0.4% glyceryl trinitrate ointment: new drug. Not useful for anal fissures.

(1) Anal fissures are very painful but often heal spontaneously. After eliminating other diagnoses, various treatments can be tried while waiting for fissures to heal: warm seat baths, local anaesthetics, and adequate fibre and fluid intake. (2) Clinical evaluation of glyceryl trinitrate 0.4% ointment, a nitrate derivative, is mainly based on a double-blind trial versus excipient in 193 adults with "chronic" fissures. This trial failed to show a clinically relevant analgesic effect of glyceryl trinitrate 0.4%, with only a 3-mm difference versus the excipient on a 100-mm pain rating scale. In another trial including 229 patients, neither 0.2% nor 0.4% glyceryl trinitrate was more effective on pain than placebo. (3) Another placebo-controlled trial including 304 adults treated for 8 weeks showed no efficacy of various doses of glyceryl trinitrate, versus the excipient, on the healing of anal fissures. (4) The most frequent adverse effect, as expected with a nitrate derivative, is headache, which affects about two-thirds of patients and is severe in 20% of cases. Abrupt-onset hypotension is a risk during concomitant use of other vasodilatory drugs. (5) There are no data on pregnant women exposed to glyceryl trinitrate. (6) In summary, glyceryl trinitrate 0.4% ointment does not reduce the pain linked to chronic anal fissures, but it does carry a risk of sometimes severe headache. It is best to continue using simple, non-aggressive treatments.