Summary on Scientific Study of HemoTreat

INTRODUCTION TO HEMORRHOIDS

Hemorrhoids have been classically defined as varicose dilatations of the anorectal veins.  The existence of the anal venous dilatations, especially of the internal plexus, is a common morphological phenomenon, the venous dilatation being constantly present and in various degrees.  These venous anal cushions are “physiological hemorrhoids” with the role of continence and sealing the orifice of the anal canal.  These anal cushions become pathologic only when they show abnormal changes and start to display symptoms such as pain, itching, bleeding, etc.

The exact cause of symptomatic hemorrhoids is unknown, but there are a few theories as well physiological and pathological factors that are believed to cause abnormal changes in these venous anal cushions.

There is no correlation between the stage of the disease and the severity of the symptoms.  There are two types of hemorrhoids: internal and external.  The internal hemorrhoids are classified in 4 stages.

–  Stage I: No prolapse.  At this stage mild discomfort, itching and bleeding can be observed.

–  Stage II: Prolapsed and spontaneously reversible.  The typical symptoms are pain, itching.

–  Stage III: Prolapsed and reversible only manually.  In this stage the symptoms are more severe with pain, bleeding, itching.

–  Stage IV: Irreversible prolapsed.  Patients experience tremendous pain as well as bleeding and possible infection.

The current management of pathological hemorrhoids included a variety of treatment options from the least invasive and most conservative to the most radical surgery.  Oral medication and/ or topical agents are options of medical treatment.  These topical agents can contain one or more various ingredients such as local anesthetic, corticosteroids, antibiotics, anti-inflammatory drugs and most of them are available without a prescription. In general, over the counter topical agents lack strong evidence showing true efficacy.

We believe that there is a need for an efficacious topical agent that not only ameliorates the symptoms, but also reduces one of the causes of pathological hemorrhoids, the inflammation.  Our clinical study had dual purposes:

  1. To show the efficacy of HemoTreat in reducing the pain, itching, bleeding and inflammation associated with   hemorrhoids and anorectal disorders.
  2. To analyze the safety and side effects of HemoTreat.

METHODS

        The clinical study included 36 patients ages 20-75 yrs old. The average age was 46.8 years. There were 25 females (69.5%) and 11 males (30.5%).

  Hemorrhoid Age Range Results 

Patients were clinically examined at 4,7 and 30 days. An anoscopy was done at 30 days. The HemoTreat ointment was applied twice a day for 15 days

Exclusions: patients with serious diseases such as neoplasm, HIV, TB, mental disease.  Patients with hemorrhoid disease secondary to severe pathologies such as portal hypertension syndrome and retroperinial tumor were excluded.

The patients that were examined had internal hemorrhoids in different stages (Stage I, II and III) as well as external hemorrhoids.

  • Internal hemorrhoids Stage I: 16% (6 patients)
  • Internal hemorrhoids Stage II: 72% (26 patients)
  • Internal hemorrhoids Stage III: 11% (4 patients)

There were 16 patients displaying internal hemorrhoids Stage II and III and external hemorrhoids.  One patient had an anal fissure.

27 of these patients (75%) had previous hemorrhoid occurrence.  Out of this group, 3 of the patients had relapse after surgical treatment. 9 patients (25%) had first time episode at the time of treatment.

The patients displayed the following symptoms:

72% (26 patients) had anal pain and discomfort

72% (22 patients) had anal pruritus (itching)

61% (22 patients) had anal bleeding after defecation

33% (12 patients) had wet anus

25% (9 patients) had acute inflammation

 

Hemorrhoidal Symptoms

RESULTS

According to the data obtained at 4, 7 and 30 days, the following therapeutic results have been noticed :

  • 88% PAIN Reduction
  • 72% Less ITCHING (pruritus)
  • 88% Reduction of acute inflammation
  • 50% No more bleeding

During the anoscopy exam at 30 days it was noticed that clinically some of the internal hemorrhoids were completely healed and the majority had shown significant improvement.

  • Out of the 6 patients with Stage I internal hemorrhoids 4 were completely healed while 2 of the patients had improvements.
  • Out of the 26 patients in the study with Stage II internal hemorrhoids, 21 had them diminished to stage I and 5 patients had shown some improvements.
  • Out of the 4 patients with Stage III internal hemorrhoids 1 patient had them diminished to Stage II while the rest had no improvement.

To summarize these findings at 30 days, clinically and visually 26 patients (72,22%) showed a gradual remission of the disease, 7 patients (19,44%) shown a significant improvement and 3 patients (8,34%) showed no improvement.

According to our results, HemoTreat reduced the patients symptoms such as pain, itching, bleeding, inflammation and it was considered efficacious by 35 patients (97,22%).  Only one patient with both internal hemorrhoids of stage III and with external hemorrhoids considered treatment ineffective (2,78%).

None of the patients has side effects or adverse events.

 

DISCUSSION

Hemorrhoidal disease is a global, common and often chronic condition that affects millions of people regardless of age or sex.  It was estimated that to 50% of the population would suffer from hemorrhoids at one point in their life[1].  In 2004, the US National Institutes of Health noted that the diagnosis of hemorrhoids was associated with 3.2 million ambulatory care visits, 306,000 hospitalizations, and 2 million prescriptions in the United States.[2]  We believe that the population suffering from hemorrhoids is under diagnosed as most people do not go to the doctor, but instead research the web for their condition and order treatments in the form of over the counter medications, homeopathic remedies, etc.

With so many over the counter topical agents available as hemorrhoids treatment but only a few that have any type of efficacy data, the goal of our clinical study was to show efficacy and safety of our product.  Based on our results, HemoTreat demonstrated high efficacy in treating the main symptoms of hemorrhoidal disease.  In addition, HemoTreat was found to reduce inflammation, one of the causes of hemorrhoidal disease.

The product design and the testing were performed in the laboratories of the Medicine and Pharmacy Faculty from “Dunarea de Jos” University Galati.  A quick overview of the main ingredients in HemoTreat:

  • CAMPHOR is a product approved in certain concentrations for use on the skin to alleviate pain, help with skin itching and irritation as well as possibly being an antimicrobial.
  • CALCIUM CARBONATE is a substance found in nature in the form of minerals. It seems to play an astringent role reducing the swelling of the anal venous vessels.
  • LANOLIN is used to treat or prevent dry skin, skin sores, itching or other skin irritation.
  • PETROLEUM JELLY is a skin protectant and a sealer that keeps the moisture inside the skin.
  • ETHANOL facilitates the transdermal absorption of active ingredients.
  • EUCALYPTUS OIL as a topical agent is an antiseptic and a potential pain reliever by reducing inflammation. It also provides a cooling sensation.
  • ADEPS SUILLUS is an emollient used to form a protective layer on the skin.

The study showed that there are no absolute contraindications to this product as there were no adverse events or side effects.  The only contraindication would be in the cases that the patients are allergic to one or more of the product’s ingredients.

In conclusion, HemoTreat is safe and efficacious over the counter ointment that minimizes the pain, swelling, bleeding, itching and inflammation and significantly improves the quality of life of the patients suffering from hemorrhoids

[1]Baker H. Hemorrhoids. In: Longe JL ed. Gale encyclopedia of medicine. 3rd ed. Detroit: Gale, 2006:1766–1769

[2]Everhart JE, ed. The burden of digestive diseases in the United States. Bethesda, MD: National Institute of Diabetes and Digestive and Kidney Diseases, US Department of Health and Human Services, 2008.