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Lack of effficacy of botulinum toxin in chronic anal fissure
Author(s) -
Siproudhis L.,
Sébille V.,
Pigot F.,
Hémery P.,
Juguet F.,
Bellissant E.
Publication year - 2003
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2003.01467.x
Subject(s) - medicine , internal anal sphincter , defecation , anal fissure , botulinum toxin , placebo , anal canal , anesthesia , adverse effect , surgery , rectum , alternative medicine , pathology
Summary Background and aim: Hypertonicity of internal anal sphincter plays a major role in the persistence of chronic anal fissure. Botulinum toxin could induce internal anal sphincter relaxation without the adverse effects of surgery (long‐term faecal incontinence) or topical nitrates (anal burning, headaches, hypotension). Methods: We conducted a placebo‐controlled, randomised, double‐blind study to assess the efficacy of a single injection of botulinum toxin in the internal anal sphincter of patients with chronic anal fissure in six ambulatory care clinics. Eligibility criteria included a mean value of post‐defecation anal pain ≥ 30 mm on a 100 mm visual analogue scale over the week preceding inclusion. Main endpoint was the proportion of patients with symptomatic improvement during the fourth week after inclusion (post‐defecation anal pain below 10 mm). Results: Forty‐four patients (22 in each group) were included. At inclusion, there was no significant difference between groups on age, sex ratio, pain duration, post‐defecation anal pain, analgesic consumption and stool frequency. Ten (45%) and 11 (50%) patients reported symptomatic improvement on the main endpoint ( P =0.76) in placebo and botulinum toxin groups, respectively. Ten patients (five in each group) had healed fissure at week 4 and ten patients (five in each group) required surgical treatment between weeks 4 and 12. Similarly, there was no significant difference between groups on other variables between weeks 4 and 12. Conclusions: The efficacy of a single injection of botulinum toxin in the internal anal sphincter does not differ from that of a placebo in patients with chronic anal fissure.