Topical Vitamin E Ovules for the Treatment of Hemorrhoids

Study Overview
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Brief Summary
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Patients with hemorrohoids grade II and III were included. Patients were randomized into 2 groups: Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus Control group: Patients will receive a treatment with corticoid ointment, with endoanal application Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment.

Detailed Description
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Patients with hemorrohoids grade II and III were included. Patients were randomized into 2 groups: Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus. 1 ovule must be inserted daily during 14 days. Control group: Patients will receive a treatment with prednisolone ointment, with endoanal application 3 times per day during 14 days. Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment. Quantification of pain will be performed following a visual analogic scale ranging from 0 (absence of symptoms) to 100 (unbearable symptoms).

Official Title
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Topical Endorectal Vietamin E Ovules for the Treatment of Grade 2 and 3 Hemorrhoids

Conditions
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Bleeding Anal, Pain, Stings

Intervention / Treatment
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* Drug: Vitamin E ovules
* Drug: Prednisolone ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Grade II and III hemorrhoids Exclusion Criteria: Grade I or IV hemorrhoids Patients with previous anal surgeries Patients having received previous pharmacological treatments for hemorrhoids

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin E ovules<br>Endoanal Vitamin E ovules will be prescriped during 14 days | Drug: Vitamin E ovules<br>* Endoanal vitamin E ovules will be prescribed<br>|
| Active Comparator: Prednisolone ointment<br>Endoanal Prednisolone ointment will be prescriped during 14 days | Drug: Prednisolone ointment<br>* Endoanal Prednisolone ointment will be prescribed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients with Bleeding | The patient refers rectal bleeding during defecation (patients´self-report) or active bleeding is observed at rectal examination. The variable will be measured as present (1) or absent(0) | 14 days after beginning the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anal pain assessed by Visual Analogic Scale | The patients will be asked to quantify their perception of pain on a VAS, ranging from 0mm(absence of pain) to 100mm (unbearable pain) | 14 days after beginning the treatment | 
| % of patients with Stinging | The patient refers stinging sensation (patients´self-report) . The variable will be measured as present (1) or absent(0) | 14 days after beginning the treatment |