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Botulinum toxin promoted healing and relieved symptoms of chronic anal fissure
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Question
In patients with chronic anal fissures, is local infiltration of
botulinum toxin effective for healing fissures and relieving symptoms?
Design
2 month randomised, double blind, placebo controlled trial.
Setting
Clinical centre in Rome, Italy.
Patients
30 patients (mean age 44 y, 67% men) with chronic, idiopathic
anal fissures. Exclusion criteria were acute fissures, anal fissures
with various causes (haemorrhoids, fistula in ano, or inflammatory
bowel diseases), or previous anal surgery. Follow up was complete.
Intervention
Patients were allocated to 0.4 ml in 2 injections of either
botulinum toxin A (Botox, Allergan, Irvine, CA, USA), 20 U (n=15), or
saline placebo (n=15), injected with a 27 gauge needle. Patients were
advised to eat food with a high fibre content and received a
prescription for laxatives.
Main outcome measures
Anal fissure healing and symptomatic relief (persistence of anal
fissure without symptoms). Patients were assessed at 1 and 2 months.
Main results
At 1 and 2 months, more patients allocated
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