Georgetown University researchers last week announced the first study to examine the safety of using venom from honeybees to treat patients with multiple sclerosis, a chronic, often-disabling disease of the central nervous system.
Multiple sclerosis afflicts an estimated 500,000 Americans annually, and there is no cure. The Food and Drug Administration has approved three drugs in recent years that can temporarily relieve symptoms in some patients. But the lack of a cure has turned many patients to alternative medical therapies to try to control their symptoms, which can vary widely. They may range from abnormal fatigue and impaired vision to loss of balance and muscle coordination, difficulty walking and moving, slurred speech, tremors and, in the most severe cases, partial or complete paralysis.
All these symptoms are caused as the disease slowly erodes the myelin sheaths surrounding nerves in the body.
One alternative treatment that has gained a great deal of publicity and loyalty among MS patients is honeybee venom. The therapy, which involves multiple bee stings several times a week, "is something that has been used by individuals with rheumatoid arthritis, multiple sclerosis and other diseases for many years," said Stephen C. Reingold, vice president of Research and Medical Programs for the National Multiple Sclerosis Society in New York. "There is no clinical data that supports its safe use or efficacy. It is not a recommended therapy for MS or, to my knowledge, for any other disease."
The Georgetown University study, which is funded by a $250,000 grant from the Multiple Sclerosis Association of America of Cherry Hill, N.J., is the first to look at the safety of using honeybee venom in humans.
One of the big concerns about the therapy is that it can cause an allergic reaction that could be life-threatening for people who are highly sensitive to bee venom. All patients in the study will be tested for bee-venom allergies. In addition, emergency treatment including epinephrine injections and antihistamines will be available to counteract any possible allergic reactions to the treatment.
According to Joseph A. Bellanti, director of Georgetown's Immunology Department and the lead investigator of the study, the year-long trial will involve eight patients with chronic progressive MS who are not receiving any other medication. All participants will receive bee venom twice a week for a year, but those in the study will receive injections of bee-venom extract rather than being stung by honey bees.
"Our position is, let's find out about this therapy," said MSAA board member Steve Shapiro, 53, who has taken regular bee-venom therapy for about eight years to control his MS. Mr. Shapiro said the treatment has enabled him to keep working and has eliminated the need for all other medications, including prednisone, a powerful corticosteroid that controls inflammation.
But some scientists questioned why such a study should cost so much. "An eight-patient study can conclude nothing about effectiveness, and even if they are only looking at safety issues there may be some questions about whether this is a large enough sample size," said Mr. Reingold. The average cost per year of most clinical trials is about $10,000 to $12,000 per patient, he said, or less than half of the $30,000 per patient budgeted for the Georgetown trial.
Critics also noted that the Georgetown researchers are not using the latest classifications for multiple sclerosis in recruiting participants in the study. The Georgetown team is looking for patients who have chronic progressive MS.
"What is chronic progressive MS?" Mr. Reingold said. "That is ill-defined and probably lumps everything together. I don't know what they mean."
The most common type of MS is called relapsing-remitting. It afflicts about 70 percent of people with the disease and is characterized by clearly defined flare-ups that are followed by partial or complete recovery periods between attacks.
Other patients tend to have what used to be called chronic progressive MS. That term has been replaced by three new subtypes of MS, after a group of international experts reviewed studies and test results, including magnetic resonance imaging scans, and found significant differences in the disease.
Some of these patients have primary progressive MS, which is characterized by a nearly continuous worsening of the disease, with no relapses or remissions.
Secondary progressive MS describes a pattern of the illness that begins with flare-ups and remissions, then progresses to a period when symptoms steadily worsen. About half of people first diagnosed with relapsing-remitting MS develop this type of disease within 10 years of their first diagnosis.
Progressive-relapsing MS describes a group of patients who have regular flare-ups, with or without periods of remission, and whose disease steadily worsens from the time of diagnosis.
Why bee venom might be effective in helping to treat multiple sclerosis is not well understood. "There are an enormous number of molecules in bee venom," said Fred Lublin, professor of neurology at the Allegheny University of the Health Sciences in Philadelphia and principal investigator of a study in which mice that develop a multiple-sclerosis-like illness are treated with bee venom.
Some of the ingredients in bee venom "are potentially very interesting, in terms of their ability to alter the immune system or to alter the ability of nerves to conduct impulses," Dr. Lublin said.
But researchers also caution that the treatment can be very tricky to use. "Allergy is certainly a major issue," Dr. Lublin said. "But there are some components in bee venom that could be potentially deleterious for nervous system function and integrity, precisely what you don't want to take if you have MS."