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Responses from the Homeopathic Community on the
Lancet Article The following are reprinted with permission:
The growth of a lie and the end of
"conventional" medicine, by D. Mastrangelo and C. Lore British Homeopathic Association: Lancet article is fundamentally flawed 07-09-2005, 3:02 pm News and Press Releases The article published on homeopathy in the Lancet recently has fundamental flaws, writes Robert Mathie, Research Development Adviser of the BHA and Faculty of Homeopathy. What the paper studied: The authors analysed placebo-controlled trials of homeopathy and conventional medicine (matched for disorder and type of clinical outcome) published up to January 2003 (1). 110 homeopathy trials and 110 matched trials in conventional medicine were included; they were not necessarily peer-reviewed papers. They were assessed using standard criteria of trial quality (randomisation, masking, data analysis methods) and by treatment effect using odds ratios (an odds ratio of less than 1.0 indicating an effect greater than placebo). The original studies included a wide range of medical conditions; nearly half the studies comprised research in respiratory tract infections, pollinosis & asthma, and gynaecology & obstetrics. The homeopathy trials concerned all forms of the therapy, including classical (individualised) homeopathy, ‘clinical homeopathy’, complex homeopathy, or isopathy. The majority of conventional medicine trials investigated specific pharmaceutical drugs (non-steroidal, anti-allergic, virostatic, or antibiotic). Treatment approach in each category of trial was either therapeutic or prophylactic. What the paper shows: Viewing the results of the trials overall, there is a broadly similar positive treatment effect in both homeopathy and conventional medicine. In both categories of trial, those with fewer patients typically showed more positive treatment effects than larger trials. This is shown in the paper’s Figure 2, where trials with the largest standard error tend to have the lowest odds ratio. The authors do not quote mean odds ratios for the two groups of trials. 21 homeopathy trials and 9 in conventional medicine were judged to be of ‘higher quality’. The author’s key analysis was then restricted to the ‘larger’ 14 of those trials (8 homeopathy and 6 conventional medicine; none of them cited specifically); this analysis resulted in a mean odds ratio of 0.88 for homeopathy trials and 0.58 for conventional medicine trials. There was thus no longer a convincing positive treatment effect of homeopathy as compared with that of conventional medicine. The paper’s main conclusion is that the clinical effects of homeopathy are probably those of placebo. What the Lancet editor says: Under the headline ‘The end of homoeopathy’, the journal editorial states ‘Now doctors need to be bold and honest with their patients about homoeopathy’s lack of benefit, and with themselves about the failings of modern medicine to address patients’ needs for personalised care’. It adds the comment ‘Surely the time has passed for selective analyses, biased reports, or further investment in research to perpetuate the homoeopathy versus allopathy debate’. Our commentary on this publication: As the following paragraphs illustrate, the paper has not demonstrated homeopathy’s lack of benefit. Regrettably, in publishing and commenting on this paper, the journal has displayed some of these unwelcome attributes of selective analysis and biased reporting. And investment in clinical research in homeopathy needs to be enhanced, not withheld. There are a number of concerns in the way the paper approaches homeopathy trials: for example, its criteria of study quality do not reflect the homeopathic relevance of the clinical outcome/s measured; in addition, placebo-controlled design was probably not appropriate in the trials of individualised homeopathy (2). In other words, standard assessment criteria are insufficient to gauge ‘high quality’ in homeopathy trials. Another fundamental concern is that the paper gives no clue about the nature of the 14 trials selected for the key analysis: whether they were mainly therapeutic or prophylactic, for example, and whether the homeopathic interventions were classical, ‘clinical’ or complex homeopathy, or isopathy. Knowledge of these would potentially make a great difference to the inferences that should be drawn. Given the heterogeneity of homeopathy trials, it seems unlikely that the design and methods of just 8 can be representative of 110. Nor are we offered proper summary data on the odds ratios for effectiveness in the two sets of 110 trials overall; without such information, it is impossible to gauge the impact of having narrowed the analysis to just 8+6 trials. There are other bizarre features of this paper. On reading its text, it seems that only the literature between 1995 and January 2003 was included in the analysis. This would have built on a previous major meta-analysis of homeopathy trials (3). However, on examination of the web-table that lists all the references, it becomes apparent that 62 of the papers analysed were actually published before 1995. The remaining papers analysed were published from that year onwards, but some of the main articles during that time have not been included. Inexplicably too, a substantial number of the papers reviewed in the previous meta-analysis are absent from the new one. The wider view: Most independent scientific observers would regard this analysis as inconclusive in its results and opaque in some of its key methods and reporting. And it has the limitations of any analysis of clinical research in homeopathy that attempts to group together all homeopathic conventions of treatment and all medical conditions that have been investigated. A comprehensive analysis of that type can merely make overall conclusions and may miss specific areas of therapeutic importance – the authors themselves highlight (but dismiss) the fact that 8 trials of homeopathy in upper respiratory tract infections have strongly positive findings overall. It is for this very reason that we adopted an analysis of the homeopathic research literature that focused instead on individual clinical trials and their findings (reference 10 in ‘Research in Homeopathy’ section of this website) (4). The way forward: We certainly agree with the Lancet paper’s authors that ‘future research efforts should focus on … the place of homeopathy in health-care systems’ and about ‘the failings of modern medicine’. That should mean concentrating more on conducting trials that compare homeopathy properly and fairly with standard medical care. There remains a place for placebo-controlled trials, but these have to considered with insight and wisdom. These and other trial design issues in homeopathy should be properly informed by prior clinical observational research and well-conceived pilot trials. The Lancet publication has done nothing to inform this important field of research in the constructive or careful manner that it deserves. References: 1. Shang A, Huwiler-Müntener K, Nartey L, Jüni P, Dörig S, Sterne JAC, Pewsner D, Egger M. Are the clinical effects of homeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet 2005; 366: 726-32. 2. Weatherley-Jones E., Thompson EA, Thomas KJ. The placebo-controlled trial as a test of complementary and alternative medicine: observations from research experience of individualised homeopathic treatment. Homeopathy 2004; 93: 186-9. 3. Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 1997; 350: 834-43. 4. Mathie RT. The research evidence base for homeopathy: a fresh assessment of the literature. Homeopathy 2003; 92: 84-91.
Doctors reject Lancet report on homeopathy 26-08-2005, 4:45 pm News and Press Releases The report published in the Lancet on homeopathy on 26 August has been questioned by the Faculty of Homeopathy - the professional body that brings together GPs and hospital doctors who also practise homeopathy. Dr Peter Fisher, Clinical Director of the Royal Homeopathic Hospital, London said: “Having read this report, the figures do not stack up. The much-trumpeted conclusion about homeopathy being only a placebo is based on not 110 clinical trials, but just eight. My suspicion is that this report is being selective to try to discredit homeopathy.” In many conditions the effectiveness of homeopathy is supported by randomised clinical trials including asthma, fibrositis, influenza, glue ear, muscle soreness, pain, side-effects of radiotherapy, sprains and upper respiratory tract infections. Doctors train in and practise homeopathy precisely because a “disease-focused technology driven medical model” does not provide all the answers. Doctors working at the five NHS homeopathic hospitals have at their disposal all the tools of both conventional and homeopathic medicine but choose to use homeopathy where most appropriate for the patient. Sally Penrose, Chief Executive of the Faculty of Homeopathy said: “Patient outcome studies at the NHS homeopathic hospitals show that on average 70% of patients report positive health changes after homeopathic treatments - these are patients who have usually exhausted all the conventional options first and are coping with intolerable suffering.” See also: www.trusthomeopathy.org/case/res_debate.htm
National Centre for Homepathy www.homeopathic.org/pressrelease082505.html Press Release For Immediate Release Contact: Peter Gold August 25, 2005 860.674.1500 (office) 860.874.7743 (cell) email: peter_gold@goldorluk.com Prominent U.S. Research Scientists Counter Lancet Claims On Homeopathy Alexandria, VA.: Prominent U.S. scientists today strongly rejected findings on homeopathic medicine to be published in the August 27, 2005 edition of the Lancet. The study in question was the work of Aijing Shang and colleagues from the University of Berne in Switzerland. The U.S. scientists rejecting the conclusions of the study are Dr. Rustum Roy Ph.D. (Penn State University), Dr. Iris Bell, M.D., Ph.D. (University of Arizona) and Dr. Joyce Frye D.O., M.B.A. (University of Pennsylvania). “Shang et al. have successfully applied a methodological approach to the articles they reviewed that is highly suitable for drawing conclusions about conventional medicine but is incomplete in evaluating homeopathic medicine. They did not include criteria that would apply to high quality homeopathic research reflecting the nature of homeopathic practice. Such criteria include consideration of the quality of the homeopathy provided”, said Iris Bell, M.D., Ph.D. “Furthermore, a single remedy selection for a given conventionally-diagnosed condition is not homeopathy, yet there are numerous conventionally-judged high quality studies that were so designed. The analogy would be to test the effects of penicillin for all patients with symptoms of an apparent infection. The quality of the studies would otherwise be excellent in design. However, penicillin will not work for patients with viral infections or bacterial infections resistant to its effects or for persons with fevers from other non-infectious causes – and it thus might show benefit only for a subset of patients with symptoms of infections, i.e., the ones with true penicillin-sensitive infections. How would penicillin fare in a meta-analysis of studies designed to ignore the intrinsic nature of penicillin in benefiting patients”, said Bell. Joyce Frye DO, MBA commented that the study’s authors seemed to begin their work with a bias. “While their analysis clearly showed effects of homeopathic treatment – they found ways to disregard those. Out of the millions of trials in conventional medicine, their primary outcome relied on the comparison of ridiculously small numbers--8 trials of homeopathy and 6 trials of conventional medicine. They began their work with the assumption ‘that the effects observed in placebo-controlled trials of homoeopathy could be explained by a combination of methodological deficiencies and biased reporting’. Sound research is not conducted from this starting position.” Among other topics, the Lancet challenges the plausibility of homeopathic effects given that homeopathic remedies are often administered in dilutions in excess of Avogadro’s number. Dr. Rustum Roy, Ph.D. distinguished material scientist from Penn State University commented that the chemistry argument made in this study and by conventional medicine in general is false science. “The underpinning of the editorial content of the Lancet as it relates to homeopathy relies on a quaint old idea from the nineteenth century that the ONLY way that the property of water can be affected or changed is by incorporating foreign molecules. This is the Avogadro-limit high-school level chemistry argument. To a materials scientist this notion is absurd, since the fundamental paradigm of materials-science is that the structure-property relationship is the basic determinant of everything. It is a fact that the structure of water and therefore the informational content of water can be altered in infinite ways” ... Comments by Dr. Iris Bell, M.D., Ph.D. on Shang Study Published in Lancet Shang et al. have successfully applied a methodological approach to the articles they reviewed that is highly suitable for drawing conclusions about conventional medicine but is incomplete in evaluating homeopathic medicine. They did not include criteria that would apply to high quality homeopathic research reflecting the nature of homeopathic practice. Such criteria include consideration of the quality of the homeopathy provided. For example, isopathy is not homeopathy by definition, but Shang et al., as have other published meta-analyses on “homeopathy,” included isopathic studies in their analysis. What it means for a study of isopathy to be positive or negative on homeopathy is unestablished. Furthermore, a single remedy selection for a given conventionally-diagnosed condition is not homeopathy, yet there are numerous conventionally-judged high quality studies that were so designed. The analogy would be to test the effects of penicillin for all patients with symptoms of an apparent infection. The quality of the studies would otherwise be excellent in design. However, penicillin will not work for patients with viral infections or bacterial infections resistant to its effects or for persons with fevers from other non-infectious causes – and it thus might show benefit only for a subset of patients with symptoms of infections, i.e., the ones with true penicillin-sensitive infections. How would penicillin fare in a meta-analysis of studies designed to ignore the intrinsic nature of penicillin in benefiting patients? Publication bias of positive studies in the literature might reflect in part the variable ability of the researchers to recruit patients with penicillin-sensitive conditions and the politics - rather than the science - of publishing positive versus negative findings in medicine in general. Were there stated criteria as to the training, credentials, or even duration of experience of the homeopaths providing the care in each study? Did they assess the confidence of the prescriber in the remedy selection? An inaccurate prescription in homeopathy is widely known by homeopathic researchers to reflect an inactive “active” treatment. Placebo effects occur in many different conditions under a wide range of treatments. Shang et al. stated in their paper that they chose a single outcome measure for each homeopathy study. At face value, such a procedure does not reflect the integrative, whole systems effects that homeopaths claim for their treatments. Homeopathy by its nature stimulates changes over multiple systems of the whole person, with both global and multidimensional local changes in patients. Conventional drugs are designed to have specific effects; homeopathic remedies administered homeopathically always have more than a single specific effect. Shang et al. did not hold the conventional and the homeopathic trials to the criterion of global and multidimensional local changes. While sample size is small in many homeopathy studies because of limited funding and the early state-of-the-science need for preliminary studies to define the proper design parameters (as in any proper research effort), the Shang et al. paper does not support the conclusion that homeopathic remedies or conventional drugs cause only placebo effects. It does support the conclusion that homeopathic or conventional drug treatments in clinical trials can produce placebo effects. This is no surprise and does not logically support the conclusion that we should discard either homeopathy or conventional drugs, when each is properly applied. Patients may choose homeopathy or acupuncture or other forms of complementary and alternative medicine because of preferences and perhaps even the potential for responding. Randomized controlled trials do not necessarily recruit such patients – they take patients with a conventional diagnosis, but do not screen for patients who typically may gravitate to homeopathy or other types of complementary and alternative medicine. The scientific evidence in this regard is emerging in some studies and requires open-minded, albeit skeptical, consideration toward understanding the true nature and potential benefits of these treatments for some, but not necessarily all, patients with a given conventional diagnosis (e.g., Honda and Jacobson Use of complementary and alternative medicine among United States adults: the influences of personality, coping strategies, and social support. Prev Med. 2005 Jan;40(1):46-53; Bell IR, Lewis DA II, Brooks AJ, Schwartz GE, Lewis SE, Caspi O, Cunningham V, Baldwin CM. Individual differences in response to randomly-assigned active individualized homeopathic and placebo treatment in fibromyalgia: Implications of a double-blind optional crossover design. J Alternative & Complementary Medicine 2004; 10(2):269-283). A pressing challenge for the field of homeopathy research is to identify objective markers of true as opposed to placebo remedy effects in homeopathic treatment to enable proper research on the subset of patients who can be true responders to active homeopathic treatment. Our own laboratory group has preliminary data published in Medline, peer-reviewed journals on this issue (Bell IR, Lewis DA II, Schwartz GE, Lewis SE, Caspi O, Scott A, Brooks AJ, Baldwin CM. Electroencephalographic cordance patterns distinguish exceptional clinical responders with fibromyalgia to individualized homeopathic medicines. J Alternative & Complementary Medicine 2004; 10(2):285-299; Bell IR, Lewis DA II, Lewis SE, Schwartz GE, Scott A, Brooks AJ, Baldwin CM. Electroencephalographic alpha sensitization in individualized homeopathic treatment of fibromyalgia. International Journal of Neuroscience 2004; 114(9):1195-1220). We plan to pursue this research in the interests of science and towards identifying the subset of patients for whom homeopathy is beneficial. We invite other scientists to pursue similar studies toward improving clinical practice as opposed to studying publication bias.
... The Society of Homeopaths (U.K.) What's new Universal Condemnation for The Lancet's Stance on Homeopathy Scientists and experts from around the world are condemning the Swiss evaluation of homeopathy trials and The Lancet medical journal for publishing such a poor quality report on 26 August (1). Leading homeopaths and researchers from the USA, India, Greece, Canada, Italy, Ireland, Norway, Germany and the UK, many of them medically qualified, are calling for an end to this kind of attack on homeopathy. At least six previous similar evaluations of homeopathy trials have all shown an effect over and above placebo. One of these studies was published by the European Commission. The report professes to be based on 110 homeopathy studies, but in the end selected only 8 studies to draw the conclusion that homeopathy is no better than placebo. The article admits that some high quality studies showed that homeopathy works, but these were ruled out. “Out of the millions of trials in conventional medicine, their primary outcome relies on the comparison of ridiculously small numbers - 8 trials of homeopathy and 6 trials of conventional medicine.” says Dr. Joyce Frye, from the University of Pennsylvania. Prof. Chaturbhuja Nayak, Director of the India Central Council for Research in Homoeopathy, challenges the study: “It conflicts with the previous meta-analyses published in the same journal in the years 1994 and 1997 where homeopathy was proved to be effective. It seems that the authors have begun their work with a bias.” Medical doctors agree: Dr. Paolo Bellavite, professor of General Pathology, University of Verona and Dr. Giuseppina Pitari, professor of Biochemistry, University of L’Aquila, went further: “A prejudice against homeopathy is shown by the authors. As a matter of fact, there is much data to support the evidence of a physical and chemical plausibility of homeopathy along with a strong scientific consistency but this evidence has been ignored.” The Guernsey branch of the British Medical Association (BMA) has defended the inclusion of homeopathy in some of its doctors’ services. Mikel Aickin PhD, Research Professor at the University of Arizona commented: “The Lancet article appears to be part of a recent trend, in which medical journals are publishing articles of exceedingly low quality to justify attacks on controversial therapies.” The Lancet’s Senior Editor, Zoë Mullan, admits an inherent conflict on the part of the authors: “Prof Eggers stated at the outset that he expected to find that homeopathy had no effect other than that of placebo. His “conflict” was therefore transparent. We saw this as sufficient”. The international list of experts in homeopathy below, as well as their professional bodies, are calling for and end to such unjustified attacks on homeopathy. Ends……………. References 1. Shang et al . Are the clinical effects of homeopathy placebo effects? Lancet 2005;366 (9487):726-733 For the full critique of, “Are the clinical effects of homeopathy placebo effects?” by leading UK researchers in this field, Kate Chatfield and Clare Relton, see below: For further information please contact: Society of Homeopaths Melanie Oxley RSHom - Communications Manager 0845 450 6611 societyofhomeopaths@yahoo.co.uk Kate Chatfield RSHom - Researcher, University of Central Lancashire 01772 893697 kchatfield@uclan.ac.uk Clare Relton RSHom - Researcher, ScHARR, University of Sheffield 0114 22 20752 c.relton@sheffield.ac.uk Zoe Mullan - Editor, The Lancet, 0207 424 4910 (insert own national contacts as above) International contacts: Country, name & position, phone number, email address
... Are the clinical effects of homeopathy placebo
effects? K Chatfield, University of Central Lancashire C Relton. ScHARR, University of Sheffield The article by Shang et al (2005) can be critiqued on number of different levels and this response has therefore been broken down into sections for ease of referral. Each of the issues raised should have been considered by the authors of the paper during production and should also have been raised during the Lancet’s peer review process prior to acceptance for publication. The fact that these issues have not been fully explored by the authors or publishers could suggest either a lack of understanding of research in homeopathy or a deliberate attempt to mislead. METHODOLOGICAL ISSUES Matching In their report Shang et al (2005) purport to match 110 homeopathy trials with 110 allopathic trials. Their description of how these trials were matched according to similar conditions and similar outcomes leaves many questions unanswered. What exactly do they mean by similar? How similar are the conditions that are matched? Variation between patient cohorts and severity of complaint do not appear to have been taken into consideration. Of the total number of homeopathy trials 16% involve individualised (classical) prescribing. This involves a lengthy case-taking and hence greater chance of the therapeutic relationship influencing the effects of treatment. Hence the trials involving classical homeopathy, a complex intervention, should have been matched with corresponding trials of complex interventions rather than with simple interventions such as pharmaceutical drugs. Selection of the final 8 homeopathy and 6 allopathy trials Of the total 220 trials the authors identify 21 homeopathy trials and 9 allopathy trials that are of higher standard according to their own set criteria. Yet they present no comparative analysis of this subset of trials. They then proceed to further select the small subset of purportedly larger and higher methodological quality trials (8 homeopathy trials and 6 conventional medicine trials) from which the paper's main conclusion is drawn. The authors fail to describe the weighting of the two attributes size and methodological quality. The authors do not provide an explanation as to how they chose the particular cut off point that they used to select the final 14 trials. The choice of the two parameters of size and methodological quality at first appears to be reasonable but is problematic for homeopathy trials for the following reasons: 1. High methodological quality in meta-analyses is defined as high internal validity but ignores whether the study has any external validity – its clinical relevance and its general real world applicability of the study findings. In placebo controlled RCTs, high internal validity is gained at the expense of low external validity such that those of apparent high quality often bear little relation to real world practice or relevance. There are difficulties in attempting to research any complex health care intervention such as individualised homeopathy. Careful modelling of complex interventions is essential to ensure that interventions fit with and reflect the complexities of the settings within which interventions will be applied, and to ensure that the outcomes chosen are those most appropriate to demonstrate any benefits or risks. 2. The use of trial size as a parameter introduces potential bias for the homeopathy trials that is not addressed in the authors’ discussion. The largest trials are ones funded by pharmaceutical companies. Pharmaceutical companies fund trials of isopathy and complex homeopathy, usually in the area of prevention (because that will involve more people potentially buying the product). Isopathy and complex homeopathy are the crudest and least clinically effective forms of homeopathy. The largest trials are subject to the bias of pharmaceutical profit funding, where the decision to fund a study will be based on potential pharmaceutical profit rather than the clinical relevance. The authors fail to identify specifically the particular trials that are used in the final analysis that would enable a fair critique of the validity of the included trials. Elucidation of the rationale for choosing this small number of studies as well as a list of which studies this seemingly comprehensive interpretation was drawn from is essential. Statistical analysis It would be normal practice when comparing two different treatment options to measure the statistical difference between the two options for a fair comparison. The authors fail to do this, presumably as this calculation shows clearly that there is no statistical difference between the effects of the two interventions. That is, the statistics tell us that there is no basis for saying that allopathic intervention is any better than homeopathic intervention. The authors use particular criteria for selection of trials that they define as being of higher quality. Of the 220 trials only 21 homeopathy trials and 8 allopathy trials meet these criteria for high quality. With such a small number of trials meeting the criteria and with there being a significantly larger number of homeopathy trials, the authors should have stopped at this point and concluded that: 1 there are not enough high quality trials on which to carry out the analysis, and 2 that the difference between the quality of the homeopathy and the allopathy trials invalidates the matching. The authors went to the great trouble of selecting 110 homeopathy trials that met their inclusion criteria, matching them with 110 allopathy trials and then ignored all but 8 trials of homeopathy and 6 of allopathy in their final statistical analysis. Moreover the original stated intention to compare trials of similar condition and outcome has been ignored in the final analysis. The final small subset of trials is not matched at all suggesting that different kinds of trials are being compared, apples are being compared with oranges – a common failing in meta-analyses. INTERPRETATION BIAS The authors generalise from an extremely small pool of data to draw their apparently broad and negative conclusions. Their statistical analysis and interpretation of results can be challenged in many respects and their main conclusion that their “findings are compatible with the notion that the clinical effects of homeopathy are placebo effects” is unfounded. While sample size is small in many individualised (classical) homeopathy studies because of limited funding and the early state-of-the-science need for preliminary studies to define the proper design parameters (as in any proper research effort), the Shang et al. paper does not support the conclusion that homeopathic remedies or conventional drugs cause only placebo effects. It does support the conclusion that homeopathic as well as conventional drug treatments in clinical trials can produce placebo effects. This is no surprise and does not logically support the conclusion that we should discard either homeopathy or conventional drugs. (Bell,2005) The authors display their own bias in interpretation when they dismiss out of hand the substantially beneficial pooled effect from 8 trials of homeopathic remedies in upper respiratory tract infections. This in spite of the fact that the trials perform well in the authors own set test of funnel plot asymmetry which demonstrated that there was no significant difference between effects in the higher quality trial and the lower quality trials. Here the authors speak of biases prevalent in these publications to excuse the effect without specifying in any way how they relate to these trials and indicate that conclusions from these trials cannot be trusted. META-ANALYSES Any meta-analysis of homeopathy will inevitably be considering only a small number of trials as there are relatively few for any one condition. This leads to the pooling of heterogeneous data, a fact so often completely ignored. Meta-Analyses as a tool are akin to public surveys to glean opinions about a politician. They are of vague value but do not reflect individual truths which may carry much more meaning. That is especially true of a meta-analysis of homeopathy, a science in which individualization of prescription and interpretation of response isfundamental to success. Meta-analyses flatten diversity and minimize nuggets of truth by imposing criteria exclusive to allopathic protocols. (Gray 2005) In this report Shang et al (2005) different types of prescribing method for homeopathy trials are all considered equally. Of the 100 trials selected only 18 (16%) deemed classical homeopathy i.e. the type of individualised prescribing that occurs in real life and there is no indication of how many of the selected 8 trials involved this type of prescribing. RANDOMISED CONTROLLED TRIALS AND HOMEOPATHY The authors’ conclusions are premised upon the supposition that the placebo controlled randomised trial represents the gold standard against which all research should be judged. It is becoming increasingly understood that there are considerable problems in using this method to test complex interventions such as homeopathy. It is always going to be difficult to adopt the reductionist research method of the placebo controlled RCT to measure effects of complex intervention such as homeopathy. Two primary concerns for homeopaths are that the treatment is holistic and that it is individualised. Treatment cannot be standardised and patient response is unpredictable. RCTs are looking for specific effects whereas homeopathy is attempting to produce general health effects as well as specific effects – homeopathy treats the whole person. Patients may choose homeopathy or acupuncture or other forms of complementary and alternative medicine because of preferences and perhaps even the potential for responding. Randomized controlled trials do not necessarily recruit such patients – they take patients with a conventional diagnosis, but do not screen for patients who typically may gravitate to homeopathy or other types of complementary and alternative medicine. The scientific evidence in this regard is emerging in some studies and requires open-minded, albeit sceptical, consideration toward understanding the true nature and potential benefits of these treatments for some, but not necessarily all, patients with a given conventional diagnosis (Bell 2005) “Actually there is no threat to anyone. Each system has its strengths and limitations. If we work hand in hand, and not against each other, it will really benefit our patients. In order to do this it is important to understand the other system, and evaluate it according to its principles and not see it from the view point of the other system.”. (Sankaran 2005) Rowlands G. Family Practice. 22(1):132-9, 2005 Feb Additional references available http://www.homeopathycourses.com/lancet.html Authors K Chatfield, University of Central Lancashire C Relton. ScHARR, University of Sheffield ... European Counci of Classical Homeopathy (ECCH) Who's biased? The Lancet declares 'the end of homeopathy" Stephen Gordon, General Secretary, ECCH Statistics: the only science that enables different experts using the same figures to draw different conclusions - Even Esar For 200 years homeopathy has suffered the slings and arrows of a frustrated medical establishment. Frustrated because they cannot understand how homeopathy's potentised remedies can work and frustrated by the fact that millions of patients around the World find that homeopathic treatments have worked for them nonetheless. That frustration has now led the editor of the Lancet to publish a flawed piece of statistical analysis (1) and trail it widely through the media in one more desperate attempt to kill homeopathy off. The study featured is a comparative statistical analysis of a number of placebo-controlled trials of homeopathy and conventional medicines and not hard research in itself. The study talks a lot about the effect of bias in research studies - both homeopathic and conventional. Yet statistics themselves are famous for their potential to be biased. The researchers in this study set out their prejudices about homeopathy from the start when in the first paragraph they declare that 'the specific effects of homeopathy seem implausible". Then in the discussion section of the paper they make the following extraordinary statement.: We assumed that the effects observed in placebo-controlled trials of homoeopathy could be explained by a combination of methodological deficiencies and biased reporting. Conversely, we postulated that the same biases could not explain the effects observed in comparable placebo-controlled trials of conventional medicine. Our results confirm these hypotheses:" These pre-assumptions exhibit extreme bias from the start of the study and are totallly inappropriate in a study that sets out to objectively compare two different methodologies. Here alone the study fails by its own standards - not to mention by proper scientific standards. In his editorial the Lancet editor writes " Going one step further, the Swiss Government, after a 5 year trial, has now withdrawn insurance cover for homoeopathy and four other complementary treatments because they did not meet efficacy and cost-effectiveness criteria." The Lancet paper was used to justify this decision. What he doesn't mention is that the study he has published is one of several studies carried out to inform the Swiss Government on the place of complementary therapies in the Swiss healthcare insurance scheme. A second far more practical study had as its results that complementary medicine (incuding acupuncture, homeopathy and phytotherapy) is as effective as conventional medicine in a range of complicated and chronic conditions and at least as cost-effective. Of the therapies included homeopathy had the best results. However, the results of this study were suppressed and their dissemination actually forbidden on pain of legal prosecution until after the Government had stopped the insurance scheme that paid doctors to provide complementary therapies. Furthermore when the Government appointed commission wrote in its draft report that homeopathy should continue to be included in the insurance scheme pressures were brought to bear to have the paragraph removed from the final report. So bias and selective publishing of results are present at all levels. The editor of the Lancet is as known for his antipathy to homeopathy in the UK as Professor Egger is in Switzerland. The Lancet recently rejected a UK study of a large number of cases of homeopathic treatment provided in an NHS setting which showed high levels of effectiveness and high levels of patient satisfaction. No doubt the study from Germany featured in the article below this one would have been rejected too. As was quoted from Kant in the Lancet editorial ' we see things not as they are, but as we are.' To be generous to the Lancet editor however he did get it right when at the end of his editorial he tacitly implied that homeopathy offers personalised care to patients. Good homeopathic treatment is individualised to each patient. This is why it works and why patients will continue to want it. NB a considered critique of the statistical analysis in the Lancet paper will follow this short article at a later date. References: 1) Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Aijang Shang, Krain Huwiler-Mûntener, Linda Nartey, Peter Juni, Stephan Dörig, Jonathon A C Sterne, Daniel Pewsner, Matthias Egger Lancet (2005); 366: 726-32 ... New German study shows homeopathic treatment to be superior to conventional treatments across a range of conditions and with similar cost levels The latest volume of Complementary therapies in Medicine contains a report of a research study evaluating the effectiveness of homeopathy versus conventional treatment in routinecare.The analyses of 493 patients (315 adults, 178 children) indicated greater improvement in patients’ assessments after homeopathic versus conventional treatment (adults: homeopathy from 5.7 to 3.2;conventional, 5.9—4.4;p = 0.002; children from 5.1 to 2.6 and from 4.5 to 3.2). Physician assessments were also more favourable for children who had received homeopathic treatment (4.6—2.0 and 3.9—2.7; p < 0.001). Overall costs showed no significant differences between both treatment groups (adults, D 2155 versus D 2013, p = 0.856;children, D 1471 versus D 786, p = 0.137). The study report concludes that: patients seeking homeopathic treatment had a better outcome overall compared with patients on conventional treatment, whereas total costs in both groups weresimilar. Outcome and costs of homoeopathic and conventional treatment strategies: A comparative cohort study in patients with chronic disorders. Claudia Witt a ,_, Thomas Keil a, Dagmar Selima, Stephanie Roll a, Will Vancea, Karl Wegscheider b, Stefan N. Willicha Complementary Therapies in Medicine (2005)13,79—86 ... Boiron laboratories Article in The Lancet A new episode: The success of homeopathy is problematic to some, once again and as always A study on the specific effects of homeopathy has been published in the August 27th issue of the weekly review, The Lancet. The editorial page of this issue draws certain astonishingly-polemic conclusions about homeopathy. Boiron laboratories, world leaders in homeopathic medicines, question what might motivate such relentless discrediting of homeopathic medicines which are prescribed by 150,000 physicians to 300 million patients throughout the world. Such relentlessness is even more surprising since the scientific basis of this publication is both criticizable and dubious, to say the least. 1. In reality, this is an analysis which confirms the conclusion of 3 previous meta-analyses* that con-cluded that homeopathic medicines were effective. As if these findings were intolerable, the authors of the study subsequently and arbitrarily chose to eliminate a number of trial series, only retaining 14 out of the 220 initial studies and leading to final conclusions which are unfavorable to homeopathy. This manner of pro-ceeding is quite simply unacceptable from a scientific point of view; it allows the authors to draw conclusions that are erroneous and probably of ill intent. Who will benefit from this publication? That is the real question. 2. This publication has arisen at a time when, in recent months, allopathic medicines have been seriously called into question concerning their effectiveness and worth. This is a most troubling coincidence. 3. In addition, The Lancet's offensive has occured, strangely enough, at a time when a preliminary World Health Organization report on homeopathy has drawn conclusions that are favorable to homeopathy. Is it possible that The Lancet has taken offense due to this, and is attempting to put pressure on the W.H.O.? This is one question that comes to mind when perusing this totally-polemic and non-scientific editorial. 4. Is The Lancet now joining the anti-homeopathy lobby, in contempt of all scientific stringency? It is apparent that this is a new dishonorable manipulation of medicine, a dishonor to the millions of patients every day who benefit from homeopathic treatments. The success of homeopathic medicines perturbs and upsets established order. Boiron laboratories, which have always contributed to developing scientific, rigorous and medical homeopathy, announce that their investments in research and studies will be multiplied eightfold over the next three years. For Christian Boiron, chairman of Boiron laboratories, "Science is the true cradle of homeopathy. And thanks to science we are progressing daily in our search for better medicinal effects. For over 200 years homeopa-thy has globally demonstrated its therapeutic worth. This is no longer the time for doubt and sectarianism; the time has come for the systematic study of the possibilities and limits of homeopathic medicines in each disease." More information on research in homeopathy *Clinical trials of homeopthy. British Medical Journal (1991). Report to the European Comission (1996). A meta-analysis of placebo-controlled trials The Lancet (1997) ... Begin forwarded message: From: Jagannath Chatterjee <jagchat01@yahoo.com> Date: September 1, 2005 7:00:33 AM CDT Subject: [hpe] Indian Govt takes on Lancet Report. Dear Friends, Incensed by the Lancet Report signalling the "End of Homeopathy", the Govt of India has declared it will supply the Lancet magazine with all data required to show that homeopathy really works. It has said that homeopathy has been extremely popular in India ever since Dr J M Hoenigberger arrived in 1839 to treat Maharaja Ranjit Singh of Punjab, curing him of paralysis of vocal chords and oedema. Dr Hoenigberger then settled at Calcutta (now Kolkata) for a long time before returning to Germany. Calcutta is supposed to be a bastion of Homeopathy in India as eminent public figures studied the science, translated Hahnemann's works, wrote about their own findings and even discovered new drugs. The homeopathic physicians of India have equally condemned the report citing statistics about the growing popularity of homeopathy in India. Dr Ramadoss, the Union Health Minister, and a physician himself, said that in today's scenario, even modern doctors were not averse to refer their patients to homeopathy. A report said that 87% of the physicians in India believed that homeopathy works. The homeopaths in India were equivocal in pointing out that it was the growing popularity of homeopathy that had led the drug industry to sponsor the unethical and flawed report. They said it was surprised that Lancet, which had previously published reports that homeopathy works, would do a turnaround and declare the "end of homeopathy". They said homeopathy was in the threshold of a new dawn. Only the Times of India in India has published the Lancet Report. And now today it has published the statement of Dr Ramadoss prominently thus atoning for its earlier sins. Homeopathy has a very large following in India and has been officially recognised since 1937. Regards, Jagannath. ... Newind Press Newindpress.com Expert questions findings in homeopathy research Friday September 2 2005 11:30 IST BHUBANESHWAR: President of the Indian Institute of Homeopathic Physicians and principal-cum-superintendent of Dr Abhin Chandra Homeopathic Medical College and Hospital here, Dr Niranjan Mohanty has questioned the research findings of Professor Matthias Egger which maintained that ‘‘homeopathic drugs worked no better than a placebo’’. In a release issued here, Mohanty wondered how researchers of a medical science other than homeopathy could conduct research on its efficacy. “It is like a history professor conducting research on physics on nano particles and coming out with findings,” he said. He said the team has adopted a standard protocol of research and used statistical tools with double blind control trials to reach conclusions. It did not apply the principles and axioms of homeopathic science like individualisation, similia similibus, minimum dose and single remedy. Homeopathic medicines were applied on principles of allopathy for research experimentation which is no homeopathy, he observed. Alleging that the findings of professor Egger’s team are unscientific, Dr Mohanty maintained that there is no standard and specific homeopathic drug for any particular ailment. The homeopathic practitioners apply their brain and prescribe different drugs for different persons on the basis of symptoms and behaviour, he said. Dr Niranjan Mohanty claimed that he has conducted several research studies with double blind control trials where homeopathic drugs have proved effective on diseases such as bronchial asthma, allergic rhinitis, rheumatic fever, rheumatic arthritis and osteo-arthritis. Mohanty wondered how researchers of a medical science other than homeopathy can conduct research on its efficacy. WebNewindpress ... www.homeopathycourses.com/lancet.html Lancet's Bias and Conflict of Interest - By Louis Klein RS Hom. Lancet has published what appears to be a report on double blind studies of homeopathy. The real story is that the authors of the report admittedly eliminated trials of homeopathy that proved it works but that they deemed did not meet their criteria. They also, knowingly, did not accept homeopathy’s methodology which is not measured accurately by the type of studies they chose. Other expert researchers have criticized the report for this and other reasons. “They did not include criteria that would apply to high quality homeopathic research reflecting the nature of homeopathic practice. ", said Iris Bell, M.D., Ph.D., a world renowned researcher from the University of Arizona. Joyce Frye, a researcher from the University of Pennsylvania, also criticized the small sampling of studies used, “While their analysis clearly showed effects of homeopathic treatment - they found ways to disregard those. Out of the millions of trials in conventional medicine, their primary outcome relied on the comparison of ridiculously small numbers--8 trials of homeopathy and 6 trials of conventional medicine.” The chief author of the study, is a known by homeopaths in Switzerland as actively anti-homeopathy. In the last 14 years, there have been many meta-analyses of the homeopathic literature, all coming out in favour of homeopathy. Only one of these meta-analyses - the smallest one, that covered only three trials - is mentioned by the study. And in spite of the small sampling used in their study, Lancet’s editors included an editorial proclaiming the “end of homeopathy”, (would they do the same thing if someone took the same number of trials and said that about regular medicine?). In the same edition, there was another editorial railing against the World Health Organization’s upcoming positive report on homeopathy. The editors made pleas for doctors to not accept alternative health modalities and paternalistic proclamations such as, “It is the attitudes of patients and providers that engender alternative-therapy seeking behaviours”. In other words, according to them, looking for an alternative is not a choice but a pathological behaviour. Why has homeopathy stimulated such an unscientific response from the editors of Lancet? Homeopathy challenges many of the assumption of modern medicine by virtue of it having a clear and consistent philosophy of individualized approach. Homeopathy also enhances the pioneering efforts made in modern physics by virtue of it being an energy medicine. Not only that, it has become extremely successful in Europe and many other countries in the world. Its phenomenal growth and patient satisfaction has alarmed many researchers and physicians alike who rely on a certain and specific type of patient compliance. The response by Lancet is similar to the Catholic Church’s response to Galileo’s assertion that the earth revolves around the sun and not the other way around. Many scholars of the time came out in such support of the Church’s “science” and inquisition that Galileo was forced to recant his assertion publicly. In spite of Lancet’s claim that the body is a sum of chemical processes and measured only by a specific double blind, there is a new, more profoundly modern view of the human body based on quantum physics and other advances in science, which is encompassed in homeopathic methodology and preparation. Chronic and acute disease continues to advance at an alarming pace even though modern medicine consumes and profits from an enormous amount of public and private resources. The structure of medicine is straining to a point of collapse. This can only be a demonstration that the fragile underpinnings of modern medicine are crumbling. A simultaneous increased patient awareness and documentation of serious iatrogenic (negative drug-related) effect with the resultant publicity has created such a defensive posturing. The very same researchers authoring the Lancet report have created and utilized the type of trials that have not effectively vetted drugs for serious life threatening side-effects. Homeopathy's stunning lack of side effect and lack of contra-indication yet profoundly curative action creates a conundrum for this methodology. In all of this, what is clear is that homeopathy will survive the dark ages of crude drugs and medicine’s controls. Homeopaths do not claim they help everyone or that their patient’s should abandon all of regular medicine. But the editors of Lancet stress that only they should approve what is good for everyone. Unbiased evaluation of the effective trials and studies of homeopathy will demonstrate its curative power. Even regular medicine itself and physicians benefit from alternatives such as homeopathy. It is not the end but an auspicious beginning. ... By Dr Rajan Sankaran, Vice-chairman For Asia of
International Council of Classical Homeopathy The Lancet has published an editorial against Homeopathy based on what appears to be a report of studies of homeopathy. Such a report is biased and not valid for several reasons.The fundamental reason is that Homeopathy is an individualized system and cannot be subject to mass testing like modern medicine. It is a system based on accurate prescribing for each individual patient and will fail if the same remedy is applied to everybody with a similar diagnosis. That is the fundamental difference between the two systems. The Lancet article also does not mention the types of trials done and whether it was truly Homoeopathy that they tested. The Lancet editorial condemns the homeopathic system that, according to it, is growing more and more popular. Nothing sustains a form of medicine for 150 years unless it is effective. Homeopaths today successfully use the same remedies that were used 150 years ago, in addition to adding new ones to their material medica. In contrast, modern medicine keeps discarding many of its wonder drugs once their side effects become known. Homeopathy is based on a definite philosophy, backed by precise observations of remedy effects and a very well recorded register of remedies. It has been a very consistent system and several modern medical practitioners who seriously looked into it with an open mind became homeopaths themselves, never to turn back. Homeopathy is getting more and more popular all over the world. Its results challenge the fundamental assumptions of modern medicine. This should send alarm signals to the billion dollar pharmaceutical industry and to rigid modern medical practitioners. One wonders if biased reporting on Homeopathy stems from this perceived threat. Actually there is no threat to anyone. Each system has its strengths and limitations. If we work hand in hand, and not against each other, it will really benefit our patients. In order to do this it is important to understand the other system , and evaluate it according to its principles and not see it from the view point of the other system,. A modern medicine model of testing is not applicable to homeopathy. It is like comparing oranges and sheep. Many diseases of modern times -- allergies, auto immune conditions, psychosomatic conditions, etc. -- find no solution in modern medicine. It should be noted that as many as 200 years ago Homeopathy had already described the oneness of the mind and body and how to use this fact in treatment. This is something that modern medical doctors acknowledge. Homeopathy's effectiveness, lack of side effects and holistic approach to health make it the medicine of choice for more and more right thinking people. Its individualized approach is its cornerstone. And if someone really wants to see its effectiveness, a study of its results at the hands of a good practitioner needs to be done. Fortunately many such studies exist and have shown the incredible effect of homeopathy. Having practiced homeopathy for over 25 years, I can say that I see everyday what homeopathy can do and how it affects the entire quality of life of the patient, in addition to helping his complaints. It is a priceless gift to humankind and it is now that it is needed the most. Let not some people with blinkers, speaking from high podiums, mislead the public. I am sure that no one who has been benefited by homeopathy is going to be fooled. This system of medicine, like the truth, shall prevail and grow more and more popular. This is not the end of Homoeopathy; this is the beginning. ...
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