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FDA ("Official") Position On Hemorrhoids

Source

 

[U.S. Food and Drug
Administration]

This article was published in FDA Consumer magazine several years ago. It is no longer being maintained and may contain information that is out of date. You may find more current information on this topic in more recent issues of FDA Consumer or elsewhere on the FDA Website, by checking the site index or home page, or by searching the site.

No Strain, No Pain: The Bottom Line in Treating Hemorrhoids
by Dori Stehlin


Say the word hemorrhoids to just about anyone and they will either roll      
their eyes, moan or both. Invariably they will want to change the subject.

According to the National Institutes of Health, about half the U.S.          
population over 50 have hemorrhoids.

"Hemorrhoids are one of the most common complaints a physician must          
evaluate," agrees Lee E. Smith, M.D., director of the division of colon and  
rectal surgery at the George Washington University Medical Center,           
Washington, D.C.

Common, but rarely a serious risk to health, hemorrhoids are the result of   
too much pressure on the hemorrhoidal veins in the rectum. The strain of     
constipation, diarrhea and pregnancy can cause the veins to swell. Other     
factors such as obesity and liver disease can also increase pressure and     
cause hemorrhoids.

There are two kinds of hemorrhoids--internal and external. Frequently, the
only sign that internal hemorrhoids exist is  
bright red blood that appears on the surface of the stool, in the toilet     
bowl, or on the toilet paper. But, if the pressure and swelling continue,    
the hemorrhoidal veins may stretch out of shape, sometimes so much that they 
bulge through the anus to the outside of the body.

The veins around the anus can also become swollen, causing external          
hemorrhoids. These swollen veins bleed easily, either from straining or      
rubbing, and irritation from draining mucus may cause itching in the anal    
area. If blood clots form in these hemorrhoids, the pain can be severe.

"If you see blood, it's probably hemorrhoids," says Smith. Hemorrhoids are   
the most common source of bleeding from the rectum and the anus. However, if 
the bleeding lasts for more than a couple of days, it's important to see a   
doctor for an exam. Smith stresses that a "thorough physical exam, not just  
talking about the symptoms" is essential.

"The unfortunate thing is every year I see somebody who has been seeing      
blood and they were treated as having hemorrhoids without really being       
examined, and they had a cancer," he says.

Treatment for hemorrhoids depends not only on the severity of the symptoms,  
but also on the patient's reaction to those symptoms.

"Hemorrhoids don't cause cancer; they're a nuisance," says Smith. "Rarely do 
they cause severe anemia and rarely do they cause something that is          
hazardous to health. If the patient doesn't mind, then let them live with    
the hemorrhoids."

Even though he's a surgeon, Smith considers surgery an option only after     
everything else has failed.

Relieving the Pressure

The first step in treating hemorrhoids is to relieve the pressure and        
straining. This can often be done by controlling constipation with a         
high-fiber diet, according to Barbara Frank, M.D., director of the division  
of gastroenterology at the Crozer-Chester Medical Center, Chester, Pa.

Eating the right amounts of bran (the outer coating of grains, available     
mainly as cereals), as well as fruits, vegetables, and whole grains results  
in a soft, bulky stool that is easily eliminated without strain or pressure  
on the hemorrhoidal veins. (See box for list of good fiber sources.)

"Bran is the cheapest way to go," says Smith, who also recommends bulk stool 
softeners (brand-name products include FiberCon, Metamucil, Citracil, and    
Serutan) as a way to relieve pressure and straining.

Lots to drink, as long as it isn't alcohol, which can actually cause         
dehydration, is also important for the regularity that can relieve           
hemorrhoids you already have and prevent new ones.

People should drink "several glasses [of liquid] a day, and it doesn't have  
to be just water," says Marilyn Stephenson, a registered dietitian with      
FDA's Center for Food Safety and Applied Nutrition. "Fruits and vegetables   
are high in fluids, too."

"Several" may seem a little too fluid an amount, but people's needs vary,    
sometimes daily, depending on things like the weather or exercise.

"Especially in hot weather, a glass [of water] every couple of hours is very 
reasonable," says Smith.

One thing to avoid when trying to relieve constipation is any laxative other 
than a stool softener, says Smith. Other laxatives frequently cause          
diarrhea, which can be just as rough on the hemorrhoidal veins as straining  
due to constipation, he explains.

Besides an improved diet, other simple steps to relieve the irritation some  
hemorrhoids cause include:
- warm soaks (sitz baths) three or four times a day
- cold packs
- good hygiene. (Be gentle about cleaning, though. Frank recommends using a  
soft, moist pad or even rinsing in the shower as an alternative to wiping.)

OTC Remedies

If necessary, there are several nonprescription drugs available that can     
help relieve certain symptoms of hemorrhoids. FDA's review of those drugs,   
published in August 1990, found 33 active ingredients safe and effective for 
protecting the skin, reducing swelling, or relieving discomfort, itching and 
inflammation. At the same time, however, FDA banned more than 30 other       
ingredients that have not been proven safe and effective.

Most of the approved ingredients are for external use on the skin, but some  
may also be used on mucous membranes just inside the rectum. The best drug   
depends on the particular individual's symptoms, and it may be advisable to  
consult a doctor or pharmacist about which one to buy, says William E.       
Gilbertson, director of FDA's division of over-the-counter drug evaluation.

No ingredients to relieve pain, soreness and burning were approved for       
internal use because there are no nerve endings inside the rectum.

Internal hemorrhoids "don't hurt and they don't itch," says Smith. "Pain     
means a fissure [break in the skin] or a thrombosed [blood-clot-filled]      
external hemorrhoid, but it doesn't mean internal hemorrhoid problems."

Manufacturers had until August 1991, when the FDA regulations went into      
effect, to reformulate products that contained ingredients for pain,         
soreness and burning or relabel with the statement "for external use only"   
and a warning not to put the product into the rectum.

In addition, nonprescription hemorrhoid remedy labels must include the       
statement "If condition worsens or does not improve within seven days,       
consult a doctor." Two other warnings--"Do not exceed the recommended daily  
dosage unless directed by a doctor" and "In case of bleeding, consult a      
doctor promptly"--must also be on the label.

Surgical Options

Occasionally, some form of surgery may be necessary to remove or destroy the 
hemorrhoid.

One of the most common surgical methods is rubber band ligation. A tiny      
rubber band--diameter 1 millimeter (about one-twenty-fifth of an inch)--is   
fitted onto a special gun-like device. When the trigger is pulled, the       
rubber band is forced onto the base of the hemorrhoid. Because there are no  
nerve endings in the rectum, no anesthesia is necessary.

It takes about a week for the strangled tissue to slough off and a scar to   
form. Rubber band ligation works best on first- and second-degree            
hemorrhoids. (See illustration.)

Other surgical techniques for these less severe hemorrhoids include:
- infrared photocoagulation--A specially designed device uses infrared light 
to create a small tissue-destroying burn around the base of the hemorrhoid.
- laser coagulation--The laser causes a minor burn, which seals off the      
blood vessels. This results in the hemorrhoid being retained in a            
non-prolapsed position.
- sclerotherapy--A solution (either quinine urea, sodium morrhuate, or       
phenol in oil) is injected into the hemorrhoid, which causes inflammation    
and eventual scarring that eliminates hemorrhoidal symptoms.

Third- and fourth-degree hemorrhoids may have to be surgically removed,      
either with traditional scalpels or with lasers.

Complications such as infection and incontinence are possible with all of    
these techniques.

External Hemorrhoids

Blood clots in external hemorrhoids are "like a black eye," says Smith.      
"Even if the patient does nothing, the clots will eventually disappear."     
Treating the pain and irritation with sitz baths, bulk stool softeners, and  
pain medication may be all that's necessary, he says.

Sometimes, however, the clots are so painful the patient can't bear to wait, 
and traditional surgery to cut out the clots is necessary.

But even surgery is only a temporary solution. If a person's diet isn't      
improved, the hemorrhoid may return. And even in the best of cases, in the   
end, "hemorrhoids don't go away, they just get better," says Smith. n

Dori Stehlin is a staff writer for FDA Consumer.
Preventing Constipation

A fiber-rich diet can help prevent constipation, which is important because  
the strain caused by constipation is how many hemorrhoid problems begin.     
Good sources of fiber include:
- potatoes
- beans--kidney, navy, lima, pinto
- whole-grain breads
- bran
- fresh fruits
- vegetables, especially asparagus, brussels sprouts, cabbage, carrots,      
cauliflower, corn, peas, kale, and parsnips.

It will also help to limit these low- or no-fiber foods: ice cream, soft     
drinks, cheese, white bread, and meat.
 

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