Clinical Trials: Key to Ongoing Research

Although these new treatments are just on the horizon, it may be years before any are available to consumers.

The process of introducing a new treatment to the public can be a long one. Before the FDA approves a drug, it must go through rigorous clinical trials, which are divided into three phases. In phase I, researchers try to find out if the drug is safe for people to take. If the drug is deemed safe, it may go on to phase II, when researchers aim to determine if the drug works as it should. They also collect more safety data. In phase III trials, they expand their research to include more patients in more places.

To conduct a clinical trial, scientists need people to participate voluntarily. Clinical trials often involve thousands of patients who volunteer to take the experimental drug. The FDA and an independent review board carefully monitor every aspect of the trial. There are rules the researchers must follow to ensure that their work is not only scientifically correct, but also ethically sound. The study volunteers have clearly defined rights, such as the right to drop out of the trial at any time.

While there are risks involved in joining a clinical trial, there may be benefits, too. You might get a new “wonder drug” long before it hits the market. If you’re interested, ask your doctor if you could benefit by joining one. Your doctor may know of a trial that is seeking volunteers in your area. The National Institutes of Health also has an online database that you can search: www.clinicaltrials.gov. This web site provides detailed information on what’s involved in joining a clinical trial.

Microbicides are another option scientists are exploring in the search for new genital herpes treatments. Microbicides are chemicals that protect against infection by killing microbes (small organisms such as bacteria and viruses) before they enter the body. One that has made some progress is called BufferGel, which would be applied to the vagina. Studies show it’s able to kill herpes, as well as some other sexually transmitted viruses.

Scientists also are working on new drugs that keep the herpes virus from replicating. To replicate (make copies of itself), a virus has to duplicate its DNA exactly. Scientists hope these new drugs will prevent the virus from doing that.

Clinical Trials: Key to Ongoing Research

Although these new treatments are just on the horizon, it may be years before any are available to consumers.

The process of introducing a new treatment to the public can be a long one. Before the FDA approves a drug, it must go through rigorous clinical trials, which are divided into three phases. In phase I, researchers try to find out if the drug is safe for people to take. If the drug is deemed safe, it may go on to phase II, when researchers aim to determine if the drug works as it should. They also collect more safety data. In phase III trials, they expand their research to include more patients in more places.

To conduct a clinical trial, scientists need people to participate voluntarily. Clinical trials often involve thousands of patients who volunteer to take the experimental drug. The FDA and an independent review board carefully monitor every aspect of the trial. There are rules the researchers must follow to ensure that their work is not only scientifically correct, but also ethically sound. The study volunteers have clearly defined rights, such as the right to drop out of the trial at any time.

While there are risks involved in joining a clinical trial, there may be benefits, too. You might get a new “wonder drug” long before it hits the market. If you’re interested, ask your doctor if you could benefit by joining one. Your doctor may know of a trial that is seeking volunteers in your area. The National Institutes of Health also has an online database that you can search: www.clinicaltrials.gov. This web site provides detailed information on what’s involved in joining a clinical trial.

Many people say that an extract of the echinacea plant helps boost the immune system’s ability to fight the genital herpes infection. Some say it decreases the frequency and severity of genital herpes outbreaks. Researchers in the U.K. compared the effect of echinacea with that of a placebo. They gave echinacea to 50 people with genital herpes for six months and a placebo for another six months. There was no significant difference in the number of herpes outbreaks during the two periods.

Another study showed that an ointment containing propolis, a waxy substance that honeybees make, may help genital herpes sores heal. Sores healed faster for people using the propolis ointment than in those using ointments containing the antiviral drug acyclovir or a placebo. The ointment was applied to herpes sores four times a day. After 10 days, 24 of the 30 people using propolis ointment said their sores healed, compared with 14 of the 30 people using acyclovir ointment and 12 of the 30 using a placebo.

Researchers have also found that the herb Prunella vulgaris, and an edible mushroom, Rozites caperata (the “gypsy mushroom”), contain chemicals that fight both the oral herpes virus (HSV-1) and the genital herpes virus (HSV-2).

These treatments have not been approved for treating genital herpes by the U.S. Food and Drug Administration (FDA). You can buy them in stores, but they are considered nutritional supplements, not drugs, so they are not subjected to the same quality standards that FDA-approved drugs are.

Most people are surprised to find out that two types of herpes viruses – the one that causes cold sores and the one that causes chickenpox – can cause serious eye problems.

These two viruses are not the same virus that causes genital herpes, and herpetic eye disease is not a sexually transmitted disease.

One of the viruses that cause herpetic eye disease is called the varicella-zoster virus. It is the same virus that causes chickenpox and the nervous system disease shingles. When this virus affects the eye, it is called herpes zoster ophthalmicus.

The other virus that causes herpetic eye disease is called herpes simplex type 1. Herpes simplex type 1 is the same virus that causes cold sores on the lips and mouth. In the eye, it usually causes an infection of the cornea. This infection is called herpes simplex keratitis.

How Does Herpetic Eye Disease Develop?

Like many viruses, the herpes simplex 1 and varicella-zoster viruses are present in most adults. The viruses in the herpes family usually live around the nerve fibers in humans without ever causing a problem. Occasionally, the viruses will start to multiply, or they will move from one area of the body to another, and that is when herpetic disease breaks out. This often happens when the immune system of the body is weakened by some other health problem.

How Is Herpetic Eye Disease Diagnosed?

The two types of herpetic eye disease have different symptoms. One thing they have in common, however, is that they can both be very painful because they affect the nerves directly. The problem is likely to be herpes zoster ophthalmicus if your doctor finds some or all of these symptoms:

• Pain in and around only one eye
• Redness, rash, or sores on the eyelids and around the eyes, especially on the forehead. Sometimes the rash breaks out on the tip of the nose.
• Redness of the eye
• Swelling and cloudiness of the cornea

The problem is likely to be herpes simplex keratitis if your doctor sees these symptoms:

• Pain in and around only one eye
• Redness of the eye
• Feeling of dirt or “grit” in the eye
• Overflowing tears
• Pain when looking at bright light
• Swelling or cloudiness of the cornea

Your doctor might want to use special tests if it looks like herpetic eye disease might be present. The pressure inside the eye will probably be checked, for example. There is also a special dye called fluorescein that the doctor might put into the eye. This dye glows under ultraviolet light and will show the doctor if the virus is causing problems on the surface of the eye.

How Is Herpes Zoster Ophthalmicus Treated?

Because herpes is a virus, antibiotics such as penicillin are not an effective treatment. The only drugs that will work against herpes infections are antiviral medications.

How Is Herpes Zoster Ophthalmicus Treated?

Depending on how serious the herpes zoster ophthalmicus is and what part of the eye is affected, your doctor will recommend antiviral eye drops, pills, or both. No matter what kind of medication is recommended, it is important to keep using the medicine for as long as your doctor recommends. Even though the eye might start to look or feel better, the infection could come back if you stop taking your medicine too soon.

If the infection is affecting the cornea, another kind of eye drops called corticosteroids might also be recommended. Corticosteroids will help control the disease, but they can also raise the pressure in the eyes of some people. If corticosteroids are being used, it is important for the patient to come back to the doctor’s office so the pressure can be checked.

Another type of eye drop might also be prescribed to keep the pupil dilated. This will help the eye’s natural fluids flow, which prevents the pressure from increasing.

Unfortunately, herpetic eye disease can be painful even after several days of treatment when the eye is starting to look better. This can be discouraging, but it does not mean that the treatment is a failure. The medications are working, and the pain will go away eventually.

How Is Herpes Simplex Keratitis Treated?

The same types of eye drops and pills that are used to treat herpes zoster ophthalmicus are prescribed to treat herpes simplex keratitis. It is also just as important to use the medications as recommended and to keep all appointments with your doctor.

The biggest risk occurs during a first-time (primary) outbreak of genital herpes. Usually, in these cases, the woman either does not have symptoms or is unaware of symptoms. Experts disagree about the use of cesarean section delivery in women with recurrent outbreaks of genital herpes. If a pregnant woman has recurrent outbreaks, the risk of passing the virus to her baby is less than 1% because the baby has some immune protection from the mother.

Cesarean section may be recommended if a woman has symptoms such as tingling or pain (prodromal symptoms) that signal an impending outbreak. For these women, acyclovir (Zovirax) used in the last 4 weeks of pregnancy may reduce the need for delivery by cesarean section by reducing the risk of a recurrent outbreak at the time of delivery.

A cesarean section is usually not done if a woman with recurrent genital herpes has blisters or sores only on her thighs, buttocks, or another area that is not close to the vagina.