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No Beneficial Effect of Bee Venom in Study Using Animal Model for MS

Medical Update Memo
June 2, 1998

Summary
The first results of a small controlled study into the use of honey bee venom as a possible therapy for MS have found no beneficial effects on mice with EAE, the animal model for MS. Researchers from Allegheny University of the Health Sciences in Philadelphia reported results at the American Academy of Neurology meeting on April 30, 1998. The investigators found that honey bee venom had no beneficial effect against the course of EAE, and some of the mice treated with bee venom developed a worse course of the disease compared to those that received placebo. A small pilot study of the effect of bee venom therapy on people with MS is scheduled to begin this spring and last for 12 months. The study at Georgetown Medical Center, Washington, D.C., is primarily gauging safety and tolerance of the therapy. Bee venom is not being compared against placebo in this particulary study.

Background
The following information is from the National Multiple Sclerosis Society (USA), the primary funder of the study at Allegheny University:

"For several decades, there have been unsubstantiated claims about the possible benefits of bee stings and bee venom for the treatment of multiple sclerosis and other diseases. There has never been a controlled clinical trial of bee venom in any disease. To begin the scientific evaluation of honey bee venom, the National Multiple Sclerosis Society gave a pilot research grant to Fred D. Lublin, M.D., and colleagues at Allegheny University of the Health Sciences in Philadelphia. This grant was supplemented by one from Vespa Laboratories. These investigators have been conducting experiments with injections of whole, raw honey bee venom

into laboratory mice with the MS-like disease EAE (experimental allergic encephalomyelitis). Dr. Lublin reported results from the initial phase of this ongoing investigation at the American Academy of Neurology meeting in Minneapolis on April 30, 1998 (Neurology 1998; 50:A424).

"In a series of small experiments, EAE was induced in the mice, and then various doses of whole, raw honey bee venom or saline solution (placebo) were injected subcutaneous, three times a week. The injected doses of honey bee venom were approximately equivalent to a range of 4 to 160 bee stings per injection.

"The investigators then tested the mice for severity of symptoms, such as hind limb paralysis. They found no clinical benefit at any dosage level. In addition, some of the mice treated with bee venom experienced a worse course of EAE than those that received inactive placebo, but the numbers of mice in this pilot study were too small to draw definitive conclusions.

"While there were no apparent benefits of whole honey bee venom in these studies, honey bee venom is a mixture of toxins and other biologically active compounds that may be more active individually. The research team is conducting additional studies to determine whether any of these individual compounds may have potential benefit, or demonstrated harm, in the treatment of EAE. The team is particularly interested in exploring the effects of the component 'apamin' which has the potential to affect nerve conduction by blocking potassium channels on nerve fibres. The team is also investigating the effects of whole honey bee venom injections and honey bee venom components on brain and spinal cord inflammation. It is possible that if a potentially beneficial component of honey bee venom is found, a treatment could be developed that maximizes any benefit and minimizes its toxicity.

"Based on his study's suggestion that honey bee venom could potentially worsen the course of MS-like disease in mice, Dr. Lublin concludes that additional safety and efficacy testing should be undertaken before honey bee venom should be used by persons with MS. It is important to note that some individuals are highly allergic to bee stings and bee venom. This allergic reaction can develop suddenly and can have significant and even life-threatening side effects, including anaphylactic shock."

A small study looking at the safety and tolerance of bee venom therapy by people with MS is scheduled to begin this spring and last for 12 months. Under the direction of Joseph Bellanti, M.D., Georgetown Medical Center, Washington, D.C., approximately eight people with progressive MS will receive two injections of honey bee venom per week. Participants will be monitored by monthly evaluations. If this Phase I pilot study proves promising, the investigators may move on to a Phase II double blind study, in which bee venom would be tested against placebo. Funding for the Phase I study is from the Multiple Sclerosis Association of America.

Disclaimer
The Multiple Sclerosis Society of Canada is an independent, voluntary health agency and does not approve, endorse or recommend any specific product or therapy but provides information to assist individuals in making their own decisions.

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