Randomised controlled trial shows that glyceryl trinitrate heals anal fissures, higher doses are not more effective, and there is a high recurrence rate

Abstract

Background-Topical application of glyceryl trinitrate (GTN) ointment heals chronic anal fissures, providing an alternative to the traditional first line treatment of surgical sphincterotomy. Aims-To determine the most eVective dose of topical GTN for treatment of chronic anal fissures and to assess long term results. Methods-Seventy consecutive patients with chronic anal fissure, were randomly allocated to eight weeks treatment with placebo, 0.2% GTN three times daily, or GTN starting at 0.2% with weekly 0.1% increments to a maximum of 0.6%, in a double blind study. Results-After eight weeks fissure had healed in 67% of patients treated with GTN compared with 32% with placebo (p=0.008). No significant diVerence was seen between the two active treatments. Headaches were reported by 72% of patients on GTN compared with 27% on placebo (p<0.001). Maximum anal sphincter pressure reduced significantly from baseline by GTN treatment (p=0.02), but not placebo (p=0.8). Mean pain scores were lower after treatment with GTN compared with placebo (NS). Of fissures healed with placebo 43% recurred, compared with 33% of those healed with 0.2% GTN and 25% healed with escalating dose GTN (p=0.7). Conclusions-GTN is a good first line treatment for two thirds of patients with anal fissure. An escalating dose of GTN does not result in earlier healing. Significant recurrence of symptomatic fissures and a high incidence of headaches are limitations of the treatment. (Gut 1999;44:727-730)

Comparison of Observational and Controlled Clinical Trials of Diltiazem in the Treatment of Chronic Anal Fissure

“…Studies showed that oral intake and topical applications of diltiazem reduced the anal pressure significantly. As compared with GTN, diltiazem reported minimal side effects, most of the side effects were facial flushing, mild headache because of changes of negligible diastolic pressure and postural changes of blood pressure, which can be avoided by applying topical diltiazem at bedtime [22,24].…”

“…Clinical trials show that healing can be achieved in 45-80% patients with GTN therapy, but significant adverse effects such as headache, tachyphylaxis and occasional loss of flatus control have also been reported. Some studies report poor long-term outcome of GTN therapy; only 6% of patients healed in 12 months [10,[20][21][22][23]. Recently, diltiazem has been found efficacious in the treatment of chronic anal fissure.…”

Nifedipine Gel with Lidocaine in the Treatment of Anal Fissure in Children: A Pilot Study and Review of the Literature

“…Associated side-effects were observed in 78% of patients, including headaches in 63% and light-headedness in 52%. Carapeti et al (1999) noted relapse rates of 33% with 0.2% GNT and 25% with escalating-dose GTN (mean followup, 9 months). Headaches were observed in 72% of the patients.…”

Anal Fissure Revisited : A Systematic Review

“…In fact, up to 20% of patients cease GTN therapy due to the severity of their headaches. [30], [31], [32], [33] A 2%GTN ointment applied twice to the anoderm for 6 weeks results in a complete healing in 98% of patients. [6] In another study, Topical diltiazem ointment was used as an agent for chemical sphincterotomy for chronic anal fissure.…”

“…[39] However, recent studies have shown that anal dilation has a higher risk of fissure persistence and higher risk of incontinence. [30] , anal stretch has been scrutinized for causing extensive damage to internal and external sphincters leading to incontinence. A recent randomized controlled trial enrolled 108 patients assigned to anal dilation (AD) versus left lateral sphincterotomy (LLS).…”