BioMed Central - Latest comments

Addendum - authorship of 'Photo 51'

Naomi Attar — 2013-05-15T16:27:35Z

In this article, I (the author) followed multiple sources in referring to 'Photo 51' as the work of Rosalind Franklin. However, medical geneticist Jim Lupski raised a query about the accuracy of the attribution, having received correspondence from Jim Watson which mentioned in passing that Ray Gosling had taken the photo.

I put the query to Gosling, who confirms that he was indeed 'Photo 51' photographer:
'It was part of the program that Rosalind and I were carrying out to check the effect of the humidity on the crystallization of DNA. This was the 51st of that program, and I was the one who took that particular diffraction pattern.'

Thanks to Jim Lupski for bringing the inaccuracy to my attention, to Ray Gosling for providing further information, and to Jim Watson for confirming that this was his understanding of events.

Promising traffic crash prevention technologies

Ediriweera Desapriya — 2013-05-14T13:42:26Z

I would agree with the authors and it may be driver¿s lack of awareness about appropriate use that would partly explain and hinder effectiveness of ABS. In addition, drivers may over rely on these promising crash prevention technologies and take some additional risks while driving to compensate the added safety value to the vehicles. However, Anti Lock Brakes (ABS) has been shown effective in reducing motor cycle crashes (Teoh, 2010). Fatal crashes are 37 per cent lower for motorcycles equipped with optional ABS than for those same models without ABS. Similarly, insurance claims for ABS equipped motor cycles are 22 per cent less than for motorcycles without ABS. In fact, European Union declared that ABS will be mandatory for new models above 125 cc from 2016. It will be mandatory for all EU motorcycles from 2017. Motor cycle crashes are significant traffic safety issue in Iran and ABS equipped motor cycle may be a promising option to consider preventing future motor cycle crashes. There need to be a national safety awareness social marketing campaign to highlight the appropriate use of ABS.

REFERENCES:

Teoh ER (2010) Effectiveness of Antilock Braking Systems in Reducing Motorcycle Fatal Crash Rates- http://almenard.typepad.com/files/r1110.pdf (Pp.6)

Highway Loss Data Institute. 2009. Insurance Special Report: Motorcycle Antilock Braking System (ABS). Arlington, VA: Highway Loss Data Institute. http://www.iihs.org/research/topics/pdf/hldi_abs.pdf (Pp. 4)

Perspective is crucial

Ellen Schultz — 2013-05-10T12:51:54Z

This article highlights the critical importance of considering perspective when addressing care planning and care coordination. From a distance, all the clinicians who participated in this study might be considered to represent the same perspective--that of health care professionals from within the same health care system--yet as so clearly demonstrated through the experience of this study, they are very much not "on the same page." The disconnect between those participants from the primary care setting who were oriented towards patients and supportive care needs and the participants from the hospital setting who were oriented towards particular diseases underscores the depth of fragmentation--cultural as well as structural--in this particular health system. Experience suggests that this cultural divide is not unique to this particular study sample. It also suggests that here, and in many other systems that likewise struggle to coordinate care, simply transferring information is unlikely to be sufficient for achieving coordination. If care is to be effectively coordinated across settings, all the providers from those various settings must be able to understand the goals, orientation and approaches of one another. A common understanding would allow these different perspectives to reinforce one another, becoming a system strength rather than an obstacle to coordinated care. For indeed, both a broader, holistic concern for patients' well-being and a narrow focus on the details of specific health conditions are important in providing comprehensive, high-quality care. We have much work to do to achieve such a common understanding. Bringing together providers from different parts of a health system, as described here, is an instructive start. Let's hope it's just the beginning.

Stratification of non-specific low back pain patients for therapeutic trials in general and illustrative suggestions for trials of manipulation in particular.

Brian Sweetman — 2013-05-08T17:31:07Z

Orrock and Myers (1) have reviewed the present status of osteopathic intervention for so-called ¿non-specific¿ low back pain. They conclude that further clinical trials into this subject are required that have consistent and rigorous methods. However their introduction states that Non Specific Low Back Pain (CNSLBP) is a common, complex and disabling condition, but go on in the discussion to note that many studies had mixed back pain populations. There in lies one of the greatest problems of trial design. Should initial data collection allow for subgroup analysis? Which symptoms and signs are best for such stratification?
Subgrouping test suggestions for such secondary (or primary) analysis are summarized in a monograph (2) based on a classification analysis based on an earlier randomized controlled therapeutic trial (3). The reatments included Short Wave Diathermy, Traction, and Extension Exercises. A recent review of the original database (4) analyzed patient comments on previous treatments including hard bed, hot bath, SWD, exercises, traction, manipulation and injection. The results are given as amalgamated standardised deviates. ¿Good¿ scores are positive over 25 and include more than average better and/or not worse. ¿Bad¿ scores are negative worse than -25 and included more than average saying worse and/or not better. ¿No effects¿ score between +25 and -25.
Manipulation was best for thoracolumbar junction pain radiating into the low back (+52), then the facet joint syndrome (+27).
The patients suggested there was ¿No effect¿ with disc prolapse and those with switching side of lumbago between episodes.
Worst was for those with what is probably disc degeneration (-262) and then rotation back strain (-63). See the monograph (2) for the clinical tests that allow for these sub diagnoses.
These results suggest how much difference there is between subgroups. The no effect cases will dilute out overall evidence of effects, and good and bad results will cancel out if looking at all cases together.
This shows how important stratification could be if studies are to make any progress. But these results should under no circumstances be taken as meaningful of them selves, and there might be dangers for example in accepting that ¿manipulation¿ would not be harmful for cases of disc prolapse. Moreover there was patient selection bias as they were by definition needing more help despite previous treatments, they were giving subjective and retrospective opinions on outcome, and the treatment titles were very very broad.
Brian Sweetman FRCP, MD, PhD.
Swansea, UK.
Email: bjsweetman@hotmail.com
References
1. Orrock PJ, Myers SP. Osteopathic intervention in chronic non-specific low back pain: a systematic review. BMC Musculoskeletal Disorders 2013, 14:129. ISSN Publication date 9 April 2013.
2. Sweetman BJ. Low back pain, some real answers. 2005. tfm Publishing, Harley SY5 6LX; UK.
3. Sweetman BJ. Numerical classification of common low back pain. MD Thesis, London University, 1985.
4. Sweetman BJ, Sweetman SJ. Back pain database analysis. 2012; Unpublished. Details available on enquiry via email to bjsweetman@hotmail.com

Different types of low back pain consequences confound the guidelines

Brian Sweetman — 2013-05-08T17:28:26Z

Premature return to the work place may risk aggravation or reprecipitation of the underlying back pain problem. Surely it would be best to fix the back or work place first. But that is easier said than done and gauging recovery of the back is difficult. In their study Hendrick et al (1) question current wisdom. They reveal many incongruities between measures of impairment, disability and handicap, which help explain why guidelines on back care may well be flawed.
Why is evidence lacking or so contrary? There are perhaps three main types of reason (2). Firstly, a patient may be asked one question, but inadvertently answers another. The visual analogue pain scale is a good example. It measures different things in different circumstances. At initial interview it describes whether pain is getting worse in preference to describing actual severity of pin. At follow up, it measures handicap and correlates best with the heaviness of work to which the patient must return, i.e. their ¿normal¿ activities.
Secondly, different types of impairment may cause different types of disability. For example exercise activity may make one type of back pain worse, have no effect on another, and help in yet other cases. Likewise different types of disability may cause more or less handicap under different work place circumstances.
Thirdly, it seems that there are distinct types of low back pain within the common presentation of the so-called non-specifics. Their differences have profound effects. They vary in terms of activities and tests that provoke the pain, characteristic disability questionnaire scores, the tendency to persist, resolve and then recur, and in terms of which measures best gauge change in outcome.
Taking these aspects into account probably explains varying natural prognosis and why observed effects of intervention dilute or cancel out and hide the real evidence. Guidelines will only improve when the assumption that all back pain is the same continues to be questioned.

Brian Sweetman FRCP, MD, PhD.
Swansea, UK.
Email: bjsweetman@hotmail.com

References
1. Hendrick P, Milosavljevic S, Hale L, Hurley DA, McDonough SM, Herbison P, Baxter GD. Does a patient's physical activity predict recovery from an episode of acute low back pain? A prospective cohort study. BMC Musculoskeletal Disorders 2013. 14:126. Published: 5 April 2013.

2. Sweetman BJ. Low back pain, some real answers. 2005. tfm Publishing, Harley SY5 6LX; UK.

Low back pain and sciatica; relationship of imaging findings to clinical symptoms.

Brian Sweetman — 2013-05-08T17:25:59Z

Takatalo et al have recently reported MRI studies of disk degeneration in the young adult Oulo cohort. In the latest article (1) body mass index and smoking were linked to disk degeneration in males. In the slightly earlier article (2) the same MRI data was used to check which changes might be the causes of actual back pain symptoms and in particular the relationship between disk degeneration and Schmorls nodes. They include a helpful review of the modern literature in their following discussion. However they conclude that it is difficult to prove cause and effect and that it would need a prospective study with annual MRI studies for many years to get round this problem. To add to these deliberations it is perhaps interesting to draw attention to similar studies undertaken with plain x-rays from the era prior to MRI (3).
Factor analyses were undertaken using ten x-ray features from lumbosacral films. There were 301 teen and adult patients all with low back pain problems and some also had sciatica. The first factor linked spondylolisthesis at L5/S1 with spondylolysis which is well known. The second factor focused on Schmorls nodes and suggested links with the disc margin osteophytes which probably reflect disc degeneration.. This second factor also seemed to include spina bifida occulta and spondylolisthesis at L4/5 as well. A recent review of the literature draws together a web of associations including the above findings and a spread of possible causative mechanisms. The third factor focused on scoliosis linking with tip to tip of transverse processes not being widest at the L4 level. The fourth factor was a horizontal facet joint at the lumbosacral junction which was poorly related to most of the above. These aspects may all be worth incorporating in future studies. But what makes this old x-ray study of interest was that it was mainly factors 2 & 3 that were useful in helping classify various subgroups within the common presentations of low back pain, which had been distinguished using cluster analysis (4,5). This seems to hint at real clinical associations between x-ray findings and morbidity even though this part of the study was not of prospective design.

Brian Sweetman FRCP, MD, PhD.
Swansea, UK.
Email: bjsweetman@hotmail.com

References
1. Takatalo J, Karppinen J, Taimela S, Niinimäki J, Laitinen J, Sequeiros RB, Paananen M, Remes J, Näyhä S, Tammelin T, Korpelainen R, Tervonen O. Body mass index is associated with lumbar disc degeneration in young Finnish males: subsample of Northern Finland birth cohort study 1986. BMC Musculoskeletal Disorders 2013, 14:87. doi:10.1186/1471-2474-14-87
2. Takatalo J, Karppinen J, Niinimäki J, Taimela S, Mutanen P, Sequeiros RB, Näyhä S, Järvelin M-R, Kyllönen E, Tervonen O. Association of modic changes, Schmorl's nodes, spondylolytic defects, high-intensity zone lesions, disc herniations, and radial tears with low back symptom severity among young Finnish adults. Spine 2011; 37(14):1231-9.
3. Sweetman BJ. Numerical classification of common low back pain. MD Thesis, London University, 1985.
4. Sweetman BJ, Sweetman SJ. Midline back pain: a literature review. International Musculoskeletal Medicine (ISSN: 17536146) Appeared or available online: 09 March 2013. DOI: 10.1179/1753614613Z.00000000036
5. Sweetman BJ. Low Back Pain: some real answers. tfm Publishing Ltd, Harley SY5 6LX, UK, 2005.

Comment on 'Potential impact of a nine-valent vaccine in human papillomavirus related cervical disease'

Norma Erickson — 2013-05-08T16:40:48Z

Dear Editors In Chief:

The article entitled 'Potential impact of a nine-valent vaccine in human papillomavirus related cervical disease' [1] lists Silvia de Sanjose as its corresponding author. This same author wrote a companion Editorial entitled 'HPV Prevention Series' [2] in the Journal.

Since a scientific report published in conjunction with an Editorial traditionally represents an opinion endorsed by the Editorial Board of a peer-reviewed medical journal which in turn carries considerable weight in influencing health care policy making in various countries, we feel obligated to comment on this article. [1] Both the Editorial [2] and the subsequent article [1] list Dr. Sanjose as the corresponding author who was financially supported by the vaccine manufacturer as disclosed; the article was also co-authored by an employee of the vaccine manufacturer and several consultants paid by the vaccine manufacturer. The publications are quite obviously promoting a new HPV vaccine.

The conclusion of the article states, 'If the nine-valent vaccine achieves the same degree of efficacy as has been shown for HPV 16 and 18, and vaccination programs are effectively implemented, almost 90% of ICC cases worldwide could be prevented' [1] is blatantly misleading. The fact is that there is no evidence that HPV vaccination has prevented a single case of invasive cervical cancer.

The endpoint used in the HPV vaccine clinical trials was CIN2/CIN3 lesions. [3] The lesions are often self-reversing and in most cases never progress to invasive cervical cancer.[4, 5] In contrast, invasive cervical cancer has been reported in at least two young women shortly after receiving a full course of HPV vaccination, and at least one of them was a subject enrolled in an HPV vaccine clinical trial project.[6]

A more appropriate conclusion of the article [1] would have been 'If the nine-valent vaccine achieves the same degree of efficacy as the current HPV vaccines in use, it may or may not prevent any ICC cases'.

The authors' estimation of the relative contribution to invasive cervical cancer (ICC) and precancerous cervical lesions of the nine HPV types was based on using 'PCR with SPF-10 broad-spectrum primers followed by DNA enzyme immunoassay and genotyping with a reverse hybridization line probe assay.'

A recent WHO survey has shown that 9 of the 12 (9/12) laboratories using the SPF-10 test were found to be 'not proficient' in detecting the HPV types. [7] Therefore, the data presented in the article [1] are analytically unreliable, based on a 'not proficient' testing method with an uncomfortably high 75% error rate.

In developed countries cervical cancer death is rare, occurring among women at a rate of 1.4-1.7 per 100,000 in countries like the USA, New Zealand and Australia [8] at an average age after 54,[9] and can be further reduced by better care through improved cervical screening, which is less invasive, cost effective and has no serious adverse outcomes. The current proposed policy of mass vaccination of young women age 9-12 at the cost of ~$40-100 million per 100,000 women, to prevent 1 or 2 cervical cancer deaths, is therefore not supported by either risk/benefit, or cost effectiveness analyses.

Numerous factors other than vaccination in a woman's life may be more important in determining the risk of developing invasive cervical cancer. [5]

Promoting an HPV vaccine at a very young age to possibly prevent cervical cancer death 45 years down the road must wait until more research is conducted to prove that the benefit of the HPV vaccine in cervical cancer prevention in fact outweighs its risk which is substantial to the young girls who are being vaccinated. [10]

Sincerely,
Norma Erickson, President
SaneVax Inc.

The SaneVax mission is to promote only Safe, Affordable, Necessary and Effective vaccines and vaccination practices.

References
[1] Serrano B, Alemany L, Tous S, Bruni L, Clifford GM, Weiss T, Bosch FX, de Sanjose S. Potential impact of a nine-valent vaccine in human papillomavirus related cervical disease. Infect Agent Canc 2012, 7:38.
[2] de Sanjose S: HPV Prevention Series. Editorial. Infect Agent and Canc 2012, 7:37.
[3] FUTURE II Study Group: Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med 2007, 356: 1915-27.
[4] Castle PE, Stoler MH, Solomon D, Schiffman M: The relationship of community biopsy-diagnosed cervical intraepithelial neoplasia grade 2 to the quality control pathology-reviewed diagnoses: an ALTS report. Am J Clin Pathol 2007, 127: 805-15.
[5] Arends MJ, Buckley CH, Wells M: Aetiology, pathogenesis, and pathology of cervical neoplasia. J Clin Pathol 1998, 51:96-103.
[6] Beller U, Abu-Rustum NR: Cervical cancers after human papillomavirus vaccination. Obstet Gynecol 2009, 113:550-2.
[7] Eklund C, Forslund O, Wallin KL, Zhou T, Dillner J; WHO Human Papillomavirus Laboratory Network: The 2010 global proficiency study of human papillomavirus genotyping in vaccinology. J Clin Microbiol 2012, 50:2289-98.
[8] http://appliedresearch.cancer.gov/icsn/cervical/mortality.html
[9] Lee NC: Testimony before the House Committee on Commerce, Subcommittee on Health and Environment. http://www.hhs.gov/asl/testify/t990316b.html
[10] Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, Izurieta HS, Ball R, Miller N, Braun MM, Markowitz LE, Iskander J: Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA 2009, 302: 750-7.

Response to Tomljenovic et al. HPV vaccines and cancer prevention, science versus activism.

Franco Maria Buonaguro — 2013-05-08T16:14:36Z

Dear Dr Tomljenovic and colleagues.

Thank you for your comment. I agree with the authors that cervical cancer prevention and control is a very complex issue. The availability of tools to prevent it for over 60 years it makes this disease a target for Public intervention and concern as still many women will suffer from it or its precursor lesions.

When trying to respond to the 8 questions that the authors bring forward I realized that Tomljenovic are questioning the whole system of how the public health stake holders are evaluating research, take decisions and monitor the safety of the population. It is thus difficult to counter argue so many queries from the part of one researcher. I am unclear if the debate should go towards analyzing the whole regulatory system for the introduction of a public health intervention or should I go point by point showing the best of the available data indicating the HPV vaccines offer an amazing opportunity to reduce cervical cancer burden in the world. Clearly I will not go for the first as this would involve to review the organization of agencies such as FDA or EMEA. As for the second I think that the reports for WHO, CDC, and those of several countries that have considered the introduction of HPV vaccines are very compelling. I would just refer to the WHO position paper. This document reflects the work over 2 years of an independent group from the related industry . Its conclusion of recommendation of the HPV vaccine is fully documented. (1)
Apart from these general consideration I will try to bring forward my personal view on each one of the specific questions .
1. HPV vaccines have not been demonstrated to prevent any cervical cancers so why
are they being promoted as cervical cancer vaccines?
It is still early to claim that exiting HPV vaccines have prevented a single cervical cancer. The acquired knowledge of the natural history of cervical cancer indicates that we will need over a decade to be able to fully estimate the impact of HPV vaccines in cervical cancer. Data from several clinical trials including a large non industry based trial have all been consistent of an enormous efficacy in the reduction of target HPV types and their related pre-neoplasic lesions. These robust data informed us that if it was possible to remove the etiological factor leading to this cancer, in the long run this should result in lowering the burden of invasive cervical cancer.
2. If the majority of HPV infections and a great proportion of pre-cancerous lesions
clear spontaneously and without medical treatment and are thus not a reliable indication of cancer later in life, then how can these end-points be used as a reliable indicator of the number of cervical cancer cases that will be prevented by HPV vaccines?

In the same way that we do not allow women to get invasive cervical cancer when undergoing screening, similarly we expect that women with cervical cancer will arise from those infected that cannot resolve spontaneously the infection. The same argument could go for any other vaccine.

3. How can the clinical trials make an accurate estimate of the risk associated with
HPV-vaccines if they are methodologically biased to produce type-2 errors (false
negatives [2, 4, 13])?
The risk associated to secondary effects of the vaccines is not exclusively evaluated on the data generated from trials phase III trials. Additional monitoring is routinely done to complement the information.
4. Can a passive monitoring system such as that used by most vaccine surveillance
systems world-wide allow the medical regulatory agencies to make accurate estimates
on the real frequency of HPV-vaccine related adverse reactions?
Surveillance systems should be able to allow identification of short and long term effect for any intervention done in the general population. If the system is wrong then it needs to be improved but why should this be different for a specific vaccine with a very good record of safety from the trials.?
5. Can an accurate estimate of the real frequency of HPV-vaccine related adverse
reactions be made if appropriate follow-up and thorough investigation of suspected
vaccine related ADRs is not conducted but instead, these cases are a-priori dismissed as being unrelated to the vaccine?

To my knowledge, ADR have been fully monitored in many countries with established surveillance systems. See as a good example the reports of the Vaccine Adverse Event Reporting System (VAERS) which publishes regularly the information for the US.

6. Why are women not informed of the fact that in some circumstances (i.e., prior
exposure to vaccine-targeted and non-targeted HPV types), HPV vaccination may
accelerate the progression of cervical abnormalities [4, 26-28]?
The most recent data support the fact that women that have a cervical abnormality and that are vaccinated do not have any acceleration of their abnormalities and that on the contrary seem to be getting a better prognosis.

7. How can women make a fully informed decision about whether or not to consent to
vaccination if crucial information regarding HPV vaccine efficacy and safety is not
being disclosed to them?
I believe that any program introducing the HPV vaccine massively has promoted the channels by which women can get information on the safety and efficacy of this vaccine. See for exemple many Goverment based web sites informing the public http://www.cdc.gov/hpv/vaccine.html for the US ; http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice-G-L/HumanpapillomavirusHPVvaccine/CON023340 for the UK;
8. Should the medical health regulators and authorities rely solely on data provided by
the vaccine manufacturers to make vaccine-policy decisions and recommendations [12,
29]?
Vaccine manufactures run the necessary trials and should provide their data as requested by the official agencies in such a way that can be evaluated and contracted. Many countries provide recommendation on a sum of different aspects of evidence not only on the manufacture trials but also on independent research studies on the natural history of the disease, mathematical models and more. Care indeed must be taken that all this information is adequately traceable.
However it cannot be dismissed that countries with high coverage of the quadrivalent vaccine have already shown a remarkable reduction of HPV related diseases such as genital warts. Similarly a reduction of high grade lesions has also been reported in Australia. It is obvious that we need to follow up the impact
I agree with the authors that cervical cytology suffers of poor repeatability for some stages of pre-neoplasic lesions and has poor sensitivity if not applied on a regular bases. Efforts to improve screening tools are regularly deployed by many research groups. New data coming from large meta-analysis show that probably HPV DNA detection tools could remove some of the caveats of cervical cytology. Still women going to screening will be triaged to negative for cervical cancer or positive for cervical cancer. The proportion of positives through the span of the suitable screening range (aprox 25-65 years) brings a significant proportion of women to be at a certain point to be positive with all the side effects that this involves. The whole concept to prevent the disease is appealing and should then not be dismissed.
It is true that at this point a vaccine to protect against the established high risk types is not yet available but the reduction of 70% of the cancer burden is a considerable adequate target in terms of public health reduction. Trial data show that a 70% reduction is a feasible aim. Probably we have not had better data before any medical intervention as what is available for HPV vaccine. Despite of this, many groups around the world are investing many efforts to improve our estimates, to refine the predictions, to genotype existing HPV related cases or to improve the existing vaccines. Evidence based medicine is supportive of this intervention providing there exist adequate infrastructure.

Yours sincerely
Silvia de Sanjose, MD PhD

Reference
(1) Human papillomavirus (HPV) vaccine background paper. Geneva: World Health Organization; 2008. Available from: http://www.who.int/immunization/documents/HPVBGpaper_final_03_04_2009.pdf [accessed 4 April 2012]

No such thing as homeopathy?

Lee Turnpenny — 2013-05-03T18:32:27Z

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.¿

Contrasting results from new study...?

Lee Turnpenny — 2013-05-03T17:50:59Z

Effect of complementary and alternative medicine on the survival and health-related quality of life among terminally ill cancer patients: a prospective cohort study.