BACKGROUND AND AIM: Hypertonicity of internal anal sphincter plays a major role in the persistence of @entity12395 . Botulinum toxin could induce internal anal sphincter relaxation without the adverse effects of surgery (long-term @entity322 ) or topical @entity3362 (anal burning, @entity10 , @entity551 ). 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 @entity1 with @entity12395 in six ambulatory care clinics. Eligibility criteria included a mean value of post-defecation anal @entity158 >or= 30 mm on a 100 mm visual analogue scale over the week preceding inclusion. Main endpoint was the proportion of @entity1 with symptomatic improvement during the fourth week after inclusion (post-defecation anal @entity158 below 10 mm). RESULTS: Forty-four @entity1 (22 in each group) were included. At inclusion, there was no significant difference between groups on age, sex ratio, @entity158 duration, post-defecation anal @entity158 , analgesic consumption and stool frequency. Ten (45%) and 11 (50%) @entity1 reported symptomatic improvement on the main endpoint (P=0.76) in placebo and botulinum toxin groups, respectively. Ten @entity1 (five in each group) had healed fissure at week 4 and ten @entity1 (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 @entity1 with @entity12395 .

Lack of effficacy of botulinum toxin in XXXX .

@entity1 :: ('9606', 'Species') :: ['patients'] @entity322 :: ('MESH:D014549', 'Disease') :: ['faecal incontinence'] @entity12395 :: ('MESH:D005401', 'Disease') :: ['chronic anal fissure'] @entity3362 :: ('MESH:D009566', 'Chemical') :: ['nitrates'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain'] @entity10 :: ('MESH:D006261', 'Disease') :: ['headaches'] @entity551 :: ('MESH:D007022', 'Disease') :: ['hypotension']
@entity12395 :: (MESH:D005401,Disease) :: ['chronic anal fissure']
