Systematic research on complaints about chiropractors, osteopaths, and physiotherapists is rare. We have often heard chiropractors claim that complaints against them are extremely rare events.
But is this true?
Two recent investigations might go some way towards answering this question.
The aim of the first investigation was to understand differences in the frequency and nature of formal complaints about Australian practitioners in these professions in order to inform improvements in professional regulation and education.
This retrospective cohort study analysed all formal complaints about all registered chiropractors, osteopaths, and physiotherapists in Australia lodged with health regulators between 2011 and 2016. Based on initial assessments by regulators, complaints were classified into 11 issues across three domains: performance, professional conduct, and health. Differences in complaint rate were assessed using incidence rate ratios. A multivariate negative binomial regression model was used to identify predictors of complaints among practitioners in these professions.
Patients and their relatives were the most common source of complaints about chiropractors, osteopaths and physiotherapists. Concerns about professional conduct accounted for more than half of the complaints about practitioners in these three professions. Regulatory outcome of complaints differed by profession. Male practitioners, those who were older than 65 years, and those who practised in metropolitan areas were at higher risk of complaint. The overall rate of complaints was higher for chiropractors than osteopaths and physiotherapists (29 vs. 10 vs. 5 complaints per 1000 practice years respectively, p < 0.001). Among chiropractors, 1% of practitioners received more than one complaint – they accounted for 36% of the complaints within their profession. Overall, nearly half of the complaints (47.7%) involved chiropractors, even though chiropractors make up less than one-sixth (13.9%) of the workforce across these three professions.
The authors concluded that their study demonstrates differences in the frequency of complaints by source, issue and outcome across the chiropractic, osteopathic and physiotherapy professions. Independent of profession, male sex and older age were significant risk factors for complaint in these professions. Chiropractors were at higher risk of being the subject of a complaint to their practitioner board compared with osteopaths and physiotherapists. These findings may assist regulatory boards, professional associations and universities in developing programs that avert patient dissatisfaction and harm and reduce the burden of complaints on practitioners.
The aim of the second study was to describe claims reported to the Danish Patient Compensation Association and the Norwegian System of Compensation to Patients related to chiropractic from 2004 to 2012.
All finalized compensation claims involving chiropractors reported to one of the two associations between 2004 and 2012 were assessed for age, gender, type of complaint, decisions and appeals. Descriptive statistics were used to describe the study population. The results show that 338 claims were registered in Denmark and Norway between 2004 and 2012 of which 300 were included in the analysis. 41 (13.7%) were approved for financial compensation. The most frequent complaints were worsening of symptoms following treatment (n = 91, 30.3%), alleged disk herniations (n = 57, 19%) and cases with delayed referral (n = 46, 15.3%). A total financial payment of €2,305,757 (median payment €7,730) were distributed among the forty-one cases with complaints relating to a few cases of cervical artery dissection (n = 11, 5.7%) accounting for 88.7% of the total amount.
The authors concluded that chiropractors in Denmark and Norway received approximately one compensation claim per 100.000 consultations. The approval rate was low across the majority of complaint categories and lower than the approval rates for general practioners and physiotherapists. Many claims can probably be prevented if chiropractors would prioritize informing patients about the normal course of their complaint and normal benign reactions to treatment.
In their discussion section the authors make the following comments: A particular concern after cervical SMT is dissection of the vertebral and carotid arteries. Seventeen claims concerning CAD were reported in this data, 14 in Denmark and three in Norway, and 11 of these were approved for financial compensation (64.7% approval rate) representing by far the highest approval rate across all complaint categories… chiropractors generally seem to receive more claims per consultation than GPs and physiotherapists, the approval rate is substantially lower and a similar trend is observed in Norway. However, it is also evident that approved claims within chiropractic bear a higher financial burden than their peers. These numbers are clearly highly influenced by the cases related to CAD. Several reasons might explain a higher complaint rate within chiropractic but this remains speculation and we do not have hard evidence supporting any of the following suggestions: (1) chiropractic treatment might be perceived as more aggressive than that of GPs and physiotherapists (2) maybe scepticism towards chiropractic among medical physicians and physiotherapists could encourage more patient complaints (3) a higher out-of-pocket expense for chiropractic services compared with GP and physiotherapist services might influence the higher number of complaints (4) chiropractors do not adequately inform patients about normal side effects and reactions and patients regard these as serious and relevant for compensation claims (5) chiropractors encourage patients to report AE more frequently than GPs and physiotherapists.
So, are complaints against chiropractors rarities?
I don’t think so.
On this blog, we have seen more than enough evidence of how some proponents of alternative medicine can react when they feel cornered by critics. They often direct vitriol in their direction. Ad hominem attacks are far from being rarities. A more forceful option is to sue them for libel. In my own case, Prince Charles went one decisive step further and made sure that my entire department was closed down. In China, they have recently and dramatically gone even further.
This article in Nature tells the full story:
A Chinese doctor who was arrested after he criticized a best-selling traditional Chinese remedy has been released, after more than three months in detention. Tan Qindong had been held at the Liangcheng county detention centre since January, when police said a post Tan had made on social media damaged the reputation of the traditional medicine and the company that makes it.
On 17 April, a provincial court found the police evidence for the case insufficient. Tan, a former anaesthesiologist who has founded several biomedical companies, was released on bail on that day. Tan, who lives in Guangzhou in southern China, is now awaiting trial. Lawyers familiar with Chinese criminal law told Nature that police have a year to collect more evidence or the case will be dismissed. They say the trial is unlikely to go ahead…
The episode highlights the sensitivities over traditional Chinese medicines (TCMs) in China. Although most of these therapies have not been tested for efficacy in randomized clinical trials — and serious side effects have been reported in some1 — TCM has support from the highest levels of government. Criticism of remedies is often blocked on the Internet in China. Some lawyers and physicians worry that Tan’s arrest will make people even more hesitant to criticize traditional therapies…
Tan’s post about a medicine called Hongmao liquor was published on the Chinese social-media app Meipian on 19 December…Three days later, the liquor’s maker, Hongmao Pharmaceuticals in Liangcheng county of Inner Mongolia autonomous region, told local police that Tan had defamed the company. Liangcheng police hired an accountant who estimated that the damage to the company’s reputation was 1.4 million Chinese yuan (US$220,000), according to official state media, the Beijing Youth Daily. In January, Liangcheng police travelled to Guangzhou to arrest Tan and escort him back to Liangcheng, according to a police statement.
Sales of Hongmao liquor reached 1.63 billion yuan in 2016, making it the second best-selling TCM in China that year. It was approved to be sold by licensed TCM shops and physicians in 1992 and approved for sale over the counter in 2003. Hongmao Pharmaceuticals says that the liquor can treat dozens of different disorders, including problems with the spleen, stomach and kidney, as well as backaches…
Hongmao Pharmaceuticals did not respond to Nature’s request for an interview. However, Wang Shengwang, general manager of the production center of Hongmao Liquor, and Han Jun, assistant to the general manager, gave an interview to The Paper on 16 April. The pair said the company did not need not publicize clinical trial data because Hongmao liquor is a “protected TCM composition”. Wang denied allegations in Chinese media that the company pressured the police to pursue Tan or that it dispatched staff to accompany the police…
Xia is worried that the case could further silence public criticism of TCMs, environmental degredation, and other fields where comment from experts is crucial. The Tan arrest “could cause fear among scientists” and dissuade them from posting scientific comments, he says.
END OF QUOTE
On this blog, we have repeatedly discussed concerns over the validity of TCM data/material that comes out of China (see for instance here, here and here). This chilling case, I am afraid, is not prone to increase our confidence.
Daniel P Wirth used to be THE star amongst researchers and proponents of paranormal healing. About 15 years ago, there was nobody who had published more studies of it than Wirth. The extraordinary phenomenon was not just the number of studies, but also the fact that these trials all reported positive findings.
At the time, this puzzled me a lot. I had conducted two trials of paranormal healing myself; and, in both, cases the results had turned out to be negative (see here and here). Thus I made several attempts to contact Wirth or his co-authors hoping to better understand the phenomenon. Yet I never received a reply and became increasingly suspicious of their research.
In 2004, it was announced that Wirth together with one of his co-workers had been arrested and later imprisoned for fraud. Several of his 20 papers published in various journals were subsequently withdrawn. I remember writing to several journal editors myself urging them to follow suit so that, in future, the literature would not be polluted with dubious studies. Eventually, we all forgot about the whole story.
Recently, I took a renewed interest in paranormal healing. To my surprise, I found that several of Wirth’s papers are still listed on Medline:
Cha KY, Wirth DP.
J Reprod Med. 2001 Sep;46(9):781-7. Erratum in: J Reprod Med. 2004 Oct;49(10):100A. Lobo, RA [removed].
Wirth DP, Cram JR, Chang RJ.
J Altern Complement Med. 1997 Summer;3(2):109-18.
Wirth DP, Cram JR.
J Altern Complement Med. 1997 Winter;3(4):355-64.
Wirth DP, Richardson JT, Eidelman WS.
J Altern Complement Med. 1996 Winter;2(4):493-502. Review.
Soc Sci Med. 1995 Jul;41(2):249-60.
Int J Psychosom. 1995;42(1-4):48-53.
Wirth DP, Cram JR.
Int J Psychosom. 1994;41(1-4):68-75.
Wirth DP, Barrett MJ.
Int J Psychosom. 1994;41(1-4):61-7.
Wirth DP, Cram JR.
Int J Psychosom. 1993;40(1-4):47-55.
Of these 9 papers, only the first one in the list carries a note indicating that the paper has been removed. In other words, 8 of Wirth’s articles are still available as though they are fine and proper.
The situation is even worse on ‘Research Gate’. Here we find all of the following articles with no indication of any suspicion of fraud:
KY Cha ·· RA Lobo
Abstract: To assess the potential effect of intercessory prayer (IP) on pregnancy rates in women being treated with in vitro fertilization-embryo transfer (IVF-ET). Prospective, double-blind, randomized clinical trial in which patients and providers were not informed about the intervention. Statisticians and investigators were masked until all the data had been collected and clinical outcomes were known. The setting was an IVF-ET program at Cha Hospital, Seoul, Korea. IP was carried out by prayer…
Article · Oct 2001 · The Journal of reproductive medicine
Daniel P. Wirth
Article · Apr 1997 · Alternative and Complementary Therapies
Daniel P. Wirth · Jeffrey R. Cram
Abstract: A comparative analysis was conducted on a series of three experimental studies that examined the effect of various local and nonlocal (distant) complementary healing methods on multisite surface electromyographic (sEMG) and autonomic measures. The series concentrated sEMG electrode placement on specific neuromuscular paraspinal centers (cervical [C4], thoracic [T6], and lumbar [L3]), along with the frontalis region, due to the fact that these sites corresponded to the location of individual…
Article · Feb 1997 · The Journal of Alternative and Complementary Medicine
Daniel P. Wirth · Jeffrey R. Cram · Richard J. Chang
Abstract: The influence of complementary healing treatment on paraspinal electromagnetic activity at specific neuromuscular sites was examined in an exploratory pilot study that used a multisite surface electromyographic (sEMG) assessment procedure. The study was a replication and extension of previous research that indicated that complementary healing had a significant effect in normalizing the activity of the “end organ” for the central nervous system (CNS). Multisite sEMG electrodes were placed on…
Article · Feb 1997 · The Journal of Alternative and Complementary Medicine
Daniel P Wirth · Joseph T. Richardson · Robert D. Martinez · William S. Eidelman · Maria E.L. Lopez
Abstract: The study described here utilized a randomized double-blind methodological protocol in order to examine the effect of non-contact therapeutic touch (NCTT) on the healing rate of full-thickness human dermal wounds. This study is the fifth experiment in a series of extensions based on the original research design, and is an exact methodological replication of the second study in the series. Thirty-two healthy subjects were randomly divided into treatment and control groups and biopsies were…
Article · Oct 1996 · Complementary Therapies in Medicine
Daniel P. Wirth · Joseph T. Richardson · William S. Eidelman
Abstract: A series of five innovative experiments conducted by Wirth et al. which examined the effect of various complementary healing interventions on the reepithelialization rate of full thickness human dermal wounds was assessed as to specific methodological and related factors. The treatment interventions utilized in the series included experimental derivatives of the Therapeutic Touch (TT), Reiki, LeShan, and Intercessory Prayer techniques. The results of the series indicated statistical…
Article · Feb 1996 · The Journal of Alternative and Complementary Medicine
Daniel P. Wirth · Richard J. Chang · William S. Eidelman · Joanne B. Paxton
Abstract: The effect of Therapeutic Touch, Reiki, LeShan, and Qigong Therapy in combination on haematological measures was examined in an exploratory pilot study utilizing a randomized, double-blind, within-subject, crossover design. Fourteen subjects were randomly assigned to treatment and control conditions for two one-hour evaluation sessions separated by a 24-hour period. Six blood samples were taken from each subject — three during the treatment condition and three during the control condition —…
Article · Jan 1996 · Complementary Therapies in Medicine
Daniel P. Wirth
Abstract: Historically, traditional cultures recognized the importance of belief and expectancy within the healing encounter and created complex rituals and ceremonies designed to elicit or foster the expectancy and participation of both the healer and patient, as well as the community as a whole. This holistic approach to health care was a fundamental component in the spiritual healing rituals of virtually all traditional native cultures. The focus of the current study was to assess the impact of…
Article · Aug 1995 · Social Science & Medicine
Daniel P. Wirth · Margaret J Barrett · William S. Eidelman
Abstract: The results demonstrated a non-significant effect for the treatment versus control groups. Several factors may have contributed to the non-significance, including: the ineffectiveness of the healers, the inhibitive or dampening effect of plastic, the use of self-regulatory techniques, the dependent variable examined, the type of dressing utilized, the influence of distance, and the healers’ belief as to the effect of distance. Future studies would benefit by examining the methodological…
Article · Oct 1994 · Complementary Therapies in Medicine
Daniel P. Wirth · David R. Brenlan · Richard J. Levine · Christine M. Rodriguez
Abstract: This study utilized a randomized, double-blind, within subject, crossover design to examine the effect of Reiki and LeShan healing in combination on iatrogenic pain experienced after unilateral operative extraction of the lower third molar. Two separate operations were performed on 21 patients with bilateral, asymptomatic, impacted lower third molar teeth. The patients were randomly assigned to the treatment or control condition prior to the first operation. For the second operation,…
Article · Jul 1993 · Complementary Therapies in Medicine
Daniel P. Wirth · Joseph T. Richardson · William S. Eidelman · Alice C. O’Malley
Abstract: The effect of non-contact Therapeutic Touch (NCTT) therapy on the healing rate of full thickness human dermal wounds was examined in a double-blind, placebo controlled study. Punch biopsies were performed on the lateral deltoid in 24 healthy subjects who were randomly assigned to treatment and control groups. Active and control treatments were comprised of daily sessions of 5 min of exposure to a hidden NCTT practitioner or control exposure. Placebo effects and the possible influences of…
Article · Jul 1993 · Complementary Therapies in Medicine
DANIEL P. WIRTH · CATHY A. JOHNSON · JOSEPH S. HORVATH
Article · Jan 1992
DANIEL P. WIRTH · BARBARA J. MITCHELL
Abstract: The effect of Noncontact Therapeutic Touch (NCTT) therapy and Intercessory Prayer (IP) on patient determined insulin dosage was exam- ined in an exploratory pilot study which utilized a randomized, double-blind, within subject, crossover design. Sixteen type I diabetes mellitus patients were examined and treated daily by NCTT and IP healers for a duration of two weeks. Each patient underwent two separate sessions-one in the treat- ment condition and one in the control condition-with the…
What is even worse, Wirth’s papers continue to get cited. In other words, Wirth’s research lives on regardless of the fact that it is highly dubious.
In my view, it is long over-due for all journal-editors to fully and completely delete Wirth’s dubious papers. This is particularly true since several experts have alerted them to the problem. Furthermore, I submit that failing to take action amounts to unethical behaviour which is quite simply unacceptable.
In the current issue of the Faculty of Homeopathy‘s Simile publication, Dr Peter Fisher, the Queen’s homeopath, re-visits the old story of the ‘Smallwood Report’. To my big surprise, I found the following two paragraphs in his editorial:
A prepublication draft [of the Smallwood report] was circulated for comment with prominent warnings that it was confidential and not to be shared more widely (I can personally vouch for this, since I was one of those asked to comment). Regrettably, Prof Ernst did precisely this, leaking it to The Times who used it as the basis of their lead story. The editor of The Lancet, Richard Horton, certainly no friend of homeopathy, promptly denounced Ernst for having “broken every professional code of scientific behaviour”.
Sir Michael Peat, the Prince of Wales’ Principal Private Secretary, wrote to the vice chancellor of Exeter University protesting at the leak, and the university conducted an investigation. Ernst’s position became untenable, funding for his department dried up and he took early retirement. Thirteen years later he remains sore; in his latest book More Harm than Good? he attacks the Prince of Wales as “foolish and immoral”.
END OF QUOTE
Sadly it is true that Horton wrote these defaming words. Subsequently, I asked him to justify them explaining that they were being used by my university against me. He ignored several of my emails, but eventually he sent a reply. In it, he said that, since the university was investigating the issue, the truth would doubtlessly be disclosed. I remember that I was livid at the arrogance and ignorance of this reply. However, being in the middle of my university’s investigation against me, never did anything about it. Looking back at this part of the episode, I feel that Horton behaved abominably.
But back to Dr Fisher.
Why did his defamatory and false accusation in his new editorial come as a ‘big surprise’ to me?
Should I not have gotten used to the often odd way in which some homeopaths handle the truth?
Yes, I did get used to this phenomenon; but I am nevertheless surprised because I have tried to correct Fisher’s ‘error’ before.
This is from a post about Fisher which I published in 2015:
In this article [available here in archive,org – Admin] which he published as Dr. Peter Fisher, Homeopath to Her Majesty, the Queen, he wrote: There is a serious threat to the future of the Royal London Homoeopathic Hospital (RLHH), and we need your help…Lurking behind all this is an orchestrated campaign, including the ’13 doctors letter’, the front page lead in The Times of 23 May 2006, Ernst’s leak of the Smallwood report (also front page lead in The Times, August 2005), and the deeply flawed, but much publicised Lancet meta-analysis of Shang et al…
If you have read my memoir, you will know that even the hostile 13-months investigation my own university did not find me guilty of the ‘leak’. The Times journalist who interviewed me about the Smallwood report already had the document on his desk when we spoke, and I did not disclose any contents of the report to him…
END OF QUOTE
So, assuming that Dr Peter Fisher has seen my 2015 post, he is knowingly perpetuating a slanderous untruth. However, giving him the benefit of the doubt, he might not have read the post nor my memoir and could be unaware of the truth. Error or lie? I am determined to find out and will send him today’s post with an offer to clarify the situation.
I will keep you posted.
Did you know that chiropractic is a religion?
Well, not quite but almost.
DD Palmer seriously toyed with the idea of turning chiropractic into a religion.
And rightly so!
In the absence of evidence, belief is everything.
And this is why, to this day, so many chiropractors bank (a most appropriate term in this context!) on belief rather than evidence.
Look, for instance at this lovely advertisement I found on Twitter (there are many more, but this one has to stand for the many).
Seven common benefits of chiropractic care!?!
Beneath the picture of a pathologically straight spine – if that is what chiro does to you, avoid it at all cost! – we see the name of the ‘doctor’ who seems to have designed this impressive picture. ‘Dr’ Schluter is even more versatile than his pretty advertisement implies; he also seems to treat newborn babies! And on his website he also tells us that he is able to treat allergies:
You may be surprised to find that chiropractic can do a great deal to alleviate some allergies. Allergies are very common and we become so used to their effect on us that we tend to ignore their symptoms. And many people are unaware of the gradual decline in health that results. Chiropractic treatment didn’t necessarily set out specifically to provide care for allergies, but due to the nature of the chiropractic care and its effect on the nervous system, it has been shown to help.
If we look at some of the common signs of allergies we find that they include some unexpected examples. Not only do we find the usual ones – asthma, sinus congestion, sneezing, itchy eyes, skin rashes and running nose – but also weight gain, Acne and even fluid retention and heartburn.
Many people approach the problem of allergies as though all allergens affect everyone in the same way; this is not the case. Because we are individuals, different allergens affect each of us in differing ways. Some allergens affect some and not others. Consequently treating the condition must be approached on this basis of individuality.
It may not be the pet fur or dried saliva that is kicked up as your pooch washes and scratches; it may also not be the pollen, grass dust or other one of the many irritants in the air at any one time. It could be that due to a misalignment of the spine (or subluxation), mild though it may be, the nervous system is finding it difficult to help the body adapt to its surroundings and is therefore unable to deal with the necessary adjustments.
As an individual you need to treat your body’s physical and nervous system as such. You could be, without even being aware of it, in a generally stressed condition – this may be through lack of sleep, poor nutrition or any one of a combination of the many other stressors affecting us daily. Suddenly you find that with the first spring pollen dust that comes along you begin to wheeze and sneeze!
You may not have previously connected chiropractors and allergies but, for you or someone you know, the connection could help.
Schluter Chiropractic works on the principle of reducing interference so the nervous system and body can work better. Providing that any symptom or condition (including pain) is occurring as a result of nerve interference from vertebral subluxation, there is a very good chance that it will improve with chiropractic care.
END OF QUOTE
Wise words indeed.
Like most chiros, ‘Dr’ Schulter seems to be a true miracle-worker; and because he can do miracles, he does not need to be rational or concerned about evidence or worried about telling the truth.
For Christ sake, it’s Easter!
We ought to show a bit of belief!!!
Because without it, the benefits of chiropractic would be just an illusion.
As I often said, I find it regrettable that sceptics often say THERE IS NOT A SINGLE STUDY THAT SHOWS HOMEOPATHY TO BE EFFECTIVE (or something to that extent). This is quite simply not true, and it gives homeopathy-fans the occasion to suggest sceptics wrong. The truth is that THE TOTALITY OF THE MOST RELIABLE EVIDENCE FAILS TO SUGGEST THAT HIGHLY DILUTED HOMEOPATHIC REMEDIES ARE EFFECTIVE BEYOND PLACEBO. As a message for consumers, this is a little more complex, but I believe that it’s worth being well-informed and truthful.
And that also means admitting that a few apparently rigorous trials of homeopathy exist and some of them show positive results. Today, I want to focus on this small set of studies.
How can a rigorous trial of a highly diluted homeopathic remedy yield a positive result? As far as I can see, there are several possibilities:
- Homeopathy does work after all, and we have not fully understood the laws of physics, chemistry etc. Homeopaths favour this option, of course, but I find it extremely unlikely, and most rational thinkers would discard this possibility outright. It is not that we don’t quite understand homeopathy’s mechanism; the fact is that we understand that there cannot be a mechanism that is in line with the laws of nature.
- The trial in question is the victim of some undetected error.
- The result has come about by chance. Of 100 trials, 5 would produce a positive result at the 5% probability level purely by chance.
- The researchers have cheated.
When we critically assess any given trial, we attempt, in a way, to determine which of the 4 solutions apply. But unfortunately we always have to contend with what the authors of the trial tell us. Publications never provide all the details we need for this purpose, and we are often left speculating which of the explanations might apply. Whatever it is, we assume the result is false-positive.
Naturally, this assumption is hard to accept for homeopaths; they merely conclude that we are biased against homeopathy and conclude that, however, rigorous a study of homeopathy is, sceptics will not accept its result, if it turns out to be positive.
But there might be a way to settle the argument and get some more objective verdict, I think. We only need to remind ourselves of a crucially important principle in all science: INDEPENDENT REPLICATION. To be convincing, a scientific paper needs to provide evidence that the results are reproducible. In medicine, it unquestionably is wise to accept a new finding only after it has been confirmed by other, independent researchers. Only if we have at least one (better several) independent replications, can we be reasonably sure that the result in question is true and not false-positive due to bias, chance, error or fraud.
And this is, I believe, the extremely odd phenomenon about the ‘positive’ and apparently rigorous studies of homeopathic remedies. Let’s look at the recent meta-analysis of Mathie et al. The authors found several studies that were both positive and fairly rigorous. These trials differ in many respects (e. g. remedies used, conditions treated) but they have, as far as I can see, one important feature in common: THEY HAVE NOT BEEN INDEPENDENTLY REPLICATED.
If that is not astounding, I don’t know what is!
Think of it: faced with a finding that flies in the face of science and would, if true, revolutionise much of medicine, scientists should jump with excitement. Yet, in reality, nobody seems to take the trouble to check whether it is the truth or an error.
To explain this absurdity more fully, let’s take just one of these trials as an example, one related to a common and serious condition: COPD
The study is by Prof Frass and was published in 2005 – surely long enough ago for plenty of independent replications to emerge. Its results showed that potentized (C30) potassium dichromate decreases the amount of tracheal secretions was reduced, extubation could be performed significantly earlier, and the length of stay was significantly shorter. This is a scientific as well as clinical sensation, if there ever was one!
The RCT was published in one of the leading journals on this subject (Chest) which is read by most specialists in the field, and it was at the time widely reported. Even today, there is hardly an interview with Prof Frass in which he does not boast about this trial with truly sensational results (only last week, I saw one). If Frass is correct, his findings would revolutionise the lives of thousands of seriously suffering patients at the very brink of death. In other words, it is inconceivable that Frass’ result has not been replicated!
But it hasn’t; at least there is nothing in Medline.
Why not? A risk-free, cheap, universally available and easy to administer treatment for such a severe, life-threatening condition would normally be picked up instantly. There should not be one, but dozens of independent replications by now. There should be several RCTs testing Frass’ therapy and at least one systematic review of these studies telling us clearly what is what.
But instead there is a deafening silence.
For heaven sakes, why?
The only logical explanation is that many centres around the world did try Frass’ therapy. Most likely they found it does not work and soon dismissed it. Others might even have gone to the trouble of conducting a formal study of Frass’ ‘sensational’ therapy and found it to be ineffective. Subsequently they felt too silly to submit it for publication – who would not laugh at them, if they said they trailed a remedy that was diluted 1: 1000000000000000000000000000000000000000000000000000000000000 and found it to be worthless? Others might have written up their study and submitted it for publication, but got rejected by all reputable journals in the field because the editors felt that comparing one placebo to another placebo is not real science.
And this is roughly, how it went with the other ‘positive’ and seemingly rigorous studies of homeopathy as well, I suspect.
Regardless of whether I am correct or not, the fact is that there are no independent replications (if readers know any, please let me know).
Once a sufficiently long period of time has lapsed and no replications of a ‘sensational’ finding did not emerge, the finding becomes unbelievable or bogus – no rational thinker can possibly believe such a results (I for one have not yet met an intensive care specialist who believes Frass’ findings, for instance). Subsequently, it is quietly dropped into the waste-basket of science where it no longer obstructs progress.
The absence of independent replications is therefore a most useful mechanism by which science rids itself of falsehoods.
It seems that homeopathy is such a falsehood.
A few days ago, the German TV ‘FACT’ broadcast a film (it is in German, the bit on homeopathy starts at ~min 20) about a young woman who had her breast cancer first operated but then decided to forfeit subsequent conventional treatments. Instead she chose homeopathy which she received from Dr Jens Wurster at the ‘Clinica Sta Croce‘ in Lucano/Switzerland.
Elsewhere Dr Wurster stated this: Contrary to chemotherapy and radiation, we offer a therapy with homeopathy that supports the patient’s immune system. The basic approach of orthodox medicine is to consider the tumor as a local disease and to treat it aggressively, what leads to a weakening of the immune system. However, when analyzing all studies on cured cancer cases it becomes evident that the immune system is always the decisive factor. When the immune system is enabled to recognize tumor cells, it will also be able to combat them… When homeopathic treatment is successful in rebuilding the immune system and reestablishing the basic regulation of the organism then tumors can disappear again. I’ve treated more than 1000 cancer patients homeopathically and we could even cure or considerably ameliorate the quality of life for several years in some, advanced and metastasizing cases.
The recent TV programme showed a doctor at this establishment confirming that homeopathy alone can cure cancer. Dr Wurster (who currently seems to be a star amongst European homeopaths) is seen lecturing at the 2017 World Congress of Homeopathic Physicians in Leipzig and stating that a ‘particularly rigorous study’ conducted by conventional scientists (the senior author is Harald Walach!, hardly a conventional scientist in my book) proved homeopathy to be effective for cancer. Specifically, he stated that this study showed that ‘homeopathy offers a great advantage in terms of quality of life even for patients suffering from advanced cancers’.
This study did, of course, interest me. So, I located it and had a look. Here is the abstract:
Many cancer patients seek homeopathy as a complementary therapy. It has rarely been studied systematically, whether homeopathic care is of benefit for cancer patients.
We conducted a prospective observational study with cancer patients in two differently treated cohorts: one cohort with patients under complementary homeopathic treatment (HG; n = 259), and one cohort with conventionally treated cancer patients (CG; n = 380). For a direct comparison, matched pairs with patients of the same tumour entity and comparable prognosis were to be formed. Main outcome parameter: change of quality of life (FACT-G, FACIT-Sp) after 3 months. Secondary outcome parameters: change of quality of life (FACT-G, FACIT-Sp) after a year, as well as impairment by fatigue (MFI) and by anxiety and depression (HADS).
HG: FACT-G, or FACIT-Sp, respectively improved statistically significantly in the first three months, from 75.6 (SD 14.6) to 81.1 (SD 16.9), or from 32.1 (SD 8.2) to 34.9 (SD 8.32), respectively. After 12 months, a further increase to 84.1 (SD 15.5) or 35.2 (SD 8.6) was found. Fatigue (MFI) decreased; anxiety and depression (HADS) did not change. CG: FACT-G remained constant in the first three months: 75.3 (SD 17.3) at t0, and 76.6 (SD 16.6) at t1. After 12 months, there was a slight increase to 78.9 (SD 18.1). FACIT-Sp scores improved significantly from t0 (31.0 – SD 8.9) to t1 (32.1 – SD 8.9) and declined again after a year (31.6 – SD 9.4). For fatigue, anxiety, and depression, no relevant changes were found. 120 patients of HG and 206 patients of CG met our criteria for matched-pairs selection. Due to large differences between the two patient populations, however, only 11 matched pairs could be formed. This is not sufficient for a comparative study.
In our prospective study, we observed an improvement of quality of life as well as a tendency of fatigue symptoms to decrease in cancer patients under complementary homeopathic treatment. It would take considerably larger samples to find matched pairs suitable for comparison in order to establish a definite causal relation between these effects and homeopathic treatment.
Even the abstract makes several points very clear, and the full text confirms further embarrassing details:
- The patients in this study received homeopathy in addition to standard care (the patient shown in the film only had homeopathy until it was too late, and she subsequently died, aged 33).
- The study compared A+B with B alone (A=homeopathy, B= standard care). It is hardly surprising that the additional attention of A leads to an improvement in quality of life. It is arguably even unethical to conduct a clinical trial to demonstrate such an obvious outcome.
- The authors of this paper caution that it is not possible to conclude that a causal relationship between homeopathy and the outcome exists.
- This is true not just because of the small sample size, but also because of the fact that the two groups had not been allocated randomly and therefore are bound to differ in a whole host of variables that have not or cannot be measured.
- Harald Walach, the senior author of this paper, held a position which was funded by Heel, Baden-Baden, one of Germany’s largest manufacturer of homeopathics.
- The H.W.& J.Hector Foundation, Germany, and the Samueli Institute, provided the funding for this study.
In the film, one of the co-authors of this paper, the oncologist HH Bartsch from Freiburg, states that Dr Wurster’s interpretation of this study is ‘dishonest’.
I am inclined to agree.
We have repeatedly discussed the journal ‘Evidence-Based Complementary and Alternative Medicine’ (see for instance here and here). The journal has recently done something remarkable and seemingly laudable: it retracted an article titled “Psorinum Therapy in Treating Stomach, Gall Bladder, Pancreatic, and Liver Cancers: A Prospective Clinical Study” due to concerns about the ethics, authorship, quality of reporting, and misleading conclusions.***
Aradeep and Ashim Chatterjee own and manage the Critical Cancer Management Research Centre and Clinic (CCMRCC), the private clinic to which they are affiliated. The methods state “The study protocol was approved by the Institutional Review Board (IRB approval Number: 2001–05) of the CCMRCC” in 2001, but a 2014 review of Psorinum therapy said CCMRCC was founded in 2008. The study states “The participants received the drug Psorinum along with allopathic and homeopathic supportive treatments without trying conventional or any other investigational cancer treatments”; withholding conventional cancer treatment raises ethical concerns.
We asked the authors and their institutions for documentation of the ethics approval, the study protocol, and a blank copy of the informed consent form. However, the corresponding author, Aradeep Chatterjee, was reported to have been arrested in June 2017 for allegedly practising medicine without the correct qualifications and his co-author and father Ashim Chatterjee was reported to have been arrested in August; the Chatterjees and their legal representative did not respond to our queries. The co-authors Syamsundar Mandal, Sudin Bhattacharya, and Bishnu Mukhopadhyay said they did not agree to be authors of the article and were not aware of its submission; co-author Jaydip Biswas did not respond.
A member of the editorial board noted that although the discussion stated that “The limitation of this study is that it did not have any placebo or treatment control arm; therefore, it cannot be concluded that Psorinum Therapy is effective in improving the survival and the quality of life of the participants due to the academic rigours of the scientific clinical trials”, the abstract was misleading because it implied Psorinum therapy is effective in cancer treatment. The study design was described as a “prospective observational clinical trial”, but it cannot have been both observational and a clinical trial.
(*** while I wrote this blog (13/3/18) the abstract of this paper was still available on Medline without a retraction notice)
In case you wonder what ‘psorinum therapy’ is, this website explains:
A cancer specialist and Psorinum clinical researcher, Aurodeep Chaterjee, believes Psorinum Therapy is less time consuming and more economical for treatment of cancer. ‘The advantage of this treatment is that the patient can continue this treatment while staying home and the hospitalization is less required,’ said Chaterjee. He added that it’s an immunotherapy treatment in which the medicine is in liquid form and the technique of consumption is oral.
Though no chemo or radiation sessions are required in it but they can be used parallel to it depending upon the stage of the cancer. He claimed that more than 30 types of cancers could be treated from this therapy. Some of them include gastrointestinal cancer, liver cancer, gall bladder cancer, ovarian cancer, stomach cancer, etc. The process requires two months duration in which the patient has to undergo 12 cycles and the cost is just Rs 5000. Moli Rapoor 55, software engineer from USA who is suffering from ovarian cancer said on Thursday (June 20) that after three chemo cycles when her cancer did not cure after being diagnosed in 2008, she decided to take up Psorinum therapy.
I am sorry, but the retraction of such a paper is far less laudable than it seems – it should not have been retracted, but it should have never been published in the first place. There are multiple points where the reviewers’ and editors’ alarm bells should have started ringing loud and clear. Take, for instance, this note at the end of the paper:
Dr. Rabindranath Chatterjee Memorial Cancer Trust provided funding for this study.
Conflict of Interests
The authors declare that they have no conflict of interests.
What this story shows, in my view, is that the journal ‘Evidence-Based Complementary and Alternative Medicine’ (EBCAM) operates an unacceptably poor system of peer-review, and is led by an editor who seems to shut both eyes when deciding about publication or rejection. And why would an editor shut his/her eyes to abuse? Perhaps the journal’s interesting business model provides an explanation? Here is what I wrote about it previously:
What I fail to understand is why so many researchers send their papers to this journal. In 2015, EBCAM published just under 1000 (983 to be exact) papers. This is not far from half of all Medline-listed articles on alternative medicine (2056 in total).
To appreciate these figures – and this is where it gets not just puzzling but intriguing, in my view – we need to know that EBCAM charges a publication fee of US$ 2500. That means the journal has an income of about US$ 2 500 000 per annum!
END OF QUOTE
To put it in a nutshell: in healthcare, fraud and greed can cause enormous harm.
START OF QUOTE
Antiretroviral Therapy (ART) is recommended for each and every case of AIDS where CD4 count goes less than 350. Aura Homeopathy does not offer cure for AIDS. However, several research and clinical studies done by various Research centre including few from CCRH (Central Council for Research in Homeopathy, Govt. of India), have prove the supportive role of homeopathic medicines. Homeopathy medicine only relief symptoms but also reduced frequency of opportunistic infections, increase appetite, weight, and sense of well being, etc. At Aura Homeopathy, we apply classical homeopathy protocols on HIV/AIDS patients, as a part of our Clinical trial and Research projects. The results were very encouraging.
At Aura Homeopathy, we have seen an increase in the CD4 count in number of patients, after using Aura homeopathy medicines. Dr.Abhishek recommend’s Homeopathy as supporting line of therapy for all HIV patients.
END OF QUOTE
When I read this I wanted to be sick; but instead I did something a little more sensible: I conducted a quick Medline search for ‘homeopathy, AIDS’.
It returned 30 articles. Of these, there were just 4 that presented anything remotely resembling data. Here are their abstracts:
Allopathic practitioners in India are outnumbered by practitioners of traditional Indian medicine and homeopathy (TIMH), which is used by up to two-thirds of its population to help meet primary health care needs, particularly in rural areas. India has an estimated 2.5 million HIV infected persons. However, little is known about TIMH use, safety or efficacy in HIV/AIDS management in India, which has one of the largest indigenous medical systems in the world. The purpose of this review was to assess the quality of peer-reviewed, published literature on TIMH for HIV/AIDS care and treatment.
Of 206 original articles reviewed, 21 laboratory studies, 17 clinical studies, and 6 previous reviews of the literature were identified that covered at least one system of TIMH, which includes Ayurveda, Unani medicine, Siddha medicine, homeopathy, yoga and naturopathy. Most studies examined either Ayurvedic or homeopathic treatments. Only 4 of these studies were randomized controlled trials, and only 10 were published in MEDLINE-indexed journals. Overall, the studies reported positive effects and even “cure” and reversal of HIV infection, but frequent methodological flaws call into question their internal and external validity. Common reasons for poor quality included small sample sizes, high drop-out rates, design flaws such as selection of inappropriate or weak outcome measures, flaws in statistical analysis, and reporting flaws such as lack of details on products and their standardization, poor or no description of randomization, and incomplete reporting of study results.
This review exposes a broad gap between the widespread use of TIMH therapies for HIV/AIDS, and the dearth of high-quality data supporting their effectiveness and safety. In light of the suboptimal effectiveness of vaccines, barrier methods and behavior change strategies for prevention of HIV infection and the cost and side effects of antiretroviral therapy (ART) for its treatment, it is both important and urgent to develop and implement a rigorous research agenda to investigate the potential risks and benefits of TIMH and to identify its role in the management of HIV/AIDS and associated illnesses in India.
2nd paper (I am a co-author of this one)
The use of complementary and alternative medicine (CAM) is widespread. Yet, little is known about the evidence supporting its use in HIV/AIDS. We conducted a systematic review of randomized clinical trials assessing the effectiveness of complementary therapies for HIV and HIV-related symptoms. Comprehensive literature searches were performed of seven electronic databases. Data were abstracted independently by two reviewers. Thirty trials met our predefined inclusion/exclusion criteria: 18 trials were of stress management; five of Natural Health Products; four of massage/therapeutic touch; one of acupuncture; two of homeopathy. The trials were published between 1989 and 2003. Most trials were small and of limited methodological rigour. The results suggest that stress management may prove to be an effective way to increase the quality of life. For all other treatments, data are insufficient for demonstrating effectiveness. Despite the widespread use of CAM by people living with HIV/AIDS, the effectiveness of these therapies has not been established. Vis à vis CAM’s popularity, the paucity of clinical trials and their low methodological quality are concerning.
Homeopathic medicine developed significant popularity in the nineteenth century in the United States and Europe as a result of its successes treating the infectious disease epidemics during that era. Homeopathic medicine is a medical system that is specifically oriented to using nanopharmacologic and ultramolecular doses of medicines to strengthen a person’s immune and defense system rather than directly attacking the microbial agents.
To review the literature referenced in MEDLINE and in nonindexed homeopathic journals for placebo-controlled clinical trials using homeopathic medicines to treat people with AIDS or who are human immunodeficiency virus (HIV)-positive and to consider a different theoretical and methodological approach to treating people with the viral infection.
A total of five controlled clinical trials were identified. A double-blinded, placebo-controlled study was conducted on 50 asymptomatic HIV-positive subjects (stage II) and 50 subjects with persistent generalized lymphadenopathy (stage III) in whom individualized single-remedy homeopathic treatment was provided. A separate body of preliminary research was conducted using homeopathic doses of growth factors. Two randomized double-blinded, placebo-controlled studies were conducted with a total of 77 people with AIDS who used only natural therapies over a 8-16-week period. Two other studies were conducted over a 2.5-year period with 27 subjects in an open-label format.
The first study was conducted by the Regional Research Institute for Homeopathy in Mumbai, India, under the Central Council for Research in Homeopathy, with the approval of the Ministry of Health and Family Welfare, Government of India. The second body of studies was conducted in clinic settings in California, Oregon, Arizona, Hawaii, New York, and Washington.
The first study found no statistically significant improvement in CD4 T-lymphocytes, but did find statistically significant pretest and post-test results in subjects with stage III AIDS, in CD4 (p = 0.008) and in CD8 (p = 0.04) counts. The second group of studies found specific physical, immunologic, neurologic, metabolic, and quality-of-life benefits, including improvements in lymphocyte counts and functions and reductions in HIV viral loads.
As a result of the growing number of people with drug-resistant HIV infection taking structured treatment interruptions, homeopathic medicine may play a useful role as an adjunctive and/or alternative therapy.
In 1996, [name removed] was convicted on charges of conspiracy and introducing an unapproved drug into interstate commerce and the 2nd U.S. Circuit Court of Appeals upheld the conviction. [Name removed]’s company, Writers and Researchers Inc. sold a drug called 714X to individuals and physicians, promoting it as a nontoxic therapy for AIDS, cancer, and other chronic diseases. The Food and Drug Administration (FDA) warned [name removed] that his marketing was illegal because the product had not been proven safe and effective for use in treating disease. [Name removed] argued that the product was a homeopathic drug, revealed by FDA tests to contain 94 percent water, and a mixture of nitrate, ammonium, camphor, chloride, ethanol, and sodium. The courts found that 714X was subject to FDA scrutiny because it was touted as a cure for cancer and AIDS.
So, what does this collective evidence tell us?
I think it makes it abundantly clear that there is no good reason to suggest that HIV/AIDS patients can be helped in any way by homeopathy. On the contrary, homeopathy might distract them from essential conventional care and it would needlessly harm their bank balance. It follows that claims to the contrary are bogus, unethical, reckless, and possibly even criminal.
Clinical trials are a most useful tool, but they can easily be abused. It is not difficult to misuse them in such a way that even the most useless treatment appears to be effective. Sadly, this sort of thing happens all too often in the realm of alternative medicine. Take for instance this recently published trial of homeopathy.
The objective of this study was to investigate the usefulness of classical homeopathy for the prevention of recurrent urinary tract infections (UTI) in patients with spinal cord injury (SCI). Patients were admitted to this trial, if they had chronic SCI and had previously suffered from at least three UTI/year. They were treated either with a standardized prophylaxis alone, or with a standardized prophylaxis in combination with homeopathy. The number of UTIs, general and specific quality of life (QoL), and satisfaction with homeopathic treatment were assessed prospectively over the period of one year. Ten patients were in the control group and 25 patients received adjunctive homeopathic treatment. The median number of self-reported UTI in the homeopathy group decreased significantly, whereas it remained unchanged in the control group. The domain incontinence impact of the KHQ improved significantly, whereas the general QoL did not change. The satisfaction with homeopathic care was high.
The authors concluded that adjunctive homeopathic treatment lead to a significant decrease of UTI in SCI patients. Therefore, classical homeopathy could be considered in SCI patients with recurrent UTI.
Where to begin?
Here are just some of the most obvious flaws of and concerns with this study:
- There is no plausible rationale to even plan such a study.
- The sample size was far too small for allowing generalizable conclusions.
- There was no adequate randomisation and patients were able to chose the homeopathy option.
- The study seems to lack objective outcome measures.
- The study design did not allow to control for non-specific effects; therefore, it seems likely that the observed outcomes are unrelated to the homeopathic treatments but are caused by placebo and other non-specific effects.
- Even if the study had been rigorous, we would need independent replications before we draw such definitive conclusions.
- Two of the authors are homeopaths, and it is in their clinics that the study took place.
- Some of the authors have previously published a very similar paper – except that this ‘case series’ included no control group at all.
- The latter paper seems to have been published more than once.
- Of this paper, one of the authors claimed that ” the usefulness of classical homeopathy as an adjunctive measure for UTI prophylaxis in patients with NLUTD due to SCI has been demonstrated in a case series”. He seems to be unaware of the fact that a case series cannot possible lend itself to demonstrate this.
- I do wonder: did they just add a control group to their case series thus pretending it became a controlled clinical trial?
What strikes me most with such pseudo-research is its abundance and the naivety – or should I call it ignorance? – of the enthusiasts who conduct it. Most of them, I am fairly sure do not mean to do harm; but by Jove they do!