Since most of the tinnitus treatments are homeopathic remedies, this week’s Hearing International investigates if Homeopathic Medicine is really just Quackery or has actually received a scientific “bum wrap” from the traditional medical community.  Homeopaths feel that new techniques are surfacing that prove homeopathic medicine actually works—-one of these new proving techniques are brain scans that observe various brain and nerve centers in patients as patients receive homeopathic remedies. Although presented in much of the information on homeopathy, there is no real documented research that demonstrates these brain images, and traditional medicine seems to dismiss these studies as pure mysticism.   If homeopathic remedies are effective, there must be a mechanism by which they work.  It IS, however,  a fact that the mechanism for the action by which these remedies might work has not been scientifically established.  If the remedies do work, they must do so in a manner which would appear to violate established principles of physics, chemistry and pharmacology or they must work in a manner which is yet to be discovered. As one early critic of homeopathy wrote, “Either Hahnemann is right, in which case our science and the basis of our thinking is nonsense, or he is wrong, in which case this teaching [Homeopathy] is nonsense.  Recall from the parts I & II of this series that the basis of Homeopathic Medication is to introduce a minimal amount of a substance usually greatly diluted in lactose, alcohol, water, or another substance and its use is supposed to causes the individual to become immune to what ever the disorder.  These homeopathic remedies are formulated according to a number of what may be loosely call “laws.” Last week in Part II we discussed the first of these  laws  which states that “like cures like” or an agent that causes certain symptoms in a healthy person will cure anybody suffering from those same symptoms. The theory behind why the law works seems more like magic than treatment, but the basic idea is also central to mainstream medicine in that most vaccines consist of at least part of the strain they are meant to vaccinate against.  Homeopathy also shares with traditional medicine the strict attention to how these various treatments are dosed. All homeopathic remedies are available in a huge range of concentrations but the big difference is that homeopathic concentrations are really small. In homeopathy, less is more, so homeopaths think of a large dose as a high dilution, instead of a high concentration.  As dosage goes, traditional medications tend to be high doses, while homeopathic doses are extremely small. The question begs….JUST HOW SMALL ARE THOSE DOSES?   Typically, homeopathic remedies are diluted by either a factor of 10 or 100.  In the 80s, Ramey et al described these dilutions in the Journal of the Franklin Institute as “D” Dilutions being prepared by serial dilutions of 1:10; “C” dilutions are prepared by serial dilutions of 1:100. Thus, a remedy marked C30 would imply a 1:100 dilution performed 30 times.  By simple mathematics, it can be calculated that at dilutions of C12 (1:100 diulution done 12 times) or D24 (1:10 dilution conducted 24 times) or greater, it is not likely that the remedies contain even a single molecule of the original substance.  Since the original substance is not present in extremely dilute homeopathic remedies, explanations for a mechanism of action of homeopathic medications have moved towards speculation. Such proposals include the formation of stable ice crystals, magnetic properties of water or the formation of protein shells in the water mixture.11 Water molecules are highly polarized, a fact that already accounts for much of the special role of water in biology. However, the likelihood that water can maintain a complex ice-like structure under the vigorous shaking that usually accompanies homeopathic preparation has not been demonstrated. Neither has any physical mechanism by which such hypothetical structures can produce the implied biological effects.

Click on the Science TV picture for a video that discusses just how homeopathic doses are prepared and their strength.  Basically these doses are extremely small and when applied to the rigerous double blind drug testing techniques, they offer no more than a placebo effect.  In other words, the group is diveded into two and one gets the homeopathic preparation and the other gest sugar pills, both groups doi the same, get no benefit.  The recipes for these preparations are contained in the Homeopathic Pharmacopoedia, a publication that began in the 19th century and has many additions and supplements.  There is even a web site that supports homeopathic medicine titled the Homeopathic Pharmacopoeduia Convention of the United States.

What Does the FDA Think?

In the US agency that oversees drugs and medical treatments is the US Food and Drug Administration(FDA).  The FDA has learned of a few reports of illness associated with the use of homeopathic remedies. However, the FDA reviewed these reports and decided that the remedies were not likely to be the cause, because of the high dilutions. Here is some general information that has been reported about risks and side effects in homeopathy:

•  Homeopathic medicines in high dilutions, taken under the supervision of trained professionals, are considered safe and unlikely to cause severe adverse reactions. •Some patients report feeling worse for a brief period of time after starting homeopathic remedies. Homeopaths interpret this as the body temporarily stimulating symptoms while it makes an effort to restore health.
• Liquid homeopathic remedies can contain alcohol and are permitted to have higher levels of alcohol than conventional drugs for adults. This may be of concern to some consumers. However, no adverse effects from the alcohol levels have been reported either to the FDA or in the scientific literature.
• Homeopathic remedies are not known to interfere with conventional drugs; however, if you are considering using homeopathic remedies, you should discuss this with your health care provider. If you have more than one provider, discuss it with each one. As with all medicinal products, a person taking a homeopathic remedy is best advised to:
• Contact his health care provider if his symptoms continue unimproved for more than 5 days
• Keep the remedy out of the reach of children.
• Consult a health care provider before using the product if the user is a woman who is pregnant or nursing a baby.

With that said,the FDA has long had issues with the quality and research into these remedies. In 2012, homeopathic products from A Nelson & Co., a British company that manufactures many products including, Nelson’s line of pain relievers, digestion aids, emotional aids, energy, acne products and Bach Rescue Remedies sold in the US were inspected by the FDA and the conclusions are alarming.  The FDA Warning letter said, “During the inspection, the investigator observed glass fragments present during the manufacture… Your firm failed to implement adequate measures to prevent glass contamination and had no documentation to demonstrate that appropriate line clearance and cleaning is conducted following occurrences of glass breakage, which has been a recurring problem.  So, not only are there some questionable results, but also these “remedies” may be hazardous to your health.

Conclusion?

In 2009 the British Science and Technology Select Committee (BSTSC) conducted a comprehensive study into whether homeopathy has any scientific validity. The report was devastating: homeopathy is not efficacious, and explanations for why homeopathy would work are scientifically implausible.  The BSTSC concluded that there was no REAL evidence these remedies actually cure disease.  To some, “the jury is still out” on homeopathic medicine but Novella , of Science Based Medicine and a number of others side with the BSTSC.  Novella indicates that homeopaths should be careful what they wish for as in the last few decades purveyors of these dubious medical treatments and products have been trying to go mainstream, and they have had some unfortunate success. They asked for serious scientific investigation into their claims and they got it. They asked to be treated like real medicine (but not really, they only want the trappings of legitimacy, not the substance), and when they actually are treated with the standards similar to science-based medicine, they cry foul.  The response of the fake-medicine lobby is not to alter their claims to fit the evidence, or to carry out better studies, or to clean up their act when problems are brought to their attention – but to attack their critics. Homeopathy in his opinion is perhaps the best example of this behavior. Homeopathy’s biggest marketing advantage is that most people don’t know what it really is.  I want people to know exactly what homeopathy is – sugar pills. They are placebos on which the equivalent of a magical ritual has been cast. Active ingredients, which themselves are as fanciful as fairy dust, are diluted into non-existence.

These charges notwithstanding, next week Hearing International will investigate these treatments for Tinnitus Treatment.