Monthly Archives: July 2020
This recently published survey aimed to investigate the use of so-called alternative medicine (SCAM) among long-term cancer survivors and its links with healthy behaviour. Data was used from the VICAN survey, conducted in 2015-2016 on a representative sample of French cancer survivors 5 years after diagnosis.
Among the 4174 participants, 21.4% reported using SCAM at the time of the survey, including 8.4% who reported uses not associated with cancer. The most frequently cited reasons for using SCAM were:
- to improve their physical well-being (83.0%),
- to strengthen their body (71.2%),
- to improve their emotional well-being (65.2%),
- to relieve the side effects of treatment (50.7%).
The SCAM users who reported using SCAM to cure cancer or prevent relapses (8.5% of the participants) also used SCAM for other reasons. They had more often experienced cancer progression, feared a recurrence, and had a poorer quality of life because of sequelae, pain, and fatigue. They also consulted their general practitioners more frequently and had changed their lifestyle by adopting more healthy practices.
The authors concluded that the use of SCAM is not an alternative but a complementary means of coping with impaired health. Further research is now required to determine whether the use of SCAM reflects a lifestyle change or whether it assists survivors rather to make behavioural changes.
The 2012 data from the same survey had previously reported that, among the participants, 16.4% claimed to have used SCAM, and 45.3% of this group had not used SCAM before cancer diagnosis (new SCAM users). Commonly, SCAMs used were:
- homeopathy (64.0%),
- acupuncture (22.1%),
- osteopathy (15.1%),
- herbal medicine (8.1%),
- diets (7.3%),
- energy therapies (5.8%).
SCAM use was found to be significantly associated with younger age, female gender and a higher education level. Previous SCAM use was significantly associated with having a managerial occupation and an expected 5-year survival rate ≥80% at diagnosis; recent SCAM use was associated with cancer progression since diagnosis, impaired quality of life and higher pain reports.
In nearly half of the SCAM users, cancer diagnosis was one of the main factors which incited patients to use SCAM. Opting for SCAM was a pragmatic response to needs which conventional medicine failed to meet during the course of the disease.
These surveys mostly confirm what has been shown over and over again in other countries. What I find remarkable with these results, however, is the increase in SCAM use over time and the extraordinary high use of homeopathy by French cancer patients (more recently, the reimbursement of homeopathy in France has changed, of course). As homeopathy has no effects beyond placebo, this suggests that SCAM use by French cancer patients is far from being driven by evidence.
So, what then does determine it?
My best answer I can give to this question is this: relentless promotion through pharmacies, advertisements and journalists. These have all been very powerful in France in relation to homeopathy (hardly surprising, as the world’s largest homeopathic producer, Boiron, is based in France).
This leads me to the conclusion that SCAM is far more commercially driven than its enthusiasts would ever admit. They think of the pharmaceutical industry as the evil exploiter of the sick. It is now time to realise that the SCAM industry is, to a large extent, part of the pharmaceutical industry and often behaves just as badly or even worse: because what could be more unethical that selling placebos to desperate and vulnerable cancer patients?
Breast cancer and its treatments lead to a decrease in patients’ quality of life (QOL). This systematic review aimed to assess the effectiveness of so-called alternative medicine (SCAM) on the QOL of women with breast cancer.
A total of 28 clinical trials were included in the systematic review, 18 of which were randomized controlled trials (RCTs). Participants included women with breast cancer who were undergoing the first three phases of breast cancer or post-cancer rehabilitation. One study tested a dietary supplement, and the other 27 tested a variety of mind-body techniques (the authors counted the following modalities in this category: acupuncture, hyperthermia, movement therapy (qigong), laser therapy, orthomolecular therapy, osteopathy, phototherapy, healing touch, homeopathy, lymphatic drainage, magnet field therapy, manual therapy, neural therapy, Shiatsu). Twenty-seven studies showed improved QOL.
The authors concluded that the findings may indicate the potential benefits of SCAMs, especially mind-body techniques on QOL in breast cancer patients. Further RCTs or long-term follow-up studies are recommended. Moreover, the use of similar QOL assessment tools allows for more meta-analysis and generalizability of results, especially for the development of clinical guidelines.
This is a somewhat odd paper:
- it is poorly written,
- it lumps together SCAMs that do not belong in the same category,
- it only considered studies published in English,
- it included studies regardless of study design, even those without any control groups.
Regardless of these consideration, it stands to reason that patients’ QoL can be improved by SCAM. Only a fool would deny that a bit of extra care, kindness, attention and time is good for patients. The relevant questions, however, are quite different:
- Is this effect due to the extra attention and care or is it due to specific effects of SCAM?
- Which SCAM is best at achieving an improvement of QoL?
- Are the truly effective SCAMs better than conventional interventions aimed at improving QoL?
These are by no means academic questions but issues that need to be addressed to improve cancer care, and tackling them is in the best interest of suffering patients. Sadly, none of them can be answered by conducting poor quality systematic reviews of the evidence. Even more sadly, few of the proponents of integrated medicine want to face the music and answer these questions. They seem to prefer to stand in the way of progress, to ignore medical ethics, to blindly and naively integrate any old nonsense from the realm of SCAM (anything from homeopathy to Reiki) into routine care without probing further and without wanting to know the facts.
It is almost as though they are afraid of the truth.
When I discuss published articles on this blog, I usually focus on recent papers. Not so today! Today I write about a small study we published 17 years ago. It was conducted in Canada by researchers whom I merely assisted in designing the protocol and interpreting the findings.
They trained 8 helpers to pretend being customers of health food stores. They entered individually into assigned stores; the helpers had been informed to browse in the store until approached by an employee. At this time they would declare that their mother has breast cancer. They disclosed information on their mother’s condition, use of chemotherapy (Tamoxifen) and physician visits, only if asked. The helpers would then ask what the employee recommend for this condition. They followed a structured, memorized, pretested questionnaire that asked about product usage, dosage, cost, employee education and product safety or potential for drug interactions.
The helpers recorded which products were recommended by the health food store employees, along with the recommended dose and price per product as well as price per month. Additionally, they inquired about where the employee had obtained information on the recommended products. They also noted whether the employees referred them on to SCAM practitioners or recommended that they consult a physician. Full notes on the encounters were written immediately after leaving the store.
The findings were impressive. Of the 34 stores that met our inclusion criteria, 27 recommended SCAMs; a total of 33 different products were recommended. Here are some further findings:
- Essiac was recommended most frequently.
- The mean cost of the recommended products per month was $58.09 (CAD) (minimum $5.28, median $32.99, maximum $600).
- Twenty-three employees (68%) did not ask whether the patient took prescription medications.
- Fifteen (44%) employees recommended visiting a healthcare professional; these included: naturopaths (9), physicians (5) and nutritionists (1).
- Health food store employees relied on a variety of sources of information. Twelve employees (35%) said they had received their information from books, 5 (15%) from a supplier, 3 (9%) had formal education in SCAM, 2 (6%) had in-store training, and 12 (35%) did not disclose their sources of information.
Since our paper has been published, several other investigations have addressed similar issues. Here are a few excerpts:
- Pharmacies and HFS in Greater Wellington provided potentially hazardous advice, recommending products, often branded for pregnancy, which contradicted NZ MOH guidelines. Regulatory reform of CAM products and those who sell them is called for in New Zealand.
- …only about one-quarter [of health food stores (HFSs)] gave appropriate advice regarding possible interactions with warfarin and management of anticoagulation compared with two-thirds of pharmacies.
- HFS promoting herbal products for medical conditions should be regulated in a similar fashion to shops that dispense pharmaceutical products.
- Staff in 25 out of 26 health food stores did not refer the researcher to a medical practitioner; instead they recommended and sold a wide variety of compounds of unproven efficacy
- Store personnel readily provided information and product recommendations, with shark cartilage being the most frequent.
But why do I mention all this today?
The answer is that firstly, I think it is important to warn consumers of the often dangerous advice they might receive in HFSs. Secondly, I feel it would worthwhile to do further research, check whether the situation has changed and repeat a similar study today. Ideally, a new investigation should be conducted in different locations comparing several countries. If you have the possibility to plan and conduct such an experiment, please drop me a line.
Frank Odds passed away on 7 July at the age of 75. He was well-known to regular readers of this blog. Having started to submit his views in 2014, he has contributed well over 1 500 insightful and helpful comments.
Prof Odds was a world leading expert in medical mycology, recognized internationally for his studies of fungal pathogens. He was recognized as an authority by academics, clinicians and those in the pharmaceutical industry. The European Confederation of Mycology wrote:
He wrote the defining text on Candida and was a major authority on fungal pathogenesis and antifungal drugs (having led Janssen’s antifungal drug discovery programme for 10 years). In no small measure he helped establish the reputation of the Aberdeen Fungal Group as a pre-eminent presence in medical mycology and was an integral part of the foundations upon which the current University of Exeter MRC-CMM was formed. He was a concert level pianist and he played the piano for the singsong at the BSMM annual meeting that was an integral part of the traditions of this society. During his career he acted as President of the BSMM, as well as of ISHAM and the ECMM.
Prof Odds has published about 300 original research and review articles on the pathogenesis, diagnosis, epidemiology and treatment of fungal infections. He acted as co-editor of the standard textbook ‘Clinical Mycology’ and was listed in the ISI Most Highly Cited Scientists (Microbiology) database in 2007 and he made many seminal contributions to his field.
Prof Odds led the antifungal drug discovery programme as Director of Bacteriology and Mycology at the Janssen Research Foundation (Johnson & Johnson) in Belgium for 10 years. He played a major role in the development of anti-fungal medicines azole and triazole. Eighteen patents bear Prof. Odds’ name as co-inventor and he served as a consultant and/or experimental contractor for more than 20 pharmaceutical companies.
Born on 29th August 1945 in Devon and educated in the South West of England. He undertook undergraduate and PhD degrees at the University of Leeds and became a visiting Fellow at the Center for Disease Control, in Atlanta USA (1970–72) before returning to the UK to undertake a postdoctoral fellowship at the University of Leeds (1972–75). He became a lecturer and then senior lecturer in Medical Microbiology at the University of Leicester (1975–89). In 1992 he accepted the post of Director of Bacteriology & Mycology at the Janssen Research Foundation, Beerse, Belgium (1992–99), and in 1999 he became Professor of Medical Mycology in the Aberdeen Fungal Group of the University of Aberdeen. He retired in 2009.
Prof Odds served as President of the International Society for Human and Animal Mycology, President of the European Confederation of Medical Mycology, Honorary Secretary and President of the British Society for Medical Mycology, and Chair of the Medical Mycology Division F of the American Society for Microbiology. He was co-chair and chair of the Wellcome Trust Immunology and Infectious Disease grant panel and on numerous editorial boards of international journals including acting as Chief Editor of Current Topics in Medical Mycology.
Prof Odd’s honours included Fellowship of the Royal Society of Edinburgh, Fellowship of the American Academy of Microbiology, and Honorary Membership of the British and International Medical Mycology societies. He received many prestigious prizes including an ISHAM award and medal, the Maxwell L. Littman Award from the New York Medical Mycology Society, and a Pfizer Award in Biology. He was also awarded an MRCPath and FRCPath in recognition of his clinical expertise.
On 9 July, Frank’s wife sent me an email:
The sad news has arrived: Frank died on Tuesday night, peacefully at home as he had wished.
During the final few days, his health deteriorated rapidly, but he was extremely well cared for by the NHS District Nurses, who could not have been kinder or more solicitous…
I feel honoured by the indefatigable attention he devoted to my blog (particularly since I had never met him in person) and am sure that we all will all miss his critical and constructive comments.
Retraction Watch has alerted us to a “Paper urging use of homeopathy for COVID-19 appears in peer-reviewed public health journal”. The paper in question is readily available on the Internet. Here is its abstract:
Today, humanity is living through the third serious coronavirus outbreak in less than 20 years, following SARS in 2002–2003 and MERS in 2012. While the final cost on human lives and world economy remains unpredictable, the timely identification of a suitable treatment and the development of an effective vaccine remain a significant challenge and will still require time.
The aim of this study is to show that the global collective effort to control the coronavirus pandemic (Covid 19) should also consider alternative therapeutic methods, and national health systems should quickly endorse the validity of proven homeopathic treatments in this war against coronavirus disease.
Subject and methods With the help of mathematics, we will show that the fundamental therapeutic law on which homeopathy is founded can be proved.
Results The mathematical proof of the law of similarity justifies perfectly the use of ultra – high diluted succussed solution products as major tools in the daily practices of homeopathy.
Conclusion It is now time to end prejudice and adopt in this fight against Covid-19 alternative therapeutic techniques and practices that historically have proven effective in corresponding situations.
And the full conclusions from the body of the paper read as follows:
Today, it is imperative that ever-safe medicinal products such as homeopathic ultra – high diluted succussed solutions are tested in this pandemic. Epidemiological research has to be carried out to include homeopathic treatment and compare it to established treatments. Patients should be assigned randomly in two different groups of at least 200–400 individuals, and receive respectively established and homeopathic treatment. The evaluation of the results from both groups could reveal which group has a superior outcome in survival, general health conditions, etc., and to what extent.
If there were a competition for the craziest paper published on so-called alternative medicine (SCAM) during 2020, this one would, I am sure, win by some margin! The authors seem to have little idea of the nature of evidence in healthcare or medicine; and they use mathematics like a drunken man uses a lamp-post: not for enlightenment, but for support.
So, who are the authors of this showcase of pseudoscience?
They are D. Kalliantas, M. Kallianta, Ch. S. Karagianni from the Department of Materials Science and Engineering, School of Chemical Engineering, NTUA, GR15780, Athens, Greece; the National Technical University of Athens, 9 Heroon Polytechniou Str. Zografos Campus, 15780 Athens, Greece; and the School of Dentistry, National and Kapodistrian University of Athens, Athens, Greece.
The first author has previously published weird stuff including a self-published book: Kalliantas D (2008) The Chaos theory of disease. Kallianta A Publications, Eleusis, Greece. On Medline, I also found this paper by two of the three authors:
Trituration is a mechanical process (a form of comminution) for reducing the particle size of a substance. In this manuscript, six different Raw Solid Materials (RSM) which are used in Homeopathy after successive grindings are studied before they are turned into homeopathic solutions. The impact of trituration, with the presence of α‑lactose monohydrate (milk sugar) seems to be quite great and interesting because of the variety of grain size which largely differentiate the properties of the materials. The grain sizes obtained triturations by hand according to C. Herring’s suggestion leads, finally, measurement scale dimensions. The obtained results can be useful information for all the pharmacy industries, as well as for preparing any kind of powder.
Sadly, this renders my suspicion unlikely that the new article is a hoax in which some pranksters were trying to show that any odd nonsense can pass the peer-review of a scientific journal.
And which journal would publish a paper that looks like a hoax but is none? It is the Journal of Public Health: From Theory to Practice (Springer). On the website, the journal tells us that:
The Journal of Public Health: From Theory to Practice is an interdisciplinary publication for the discussion and debate of international public health issues, with a focus on European affairs. It describes the social and individual factors determining the basic conditions of public health, analyzing causal interrelations, and offering a scientifically sound rationale for personal, social and political measures of intervention. Coverage includes contributions from epidemiology, health economics, environmental health, management, social sciences, ethics, and law.
- An interdisciplinary publication for the discussion and debate of international public health issues
- Includes contributions from epidemiology, health economics, environmental health, management, social sciences, ethics, and law
- Offers a scientifically sound rationale for personal, social and political measures of intervention
- 94% of authors who answered a survey reported that they would definitely publish or probably publish in the journal again.
_______________________________
The twice mentioned term SCIENTIFICALLY SOUND does not quite ring true in the present instance, does it?
This analysis was aimed at assessing the associations of acupuncture use with mortality, readmission and reoperation rates in hip fracture patients using a longitudinal population-based database. A retrospective matched cohort study was conducted using data for the years 1996-2012 from Taiwan’s National Health Insurance Research Database. Hip fracture patients were divided into:
- an acupuncture group consisting of 292 subjects who received at least 6 acupuncture treatments within 183 days of hip fracture,
- and a propensity score matched “no acupuncture” group of 876 subjects who did not receive any acupuncture treatment and who functioned as controls.
The two groups were compared using survival analysis and competing risk analysis.
Compared to non-treated subjects, subjects treated with acupuncture had
- a lower risk of overall death (hazard ratio (HR): 0.41, 95% confidence interval (CI): 0.24-0.73, p = 0.002),
- a lower risk of readmission due to medical complications (subdistribution HR (sHR): 0.64, 95% CI: 0.44-0.93, p = 0.019)
- and a lower risk of reoperation due to surgical complications (sHR: 0.62, 95% CI: 0.40-0.96, p = 0.034).
The authors concluded that postoperative acupuncture in hip fracture patients is associated with significantly lower mortality, readmission and reoperation rates compared with those of matched controls.
That’s a clear and neat finding; the question is, what does it mean?
Here are a few possibilities for consideration:
- As a result of having at least 6 acupuncture sessions, patients had lower rates of mortality, readmission and reoperation.
- As a result of having lower rates of mortality, readmission and reoperation, patients used acupuncture.
- As a result of some other factor, patients had both lower rates of mortality, readmission and reoperation and at least 6 sessions of acupuncture.
Which of the three possibilities is the most likely?
- Some enthusiasts might think that acupuncture makes you live longer. But does anyone truly believe it reduces the likelihood of needing a reoperation? Seriously? Well, I don’t see even a hint of a mechanism by which acupuncture might achieve this. Therefore, I would categorise this possibility as highly unlikely.
- It stands to reason that patients who are alive and well use more acupuncture than those who are dead or in need of surgery. So, this possibility is not entirely inconceivable.
- It seems very likely that people who are more health conscious might use acupuncture and live longer, need less readmissions or surgery. No doubt, this possibility is by far the best explanation of the findings of this retrospective matched cohort study.
If that is so, does this paper tell us anything useful at all?
Not really (that’s why it was published in an acupuncture journal which few people would read)
On second thought, perhaps it does tell us something valuable: retrospective matched cohort studies are hopeless when it comes to establishing cause and effect!
Spinal manipulative therapy (SMT) is frequently used to manage cervicogenic headache (CGHA). No meta-analysis has investigated the effectiveness of SMT exclusively for CGHA.
The aim of this review was to evaluate the effectiveness of SMT for cervicogenic headache (CGHA). Seven RCTs were eligible. At short-term follow-up, there was a significant, small effect favouring SMT for pain intensity and small effects for pain frequency. There was no effect for pain duration. There was a significant, small effect favouring SMT for disability. At intermediate follow-up, there was no significant effects for pain intensity and a significant, small effect favouring SMT for pain frequency. At long-term follow-up, there was no significant effects for pain intensity and for pain frequency.
The authors concluded that for CGHA, SMT provides small, superior short-term benefits for pain intensity, frequency and disability but not pain duration, however, high-quality evidence in this field is lacking. The long-term impact is not significant.
This meta-analysis can be criticised for a long list of reasons, the most serious of which, in my view, is that it is bar of even the tiniest critical input. The authors state that there has been no previous meta-analysis on this topic. This might be true, but there has been a systematic review of it (published in the leading journal on the subject) which the authors fail to mention/cite (I wonder why!). It is from 2011 and happens to be one of mine. Here is its abstract:
The objective of this systematic review was to assess the effectiveness of spinal manipulations as a treatment option for cervicogenic headaches. Seven databases were searched from their inception to February 2011. All randomized trials which investigated spinal manipulations performed by any type of healthcare professional for treating cervicogenic headaches in human subjects were considered. The selection of studies, data extraction, and validation were performed independently by 2 reviewers. Nine randomized clinical trials (RCTs) met the inclusion criteria. Their methodological quality was mostly poor. Six RCTs suggested that spinal manipulation is more effective than physical therapy, gentle massage, drug therapy, or no intervention. Three RCTs showed no differences in pain, duration, and frequency of headaches compared to placebo, manipulation, physical therapy, massage, or wait list controls. Adequate control for placebo effect was achieved in 1 RCT only, and this trial showed no benefit of spinal manipulations beyond a placebo effect. The majority of RCTs failed to provide details of adverse effects. There are few rigorous RCTs testing the effectiveness of spinal manipulations for treating cervicogenic headaches. The results are mixed and the only trial accounting for placebo effects fails to be positive. Therefore, the therapeutic value of this approach remains uncertain.
The key points here are:
- methodological quality of the primary studies was mostly poor;
- adequate control for placebo effect was achieved in 1 RCT only;
- this trial showed no benefit of SMT beyond a placebo effect;
- the majority of RCTs failed to provide details of adverse effects;
- this means they violate research ethics and should be discarded as not trustworthy;
- the therapeutic value of SMT remains uncertain.
The new paper was published by chiropractors. Its positive result is not clinically relevant, almost certainly due to residual bias and confounding in the primary studies, and thus most likely false-positive. The conclusions seem to disclose more the bias of the review authors than the truth. Considering the risks of SMT of the upper spine (a subject not even mentioned by the authors), I cannot see that the risk/benefit balance of this treatment is positive. It follows, I think, that other, less risky and more effective treatments are to be preferred for CGHA.
In my never-ending search for novel so-called alternative medicines (SCAMs) I came across WATSU. If you had never heard of WATSU, you are in good company (for instance mine). WATSU (water and shiatsu) is a form of passive hydrotherapy in chest-deep thermoneutral water. It was created in the early 1980s by the California-based Shiatsu teacher Harold Dull and combines elements of myofascial stretching, joint mobilization, massage, and shiatsu and is used to address physical and mental issues.
To me, this sounds as though an old physiotherapeutic approach has been re-vamped in order to seem more attractive to the affluent sections of the SCAM brigade. My suspicion seems to be confirmed by SCAM ueber-guru Dr Andrew Weil’s comments:
Dr. Weil has received the therapy many times and often recommends it.
While other bodywork modalities are based on touch in a stationary, two-dimensional world, Watsu offers a different experience. A three-dimensional environment, nearly free from gravity, within a warm and comforting fluid-space and the opportunity to connect with another person all have obvious therapeutic potential.
Achieving states of deep relaxation combined with the therapeutic benefits of good massage therapy can be of great benefit in controlling pain, relieving stress, and recovering from emotional and physical trauma.
But never mind the one-dimensional Dr Weil. The question is: does WATSU work? According to a recent paper, it is effective for a wide range of conditions.
The objective of this systematic review and meta-analyses was to assess the applications, indications, and the effects of WATSU to form a basis for further studies.
Literature searches for “WATSU OR watershiatsu OR (water AND shiatsu)” were conducted without any restrictions in 32 databases. Peer reviewed original articles addressing WATSU as a stand-alone hydrotherapy were assessed for risk of bias. Quantitative data of effects on pain, physical function, and mental issues were processed in random model meta-analyses with subgroup analyses by study design.
Of 1,906 unique citations, 27 articles regardless of study design were assessed for risk of bias. WATSU has been applied to individuals of all ages. Indications covered acute (e.g. pregnancy related low back pain) and chronic conditions (e.g. cerebral palsy) with beneficial effects of WATSU regarding e.g. relaxation or sleep quality. Meta-analyses suggest beneficial effect sizes of WATSU on pain, physical function, and mental issues.
The authors concluded that various applications, indications and beneficial effects of WATSU were identified. The grade of this evidence is estimated to be low to moderate at the best. To strengthen the findings of this study, high-quality RCTs are needed.
Of the 27 studies included in this review, most were case-reports or case series, and only 5 were RCTs. Of these RCTs, none was robust. Some, for instance compared WATSU against no treatment at all, thus not controlling for placebo effects. All of these RCTs had small sample sizes, and all had been published in odd journals of dubious repute.
So, is it justified to categorically conclude that beneficial effects of WATSU were identified?
No, I don’t think so.
That physiotherapy in water can have positive effects on some symptoms would hardly be surprising. But, to convince people who think more critically than Dr Weil, better evidence would be needed.
Acupressure is the stimulation of specific points, called acupoints, on the body surface by pressure for therapeutic purposes. The required pressure can be applied manually of by a range of devices. Acupressure is based on the same tradition and assumptions as acupuncture. Like acupuncture, it is often promoted as a panacea, a ‘cure-all’.
Several systematic reviews of the clinical trials of acupressure have been published. An overview published in 2010 included 9 such papers and concluded that the effectiveness of this treatment has not been conclusively demonstrated for any condition.
But since 2010, more trials have become available.
Do they change the overall picture?
The objective of this study was to test the efficacy of acupressure on patient-reported postoperative recovery. The researchers conducted a single centre, three-group, blind, randomised controlled, pragmatic trial assessing acupressure therapy on the PC6, LI4 and HT7 acupoints. Postoperative patients expected to stay in hospital at least 2 days after surgery were included and randomised to three groups:
- In the acupressure group, pressure was applied for 6 min (2 min per acupoint), three times a day after surgery for a maximum of 2 postoperative days during the hospital stay.
- In the sham group, extremely light touch was applied to the acupoints.
- The third group did not receive any such intervention.
All patients also received the normal postoperative treatments.
The primary outcome was the change in the quality of recovery (QoR), using the QoR-15 questionnaire, between postoperative days 1 and 3. Key secondary outcomes included patients’ satisfaction, postoperative nausea and vomiting, pain score and opioid (morphine equivalent) consumption. Assessors for the primary and secondary endpoints were blind to the group allocation.
A total of 163 patients were randomised (acupressure n=55, sham n=53, no intervention n=55). The mean (SD) postoperative change in QoR-15 did not differ statistically (P = 0.27) between the acupressure, sham and no intervention groups: 15.2 (17.8), 14.2 (21.9), 9.2 (21.7), respectively. Patient satisfaction (on a 0 to 10 scale) was statistically different (P = 0.01) among these three groups: 9.1 (1.5), 8.4 (1.6) and 8.2 (2.2), respectively. Changes in pain score and morphine equivalent consumption were not significantly different between the groups.
The authors concluded that two days of postoperative acupressure therapy (up to six treatments) did not significantly improve patient QoR, postoperative nausea and vomiting, pain score or opioid consumption. Acupressure, however, was associated with improved patient satisfaction.
This study is a good example to show why it is so difficult (or even impossible) to use a clinical trial for demonstrating the ineffectiveness of a therapy for any given condition. The above trial fails to show that acupressure had a positive effect on the primary outcome measure. Acupressure fans will, however, claim that:
- there was a positive effect on patient satisfaction,
- the treatment was too intense/long,
- the treatment was not intense/long enough,
- the wrong points were used,
- the sample size was too small,
- the patients were too ill,
- the patients were not ill enough,
- etc., etc.
In the end, such discussions often turn out to be little more than a game of pigeon chess. Perhaps it is best to ask before planning such a trial:
IS THE ASSUMPTION THAT THE TREATMENT WORKS FOR THIS CONDITION PLAUSIBLE?
If the answer is no, why do the study in the first place?
I have long cautioned that chiropractic overuse of X-rays is a safety problem. Is this still an issue? A recent paper was aimed at finding out.
The objective of this review was to determine the diagnostic and therapeutic utility of routine or repeat radiographs (in the absence of red flags) of the cervical, thoracic or lumbar spine for the functional or structural evaluation of the spine. Investigate whether functional or structural findings on repeat radiographs are valid markers of clinically meaningful outcomes. The research objectives required that the researchers determine the validity, diagnostic accuracy and reliability of radiographs for the structural and functional evaluation of the spine.
The investigators searched MEDLINE, CINAHL, and Index to Chiropractic Literature from inception to November 25, 2019. They used rapid review methodology recommended by the World Health Organization. Eligible studies (cross-sectional, case-control, cohort, randomized controlled trials, diagnostic and reliability) were critically appraised. Studies of acceptable quality were included in our synthesis.
Twenty-three papers were critically appraised. No relevant studies assessed the clinical utility of routine or repeat radiographs (in the absence of red flags) of the cervical, thoracic or lumbar spine for the functional or structural evaluation of the spine. No studies investigated whether functional or structural findings on repeat radiographs are valid markers of clinically meaningful outcomes. Nine low risk of bias studies investigated the validity (n = 2) and reliability (n = 8) of routine or repeat radiographs. These studies provided no evidence of clinical utility.
The authors’ conclusions are clear: We found no evidence that the use of routine or repeat radiographs to assess the function or structure of the spine, in the absence of red flags, improves clinical outcomes and benefits patients. Given the inherent risks of ionizing radiation, we recommend that chiropractors do not use radiographs for the routine and repeat evaluation of the structure and function of the spine.
In the paper, the authors provided further valuable information and background:
In the United States in 2010, the rate of spine radiographs within 5 days of presenting to a chiropractor was 204 per 1000 new patients. An analysis of national trends in the United States suggests that the rate of spinal radiography by chiropractors and podiatrists increased by 14.4% between 2003 and 2015. This increase occurred despite the publication of several evidence-based clinical practice guidelines and clinical prediction rules to assist chiropractors in determining the indication for spine radiographs to assist with diagnosing a pathology. Overall, guidelines suggest that radiographs are indicated when signs and symptoms of potentially serious underlying pathology (red flags) are identified through the clinical history and physical examination. However, on its own, an isolated “red flag” may have a high false positive rate for the diagnosis of underlying spinal pathology, such as cancer. For example, the presence of a solitary “red flag” such as age over 50 years may not be sufficient to warrant taking spine radiographs. Therefore, clinicians are encouraged to combine sound clinical judgement and the assessment of red flags when ordering radiographs.
In the absence of “red flags”, the use of spinal radiographs is not recommended. Nevertheless, factions of chiropractors, including the International Chiropractic Association promote the use of routine or repeat radiographs to assess the structure and function of the spine. This practice which dates back to 1910 was initiated when no evidence was available to guide the judicious use of spine radiographs. Historically, these groups of chiropractors have argued that radiographs are helpful to measure postural abnormalities, identify vertebral misalignment or subluxation and guide treatment with spinal manipulative therapy. The belief that radiographs are useful to detect and correct spine structure and function provides the foundation for many chiropractic technique systems that are still in use today. To our knowledge, approximately 23 chiropractic techniques use spine radiography (including full spine radiography) to guide the clinical management of patients. These include the Gonstead, Chiropractic BioPhysics®, Toggle-Recoil, and National Upper Cervical Chiropractic Association (NUCCA) techniques. Proponents of these techniques claim that the use of routine and repeat radiographs is supported by scientific evidence and have published a guideline to assist clinicians with the biomechanical assessment of spinal subluxation in chiropractic clinical practice using radiography. However, these claims have not yet been evaluated for their clinical utility, the benefit a patient gains from a test or treatment. This was a particular concern for the College of Chiropractors of British Columbia (CCBC) which regulates the practice of chiropractic in the province of British Columbia, Canada. The mission of the CCBC is to protect the public by regulating British Columbia’s doctors of chiropractic to ensure safe, qualified and ethical delivery of care.
The references from these two paragraphs can be found in the original paper. One reference the authors did not include was my article of 1998 which, at the time, received plenty of angry responses from chiropractors. Here is its conclusion: DATA SUGGEST AN OVERUSE OF RADIOGRAPHY BY THE CHIROPRACTIC PROFESSION. THIS CONSTITUTES A SAFETY PROBLEM THAT DESERVES TO BE TAKEN SERIOUSLY AND REQUIRES FURTHER RESEARCH.
Twenty-two years later, do I get the impression that the chiropractic profession might not be the fastest in getting its act together?
