Some cures that weren't.
This is not a new problem in MS. Exploring three older "cures that weren't" might be helpful for people who are on this difficult path today.
Hyperbaric oxygen treatment, also known as HBO, involves having a person breathe oxygen while sitting in a specially designed, high-pressure chamber. There is FDA approval of this therapy for a limited number of medical conditions such as decompression sickness ("the bends" that affects deepsea divers) and severe burns and infections. With little or no supportive evidence, HBO has also been claimed to be effective for a wide array of other medical conditions, including MS.
In the late 1970s and early 1980s, studies in the animal model of MS and limited studies in people with MS indicated that HBO might be an effective MS therapy. The most notable of these was a small clinical trial reported in 1983 in the New England Journal of Medicine. This study showed improvement with HBO in 12 out of 17 people with MS.
But these positive results were never repeated. Instead, many additional trials of HBO in people with MS produced disappointing results. No consistent therapeutic effects were seen. Ultimately, three independent reviews of HBO and MS studies concluded that HBO therapy does not produce consistent beneficial effects and should not be used to treat MS. In fact, the reviews concluded that HBO did not merit more investigation in MS.
HBO is usually well tolerated. It is associated rarely with side effects including visual changes, seizures, pressure injury to the ears, cataracts and collapsed lungs. For everyone, it is time-consuming and expensive--a course of treatment could involve up to 20 HBO sessions and cost several thousand dollars.
Despite the negative study findings and the reviews, and despite a warning letter from the FDA to at least one commercial center promoting unproven uses, one can still find HBO being advertised as a therapy for MS.
Bee venom therapy
Bee venom therapy--or BVT-has also been claimed to be effective for many medical conditions. BVT is given by placing bees on specific body parts with tweezers and allowing the bees to sting.
This therapy was proposed as an arthritis treatment in the early 1900s. It was later claimed--without any supportive evidence--that the antiinflammatory response mounted by the body to bee stings would relieve other types of inflammation, such as that which occurs with MS.
BVT is actually well tolerated, in general. Swelling and redness at the sting sites are common, and stings may cause itching, hives, fatigue and anxiety. Very rarely, BVT can spark potentially fatal allergic reactions. For decades, there were no formal studies of the safety or effectiveness of BVT in MS. But starting in the late 1990s, several investigations were conducted. Small studies in an animal model of MS indicated that BVT might actually worsen the condition. In the highest quality clinical trial conducted to date, investigators in the Netherlands evaluated BVT over a whole year in 26 people with MS. This study, published in Neurology in 2005, found that BVT did not have a beneficial effect on frequency of MS attacks, progression of disability, disease activity as seen on MRI scans, fatigue, or overall quality of life. Although this was a small study and thus lacked the power to be considered absolutely definitive, the results were so consistently negative on so many different measures that it seems unlikely larger studies would produce significant positive findings.
In spite of this negative data, one can still find BVT being advocated for use in MS, but as with HBO, its popularity appears to have waned.
Pemoline, known by its trade name, Cylert, is a prescription medication that was once used for MS-related fatigue. Pemoline was first approved by the FDA in 1975 primarily for attention-deficit hyperactivity disorder (ADHD) and excessive sleepiness (narcolepsy). As with Provigil, a more recent drug for narcolepsy, it quickly drew the attention of MS clinicians eager to try anything with an acceptable safety profile that might relieve this difficult symptom.
In the 1990s, some studies suggested that pemoline might improve MS fatigue, but the studies were not particularly convincing. A relatively small 1992 clinical trial showed a trend for beneficial effects on MS fatigue, but the findings were not quite statistically significant. (For those who know statistics, the "p value"--which should be 0.05 or less--was 0.06.) Then another clinical trial, reported in 1996, found that pemoline was no better than an inert placebo for MS fatigue.
There was worse to come. Between the 1970s and the 1990s, it was believed that pemoline was generally well tolerated. However, there were intermittent reports of liver toxicity in children, some of which were fatal or required liver transplantation. In 2005, the FDA concluded that the medications risks exceeded its benefits for any condition and pemoline was withdrawn from the U.S. market.
The long delay in addressing pemoline safety issues helped point out some deficiencies in the FDA's safety monitoring practices. Since that time, there have been significant improvements in drug safety monitoring.
I think these examples highlight several important points:
* Promising results in animal studies or small human studies are not definitive. They should be viewed as preliminary and used to guide further research directions, but not to support widespread use of a therapy.
* Commercial interests may lead to inaccuracies, distortions, and other types of unfair reporting of scientific and clinical evidence. This can be true regardless of the size of the commercial firm. Always look for evidence-based information from a source that is not commercially involved. Examples include the FDA, the NIH, the National MS Society and references these agencies offer. (My book is one of them.)
* Over time, there may be significant changes in scientific understanding of the relative risks and benefits of a therapy. Try to obtain the most recent information.
* Reach out for support. The failure of a current therapy is a crisis, a blow to hope. Individuals and their family members may need the help of others to move forward again.
* First and last, talk with your healthcare provider, who knows your MS history--and call the National MS Society if you and your provider have communication problems.
Dr. Allen Bowling is the medical director of the Multiple Sclerosis Service and director of the Complementary and Alternative Medicine Service at the Colorado Neurological Institute. He is also clinical associate professor of Neurology at the University of Colorado. Additional information about unconventional medicine (CAM) may be found in his book, Complementary and Alternative Medicine and Multiple Sclerosis (2nd edition, Demos Medical Publishing), and on his website, NeurologyCare.net/cam.
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|Title Annotation:||multiple sclerosis treatments; CAM|
|Author:||Bowling, Allen C.|
|Date:||Sep 22, 2011|
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