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--- en:misc:talk-saine-schwarcz [2012/12/13 16:59]
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+++ en:misc:talk-saine-schwarcz [2012/12/13 17:43]
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 {{anchor:s187}}Now let’s look at observational studies:
-{{anchor:s188}}Observational studies provide verifiable information that is complementary to the results of clinical trials, and here it is particularly helpful to evaluate real-life outcomes over many years. {{anchor:s189}}First, this 2005 review paper entitled “//Research on Homeopathy: State of the Art//,” in which it is stated, “//Observational research of homeopathic practice documents consistently strong therapeutic effects and sustained satisfaction in patients//.”
+{{anchor:s188}}Observational studies provide verifiable information that is complementary to the results of clinical trials, and here it is particularly helpful to evaluate real-life outcomes over many years. {{anchor:s189}}First, [[http://www.ncbi.nlm.nih.gov/pubmed/16296915|this 2005 review paper]] entitled “//Research on Homeopathy: State of the Art//[(Walach H, Jonas WB, Ives J, van Wijk R, Weingärtner O. Research on homeopathy: state of the art. University College Northampton, School of Social Sciences, UK. J Altern Complement Med. 2005 Oct;11(5):813-29.)],” in which it is stated, “//Observational research of homeopathic practice documents <wrap hi>consistently strong therapeutic effects and sustained satisfaction in patients</wrap>//.”
 {{anchor:s190}}“//Historically, homeopaths were among the first to introduce double-blinded experiments in human subjects//.”
@@ Line 158: / Line 158: @@
 {{anchor:s191}}Now let’s look at two large-scale perspective observational studies over many years:
-{{anchor:s192}}The first one is out of the UK, in which the author reports, “ //This was an observational study of 6544 consecutive follow-up patients during a 6-year period. . . . {{anchor:s193}}Results: Homeopathic intervention offered positive health changes to a substantial proportion (71%)// .”
+{{anchor:s192}}[[http://www.ncbi.nlm.nih.gov/pubmed/16296912|The first one]] is out of the UK, in which the author reports, “ //This was an observational study of 6544 consecutive follow-up patients during a 6-year period. . . . {{anchor:s193}}Results: Homeopathic intervention offered <wrap hi>positive health changes to a substantial proportion (71%)</wrap>//.”[(Spence DS, Thompson EA, Barron SJ. Homeopathic treatment for chronic disease: a 6-year, university-hospital outpatient observational study. United Bristol Healthcare, National Health Service Trust, Bristol, United Kingdom. //J Altern Complement Med.// 2005 Oct;11(5):793-8.)]
-{{anchor:s194}}The second study I’m going to show comes from Germany and Switzerland. {{anchor:s195}}It was published in 2008, and the authors report, “ //In a prospective, multicentre cohort study with 104 homeopathic primary care practices in Germany and Switzerland, data from all patients (age >1 year) consulting the physician for the first time were observed. ... {{anchor:s196}}Results: A total of 3,709 patients were studied, 73% contributed data to the 8-year follow-up. ... {{anchor:s197}}Disease severity decreased significantly (p < 0.001),” --// this is extraordinary: One chance in a thousand that it could have happened— “ //between baseline, 2 and 8 years. {{anchor:s198}}Physical and mental quality of life scores also increased considerably... {{anchor:s199}}Conclusion: Patients who seek homeopathic treatment are likely to improve significantly. {{anchor:s200}}These effects last for as long as 8 years// .”
+{{anchor:s194}}[[http://www.biomedcentral.com/1471-2458/8/413|The second study]] I’m going to show comes from Germany and Switzerland. {{anchor:s195}}It was published in 2008, and the authors report, “ //In a prospective, multicentre cohort study with 104 homeopathic primary care practices in Germany and Switzerland, data from all patients (age >1 year) consulting the physician for the first time were observed. ... {{anchor:s196}}Results: A total of 3,709 patients were studied, 73% contributed data to the 8-year follow-up. ... {{anchor:s197}}<wrap hi>Disease severity decreased significantly (p < 0.001)</wrap>,” --// this is extraordinary: One chance in a thousand that it could have happened— “ //between baseline, 2 and 8 years. {{anchor:s198}}<wrap hi>Physical and mental quality of life scores also increased considerably</wrap>... {{anchor:s199}}Conclusion: <wrap hi>Patients who seek homeopathic treatment are likely to improve significantly.</wrap> {{anchor:s200}}These effects last for as long as 8 years// .”[(Claudia M Witt, Rainer Lüdtke, Nils Mengler and Stefan N Willich; How healthy are chronically ill patients after eight years of homeopathic treatment? – Results from a long term observational study. BMC Public Health. December 2008, 8:413)]
 {{anchor:s201}}Now let’s look at therapeutic trials:
-{{anchor:s202}}There are all kinds of wonderful trials throughout the long history of homeopathy; however, I will focus on two RCTs (Randomized Control Trials). {{anchor:s203}}For the first one we are going to look at, the outcome is very interesting because the outcome is life or death, so it’s a bit more dramatic. {{anchor:s204}}This is a study on sepsis in an intensive care unit:
+{{anchor:s202}}There are all kinds of wonderful trials throughout the long history of homeopathy; however, I will focus on two RCTs (Randomized Control Trials). {{anchor:s203}}For the first one we are going to look at, the outcome is very interesting because the outcome is life or death, so it’s a bit more dramatic. {{anchor:s204}}This is a [[http://www.ncbi.nlm.nih.gov/pubmed/15892486|study on sepsis]] in an intensive care unit:
-{{anchor:s205}}“ //Mortality in patients with severe sepsis remains high despite the development of several therapeutic strategies. ... {{anchor:s206}}The incidence of severe sepsis is between 70,000 to 300,000 patients in the United States each year. {{anchor:s207}}The aim of this randomized, double-blind, placebo-controlled trial was to evaluate whether homeopathy is able to influence long-term outcome in critically ill patients suffering from severe sepsis. .. {{anchor:s208}}Seventy patients with severe sepsis received homeopathic treatment or placebo. {{anchor:s209}}Five globules in a potency of 200 C were given at 12 h interval during the stay at the intensive care unit. {{anchor:s210}}Survival after 30 and 180 days was recorded. ... {{anchor:s211}}Results: On day 180, survival was statistically significantly higher with verum homeopathy (75.8% vs. 50.0%, P=0.043). No adverse effects were observed// .”
+{{anchor:s205}}“ //Mortality in patients with severe sepsis remains high despite the development of several therapeutic strategies. ... {{anchor:s206}}The incidence of severe sepsis is between 70,000 to 300,000 patients in the United States each year. {{anchor:s207}}The aim of this randomized, double-blind, placebo-controlled trial was to evaluate whether homeopathy is able to influence long-term outcome in critically ill patients suffering from severe sepsis. .. {{anchor:s208}}Seventy patients with severe sepsis received homeopathic treatment or placebo. {{anchor:s209}}Five globules in a potency of 200 C were given at 12 h interval during the stay at the intensive care unit. {{anchor:s210}}Survival after 30 and 180 days was recorded. ... {{anchor:s211}}Results: On day 180, <wrap hi>survival was statistically significantly higher with verum homeopathy</wrap> (75.8% vs. 50.0%, P=0.043). No adverse effects were observed//.” [(sepsisstudy>Frass M, Linkesch M, Banyai S, Resch G, Dielacher C, Löbl T, Endler C, Haidvogl M, Muchitsch I, Schuster E. Adjunctive homeopathic treatment in patients with severe sepsis: a randomized, double-blind, placebo-controlled trial in an intensive care unit. Ludwig Boltzmann Institute for Homeopathy, Graz, Austria. Homeopathy. 2005 Apr;94(2):75-80.)]
-{{anchor:s212}}Here we have a skeptic from England, in the Guardian stating, “ //This RCT trial has been done, time and time again, with homeopathy ... you find, overall, that the people getting the placebo sugar pills do just as well as those getting the real, posh, expensive, technical, magical homeopathy pills// .”
+{{anchor:s212}}Here we have a skeptic from England, in the Guardian stating, “ //This RCT trial has been done, time and time again, with homeopathy ... you find, overall, that the people getting the placebo sugar pills do just as well as those getting the real, posh, expensive, technical, magical homeopathy pills//.”[(Ben Goldacre. A kind of Magic? //The Guardian.// November 16, 2007))]
-{{anchor:s213}}Now, a valid question to ask Goldacre is whether he considers the other 26% extra in the sepsis placebo group as doing just as well as the group receiving homeopathy.
+{{anchor:s213}}Now, a valid question to ask Goldacre is whether he considers the other 26% extra[(sepsisstudy)] in the sepsis placebo group as doing just as well as the group receiving homeopathy.
-{{anchor:s214}}Now, let’s look at a second RCt:
+{{anchor:s214}}Now, let’s look at a second RCT:
-{{anchor:s215}}This one is of great interest as researchers were able to isolate the strength of homeopathic response from the clinical skill of the homeopaths. {{anchor:s216}}It’s on hyperactivity in children:
+{{anchor:s215}}This one is of great interest as researchers were able to isolate the strength of homeopathic response from the clinical skill of the homeopaths. {{anchor:s216}}It’s on [[http://www.ncbi.nlm.nih.gov/pubmed/16047154|hyperactivity in children]]:
 {{anchor:s217}}“ //An increasing number of parents turn to homeopathy for treatment of their hyperactive child. {{anchor:s218}}Two publications, a randomised, partially blinded trial and a clinical observation study, conclude that homeopathy has positive effects in patients with ADHD. {{anchor:s219}}The aim of the study was to obtain scientific evidence of the effectiveness of homeopathy in ADHD. {{anchor:s220}}Method: Prior to the randomised, double blind, placebo controlled crossover study, they were treated with individually prescribed homeopathic medications// .”
-{{anchor:s221}}So they found out who responded to the remedy. “ //62 of 83 patients [or 75% accuracy in prescribing], who achieved an improvement of 50% in the Conner’s’ Global Index (CGI), participated in the trial. ... {{anchor:s222}}Results: At entry to the crossover trial, cognitive performance such as visual global perception, impulsivity and divided attention had improved significantly under open label treatment (with a P value of ) (P<0.0001).// ”
+{{anchor:s221}}So they found out who responded to the remedy. “ //62 of 83 patients [or 75% accuracy in prescribing], who achieved an improvement of 50% in the Conner’s’ Global Index (CGI), participated in the trial. ... {{anchor:s222}}Results: At entry to the crossover trial, cognitive performance such as visual global perception, impulsivity and divided attention had <wrap hi>improved significantly under open label treatment with a P value of  P<0.0001</wrap>.//”[(Frei H, Everts R, von Ammon K, Kaufmann F, Walther D, Hsu-Schmitz SF, Collenberg M, Fuhrer K, Hassink R, Steinlin M, Thurneysen A. Homeopathic treatment of children with attention deficit hyperactivity disorder: a randomised, double blind, placebo controlled crossover trial. Swiss Association of Homeopathic Physicians SAHP, Lucerne, Switzerland. //Eur J Pediatr.// 2005 Dec;164(12):758-67. Epub 2005 Jul 27.)]
-{{anchor:s223}}Extraordinary. {{anchor:s224}}One chance in 10,000. {{anchor:s225}}That is because they isolated - they removed from the equation - the prescriber’s skill, so you are just looking at the reaction to the homeopathic remedy.
+{{anchor:s223}}Extraordinary. {{anchor:s224}}One chance in 10,000. {{anchor:s225}}That is because they isolated -- they removed from the equation -- the prescriber’s skill, so you are just looking at the reaction to the homeopathic remedy.
-{{anchor:s226}}“ //The trial suggests scientific evidence of the long-term effectiveness of homeopathy in the treatment of attention deficit hyperactivity disorder, particularly in the areas of behavioural and cognitive functions// .”
+{{anchor:s226}}“ //The trial suggests <wrap hi>scientific evidence of the long-term effectiveness of homeopathy</wrap> in the treatment of attention deficit hyperactivity disorder, particularly in the areas of behavioural and cognitive functions// .”
-{{anchor:s227}}I have a couple of minutes to start to look at systemic activity and meta-analysis, and this is where skeptics say they rely much on the meta-analysis. {{anchor:s228}}In 2004, medical historian Michael Dean published the first systematic review of all clinical trials of homeopathy published in the medical literature from 1821 until 1998, and he found and analyzed 45 prospective trials and 205 controlled trials. {{anchor:s229}}Some of the main findings of this extensive search analysis are:
+{{anchor:s227}}I have a couple of minutes to start to look at systematic reviews and meta-analysis, and this is where skeptics say they rely much on the meta-analysis. {{anchor:s228}}In 2004, medical historian Michael Dean published the first systematic review of all clinical trials of homeopathy published in the medical literature from 1821 until 1998, and he found and analyzed 45 prospective trials and 205 controlled trials.[(Michael Emmans Dean -- The Trials of Homeopathy.)] {{anchor:s229}}Some of the main findings of this extensive search analysis are:
   * {{anchor:s230}}“//Homeopathy has a long history of scientifically conducted trials//.”
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 {{anchor:s637}}And to compare Randi and Marketplace with researchers from renowned centers -- it is not equal. {{anchor:s638}}There are serious scientists out there doing serious research, and the work of Benveniste was replicated by several labs since, and it was published a long time ago -- over 10 years ago.
-{{anchor:s639}}In terms of history, Joe, you don’t know your history. {{anchor:s640}}The process of serial dilution and succussion was not an invention of Hahnemann. {{anchor:s641}}It has been known at least since Paracelsus. {{anchor:s642}}And Hahnemann used those at least till 1822. {{anchor:s643}}In other words, he went to the process of serial dilution slowly, slowly over the years. {{anchor:s644}}It was only around 1812 that he went beyond Avogadro’s number.
+{{anchor:s639}}In terms of history, Joe, you don’t know your history. {{anchor:s640}}The process of serial dilution and succussion was not an invention of Hahnemann. {{anchor:s641}}It has been known at least since Paracelsus. {{anchor:s642}}And Hahnemann used crude doses at least till 1822. {{anchor:s643}}In other words, he went to the process of serial dilution slowly, slowly over the years. {{anchor:s644}}It was only around 1812 that he went beyond Avogadro’s number.
 {{anchor:s645}}He took many years. {{anchor:s646}}It was not a flash of genius; it was a process of experimentation. {{anchor:s647}}And as he experimented, he noticed greater response from the patients, and he said, //“Let’s do it further//.{{anchor:s648}}” Greater response. {{anchor:s649}}This is confirmed now from the work on Nano-bubbles, where there is an augmentation of the effect.
-{{anchor:s650}}In terms of the placebo effect, Joe, I think you are in 1955 with Beaker’s study of the powerful placebo effect. {{anchor:s651}}This was reviewed many, many times since 1955, and the Cochran calibration came out, I think, this year with a review of all the trials where they compare placebo with effective treatment and the no treatment arm. {{anchor:s652}}And when they used this, when they looked at about 200 trials with the no treatment arm, and they found out that the placebo effect in clinical trials is really negligible.
+{{anchor:s650}}In terms of the placebo effect, Joe, I think you are in 1955 with Beaker’s study of the powerful placebo effect. {{anchor:s651}}This was reviewed many, many times since 1955, and the Cochrane collaboration came out, I think, this year with a review of all the trials where they compare placebo with effective treatment and the no treatment arm. {{anchor:s652}}And when they used this, when they looked at about 200 trials with the no treatment arm, and they found out that the placebo effect in clinical trials is really negligible.
 {{anchor:s653}}I was telling you that I am going to present you the findings of the most comprehensive review of homeopathy. {{anchor:s654}}This was the one that I referred to before, and Joe also referred to -- also called the Swiss study.

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