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http://www.webmedcentral.com/images/Header_Logo.giftext/html2010-11-06T10:36:33+01:00http://www.webmedcentral.com/Dr. Lex RuttenHomeopathy In Upper Respiratory Tract Infections ? The Impact Of Plausibility Bias
http://www.webmedcentral.com/article_view/1126
A meta-analysis of a subset of eight ‘larger higher quality’ randomised controlled trials (RCTs), drawn from 110 matched RCTs each of homeopathy and conventional medicine, concluded that the results of the trials were consistent with the hypothesis that homeopathy is a placebo effect [1]. This meta-analysis was criticised for the heterogeneity of the trials on which its conclusion was based (all eight were for different conditions).In an apparent paradox, the same meta-analysis concluded that homeopathy had a ‘substantial beneficial effect’ in acute upper respiratory tract infections (URTI), without evidence of positive bias. Other meta-analyses have reached similar conclusions [2, 3]. There is evidence from clinical studies of varying designs that homeopathy may be effective in treating acute otitis media [4-6]. Homeopathy is frequently prescribed for URTI by homeopathic GPs [7]. There is also some evidence from western Europe that general practitioners (GPs) with homeopathic training prescribe fewer antibiotics than their counterparts in conventional medicine [8-10].The plausibility paradoxThe problem with homeopathy for most doctors and scientists is the inherent implausibility of the idea that ultra-diluted solutions can have chemical effects [11]. Clearly it is highly unlikely that a medicine that does not contain a single molecule of the original substance could work like a conventional medicine. Sometimes the outcome of RCTs overturns theory, but at other times evidence is dismissed because of theory. Vandenbroucke states “Accepting that infinite dilutions work would subvert more than conventional medicine; it wrecks a whole edifice of chemistry and physics” [12].An early systematic review of clinical trials stated, “we would accept that homoeopathy can be efficacious, if its mechanism of action were more plausible” [13]. Contrary views have also been expressed: demanding more evidence may itself be considered unscientific; the same level of supporting clinical trial evidence should be accepted for all scientific developments. If a lower level of proof is set for hypotheses that fit prior beliefs then we bias our view of science in favour of such beliefs and may be easily misled [14].Does the fact that it is highly unlikely that many homeopathic medicines have a chemical effect really wreck a ‘whole edifice of chemistry and physics’? Chaplin mentions a number of possible mechanisms of action that are more likely than chemical effects, like water clustering and nanobubbles [14]. ‘Inherent implausibility’ is a poor guide to future understanding. History is littered with examples of ideas that at one time appeared highly implausible but are now accepted as fundamental truths: the Copernican revolution and quantum physics are well-known examples [15].The possibility of other mechanisms, the opinions of users and prescribers, fundamental research and epidemiological evidence are all ignored because of the implausibility of a chemical effect of extremely high dilutions. Goodman used Bayes’ theorem to illustrate that the usual proof is not sufficient for belief in efficacy [16]. Rosendaal and Bouter illustrated this by assigning one significantly positive RCT a likelihood ratio (LR) of 16 [17]. This LR is then entered into Bayes’ formula:Posterior odds = LR x prior odds#Their estimate of the prior that homeopathy ‘works’ was one in a million; implying that ‘works’ actually meant ‘works in an accepted pharmacological way’. Then they calculate using Bayes’ formula that the chance that homeopathy works goes from one in a million to less than one in ten thousand after one positive RCT. The principal weakness of Bayesian statistics is the subjectivity in estimating the prior chance [18]. Priors are usually estimated by experts in the field. Should the prior for homeopathy be the chance that it has a chemical effect or the chance of other effects? In Bayesian reasoning all evidence should be used for sequential updating with the Bayes’ formula, and very low priors especially are particularly influenced by this updating [19]. If we suppose that the proof of one RCT has LR=16, sequential updating for eight positive trials proceeds as in table 1.Illustration 1: Table 1This example merely shows that evidence consisting of a considerable number of RCTs and a variety of other evidence cannot be dismissed by a simple Bayesian argument. A complete Bayesian discourse about proof is much more complex [20]. We see that 7 consecutive, positive, trials suffice to bring belief from one in a million to very nearly 100%, and that there is a ‘ceiling effect’: additional positive studies have very little impact. The 8 trials on homeopathy for URTI have certainly not had such an impact on beliefs in the medical community. This might be due to suspicion of bias based on the plausibility fallacy.Sources of biasSterne et al assumed that quality bias accounted for the positive results of RCTs of homeopathy [21], but several authors have concluded that the quality of evidence for homeopathy is not inferior to that for conventional medicine [12, 13]. Shang's analysis was the first to make direct comparison of homeopathy trials with conventional trials. Plots of odds ratio versus the standard error of RCTs show a picture that is not consistent with a placebo effect and a similar pattern for homeopathy and conventional medicine (figure 1)[12]. There was no statistically significant difference in asymmetry.But there is incommensurability between the homeopathic and conventional data sets: for instance it excluded some larger homeopathy trials with positive effect because no matching trial could be found [22-24]. The plot for homeopathy included 16 unpublished trials, the conventional plot none. There was an additional difference in quality: homeopathy had 21 out of 110 (19%) good quality trials, conventional medicine had 9 out of 110 (8%). Both publication bias and quality bias lead to exaggerated effects. Adding the difference in quality for 12 trials results in a less biased effect in 28 out of 110 (25%) of the homeopathy trials.Comparison of 110 homeopathy trials with 110 matched conventional trials does not indicate a difference in efficacy of both methods. Several authors show statistically non-significant results with subsets of trials. Reconstruction of the meta-analysis shows that other, equally justifiable, subsets of high quality trials yield statistically significant positive results [25]. Considering the plot of both methods, this would also be a common occurrence with subsets of conventional medical trails.Illustration 2: Figure 1Plausibility biasThe differing conclusions of the meta-analyses of the homeopathy and conventional medicine subsets, and particularly for the homeopathy URTI subset, do not reflect the nature of the evidence, nor its quality, but negative ‘plausibility bias’. There is growing evidence that antibiotics do more harm than good in URTI, despite a plausible rationale for their use; their continued use reflects positive plausibility bias. Plausibility bias obstructs a fair evaluation of the evidence around homeopathy; its extent and implications have not been adequately recognised or discussed. In the current circumstances, negative plausibility bias concerning homeopathy should not impede further research. Nevertheless, such new research in homeopathy, if positive, may have limited impact on practice unless and until homeopathy can be established within a plausible theoretical framework.Treatment of URTI and further research in homeopathyThe use of homeopathy for URTI, on the available evidence, demands further investigation. URTI is an ‘effectiveness gap’ condition, a common clinical problem for which there is a lack of effective treatments [26]. Extensive discussions about RCT evidence in homeopathy are so far inconclusive, but do these discussions not mirror the problems with the interpretation of conventional evidence?Antibiotics have saved countless lives, but it is clear that there is little place for them in uncomplicated URTI: they do not reduce the risk of serious complications [27, 28] and they are ineffective in otitis media [29]. Bezáková et al suggest that acute otitis media recurs more frequently in young children treated with antibiotics than in those given placebo, perhaps due to selection of more virulent microflora [30], and the use of antibiotics for respiratory tract infections leads to increased antibiotic resistance [31]. Despite widespread awareness of the need to reduce the use of antibiotics for URTI, they are still frequently prescribed [32-25]. URTI is the most prevalent disease category in general practice [36]. As the problems associated with antibiotic use are increasingly recognised there is a need to consider alternative treatments such as homeopathy.The specific research we propose, conducted in primary care, is to test the hypothesis that homeopathy averts, reduces or delays antibiotic prescriptions in the management of acute otitis media or other URTI.There are a number of considerations to be taken into account in designing such a study. These include:Trials using an antibiotic treated group in uncomplicated URTI are unethical since the evidence suggests that they do more harm than good in this situation.-Trials should be of relatively long duration: URTI are often recurrent and the disadvantages of antibiotics are most evident in this context.-Homeopathic prescribing requires skilled practitioners.-Homeopathy is associated with strong patient preferences; previous RCTs in primary care have foundered on this issue [37].The research question would not be: ‘Can ultra-diluted medicines exert physiological effects?’. A clinical trial is a clumsy and expensive way of answering such a question, which would be much better answered by biological models. A number of such models have been described [38], and their further development might enable homeopathy to become framed in the plausible theoretical background that it requires.# Odds = chance / (1 – chance); in words, the chance that something will happen divided by the chance that it will not happen. Odds = 1 means: chance is fifty-fifty.LR = Likelihood ratio = True positives / False positivestext/html2011-11-07T16:07:31+01:00http://www.webmedcentral.com/Dr. Salvatore ChirumboloStrange Ways to Address a Debate on the Scientific Ground
http://www.webmedcentral.com/article_view/2434
WebMed Central represents one of those world wide web platforms able to give a considerable amount of opportunities to expand the debate on a scientific ground. Some journals, for example, offer the possibility to rapid responses, so enhancing the forum discussion about a scientific concern or whatever an issue raised by suggested hypothesis, models and published evidence. This is the essence of democracy, we cannot do without even in scientific research. There are also some topics for which this debate is laid waste and some researcher may show strange ways to address any discussion forum. I know one of them who is used to play a chicken-hearted fashion to suppress the honorable opinion of colleagues of him, particularly if the argument deals with bias in homeopathy. When I submitted a paper of mine, about one year ago, this colleague wrote to the Editor-in-Chief that, according to his opinion, the paper was illicit: a sudden answer follows by two Editors and then the paper was published (Chirumbolo S et al., 2011). Unfortunately, this was not an isolate case. You can track clues down by yourselves, clicking at http://www.paolobellavite.it. In the .pdf file included in the News section “omeopatia nao es agua” the colleague introduced, in a first version, a comment by two researchers from Mario Negri Institute of Pharmacological Science, Milan (Italy) with the purpose to show, to the many attendants of the UFRJ Congress held in Brazil, that their comment was rejected by Psychopharmacology, thus highlighting and enhancing the scientific value of “only” his work, contrariwise to the Mario Negri’s forwarded criticism. The slides were removed following an explicit order by those researchers. Other insights about this cockeyed method in presenting original results can be still found in the sub-heading News, point 5, where the Author posted his scientific masterpiece associated with his reply to a commentary of mine and stating that this reply was reviewed by the Italian Institute of Health, one way as another to assess the mighty and indisputable truth within his “only” worth of praise comment (Magnani P et al, 2010; Bellavite P, 2011). But, what about my Commentary (Chirumbolo S, 2011a)? A fair manner to expand the debate could be to ask for other opinions by honestly publishing both the commentaries..anyway…I replied to his commentary, as the Author compelled a response of mine due to his criticism about the absence of a substantial issue (Chirumbolo S, 2011b). Bur, whether any colleague worldwide would like to read this Commentary, he will be disappointed, because the commented author obliges the Editor-in-Chief to immediately withdraw the comment. On cue (for him, I suppose). The Editor-in-Chief, although the previously forwarded congratulations to the Author of the manuscript, withdrew the paper because of an “oversight” of the editorial office. Hitchcock should not have done this so better.
No mind: readers have other opportunities to watch at the end of this whodunit, anyway.
What it is really awkward, concerns the fashion by which this creative colleague deals with freedom in addressing criticism to his experimental setting, when other colleagues of him are trying to open a debate about possible biases in his papers, if any. He believes that this “normal” occurrence in a worldwide scientific arena, is a frontal attack against his person. Nothing else. So, any reply from him is a real defensive outing. Probably he is trusting the hypothesis that colleagues throughout the globe are investigating magistrates able to summons his person. I found that this way to struggle on the fair playground of science with a self-pitying attitude, is a typical hallmark of some homeopaths, used to self-making science (see the video in his website: no team is shown, he is explaining by himself alone). In BMJ a strong objection suddenly appeared (by rallying main scientists and launching a signature-raising campaign), simply because of the existence of a single reply (Bewley S, 2011). This is becoming a typical behavior also in politics. Therefore, I am quite freightened: is there still a place for science, honestly and properly? “Minority” attacks, survivorship basic instinct, muzzles, personalisms: a strange way to address a debate on the scientific ground.text/html2011-11-11T17:16:49+01:00http://www.webmedcentral.com/Dr. Deepak GuptaElusive Mechanism of Homeopathy: Its Miracle may be Its Curse and Time to consider Homeopathy Vacation
http://www.webmedcentral.com/article_view/2452
Homeopathy originated in Germany and is extremely popular in India. The reasons for its popularity in Indian population may be related to the ease of its ‘sweetened’ administration, almost the certain minisculity of side-effects (if any) in comparison to allopathic medicines, and possibly the lower costs involved in homeopathy for the self-paying patients. However, the mechanism of action for the medicinal effects of homeopathy has been eluding the scientific communities since its origin. Herein, despite being an anesthesiologist, I as an astute observer of science with sincere acceptance to all form of medicine want to postulate that the not-so-clear Quantum Transfer of Homeopathy (1) although provides the answers for the unclear ‘essence’ or ‘energy’ of the extremely diluted homeopathic medications in regards to giving the Quantum form for the in-between state of homeopathic medications (more than just energy and less than formed molecule/matter); however there are quite a few answers that needs to be answered as far as pharmacodynamics of homeopathy is concerned (Quantum can only explain the active ‘ingredient’ of homeopathic drug re-constitution). It is my humble understanding as an ‘outsider’ that as almost all of the homeopathic medication ‘quantum’ are administered by oral route, they are utilizing the gut that has one of the largest immune system of human body; and no matter what form or state of homeopathy (energy or quantum or sub-molecular matter) acts on the human body, the absence of the molecule and repetitive dilutions providing medicinal effects in the large human populations can only be explained by the transfer of activated antigenicity of the original molecules that ‘vaporize’ during the repetitive dilutions for the final re-constitution of the final homeopathic drug product. This highly activated antigenicity of homeopathic drug product may then be utilizing the immunogenic system of the human body to further and to strengthen the natural protective mechanisms (eradicating the exogeneous and remodeling the endogeneous) of the human body in the event of the acute, sub-acute or chronic persistent insults and intrusions (mechanical, chemical and biological). However, the patients who are ‘religiously’ following and chronically ingesting homeopathic drug products may be exposing themselves to this ‘upregulated’ immunogenicity within their bodies even when there are no exogeneous substances to fight and kill and no endogeneous ingredients to remodel; and this ‘upregulated’ immunogenic system may then mistakenly direct its attention to the unrequited healthy endogeneous cells that may lead to the birth of the auto-immunity of varying degrees. This domain and perspective is yet unexplored because the understanding of the mechanism of action of Quantum Homeopathy is still evolving; however, my ‘layman’ outlook finds it prudent to initiate the discussions among the homeopathic scientific community for possible considerations of regular interval homeopathic vacation (for example, one month placebo products after every five months of homeopathic products) in long term patients till the time when more conclusive evidences behind the homeopathic miracles are put forward by the homeopathic scientists.