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

case-control study

A recent blog-post pointed out that the usefulness of yoga in primary care is doubtful. Now we have new data to shed some light on this issue.

The new paper reports a ‘prospective, longitudinal, quasi-experimental study‘. Yoga group (n= 49) underwent 24-weeks program of one-hour yoga sessions. The control group had no yoga.

Participation was voluntary and the enrolment strategy was based on invitations by health professionals and advertising in the community (e.g., local newspaper, health unit website and posters). Users willing to participate were invited to complete a registration form to verify eligibility criteria.

The endpoints of the study were:

  • quality of life,
  • psychological distress,
  • satisfaction level,
  • adherence rate.

The yoga routine consisted of breathing exercises, progressive articular and myofascial warming-up, followed by surya namascar (sun salutation sequence; adapted to the physical condition of each participant), alignment exercises, and postural awareness. Practice also included soft twists of the spine, reversed and balance postures, as well as concentration exercises. During the sessions, the instructor discussed some ethical guidelines of yoga, as for example, non-violence (ahimsa) and truthfulness (satya), to allow the participant to have a safer and integrated practice. In addition, the participants were encouraged to develop their awareness of the present moment and their body sensations, through a continuous process of self-consciousness, keeping a distance between body sensations and the emotional experience. The instructor emphasized the connection between breathing and movement. Each session ended with a guided deep relaxation (yoga nidra; 5–10 min), followed by a meditation practice (5–10 min).

The results of the study showed that the patients in the yoga group experienced a significant improvement in all domains of quality of life and a reduction of psychological distress. Linear regression analysis showed that yoga significantly improved psychological quality of life.

The authors concluded that yoga in primary care is feasible, safe and has a satisfactory adherence, as well as a positive effect on psychological quality of life of participants.

Are the authors’ conclusions correct?

I think not!

Here are some reasons for my judgement:

  • The study was far to small to justify far-reaching conclusions about the safety and effectiveness of yoga.
  • There were relatively high numbers of drop-outs, as seen in the graph above. Despite this fact, no intention to treat analysis was used.
  • There was no randomisation, and therefore the two groups were probably not comparable.
  • Participants of the experimental group chose to have yoga; their expectations thus influenced the outcomes.
  • There was no attempt to control for placebo effects.
  • The conclusion that yoga is safe would require a sample size that is several dimensions larger than 49.

In conclusion, this study fails to show that yoga has any value in primary care.

PS

Oh, I almost forgot: and yoga is also satanic, of course (just like reading Harry Potter!).

 

The objective of this ‘real world’ study was to evaluate the effectiveness of integrative medicine (IM) on patients with coronary artery disease (CAD) and investigate the prognostic factors of CAD in a real-world setting.

A total of 1,087 hospitalized patients with CAD from 4 hospitals in Beijing, China were consecutively selected between August 2011 and February 2012. The patients were assigned to two groups:

  1. Chinese medicine (CM) plus conventional treatment, i.e., IM therapy (IM group). IM therapy meant that the patients accepted the conventional treatment of Western medicine and the treatment of Chinese herbal medicine including herbal-based injection and Chinese patent medicine as well as decoction for at least 7 days in the hospital or 3 months out of the hospital.
  2. Conventional treatment alone (CT group).

The endpoint was a major cardiac event [MCE; including cardiac death, myocardial infarction (MI), and the need for revascularization].

A total of 1,040 patients finished the 2-year follow-up. Of them, 49.4% received IM therapy. During the 2-year follow-up, the total incidence of MCE was 11.3%. Most of the events involved revascularization (9.3%). Cardiac death/MI occurred in 3.0% of cases. For revascularization, logistic stepwise regression analysis revealed that age ⩾ 65 years [odds ratio (OR), 2.224], MI (OR, 2.561), diabetes mellitus (OR, 1.650), multi-vessel lesions (OR, 2.554), baseline high sensitivity C-reactive protein level ⩾ 3 mg/L (OR, 1.678), and moderate or severe anxiety/depression (OR, 1.849) were negative predictors (P<0.05); while anti-platelet agents (OR, 0.422), β-blockers (OR, 0.626), statins (OR, 0.318), and IM therapy (OR, 0.583) were protective predictors (P<0.05). For cardiac death/MI, age ⩾ 65 years (OR, 6.389) and heart failure (OR, 7.969) were negative predictors (P<0.05), while statin use (OR, 0.323) was a protective predictor (P<0.05) and IM therapy showed a beneficial tendency (OR, 0.587), although the difference was not statistically significant (P=0.218).

The authors concluded that in a real-world setting, for patients with CAD, IM therapy was associated with a decreased incidence of revascularization and showed a potential benefit in reducing the incidence of cardiac death or MI.

What the authors call ‘real world setting’ seems to be a synonym of ‘lousy science’, I fear. I am not aware of good evidence to show that herbal injections and concoctions are effective treatments for CAD, and this study can unfortunately not change this. In the methods section of the paper, we read that the treatment decisions were made by the responsible physicians without restriction. That means the two groups were far from comparable. In their discussion section, the authors state; we found that IM therapy was efficacious in clinical practice. I think that this statement is incorrect. All they have shown is that two groups of patients with similar diagnoses can differ in numerous ways, including clinical outcomes.

The lessons here are simple:

  1. In clinical trials, lack of randomisation (the only method to create reliably comparable groups) often leads to false results.
  2. Flawed research is currently being used by many proponents of  SCAM (so-called alternative medicine) to mislead us about the value of SCAM.
  3. The integration of dubious treatments into routine care does not lead to better outcomes.
  4. Integrative medicine, as currently advocated by SCAM-proponents, is a nonsense.

Patients with rheumatoid arthritis (RA) have a higher risk of coronary heart disease (CHD). Despite good evidence for effectiveness, acupuncture is often advocated for RA, and it has not been reported to prevent CHD in patients with RA.

The authors of this analysis aimed to assess the risk of developing CHD in acupuncture-users and non-users of patients with RA. They identified 29,741 patients with newly diagnosed RA from January 1997 to December 2010 from the Registry of Catastrophic Illness Patients Database from the Taiwanese National Health Insurance Research Database. Among them, 10,199 patients received acupuncture (acupuncture users), and 19,542 patients did not receive acupuncture (no-acupuncture users). After performing 1:1 propensity score matching by sex, age, baseline comorbidity, conventional treatment, initial diagnostic year, and index year, there were 9932 patients in both the acupuncture and no-acupuncture cohorts. The main outcome was the diagnosis of CHD in patients with RA in the acupuncture and no-acupuncture cohorts.

Acupuncture users had a lower incidence of CHD than non-users (adjusted HR = 0.60, 95% CI = 0.55-0.65). The estimated cumulative incidence of CHD was significantly lower in the acupuncture cohort (log-rank test, p < .001). Subgroup analysis showed that patients receiving manual acupuncture of traditional Chinese medicine style, electroacupuncture, or combination of both all had a lower incidence of CHD than patients never receiving acupuncture treatment. The beneficial effect of acupuncture on preventing CHD was independent of age, sex, diabetes mellitus, hypertension, hyperlipidemia, and statins use.

The authors concluded that this is the first large-scale study to reveal that acupuncture might have beneficial effect on reducing the risk of CHD in patients with RA. This study may provide useful information for clinical utilization and future studies.

Pigs might fly, but – call me a sceptic – I somehow doubt it almost as much as I doubt that acupuncture might have beneficial effect on reducing the risk of CHD.

Why?

Because of two reasons mainly:

  1. For the life of me, I cannot see a mechanism by which acupuncture achieves this extraordinary feast (the authors allege an anti-inflammatory effect of acupuncture which I find wholly unconvincing).
  2. There is a much simpler explanation for the observed outcomes.

The propensity score used here did, of course, only match the groups for a hand-full of factors. Yet there are many more that could play a part which the authors could not consider because they did not have the data to do so. The one that foremost comes to my mind is a generally healthier life-style of the patients using acupuncture. I think it stands to reason that people who bother to have and pay for an additional treatment are higher motivated to adhere to a life-style (e. g. smoking-cessation, exercise, nutrition, stress) that reduces the CHD-risk. And the influence of this factor could be very significant indeed. As the devil’s advocate, I could therefore even postulate that acupuncture itself had a slightly detrimental effect which, however, was over-ridden by the massive effect of the healthier life-style.

And the lesson to learn from all this?

Before we conclude about ‘beneficial effects’ of acupuncture or any other therapy, we need RCTs that effectively eliminate these rather obvious confounders.

 

The notion that ‘chiropractic adds years to your life’ is often touted, particularly of course by chiropractors (in case you doubt it, please do a quick google search). It is logical to assume that chiropractors themselves are the best informed about what they perceive as the health benefits of chiropractic care. Chiropractors would therefore be most likely to receive some level of this ‘life-prolonging’ chiropractic care on a long-term basis. If that is so, then chiropractors themselves should demonstrate longer life spans than the general population.

Sounds logical?

Perhaps, but is the theory supported by evidence?

Back in 2004, a chiropractor, Lon Morgan,  courageously tried to test the theory and published an interesting paper about it.

He used two separate data sources to examine the mortality rates of chiropractors. One source used obituary notices from past issues of Dynamic Chiropractic from 1990 to mid-2003. The second source used biographies from Who Was Who in Chiropractic – A Necrology covering a ten year period from 1969-1979. The two sources yielded a mean age at death for chiropractors of 73.4 and 74.2 years respectively. The mean ages at death of chiropractors is below the national average of 76.9 years; it also is below the average age at death of their medical doctor counterparts which, at the time, was 81.5.

So, one might be tempted to conclude that ‘chiropractic substracts years from your life’. I know, this would be not very scientific – but it would probably be more evidence-based than the marketing gimmick of so many chiropractors trying to promote their trade by saying: ‘chiropractic adds years to your life’!

In any case, Morgan, the author of the paper, concluded that this paper assumes chiropractors should, more than any other group, be able to demonstrate the health and longevity benefits of chiropractic care. The chiropractic mortality data presented in this study, while limited, do not support the notion that chiropractic care “Adds Years to Life …”, and it fact shows male chiropractors have shorter life spans than their medical doctor counterparts and even the general male population. Further study is recommended to discover what factors might contribute to lowered chiropractic longevity.

Another beautiful theory killed by an ugly fact!

Personally, I like sauna bathing. It makes me feel fine. But is it healthy? More specifically, is it good for the cardiovascular system?

Finnish researchers had already shown in a large cohort study with 20 years of follow-up that increased frequency of sauna bathing is associated with a reduced risk of sudden cardiac death (SCD), fatal coronary heart disease (CHD), fatal cardiovascular disease (CVD), and all-cause mortality. Now the same group of researchers report more encouraging news for sauna-fans.

The aim of their new study was to investigate the relationship between sauna habits and CVD mortality in men and women, and whether adding information on sauna habits to conventional cardiovascular risk factors is associated with improvement in prediction of CVD mortality risk.

Sauna bathing habits were assessed at baseline in a sample of 1688 participants (mean age 63; range 53-74 years), of whom 51.4% were women. Multivariable-adjusted hazard ratios (HRs) were calculated to investigate the relationships of frequency and duration of sauna use with CVD mortality.

A total of 181 fatal CVD events occurred during a median follow-up of 15.0 years (interquartile range, 14.1-15.9). The risk of CVD mortality decreased linearly with increasing sauna sessions per week with no threshold effect. In age- and sex-adjusted analysis, compared with participants who had one sauna bathing session per week, HRs (95% CIs) for CVD mortality were 0.71 (0.52 to 0.98) and 0.30 (0.14 to 0.64) for participants with two to three and four to seven sauna sessions per week, respectively. After adjustment for established CVD risk factors, potential confounders including physical activity, socioeconomic status, and incident coronary heart disease, the corresponding HRs (95% CIs) were 0.75 (0.52 to 1.08) and 0.23 (0.08 to 0.65), respectively. The duration of sauna use (minutes per week) was inversely associated with CVD mortality in a continuous manner. Addition of information on sauna bathing frequency to a CVD mortality risk prediction model containing established risk factors was associated with a C-index change (0.0091; P = 0.010), difference in - 2 log likelihood (P = 0.019), and categorical net reclassification improvement (4.14%; P = 0.004).

(Hazard ratios for cardiovascular mortality by quartiles of the duration of sauna bathing. a Adjusted for age and gender. b Adjusted for age, gender, body mass index, smoking, systolic blood pressure, serum low-density lipoprotein cholesterol, alcohol consumption, previous myocardial infarction, and type 2 diabetes. CI, confidence interval.)

The authors concluded that higher frequency and duration of sauna bathing are each strongly, inversely, and independently associated with fatal CVD events in middle-aged to elderly males and females. The frequency of sauna bathing improves the prediction of the long-term risk for CVD mortality.

These results are impressive. What could be the underlying mechanisms? The authors offer plenty of explanations: Dry and hot sauna baths have been shown to increase the demands of cardiovascular function. Sauna bathing causes an increase in heart rate which is a reaction to the body heat load. Heart rate may be elevated up to 120–150 beats per minute during sauna bathing, corresponding to low- to moderate-intensity physical exercise training for the circulatory system without active muscle work. Acute sauna exposure has been shown to produce blood pressure lowering effects, decrease peripheral vascular resistance and arterial stiffness, and improve arterial compliance. Short-term sauna exposure also activates the sympathetic nervous and the renin-angiotensin-aldosterone systems and the hypothalamus-pituitary-adrenal hormonal axis, and short-term increases in levels of their associated hormones have been reported. Repeated sauna exposure improves endothelial function, suggesting a beneficial role of thermal therapy on vascular function. Long-term sauna bathing habit may be beneficial in the reduction of high systemic blood pressure, which is in line with previous evidence showing that blood pressure may be lower among those who are living in warm conditions with higher ambient temperature. Regular sauna bathing is associated with a lowered risk of future hypertension. Typical hot and dry Finnish sauna increases body temperature which causes more efficient skin blood flow, leading to a higher cardiac output, whereas blood flow to internal organs decreases. Sweat is typically secreted at a rate which corresponds to an average total secretion of 0.5 kg during a sauna bathing session. Increased sweating is accompanied by a reduction in blood pressure and higher heart rate, while cardiac stroke volume is largely maintained, although a part of blood volume is diverted from the internal organs to body peripheral parts with decreasing venous return which is not facilitated by active skeletal muscle work. However, it has been proposed that muscle blood flow may increase to at least some extent in response to heat stress, although sauna therapy-induced myocardial metabolic adaptations are largely unexplored. There is also evidence that regular long-term sauna bathing (average of two sessions per week) increases left ventricular ejection fraction. Heat therapy may improve left ventricular function with decreased cardiac pre- and afterload, thereby maintaining appropriate stroke volume despite large reductions in ventricular filling pressures. Additionally, previous studies have demonstrated a positive alteration of the autonomic nervous system and reduced levels of natriuretic peptides, oxidative stress, inflammation, and norepinephrine due to regular sauna therapy.

It is possible that the results are influenced by confounding factors that the researchers were unable to account for. It is also possible that people who are already ill avoid sauna bathing and that this contributed to the findings. However, the authors did their best to explore such phenomena in sub-group analysis and found that a causal relationship between sauna and CVD risk is still very likely. As a sauna-fan, I am inclined to believe them and the sceptic in me tends to agree.

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

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

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

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

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

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

Remember when an international delegation of homeopaths travelled to Liberia to cure Ebola?

Virologists and other experts thought at the time that this was pure madness. But, from the perspective of dedicated homeopaths who have gone through ‘proper’ homeopathic ‘education’ and have the misfortune to believe all the nonsense they have been told, this is not madness. In fact, the early boom of homeopathy, about 200 years ago, was based not least on the seemingly resounding success homeopaths had during various epidemics.

I fully understand that homeopath adore this type of evidence – it is good for their ego! And therefore, they tend to dwell on it and re-hash it time and again. The most recent evidence for this is a brand-new article entitled ‘Homeopathic Prevention and Management of Epidemic Diseases’. It is such a beauty that I present you the original abstract without change:

START OF QUOTE

___________________________________________________________________________

Homeopathy has been used to treat epidemic diseases since the time of Hahnemann, who used Belladonna to treat scarlet fever. Since then, several approaches using homeopathy for epidemic diseases have been proposed, including individualization, combination remedies, genus epidemicus, and isopathy.

METHODS:

The homeopathic research literature was searched to find examples of each of these approaches and to evaluate which were effective.

RESULTS:

There is good experimental evidence for each of these approaches. While individualization is the gold standard, it is impractical to use on a widespread basis. Combination remedies can be effective but must be based on the symptoms of a given epidemic in a specific location. Treatment with genus epidemicus can also be successful if based on data from many practitioners. Finally, isopathy shows promise and might be more readily accepted by mainstream medicine due to its similarity to vaccination.

CONCLUSION:

Several different homeopathic methods can be used to treat epidemic diseases. The challenge for the future is to refine these approaches and to build on the knowledge base with additional rigorous trials. If and when conventional medicine runs out of options for treating epidemic diseases, homeopathy could be seen as an attractive alternative, but only if there is viable experimental evidence of its success.

END OF QUOTE

____________________________________________________________________________________

I don’t need to stress, I think, that such articles are highly irresponsible and frightfully dangerous: if anyone ever took the message that homeopathy has the answer to epidemic seriously, millions might die.

The reasons why epidemiological evidence of this nature is wrong has been discussed before on this blog; I therefore only need to repeat them:

In the typical epidemiological case/control study, one large group of patients [A] is retrospectively compared to another group [B]. 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.

In essence, this means that epidemiological evidence of this type can be valuable for generating hypotheses which, in turn, need testing in rigorous clinical trials. Without these tests, the evidence can be dangerously misleading.

But, of course, Jennifer Jacobs, the author of the new article, knows all this – after all, she has been employed for many years by the Department of Epidemiology, School of Public Health and Community Medicine, University of Washington, Seattle, Washington, United States!

In this case, why does she re-hash the old myth of homeopathy being the answer to epidemics?

I do not know the answer to this question, but I do know that she is a convinced homeopath with plenty of papers on the subject.

And what sort of journal would publish such dangerous, deeply unethical rubbish?

It is a journal we have discussed several before; its called HOMEOPATHY.

This journal is, I think, remarkable: not even homeopaths would deny that homeopathy is a most controversial subject. One would therefore expect that the editorial board of the leading journal of homeopathy (Impact Factor = 1.16) has a few members who are critical of homeopathy and its assumptions. Yet, I fail to spot a single such person of the board of HOMEOPATHY. Please have a look yourself and tell me, if you can identify such an individual:

Editor

Peter Fisher
FRCP, FFHom, London, UK

Senior Deputy Editor

Robert T. Mathie
BSc (Hons), PhD, London, UK

Deputy Editors

Leoni Bonamin
Paulista University, São Paulo, Brazil

Menachem Oberbaum
Shaare Zedek Medical Center, Jerusalem, Israel

Ethics Adviser

Kate Chatfield
University of Central Lancashire, Preston, UK

Editorial Advisory Board

Cees Baas
Centre for Integrative Psychiatry, Groningen, The Netherlands

Stephan Baumgartner
University of Witten-Herdecke, Germany

Iris R. Bell
University of Arizona, USA

Jayesh Bellare
Indian Institute of Technology, Mumbai, India

Philippe Belon
Centre de Recherche et de Documentation Thérapeutique, France

Brian Berman
University of Maryland, School of Medicine, USA

Martien Brands
Centre for Integrative Care, Amsterdam, The Netherlands

Michael Carlston
University of California, Santa Rosa, USA

Kusum S. Chand
Pushpanjali Crosslay Hospital, Ghaziabad, India

Martin Chaplin
London South Bank University, UK

Flávio Dantas
University of Uberlândia, Brazil

Peter Darby
Faculty of Homeopathy, UK

Jonathan Davidson
Duke University, USA

Jean-Louis Demangeat
Haguenau Hospital, France

Christian Endler
Interuniversity College Graz/Castle of Seggau, Austria

Madeleine Ennis
Queen’s University Belfast, UK

Edoardo Felisi
Milan, Italy

Peter Gregory
Veterinary Dean, Faculty of Homeopathy, UK

German Guajardo-Bernal
University of Baja California, Mexico

Carla Holandino Quaresma
Universidade Federal do Rio de Janeiro, Brazil

Jennifer Jacobs
University of Washington, USA

Wayne Jonas
Samueli Institute, Alexandria, USA

Lee Kayne
Faculty of Homeopathy, UK

Steven Kayne
Glasgow Homoeopathic Hospital, UK

David Lilley
Pretoria, South Africa

Klaus Linde
Technical University, Munich, Germany

Russell Malcolm
Faculty of Homeopathy, UK

Raj K. Manchanda
Central Council for Research in Homoeopathy, New Delhi, India

David Peters
University of Westminster, London, UK

Bernard Poitevin
Association Française pour la Recherche en Homéopathie, France

David Reilly
Glasgow Homoeopathic Hospital, UK

David Riley
Integrative Medicine Institute, Portland, USA

ALB Rutten
Breda, The Netherlands

Jürgen Schulte
University of Technology, Sydney, Australia

Trevor Thompson
University of Bristol, UK

André Thurneysen
Centre de médecines intégrées, Switzerland

Alexander Tournier
Homeopathy Research Institute, UK

Francis Treuherz
London, UK

Robbert van Haselen
International Institute for Integrated Medicine, Kingston, UK

Michel Van Wassenhoven
Unio Homeopathica Belgica, Belgium

Harald Walach
University of Witten-Herdecke, Germany

Fred Wiegant
University of Utrecht, The Netherlands

___________________________________________________________________________

I rest my case.

 

Have you ever wondered whether doctors who practice homeopathy are different from those who don’t.

Silly question, of course they are! But how do they differ?

Having practised homeopathy myself during my very early days as a physician, I have often thought about this issue. My personal (and not very flattering) impressions were noted in my memoir where I describe my experience working in a German homeopathic hospital:

some of my colleagues used homeopathy and other alternative approaches because they could not quite cope with the often exceedingly high demands of conventional medicine. It is almost understandable that, if a physician was having trouble comprehending the multifactorial causes and mechanisms of disease and illness, or for one reason or another could not master the equally complex process of reaching a diagnosis or finding an effective therapy, it might be tempting instead to employ notions such as dowsing, homeopathy or acupuncture, whose theoretical basis, unsullied by the inconvenient absolutes of science, was immeasurably more easy to grasp. 

Some of my colleagues in the homeopathic hospital were clearly not cut out to be “real” doctors. Even a very junior doctor like me could not help noticing this somewhat embarrassing fact… 

But this is anecdote and not evidence!

So, where is the evidence?

It was published last week and made headlines in many UK daily papers.

Our study was aimed at finding out whether English GP practices that prescribe any homeopathic preparations might differ in their prescribing of other drugs. We identified practices that made any homeopathy prescriptions over six months of data. We measured associations with four prescribing and two practice quality indicators using multivariable logistic regression.

Only 8.5% of practices (644) prescribed homeopathy between December 2016 and May 2017. Practices in the worst-scoring quartile for a composite measure of prescribing quality were 2.1 times more likely to prescribe homeopathy than those in the best category. Aggregate savings from the subset of these measures where a cost saving could be calculated were also strongly associated. Of practices spending the most on medicines identified as ‘low value’ by NHS England, 12.8% prescribed homeopathy, compared to 3.9% for lowest spenders. Of practices in the worst category for aggregated price-per-unit cost savings, 12.7% prescribed homeopathy, compared to 3.5% in the best category. Practice quality outcomes framework scores and patient recommendation rates were not associated with prescribing homeopathy.

We concluded that even infrequent homeopathy prescribing is strongly associated with poor performance on a range of prescribing quality measures, but not with overall patient recommendation or quality outcomes framework score. The association is unlikely to be a direct causal relationship, but may reflect underlying practice features, such as the extent of respect for evidence-based practice, or poorer stewardship of the prescribing budget.

Since our study was reported in almost all of the UK newspapers, it comes as no surprise that, in the interest of ‘journalistic balance’, homeopaths were invited to give their ‘expert’ opinions on our work.

Margaret Wyllie, head of the British Homeopathic Association, was quoted commenting: “This is another example of how real patient experience and health outcomes are so often discounted, when in actuality they should be the primary driver for research to improve our NHS services. This study provides no useful evidence about homeopathy, or about prescribing, and gives absolutely no data that can improve the health of people in the UK.”

The Faculty of Homeopathy was equally unhappy about our study and stated: “The study did not include any measures of patient outcomes, so it doesn’t tell us how the use of homeopathy in English general practice correlates with patients doing well or badly, nor with how many drugs they use.”

Cristal Summer from the Society of Homeopathy said that our research was just a rubbish bit of a study.

Peter Fisher, the Queen’s homeopath and the president of the Faculty of Homeopathy, stated: “We don’t know if these measures correlate with what matters to patients – whether they get better and have side-effects.”

A study aimed at determining whether GP practices that prescribe homeopathic preparations differ in their prescribing habits from those that do not prescribe homeopathics can hardly address these questions, Peter. A test of washing machines can hardly tell us much about the punctuality of trains. And an investigation into the risks of bungee jumping will not inform us about the benefits of regular exercise. Call me biased, but to me these comments indicate mainly one thing: HOMEOPATHS SEEM TO HAVE GREAT DIFFICULTIES UNDERSTANDING SCIENTIFIC PAPERS.

I much prefer the witty remarks of Catherine Bennett in yesterday’s Observer: Homeopath-GPs, naturally, have mustered in response and challenge Goldacre’s findings, with a concern for methodology that could easily give the impression that there is some evidential basis for their parallel system, beyond the fact that the Prince of Wales likes it. In fairness to Charles, his upbringing is to blame. But what is the doctors’ excuse?

Amongst all the implausible treatments to be found under the umbrella of ‘alternative medicine’, Reiki might be one of the worst, i. e. least plausible and outright bizarre (see for instance here, here and here). But this has never stopped enthusiasts from playing scientists and conducting some more pseudo-science.

This new study examined the immediate symptom relief from a single reiki or massage session in a hospitalized population at a rural academic medical centre. It was designed as a retrospective analysis of prospectively collected data on demographic, clinical, process, and quality of life for hospitalized patients receiving massage therapy or reiki. Hospitalized patients requesting or referred to the healing arts team received either a massage or reiki session and completed pre- and post-therapy symptom questionnaires. Differences between pre- and post-sessions in pain, nausea, fatigue, anxiety, depression, and overall well-being were recorded using an 11-point Likert scale.

Patients reported symptom relief with both reiki and massage therapy. Reiki improved fatigue and anxiety  more than massage. Pain, nausea, depression, and well being changes were not different between reiki and massage encounters. Immediate symptom relief was similar for cancer and non-cancer patients for both reiki and massage therapy and did not vary based on age, gender, length of session, and baseline symptoms.

The authors concluded that reiki and massage clinically provide similar improvements in pain, nausea, fatigue, anxiety, depression, and overall well-being while reiki improved fatigue and anxiety more than massage therapy in a heterogeneous hospitalized patient population. Controlled trials should be considered to validate the data.

Don’t I just adore this little addendum to the conclusions, “controlled trials should be considered to validate the data” ?

The thing is, there is nothing to validate here!

The outcomes are not due to the specific effects of Reiki or massage; they are almost certainly caused by:

  • the extra attention,
  • the expectation of patients,
  • the verbal or non-verbal suggestions of the therapists,
  • the regression towards the mean,
  • the natural history of the condition,
  • the concomitant therapies administered in parallel,
  • the placebo effect,
  • social desirability.

Such pseudo-research only can only serve one purpose: to mislead (some of) us into thinking that treatments such as Reiki might work.

What journal would be so utterly devoid of critical analysis to publish such unethical nonsense?

Ahh … it’s our old friend the Journal of Alternative and Complementary Medicine

Say no more!

Do chiropractors even know the difference between promotion and research?

Probably a rhetorical question.

Personally, I have seen them doing so much pseudo-research that I doubt they recognise the real thing, even if they fell over it.

Here is a recent example that stands for many, many more such ‘research’ projects (some of which have been discussed on this blog).

But first a few sentences on the background of this new ‘study’.

The UD chiropractic profession is currently on the ‘opioid over-use bandwagon’ hoping that this move might promote their trade. Most chiropractors have always been against using (any type of) pharmaceutical treatment and advise their patients accordingly. D D Palmer, the founder of chiropractic, was adamant that drugs are to be avoided; he stated for instance that Drugs are delusive; they do not adjust anything. And “as the Founder intended, chiropractic has existed as a drug-free healthcare profession for better than 120 years.” To this day, chiropractors are educated and trained to argue against non-drug treatments and regularly claim that chiropractic is a drug-free alternative to traditional medicine.

Considering this background, this new piece of (pseudo) research is baffling, in my view.

The objective of this investigation was to evaluate the association between utilization of chiropractic services and the use of prescription opioid medications. The authors used a retrospective cohort design to analyse health insurance claims data. The data source was the all payer claims database administered by the State of New Hampshire. The authors chose New Hampshire because health claims data were readily available for research, and in 2015, New Hampshire had the second-highest age-adjusted rate of drug overdose deaths in the United States.

The study population comprised New Hampshire residents aged 18-99 years, enrolled in a health plan, and with at least two clinical office visits within 90 days for a primary diagnosis of low-back pain. The authors excluded subjects with a diagnosis of cancer. They measured likelihood of opioid prescription fill among recipients of services delivered by chiropractors compared with a control group of patients not consulting a chiropractor. They also compared the cohorts with regard to rates of prescription fills for opioids and associated charges.

The adjusted likelihood of filling a prescription for an opioid analgesic was 55% lower among chiropractic compared to non-chiropractic patients. Average charges per person for opioid prescriptions were also significantly lower among the former group.

The authors concluded that among New Hampshire adults with office visits for noncancer low-back pain, the likelihood of filling a prescription for an opioid analgesic was significantly lower for recipients of services delivered by doctors of chiropractic compared with nonrecipients. The underlying cause of this correlation remains unknown, indicating the need for further investigation.

The underlying cause remains unknown???

Really?

Let me speculate, or even better, let me extrapolate by drawing an analogy:

Employees by a large Hamburger chain set out to study the association between utilization of Hamburger restaurant services and vegetarianism. The authors used a retrospective cohort design. The study population comprised New Hampshire residents aged 18-99 years, who had entered the premises of a Hamburger restaurant within 90 days for a primary purpose of eating. The authors excluded subjects with a diagnosis of cancer. They measured the likelihood of  vegetarianism among recipients of services delivered by Hamburger restaurants compared with a control group of individuals not using meat-dispensing facilities. They also compared the cohorts with regard to the money spent in Hamburger restaurants.

The adjusted likelihood of being a vegetarian was 55% lower among the experimental group compared to controls. The average money spent per person in Hamburger restaurants were also significantly lower among the Hamburger group.

The authors concluded that among New Hampshire adults visiting Hamburger restaurants, the likelihood of vegetarianism was significantly lower for consumers frequenting Hamburger restaurants compared with those who failed to frequent such places. The underlying cause of this correlation remains unknown, indicating the need for further investigation.

Daaaahhhhhhh!

 

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