homeopathy

[mahakala]

Benefits and risks of Homoeopathy:

a rejoinder to the article published in the Lancet

Prof. Chaturbhuja Nayak

Director,

Central Council for Research in Homoeopathy

New Delhi, INDIA

The Lancet has recently published a comment entitled “Benefits and risks of homoeopathy”1. The commentator Ben Goldacre has denigrated Homoeopathy by citing the results of five studies2-6 which have not produced statistically significant benefit over placebo. But, he has taken a partial view of the results of some of the studies, referred by him, where the authors have not totally branded homoeopathy as placebo response. Rather the authors have admitted that there was some evidence that homoeopathic treatments are more effective than placebo, that the evidence of clinical trials is positive. However, they have suggested to undertake further high quality studies to confirm these results. While many high quality trials with proven efficacy of homoeopathy have been done, Ben Goldacre has cherry-picked five only to suit his own conclusions.
ii. Goldacre has rightly cited that during the Cholera epidemic in the 19th century, death rate at London Homoeopathic Hospital was three times lower than those at Middlesex hospital. While admitting that the then contemporary treatments were harmful, he is not ready to accept the credibility of London Homoeopathic Hospital, where the mortality rate was three times less than an allopathic hospital. On the other hand, he jokes, “the homoeopathic treatments were at least inert”. How could the inert homoeopathic medicines result in 3 times less mortality than the conventional medicine?
iii. The homoeopathic doctor knows that the medicine he is administering to his patient is surely more effective than placebo. As such, the question of violating the informed consent and autonomy of the patient, as stated by Goldacre, does not arise.
iv. Goldacre’s comment that “ a routine feature of homoeopathy marketing practice is to denigrate mainstream medicine” is quite malicious and aims at widening the rift between the Allopathy and Homoeopathy practitioners. Most of the qualified homoeopathic doctors usually do not criticise the Allopathic treatment, nor do they advocate against the established prophylactic programmes, as alleged by the commentator. Rather, most of the Indian qualified homoeopathic doctors advise the patients to follow the immunization programmes which are universally accepted. They also do not undermine public health campaign, do not leave their patients exposed to fatal diseases, nor disregard fatal diagnoses, as commented. To the chronic patients who have been under Allopathy treatment for a long time, whenever switch over to homoeopathy for the reasons best known to them, the conscientious and qualified homoeopathic doctors usually do not advise to stop the previous treatment abruptly, particularly in conditions like Diabetes Mellitus, Bronchial Asthma, Epilepsy, High BP, mental illnesses etc. Rather they advise to continue the previous therapy along with the homoeopathic treatment, for certain period. On the basis of further response, the patient is advised either to continue the previous one as such or in tapering doses or to stop.
Goldacre should remember that, there are negligent, incompetent and irresponsible doctors in every medical stream. If a surgeon leaves an instrument inside the chest or abdomen, after completing the operation, should we undermine Surgery or Allopathy? For the fault of a few homoeopathic doctors, the entire system should not be crucified.
v. Ben Goldacre has opined that publication bias in alternative therapy journals is high. But he has referred to an article7 where the authors have observed that the publication bias in alternative medicine has come down in 2000 when compared to 1995. The commentator’s criticism of ‘lack of a culture of critical self-appraisal in alternative medicine’ is quite unfortunate and far from reality.
vi. Goldacre has referred to the article6 published in the Lancet (2005, vol-366) which denigrated homoeopathy as placebo response. In the said article, the authors have analysed 110 homoeopathy trials and 110 matched conventional medicine trials. Table-2 of the article shows that they have screened 21 (19%) Homoeopathy trials and 9 (8%) Allopathy trials as the high quality trials (double blind, with adequate generation of allocation sequence and adequate concealment of allocation). In reality, they have framed their opinion by analyzing the outcomes of 08 homoeopathic trials and 06 conventional medicine trials, on the plea of considering large trials of higher quality. Instead of identifying 12 more allopathy trials of high quality to match 21 homoeopathic trials, it is not known, why they have come down to the unmatching ratio of 8:6. Did the authors fail to procure the additional high quality Allopathy trials to match the homoeopathic numbers?
vii. Homoeopaths never routinely respond to negative meta-analyses by cherry-picking positive studies, as alleged by the author. But, if the meta-analysis is designed to serve the malicious intention of the votaries of a particular system to belittle others and is not based on actual facts and truth, then the best option is to ignore it.
It is established beyond doubt that randomized placebo control trial (RCT) is not a fitting research tool to test homoeopathy, where the medicine is tailored to each individual patient, but not to the medical diagnosis. Besides considering the complaints of each patient and their variation at different times and under varying circumstances, his/her physical attributes and mental state are also taken into account to choose the most appropriate medicine. It is therefore, difficult to conduct double blind placebo control trials with homoeopathic medicines. Masking the therapeutic intervention from the therapists can not be conceived for in-vivo trials in homoeopathy and if done, results in inappropriate conclusions in outcome assessments. But the authors of the most of the meta-analyses whose results went against Homoeopathy, have wrongly come to conclusion by advocating that homoeopathy trials were of poor/low quality, on the pretext that those did not follow the tenets of RCT. Is it not irrational to judge a therapy by the bench mark which is not appropriate to that system, and compare two medical streams which are based on quite distinct and different doctrines and philosophies?
viii. The homoeopaths do not promote the only observational study8, as cited by Goldacre. There are a large number of human9-13 clinical trials, in vitro and in vivo studies on animal14-22 and plant23-27 models, which have been published in the internationally reputed journals and have been authored by the scientists of other disciplines. How could the diseased plants and animals respond favourably to homoeopathic treatment, had it been a placebo response!
ix. It is derogatory on the part of the Goldacre to comment that “Homoeopaths can misrepresent scientific evidence freely to an unsuspecting and scientifically illiterate public”. The people have been attracted towards homoeopathy, not by the advertisements made by a few homoeopaths, but by its effectiveness, absence of side effects, simple way of application of medicines and cost-effectiveness. The author’s criticism of “society’s eagerness to endorse the healing claims of homoeopaths” has no base since the society is bound to acknowledge the people’s satisfaction obtained through homoeopathic treatment. The Govt.’s recognition of homoeopathy, particularly in India, is based on the demand of the people owing to the success of homoeopathy in addressing the health problems of the people, but certainly not due to the healing claims of homoeopaths. Rather, the Govt. of India has enacted ‘Drugs and Magic Remedies (Objectionable Advertisements)’ Act, 1995 which prevents the practitioners from making unethical claims.
x. Goldacre’s observation that “homoeopaths have worked themselves off from academic medicine and critique has been all too often met with avoidance rather than argument” might be his own experience in his own country, but certainly does not hold good for all places, particularly for India. The reputed institutions and research scholars have their own portals and people can easily access to their academic and research activities. If his comment that “placebo could have a clinical role” is true, then the effect of medicine of any system could be told as placebo effect? Why is Homoeopathy alone targeted?
Homoeopathy has thrived on the basis of patients’ benefit and public acceptance due to its efficacy. It will never perish by the heinous propaganda of a few critics having bias and jaundiced views against Homoeopathy.

References:

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Beynen. :Does Chelidonium 3X Lower Serum Cholesterol? “The British Homoeopathic Journal, 76 (Jan.1987). <LI class=MsoNormal style="COLOR: blue; TEXT-ALIGN: justify; mso-layout-grid-align: none; tab-stops: list .5in; mso-list: l6 level1 lfo12">Christopher Day “Control of Stillbirths in Pigs Using Homoeopathy.” Veterinary Record, 114 (March 3, 1984): 216; reprinted in Journal of American Institute of Homoeopathy, 779 (Dec. 1986). <LI class=MsoNormal style="COLOR: blue; TEXT-ALIGN: justify; mso-layout-grid-align: none; tab-stops: list .5in; mso-list: l6 level1 lfo12">Christopher Day “Clinical Trials in Bovine Mastitis: Use of Nosodes for Prevention” The British Homoeopathic Journal, 75 (Jan.1986). <LI class=MsoNormal style="COLOR: blue; TEXT-ALIGN: justify; mso-layout-grid-align: none; tab-stops: list .5in; mso-list: l6 level1 lfo12">Lobreiro J. 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Assessment of cytogenetical damages in x-irradated mice and their alteration by the oral administration of a potentized homoeopathic drug, Ginseng 200. Perspective in Cytology and Genetics. 1992 Vol.7: 1217-1231. <LI class=MsoNormal style="COLOR: blue; TEXT-ALIGN: justify; mso-layout-grid-align: none; tab-stops: list .5in; mso-list: l6 level1 lfo12">Gupta G., B.P. Singh “Homoeopathy Drugs as Inhibitors of Tobacco Mosaic Virus”. Indian Journal of Homoeopathy, 1980 Oct. <LI class=MsoNormal style="COLOR: blue; TEXT-ALIGN: justify; mso-layout-grid-align: none; tab-stops: list .5in; mso-list: l6 level1 lfo12">Khanna K. K., and S.Chandra (1976a), Effect of Some Homoeopathic Drugs on the Spore Germination of Four Isolates oif Alternaria Alternata. Ind.Phytopathol., 29, pp.195-197. <LI class=MsoNormal style="COLOR: blue; TEXT-ALIGN: justify; mso-layout-grid-align: none; tab-stops: list .5in; mso-list: l6 level1 lfo12">Khanna KK et al. Control of tomato fruit rot caused by fusarium roseum with homoeopathic drugs. Indian Phytopathology, 1976; 269-272. <LI class=MsoNormal style="COLOR: blue; TEXT-ALIGN: justify; mso-layout-grid-align: none; tab-stops: list .5in; mso-list: l6 level1 lfo12">Koffler AH. Effect on the growth, weight and composition of onions due to dynamization of sulfur. J am Inst Homeopath, 1965, Vol.58 (11-12):345-349.
• Gangar H.U. Management and Control of Genetic Processes in Cotton Plants through Homoeopathy; Indian Journal of Research in Homoeopathy;vol-1 (1); 2007

[FarSideOfTheMoon]

And your point is?

[vbloke]

a quick question:
rather than just writing back and forth about how you believe it works - why not prove it for a change?

[bindeweede]

Homeopaths show Arsenic 45x is indistinguishable from water

December 31st, 2007 · 3 Comments

Happy new year. not least to the folks at the homeopathy4health site . They are jubilant about a “proof” that homeopathic dilutions could produce effects. albeit only on wheat seedlings. But guess what? After some questioning it was found that they hadn’t actually read the paper. Well I have read it, and this is the result.
The paper is “A Biostatistical Insight into the As2O3 High Dilution Effects on the Rate and Variability of Wheat Seedling Growth”. Brizzi,
Lazzarato, Nani, Borghini, Peruzzi and Betti, Forsch Komplementärmed Klass Naturheilkd 2005;12:277–283
The authors compared these treatments (30 seedlings each).

• C1, C2, C3 (untreated water p.a. Merck, control);
• WP (potentized water p.A. Merck) 5x, 15x, 25x, 35x, 45x;
• AD (diluted arsenic trioxide) 10–5, 10–15, 10–25, 10–35, 10–45;
• AP (potentized arsenic trioxide) 5x, 15x, 25x, 35x, 45x.

The allocation of seedlings to treatments was stated to be blind and randomised. So far, so good.
But just look at the results in Figure 1. They are all over the place, with no obvious trend as ‘potency’ (i.e. dilution) is increased. The
results with homeopathic arsenic at 45 days (the only effect that is claimed to be real) is very little different from the that of shaken water (water that has been though the same process but with no arsenic present initially).

For some (unstated) reason the points have no standard errors on them. Using the values given in Table 3 I reckon that the observation for AP45 is 1.33 ± 0.62 and for the plain water (WP45). it is 1.05 ± 0.69. The authors claim (Table 3) that the former is ’significant’ (with a profoundly unimpressive P = 0.04) and the latter isn’t. I can’t say that I’m convinced, and in any case, even if the effect were real, it would be tiny.
Later the authors do two things that are a very dubious from the statistical point of view. First they plot cumulative distributions which are notoriously misleading about precision (because the data in adjacent bins are almost the same). They then do some quite improper data snooping by testing only the half of the results that came out lowest. If this were legitimate (it isn’t) the results would be even worse for homeopaths, because the difference between the controls and plain water (WP45) now, they claim, comes out “significant”.
Homeopaths claim that the smaller the dose, the bigger the effect (so better water down your beer as much as possible, making sure to bang the glass on the bar to potentise it). I have yet to see any dose-response curve that has the claimed negative slope. Figure 1 most certainly doesn’t show it.
Of course there is no surprise at all for non-homeopaths in the discovery that arsenic 45x is indistinguishable from water 45x.
That is what we have been saying all along.


(From http://dcscience.net/?p=213 )

[Janot]

Goldacre has rightly cited that during the Cholera epidemic in the 19th century, death rate at London Homoeopathic Hospital was three times lower than those at Middlesex hospital. While admitting that the then contemporary treatments were harmful, he is not ready to accept the credibility of London Homoeopathic Hospital, where the mortality rate was three times less than an allopathic hospital. On the other hand, he jokes, “the homoeopathic treatments were at least inert”. How could the inert homoeopathic medicines result in 3 times less mortality than the conventional medicine?

Hasn't he already answered his own question?

[Mojo]

The paper is “A Biostatistical Insight into the As2O3 High Dilution Effects on the Rate and Variability of Wheat Seedling Growth”. Brizzi,
Lazzarato, Nani, Borghini, Peruzzi and Betti, Forsch Komplementärmed Klass Naturheilkd 2005;12:277–283

Interestingly, the very next paper in the same journal also studied the alleged effects of 45x arsenic on wheat seedlings. It attempted to repeat the results of a trial published in 1997, in which (apparently - I have so far been unable to track down any other reference to the 1997 trial) it had been found that 45x arsenic produced increased growth in seedlings that had previously been poisoned with arsenic.

The effects of a 45x potency of arsenicum album on wheat seedling growth -- a reproduction trial
Binder M, Baumgartner S, Thurneysen A
Forsch Komplementarmed Klass Naturheilkd. 2005 Oct;12(5):284-91

CONCLUSION: The result of this replication trial is a reversal of the original study, since Arsenicum album 45x inhibited wheat shoot growth instead of enhancing it.

Oops.

Let's see what they can salvage...

Nevertheless, high homeopathic potencies may induce statistically significant effects in biological systems. However, the magnitude and direction of these effects seem to depend on yet unknown parameters.

So, there you have it. Seedlings treated with homoeopathic arsenic may exhibit increased growth, or they may exhibit decreased growth, and which of these we see, and how much, depends on "unknown parameters" - presumably parameters other than those controlled for in these trials (which seems to have included using different species of wheat, for example), and other than the remedy administered, which was the same in each trial.

[Mojo]

a quick question:
rather than just writing back and forth...

Actually, it seems to have been a simple copy and paste of this page.

[seren]

They wear you down after a while. Mahakala why don't you go through the article you posted and think what responses we here might give, because frankly I can't be bothered. We're doing your thinking for you and it's boring.

[FarSideOfTheMoon]

I wonder sometimes if the believer community has become so dominated by rational and critical thinking, that they have moved on to strategic and deliberate time wasting of skeptics.

[Pebble]

Dear Mahakala,

You are missing the point completely with your arguments.

1. For a medicine to be accepted as effective many hurdles must be overcome. The mode of action must be plausable, the magnitude of effect must be estimable (from small trials), the primary end point must be statistically acheivable with the numbers recruited, and more than one centre must acheive the same result. Thus simply having some positive trials is not enough.

2. In the analysis published by the Lancet, there was no inherent bias against homeopathy despite your protestations. It was simply acknowledged that both in homeopathy and conventional medicine, many small trials get published simply because the outcome was favourble even though the trial was not adequately designed (see above) and could not support other than tentative conclusions. WHat was shown was that irrespective of the group (homeopathy or conventional) small trials tended to be positive, and that when one removed this known source of bias from both groups only conventional medicines remained effective. Note some of these trials included only 10 patients!

3. Your protestations about double blind trials are wrong. Get the practicitoner to determine what he feels would be appropriate for each patient, have a second investigator make up the remedy as directed, and then have a third independent individual dispense to patients either the remedy or placebo according to standard randomisation rules. Finally ensure that the assessment of benefit is done according to preset rules, with a clear and acheivable primary endpoint. This splitting of responsibilities sorts both the problem of tailoring the remedy for the patient and the blinding.

When you look at the rigor I have set out, tell me which homeopathic trials you feel have met these criteria. I can point to hundreds of conventional medical trials meeting this level of rigor, so stop bleating about conventional medicine not practicing in accordance with the strictures they would have placed on homeopathy.