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Clinical Trials

Joe Giffels, MAS, has written extensively on the regulation and practice of clinical research and is here to offer information. Here he shares information and advice on what you should know before, and how to decide if you should volunteer to participate in a clinical trial.

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WebMD Health News

Monday, March 10, 2008

Putting Alternative Medicine to the Test
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Alternative, or complementary, medicine encompasses all of the therapeutic and preventive strategies which enjoy a measure of success, despite not having been developed based on solid scientific principles. They include everything from herbal remedies to acupuncture, yoga and mindful thinking. Practitioners and patients alike swear by the effectiveness of particular healing methods, even where there may not be a scientific explanation of how they work or even empirical evidence that they do really work.

That alternative medicine has been taken seriously of late is evidenced by the establishment of one of the newest units of the National Institutes of Health - the National Center for Complementary and Alternative Medicine. The web site http://nccam.nih.gov/ lists a large number of clinical trials in this arena, involving the use of such interesting therapies as magnetic brain stimulation, broccoli sprout tea, moxibustion, polarity therapy, and expressive writing.

Criticism of research on alternative medicine arises on occasion, and when it does, is met with fierce opposition from advocates. The discussion customarily goes something like this:

"Alternative medicine is baloney."

"But many patients feel they've been helped by it."

"The science that is being done to prove whether or not these things work is pretty lame and, where it's been done properly, there's not much evidence of any real clinical effects."

"But many patients feel they've been helped by it."

"Patients aren't helped by the therapy at all - it's just the placebo effect at work."

"But many patients feel they've been helped by it."

I believe rigorously conducted clinical trials can make significant contributions to the conversation about alternative and complementary medicine.

First, clinical research on particular therapy or preventive measures could demonstrate their safety and weed out those that are actually harmful to patients.

Second, clinical research could demonstrate whether or not a particular therapy had a particular effect on patients, irrespective of whether or not the patient felt better. This would provide solid scientific information useful both inside and outside the alternative medicine debate.

Third, clinical research could quantify how much better patients felt as a result of a therapy, or by how much the incidence of a particular condition was lowered in a patient population as a result of a preventive measure.

I'm not sure there needs to be a determination, using clinical trials, of which alternative and complementary approaches should or should not be allowed, except in the case where significant health safety issues are raised. Rather, clinical trials can show whether or not a particular approach can be moved out of the "Alternative" realm and be accepted by the medical establishment and the communities it serves as a scientifically proven approach. And in the meantime, those approaches that have yet to be proven to have a measurable physiological explanation or effect can continue to benefit those patients who believe in them.

-Joe

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Posted by: Joe Giffels_ WebMD at 6:18 PM

4 Comments:

Anonymous Anonymous said...

Question: What percentage of psychotic (eg schizophrenia or bipolar disorder) of patients require three or more antipsychotic drugs simultaneously for treatment.

12:49 PM  
Anonymous Anonymous said...

my spouse started taking niaicin to clean his system out. is this true?

4:31 PM  
Blogger Norman A. Smith said...

Intense persuasion, over expression of PPAR will initiate the adaptive immune system. A chronic immune response maybe interpreted as weak metabolic signaling. The involved dendritic cells, T cells and macrophages have not been provoked beyond tolerance. Using nicotinic acid to over express PPAR will cause unfurling of complement genes. Complete genes expression will improve dendrite cells to form MHC, T cells to increase TNF and macrophage phagocytotis. Improved functions of PPAR will also facilitate the ubiquitin-proteasome system, and other pathways. The enhanced metabolic signals will provoke the adaptive immune system to differentiate lymphocytes to memory T cells and memory B cells. Any chronic infection that has establishes suboptimal activation of dendritic cells, memory B cells and of macrophages can be eradicated once metabolic signals are enhanced.

Achieving full immunity will occur between six to nine months. The ability of pathogens to use camouflage, such as ceramide, will not shield it. The efficacy of nicotinic acid can be impaired by agents (including lysine) that suppress transcription activities. Viral infected subjects must be healthy to endure the six to nine months. Those subjects with genital herpes should expect an outbreak each 28-days cycle for six months. Aspirin may help to limit the pro-inflammatory response. Subjects with drug resistant bacterial infection will be able to continue antibiotic therapy. The timescale for adaptive immunity is typical of a vaccine regiment.

Nicotinic acid (flush-free or slow release) dosage is 1500 to 2000mg, divided doses, per day for six months. The dose is lowered to 1000 to 1500mg, divided doses, per day for the next six to twelve months.


Sincerely,

Norman A. Smith

4:20 PM  
Anonymous Anonymous said...

Has anyone use Dan Active? it is said to help the immune system

10:08 PM  

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