DO HOMEOPATHY TRIALS SHOW LESS POSITIVE RESULTS AS PROTCOLS TIGHTEN?

Finally someone from the camp of the opposition has posted something that is worthy of discussion . . Here is a comment from “ISayISaw” . .

ISayISaw submitted the following response on 2010/12/01 at 1:08 pm | In reply to Nigel.

“It’s curious when homeopaths trot out their pet meta-analyses they almost always include Linde’s 1997 study, but not the re-analysis of 1999.

http://www.ncbi.nlm.nih.gov/pubmed/10391656

“Why is that?

“Could it be the damning words: “We conclude that in the study set investigated, there was clear evidence that studies with better methodological quality tended to yield less positive results.” which do rather undermine the homeopaths’ case.

“Also they said this;

“’The evidence of bias weakens the findings of our original meta-analysis. Since we completed our literature search in 1995, a considerable number of new homeopathy trials have been published. The fact that a number of the new high-quality trials … have negative results, and a recent update of our review for the most “original” subtype of homeopathy (classical or individualized homeopathy), seem to confirm the finding that more rigorous trials have less-promising results. It seems, therefore, likely that our meta-analysis at least overestimated the effects of homeopathic treatments”

“Homeopathy: never letting the facts get in the way of a good story.

I, John Benneth respond:

Dear I Say,

Bravo for finally ponying up some seemingly reasonable opposition, it certainly is better than most of the other garbage being dumped on us from the opponents of homeopathy. But shame on you for leaving important concluding remarks that put what you have quoted in contrast in context, which reveals your negative bias. The quote actually runs: “We conclude that in the study set investigated, there was clear evidence that studies with better methodological quality tended to yield less positive results. Because summarizing disparate study features into a single score is problematic, meta-regression methods simultaneously investigating the influence of single study features seem the best method for investigating the impact of study quality on outcome.”

But like them all, you’re missing the point entirely, switching criteria away from what is important to what can be made vituperative. The unproven underlying assumption in all opposition to homeopathy is that there is no physical basis for its action, that its action is psychogenic, therefore a medical sham, wrapped up into one vague term, placebo.
Would you be laying the charge of medical sham at the doorstep of psychology because it uses a “talking cure”, attempts to treat mental disorders without psychoactive drugs? The success of psychology, a derivative of hypnosis, is also considered to be a psychological construction. This part of the argument against homeopathy contradicts the second, that homeopathy doesn’t work, for if the terms did not reflect reported benefits, they wouldn’t exist, nor would there be a doctrine such as psychology that is in full support of them.
This may seem a wandering from Linde, but it goes right to the point. The Linde study explicitly asks “Are the Clinical Effects of Homeopathy Placebo Effects?” and then says it is “A Meta-analysis of Placebo-Controlled Trials.” (Linde,1)The results of their meta-analysis, they say, “are not compatible with the hypothesis that the clinical effects of homoeopathy are completely due to placebo. Lancet 1997; 350: 834–43.
The subsequent re-analysis of Linde by the authors does not recant this, it merely says they may have overestimated the effects, and this is prima facie, only within the context of the meta-analysis.
But who can expect Linde questioning placebo effects to be a reasonable investigation when the trials are for verum? Linde has fallen into the common trap of allowing allopathy to set the terms criteria and question. But even so it still favors homeopathy, even in re-analysis.
If we are to ask the placebo question, then we must explore it using a protocol for placebo, not verum, and all testing I have seen is testing for verum. For instance, if we are asking if this is placebo, we would first strip away the psychogenic influence, and using homeopathic high dilutes, perform objective biochemical tests on human products, such as red and white blood cells, in vitro.
It then should come as a great surprise to anyone who believes homeopathics are placebos, to learn that biochemical testing has been done, repeatedly, showing overwhelming results in favor of homeopathy. The majority of results are positive, and they rate higher in methodological assessment than the negative tests. Unless you are willing to believe that the majority of the investigators in biochemical tests for homeopathics, like Prof. Madeleine Ennis of Queens University in Belfast, have psychokinetic powers, or are all making the same unknown error, or are liars, then you have to conclude that it is most likely that the effect of these substances in the subjects they came from are not solely due to psychogenesis. How can the placebos have an effect on blood cells in a petri dish?
Now compare this to human testing in vivo, which is confused by visible results, patient satisfaction and credibility, time, administrator’s skill and influence . . and the placebo effect. How can you expect to get credible results from one thing when it can be influenced by another? An engine mechanic, investigating the cause of stoppage, doesn’t test for lack of fire and fuel at the same time, he reduces the problem by checking oen at a time, such first testing for a spark, then if the spark is getting fuel . That’s what makes him a mechanic, he can make that distinction. But that reductionism isn’t being applied here by Edzard Ernst or anyone else who has intentionally pitted himself against homeopathy, and that is why Ernst is intentionally leaving biochemical testing out of his damning reviews of it. The foregone conclusion of placebo, based on criteria selected for its support of the foregone conclusion, most likely will not be supported by a reductionist approach. If the placebo effect was real, then we would simply be investigating its marvels and how to improve on them, such as in hypnosis. Please belive me when I tell you, many a practitioner of homeopathy is comfortable with the placebo conclusion, it makes him a maven.
One other thing . . and this is the knockout punch. Notice the last name on the list of authors of “ Impact of study quality . .” (Linde, 2) Jonas WB.
This is Dr. Wayne B. Jonas, a medical doctor and practicing physician who still treats members of the US Armed Forces. He was also one of the authors of the Linde 1997 meta-analysis of homeopathy (Linde, 1). He spent 20 years as a military physician. He was the keynote speaker Bastyr University in Seattle .He has conducted serious in vivo epidemiological research, testing prophylaxis against rabbit fever in mice at Walter Reed Army Hospital.
Rabbit fever, or tularemia is a serious contagion because it hits humans quickly and hard enough to incapacitate. Tularemia is a potential bio-warfare agent. It is highly contagious but not infectious or especially fatal and can be used specifically against troops without great danger to nearby civilian populations. Given its bio-warfare potential, finding a tularemia prophylaxis should be and presumably is of interest to the government, and so handling this kind of a study requires some extremely strict protocols.
In that he is being cited here in criticism of homeopathy admits him as a good witness for homeopathy. Critical of av past assessments by himself and his colleagues adds to his credibility, and certainly you wouldn’t have quoted his efforts if you did not think them to have some authority. He is also very critical of homeopathic research in other assignments we can see, such as in Wallach’s Research on Homeopathy: State of the Art, which he co-authored (Wallach).
In this report he and his colleagues say. “There is, to our knowledge, no single clinical area where reported effects have been demonstrated unequivocally. Thus, the overall picture of clinical evidence that is emerging is quite disappointing for the homeopathic community.”
They then go on to say, ”Viewed together, the clinical research on homeopathy compared to placebo is not much different from conventional medicine research where approximately the same proportion of studies are positive and negative. Once unpublished studies are retrieved from drug-licensing agencies, well-supported substances, such as selective serotonin reuptake inhibitors for depression, show diminishing effects.”
Homeopathy critics should take comfort though in that Wallach qualifies this: “But overall, effect sizes are still statistically robust, even if diminished. This same result cannot be claimed for homeopathy, except in a few clearly delineated areas”

Then all of a sudden, tt gets worse, for the opponents of homeopathy, that is. “Several high-quality reviews of all published or a selection of published studies exist. There is even a comprehensive review of all clinical studies ever conducted, including early studies published in German. This review concluded that homeopathy is clinically effective. In addition, meta-analyses and reviews of several specific diagnoses have been carried out. Most of these reviews and meta-analyses, with some exceptions, reached the conclusion that the effects observed in all trials are not compatible with the hypothesis that homeopathy is identical with placebo but that too few trials exist in any single clinical areas to recommend homeopathy clinically.”

In other words, when you do all the math, homeopathy works. As Wallach says, one comprehensive review of all clinical studies ever conducted concluded homeopathy is clinically effective. Wallach and Jonas do not disagree with this, but qualify their ellipses by saying too few studies exist in single clinical areas to recommend it clinically. But then Wallach goes on further to say that it depends on who you are and who you’re quoting,
“Whether homeopathy is a placebo or not is also dependent on the inclusion and analysis criteria used by a meta-analysis or a review. If the analysis is based on studies retrievable only through MEDLINE® and published in the peer-reviewed literature, the outcome is normally not different from placebo. If all evidence is included, there is a difference from placebo. Hence, the conclusion varies with the decision as to what one is willing to accept as scientific information.”

So, if you cherry pick the clinical data, as Edzard Ernst and others do, you can conclude its nothing more than placebo. Wallach says, “As a result of the bias in the scientific community against homeopathy, it is easier to publish negative results in the peer-reviewed literature than positive ones. The latter are scrutinized more closely for methodological shortcomings than studies with the expected negative outcome, a prominent example being the recently published meta-analysis by Shang and colleagues the reporting of which is unacceptably bad and yet it passed peer-review.”
So much for Shang and peer review. The one study that Edzard Ernst and all critics eventually hold up above all others. Shang, by Wallach’s report, is just flat out “unacceptably bad.”
Now here’s the killshot: Jonas, who is quoted here as not recommending homeopathy clinically, conducted perhaps the most amazing trials of high dilutes as used in homeopathy. It was that bio-warfare tularemia study. What he found was able to reduce the effects of tularemia in mice was . . You guessed it, homeopathy. Tularemia, for which there is no vaccine, only prophylaxis . . Homeopathic prophylaxis.
How do you explain that? (Jonas)
Homeopathy, the story just keeps getting better.

References

JONAS. WB Journal of Scientific Exploration, Vol. 14, No. 1, pp. 35–52, 2000 “Protection of mice from tularemia infection with ultra low serial agitated dilutions prepared from franciscella tularemia infected tissue. Jonas WB, Dillner D

LINDE 1: The Lancet Vol 350 • September 20, 1997“Are the Clinical Effects of Homeopathy Placebo Effects? A Meta-analysis of Placebo-Controlled Trials Klaus Linde, Nicola Clausius, Gilbert Ramirez, Dieter Melchart, Florian Eitel, Larry V Hedges, Wayne B Jonas

LINDE 2: J Clin Epidemiol. 1999 Jul;52(7):631-6. “Impact of study quality on outcome in placebo-controlled trials of homeopathy.” Linde K, Scholz M, Ramirez G, Clausius N, Melchart D, Jonas WB.
Münchener Modell–Centre for Complementary Medicine Research, Department of Internal Medicine II, Technische Universität München, Munich, Germany.
Comment in:
J Clin Epidemiol. 2000 Nov;53(11):1188.
J Clin Epidemiol. 2002 Jan;55(1):103-4.

Witt: “The in vitro evidence for an effect of high homeopathic potencies—–A systematic review of
the literature” Claudia M. Witt (a), Michael Bluth (b), Henning Albrecht ©, Thorolf E.R. Weighing (a), Stephan Baumgartner (d), Stefan N. Willich (a)
a) Institute for Social Medicine, Epidemiology and Health Economics, Charit´e University Medical Center,
D-10098 Berlin, Germany
b) Klinik f¨ur Tumorbiologie, D-Freiburg/Br, Germany
c) Karl and Veronica Carstens-Foundation, D-Essen, Germany
d) Institute for Complementary Medicine (KIKOM), University of Bern, CH-Bern, Germany

Wallach: Research on Homeopathy: State of the Art HARALD WALACH, Ph.D.,1–3 WAYNE B. JONAS, M.D., Ph.D.,3 JOHN IVES, Ph.D.,3 ROEL VAN WIJK, Ph.D.,4 and OTTO WEINGÄRTNER, Dr.Phil.Nat.5 http://www.sld.cu/galerias/pdf/sitios/mednat/research_on_homeopathy_state_of_the_art_(3).pdf