of 1577 patients from 34 prospective studies used either Botox or Dysport formulations were qualified for this meta-analysis. A total number of BT units per session ranged from 5 to 150 IU, whereas the efficiency across analyzed studies ranged from 33 to 96 %. Surprisingly, we did not observe a dose-dependent efficiency (Spearman’s rank correlation coefficient, ρ = 0.060; p = 0.0708). Moreover, there were no BT dose-dependent postoperative complications or fecal incontinence and significant difference in healing rates compared BT injection into the anal sphincter muscles.


      BT injection has been an accepted method for the management of CAF. Surprisingly, there is no dose-dependent efficiency, and the postoperative incontinence rate is not related to the BT dosage regardless the type of formulation of botulinum neurotoxin used. Moreover, no difference in healing rate has been observed in regard to the site and number of injections per session.

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      Most cited references 60

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      Therapeutic uses of botulinum toxin.

       M Brin,  J. Jankovic (1991)
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        A comparison of botulinum toxin and saline for the treatment of chronic anal fissure.

        Chronic anal fissure is a tear in the lower half of the anal canal that is maintained by contraction of the internal anal sphincter. Sphincterotomy, the most widely used treatment, is a surgical procedure that permanently weakens the internal sphincter and may lead to anal deformity and incontinence. We conducted a double-blind, placebo-controlled study of botulinum toxin for the treatment of chronic anal fissure in 30 consecutive symptomatic adults. All the patients received two injections (total volume, 0.4 ml) into the internal anal sphincter; the treated group (15 patients) received 20 U of botulinum toxin A, and the control group (15 patients) received saline. Success was defined as healing of the fissure (formation of a scar), and symptomatic improvement was defined as the presence of a persistent fissure without symptoms. After two months, 11 patients in the treated group and 2 in the control group had healed fissures (P=0.003); 13 in the treated group and 4 in the control group had symptomatic relief (P=0.003). The maximal voluntary pressures were similar to those at base line in both groups, and the resting anal pressure was reduced by 25 percent in the treated group but not in the control group. Three patients in the control group later underwent sphincterotomy, and 10 received botulinum-toxin injections (20 U). Of the latter, seven had healed fissures after two months; the other three left the study and underwent surgery. Four patients in the treated group were later re-treated (with 25 U of botulinum toxin); all had healed fissures after two months. One patient in the control group had temporary flatus incontinence after treatment with botulinum toxin. No relapses occurred during an average of 16 months of follow-up. Local infiltration of botulinum toxin into the internal anal sphincter is an effective treatment of chronic anal fissure.
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          Aetiology and treatment of anal fissure.

          Anal fissure is a common problem that causes significant morbidity in a young and otherwise healthy population. Treatment has remained largely unchanged for over 150 years and the pathogenesis of this condition is not yet fully explained. Acute fissure should be treated conservatively with dietary modification. Chronic fissures do not respond to conservative treatment. The current recommended surgical treatment for chronic fissure is lateral internal sphincterotomy. However, there is a disturbance of continence in a sizeable proportion of those undergoing this procedure. As yet there is no proven non-surgical treatment for chronic fissure. Although local injection of botulinum toxin and the topical application of nitrates show early promise, further controlled trials are needed.

            Author and article information

            [1 ]Department of General, Endocrinological Surgery and Gastroenterological Oncology, Poznan University of Medical Sciences, Przybyszewskiego 49, 60-355 Poznan, Poland
            [2 ]Department of Dermatology, Venerology and Allergology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany
            +48 618 691 122 ,
            World J Surg
            World J Surg
            World Journal of Surgery
            Springer International Publishing (Cham )
            18 August 2016
            18 August 2016
            : 40
            : 12
            : 3064-3072
            27539490 5104788 3693 10.1007/s00268-016-3693-9
            © The Author(s) 2016

            Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

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