Jan 16, 2010

The Clinical Evidence for Homeopathy

The Clinical Evidence for Homeopathy

Before discussing the recent well-controlled and double-blind clinical trials, it is important to make reference to homeopathy’s history in order to provide additional evidence for the clinical efficacy of homeopathic nanopharmacology.
Homeopathy first developed a significant popularity in Europe and the United States primarily because of the astounding successes it experienced in treating people suffering from the various infectious disease epidemics in the 19 th century. The death rates in the homeopathic hospitals from cholera, scarlet fever, typhoid, yellow fever, pneumonia, and others was typically one-half to even one-eighth of conventional medical hospitals (Bradford, 1900; Coulter, 1973). Similar good results were also observed in mental institutions and prisons under the care of homeopathic physicians compared to those under the care of conventional doctors. These consistent and significant results could not be attributed to a placebo effect. In other words, there is clear empirical evidence that homeopathic medicines were highly effective in treating various infectious diseases and in psychiatric disorders.

Unfortunately, conventional physicians and scientists have continually provided misinformation about the status of scientific evidence about homeopathic medicine. They have frequently and incorrectly asserted that there is no research to prove that homeopathic medicines work, and they further have asserted that there is no way that the extremely small doses can have any effect whatsoever.
This type of statement simply reflects ignorance of the scientific literature. It is remarkable to note that some of the earliest placebo-controlled and double-blinded studies ever performed were actually conducted by homeopathic physicians. For a detailed history of the 19 th century and early 20 th century studies, see The Trials of Homeopathy by Dr. Michael Emmans Dean. For those people who want an excellent summary of this history, it is a part of a special e-book, Homeopathic Family Medicine (anyone interested in a comprehensive, historical, and up-to-date review of clinical research testing homeopathic medicines would benefit from obtaining and subscribing to this e-book). Another source of modern basic science and clinical research on homeopathic medicine is the Samueli Institute.
A short summary of some of the modern placebo-controlled and double-blind studies is reported below.
An independent group of physicians and scientists evaluated homeopathic clinical research prior to October, 1995 (Linde, 1997). They reviewed 186 studies, 89 of which met their pre-defined criteria for their meta-analysis. They found that on average patients given a homeopathic medicine were 2.45 times more likely to have experienced a clinically beneficial effect. When reviewing only the highest quality studies and when adjusting for publication bias, the researchers found that subjects given a homeopathic medicine were still 1.86 times more likely to experience improved health as compared with those given a placebo. The researchers have also noted that it is extremely common in conventional medical research for more rigorous trials to yield less positive results than less rigorous trials.
The most important question that good scientists pose about any clinical research is: have there been replications of clinical studies by independent researchers? When at least three independent researchers verify the efficacy of a treatment, it is considered to be a valid and effective treatment.
Four separate bodies of researchers have conducted clinical trials in the use of a homeopathic medicine (Oscillococcinum 200C) in the treatment of influenza-like syndromes (Ferley, 1989; Casanova, 1992; Papp, 1998). Each of these trials was relatively large in the number of subjects (487, 300, 100, and 372), and all were multi-centered placebo-controlled and double-blinded (two of the three trials were also randomized). Each of these trials showed statistically significant results.  Even the highly respected Cochrane Collaboration acknowledged that these results were "promising" (Vickers, 2007).
One other body of research in the use of Galphimia glauca in the treatment of hay fever was replicated successfully seven times, but this research was conducted by the same group of researchers (Wiesenauer, Ludtke, 1996), and thus far, this work has not been conducted by any other researchers.
A body of clinical research in homeopathy that has been consistently recognized as some of the highest quality scientific research has been conducted by a group of researchers at the University of Glasgow and Glasgow Homeopathic Hospital. They conducted four studies on people suffering from various respiratory allergies (hay fever, asthma, and perennial allergic rhinitis) (Taylor, Reilly, Llewellyn-Jones, et al, 2000). In total, they treated 253 patients and found a 28% improvement in visual analogue scores in those given a homeopathic medicine, as compared with a 3% improvement in patients given a placebo (P=.0007)(The “P” refers to the “probability” of these results occurring simply by chance, and thus, the lower the number, the greater the likelihood that the treatment used is effective. When “P” equals .05, this means that there are 5 chances out of 100 that the effective of a specific treatment happened by chance, and scientists today consider this 5% chance as adequate evidence of a treatment’s effectiveness. In this study, however, there was an extremely high likelihood that the treatment was effective because there were only seven chances out of 10,000 (!) that this result happened by chance.)
In the hay fever study, homeopathic doses of various hayfever-inducing flowers were prescribed, and in the other studies, the researchers conducted conventional allergy testing to assess to which substance each person was most allergic. The researchers then prescribed the 30C (100 -30) of this allergic substance (House dust mite 30C was the most commonly prescribed homeopathic medicine).
The researchers called this type of prescribing “homeopathic immunotherapy,” and they concluded from their research that either homeopathic medicines work or controlled clinical trials do not.
One of the most impressive studies ever conducted testing homeopathic medicines was in the treatment of people with chronic obstructive pulmonary disease (COPD).  COPD is a general term for a group of respiratory ailments and is the fourth leading cause of death in the U.S.  Chronic bronchitis and emphysema are two conditions that are included in the more broad diagnosis of COPD.
At the University of Vienna Hospital a prospective, randomized, double-blind, placebo-controlled study with parallel assignment was performed to assess the influence of sublingually administered Kali bichromicum (potassium dichromate) 30C on the amount of tenacious, stringy tracheal secretions in critically ill patients with a history of tobacco use and COPD  (Frass, Dielacher, Linkesch, et al, 2005).  The amount of tracheal secretions was reduced significantly in patients given the homeopathic medicine (p < 0.0001).  Extubation (the removal of obstructive mucus from the lung with a tube) could be performed significantly earlier in group 1 (p < 0.0001). Similarly, length of stay was significantly shorter in group 1 (4.20 +/- 1.61 days vs 7.68 +/- 3.60 days, p < 0.0001 [mean +/- SD]).  This data suggest that potentized (diluted and vigorously shaken) Kali bichromicum may help to decrease the amount of stringy tracheal secretions in COPD patients. 
Three studies of children with diarrhea were also conducted and published in peer-review scientific journals (Jacobs, Jonas, Jimenez-Perez, Crothers, 2003). A meta-analysis of the 242 children who were involved in these three studies showed that the children who were prescribed a homeopathic medicine experienced a highly significant reduction in the duration of diarrhea, as compared with the children who were given a placebo (P=0.008). The World Health Organization has deemed that childhood diarrhea is the most serious public health problem today because several million children die each year as a result of dehydration from diarrhea. The fact that homeopathy is not included in the standard of care for diarrhea in children could be considered malpractice.
One other study is worth mentioning. This study was on 53 patients with fibromyalgia, which is a newly recognized syndrome that includes musculoskeletal symptoms, fatigue, and insomnia (Bell, Lewis, Brooks, et al, 2004) . Participants given individually chosen homeopathic treatment showed significantly greater improvements in tender point count and tender point pain, quality of life, global health and a trend toward less depression compared with those on placebo. “Helpfulness from treatment” in homeopathic patients as compared to those given a placebo was very significant (P=.004). What is also extremely interesting about this study was that the researchers found that people on homeopathic treatment also experienced changes in EEG readings. Not only did subjects who were given a homeopathic medicine experience improved health, they were shown to experience different changes in the brain wave activity. This evidence of clinical benefits and objective physiological action from homeopathic medicines in people with chronic symptoms constitutes very strong evidence that these nanodoses can have observable effects.
The above body of evidence should be adequate for verifying that homeopathic medicines can have therapeutic benefits, but there is even evidence that these nanodoses can have significant biological activity. One important study was led by a professor of chemistry who was formerly a skeptic of homeopathy (Dr. Madeleine Ennis) but who now recognizes that these medicines have significant effects (Belon, Cumps, Ennis, et al., 2004). Four independent laboratories, each associated with a university, conducted a series of 3,674 experiments using dilutions of histamine beyond Avogadro's number, by which we mean the dose in which there should be in all probability no remaining molecules of the original substance remaining (the 15th through 19th centesimal dilution, that is 100 -15 to 100 –19). The researchers found inhibitory effects of histamine dilutions on a type of white blood cell called basophils. The overall effects were substantially significant (p<0.0001). The test solutions were made in independent laboratories, the participants were blinded to the content of the test solutions, and the data analysis was performed by a biostatistician who was not involved in any other part of the trial.
It should be mentioned and even highlighted that the BBC (British Broadcasting Corporation) has a science show called "Horizon" which conducted a "test" of homeopathy in 2002.  They claimed on air that they were "repeating" Professor Ennis' experiment.  However, this television experiment did not get the same results as Ennis' or the other three university laboratories.  This "reality TV science" experiment created a tremendous amount of media and suggested that homeopathy didn't work afterall. 
In 2004, American television's 20/20 program also sought to repeat Ennis' experiment.  However, just before the experiment started, the experimenter sent me (Dana Ullman) a copy of his protocol, and I sent it to Professor Ennis.  She was shocked to discover that there were several significant differences in this experiment, all of which led to the negative result.  For details about these differences, see Professor Ennis's email as well as other evidence of the serious problems with this television experiment.
Despite knowing prior to the experiment that they were conducting a flawed study and one that was not a "repeat" of any other research that had ever been performed, the 20/20 producer still filmed the study as though it was valid.  The narrator of the program noted that "Dana Ullman questioned the design of the study," though they quickly asserted that "their" experts confirmed that the study was well-designed and properly conducted, even though they conducted the wrong experiment. 
The website of the New Scientist, one of the world’s most respected popular science magazines, includes articles it has published on homeopathy, with numerous positive studies and comments from world renowned physicists, chemists, physicians, biologists, and other scientists.
For example, Nobel Laureate and physicist Brian D. Josephson (1997) of the University of Cambridge wrote to the New Scientist :
“Simple-minded analysis may suggest that water, being a fluid, cannot have a structure of the kind that such a picture would demand. But cases such as that of liquid crystals, which while flowing like an ordinary fluid can maintain an ordered structure over macroscopic distances, show the limitations of such ways of thinking. There have not, to the best of my knowledge, been any refutations of homeopathy that remain valid after this particular point is taken into account. A related topic is the phenomenon, claimed by Yolene Thomas and by others to be well established experimentally, known as the ‘memory of water’. If valid, this would be of greater significance than homeopathy itself, and it attests to the limited vision of the modern scientific community that, far from hastening to test such claims, the only response has been to dismiss them out of hand.”

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