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

pseudo-science

Although many conservative management options are being promoted for shoulder conditions, there is little evidence of their effectiveness. This review investigated one manual therapy approach, thrust manipulation, as a treatment option.

A systematic search was conducted of the electronic databases from inception to March 2016: PubMed, PEDro, ICL, CINAHL, and AMED. Two independent reviewers conducted the screening process to determine article eligibility. Inclusion criteria were manuscripts published in peer-reviewed journals with human participants of any age. The intervention included was thrust, or high-velocity low-amplitude, manipulative therapy directed to the shoulder and/or the regions of the cervical or thoracic spine. Studies investigating secondary shoulder pain or lacking diagnostic confirmation procedures were excluded. Methodological quality was assessed using the PEDro scale and the Cochrane risk-of-bias tool.

The initial search rendered 5041 articles. After screening titles and abstracts, 36 articles remained for full-text review. Six articles studying subacromial impingement syndrome met inclusion criteria. Four studies were randomized controlled trials (RCTs) and two were uncontrolled clinical studies. Five studies included one application of a thoracic spine thrust manipulation and one applied 8 treatments incorporating a shoulder joint thrust manipulation. Statistically significant improvements in pain scores were reported in all studies. Three of 4 RCTs compared a thrust manipulation to a sham, and statistical significance in pain reduction was found within the groups but not between them. Clinically meaningful changes in pain were inconsistent; three studies reported that scores met minimum clinically important difference, one reported scores did not, and two were unclear. Four studies found statistically significant improvements in disability; however, two were RCTs and did not find statistical significance between the active and sham groups.

The authors concluded that there is limited evidence to support or refute thrust manipulation as a solitary treatment for shoulder pain or disability associated with subacromial impingement syndrome. Studies consistently reported a reduction in pain and improvement in disability following thrust manipulation. In RCTs, active treatments were comparable to shams suggesting that addressing impingement issues by manipulation alone may not be effective. Thrust manipulative therapy appears not to be harmful, but AE reporting was not robust. Higher-quality studies with safety data, longer treatment periods and follow-up outcomes are needed to develop a stronger evidence-based foundation for thrust manipulation as a treatment for shoulder conditions.

This is yet another very odd conclusion from an otherwise almost acceptable analysis (but why include non-randomised studies on a subject where randomised trials are available?) . If pain reductions are found within groups but not between real and sham manipulation, the evidence is as clear as it can be: manipulations have no specific effects. In other words, they are a pure placebo therapy.

And what about this nonsense: there is limited evidence to support or refute thrust manipulation as a solitary treatment for shoulder pain? For responsible healthcare, we don’t need such weasel words, all we need is to stress loud and clear that there is no good positive evidence. This means the therapy is not evidence-based and we therefore should not recommend or use manipulation for shoulder pain.

But, in my view, the worst part in the conclusion section is this: thrust manipulative therapy appears not to be harmful, but AE reporting was not robust. Even if there had been adequate reporting of side-effects and even if this had not disclosed any problems, the safety of manipulation cannot be judged on the basis of such a small sample. Any responsible researcher should make it abundantly clear that the nasty habit by chiropractic pseudo-researchers of not reporting adverse effects is unethical and totally unacceptable.

My conclusion from all this: yet another attempt to white-wash a dodgy alternative therapy.

 

Yes, homeopaths are incredibly fond of the notion that homeopathy has been proven to work in numerous population studies of outbreaks of infectious diseases. The argument is bound to come up in any discussion with a ‘well-informed’ homeopathy fan. Therefore, it might be worth addressing it once and for all.

This website offers a fairly good summary of what homeopaths consider to be convincing evidence. It also provides links to the original articles which is valuable for all who want to study them in full detail. I will therefore present the crucial passage here unchanged.

START OF QUOTE

By the end of year 2014, there have been 19 papers published on Epidemiological studies on 7 epidemic diseases (scarlet fever, typhus fever, Cholera, Dengue, meningococcal, influenza and Leptospirosis) in 11 peer-reviewed (beyond year 1893) journals in evidence of Homeopathy including 2 Randomised Controlled Trials.

1. Samuel Hahnemann, “The Cure and prevention of scarlet fever”, Zeitschrift für Praktischen Medizin (Journal of Practical Medicine), 1801, Republished in Lesser Writings. B.Jain Publishing, New Delhi

Preventive use of homeopathy was first applied in 1799 during an epidemic of scarlet fever in Königslütter, Germany, when Dr. Hahnemann prescribed a single dose of Belladonna, as the remedy of the genus epidemicus to susceptible children in the town with more than 95% success rate. In this paper, he also specified how the Belladonna has to be potentised to 1/24,000,000 dilution. His recommended dose of Belladonna was 0.0416 nanograms to be repeated every 72 hrs. This is the first recorded nano dose of medicine used in treatment of any disease [6]. It was another 125 years before Gladys Henry and George Frederick developed a vaccine for scarlet fever in 1924.

2. Samuel Hahnemann, “Scarlet fever and Purpura miliaris, two different diseases”, Zeitschrift für Praktischen Medizin, vol. 24, part. 1, 1806

3. Samuel Hahnemann, “Observations on scarlet fever”, Allgemeine Reichanzeiger (General Reich Gazette), No. 160, Germany, 1808

4. Samuel Hahnemann, “Reply to a question about the prophylactic for scarlet fever”, Zeitschrift für Praktischen Medizin, vol. 27, part. 4, p. 152-156, 1808

5. Samuel Hahnemann, “Treatment of typhus & fever at present prevailing”, Allgemeine Reichanzeiger, No. 6, Jan. 1814.

6. Hufeland, Prophylactic powers of Belladonna against Scarlet Fever , The Lancet, 1829
The proper use of belladonna has, in most cases, prevented infection. Numerous observations have shown that, by the general use of belladonna, epidemics of scarlet fever have actually been arrested. In those few instances where the use of belladonna was insufficient to prevent infection, the disease has been invariably slight. The Prussian (German Empire) Government ordered the use of the prophylactic during all scarlet fever epidemics

7. Samuel Hahnemann, “Cure and prevention of Asiatic cholera”, Archiv für die homöopathische Heilkunst (Archives for the Homoeopathic Healing Art), Vol. 11, part 1, 1831.
Cuprum 30c once every week as preventive medicine

8. Samuel Hahnemann, “On the contagiousness of cholera”. British Homoeopathic Journal, Vol. 7, 1849

9. Samuel Hahnemann, “Appeal to Thinking Philanthropists Respecting the Mode of Propagation of the Asiatic Cholera”, 20 pages, 1831. Republished in British Homoeopathic Journal, Oct 1849.

He said, “On board ships – in those confined spaces, filled with mouldy watery vapours, the cholera-miasm finds a favourable element for its multiplication, and grows into an enormously increased brood of those excessively minute, invisible, living creatures, so inimical to human life, of which the contagious matter of the cholera most probably consists millions of those miasmatic animated beings, which, at first developed on the broad marshy banks or the tepid Ganges– on board these ships, I say, this concentrated aggravated miasm kills several of the crew …” [7].
It was another 59 years (1890) before Koch saw these organisms, and later on orthodox medicine gave them the name ‘germs’

10. Charles Woodhull Eaton, The Facts about Variolinum, Transactions of the American Institute of Homoeopathy, 1907
2806 patients were treated prophylactically with Variolinum 30 (a nosode) for prevention of smallpox in Iowa. Of the 547 patients definitely exposed, only 14 developed the disease. Efficacy rate of 97.5%

11. Taylor Smith A, Poliomyelitis and prophylaxis British Homoeopathic Journal, 1950
In 1950 during an epidemic of poliomyelitis, Dr Taylor Smith of Johannesburg, South Africa protected 82 people with homoeopathic Lathyrus sativus. Of the 82 so immunised, 12 came into direct contact with disease. None were infected.

12. Oscillococcinum 200c in the treatment of influenza during epidemic in France from 1984-1987, British Journal of Clinical Pharmacology (1989)
A DBRPCT, Oscillococcinum 200c taken twice daily for 5 days significantly increased the rate of cure within two days (n=487, 237 treated and 241 on placebo), absence of symptoms at 48 hours, relative risk estimate significantly favour homeopathy (p=0.048), no pain and no fever (p=0.048), recovery rate (headache, stiffness, articular pain, shivering reduction) at 48 hours better in homeopathy group (p=0.032)

13. Bernard Leary, Cholera 1854 Update, British Homoeopathic Journal, 1994
Sir William Wilde, the well-known allopathic doctor of Dublin, which in his work entitled “Austria and its Institutions”, wrote: “Upon comparing the report of the treatment of Cholera in the Homeopathic hospital testified to by two allopathic medical inspectors appointed by Government with that of the treatment of the same disease in the other hospitals of Vienna during the same period the epidemic of 1836, it appeared that while two-thirds of the cases treated by Dr. Fleischmann the physician of the Homeopathic hospital, recovered, two-thirds of those treated by the ordinary methods in the other hospitals died.”

14. Meningococcinum – its protective effect against meningococcal disease, Homeopathy Links, 2001 (2001)
A total of 65,826 people between the ages of 0–20 were immunised homeopathically to protect against meningococcal disease while 23,532 were not. Over a year period, 4 out of 65,826 protected homeopathically developed meningococcal infection. 20 out of 23,532 not protected developed meningococcal infection. Based on the infection rate in the unprotected group, 58 cases of infection could have been expected in the homeopathically protected group. Instead, there were only four cases of meningococcal infection. Statistical analysis showed that homeopathic immunisation offered 95% protection in the first six months and 91% protection over the year against meningococcal disease. [8]

15. Contribution of homeopathy to the control of an outbreak of dengue epidemic in Macaé, Rio de Janeiro, Brazil in 2007-8 , International Journal of High Dilution Research, 2008
In a campaign ‘Homeopathy campaign against dengue’ by Brazilian Govt, “156,000 doses of homeopathic remedy were freely distributed in April and May 2007 to asymptomatic patients and 129 doses to symptomatic patients treated in outpatient clinics, according to the notion of genus epidemicus . The remedy used was a homeopathic complex against dengue containing Phosphorus 30c, Crotalus horridus 30c and Eupatorium perfoliatum 30c. The incidence of the disease in the first three months of 2008 fell 93% by comparison to the corresponding period in 2007, whereas in the rest of the State of Rio de Janeiro there was an increase of 128%.”

16. Marino R. Eupatorium perfoliatum 30c for the Dengue Epidemics in Brazil in 2007. International Journal of High Dilution Research, 2008
In May 2001, prophylactic use of Eupatorium perfoliatum 30c single dose was given during a dengue outbreak to 40% of residents in the most highly affected neighbourhood which resulted in significant decrease in dengue incidence by 81.5% (p<0.0001) when compared with those neighbourhoods that did not receive homeopathic prophylaxis.

17. Bracho et. al. Application of 200C potency of bacteria for Leptospirosis epidemic control in Cuba 2007-8 (2010)
Conducted by the Finlay Institute, a vaccines producer in Cuba gave 2.308562 million (70% of the target population above the age of 1 year) people in Cuba given two doses (1 dose=5 drops) of 200C potency of a nosode prepared from Leptospirosis bacteria, each (7-9 days apart), for protection against Leptospirosis (fever+jaundice+ inflammation in kidney+enlargement of spleen) with 84% decrease in disease incidence and only 10 reported cases. Dramatic decrease in morbidity within two weeks and zero morbidity of hospitalised patients, non-treated (8.8 millions) area saw an increase in number of cases from 309 cases in 2007 to 376 in 2008 representing a 21% increase. The cost of homeopathic immunization =1/15th of conventional vaccine.

18. Effect of individualized homoeopathic treatment in influenza like illness, Indian Journal of Research in Homeopathy (2013)
A multicenter, single blind, randomized, placebo controlled study to evaluate the effect of homoeopathic medicines in the treatment of Influenza like illness and to compare the efficacy of LM (50 millisimal) potency vis-à-vis centesimal (C) potency. In LM group (n=152), C group (n=147) or placebo (n=148) group. The study revealed the significant effect of individualized homoeopathic treatment in the patients suffering from ILI with no marked difference between LM and Centesimal groups. The medicines which were commonly prescribed were: Arsenic album, Bryonia alba, Rhus tox., Belladonna, Nux vomica, Sepia, Phosphorus, Gelsemium, Sulphur, Natrum mur. and Aconitum napellus. [9]

19. Reevaluation of the Effectiveness of Homoeoprophylaxis Against Leptospirosis in Cuba in 2007-8, Journal of Evidence-based Complementary & Alternative Medicine (2014)
The results support the previous conclusions that homoeoprophylaxis can be used to effectively immunize people against targeted infectious diseases such as leptospirosis.

References
[1] Iman Navab, Lives saved by Homeopathy in Epidemics and Pandemics, https://drnancymalik.wordpress.com/2013/01/23/epidemics-and-pandemics/

[2] Reshu Agarwal, Natural History of Disease and Homeopathy at different levels of Intervention, http://www.homeorizon.com/homeopathic-articles/homeopathic-philosophy/disease-history

[3] Homoeopathy- Science of Gentle Healing, Deptt. of AYUSH, Ministry of Health & Family Welfare, Govt, of India, 2013, http://www.ccrhindia.org/Dossier/content/page22.html

[4] Conversation with David Little, http://hpathy.com/homeopathy-papers/conversations-with-david-little/

[5] Nancy Malik, Principles of Homeopathy Explained, 2015, https://drnancymalik.wordpress.com/article/homeopathy-explained/

[6] Nancy Malik, Recent Advances in Nanoparticle Research in Homeopathy, Homeopathy 4 Everyone, Vol.12, Issue 6, 18 June 2015, http://hpathy.com/scientific-research/recent-advances-in-nanoparticle-research-in-homeopathy/

[7] Samuel Hahnemann, “Appeal to Thinking Philanthropists Respecting the Mode of Propagation of the Asiatic Cholera”, 20 pages, 1831, Translated by R E Dudgeon, M.D. in The Lesser Writings of Samuel Hahnemann, 1851, B Jain Publishers, reproduced edition, 2002, p. 758

[8] Fran Sheffield, Homeoprophylaxis: Human Records, Studies and Trials, 2014, http://homeopathyplus.com/Homeoprophylaxis-Human-Records-Studies-Trials.pdf

[9] Homoeopathy in Flu-like Illness- Factsheet, Central Council for Research in Homoeopathy, Deptt. of AYUSH, Ministry of Health & Family Welfare, Govt, of India, 2015, http://ccrhindia.org/pdf/swineflu.pdf

END OF QUOTE

Whenever I read articles of this nature, I get a little embarrassed. It seems obvious to me that the authors of such reviews have done some ‘research’ and believe strongly in the correctness in what they write. It embarrasses me to see how such people, full of good will, can be so naïve, ignorant and wrong. They clearly fail to understand several crucial issues. To me. this seems like someone such as me lecturing others about car mechanics, quantum physics or kite flying. I have no idea about these subjects, and therefore it would be idiotic to lecture others about them. But homeopaths tend to be different! And this is when my embarrassment quickly turns into anger: articles like the above spread nonsense and misguide people about important issues. THEY ARE DANGEROUS! There is little room for embarrassment and plenty of room for criticism. So, let’s criticise the notions advanced above.

In my recent book, I briefly touched upon epidemics in relation to homeopathy:

Epidemics are outbreaks of disease occurring at the same time in one geographical area and affecting large number of people. In homeopathy, epidemics are important because, in its early days, they seemed to provide evidence for the notion that homeopathy is effective. The results of homeopathic treatment seemed often better than those obtained by conventional means. Today we know that this was not necessarily due to the effects of homeopathy per se, but might have been a false impression caused by bias and confounding.

This tells us the main reason why the much-treasured epidemiological evidence of homeopaths is far from compelling. The review above does not mention these caveats at all. But it is lousy also for a whole host of other reasons, for instance:

  • The text contains several errors (which I find too petty to correct here).
  • The list of studies is the result of cherry-picking the evidence.
  • It confuses what epidemiological studies are; RCTs are certainly not epidemiological studies, for instance.
  • It also omits some of the most important epidemiological studies suggesting homeopathy works.
  • It cites texts that are clearly not epidemiological studies.
  • Several studies are on prevention of illness rather than on treatment.
  • Some studies do not even employ homeopathy at all.

In the typical epidemiological case/control study, one large group of patients [A] is retrospectively compared to another group [B]. By large, I mean with a sample size of thousands of patients. In our case, group A has been treated homeopathically, while group B received the treatments available at the time. It is true that several of such reports seemed to suggest that homeopathy works. But this does by no means prove anything; the result might have been due to a range of circumstances, for instance:

  • group A might have been less ill than group B,
  • group A might have been richer and therefore better nourished,
  • group A might have benefitted from better hygiene in the homeopathic hospital,
  • group A might have received better care, e. g. hydration,
  • group B might have received treatments that made the situation not better but worse.

Because these are RETROSPECTIVE studies, there is no way to account for these and many other factors that might have influenced the outcome. This means that epidemiological studies of this nature can generate interesting results which, in turn, need testing in properly controlled studies where these confounding factors are adequately controlled for. Without such tests, they are next to worthless for recommendations regarding clinical practice.

As it happens, the above author also included two RCT in the review (these are NOT epidemiological studies, as I already mentioned). Let’s have a quick look at them.

The first RCT is flawed for a range of reasons and has been criticised many times before. Even its authors state that “the result cannot be explained given our present state of knowledge, but it calls for further rigorously designed clinical studies.” More importantly, the current Cochrane review of Oscillococcinum, the remedy used in this study, concluded: “There is insufficient good evidence to enable robust conclusions to be made about Oscillococcinum® in the prevention or treatment of influenza and influenza-like illness.”

The second RCT is equally flawed; for instance, its results could be due to the concomitant use of paracetamol, and it seems as though the study was not double blind. The findings of this RCT have so far not been confirmed by an independent replication.

What puzzles me most with these regularly voiced notions about the ‘epidemiological evidence’ for homeopathy is not the deplorable ineptitude of those who promote them, but it is this: do homeopaths really believe that conventional medics and scientists would ignore such evidence, if it were sound or even just encouraging? This assumes that all healthcare professionals (except homeopaths) are corrupt and cynical enough not to follow up leads with the potential to change medicine for ever. It assumes that we would supress knowledge that could save the lives of millions for the sole reason that we are against homeopathy or bribed by ‘BIG PHARMA’.

Surely, this shows more clearly than anything else how deluded homeopaths really are!!!

 

Tomorrow is WORLD CANCER DAY. To mark this important occasion, I intend to publish not just one but two posts. Today’s post discloses one of the more sickening alternative cancer scams I have seen for a long time (tomorrow’s post will be a lot more encouraging): baking soda as a cancer cure. Here is what some charlatans tell the most vulnerable of our patients.

START OF QUOTE

Even the most aggressive cancers which have metastasized have been reversed with baking soda cancer treatments… Doctors and pharmaceutical companies make money from it. That’s the only reason chemotherapy is still used. Not because it’s effective, decreases morbidity, mortality or diminishes any specific cancer rates. In fact, it does the opposite. Chemotherapy boosts cancer growth and long-term mortality rates and oncologists know it…

Studies have shown that dietary measures to boost bicarbonate levels can increase the pH of acidic tumors without upsetting the pH of the blood and healthy tissues. Animal models of human breast cancer show that oral sodium bicarbonate does indeed make tumors more alkaline and inhibit metastasis. Based on these studies, plus the fact that baking soda is safe and well tolerated, world renowned doctors such as Dr. Julian Whitaker have adopted successful cancer treatment protocols as part of an overall nutritional and immune support program for patients who are dealing with the disease…

When taken orally with water, especially water with high magnesium content, and when used transdermally in medicinal baths, sodium bicarbonate becomes a first-line medicinal for the treatment of cancer, and also kidney disease, diabetes, influenza and even the common cold. It is also a powerful buffer against radiation exposure, so everyone should be up to speed on its use. Everybody’s physiology is under heavy nuclear attack from strong radioactive winds that are circling the northern hemisphere…

The pH of our tissues and body fluids is crucial and central because it affects and mirrors the state of our health or our inner cleanliness. The closer the pH is to 7.35-7.45, the higher our level of health and wellbeing. Staying within this range dramatically increases our ability to resist acute illnesses like colds and flues as well as the onset of cancer and other diseases. Keeping our pH within a healthy range also involves necessary lifestyle and dietary changes that will protect us over the long term while the use of sodium bicarbonate gives us a jump-start toward increased alkalinity…

Basically, malignant tumors represent masses of rapidly growing cells. The rapid rate of growth experienced by these cells means that cellular metabolism also proceeds at very high rates. Therefore, cancer cells are using a lot more carbohydrates and sugars to generate energy in the form of ATP (adenosine triphosphate). However, some of the compounds formed from the energy production include lactic acid and pyruvic acid. Under normal circumstances, these compounds are cleared and utilized as soon as they are produced. But cancer cells are experiencing metabolism at a much faster rate. Therefore, these organic acid accumulate in the immediate environment of the tumor. The high level of extracellular acidity around the tumor is one of the chief driving force behind the metastasis of cancer tumors. Basically, cancer cells need an acidic environment to grow and spread rapidly…

One does not have to be a doctor to practice pH medicine. Every practitioner of the healing arts and every mother and father needs to understand how to use sodium bicarbonate. Bicarbonate deficiency is a real problem that deepens with age so it really does pay to understand and appreciate what baking soda is all about.

END OF QUOTE

I am sure you agree: this is not just unethical and irresponsible; it is vile!

There are far too many falsehoods in this text (and most of them are too obvious) for me to even begin to correct them.

Why do I post this just before WORLD CANCER DAY?

Because I believe that cancer patients need to be protected from people and institutions who tout dangerous nonsense. Sadly, in the realm of alternative medicine, there are many of such charlatans.

Wellness?

Yes, it’s a new buzz-word in the realm of alternative medicine – actually, not so new; it’s been around for years and seems to attract charlatans of all imaginable types.

But what precisely is it?

The authors of this paper explain: “While the concept of wellness is still evolving, it is generally recognized that wellness is a holistic concept best represented as a continuum, with sickness, premature death, disability, and reactive approaches to health on one side and high-level wellness, enhanced health, and proactive approaches to health and well-being on the other. It is further acknowledged that wellness is multidimensional and includes physiologic, psychological, social, ecologic, and economic dimensions. These multiple dimensions make wellness difficult to accurately assess as multiple subjective and objective measures are required to account for the different dimensions. Thus, the assessment of wellness in individuals may include a variety of factors, including assessment of physiologic functioning, anthropometry, happiness, depression, anxiety, mood, sleep, health symptoms, toxic load, neurocognitive function, socioeconomic status, social connectivity, and perceived self-efficacy.”

Sounds a bit woolly?

I agree! It sounds like a gimmick for getting at the cash of the gullible public.

Is there money to be made with ‘wellness’?

Sure! Lots!

For instance, with so-called ‘wellness retreats’.

Wellness retreats are all the rage. They use all sorts of bogus therapies within luxurious holiday settings for the ‘well to do’ end of our societies.

But is there any science behind this approach?

Few studies have evaluated the effect of retreat experiences, and no published studies have reported health outcomes. The objective of this new study therefore was to assess the effect of a week-long wellness-retreat experience in wellness tourists. The study was designed as a longitudinal observational study without a control group. Outcomes were assessed upon arrival and departure and 6 weeks after the retreat. The intervention was a ‘holistic, 1-week, residential, retreat experience that included many educational, therapeutic, and leisure activities and an organic, mostly plant-based diet’.

The outcome measures included anthropometric measures, urinary pesticide metabolites, a food and health symptom questionnaire, the Five Factor Wellness Inventory, the General Self Efficacy questionnaire, the Pittsburgh Insomnia Rating Scale, the Depression Anxiety Stress Scale, the Profile of Mood States, and the Cogstate cognitive function test battery.

Statistically significant improvements were seen in almost all measures after 1 week. Many of these improvements were also sustained at 6 weeks. There were statistically significant improvements in all anthropometric measures after 1 week, with reductions in abdominal girth, weight, and average systolic and diastolic pressure. Statistically significant improvements were also noted in psychological and health symptom measures. Urinary pesticide metabolites were detected in pooled urine samples before the retreat and were undetectable after the retreat.

The authors concluded that “the retreat experiences can lead to substantial improvements in multiple dimensions of health and well-being that are maintained for 6 weeks. Further research that includes objective biomarkers and economic measures in different populations is required to determine the mechanisms of these effects and assess the value and relevance of retreat experiences to clinicians and health insurers.”

IS THIS GOOD OR BAD RESEARCH?

Let’s apply my checklist from the previous post:

  • published in one of the many dodgy CAM journals? YES
  • single author? NO
  • authors are known to be proponents of the treatment tested? YES
  • author has previously published only positive studies of the therapy in question? YES
  • lack of plausible rationale for the study? YES
  • lack of plausible rationale for the therapy that is being tested? YES
  • stated aim of the study is ‘to demonstrate the effectiveness of…’ ? NO
  • stated aim ‘to establish the effectiveness AND SAFETY of…’? NO
  • text full of mistakes, e. g. spelling, grammar, etc.? NO
  • sample size is tiny? YES
  • pilot study reporting anything other than the feasibility of a definitive trial? NO
  • methods not described in sufficient detail? YES
  • mismatch between aim, method, and conclusions of the study? YES
  • results presented only as a graph? NO
  • statistical approach inadequate or not sufficiently detailed? NO
  • discussion without critical input? NO
  • lack of disclosures of ethics, funding or conflicts of interest? NO
  • conclusions which are not based on the results? YES

To me, this rough and ready assessment indicates that there are too many warning signals for characterising this as a rigorous study. It looks a lot like pseudo-science, I fear.

But these are at best formal markers. More important is the fact that the whole idea of measuring the effects of a ‘wellness retreat’ makes little sense, particularly in the absence of a control group. If we take a few people out of their usual, stressful work-environment and put them into a nice and luxurious holiday atmosphere where they get papered, eat better food, exercise more, sleep better and relax a lot – what would we expect after one week?

Yes, precisely! We would expect that almost anything measurable has changed for the better!

In fact, this result is so predictable that it is hardly worth documenting. Crucially, the outcome has very little to do with wellness, holism, or alternative medicine.

My conclusion: wellness not only attracts charlatans, entrepreneurs and windbags, it also is firmly steeped in pseudoscience.

 

 

 

One of the questions I hear frequently is ‘HOW CAN I BE SURE THIS STUDY IS SOUND’? Even though I have spent much of my professional life on this issue, I am invariably struggling to provide an answer. Firstly, because a comprehensive reply must inevitably have the size of a book, perhaps even several books. And secondly, to most lay people, the reply would be intensely boring, I am afraid.

Yet many readers of this blog evidently search for some guidance – so, let me try to provide a few indicators – indicators, not more!!! – as to what might signify a good and a poor clinical trial (other types of research would need different criteria).

INDICATORS SUGGESTIVE OF A GOOD CLINICAL TRIAL

  • Author from a respected institution.
  • Article published in a respected journal.
  • A clear research question.
  • Full description of the methods used such that an independent researcher could repeat the study.
  • Randomisation of study participants into experimental and control groups.
  • Use of a placebo in the control group where possible.
  • Blinding of patients.
  • Blinding of investigators, including clinicians administering the treatments.
  • Clear definition of a primary outcome measure.
  • Sufficiently large sample size demonstrated with a power calculation.
  • Adequate statistical analyses.
  • Clear presentation of the data such that an independent assessor can check them.
  • Understandable write-up of the entire study.
  • A discussion that puts the study into the context of all the important previous work in this area.
  • Self-critical analysis of the study design, conduct and interpretation of the results.
  • Cautious conclusion which are strictly based on the data presented.
  • Full disclosure of ethics approval and informed consent,
  • Full disclosure of funding sources.
  • Full disclosure of conflicts of interest.
  • List of references is up-to-date and includes also studies that contradict the authors’ findings.

I told you this would be boring! Not only that, but each bullet point is far too short to make real sense, and any full explanation would be even more boring to a lay person, I am sure.

What might be a little more fun is to list features of a clinical trial that might signify a poor study. So, let’s try that.

WARNIG SIGNALS INDICATING A POOR CLINICAL TRIAL

  • published in one of the many dodgy CAM journals (or in a book, blog or similar),
  • single author,
  • authors are known to be proponents of the treatment tested,
  • author has previously published only positive studies of the therapy in question (or member of my ‘ALT MED HALL OF FAME’),
  • lack of plausible rationale for the study,
  • lack of plausible rationale for the therapy that is being tested,
  • stated aim of the study is ‘to demonstrate the effectiveness of…’ (clinical trials are for testing, not demonstrating effectiveness or efficacy),
  • stated aim ‘to establish the effectiveness AND SAFETY of…’ (even large trials are usually far too small for establishing the safety of an intervention),
  • text full of mistakes, e. g. spelling, grammar, etc.
  • sample size is tiny,
  • pilot study reporting anything other than the feasibility of a definitive trial,
  • methods not described in sufficient detail,
  • mismatch between aim, method, and conclusions of the study,
  • results presented only as a graph (rather than figures which others can re-calculate),
  • statistical approach inadequate or not sufficiently detailed,
  • discussion without critical input,
  • lack of disclosures of ethics, funding or conflicts of interest,
  • conclusions which are not based on the results.

The problem here (as above) is that one would need to write at least an entire chapter on each point to render it comprehensible. Without further detailed explanations, the issues raised remain rather abstract or nebulous. Another problem is that both of the above lists are, of course, far from complete; they are merely an expression of my own experience in assessing clinical trials.

Despite these caveats, I hope that those readers who are not complete novices to the critical evaluation of clinical trials might be able to use my ‘warning signals’ as a form of check list that helps them to tell the chaff from the wheat.

We have repeatedly discussed the risks of chiropractic spinal manipulation (see, for instance here, here and here). Some chiropractors seem to believe that using a hand-held manipulator, called ‘activator’, better controls the forces used on the spine and therefore is safer. This recent paper raises doubts on this hypothesis.

A neurosurgeon from Florida published the case-report of a 75-year-old active woman who presented to a local hospital emergency room with a 3-day history of the acute onset of severe left temporal headache, initially self-treated with non-steroidals, to which they were resistant. Additional complaints included some vague right eye blurring of vision and a mild speech disturbance. Her primary-care physician had ordered an outpatient MRI, which was interpreted as showing a small sub-acute left posterior temporal lobe haemorrhage. He then referred her to the emergency room where she was categorized as a “stroke alert” and evaluated according to the hospital “stroke-alert” protocol.

There was no prior history of migraine, but some mild treated hypertension. The patient subsequently gave a history of chronic neck and back pain, but no headache, for which she had intermittently received chiropractic adjustments. Her current problem started after an activator treatment to the base of the left side at the junction of the skull with the upper cervical spine. She became concerned enough a few days later, because of the persistence of unremitting headache, to contact her primary-care physician. The patient was not taking any anticoagulants or antiplatelet agents and had a relatively unremarkable past medical and surgical history. Although she did not have a formal visual field examination or an ophthalmology consultation, she was found to have an incomplete right homonymous hemi-anopsia on clinical exam by the neurologist.

Based on MRI characteristics, the haemorrhage was determined to be primarily subarachnoid and displacing but not involving any brain parenchyma, and without any extra-axial component. After a 4-day hospitalization for evaluation and observation, the patient was discharged, neurologically improved in terms of visual and speech symptoms as well as headache complaints, to outpatient follow-up. She has remained well with resolution of imaging abnormalities and no reoccurrence of symptoms.

The authors explain how difficult it is to prove specific causation in such cases. It is frequently inferred by epidemiological reasoning or evidence. While there are other potential causes of the haemorrhage that occurred in this case, none is as or more likely than the activator stimulus. In support of the activator as the cause of the haemorrhage, the symptoms began almost immediately after the activator treatment (a temporal relationship), the area to which the activator was applied is almost directly superficial to the area of haemorrhage (a spatial relationship), the anatomic location of this haemorrhage is statistically unusual for any underlying and/or preexisting conditions, including stroke. The MRI confirmed that there was no infarction underlying the area of haemorrhage. The MRA disclosed no dissections or vascular lesions present. The only mechanisms left are trauma or cryptic vascular lesion that ruptured, obliterated itself, and occurred coincident to the activator stimulus. Although Activator stimulus is not high energy, it nonetheless was targeted to the cervico-occipital junction, an area where neural tissue is among the most vulnerable and least protected and closest to the skin (as opposed to the lower cervical or any of the thoracic or lumbar spine). There are many articles that make reference to minor or trivial head injury as a likely cause of intracranial haemorrhage.

The author concluded that he was unable to find a single documented case in which a brain hemorrhage in any location was reported from activator treatment. As such, this case appears to represent the first well-documented and reported brain hemorrhage plausibly a consequence of activator treatment. In the absence of any relevant information in the chiropractic or medical literature regarding cerebral hemorrhage as a consequence of activator treatment, this case should be instructive to the clinician who is faced with a diagnostic dilemma and should not forget to inquire about activator treatment as a potential cause of this complication. Our case had a benign course, but we do not rule out a more serious or potentially dangerous clinical course or adverse outcome. This is of heightened concern in the elderly and/or those with treatment-induced coagulopathy or platelet inhibition.

In light of all of the difficulties inherent in linking chiropractic treatments, including activator treatments, with serious neurological events, it is very possible that intracranial hemorrhage is far more frequent than reported. Several articles comment on the likelihood that complications of this type are almost certainly underreported. Most of the incidents mentioned in case series or surveys had never been previously reported. Neurologists, neurosurgeons, and chiropractors should be more vigilant both in the application and evaluation of these methods in all patients who report new neurologic-type symptoms following a manipulation (including an activator application) to the occiput or the cranio-cervical junction.

I think that case-report speaks for itself.

Chiropractors will, of course, argue (yet again) that:

  • conventional treatments cause much more harm,
  • spinal manipulation is highly effective,
  • such complications are extreme rarities,
  • the risk/benefit profile of spinal manipulation is positive,
  • some studies have failed to show a risk of spinal manipulation,
  • case-reports cannot establish causality.

We have rehearsed these arguments ad nauseam on this blog. The bottom line is well-expressed in the above conclusions: it is very possible that intracranial hemorrhage is far more frequent than reported. And that obviously applies to all other types of complications after chiropractic treatments.

Originally, I had meant this blog to discuss all types of alternative therapies – well, perhaps not all (there are simply too many of them), but at least the most popular ones. And so far, I have omitted one that seems certainly quite wide-spread: CRYSTAL HEALING.

What the Dickens is crystal healing, you ask? It is the attempt to bring about healing with the power of crystals, of course. And how is it supposed to work? This is where things get quite nebulous; this website, for instance tells us that the repeating chemical structure of crystals is said to invest them with a kind of memory. This means that crystals have the power to hold energies. You may hold a quartz crystal with the intention of filling it with your love. This is what is meant by programming a crystal. You do not need any wires or a special connection with God – all you need is intention and focus. The crystal will remember your love, which will then permeate any environment in which the crystal is placed. Crystals can remember negative as well as positive energies and so will sometimes need to be cleansed. For instance, an amethyst will actually help to cleanse a room of negative energies (eg. anger) but this means that the amethyst, which will retain an element of that negative energy, will itself occasionally require cleansing.

Most crystal healers make fairly specific claims about the healing power of specific crystals. This website explains it in some detail. The following text is an extract of several key (only marginally altered) passages from much longer instructions about the use of different crystals for healing purposes:

Crystal healing specialists generally agree that garnet promotes rapid general healing and regeneration in users. Garnet also has a positive effect on disorders such as acid reflux, blood-related illnesses, and physical strength.

Rose quartz is considered, by practitioners of alternative medicine, to be the stone of love—in this case, love of the self, in the form of self-esteem and self-worth. Rose quartz is simply brimming with happiness, and is a very positive stone that can help bring out forgiveness, compassion, and tolerance in users.

Fluorite is of mental order and clarity, and can be used to help alleviate instability, paving the way for a more balanced view of life. Feeling tossed about on a sea of restless emotions? Try carrying fluorite with you throughout the day—it helps cleanse and detoxify the centers of emotion. Fluorite is also the stone of learning, and can improve concentration and focus, while simultaneously reducing the anxiety that can sometimes make retaining information difficult. If you’re a student, learning a new instrument, or facing a complex new job, fluorite may be the stone you’ll want to keep on your person.

Lapis lazuli is beneficial to the throat, vocal cords, and larynx, and can help to regulate endocrine and thyroid issues. This is one of the most effective stones to meditate with, as lapis lazuli is the stone of higher awareness, able to bring information to the mind in images rather than words. This is an especially great boon to those who have creative jobs, as their next big inspiration can come from this.

If you suffer from anxiety, hematite is for you. A heavy, calming stone, hematite is very grounding—it leaves the user feeling comfortable and “in the moment,” rather than being lost in memory or worry. This disconnection from the present—which many of us suffer from—is the cause of much discomfort. But by practicing mindfulness through meditation with hematite, you can reconnect with what’s currently going on in your life.

Alternative medicine practitioners consider jade to be the stone of the heart, and as such, affects this organ in a positive way, promoting heart health. Not only does jade promote physical heart health, but heals emotionally, as well. Focusing energies on the emotional heart, jade helps regulate what we embrace and what we resist, giving us better self-control, as well as a better picture of our own wants and needs.

Turquoise is powerful, giving peace to the spirit and well-being to the body. This stone induces a sense of serenity, keeping physically harmful stress and inflammation at bay. Holding turquoise can bring back focus and restore vitality. Turquoise is also a stabilizer, and can calm the nerves when working on a difficult problem, or when performing or speaking in public. It is known for its effectiveness in alleviating the fear of flying.

Obsidian is a protective stone, able to remove and guard against negativity. If you are trying to release issues from your past, including emotions such as anger, resentment, and fear, handling obsidian can help by allowing you to see them for what they are so that they can be dealt with. Physically, obsidian is said to benefit good health in muscle tissue and the digestive system, and can help rid the body of infection. It helps to reduce the pain of arthritis, joint problems, and cramps.

Citrine holds the power of granting energy and stamina and supporting proper metabolism. Especially beneficial for those suffering from chronic fatigue syndrome, this stone can bring back some much-needed vitality, and can even alleviate nausea and vomiting for those suffering from morning sickness. This gem also aids in keeping the nails, skin, and hair healthy, and is effective in relieving skin irritation of any kind. Emotionally, citrine is the gem of joy, helping the subconscious mind to accept happiness in life, releasing anger and negativity. This is the most effective gem for those suffering from depression—combined with the skills of a trained counselor, meditation with citrine can help channel happiness through you, imbuing you with real joy.

Whether you believe in the healing power of crystals or not, they are worth trying alongside your normal health regimen. At best, you’ll find a spiritual support for your physical and mental health goals. And at worst? You’ll be in possession of a few beautiful stones that make great meditative focal points. So do a little research and go try out a few of your favorite stones!

END OF QUOTES

Recently, I promised to be more respectful in my criticism of quackery, but when it comes to things like crystal healing this is a difficult task indeed. It goes almost without saying that there is not a jot of evidence for any of the therapeutic claims made in the above quotes or other promotional texts on crystal healing.

Who publishes this sort of nonsense? The above excerpts come from ‘BELIEFNET‘, the “leading lifestyle site dedicated to faith and inspiration. Beliefnet helps people find and walk a spiritual path that instills comfort, hope, strength and happiness. It is through this discovery that our readers are empowered to live a more meaningful life.”

Say no more!

The ‘CHRONICLE OF CHIROPRACTIC’ recently reported on the relentless battle within the chiropractic profession about the issue of ‘subluxation’. Here is (slightly abbreviated) what this publication had to say:

START OF QUOTE

Calling subluxation based chiropractors “unacceptable creatures” chiropractic researcher Keith H Charlton DC, MPhil, MPainMed, PhD, FICC, recently stated “. . . that it is no longer scientifically acceptable for any responsible chiropractic clinician to ever use the word subluxation except as theory . . .” Charlton made the comment to members of the Chiropractic Research Alliance a group of subluxation deniers who routinely disparage the concept of subluxation.

Charlton is a well known “Subluxation Denier” and frequently attacks subluxation based chiropractors in his peer reviewed research papers and on Facebook groups. According to Charlton in a paper published in the journal Chiropractic and Osteopathy: “The dogma of subluxation is perhaps the greatest single barrier to professional development for chiropractors. It skews the practice of the art in directions that bring ridicule from the scientific community and uncertainty among the public.”

On January 5, 2017 Charlton further stated: “We need NOW in 2017 and beyond to get rid of the quacks that do us so much harm. They need to be treated personally and professionally as utterly unacceptable creatures to be shunned and opposed at every turn. Time to get going on cleaning out the trash. And that includes all signs, websites, literature, handouts and speech of staff and chiropractors.”

…Charlton has testified against subluxation based chiropractors in regulatory board actions and appears to revel in it.

In his most recent pronouncement Charlton states that he is okay with subluxation as a “regional spine shape distortion” and asserts that this is a CBP subluxation. This contention is common with subluxation deniers who are willing to accept an orthopedic definition of subluxation absent the neurological component.

…Charlton states he uses the following techniques on his website:

  • Applied Kinesiology
  • Diversified
  • Motion Palpation
  • Sacro-Occipital Technique
  • Activator
  • Logan Basic

When this self-declared scientist was confronted with his use of Applied Kinesiology and these other techniques his response was essentially that he is engaging in a “bait and switch” and that he just has those on his website to get patients who are looking for those things. Charlton lists 21 “research papers” on his curriculum vitae though they are all simply commentaries or reviews not original clinical research. The majority of these opinion pieces are attacks on subluxation and the chiropractors who focus on it.

END OF QUOTE

What does this tell us?

  • It seems to me that the ‘anti-subluxation’ movement with in the chiropractic profession is by no means winning the battle against the ‘hard-core subluxationists’.
  • Chiropractors cannot resist the temptation to use ad hominem attacks instead of factual arguments. I suppose this is because the latter are in short supply.
  • The ‘anti-subluxationists’ present themselves as the evidence-based side of the chiropractic spectrum. This impression might well be erroneous. Giving up the myth of subluxation obviously does not necessarily mean abandoning other forms of quackery.

The ACUPUNCTURE NOW FOUNDATION (ANF) has featured on this blog before. Today I want to re-introduce them because I just came across one of their articles which I found remarkable. In it, they define what many of us have often wondered about: the most important myth about acupuncture.

Is it acupuncture’s current popularity, its long history, its mode of action, its efficacy, its safety?

No, here is the answer directly from the ANF:

The most important myth that needs to be put to rest is the idea promoted by a small group of vocal critics that acupuncture is nothing more than a placebo. Many cite the fact that studies showing acupuncture to be highly effective were of low quality and that several higher quality studies show that, while acupuncture was clinically effective, it usually does not outperform “sham” acupuncture. But those studies are dominated by the first quality issue cited above; studies with higher methodological rigor where the “real” acupuncture was so poorly done as to not be a legitimate comparison. Yet despite the tendency toward poor quality acupuncture in studies with higher methodological standards, a benchmark study was done that showed “real” acupuncture clearly outperforming “sham” acupuncture in four different chronic pain conditions.3 When you add this study together with the fact veterinary acupuncture is used successfully in many different animals, the idea of acupuncture only being placebo must now be considered finally disproven. This is further supported by studies which show that the underlying physiological pathways activated by acupuncture sometimes overlap, but can be clearly differentiated from, those activated by placebo responses.

Disappointed?

Yes, I was too.

The myth, according to the ANF, essentially is that sceptics do not understand the scientific evidence. And these blinkered sceptics even go as far as ignoring the findings from what the ANF consider to be a ‘benchmark study’! Ghosh, that’s nasty of them!!!

But, no – the benchmark study (actually, it was not a ‘study’ but a meta-analysis of studies) has been discussed fully on this blog (and in many other places too). Here is what I wrote in 2012 when it was first published:

An international team of acupuncture trialists published a meta-analysed of individual patient data to determine the analgesic effect of acupuncture compared to sham or non-acupuncture control for the following 4 chronic pain conditions: back and neck pain, osteoarthritis, headache, and shoulder pain. Data from 29 RCTs, with an impressive total of 17 922 patients, were included.

The results of this new evaluation suggest that acupuncture is superior to both sham and no-acupuncture controls for each of these conditions. Patients receiving acupuncture had less pain, with scores that were 0.23 (95% CI, 0.13-0.33), 0.16 (95% CI, 0.07-0.25), and 0.15 (95% CI, 0.07-0.24) SDs lower than those of sham controls for back and neck pain, osteoarthritis, and chronic headache, respectively; the effect sizes in comparison to no-acupuncture controls were 0.55 (95% CI, 0.51-0.58), 0.57 (95% CI, 0.50-0.64), and 0.42 (95% CI, 0.37-0.46) SDs.

Based on these findings, the authors reached the conclusion that “acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture”.

… even the enthusiastic authors of this article admit that, when compared to sham, the effect size of real acupuncture is too small to be clinically relevant. Therefore one might argue that this meta-analysis confirms what critics have suggested all along: acupuncture is not a useful treatment for clinical routine.

Unsurprisingly, the authors of the meta-analysis do their very best to play down this aspect. They reason that, for clinical routine, the comparison between acupuncture and non-acupuncture controls is more relevant than the one between acupuncture and sham. But this comparison, of course, includes placebo- and other non-specific effects masquerading as effects of acupuncture – and with this little trick (which, by the way is very popular in alternative medicine), we can, of course, show that even sugar pills are effective.

I do not doubt that context effects are important in patient care; yet I do doubt that we need a placebo treatment for generating such benefit in our patients. If we administer treatments which are effective beyond placebo with kindness, time, compassion and empathy, our patients will benefit from both specific and non-specific effects. In other words, purely generating non-specific effects with acupuncture is far from optimal and certainly not in the interest of our patients. In my view, it cannot be regarded as not good medicine, and the authors’ conclusion referring to a “reasonable referral option” is more than a little surprising in my view.

Acupuncture-fans might argue that, at the very minimum, the new meta-analysis does demonstrate acupuncture to be statistically significantly better than a placebo. Yet I am not convinced that this notion holds water: the small residual effect-size in the comparison of acupuncture with sham might not be the result of a specific effect of acupuncture; it could be (and most likely is) due to residual bias in the analysed studies.

The meta-analysis is strongly driven by the large German trials which, for good reasons, were heavily and frequently criticised when first published. One of the most important potential drawbacks was that many participating patients were almost certainly de-blinded through the significant media coverage of the study while it was being conducted. Moreover, in none of these trials was the therapist blinded (the often-voiced notion that therapist-blinding is impossible is demonstrably false). Thus it is likely that patient-unblinding and the absence of therapist-blinding importantly influenced the clinical outcome of these trials thus generating false positive findings. As the German studies constitute by far the largest volume of patients in the meta-analysis, any of their flaws would strongly impact on the overall result of the meta-analysis.

So, has this new meta-analysis finally solved the decades-old question about the effectiveness of acupuncture? It might not have solved it, but we have certainly moved closer to a solution, particularly if we employ our faculties of critical thinking. In my view, this meta-analysis is the most compelling evidence yet to demonstrate the ineffectiveness of acupuncture for chronic pain.

END OF QUOTE

The ANF-text then goes from bad to worse. First they cite the evidence from veterinary acupuncture as further proof of the efficacy of their therapy. Well, the only systematic review in this are is, I think, by my team; and it concluded that there is no compelling evidence to recommend or reject acupuncture for any condition in domestic animals. Some encouraging data do exist that warrant further investigation in independent rigorous trials.

Lastly, the ANF mentions acupuncture’s mode of action which they seem to understand clearly and fully. Congratulations ANF! In this case, you are much better than the many experts in basic science or neurology who almost unanimously view these ‘explanations’ of how acupuncture might work as highly adventurous hypotheses or speculations.

So, what IS the most important myth about acupuncture? I am not sure and – unlike the ANF – I do not feel that I can speak for the rest of the world, but one of the biggest myths FOR ME is how acupuncture fans constantly manage to mislead the public.

Can intercessory prayer improve the symptoms of sick people?

Why should it? It’s utterly implausible!

Because the clinical evidence says so?

No, the current Cochrane review concluded that [the] findings are equivocal and, although some of the results of individual studies suggest a positive effect of intercessory prayer, the majority do not and the evidence does not support a recommendation either in favour or against the use of intercessory prayer. We are not convinced that further trials of this intervention should be undertaken and would prefer to see any resources available for such a trial used to investigate other questions in health care.

Yet, not all seem to agree with this; and some even continue to investigate prayer as a medical therpy.

For this new study (published in EBCAM), the Iranian investigators randomly assigned 92 patients in 2 groups to receive either 40 mg of propranolol twice a day for 2 month (group “A”) or 40 mg of propranolol twice a day for 2 months with prayer (group “B”). At the beginning of study and 3 months after intervention, patients’ pain was measured using the visual analogue scale.

All patients who participate in present study were Muslim. At the beginning of study and before intervention, the mean score of pain in patients in groups A and B were 5.7 ± 1.6 and 6.5 ± 1.9, respectively. According to results of independent t test, mean score of pain intensity at the beginning of study were similar between patients in 2 groups (P > .05). Three month after intervention, mean score of pain intensity decreased in patients in both groups. At this time, the mean scores of pain intensity were 5.4 ± 1.1 and 4.2 ± 2.3 in patients in groups A and B, respectively. This difference between groups was statistically significant (P < .001).

figure

The above figure shows the pain score in patients before and after the intervention.

The authors concluded that the present study revealed that prayer can be used as a nonpharmacologic pain coping strategy in addition to pharmacologic intervention for this group of patients.

Extraordinary claims require extraordinary proof. This study is, in fact, extraordinary – but only in the sense of being extraordinarily poor, or at least it is extraordinary in its quality of reporting. For instance, all we learn in the full text article about the two treatments applied to the patient groups is this: “The prayer group participated in an 8-week, weekly, intercessory prayer program with each session lasting 45 minutes. Pain reduction was measured at baseline and after 3 months, by registered nurses who were specialist in pain management and did not know which patients were in which groups (control or intervention), using a visual analogue scale.”

Intercessory prayer is the act of praying on behalf of others. This mans that the patients receiving prayer might have been unaware of being ‘treated’. In this case, the patients could have been adequately blinded. But this is not made clear in the article.

More importantly perhaps, the authors fail to provide any numeric results. All that we are given is the above figure. It is not possible therefore to run any type of check on the data. We are simply asked to believe what the authors have written. I for one have great difficulties in doing so. All I do believe in relation to this article is that

  • the journal EBCAM is utter trash,
  • constantly publishing rubbish is unethical and a disservice to everyone,
  • prayer does not need further research of this nature,
  • and poor studies often generate false-positive findings.
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