Non surgical approaches to Hemorrhoidal Pain Reduction A itching

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					Hemorrhoids and Treatments

Acute Hemorrhoid Attacks
While hemorrhoid medications have come a long way over recent decades, the
use of ointments, creams and drugs has proven ineffective at managing
hemorrhoid pain. In an effort to provide improve the management of this type of
pain, a simple and cost-effective device worn during the acute episode has been
developed to complement these topical treatments, and offer relief that they fail
to provide.

Magnitude of the Problem
The incidence of hemorrhoid attacks is a recognized problem in the medical
community. According to the 1989 Vital and Health Statistics of the National
Center of Health Statistics, hemorrhoids are the most commonly reported
condition among the major digestive disorders. This study found that
approximately 23 million people experienced hemorrhoids during 1989 alone;
overall, 36 million reported having hemorrhoids in their lifetime.       From 1983 to
1987, the National Digestive Diseases Clearinghouse found that 52,000 people
reported hemorhoid-related disability. 2

Patients susceptible to hemorrhoid pain
Patients of all ages and walks of life visit their physicians’ office, seeking relief
from pain that their over-the-counter medications, such as Preparation H,
suppositories, and anal creams, fail to deliver. Frequently, patients run to the
emergency room or doctor’s office with acute pain and/or bleeding, in search of a
fast and effective way to relieve their symptoms. Beyond causing pain, this
condition also interferes with the pursuit of daily activities.

The physiology of hemorrhoid pain
Symptoms of hemorrhoids include; prolapse, bleeding, anal discomfort, pain,
itching and anal discharge.3 Pain associated with the anus reflects the high

concentration of somatic nerves in the anal area below the dentate line. The anal
canal has the ability to sense temperature, vibration, stretch, noxious stimuli, as
well as differentiate among gas, liquid and solid material. This concentration may
explain why an acute hemorrhoid attack is such a painful and disabling condition.
Patients describe the pain of an acute hemorrhoid attack as sharp, throbbing,
shooting, burning and continuous.

Hemorrhoid classification
Hemorrhoids are classified by their location – internal and external-- and by their
severity -- from grade1 to grade 4.
      Grade 1 hemorrhoids are characterized by bleeding.
      Grade 2 hemorrhoids protrude with defecation and reduce spontaneously.
      Grade 3 hemorrhoids protrude with defecation and remain protruded,
       unless the patient replaces them manually.
      Grade 4 hemorrhoids are always prolapsed and cannot be reduced.

External hemorrhoids can thrombose and become extremely painful, and the
sudden onset of acute hemorrhoid attacks due to external or thrombosed
hemorrhoids is common. In a study of the etiology of hemorrhoids, Thomson
found that prolapse was the first symptom in the majority of study participants.
Thomson also found bleeding and anorectal pain are the most common
complaints of patients suffering from symptomatic hemorrhoids 4.

The duration of a hemorrhoid attack is usually from 1 day to 2 weeks. The most
usual duration of severe pain of a hemorrhoid attack is 3 days. The mass will
usually subside over 10 to 60 days.

Risk Factors
A study by Corman, Allison and Kuehne suggests the following factors as
contributors: heredity, anatomic features, nutrition, occupation, climate,

psychological problems, senility, endocrine changes, food and drugs, infection,
pregnancy, exercise, coughing, straining, vomiting, constrictive clothing and
constipation.5 Certain of these factors are described below.

Drugs and disease
A University of New Mexico study has found diseases leading to diarrhea to be
the most common comorbid condition of patients suffering from symptomatic
hemorrhoids. Gout and psychiatric disorders were also found to be highly
associated. Diarrhea is a common side effect of psychiatric drug therapy, which
was believed by the investigators of this study to be the reason for the frequent
incidence of hemorrhoids in these patients.

Other diseases associated with diarrhea include:
      Unspecified colitis
      Ulcerative colitis
      Radiation colitis
      Chronic pancreatitis/steatorrhea
      malabsorption
      Status-post gastric surgery
      Status-post intestinal bypass

Neurologic disease and acute spinal cord injuries were also found to be common
among patients suffering from hemorrhoids 6. A 25% prevalence of symptomatic
hemorrhoids was also found in cirrhotic patients, according to one study
conducted by the University of Pittsburgh.

Pregnancy and childbirth
A high incidence of symptomatic hemorrhoids has also been found in pregnant
woman, before and after childbirth. Thrombosed hemorrhoids are a common
and painful condition during pregnancy and in the postpartum period. Traumatic
delivery and heavy babies were found to be associated with thrombosed

hemorrhoids; In addition, one study in France found a 9.1 % incidence in the last
three months of pregnancy, and a large study in Australia showed a 25%
incidence of hemorrhoids in women who underwent caesarean sections.8-10

Diet and lifestyle
Studies present conflicting results about the etiologic factors associated with the
development of hemorrhoids. Diets lacking in fiber, and constipation due to
unnecessary straining, have both been considered major factors. A double-blind,
placebo-controlled trial found that the regular use of a high-fiber supplement
significantly reduced both bleeding and pain after defecation for patients with
hemorrhoids.10 In truck drivers with hemorrhoids, the risk was significantly
increased by a narrow working space, sleeping in the truck, longer driving
distance, squatting posture and driving stress.

Anal disorders
Hypertonicity of the anal sphincter has been commonly found in patients
suffering from hemorrhoids. A study by Arabi et al found that the highest anal
pressures in hemorrhoid patients were found in those with pain, bleeding and
irritation. 12 Stress and hypertensive anal cushions have also been considered
as the cause of high anal pressure in patients with hemorrhoids.

A study by Delco and Sonnenberg found anal spasm and anal fissures among
the comorbidities in hemorrhoid sufferers . 6 Anal fissures are treated successfully
by reducing anal sphincter pressure, suggesting that sphincter pressure plays a
role in the condition of hemorrhoids. However, some patients with hemorrhoids
do not have raised pressures, so it is unclear if this elevated presssure is an
etiologic or epidemiologic factor.15, 16

Treatment Approaches
There are various surgical and non-surgical alternatives for the management of
symptomatic hemorrhoids. Doctors recommend high fiber diets, sitz baths, stool

softeners, bed rest, and pain medication. Other non-surgical procedures such as
sclerotherapy, infrared coagulation, bipolar diathermy, direct current therapy,
cryotherapy, and rubber band ligation are among the various techniques
currently used to treat patients with symptomatic hemorrhoids.

Among these techniques, the most widely used in the United States is rubber
band ligation. Rubber band ligation is the treatment of choice for first and second
degree hemorrhoids. Although rubber band ligation is a widely favored
technique, its post-procedural complications include pain, local swelling, urinary
symptoms and fecal urgency. 17 These symptoms are more prevalent in
procedures where multiple bandings are applied; the incidence of pain after
banding has been found to be approximately 91 percent. 18

Surgical procedures
Most patients are familiar with the painful and sometimes prolonged recovery
after traditional excisional hemorrhoidectomy. Post-operative pain is the main
reason that patients have been reluctant to seek treatment for their hemorrhoids.

Stapled hemorrhoidectomy is a new technique in which hemorrhoids are
removed by insertion of cirmcumferential purse-string sutures and the
subsequent firing of a circular stapler. It is a significantly less painful surgical
method for third degree hemorrhoids, but it is still too early to assess the long
term symptomatic and functional outcomes of this procedure19.

Non-surgical approaches to Hemorrhoidal Pain Reduction

Table 1
 Preparation H                Anusol –HC                    Lidocaine Ointment
 Anal pram HC cream           Topical Nifedipine            Analpram HC 2.5

 Anusol HC Cream 1%          Donut Cushion                Warm Sitzbaths

All of these medications or treatments are short-acting. In addition, prolonged
use of some ointments could be potentially harmful, and do not improve the
patient’s functional ability or reduce pain immediately during acute hemorrhoid

Over-the-counter medications such as Preparation H were proven ineffective in
one study, which compared healing rates of rectal mucosal ulceration in patients
using proprietary hemorrhoid cream vs placebo.

Anusol HC contains hydrocortisone, a topical steroid. It is thought that the use of
hydrocortisone (1 or 2%) may benefit patients suffering from pruritis. However,
long-term use of corticosteroids is to be avoided because it will cause thinning
and atrophy of the perianal skin. Analpram contains hydrocortisone as well as
pramoxine, a topical anesthetic.

Topical nifedipine is a dihydropyridine, calcium antagonistic. One study found
that total remission of symptoms during a 14-day treatment period occurred in
92% of the nifedipine patients, vs 45.8% of control patients.4% of the treated
group had local hyperemia, which disappeared when treatment was
discontinued. 21

Local anesthetics like lidocaine are not to be taken by pregnant women, nursing
mothers, elderly people, subjects with heart failure and liver insufficiency. In
addition, topical creams with cortisteroids are considered teratogenic, thus
should not be used by pregnant women or nursing mothers. Topically applied,
these types of medications can be absorbed in sufficient amounts to produce
systemic effects. Other side effects include itching, burning and stinging.

A study by Shafik found that warm sitz baths significantly relaxed the anal-
sphincter and thus are able to relieve pain related to anorectal conditions.
Bed rest is the only alternative to alleviate pain caused by the external

The donut cushion is not listed in any medical publication as a recommended
treatment for symptomatic hemorrhoids. However, it is commonly understood
that it is widely used for this condition. The donut’s effectiveness is directly
related to the patient being seated. It also does not allow for patient control or to
adjust for different body shapes or sizes. Some physicians believe it could
possibly make the condition worse, as it overly-stretches the anal area.

Alternative Approaches to Pain due to Hemorrhoids
Given the limitations of the above approaches, there is a need for an alternative
therapy that would reduce both the pain, and its interference with functional
ability in a safe, convenient and cost-effective manner.

This alternative therapy, Anuleaf AD, is an adhesive device that could also
provide a drug-free alternative and/or complementary treatment option that would
improve upon previous approaches. Anuleaf AD was developed on the premise
that freeing the anal area from friction while denuded or inflamed would provide
relief by reducing unnecessary mechanical trauma caused by our most basic
body movements.

Other potential conditions for which Anuleaf AD may be effective
Many anorectal conditions, such as fistulas, anal warts, pruritis ani, anal fissures
and ulcers share similar symptoms of pain, bleeding, itching, discharge and
discomfort. Anuleaf AD may also be effective for pain reduction after anal

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Important: Be sure to seek the advice and evaluation of your physician before
making any significant changes in your diet, or level of physical activity. These
statements are not intended to diagnose, treat, cure or prevent any condition.


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