University of Miami CFS Study

August 8, 2003

The CFIDS Chronicle, Fall 2002

http://www.cfids.org/archives/2002/2002-4fall-toc.asp

Chronicle Q & A:

Procrit Trial Focuses on Red Blood Cells

By Mark Giuliucci

Researchers at the University of Miami are testing the effects of the drug

Procrit (epoetin alfa) on people with CFIDS. The drug, also manufactured as

Epogen, increases the body’s production of oxygen-carrying red blood cells. The

study has received substantial coverage from national media outlets this year.

As part of an ongoing Question and Answer series with CFIDS researchers, the

Chronicle interviewed Barry Hurwitz, PhD, the principal investigator in the

Procrit-CFIDS study.

Q: What is the theory behind Procrit and CFIDS?

A: Procrit was developed to treat anemia. It’s highly effective in inducing

bone marrow to produce red blood cells. Procrit has been used on two groups of

patients so far: people who have cancer and have undergone chemotherapy, and

people with kidney disease who are on dialysis. To date the medication has not

been used on CFIDS patients in a large clinical trial.

Our preliminary data indicated that many of our CFIDS patients who had

difficulty with fainting spells and light-headedness also displayed decreased

red blood cell volume. We hypothesized that the lack of sufficient oxygen supply

could be a cause for these symptoms and possibly explain the fatigue as well.

The study we’re conducting is looking at whether increasing red blood cell

volume can improve these symptoms in people diagnosed with CFIDS.

Q: Do people with CFIDS have low numbers of red blood cells?

A: We have found that 60-70 percent of people with CFIDS have low-normal, or

below-normal, red blood cell volume. This was not known before we began our

work. It’s usually missed by standard blood tests.

The test we use is called a dual tag blood volume test. It is the gold standard,

the most accurate way to measure both plasma volume and red blood cell volume in

the blood. It’s commonly done in the radiology departments at most hospitals.

It’s important for those who are wondering if they have red blood cell volume

deficit that the right test be performed. Some tests only measure the plasma

volume and estimate the red blood cell volume. Those are inaccurate. For

instance, there’s a measure called hematocrit. The percentage of red blood cells

in the blood is derived from a drop of blood, but it’s really an estimate.

Q: How is the Procrit study being run?

A: We have a randomized, placebo-controlled trial funded by the National

Institutes of Health’s National Heart, Lung and Blood Institute. Dr. Nancy

Klimas and I are the principal investigators, and we work with a team of other

medical scientists. It’s a four-year study, and we’re in year two. We want to

enroll 150 people, and we’re about halfway to that goal.

We assess individuals as to whether or not they have diminished red blood cell

volume. We also give them a complete cardiovascular workup, and take other

measures that will help us test what role the immune system might play in

influencing red blood cell volume.

The actual treatment phase lasts four months, with check-ups every two weeks.

People with low red blood cell volume are randomized to Procrit or placebo

treatment. People with low red blood cell volume who receive placebo will later

receive an opportunity to obtain the four months of Procrit treatment and repeat

the testing.

If it’s determined up front that you do not have low red blood cell volume,

you’re given a placebo. That way we can compare people who have low red blood

cell volume to those with normal blood volume levels.

The drug is administered three times a week by injection. Subjects are tested

before treatment begins and after the four months of treatment. By using daily

diaries, simple reflex tests and a tilt test we examine changes in CFIDS

symptomatology, as well as the individual’s ability to control the circulatory

system. These circulatory tests are performed because in CFIDS patients the

light-headedness and fainting typically occur when the person is in an upright

posture, suggesting a circulatory regulation problem.

Q: Is it too early to comment on study results?

A: Yes, because it’s a double-blind study. The experimenters and the subjects

are unaware of the treatment assignments until after the study is finished. Then

we’ll be able to analyze the results. Subjects are provided copies of their test

results at the completion of their testing.

Q: What is the best-case scenario?

A: If individuals are fatigued, one possible cause is a lack of oxygenation in

the blood, or an inability to transport oxygen. If you have diminished red blood

cell volume, then you have less capability to deliver oxygen to the cells.

There’s a high probability that if we’re able to increase red blood cell volume

it will diminish fatigue, assuming that fatigue is a function of the capacity to

deliver oxygen to the tissues.

Q: If it turns out that Procrit does help, how long would treatments have to

be taken for a lasting effect?

A: That’s an empirical question. First, we’ll have to determine if there is a

measurable change in people who take the drug — in fatigue levels, quality of

life, exercise fitness, ability to sustain an upright posture, and in immune

function and profile.

If there is a change, then the next question is whether the treatment has to be

maintained for a long period of time. One possibility is that restoring red

blood cell volume will have a positive effect on what’s causing the problem in

the first place. Theoretically, the treatments could end at that point. That

would be a very positive outcome, because at this time Procrit is an expensive

drug.

Alternatively, we’ll have to keep searching for the main cause for the decreased

red blood cell volume. We suspect that the immune system may be involved. That’s

why we’re taking a number of immune system measures, to find out how the immune

system might be related to the decrease in red blood cell production.

Q: Why is there such a buzz about this study?

A: The fact is that there’s no accepted treatment for CFIDS. People are

desperate to find some recognizable cause. There’s obviously a strong demand for

an effective treatment.

It is very exciting to have learned from our study so far that 60-70 percent of

people with CFIDS have diminished red blood cell volume. We did not know that

before we began the study. To me, that tells people that there’s something

really physically wrong with them. For individuals who have been told before

that it’s all in your head, that you’re malingering, the knowledge that there

are real physical changes going on is confirming for them.

Even if Procrit does not improve CFIDS symptoms, the information we’re

collecting regarding circulatory functioning and immune system interactions in

relation to fatigue will shed a great deal of light on some of the important

disease pathophysiology.

Q. How can people participate in the study?

A: We’re including individuals18-55 years of age who have been diagnosed with

CFIDS by their physicians. Participants must have no diagnosed medical history

of abnormal cardiovascular conditions, epilepsy, chronic respiratory conditions,

alcohol or drug abuse, and must not be taking prescribed medications that would

have an impact on their cardiovascular system. Participants must be willing to

be available for assessments at the study site every two weeks for a seven-month

period. They have to travel to Miami at their own expense. Qualifying people

must fill out and submit a questionnaire on our Web site,

http://www.bmrc.miami.edu/research/niaid/procrit.asp. Other questions or

comments may be forwarded via e-mail to CFSresearch.

August 9, 2003

I would hope that someone with CFS would try improving their diet first,

before trying a drug with many side effects. So much can be done with

just diet alone, if only people were willing to help themselves, instead

of relying on their doctors, who afterall, are still just " practicing "

on their patients.

Carol

CFSresearch [CFSresearch]

Friday, August 08, 2003 8:21 AM

University of Miami CFS Study

The CFIDS Chronicle, Fall 2002

http://www.cfids.org/archives/2002/2002-4fall-toc.asp

Chronicle Q & A:

Procrit Trial Focuses on Red Blood Cells

By Mark Giuliucci

Researchers at the University of Miami are testing the effects of the

drug Procrit (epoetin alfa) on people with CFIDS.

August 9, 2003

gentile22x <gentile22x wrote:I believe people on this forum are not interested in allopathic drugs of any kind.

- tom

Re: University of Miami CFS Study

I'll second that. Until every natural or home grown remedy has first been explored I'm absolutely happy for drug companies with their patented synthesised products to wait out in the cold.I've done trials with Noni juice and Colostrum that I believe would yield far better results with chronic fatigue than any drug would. As a matter of fact every C.F.S person I've put on my Quantum Booster Frequency device has given me very positive feedback. One woman didn't want to give it back and a labourer said he felt he had been on three weeks holiday every time he went on it. Perhaps our learned friend would like to tell us what the budget is for this study and whether you surveyed Alternative health clinics and CFS people using alternative protocols so as to ensure that your work is not a superfluous third best. I get bloody fed up with reading in the paper what these glorified pseudo scientific experts are "discovering" day in day out when they refuse to look at the glaringly obvious first simply because it's unpatentable.Tell us whether you looked at the diet and exercise regimes of any of your subjects first and whether you advised a liver flush or bowel cleanse...or would that be encouraging too much initiative amongst your subjects? Did it occur to you that you may have got better results if you had used any one of the following: Colloidal silver, OPC, Aloe vera or Barley grass juice? Tom Reardon