Treatment of Hemorrhoids

Hemorrhoids are normal anatomic features of the human anal canal, forming pads that bulge into the lumen. The anorectal area has a mucosal lining, a framework composed of blood vessels, smooth muscle and supporting tissues, as well as an anchoring connective tissue system that secures the hemorrhoidal tissues to the internal sphincters. This hemorrhoidal system is reported to cushion the anal canal during defecation.l

The anal canal submucosa is discontinuous and composed of three complexes located at the right posterior, right anterior and left lateral anal wall.2-4 These three areas are often referred to as the anal canal cushions. Their distribution is important because the discontinuous arrangement allows the anal canal to distend, when signaled by the pressure receptors, during a bowel movement. In addition, these cushions have a rich vascular system, both arterial and venous.3

The dentate, pectinate or anorectal line is the point where squamous epithelium of the outer anal skin transitions to a mucosal glandular epithelium. This is significant to note because pain fibers generally cease at the dentate line. As a result, hemorrhoidal disorders above the dentate line rarely cause discomfort and those below the line usually cause pain.3,4

Also important to the anatomy of the anorectal area are the encircling muscles. The internal and external sphincters control the passage of fecal material into and out of the anal canal. The involuntary muscle responsible for the control of defecation is the internal sphincter. Feces are passed into the canal via autonomic stimulation. On the other hand, the external sphincter is under voluntary control and remains closed to prohibit the passage of fecal materials out of the rectum.4,5

Hemorrhoidal disease is present when there are alterations to this normal anatomy, causing blood vessels that lie beneath the anal mucosa and perianal skin to dilate. In addition, the muscular and connective tissue supports may become damaged, resulting in the downward displacement of hemorrhoidal cushions. These events then lead to symptomatology and possible complications of hemorrhoids.

Classification of Hemorrhoids

Hemorrhoids are classified by their point of origin: internal, external, and internal-external.

Internal Hemorrhoids: Internal hemorrhoids originate above the pectinate or dentate line in the anal canal and are covered by a mucous membrane. The internal hemorrhoids become symptomatic when the anal lining and connective tissues become loose and weakened and the vascular system becomes engorged. A grading system has been defined for internal hemorrhoids to assist with the selection of a treatment plan. The grade of the hemorrhoid depends on the extent of descent into the anal canal and out of the anus. First degree internal hemorrhoids are enlarged; however, they never prolapse and rarely produce symptomatology. Second degree internal hemorrhoids prolapse with defecation but they return to their original position spontaneously. Neither first nor second degree hemorrhoids can be visualized during an external examination but require the use of a proctoscope. On the other hand, third degree internal hemorrhoids prolapse with each bowel movement and even with physical exertion. These specific hemorrhoids require manual replacement back to their point of origin. Fourth degree internal hemorrhoids are permanently prolapsed despite attempts to reintroduce them to their original position.1-4 They are especially at risk for thrombosis, severe pain and bleeding.

External Hemorrhoids: External hemorrhoids are swollen areas of skin and blood vessels around the anus (below the dentate line).4 They are lined with squamous epithelium that is highly innervated and sensitive.3 These particular hemorrhoids are also at risk for thrombosis.3,4

Internal-External: When internal and external hemorrhoids occur simultaneously, they are referred to as mixed hemorrhoids.3,4

Epidemiology/Etiology

Hemorrhoidal disease is a common disorder of the anorectal area. It has been estimated that hemorrhoids affect over 10 million individuals in the United States.l,4 Reports suggest that one-half of all Americans over the age of 50 have suffered from hemor-rhoids.4-6 The exact cause of hemorrhoids has not been determined. However, several factors appear to contribute to their etiology. Patients with a low dietary fiber intake may be at risk for developing hemorrhoids.1,4,5 Typically, these patients’ stool is hard with very little bulk or moisture, thereby increasing the risk of straining during a bowel movement. This results in elevated pressure in the rectal vascular system which could lead to hemorrhoidal disorders.5

Pregnancy is another factor linked to hemorrhoids. Due to the in utero placement of the fetus, pregnant women have increased pressure in the anorectal area which may result in internal hemorrhoids.l,4,5 In addition, labor may aggravate the condition, prolonging symptoms after the birth process.4

Another population at risk for hemorrhoids are those individuals whose occupations require heavy lifting or prolonged standing.2,5 Heavy lifting may put additional strain on both the muscles and venous system in the anorectal area, making hemorrhoidal development a possibility. Prolonged standing may cause blood to pool in the rectal vascular system, especially since there are no venous valves in this area, thus predisposing workers to hemorrhoidal problems.

Decreased physical activity may also contribute to hemorrhoidal development.5 Less active individuals may experience a decline in muscle tone of the anorectal area, thereby making the patient prone to weak hemorrhoidal cushions. Other patients at risk for the development of hemorrhoids are those who overuse stimulant laxatives. These individuals are at risk of chronically straining the anal sphincters during defecation, which may result in symptomatology.5

Finally, there may be a genetic link toward the development of hemorrhoids.2-4 However, whether this trend is due to a familial trait (e.g., weak blood vessels) or to similar environmental factors (e.g., dietary habits) is unclear.

Signs and Symptoms

Signs and symptoms of hemorrhoidal disease are the result of vascular congestion that occurs when veins become engorged secondary to obstructed blood flow. In addition, collagen and elastin that support the anorectal region weaken, causing hemorrhoidal cushions to lose their support and become displaced.

Bleeding: One of the most common symptoms of hemorrhoids is bleeding from the rectal area before, during and after defecation. The anal mucosa becomes eroded, releasing a bright red blood usually evident to the patient via blood-tinted toilet bowl water, stool or toilet tissue. The blood may result from external or internal hemorrhoids.1,2,4

Itching: Itching may result secondary to mild inflammation usually associated with prolapsed internal hemorrhoids that secrete a mucous discharge. Further irritation and itching can occur when dyes and perfumes in fabrics and toilet tissue come into contact with the already sensitive area.4

Inflammation and Swelling: Inflammation and swelling may result from trauma imposed on the anorectal area due to engorged hemorrhoidal tissues. Inflamed tissues may cause pain, especially to a patient with external hemorrhoids. Standing for prolonged periods of time or defecation may intensify the pain. As expected, those with uncomplicated internal hemorrhoids should not feel pain secondary to an absence of pain receptors above the dentate line.4

Seepage: Seepage of fecal matter or mucus may occur if persistent swelling or inflammation in the anorectal area prevents the anal sphincter from closing properly.4

Protrusion and Prolapse: A frequent sign of uncomplicated internal or external hemorrhoids is protrusion, a projection of tissue outside the anal canal. The protrusion may be evident following a bowel movement, prolonged standing or physical exertion. Unless the protrusion becomes thrombosed, infected, or ulcerated, it is painless. A prolapsed hemorrhoid is an internal hemorrhoid that protrudes beyond the dentate line and is seen at the anal orifice.4

Thrombosis: When hemorrhoids remain persistently prolapsed, patients are at risk for thrombosis. This is a lump or clot that may cause severe pain in the rectal area for approximately a week.2,4 The lump does slowly disappear; however, a skin tag remains evident. If, by chance, the thrombosed hemorrhoid does not heal, then gangrene as well as ulceration may ensue, leading to further complications of the anorectal area.4

Assessment

Pharmacists should question patients about the nature of their signs and symptoms to determine whether self-treatment is an option or whether a visit to the physician is best. Mild hemorrhoidal symptoms may be relieved by self-medication; therefore, the pharmacist should be able to assist the patient with proper drug selection based on the reported symptoms.4,5 No medications cure hemorrhoids; however, products are available to ease patients’ discomfort. The goal of self-medication is to ease those symptoms described by the FDA as burning, discomfort, inflammation, irritation, itching, pain, soreness and swelling.5 Pharmacists may also educate the patient about the causes of hemorrhoids and recommend ways to alter their lifestyle in order to prevent future hemorrhoidal problems.

Advanced cases of hemorrhoidal disease with more severe symptoms (e.g., seepage, protrusion, prolapse, thrombosis, abdominal discomfort, persistent bleeding, pain, and itching) may indicate potentially serious medical conditions for which self-treatment is not adequate or advisable. Patients with severe symptoms should see a health care provider for a thorough examination.4

Treatment

Hemorrhoids that respond to self-treatment are usually mild and self-limiting and should heal without medication. There are numerous nonpharmacological ways to manage hemorrhoids. All patients are encouraged to sit in warm water or sitz baths for 15 minutes, three to four times a day, and to cleanse the anorectal area with mild, unscented soap and water after bowel movements to decrease symptoms.4,6 Serious cases of hemorrhoids (third and fourth degree) may require hemorrhoidectomy, rubber band ligation, sclerotherapy, infrared photocoagulation, cryotherapy, bipolar diathermy or laser therapy.

The most important aspect of hemorrhoid management is prevention. The following measures not only will help prevent hemorrhoids but may also cause shrinking of less severe cases:

* Avoid constipation by not postponing the urge to defecate;
* Eat a balanced, high-fiber diet;
* Drink plenty of water, fluids;
* Exercise; and
* Avoid excessive pressure and straining during defecation.6,7

Other advice for the patient may be found in TABLE 1. There are a variety of over-the-counter (OTC) pharmacologic agents for symptomatic management of hemorrhoids including vasoconstrictors, astringents, protectants, local anesthetics, keratolytics, hydrocortisone and antipruritics (TABLE 2). Most hemorrhoidal symptoms should resolve within seven days of treatment with the available products.5,8 If symptoms do not resolve, a physician should be consulted due to the threat of other, more serious, anorectal conditions.


The FDA has divided these products into those that can be inserted intrarectally for internal hemorrhoids and those intended for external use only. Astringents, protectants and vasoconstrictors can be used for internal hemorrhoids. No ingredients are approved by the FDA for intrarectal use to alleviate pain, soreness or burning.5,8

Astringents: Astringents coagulate the proteins in surface skin cells, which results in decreased cellular volume and a leaves a thin layer protecting underlying tissue. In addition, these agents decrease mucous and other secretions in order to decrease inflammation and irritation of the area.4-6,8 Astringents also provide relief of burning and itching but not of pain.4,5,8 Calamine and zinc oxide (in concentrations of 5%–25%) are recommended for both internal and external use up to six times a day, whereas witch hazel, also known as hamamelis water (concentration of 10%–50%), is recommended for external use, providing temporary relief of itching, discomfort, irritation and burning.4

Protectants: Protectants form a physical barrier over the skin and mucous membranes, thereby decreasing inflammation and preventing water loss from the stratum corneum.4-6,8 When protectants such as absorbents, adsorbents, demulcents and emollients are included in an OTC formulation, they should make up at least 50% of the dosage unit.4,6 Recommended protectants include: aluminum hydroxide gel, cocoa butter, glycerin in aqueous solution, hard fat, kaolin, lanolin, mineral oil, white petrolatum, petrolatum and topical starch.4 All of these are approved for intrarectal and external use with the exception of glycerin, which is reserved for external use only.4 Calamine, zinc oxide, cod liver oil and shark liver oil are recommended only when combined with one to three other protectants listed above. Side effects are minimal but may include hypersensitivities.4,6

Vasoconstrictors: Vasoconstrictors stimulate the alpha-adrenergic receptors in the vasculature and promote constriction of the blood vessels.4-6,8 One sequela of hemorrhoids is the pooling of blood in dilated veins. The vasoconstrictors may be used to reduce swelling of these engorged blood vessels.4,5,8 Vasoconstrictors relieve itching, discomfort and irritation due to a slight anesthetic effect.4-6,8 These products, ephedrine sulfate and phenylephrine hydrochloride, are chemically similar to naturally occurring catecholamines (i.e., epinephrine and norepinephrine). Serious adverse effects of vasoconstrictors include elevation of blood pressure, cardiac arrhythmias, nervousness, tremor, insomnia, and aggravation of symptoms of hyperthyroidism.4,8 Vasoconstrictors should be avoided in patients with diabetes, hyperthyroidism and hypertension, as well as patients who experience difficulty urinating due to enlarged prostate or those patients taking monoamine oxidase inhibitors or tricyclic antidepressants.4

Local anesthetics: Anesthetics relieve the sensations of pain, burning, itching, discomfort and irritation by reversibly blocking nerve conduction.4-6,8 These products should be used externally on the perianal area due to the sensory nerve endings saturated in this area.4-6,8 If absorbed by the rectal mucosa, potential toxic effects can occur systemically. Allergic reactions can also occur, including burning and itching, which can aggravate the already inflamed tissues.4,6 Active ingredients often found in local anesthetics include benzocaine, benzyl alcohol, dibucaine, cyclonine, lidocaine, pramoxine and tetracaine.4

Keratolytics: Keratolytics cause desquamation and sloughing of the epidermal surface of cells in the perianal area.4-6,8 This turnover and debridement of the epidermis allows exposure of inflamed tissues to therapeutic agents.4,6 Keratolytics are also useful in reducing itching and discomfort.4 Keratolytics, aluminum chlorhydroxy allantoinate (alcloxa) and resorcinol are for use in external hemorrhoids only.4,5,8 Pharmacists must warn against using products containing resorcinol near open wounds around the perianal area.4

Antipruritics: Formerly classified as counterirritants, antipruritics have now been redesignated by the FDA as "analgesics, anesthetics, and antipruritics."4-6,8 These products stimulate the cold receptors and depress cutaneous sensory receptors in the perianal area, resulting in sensations that distract from the annoying symptoms of hemorrhoids.4-6,8 Analgesics, anesthetics, and antipruritics include menthol, juniper tar, and camphor; however, menthol, camphor and turpentine oil are not considered safe or effective.4

Hydrocortisone: Hydrocortisone is safe and effective for relief of anorectal itching and swelling; however, OTC products containing hydrocortisone are not recommended by the FDA for anorectal use.4-6,8 Anorectal products containing hydrocortisone must be obtained by prescription. Hydrocortisone has anti-inflammatory, lysosomal membrane stabilization, antimitotic and vasoconstrictive properties that may be beneficial in relieving hemorrhoids.4,5,8 Like other ingredients, hydrocortisone can cause local irritation and allergic reactions that would interfere with the healing of perianal tissue.5

Live yeast cell derivative (LYCD): This has recently been removed from the list of safe and effective active ingredients and is prohibited in OTC hemorrhoidal products such as Preparation H and Wyanoids.4-6,8,9 The manufacturers of LYCD claimed that it effectively promoted wound healing and tissue repair in the anorectal area, resolving symptoms such as pain, itching, burning, swelling, and irritation.4,5,8,9

Dosage Forms

There are a variety of dosage forms for the treatment of hemorrhoids. For internal use, suppositories, creams, ointments, gels and foams are available. Some have applicators and pile pipes while others require manual insertion.4,6 Products approved for external use include creams, ointments, gels, pastes, wipes, liquids, pads, and foams.4

Topical ointments, creams and gels should be applied as a thin covering to the perianal area, and some of these products have rectal pipes or applicators to allow intrarectal administration.4,6 Caution should be used with these devices so the inflamed tissues receive no further trauma.4 Foams have no significant advantages over ointments, creams, and gels except for their rapid onset of action.4 However, these may be more difficult to apply and sometimes demonstrate erratic absorption depending on the concentration of the bubbles.4 Suppositories may decrease the straining associated with defecation; however, they are not considered the ideal dosage form since they can be inserted too deeply.4-6

Product Selection

Pharmacists play an important role in assisting patients in selecting a nonprescription product for the treatment of hemorrhoidal symptoms. Prior to recommending any OTC product, pharmacists must determine the type of hemorrhoid from which the patient suffers. Nonprescription products containing a vasoconstrictor, astringent or protectant are the only FDA-approved agents for treating internal hemorrhoids. For external hemorrhoids, the symptoms that the patient describes dictate the appropriate OTC therapy.4,6

Products containing vasoconstrictors should not be recommended for a patient who has a diagnosis of diabetes, hypertension, hyperthyroidism, difficulty in urinating or is taking a prescribed drug for depression, especially a monoamine oxidase inhibitor or a tricyclic antidepressant. Additional precautions for products containing local anesthetics are that certain individuals may be allergic or hypersensitive to the ingredients. If swelling, irritation, redness, pain or other symptoms develop or increase, the patient must notify his/her physician. Also, the patient should contact a physician if seepage, bleeding, protrusion or severe pain occurs. If the symptoms have worsened or not improved after seven days of hemorrhoidal self-treatment, the patient should consult the physician.4,6

Conclusion

Symptomatic hemorrhoids can be self-treated by nonpharmacological methods including avoidance of chronic constipation and straining during defecation. Also, bulk-forming laxatives or stool softeners may provide relief of hemorrhoidal symptoms. Sitz baths or sitting in warm water for 15 minutes at a time, increasing fiber in the diet, drinking plenty of fluids, and exercising are all recommended. OTC products may also be suggested to relieve symptoms. It is imperative that only FDA-approved hemorrhoidal products be recommended. However, the pharmacist must elicit a detailed patient history prior to recommending a product.


source:www.uspharmacist.com