BVT for MS – the sham was a shame

DR. WEEKS’  COMMENT:   Shame on those “scientists” who forsake the essence of science “methodology” and focus of financial results.  Bee venom therapy for the treatment of MS is decades old in America and boasts impressive results and hoards of grateful patients. But when the scientists studied the treatment, they either didn’t bother to honor the methodology or they were less well intended. At any rate the published results is that BVT is not effective yet the scientists didn’t test it honorably.

AAS’s response to the recent article on MS in “Neurology”

A few months ago the Journal “Neurology” published an article with the title “A[.] Study of Bee Sting Therapy for Multiple Sclerosis,” written by a team of neurologists. Their idea was to examine how well bee sting therapy works for MS.

They used 25 volunteers, divided into two groups of 12 and 13. In order to assess the activity of the disease, that is, the state of health of their subjects, the doctors used MRI’s on all subjects for examination of brain lesions. They also administered questionnaires to all subjects, aimed at measuring symptoms, for instance, fatigue.

In the first half of the study one group received bee sting treatment, while the other was just observed and assessed.

Their protocol for this first group consisted of stinging patients three times a week with up to twenty stings each session, applied exclusively on the thighs. This protocol lasted twenty-four weeks. This group then received no treatment for the next twenty-four weeks, but their observation and assessment continued.

In the second half of the study, the second group, who had only been observed and assessed for twenty-four weeks, now received the same protocol of bee stings.

This work led the neurologists to the following conclusion:

“.we found that the sting therapy had no significant effect on disease activity as measured using..” the MRI.

We apitherapists and health care providers have serious reservations about this team’s design, the execution, and their conclusion.

Now, let me present some commentary about the response we sent to the Journal “Neurology,” the text of which follows this introduction.

Our first reservation regards their technique. They followed an approach of stinging exclusively on the thighs; this approach corresponds to nothing that experienced apitherapists do.

Our second reservation concerns the team’s assessment of disease activity and the markers of disease they used: brain lesions as seen on an MRI. The patients in the second group (who had no treatment in the initial twenty-four weeks) developed four times as many lesions as they had developed in the preceding eight to nine years of their illness. We question, therefore, the relevance of the markers chosen.

Our last major concern addresses their statistics. Statistics are ways to evaluate the meaning of measurements. The results the team obtained had such a wide range of values that their
statistics did not show significant differences between the
beginning and ending measurements.  This, however, may have been due to the type of statistical analysis that was done.

We are pleased that neurologists studied this interesting issue. We regret that their work was not better designed. They could have had a positive contribution to this field.

Th. Cherbuliez, MD

February 16, 2006

We read with interest and anticipation the article “A Randomized Crossover Study of Bee Sting Therapy for Multiple Sclerosis” by T. Wesselius and colleagues published in NEUROLOGY, of the American Academy of Neurology, 2005; 65;1764-1768.

This paper describes the work of a team of Dutch neurologists who gave bee stings to two groups of MS patients for 48 weeks. One group was observed for 24 weeks without any treatment and the other received bee stings. Then for the next 24 weeks the groups were reversed, and those patients who had received no treatment got bee stings, and the previously treated group was then just observed without any further therapy.

There are several troubling aspects to this paper.

•  The authors state: ” Our aim was to evaluate bee sting therapy as it is commonly being practiced by apitherapists.” However, no knowledgeable apitherapist would ever use the technique they employed which consisted of stinging exclusively on the thighs to treat MS. Even beginning apitherapists know that it is necessary to sting patients in the area of the pain or problem. Thus, in MS patients treatment always starts with stings over the spine. They apparently did not consult any experts in Apitherapy as to “standard” practices in treating MS.

Thus, the authors have attempted to investigate a treatment technique, ignoring basic established principles and protocols.

•  The number of brain lesions seen on MRI scans was used as a marker of the severity of the patient’s disease. According to Table 1 the patients in the “no treatment first” group had been ill for an average of about 9 years and had on average 1.7 brain lesions each at the start of the study. Table 2 reveals that after six months of just observation these patients had added more than four times (7.1) as many lesions as they had developed in the preceding 8+ years of their illness! The authors fail to explain or address this dramatic increase in lesions associated with just observation and it throws into question the validity of their measurement technique. In addition, since there was reportedly no change in the effect of bee sting therapy on relapses, disability, fatigue or health-related quality of life what is the relevance of this marker?

•  The statistical analysis of the results data, as presented here, has serious shortcomings. The standard deviation of the mean number of “new enhancing lesions” as seen in almost all the results reported Table 2 is very large compared to the mean values themselves. Whenever the standard deviation in larger than the mean, the distribution is skewed caused either by outliers or because of the “natural process”. This variance was not examined statistically, nor was there an attempt to adjust for a badly skewed distribution. In addition, p-values are suspect when applied to badly skewed distributions so the conclusion that there was no significant difference in the number of enhancing lesions during treatment or with no treatment is brought into question.

Despite the problems with the methodology and analysis of this study the authors have shed some light on two issues regarding bee sting therapy.

1) They have shown that when appropriate precautions are taken bee sting therapy is safe and well tolerated. This adds further to the evidence of the safety of bee sting therapy dating back more than 25 centuries to before Hippocrates who also employed bee sting therapy.

2) The researchers’ technique of stinging only the thighs of patients with MS presupposes that bee venom works through some type of systemic mechanism. What they have shown in this study is that bee venom has minimal if any effect on MS by a systemic mechanism. However, due to their use of a unique, non-standard technique they leave open the possibility that bee sting therapy may work through a more local or neurologically segmental mechanism.

We were excited that a major respected mainstream medical journal would be open to publishing research about an alternative medical technique which has been used for thousands of years for treatment of a wide variety of diseases. Unfortunately, the research presented in this article has major flaws in its methods and in its interpretation of the data. These flaws render their conclusions from this study of limited usefulness in resolving the question of the effectiveness of bee sting therapy in MS. The authors’ last statement is, “Patients with MS should be advised to refrain from bee venom therapy unless better evidence to justify its use becomes available.” We, however, will continue to support the use of bee sting therapy to help lessen the symptoms of MS based on our multiple personal and admittedly anecdotal observations of its effectiveness.

Written by Theodore Cherbuliez, M.D President of the Apitherapy Commission of Apimondia, Andrew Kochan, M.D., President of the American Apitherapy Society and Prof Roch Domerego, President of the European Apitherapy Association, with contributions from Glenn Perry and Jim Higgins, members of the Board of the American Apitherapy Society; and Prof. Ahmed Hegazy and Igor Krivopalov-Moscvin, members of the Apitherapy Commission of Apimondia.

CITATION
A randomized crossover study of bee sting therapy for multiple sclerosis Wesselius et al. Neurology.2005; 65: 1764-1768.

This abstract is available on PubMed:
1: Neurology. 2005 Dec 13;65(11):1764-8. Epub 2005 Oct 12. Related Articles, Links

Authors are: Wesselius T, Heersema DJ, Mostert JP, Heerings M,
Admiraal-Behloul F,
Talebian A, van Buchem MA, De Keyser J.

Department of Neurology, University Medical Center Groningen, Groningen, The Netherlands.

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