Well, I don’t know what bugs are at play in the BMC Cancer system. Almost three weeks since submitting the latest re-worked version of my comment (which I append below so it may be read by somebody), not only has it not appeared under the paper in question, but the continued lack of response (excepting one message informing me that – again – my query has been forwarded to the Editorial team) to my interim e-mails to the relevant provided BioMed Central e-mail addresses suggests… I don’t know what. Though, noting that my previous (eventually posted) comment is the latest on the Comments listing, I deduce that I ought not to take it personally.
Because it would be interesting to learn what the authors make of this newly-published paper, and whether it has any relevance to their work, and/or how the findings align or otherwise with their own. I am paywall-blocked from getting at the full text, so I don’t know whether the evaluated CAM included homeopathy. But Edzard Ernst provides summary treatment and ensuing discussion here.
I wonder whether WDDTY will quack a reference to this one.
Comment submitted to BMC Cancer, 5 April 2013:
This paper was recently cited in a short article entitled ‘Homeopathy is more than placebo’, in the February 2013 edition of the magazine What Doctors Don’t Tell You, on sale in various UK outlets. (It also formed the basis for an article entitled ‘Homeopathy has a ‘clinically relevant’ effect way beyond placebo’, in June 2011 on the same magazine’s website.) The title of this paper suggests description of a study methodology, but with no conclusory statement regarding the relative efficacy of homeopathy and placebo. Nevertheless, two years after publication, WDDTY still considers it a cherry ripe enough for re-picking. As such, it would be of interest to ascertain whether or not the authors/publishers of the paper consider that WDDTY misappropriates their work? Or do they concur that ‘Homeopathy is more than placebo’?
The authors invoke the popularity of homeopathy in apparent justification for this study. There is prevarication somewhat as to whether homeopathy is clinically effective – ‘a matter of heated debate’. But there is no (scientific) debate concerning clinical effectiveness. Homeopathy is not clinically effective, in that it has no effect on organic disease. So, regarding cancer, it does not cause tumours to shrink or disappear.
The question then, properly put, is not whether homeopathy is clinically effective… but whether it has an ‘effect’ on patients in a clinic – in this case, cancer patients. And this, I think (I hope), is actually the question that the author’s of this study attempted to address. In writing, ‘We wanted to study the clinical effects of classical homeopathy’, surely they mean ‘We wanted to study the effects of classical homeopathy on patients in a clinic’. Indeed, they state that, ‘The effects of homeopathy on quality of life in cancer patients has been studied very rarely’, a statement that this report is indeed of a study of the effects of homeopathy – not on disease – but on ‘quality of life.’ It is not about homeopathic ‘remedies’ and organic disease; it is about psychological/psychotherapeutic well-being. It is thus not specifically about homeopathy at all.
Who can dispute the improved ‘quality of life’ reported by cancer patients receiving some or other ‘alternative’ treatment to complement (prior or ongoing) conventional adjuvant therapy (ie chemotherapeutic drugs, radiotherapy, or other supplemental treatment following surgery)? Attentive care does make people feel better. This has nothing to do with the ‘remedies’ they are administered – not physiologically anyway. Yet the authors seem to be at pains to include attentive care under ‘classical’ homeopathy, with critics being wrong to focus on the implausibility of potentised diluted remedies (ie, shaken water), when this is not classical homeopathy in totality. Such detractors miss the point that ‘classical’ also denotes the lengthy, detailed ‘individualisation’ that matches a patient to a continually adjusted ‘remedy’ regimen. Hence, in one fell swoop, the double-blind Randomised Clinical Trial is rendered inapplicable, inappropriate; it is impossible to conduct such a trial of homeopathy proper, as (homeopathically-treated) patients, being different individuals, cannot be randomly combined into a group for objective measure. If a RCT only concentrates on the pilules dispensed for a specific ailment, and those pilules turn out to be no more beneficial than placebo, then that trial is invalidated because it has not taken into account the individualisation of subjects – which, as a RCT, it cannot do. Therein lies the circular logic of the homeopath’s justification for rejection of the assertion that homeopathy is no more effective than placebo.
What is necessary, this paper argues, is that because cancer (or other serious chronic disease) patients who seek out homeopathic care have preferences which exclude willingness to participate in a RCT, then any study is obligated to only consider treatments actively chosen by those patients ‘… since free choice is part and parcel of a potentially important therapeutic step.’ This would seem self-fulfilling – the patient will ‘feel’ better, because they have been empowered through choice. Control is impossible. A point to note is that this homeopathic treatment was offered at homeopathic clinics, along with, or following, conventional cancer treatment (90% of those opting for homeopathy did so to complement ongoing adjuvant treatment; only 10% went fully alternative, discontinuing conventional treatment). This presents limitations: for direct ‘matched pair’ (homeopathic versus conventional) comparisons, patients of comparable case history, disease progression and prognosis are necessary. And these could only be recruited from palliative stage care groups – that is, patients no longer receiving adjuvant treatment. However, the large differences between patient groups limited formable matched pairs to a number deemed insufficient for meaningful study. Therefore, the results are those of a longitudinal observational study of all consenting cancer patients, without separation of adjuvant and palliative stages.
The second paragraph of the Discussion is confusing: we are informed that the homeopathic versus conventional group comparison is further complicated by the fact that patients receiving homeopathy were more severely affected and, for some reason, delayed commencing their care until four (diagnosis of tumour progress) to seven (initial diagnosis) months after those in the conventional group commenced theirs. This is given as explanation for the homeopathic care group having a higher rate of prior adjuvant (chemotherapy/radiotherapy) treatment. Why the delays? Why the higher rate of prior adjuvant treatment in the homeopathic group?
Presumably, these, and other, confounding factors were corrected for during the analyses of the data generated from the ‘… patient self-reports, taken at study entry and every 3 months over the course of one year…’ – a year in which ‘… a larger proportion of patients under conventional treatment received chemotherapy or radiation…’. Nevertheless, the validity of those self-reports is questionable. Chemotherapy/radiotherapy is often uncomfortable, painful, miserable. It actually makes recipients very ill – and feel it for a while after – and consequently likely (one might not unreasonably predict) to tick low for ‘quality of life’; a score likely (again, predictably) to increase as side-effects fade with time following the treatment. So, if at the commencement of the study more time had elapsed since your last course of chemo/radiotherapy, that lengthening interim will affect how you score yourself. Particularly if you’ve felt empowered by exercising the option of ‘alternative’ care; and further opting, as did a much higher number in this grouping (with a higher rate of prior adjuvant treatment), for no more courses of misery-inducing chemo/radiotherapy. Couple that with lots of personalised attention and follow-up phone consultations, at a time when you perhaps feel vulnerable and alone, then you are bound to experience a sense of improved well-being (however marginal; however influenced by the ethnographical intervention of being asked how you feel – because the ‘presence’ of the attendant, attentive observer affects the ‘behaviour’ response).
If a clinical/medical/scientific journal such as BMC Cancer deems it legitimate to publish this ‘alternative’ kind of thing, then it ought, for the sake of its readers, to nevertheless assign referees who will provide scientifically valid reviews. But the validity of the self-scoring does not appear to have overly concerned the peer reviewers assigned this paper. Both seemingly believe in the efficacy of homeopathic remedies in treating organic disease – including tumours. In a scientific medical journal, this is alarming. Why this concern with (the supposed effects of) remedies, when the study is supposedly not about them? And despite seeming recognition of the study’s uncontrollability, the authors are commended for ‘very successful research’. Where, specifically, did this study ‘succeed’? Didn’t we already know that more attentive, personalised care makes people feel better?
Which brings us back to WDDTY and its citing of this paper as evidential argument that ‘Homeopathy is more than placebo.’ This now reads as an ambiguous statement, because it is unclear whether or not it refers to the administering of useless shaken water and sugar pilules (on which WDDTY has shameless form); or whether it is alluding to the other ‘aspect’ of homeopathy, the individualised care, as this study considers. In which case the statement reads as though accepting that the water and pilules are merely placebo; and misses the point that this study does not – because it cannot – evaluate against placebo. One is left to conclude, therefore, that the editors of WDDTY failed to properly read the paper they refer to. Or deliberately mis-appropriate it. Because this paper, in its emphasis on ‘classical’, delineating homeopathy into two separate components (‘It is important to notice that we have not studied the effect of homeopathic remedies, but of homeopathic care’) leads to the conclusion that there is no such thing as homeopathy at all. The homeopathic remedies themselves are no more than placebo; the homeopathic care is simply… care. Homeopaths have no monopoly on claiming origination of the provision of good care (palliative or otherwise), which ought to be separated out from homeopathy and its claims to treating the organic basis of disease.
From the final paragraph of the Discussion:
‘It goes without saying that this [care] is an intensive communicative, interactive process that operates via many different pathways, some of which are likely to be psychological and very general in the sense of a meaning response, some of which might be specific to homeopathic therapy and its usage of the remedies. It is also a likely scenario that homeopathic remedies are only active in an unbroken therapeutic context and that, at least for practical therapeutic reasons, the question whether homeopathic remedies are placebo or not, is irrelevant.’
It doesn’t go without saying – it needs to be said. Either the remedies have a biochemical, physiological effect, or they do not. We know they do not… because they contain no active ingredient. If, then, they can only ‘function’ as a ‘psychological device’, the question as to whether or not they are placebo is not irrelevant. It is what they are. I read this excerpt as arguing that ‘homeopathic’ care ‘works’ – in part – due to the anticipation of its remedies; and conversely, that those remedies can only ‘work’ as part of an overall ongoing individualised care process engendering that anticipation, leading inevitably to improved scores on subjective self-reported surveys. Thus (conveniently for the pill-peddling homeopath), it is impossible to extricate and evaluate the discrete remedies relative to placebo in a properly controlled RCT – thereby shielding them from scrutiny. But if homeopaths use such interpretation as bullet-proofing their case that the RCT is inapplicable, then he/she cannot conclude – as WDDTY would have you – that Homeopathy is more than placebo.
Actually, this realisation, that any beneficial effect wrought by homeopathy is a consequence of the care and not the remedies, is nothing new. Do those opting for homeopathy (providers and recipients) not do so in the belief that it (will) make(s) them feel better, and so will be inclined to respond to questions as to their quality of life and (‘spiritual’) well-being in a more positive manner?
In its reaching effort to justify the irrelevance of the randomised controlled trial to homeopathic remedies – because their usage cannot be extricated from the individualised care process prescribing them – this paper is self-contradictory. Evaluation of the effects of the care component of ‘classical’ homeopathy is likewise impossible if those effects rely on the anticipation of remedies which are ‘…likely… only active in an unbroken therapeutic context’ engendering that anticipation. Yet, whilst seemingly arguing the inseparability of remedy and care elements, this is what the authors half-quixotically attempted: ‘It is important to notice that we have not studied the effect of homeopathic remedies, but of homeopathic care.’ But leave out the remedies – thereby eliminating the anticipation of them – and what are you left with?
If this paper is successful at all, it is by the subtle affirmation that there is no such thing as ‘homeopathy.’
Update (3/5/13 @ 1830) This comment has now been posted here (see comment below – thanks, Ciaran).