Application of Vitamin E on Anal Fissure

Hospital General Universitario Elche160 enrolled

Overview

Patients were randomized into 2 groups: * Vitamin E: Vitamin E ointment will be applied during 8 weeks * Nitroglycerin: Nitroglycerin ointment will be applied during 8 weeks Healing rate of chronic anal fissure in patients receiving Nitroglycerin ointment and subjects patients receiving Vitamin E ointment were evaluated .

Patients were randomly assigned to experimental and control groups: those patients receiving vitamin E ointment (Experimental Group - EG) and those receiving glyceryl trinitrate ointment (Control Group - CG). Treatments: Glyceryl trinitrate ointment (GTO): Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period. Vitamin E acetate ointment (VEA): Commercially available plastic tubes containing VitaminE acetate ointment (Filme Olio, Hulka SRL, Italy) were purchased from pharmacies. The dosage for all the patients was 1ml, applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period. Healing rate of chronic anal fissure was investigated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

160

Conditions

Pain

Interventions

Vitamin E Acetate ointmentDRUG

Application of 1 ml of ointment to the distal anal canal, every 12 hours for an 8-week period.

Glyceryl trinitrate ointmentDRUG

Application of 375 mg of ointment to the distal anal canal, every 12 hours for an 8-week period.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with diagnosis of chronic anal fissure Exclusion Criteria: * patients with associated anal pathologies * intestinal inflammation disorders * immunosuppression * fissures secondary to underlying diseases (eg, AIDS, tuberculosis, or sexually transmitted diseases) * patients with a history of headaches, heart disease, or intolerance to nitrates * pregnant or lactating women * patients with closed angle glaucoma

Locations (1)

Garcilaso Clinic

Madrid, Spain

Outcomes

Primary Outcomes

Pain associated to anal fissure: Visual Analogic Scale

Pain will be evaluated after finishing the treatment, by a Visual Analogic Scale, ranging from 0 (absence of pain) to 100mm (unbearable pain)

Time frame: 8 weeks

Secondary Outcomes

Number of participants achieving the healing of the fissure

Healing, defined as evidence of fissure reepithelization

Time frame: 8 weeks

Data from ClinicalTrials.gov

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