|Henry Kaminski, M.D.|
Since the 1930s, many people with myasthenia gravis (MG) have opted to have a thymectomy, or surgery to remove the thymus gland, an organ in the upper chest that helps produce infection-fighting cells during childhood. Some patients who’ve had thymectomies have had their MG go into remission afterward.
However, some MG patients who’ve not had a thymectomy have also seen their disorder go into remission spontaneously, leaving unclear the effectiveness of or need for the surgery, said Henry Kaminski, M.D., chairman of the department of neurology and psychiatry at the Saint Louis University School of Medicine and one of the nation’s leading experts on myasthenia gravis.
“Here we have a treatment for myasthenia gravis that’s been around for 70-plus years, and we really have not evaluated it properly, especially given discoveries made in treatment in the last couple of decades. There’s no definitive evidence that it works,” said Kaminski, national vice-chair of the study, which is being funded by the National Institutes of Health. “This study will attempt to provide an answer.”
Myasthenia gravis is a chronic neuromuscular disorder that affects about 400 to 600 per 1 million people — roughly 1,100 to 1,700 people in the St. Louis area. Symptoms include weakness in the arms and legs, chronic muscle fatigue, difficulty breathing, difficulty chewing and swallowing, slurred speech, droopy eyelids and blurred or double vision.
In addition to thymectomy, MG is often treated with prednisone, a corticosteriod. Prednisone can be effective in treating the disorder, but it can carry a host of very severe side effects, including pronounced weight gain, osteoporosis, glaucoma and diabetes.
The new study will be carried out at 80 sites around the country and the world, including Saint Louis University. A total of 200 patients — from 18 to 60 years old — will be enrolled altogether, four of them in the St. Louis area.
Patients will be assigned randomly to one of two groups. One group will be given prednisone, starting out at about 80 mg every other day. The other group will receive a similar dose of prednisone to start with, in addition to undergoing a thymectomy.
Patients in both groups will be followed over the course of three years to see whether they show improvement. When patients are being evaluated in the clinic, they’ll wear turtleneck sweaters, so the doctor won’t know to which group the patient belongs. (Thymectomies leave a scar near the base of the throat.)
If a patient appears to be doing better and is experiencing fewer symptoms, the dose of prednisone will be adjusted downward. After three years, if the group receiving thymectomies ends up needing less prednisone than the other group — at least 30 percent less prednisone — then the surgery will be judged an effective treatment for MG, Kaminski said.
“We believe this will demonstrate whether thymectomies are indeed a proper and effective therapy for myasthenia gravis,” Kaminski said.
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious disease.
Those with myasthenia gravis living in the St. Louis area who are interested in being enrolled in the study should contact Saint Louis University, at 314-977-4900, for more information.