MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Cancer

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The authors of this paper wanted to establish and compare the effectiveness of Healing Touch (HT) and Oncology Massage (OM) therapies on cancer patients’ pain. They conducted pre-test/post-test, observational, retrospective study. A total of 572 outpatient oncology were recruited and asked to report pain before and after receiving a single session of either HT or OM from a certified practitioner.

Both HT and OM significantly reduced pain. Unadjusted rates of clinically significant pain improvement (defined as ≥2-point reduction in pain score) were 0.68 HT and 0.71 OM. Adjusted for pre-therapy pain, OM was associated with increased odds of pain improvement. For patients with severe pre-therapy pain, OM was not more effective in yielding clinically significant pain reduction when adjusting for pre-therapy pain score.

The authors concluded that both HT and OM provided immediate pain relief. Future research should explore the duration of pain relief, patient attitudes about HT compared with OM, and how this may differ among patients with varied pretherapy pain levels.

This paper made me laugh out loud; no, not because of the ‘certified’ practitioners (in the UK, we use this term to indicate that someone is not quite sane), but because of the admission that the authors aimed at establishing the effectiveness of their therapies. Most researchers of alternative medicine have exactly this motivation, but few make the mistake to write it into the abstract of their papers. Little do they know that this admission discloses a fatal amount of bias. Science is supposed to test hypotheses, and researchers who aim at establishing the effectiveness of their pet-therapy oust themselves as pseudo-researchers.

It comes therefore as no surprise that the study turns out to be a pseudo-study. As there was no adequate control group, these outcomes cannot be attributed to the interventions administered. The results could therefore be due to:

  • the time that has passed;
  • regression to the mean;
  • the attention provided by the therapists;
  • the expectation of the patient;
  • social desirability;
  • all of the above.

It follows that – just as with the study discussed in the previous post – the conclusion is wholly misleading. In fact, the data are consistent with the hypothesis that HT and OM both aggravated the pain (the results might have been better without HT and OM). The devils advocate concludes that both HT and OM provided an immediate increase in pain.

The ‘Schwaebische Tageblatt’ is not on my regular reading list. But this article of yesterday (16/10/2018) did catch my attention. For those who read German, I will copy it below, and for those who don’t I will provide a brief summary and comment thereafter:

Die grün-schwarze Landesregierung lässt 2019 den ersten Lehrstuhl für Naturheilkunde und Integrative Medizin in Baden-Württemberg einrichten. Lehrstuhl für Naturheilkunde und Integrative Medizin

Ihren Schwerpunkt soll die Professur im Bereich Onkologie haben. Strömungen wie Homöopathie oder Anthroposophie sollen nicht gelehrt, aber innerhalb der Lehre beleuchtet werden, sagte Ingo Autenrieth, Dekan der Medizinischen Fakultät in Tübingen am Dienstag der Deutschen Presse-Agentur. «Ideologien und alles, was nichts mit Wissenschaft zu tun hat, sortieren wir aus.»

Die Professur soll sich demnach mit Themen wie Ernährung, Probiotika und Akupunktur beschäftigten. Geplant ist laut Wissenschaftsministerium, die Lehre in Tübingen anzusiedeln; die Erforschung der komplementären Therapien soll vorwiegend am Centrum für Tumorerkrankungen des Robert-Bosch-Krankenhauses in Stuttgart stattfinden. Die Robert-Bosch-Stiftung finanziert die Professur in den ersten fünf Jahren mit insgesamt 1,84 Millionen Euro, danach soll das Land die Mittel dafür bereitstellen.

«Naturheilkunde und komplementäre Behandlungsmethoden werden von vielen Menschen ganz selbstverständlich genutzt, beispielsweise zur Ergänzung konventioneller Therapieangebote», begründete Wissenschaftsministerin Theresia Bauer (Grüne) das Engagement. Sogenannte sanfte oder natürliche Methoden könnten schwere Krankheiten wie etwa Krebs alleine nicht heilen, heißt es in einer Mitteilung des Ministeriums. Wissenschaftliche Ergebnisse zeigten aber, dass sie häufig zu Therapieerfolgen beitragen könnten, da sie den Patienten helfen, schulmedizinische Therapien gut zu überstehen – etwa die schweren Nebenwirkungen von Chemotherapien mindern.

Im Gegensatz zur Schulmedizin gebe es bisher aber kaum kontrollierte klinische Studien zur Wirksamkeit solcher Therapien, ergänzte Ingo Autenrieth. Ihre Erforschung am neuen Lehrstuhl solle Patienten Sicherheit bringen und ermöglichen, dass die gesetzlichen Krankenkassen die Kosten dafür übernehmen.

Hersteller alternativer Arzneimittel loben den Schritt der Politik. «Baden-Württemberg nimmt damit eine Vorreiterrolle in Deutschland und in Europa ein», heißt es beim Unternehmen Wala Heilmittel GmbH in Bad Boll. Die Landesregierung trage mit der Entscheidung dem Wunsch vieler Patienten und Ärzte nach umfassenden Behandlungskonzepten Rechnung.

Auch hoffen die Unternehmen, dass Licht in die oft kritische Debatte um Homöopathie gebracht wird. «Wir sehen mit Erstaunen und Befremden, dass eine bewährte Therapierichtung wie die Homöopathie, die Teil der Vielfalt des therapeutischen Angebots in Deutschland ist, diskreditiert werden soll», sagte ein Sprecher des Herstellers Weleda AG mit Sitz in Schwäbisch Gmünd der Deutschen Presse-Agentur. Deshalb begrüße man den Lehrstuhl: «Es ist gut, dass Forschung und Lehre ausgebaut werden, da eine Mehrheit der Bevölkerung Komplementärmedizin wünscht und nachfragt. Es braucht Ärzte, die in diesen Bereichen auch universitär ausgebildet werden.»

Laut Koalitionsvertrag will Baden-Württemberg künftig eine Vorreiterrolle in der Erforschung der Komplementärmedizin einnehmen. Bisher gab es im Südwesten mit dem Akademischen Zentrum für Komplementäre und Integrative Medizin (AZKIM) zwar einen Verbund der Unikliniken Tübingen, Freiburg, Ulm und Heidelberg, aber keinen eigenen Lehrstuhl. Bundesweit existieren nach Angaben der Hufelandgesellschaft, dem Dachverband der Ärztegesellschaften für Naturheilkunde und Komplementärmedizin, Lehrstühle für Naturheilkunde noch an den Universitäten Duisburg-Essen, Rostock und Witten/Herdecke sowie drei Stiftungsprofessuren an der Berliner Charité.

END OF QUOTE

And here is my English summary:

The black/green government of Baden-Wuerttemberg has decided to create a ‘chair of naturopathy and integrated medicine’ at the university of Tuebingen in 2019. The chair will focus in the area of oncology. Treatments such as homeopathy and anthroposophical medicine will not be taught but merely mentioned in lectures. Ideologies and everything that is not science will be omitted.

The chair will thus deal with nutrition, acupuncture and probiotics. The teaching activities will be in the medical faculty at Tuebingen, while the research will be located at the Robert-Bosch Hospital in Stuttgart. The funds for the first 5 years – 1.84 million Euro – will come from the Robert-Bosch Foundation; thereafter they will be provided by the government of the county.

So-called gentle or natural therapies cannot cure serious diseases on their own, but as adjuvant treatments they can be helful, for instance, in alleviating the adverse effects of chemotherapy. There are only few studies on this, and the new chair will increase patient safety and facilitate the reimbursement of these treatments by health insurances.

Local anthroposophy manufacturers like Wala welcomed the move stating it would be in accordance with the wishes of many patients and doctors. They also hope that the move will bring light in the current critical debate about homeopathy. A spokesperson of Weleda added that they ‘note with surprise that time-tested therapies like homeopathy are being discredited. Therefore, it is laudable that research and education in this realm will be extended. The majority of the public want complementary medicine and need doctors who are also university-trained.’

Baden-Wurttemberg aims for a leading role in researching complementary medicine. Thus far, chairs of complementary medicine existed only at the universities of Duisburg-Essen, Rostock und Witten/Herdecke as well as three professorships at the Charité in Berlin.

END OF MY SUMMARY

As I have occupied a chair of complementary medicine for 19 years, I am tempted to add a few points here.

  • In principle, a new chair can be a good thing.
  • The name of the chair is odd, to say the least.
  • As the dean of the Tuebingen medical school pointed out, it has to be based on science. But how do they define science?
  • Where exactly does the sponsor, the Robert-Bosch Stiftung, stand on alternative medicine. Do they have a track-record of being impractical and scientific?
  • In order to prevent this becoming a unrealistic prospect, it is essential that the new chair needs to fall into the hands of a scientist with a proven track record of critical thinking.
  • Rigorous scientist with a proven track record of critical thinking are very rare in the realm of alternative medicine.
  • The ridiculous comments by Wala and Weleda, both local firms with considerable local influence, sound ominous and let me suspect that proponents of alternative medicine aim to exert their influence on the new chair.
  • The above-voiced notion that the new chair is to facilitate the reimbursement of alternative treatments by the health insurances seems even more ominous. Proper research has to be objective and could, depending on its findings, have the opposite effect. To direct it in this way seems to determine its results before the research has started.
  • I miss a firm commitment to medical ethics, to the principles of EBM, and to protecting the independence of the new chair.

Thus, I do harbour significant anxieties about this new chair. It is in danger of becoming a chair of promoting pseudoscience. I hope the dean of the Tuebingen medical school might read these lines.

I herewith offer him all the help I can muster in keeping pseudoscience out of this initiative, in defining the remit of the chair and, crucially, in finding the right individual for doing the job.

After a previous post about aromatherapy, someone recently commented:

I love essential oils and use them daily. Essential oils became a part of my life! I do feel better with it! Why I need clinical trials so?

The answer is probably: you don’t need clinical trials for a little pampering that makes you feel good.

But, if someone claims that aromatherapy (or indeed any other treatment) is effective for this or that medical condition, we need proof in the form of a clinical trial. By proof, we usually mean a clinical trial.

One like this new study, perhaps?

The aim of this study was to evaluate the use of a lavender aromatherapy skin patch on anxiety and vital sign variability during the preoperative period in female patients scheduled for breast surgery. Participants received an aromatherapy patch in addition to standard preoperative care. Anxiety levels were assessed with a 10-cm visual analogue scale (VAS) at baseline and then every 15 minutes after patch placement. Vital sign measurements were recorded at the same interval. There was a statistically significant decrease (P = .03) in the anxiety VAS measurements from baseline to final scores.

The authors concluded that the findings from this study suggest the use of aromatherapy is beneficial in reducing anxiety experienced by females undergoing breast surgery. Further research is needed to address the experience of preoperative anxiety, aromatherapy use, and the challenges of managing preoperative anxiety.

No, not one like this study!

This study – its called it a ‘pilot study’ – tells us nothing of value.

Why?

  1. It was not a pilot study because it did not pilot anything; its aim was to evaluate aromatherapy.
  2. But it could not evaluate aromatherapy because it had no control group. This means the reduction in anxiety was almost certainly not a specific effect of the therapy, but a non-specific effect due to the extra attention, expectation, etc.
  3. This means that the conclusion (the use of aromatherapy is beneficial) is not justified.
  4. In turn, this means that the paper is not helpful in any way. All it can possibly do is to mislead the public.

In summary: another fine example of pseudo-research that, I believe, is worse than no research at all.

Dr Alok Pareek has been elected as the World President of the International Homeopathic Medical league (LMHI – Liga Medicorum Homoeopathica Internationalis), the largest, oldest and only association of Medical Homeopaths in the World. He is the first Asian in 4 decades to bring this honour to India. Dr Alok Pareek was elected at the 71st World Congress of the LMHI held in Buenos Aires, Argentina on 23rd August 2016. He was elected unopposed by over 70 member countries. He has been elected for a three year tenure from 2016 to 2019

Dr. Alok Pareek runs a homeopathic hospital together with his father R.S. Pareek in Agra, India with fifty beds, treating around two hundred patients daily. His clinical practice spans thirty years. This extensive experience has given him a wealth of opportunity to carry out and refine homeopathic treatment in a wide range of acute and emergency situations…  Dr. Pareek demonstrates that homeopathy has much to offer in acute and emergency settings. He aims to increase the confidence of practitioners, to improve results and encourage them to offer safe and effective treatment in this important field, enabling homeopathy to take its place alongside conventional approaches within mainstream medicine. “As an Emergency Medicine physician who deals with life threatening diseases on a daily basis, I found Dr. Pareek’s homeopathic approach to be full of well-rounded clinical criteria and plenty of wise advice to the homeopathic doctor. I truly hope to be in medicine long enough to see us practice ‘hand in hand’ and enjoy the great benefits of this marvelous ‘scientific marriage’ in my emergency medicine patients.” Gladys H. Lopez M.D., M.P.H. USA Board Certified in Emergency ­Medicine

These two quotes might give you a fairly good impression of Dr Alok Pareek.

But why do I dedicate an entire post to him?

The reason is that I was alerted to one of his books entitled ‘Cancer is curable with homeopathy’. Even though it is obviously a translation from English, I could not find the original; so you have to bear with me as I translate for you the German abstract copied below:

75 years of homeopathic experience by father and son from India are expressed in this book about the homeopathic cure of cancers. Based on excellently documented cases, it demonstrates how homeopathy is clearly superior to chemotherapy and radiotherapy. We experience how a cure is possible even for such a serious disease as cancer in advanced stages. Dr D. Spinedi (Switzeralnd) estimates the immense experience of the doctors Pareek as ‘essential basic knowledge that should be accessible to all homeopaths’. It is a book that gives courage to both patients and therapists.

Zusammen 75 Jahre homöopathischer Erfahrung von Vater und Sohn Pareek aus Indien mit Tausenden von Patienten finden in diesem Buch ihren Niederschlag in der homöopathischen Heilung von Krebserkrankungen. Anhand exzellent dokumentierter Fallbeispiele wird gezeigt, wie in klassischer Arbeitsweise die Homöopathie der Chemotherapie und der Strahlentherapie deutlich überlegen ist. Wir erleben mit, wie Heilung bei einer so schweren Krankheit wie Krebs auch noch in fortgeschrittenen Stadien durch Homöopathie möglich ist. Dr. D. Spinedi (Schweiz) wertet die immense Erfahrung der Dres. Pareek als “unverzichtbares Grundlagenwissen, das allen Homöopathen zugänglich sein sollte.” Ein Buch, das Patienten wie Therapeuten Mut macht!

It is by Jove not often that I am speechless, but today, that’s exactly what I am.

Endocrine therapy (ET) is often used to reduce the risk of recurrence in hormone receptor-expressing disease. It is associated with worsening of climacteric symptoms can therefore have a negative impact on the quality of life (QoL) of those affected. Homeopathy is sometimes recommended for management of hot flushes (HF), and a new study aimed to test whether it is effective.

In this multi-centre, double-blind, placebo-controlled RCT, women were included suffering from histologically proven non-metastatic localized breast cancer, with Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) ≤ 1, treated for at least 1 month with adjuvant ET, and complaining about moderate to severe HF. Patients scheduled for chemotherapy, or radiotherapy, or those with associated pathology known to induce HF were excluded. After a 2- to 4-week placebo administration, patients were randomly assigned to receiving the homeopathic medicine complex Actheane® (arm A) or placebo (arm P). Randomization was stratified by adjuvant ET (taxoxifen/aromatase inhibitor) and recruiting site. HF scores (HFS) were calculated as the mean of HF frequencies before randomization, at 4, and at 8 weeks post-randomization (pre-, 4w,- and 8w-) weighted by a 4-level intensity scale. The primary endpoint was the variation between pre- and 4week-HFS. Secondary endpoints included HFS variation between pre- and 8week-HFS. Compliance and tolerance were assessed 8 weeks after randomization, and QoL and satisfaction were assessed at 4- and 8-week post-randomization.

In total, 138 patients were randomized (A, 65; P, 73). Median 4week-HFS absolute variation (A, - 2.9; P, - 2.5 points, p = 0.756) and relative decrease (A, - 17%; P, - 15%, p = 0.629) were not statistically different between the two arms. However, 4week-HFS decreased for 46 (75%) in A vs 48 (68%) patients in P arm. 4week-QoL was stable or improved for respectively 43 (72%) vs 51 (74%) patients (p = 0.470).

The authors concluded that the efficacy endpoint was not reached, and BRN-01 administration was not demonstrated as an efficient treatment to alleviate HF symptoms due to adjuvant ET in breast cancer patients. However, the study drug administration led to decreased HFS with a positive impact on QoL. Without any recommended treatment to treat or alleviate the HF-related disabling symptoms, Actheane® could be a promising option, providing an interesting support for better adherence to ET, thereby reducing the risk of recurrence with a good tolerance profile.

At the start of their abstract, the authors state that homeopathy might allow a better management of hot flushes (HF). Frankly, I fail to see the evidence for this statement. The only study I know of (by a known advocate of homeopathy) showed no effect of homeopathy.

Acthéane is a mixture marketed by Boiron of 5 ingredients:
– Actaea racemosa 4 CH : 0,5 mg
– Arnica montana 4 CH : 0,5 mg
– Glonoinum 4 CH : 0,5 mg
– Lachesis mutus 5 CH : 0,5 mg
– Sanguinaria canadensis 4 CH : 0,5 mg

I am not aware of evidence that this remedy might work.

If there is no plausible rationale for conducting a study, does that not mean it is ethically questionable to do it?

Apart from that, the study seems well-designed. It is not very well presented, but the paper is clear enough. Its results are as one would expect from a rigorous trial of homeopathy. The fact that the authors try to squeeze out some positive messages from this squarely negative study is, of course, pathetic. To mention in the abstract that 4week-HFS decreased for 46 (75%) in A vs 48 (68%) patients (not the primary outcome measure) in P arm is little more than an embarrassing tribute to the sponsor, in my view.

Boiron Canada state on their website that Acteane® is a homeopathic medicine used for the relief of perimenopause and menopause symptoms such as hot flashes, night sweats, sleep disorders, headache, irritability and mood swings.

The benefits of Acteane, a new solution for women:

• Hormone-free
• Soy-free
• Can be associated with other treatments used during perimenopause
• Non-drowsy
• Chewable tablets
• Does not require water

WILL THEY NOW ADD ‘EFFECT-FREE’ TO THEIR LIST?

Do musculoskeletal conditions contribute to chronic non-musculoskeletal conditions? The authors of a new paper – inspired by chiropractic thinking, it seems – think so. Their meta-analysis was aimed to investigate whether the most common musculoskeletal conditions, namely neck or back pain or osteoarthritis of the knee or hip, contribute to the development of chronic disease.

The authors searched several electronic databases for cohort studies reporting adjusted estimates of the association between baseline neck or back pain or osteoarthritis of the knee or hip and subsequent diagnosis of a chronic disease (cardiovascular disease , cancer, diabetes, chronic respiratory disease or obesity).

There were 13 cohort studies following 3,086,612 people. In the primary meta-analysis of adjusted estimates, osteoarthritis (n= 8 studies) and back pain (n= 2) were the exposures and cardiovascular disease (n=8), cancer (n= 1) and diabetes (n= 1) were the outcomes. Pooled adjusted estimates from these 10 studies showed that people with a musculoskeletal condition have a 17% increase in the rate of developing a chronic disease compared to people without a musculoskeletal condition.

The authors concluded that musculoskeletal conditions may increase the risk of chronic disease. In particular, osteoarthritis appears to increase the risk of developing cardiovascular disease. Prevention and early

treatment of musculoskeletal conditions and targeting associated chronic disease risk factors in people with long

standing musculoskeletal conditions may play a role in preventing other chronic diseases. However, a greater

understanding about why musculoskeletal conditions may increase the risk of chronic disease is needed.

For the most part, this paper reads as if the authors are trying to establish a causal relationship between musculoskeletal problems and systemic diseases at all costs. Even their aim (to investigate whether the most common musculoskeletal conditions, namely neck or back pain or osteoarthritis of the knee or hip, contribute to the development of chronic disease) clearly points in that direction. And certainly, their conclusion that musculoskeletal conditions may increase the risk of chronic disease confirms this suspicion.

In their discussion, they do concede that causality is not proven: While our review question ultimately sought to assess a causal connection between common musculoskeletal conditions and chronic disease, we cannot draw strong conclusions  due  to  poor  adjustment,  the  analysis methods employed by the included studies, and a lack of studies investigating conditions other than OA and cardiovascular disease…We did not find studies that satisfied all of Bradford Hill’s suggested criteria for casual inference (e.g. none estimated dose–response effects) nor did we find studies that used contemporary causal inference methods for observational data (e.g. a structured identification approach for selection of confounding variables or assessment of the effects of unmeasured or residual confounders. As such, we are unable to infer a strong causal connection between musculoskeletal conditions and chronic diseases.

In all honesty, I would see this a little differently: If their review question ultimately sought to assess a causal connection between common musculoskeletal conditions and chronic disease, it was quite simply daft and unscientific. All they could ever hope is to establish associations. Whether these are causal or not is an entirely different issue which is not answerable on the basis of the data they searched for.

An example might make this clearer: people who have yellow stains on their 2nd and 3rd finger often get lung cancer. The yellow fingers are associated with cancer, yet the link is not causal. The association is due to the fact that smoking stains the fingers and causes cancer. What the authors of this new article seem to suggest is that, if we cut off the stained fingers of smokers, we might reduce the cancer risk. This is clearly silly to the extreme.

So, how might the association between musculoskeletal problems and systemic diseases come about? Of course, the authors might be correct and it might be causal. This would delight chiropractors because DD Palmer, their founding father, said that 95% of all diseases are caused by subluxation of the spine, the rest by subluxations of other joints. But there are several other and more likely explanations for this association. For instance,  many people with a systemic disease might have had subclinical problems for years. These problems would prevent them from pursuing a healthy life-style which, in turn, resulted is musculoskeletal problems. If this is so, musculoskeletal conditions would not increase the risk of chronic disease, but chronic diseases would lead to musculoskeletal problems.

Don’t get me wrong, I am not claiming that this reverse causality is the truth; I am simply saying that it is one of several possibilities that need to be considered. The fact that the authors failed to do so, is remarkable and suggests that they were bent on demonstrating what they put in their conclusion. And that, to me, is an unfailing sign of poor science.

The AMERICAN INSTITUTE OF HOMEOPATHY (AIH) is the oldest national medical association in the United States. The AIH’s mission is “to promote the science and art of homeopathic medicine, to safeguard the interests of the homeopathic medical profession, to improve the standards of homeopathic medical education, to educate the medical and scientific communities about the scientific basis for homeopathic medicine, and to increase public knowledge and acceptance of homeopathy as a medical specialty.”

The AIH is about to hold its annual conference. This year’s theme is “Tackling Patients with Severe Pathology”. The announcement reads as follows:

Homeopathy has been found to be effective in the great majority of patients suffering from infectious and autoimmune diseases. The limits of homeopathic treatment are encountered in the treatment of patients with Parkinson’s disease, ALS and late-stage cancers. After finding a way to treat patients with Parkinson’s disease with homeopathy, Dr. Saine began to apply this approach to cancer patients in stages III and IV. In this seminar, he will review case analysis, posology and case management for this cohort of patients.

We are fortunate to have the opportunity to learn from Dr. Saine in this seminar. He is recognized as one of the foremost homeopathic teachers and clinicians in the world, with special expertise in extremely difficult cases of severe and advanced pathology.

Who, for heaven sake, is this foremost homeopathic teachers and clinicians in the world, Dr Saine?, I asked myself after reading this (and even more so after listening to the rather spectacular video provided with the announcement). Here is what I found out about him:

Dr. Saine is a 1982 graduate of the National College of Naturopathic Medicine in Portland, Oregon. He is board-certified in homeopathy (1988) by the Homeopathic Academy of Naturopathic Physicians and has been teaching and lecturing on homeopathy since 1985. He is considered one of the world’s foremost experts on the subject of homeopathy.

And this is what non-doctor* Saine writes about medicine etc.:

The Organon of Medicine is a blueprint on how to practice medicine rationally and wisely through an integration of all the fundamental principles of medicine into a comprehensive whole. Unfortunately, to the detriment of the sick, very few homeopaths have delved, as Hahnemann did, into the practice of lifestyle medicine and the use of complementary care to homeopathy.

With rare exceptions, patients will present with a portion of their disease that ensues from an unhealthy environment or ways of living. The role of the physician is to determine in the equation of disease what is primarily due to an untuned vital force versus a causa occasionalis, as both will have to be addressed in due time.

After reading and listening to all this I am mildly shocked.

It does not seem to me that the AIH is fit for purpose. Neither am I convinced that non-doctor Saine should be let near any patient, let alone one with cancer or another severe pathology.

There should be a law protecting patients from this sort of thing!

[*in the context of healthcare, a doctor is for me someone who has studied medicine]

Osteopathy is a form of manual therapy invented by the American Andrew Taylor Still (1828-1917). Today, US osteopaths (doctors of osteopathy or DOs) practise no or little manual therapy; they are fully recognised as medical doctors who can specialise in any medical field after their training which is almost identical with that of MDs. Outside the US, osteopaths practice almost exclusively manual treatments and are considered alternative practitioners. This post deals with the latter category of osteopaths.

Still defined his original osteopathy as a science which consists of such exact, exhaustive, and verifiable knowledge of the structure and function of the human mechanism, anatomical, physiological and psychological, including the chemistry and physics of its known elements, as has made discoverable certain organic laws and remedial resources, within the body itself, by which nature under the scientific treatment peculiar to osteopathic practice, apart from all ordinary methods of extraneous, artificial, or medicinal stimulation, and in harmonious accord with its own mechanical principles, molecular activities, and metabolic processes, may recover from displacements, disorganizations, derangements, and consequent disease, and regained its normal equilibrium of form and function in health and strength.

Based on such vague and largely nonsensical statements, traditional osteopaths feel entitled to offer treatments for most human diseases, conditions and symptoms. The studies they produce to back up their claims tend to be as poor as Still’s original assumptions were fantastic.

Here is an apt example:

The aim of this new study was to study the effect of osteopathic manipulation on pain relief and quality of life improvement in hospitalized oncology geriatric patients.

The researchers conducted a non-randomized controlled clinical trial with 23 cancer patients. They were allocated to two groups: the study group (OMT [osteopathic manipulative therapy] group, N = 12) underwent OMT in addition to physiotherapy (PT), while the control group (PT group, N = 12) underwent only PT. Included were postsurgical cancer patients, male and female, age ⩾65 years, with an oncology prognosis of 6 to 24 months and chronic pain for at least 3 months with an intensity score higher than 3, measured with the Numeric Rating Scale. Exclusion criteria were patients receiving chemotherapy or radiotherapy treatment at the time of the study, with mental disorders (Mini-Mental State Examination [MMSE] = 10-20), with infection, anticoagulation therapy, cardiopulmonary disease, or clinical instability post-surgery. Oncology patients were admitted for rehabilitation after cancer surgery. The main cancers were colorectal cancer, osteosarcoma, spinal metastasis from breast and prostatic cancer, and kidney cancer.

The OMT, based on osteopathic principles of body unit, structure-function relationship, and homeostasis, was designed for each patient on the basis of the results of the osteopathic examination. Diagnosis and treatment were founded on 5 models: biomechanics, neurologic, metabolic, respiratory-circulatory, and behaviour. The OMT protocol was administered by an osteopath with clinical experience of 10 years in one-on-one individual sessions. The techniques used were: dorsal and lumbar soft tissue, rib raising, back and abdominal myofascial release, cervical spine soft tissue, sub-occipital decompression, and sacroiliac myofascial release. Back and abdominal myofascial release techniques are used to improve back movement and internal abdominal pressure. Sub-occipital decompression involves traction at the base of the skull, which is considered to release restrictions around the vagus nerve, theoretically improving nerve function. Sacroiliac myofascial release is used to improve sacroiliac joint movement and to reduce ligament tension. Strain-counter-strain and muscle energy technique are used to diminish the presence of trigger points and their pain intensity. OMT was repeated once every week during 4 weeks for each group, for a total of 4 treatments. Each treatment lasted 45 minutes.

At enrolment (T0), the patients were evaluated for pain intensity and quality of life by an external examiner. All patients were re-evaluated every week (T1, T2, T3, and T4) for pain intensity, and at the end of the study treatment (T4) for quality of life.

The OMT added to physiotherapy produced a significant reduction in pain both at T2 and T4. The difference in quality of life improvements between T0 and T4 was not statistically significant. Pain improved in the PT group at T4. Between-group analysis of pain and quality of life did not show any significant difference between the two treatments.

The authors concluded that our study showed a significant improvement in pain relief and a nonsignificant improvement in quality of life in hospitalized geriatric oncology patients during osteopathic manipulative treatment.

GOOD GRIEF!

Where to begin?

Even if there had been a difference in outcome between the two groups, such a finding would not have shown an effect of OMT per se. More likely, it would have been due to the extra attention and the expectation in the OMT group (or caused by the lack of randomisation). The A+B vs B design used for this study  does not control for non-specific effects. Therefore it is incapable of establishing a causal relationship between the therapy and the outcome.

As it turns out, there were no inter-group differences. How can this be? I have often stated that A+B is always more than B alone. And this is surely true!

So, how can I explain this?

As far as I can see, there are two possibilities:

  1. The study was underpowered, and thus an existing difference was not picked up.
  2. The OMT had a detrimental effect on the outcome measures thus neutralising the positive effects of the extra attention and expectation.

And which possibility does apply in this case?

Nobody can know from these data.

Integrative Cancer Therapies, the journal that published this paper, states that it focuses on a new and growing movement in cancer treatment. The journal emphasizes scientific understanding of alternative and traditional medicine therapies, and the responsible integration of both with conventional health care. Integrative care includes therapeutic interventions in diet, lifestyle, exercise, stress care, and nutritional supplements, as well as experimental vaccines, chrono-chemotherapy, and other advanced treatments. I feel that the editors should rather focus more on the quality of the science they publish.

My conclusion from all this is the one I draw so depressingly often: fatally flawed science is not just useless, it is unethical, gives clinical research a bad name, hinders progress, and can be harmful to patients.

The aim of palliative care is to improve quality of life for patients with serious illnesses by treating their symptoms, often in situations where all the possible causative therapeutic options have been exhausted. In many palliative care settings, complementary and alternative medicine (CAM) is used for this purpose. In fact, this is putting it mildly; my impression is that CAM seems to have flooded palliative care. The question is therefore whether this approach is based on sufficiently good evidence.

This review was aimed at evaluating the available evidence on the use of CAM in hospice and palliative care and to summarize their potential benefits. The researchers conducted thorough literature searches and located 4682 studies of which 17 were identified for further evaluation. The therapies considered included:

  • acupressure,
  • acupuncture,
  • aromatherapy massage,
  • breathing,
  • hypnotherapy,
  • massage,
  • meditation,
  • music therapy,
  • reflexology,
  • reiki.

Many studies demonstrated a short-term benefit in symptom improvement from baseline with CAM, although a significant benefit was not found between groups.

The authors concluded that CAM may provide a limited short-term benefit in patients with symptom burden. Additional studies are needed to clarify the potential value of CAM in the hospice or palliative setting.

When reading research articles in CAM, I often have to ask myself: ARE THEY TAKING THE MIKEY?

??? “Many studies demonstrated a short-term benefit in symptom improvement from baseline with CAM, although a significant benefit was not found between groups.” ???

Really?!?!?

Controlled clinical trials are only about comparing the outcomes between the experimental and the control groups (and not about assessing improvements from baseline which can be [and often is] unrelated to any effect caused by the treatment per se). Therefore, within-group changes are irrelevant and should not even deserve a mention in the abstract. Thus the only finding worth reporting in the abstract is this:

No significant benefit was found.

It follows that the above conclusions are totally out of line with the data.

They should, according to what the researchers report in their abstract, read something like this:

CAM HAS NO PROVEN BENEFIT IN PALLIATIVE CARE. ITS USE IN THIS AREA IS THEREFORE HIGHLY PROBLEMATIC.

We have previously seen that SCAM-use is associated with shorter survival of cancer patients. A new article now confirms this notion.

The investigators wanted to find out what patient characteristics are associated with use of SCAM for cancer and what is the association of SCAM with treatment adherence and survival. They thus  compared the overall survival between patients with cancer receiving conventional treatments with or without SCAM and the adherence to treatment and characteristics of patients in both groups.

Their retrospective observational study used data from the National Cancer Database on 1 901 815 patients from 1500 Commission on Cancer–accredited centers across the United States who were diagnosed with nonmetastatic breast, prostate, lung, or colorectal cancer between January 1, 2004, and December 31, 2013. Patients were matched on age, clinical group stage, Charlson-Deyo comorbidity score, insurance type, race/ethnicity, year of diagnosis, and cancer type.  Overall survival, adherence to treatment, and patient characteristics were the study endpoints.

The cohort comprised 1 901 815 patients with cancer (258 patients in the SCAM group and 1 901 557 patients in the control group). In the main analyses following matching, 258 patients were in the SCAM group, and 1032 patients were in the control group. Patients who chose SCAM did not have a longer delay to initiation of conventional therapies, but had higher refusal rates of surgery, radiotherapy, and hormone therapy. Use of SCAM was associated with poorer 5-year overall survival compared with no SCAM (82.2% [95% CI, 76.0%-87.0%] vs 86.6% [95% CI, 84.0%-88.9%]; P = .001) and was independently associated with greater risk of death (hazard ratio, 2.08; 95% CI, 1.50-2.90) in a multivariate model that did not include treatment delay or refusal. However, there was no significant association between SCAM and survival once treatment delay or refusal was included in the model.

The authors concluded that patients who received CM were more likely to refuse additional CCT, and had a higher risk of death. The results suggest that mortality risk associated with CM was mediated by the refusal of CCT.

This new evidence confirms previous papers: SCAM-use is associated with shorter survival of cancer patients. As it is based on a large sample size, its results are more compelling. They indicate that it is not SCAM per se, but the attitude of SCAM-users to conventional therapies that is the cause of the effect. As I have said and written hundreds of times: the most serious risk of SCAM is not a direct but an indirect one: the risk of neglecting effective therapies. Essentially, this means that better information targeted at vulnerable patients must be the way forward (one of the main ambitions of this blog, I hasten to add).

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