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Tocopherol acetate (vitamin E) ointment is effective for chronic anal fissure
Clinical Question
Is tocopherol acetate (vitamin E) ointment useful in the treatment of chronic anal fissure in adults?
Bottom line
This study found that TAO (vitamin E) significantly reduced anal pain associated with chronic anal fissure more than GTO in adults. Significantly more patients assigned to GTO stopped treatment because of side effects (mainly severe headaches) and patients were not masked to treatment group assignment, likely overestimating the true effect of TAO compared with GTO. 1b-
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Self-funded or unfunded
Setting: Outpatient (specialty)
Synopsis
Although glyceryl trinitrate ointment (GTO) is effective for reducing anal pain associated with chronic anal fissure, withdrawal rates are high because of side effects (mainly headache). These investigators 160 identified adults (mean age 49.6 years) with persistent anal fissure lasting 6 weeks or longer despite hygienic and dietary measures. Eligible patients randomly received (concealed allocation assignment) GTO or tocopherol acetate ointment (TAO) with instructions to apply a small amount of ointment with a gloved finger to the digital anal canal every 12 hours. Both groups continued conservative measures, including a high-fiber diet and daily sitz bath. The patients, who self-reported pain and recurrence, were not masked to treatment group assignment. Complete follow-up occurred for all patients at 8 weeks. Using intention-to-treat analysis, a report of no pain at 8 weeks occurred significantly more often in the TAO group than in the GTO group (87.5% vs 70%; number needed to treat = 5.7; 95% CI 3.4 - 20.8). Similarly, mean anal pain at 8 weeks (scored using a visual analog scale of 0 to 100 mm) declined significantly more in the TAO group than in the GTO group (mean difference 10.9 mm; 4.3 - 18.6). Finally, anal fissure recurred significantly more often in the GTO group than in the TAO group at 24 weeks (13.2% vs 2.9%). Fourteen patients (17.5%) in the GTO group reported severe headache leading to withdrawal from treatment. No patients in the TAO group withdrew because of side effects.
Reviewer
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Atrium Health
Professor of Family Medicine, UNC Chapel Hill
Charlotte, NC
Comments
Not double blinded
Study misrepresented as double blinded, however patients were not masked to treatment group
Tocopherol and anal fissure
Would have been useful for the review include include a sentence on why tocopherol was considered as a treatment (the biologic plausibility). Also it is not all that clear but the review seems to suggest that resolution of pain equates with healing of a fissure. Would have liked a clearer statement for purposes of discussing this with patients.
Vit E for anal Fissure
The concentration of both the Vit E and the GTO ointments should be given as well as stating whether either or both are standard OTC or prescription items.
painfull fissure
vit e oint
anal fissure
topical vitamin E effective in the treatment