Botulinum toxin versus botulinum toxin with low dose Glyceryltrinitrite (GTN) cream for healing of chronic anal fissure: prospective, randomised trial

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Anal fissure is one of the most common benign anorectal conditions, which may result from high internal anal sphincter (IAS) pressure. The goals of therapy are to break the cycle of sphincter spasm and tearing of anal mucosa, and to promote healing of fissure. Medical therapy is successful in the majority of patients with surgery reserved for refractory cases. Acute anal fissure usually heals spontaneously or with conservative treatment within six weeks, whereas chronic anal fissure is more intractable and is unlikely to heal with conventional conservative management. Surgery by means of lateral internal sphincterotomy (LIS) carries the risk of permanent faecal incontinence. The risk has varied among reports from as low as 0 to as high as 24 percent. In Vitro and in vivo studies in animals have established that nitric oxide (NO) is probably the most important inhibitory neurotransmitter in IAS. Glyceryl trinitrite cream applied locally to the anus has been shown to cause lowering of IAS pressure in healthy subjects and to promote healing of anal fissures. Another non surgical agent for treatment for anal fissure is botulinum toxin (BT) which decreases the anal pressure by preventing release of acetylcholine from presynaptic nerve terminals. Maria et al reported a 73% healing rate for anal fissure after BT injection alone. There is only one study previously, by Lysy et al., looking at the synergistic effect of BT and topical nitrates (isosorbide dinitrate) for healing of anal fissure, which showed significantly higher healing, 66%, in the combined treatment group compared to BT alone, 20%. Scholefield et al. conducted a dose finding study with different strengths of GTN for chronic anal fissure and found that 0.1% GTN cream has a higher healing rate compared to 0.2% cream, with a smaller percentage of patients reporting headaches: 18% versus 36% with 0.2% GTN cream. The aims of the present study were to assess the efficacy, safety and patient compliance related to BT injection and combined treatment with BT injection and lowered dose 0.2% Glycerlytrinitite (GTN) cream for the treatment of CAF. We hypothesised that combined treatment would have a synergistic effect on healing and lowered dose GTN would help with patient compliance as GTN application is associated with severe headaches in some patients.

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