Patient reports relief from fibromyalgia in IU School of Med study

Sandra Hayes with Anne Marie Tiernon

IU Associate Professor Dennis Ang is excited that a hunch may be paying off for patients diagnosed with Fibromyalgia. He wanted to test Ketotifen, an antihistamine, to see if it offered relief from chronic pain.

Sandra Hayes enrolled. Hayes was diagnosed nine years ago and didn't have much hope.

"I had been told I had to deal with the pain because I was going to hurt the rest of my life," Hayes said.

Fibromyalgia impairs the joints and causes chronic pain, and approximately 80 to 90 percent of the US cases are in women. It changes patients' lives.

"Everything you do hurts. Sitting, standing, walking, " Hayes said.

Right now, the FDA has three approved treatments for fibromyalgia. They are Lyrica, an anti-seizure medicine, and Cymbalta and Savella, which are antidepressants.

Ang is a Rheumatologist. He says those drugs work for 30 percent of patients but that he wanted to test an antihistamine to see if it helped the other 70 percent. The drug is Ketotifen. Ang explains his theory.

"I read in my literature review that these immune cells called mast cells, there's an increase in the number of these cells in patients with fibromyalgia compared to a healthy, pain-free person. So I thought that because massed cells, they communicate with the peripheral nerve endings, and if there's an interaction between the two, this peripheral nerve ending gets excited and sends signals to the spinal cord and brain. So my hypothesis is that if we quiet these immune cells then it will not send too many signals to the peripheral nerve endings and therefore would lessen the transmission of signals or pain to the brain and spinal chord and hopefully reduce the overall pain," he said.

Sandra is one of nearly 40 patients currently enrolled in the study of Ketotifen at the IU School of Medicine. The Novartis drug is sold world wide but only available in the US in an eyedrop.

Dr. Ang ordered the drug in powdered pill form and gave it to half of the patients enrolled in his National Institutes of Health double blind study.

"I was sure I had medicine, not the placebo. I was pain free. It was amazing. I was like I can't believe this, I think they're on to something," Sandra said.

Ang says the preliminary results are promising. "I am quite excited. I think we are on the right track. The most rewarding thing I think that I can tell you being a physician scientist, is hearing from patients that they are responding to the medication that we are testing."

Ang is now recruiting 12 to 15 more patients to wrap up this ten-week study. His goal is to open a second five-year and $1.5 million NIH study to test in 200 or more patients.

"That makes me feel good because other people are going to get some relief, too," Sandra said.

If you would like to learn more about this and other Fibromyalgia clincial trials now underway at the IU School of Medicine. You may call 317-274-1755.