Feeling better from homeopathy no more than placebo effect?

The Lancet, a leading British medical journal, published an article in August of 05 which would like us to think that homeopathic medicine is no more effective than placebo. Statistics can be manipulated to fit any opinion. Select which double blind studies are not homeopathy-friendly and use those as evidence that homeopathy is no better than placebo, and of course you will find your conclusions to be biased against homeopathy.

The arguement that homeopathy is merely placebo has been used to discredit homeopathic medicine for nearly 200 years. Physicians specializing in homeopathic medicine have countered that if it's placebo that's at work here, then how can it work on a person in a coma? Or a baby?

You are invited to read on, and make your own conclusions... The article that follows is reprinted from Toronto's Globe and Mail. It is followed by two press releases in response to the Lancet article, the first by the British Homeopathic Association, the second by the National Center for Homeopathy.

25/08/2005 6:44:00 PM 

TORONTO (CP) - Homeopathic remedies may help people feel better, but their impact appears to be no greater than a placebo effect, a comparison of more than 200 studies of the alternative medicine and conventional treatments concludes.

Homeopathy, which aims to stimulate a patient's own healing processes with minute dilutions of specific remedies, is based on the theory of treating "like with like." The patient describes symptoms in detail and the practitioner prescribes tiny, non-toxic doses of a selected substance that, at higher doses, would produce those symptoms in a healthy person.

A group of international researchers wanted to determine whether homeopathic medicine actually works beyond the power of suggestion.

"We do know that people do get better with homeopathy," said co-investigator Dr. Matthias Egger, head of social and preventive medicine at the University of Bern in Switzerland. "I have friends who tell me they went to see a homeopath and got better.

"But the question is how does it work?"

After searching the medical literature, the researchers distilled 110 studies that compared homeopathic remedies to placebo, or dummy pills, and an equal number that compared conventional medicine treatments to placebo.

The team, whose paper appears Friday in the Lancet, matched the studies to ensure patient profiles were similar and the ailment being treated was the same. Ailments included respiratory tract infections, asthma and gastrointestinal problems.

Because small studies tend to produce effects that appear significant but may actually be misleading, the authors limited their analysis to patient trials for both homeopathic and conventional therapies that were well-designed and involved large numbers of patients.

"What we saw was when you looked at these good, large studies, you did no longer see an effect for homeopathy, whereas you still saw an effect for conventional medicine," Egger said Thursday from Bern.

"Conventional medicine interventions did better than placebo, whereas the homeopathy interventions basically did the same as placebo."

Egger stressed that the researchers aren't disputing patients' reports that taking homeopathic remedies makes them feel better.

"It just means that the reason why they feel better is probably not because of that little white pill," he said. "It's more likely to be due to the fact that they see someone, spend quite a bit of time with someone who takes a very detailed history of his or her symptoms and gives a lot of attention to this patient."

But Toronto naturopath Ruth Anne Baron disputed the researchers conclusions.

"They're saying that by looking at these 110 studies and subjecting them to this kind of statistical analysis that it conclusively proves that homeopathic treatment is no better than placebo," said Baron, president of the Ontario Association of Naturopathic Doctors.

"Now, all of us who use homeopathy clinically would definitely argue with that, and patients who use homeopathy would argue with that, as well.

"The homeopathic effect, I have felt it myself, I have seen it in my patients, but it's very elusive, it's so difficult to quantify it," she said. I personally believe we don't have a fine enough measurement tool yet."

Baron said the Lancet analysis involved studies using several different homeopathic approaches, not all of them considered valid by many practitioners. Furthermore, the alternative medicine system can't be studied using the same methods as conventional medicine, she added.

"One of the challenges always of studying homeopathy is that the basic, core premise of the homeopathic prescription is you must prescribe on the basis of the individual symptoms of the patient.

"We always come up with this big stumbling block with trying to study homeopathy in the same way that we study conventional medicine, which is: 'Here's the condition, here's the medicine. Let's put some (patients) on the medicine, others on placebo.'

"So it would be argued by homeopaths that the only valid study of the homeopathic effect is by doing the homeopathic technique, which is giving them the exact medicine that best supports that person's symptoms and comparing that to a sham treatment.

"The problem is you can't compare, they're very different approaches."

In an editorial accompanying the research, the Lancet writes that the conclusion drawn by Egger's team is not surprising. "Of greater interest is the fact that this debate continues, despite 150 years of unfavourable findings. The more dilute the evidence for homeopathy becomes, the greater seems its popularity.

"Surely the time has passed for selective analyses, biased reports or further investment in research to perpetuate the homeopathy versus allopathy (conventional medicine) debate. Now doctors need to be bold and honest with their patients about homeopathy's lack of benefit and with themselves about the failings of modern medicine to address patients' needs for personalized care."

Egger agrees there is a need for conventional doctors to offer patients the kind of personalized attention provided by homeopathic practitioners, because it appears to promote healing.

"The problem is that conventional doctors try to do this, but they often find it more difficult to do," he said. "For example, in the U.K. and also in Canada, they are basically in a strict system and the system to some extent dictates how long they can spend with a patient in a normal consultation.

"At the end of the day, it's all about costs."

Here are some facts about homeopathy:

WHAT IT IS:

-A method of healing based on the idea that substances causing specific symptoms in a healthy person can cure these symptoms in someone who is sick.

-Derived from the Greek "homeo," meaning same, and "pathos," meaning suffering.

-The remedies, among them pills and liquids, are prepared from plant, mineral and animal extracts that are highly diluted in a specific way that makes them non-toxic.

WHERE IT CAME FROM:

-Homeopathy was developed by German physician Samuel Hahnemann, who first published his treatise on treating illness in 1810. The sixth edition of Organon of Rational Therapeutics, published in 1921, is still used today as homeopathy's basic text.

THE CONTROVERSY:

-In the latest scientific questioning of homeopathy, an analysis of more than 200 international trials concludes the alternative medicine system may make patients feel better, but the impact is no greater than that of the placebo effect - a beneficial result that occurs because of a patient's expectation that the therapy will help.

-Practitioners and proponents of homeopathy dispute that the "homeopathic effect" is merely psychological.

QUICK QUOTE:

"If it is truly a placebo effect, isn't that a fine medicine. No side-effects. The symptoms are fine, the patient feels better. Perhaps we should be looking at how we could better harness the placebo effect, because it's certainly better than toxic side-effects that we have in many conventional medicines. . . . But I'm not granting that it is a purely placebo effect." - Toronto naturopath Ruth Anne Baron.

Lancet article is fundamentally flawed
07-09-2005, 3:02 pm
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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. 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. 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. 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).

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.

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NCH Press Release
August 25, 2005
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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"