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Bees are creatures that people usually work fairly hard to avoid. Despite their small size, these fuzzy flying insects can cause considerable pain with their stingers—and occasionally severe allergic reactions. But many people with multiple sclerosis (MS) have taken an interest in bee venom, and some even arrange to be stung in an effort to treat their symptoms.
People who practice apitherapy, or the medical use of honeybee products, believe that bee venom can be used to treat MS, as well as arthritis, inflammation from injuries and other conditions. Its popularity has led to the proliferation of journals devoted to bee venom, alternative medicine practioners and beekeepers offering bee venom injections or simply a hive of bees, and companies selling bee venom products. Yet little research has been conducted in the United States, and experts caution that its safety and effectiveness have not been established.
Joseph A. Bellanti, MD, a professor of pediatrics and microbiology-immunology and director of the International Center for Interdisciplinary Studies of Immunology at Georgetown University Medical Center in Washington, DC, has just concluded the first Phase I study of the safety of honey-bee venom extract as a possible treatment for patients with progressive forms of multiple sclerosis. Below, Dr. Bellanti discusses the future of bee venom therapy for this debilitating autoimmune disorder.
Do you know where the idea of using bee venom as a therapy came from?
The use of bee venom goes back to antiquity, to the time of the ancient Greeks. And bee venom has been advocated not only for multiple sclerosis but also for rheumatoid arthritis. There may be some products of the immune system that are produced by the stinging insect or by the injection of these venoms that ameliorates these diseases. It's all anecdotal, and it's never been studied critically. I think ours is the only study that attempted to use the scientific method to critically examine the question.
Why you did you decide to study bee venom extract in people with MS?
There have been a lot of anecdotal reports suggesting that bee venom may be an effective treatment for multiple sclerosis. So there's been a lot of media exposure and a large underground movement of patients who go to zealous lay practitioners who subject multiple sclerosis patients to multiple and repeated bee stings. Since we felt that this practice entailed a real risk of possible allergic reactions, some of which could be fatal, as well as the emotional and economic burdens of chasing false hopes, we felt properly conducted studies of safety and efficacy were needed.
What did your study involve?
With funding from the Multiple Sclerosis Association of America (MSAA) and the collaboration of my Georgetown colleagues, neurologist Dr. John Richert, and my fellows, we treated a group of patients with multiple sclerosis with a commercially available and prepared extract that had a definable concentration of bee venom. We could then do a very carefully controlled dose-related response study, starting with very small doses and gradually increasing. Our main concern, of course, was to maintain safety.
One of the entry criteria was that the diagnosis be primary or secondary progressive multiple sclerosis. There are various types of multiple sclerosis, some of which occur in peaks and waves, and others that have a steadier progressive course. The reason that we chose the stable progressive patients was to try to eliminate the variations in disease expression that could be unrelated to the treatment. Another requirement was that they not be receiving any other immunomodulatory treatment such as steroids or interferon.
The patients were given a diary card to record any symptoms experienced, the dates of the onset of these symptoms and any other pertinent information. We also performed blood counts, urinalyses and chemical tests, to make sure that there were no adverse effects that were resulting from the treatment.
We ended the study with nine patients, among whom the mean age was about 45 years of age and the mean duration of the disease was about 14 years. It was a safety study, primarily, and our one-year results indicated that there were no serious adverse effects observed during the study. There were some minor localized reactions because the injections were given at multiple injection sites twice a week.
Four patients had to drop out of the study because of exacerbations of their disease or because of possible progression of the disease. We didn't think that this was related to the bee venom but, to be on the safe side, we discontinued their treatment at the first sign of neurological worsening. Three of the remaining five improved, which would be 60 percent, but the numbers are too small to draw any definitive conclusions about whether this is an effective treatment. We certainly would not recommend this as a form of treatment yet, but it's an encouraging study and it opens up the possibility for some additional studies that could be performed at multiple centers.
What symptoms were relieved?
Many of them had pain and stiffness or tingling or weakness of their extremities. The participants who improved felt that this form of treatment increased strength or decreased pain. One woman thought that there was improvement in pain and swelling of her joints and in her muscles around her joints. We, however, could not objectively quantify improvements in symptoms such as pain and tingling.
How might bee venom improve MS symptoms?
We really don't know. We think that the pathogenesis of multiple sclerosis is related to the demyelinization of the coverings of the nerves. If you view a nerve as an electrical cord that conducts an electrical current, the myelin is the insulation. In this disease, there is a stripping away of the covering of the electrical wire so that the current that's passed in the nerve is short-circuited and that contributes to the symptoms of the disease.
Why this happens we're not entirely sure, but it appears to be related to a viral infection, and in a genetically susceptible host, his or her immune response is being directed against their own tissues; in this case, against the nerves. If this treatment works, it is somehow preventing that attack. One of the proteins in bee venom has been shown to increase nerve conduction velocity, and this could be how it works.
Why is it dangerous to receive bee venom therapy outside of a controlled study?
We would not advocate the use of whole bee venom of stinging insects. I think the dosing is very erratic and potentially dangerous. When you're giving this material through stinging insects, you don't know how much venom is being administered. We knew exactly how much we were giving.
But even with this type of study, there is a potential danger whenever you administer a protein such as venom extract to a patient. Allergists treat patients with allergic disease with extracts all the time. They safeguard against any adverse reactions by using very small doses and then gradually increasing them and watching the patient very carefully after every injection for a period of about 20 or 30 minutes. The one danger that we worry about most is an allergic reaction called anaphylaxis, in which there is a swelling of the tissues. Swelling could lead to low blood pressure, respiratory failure and shock . Fortunately, we didn't encounter this, but there is that potential danger.
What is your advice to people with MS who are interested in bee venom therapy?
I would encourage them to be followed by their physician or their neurologist and use the appropriate standard treatments, which are basically interferon and other preparations that influence the immune system, such as steroids and immunosuppressive drugs. I would not recommend this form of therapy until we accumulate more data.
Our hope is that we can continue to do research at academic centers exploring these new techniques and new procedures. But these studies should be done, as best we can, using the scientific method of carefully conducting careful research, where we can draw proper conclusions.
In a new study of patients diagnosed with multiple sclerosis (MS) after the age of 60, nearly half of relapsing patients with relapsing-remitting multiple sclerosis (RRMS) and patients with clinically isolated syndrome presented with signs of inflammation on magnetic resonance imaging (MRI).
This finding suggests that the disease course depends on the inflammatory component of MS and not just age, said researchers who presented the findings here on September 29th at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
"We have found that persons over 60 can have active relapses, emergence of new lesions and signs of inflammation just like people in their 20's," said lead investigator Robert Bermel, MD, fellow, Cleveland Clinic, Cleveland, Ohio. "So these older patients are potentially candidates for treatment. But clinicians have been hesitant to make the diagnosis in older people."
In this retrospective chart analysis study, the researchers identified patients who had been diagnosed with MS at or after age 60 and evaluated at a tertiary referral center over the last 5 years. The investigators reviewed each patient's chart to confirm the diagnosis and to identify clinical, laboratory, and imaging characteristics of each subject.
The researchers identified 111 cases, with a mean age at diagnosis of 64 years (range 60-76; 15 were over 70 years), a mean duration of symptoms prior to diagnosis of 9.8 years (age at symptom onset 8-71; 47 developed initial symptoms at or over 60 years). Women made up 67% of the cohort and 90% of patients were Caucasian.
Subjects presented a variety of forms of the disease: relapsing remitting (n = 37), primary progressive (n = 35), secondary progressive (n = 26), clinically isolated syndrome (n = 9), and progressive relapsing (n = 4).
Two patients with relapsing-remitting MS showed biopsy-verified MS. In those cases where an MS specialist reviewed the patient's scan, 86% of brain MRIs showed changes typical of MS, as did 80% of spine MRIs. In those cases when gadolinium was administered, 46% of subjects with relapsing-remitting MS or clinically isolated syndrome demonstrated gadolinium enhancement, and 75% of all subjects showed oligoclonal bands or elevated immunoglobulin G index.
At diagnosis, 39% of subjects were mildly disabled, as demonstrated by an Expanded Disability Status Scale (EDSS) score less than or equal to 3), and 34% needed a walking device or were non-ambulatory (EDSSgreater than or equal to 6.0).
"MS in older adults may be under-recognized and accurate diagnosis is often delayed by many years," the authors concluded in their abstract. "Some patients have symptom onset at more typical ages, but a sizable proportion have onset after age 60."
"Nearly half of relapsing patients (RRMS and CIS) presented with inflammation on MRI, which suggests that the disease course is dependent upon the inflammatory component of MS and not just age," they wrote.
"We now believe now that age should not bear upon diagnosis," Dr. Bermel added.
