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

Monthly Archives: December 2018

For some researchers, the question whether homeopathy works beyond a placebo effect is not as relevant as the question whether it works as well as an established treatment. To answer it, they must conduct RCTs comparing homeopathy with a therapy that has been shown beyond reasonable doubt to be effective, i.e better than placebo. Such a drug is, for instance, Ibuprofen.

The purpose of this study was to compare the efficacy of Ibuprofen and homeopathic Belladonna for orthodontic pain. 51 females and 21 males, were included in this study. Cases with non-extraction treatment plan having proper contacts’ mesial and distal to permanent first molar and currently not taking any analgesics or antibiotics were included in the study. They were randomly divided into two groups; one group was assigned to ibuprofen 400 mg and second group took Belladonna 6C (that’s a dilution of 1: 1000000000000). Patients were given two doses of medication of their respective remedies one hour before placement of elastomeric separators (Ormco Separators, Ormco Corporation, CA, USA) and one dose 6 h after the placement. Pain scores were recorded on a visual analogue scale (VAS) 2 h after placement, 6 h after placement, bedtime, day 1 morning, day 2 morning, day 3 morning and day 5 morning.

The comparisons showed that there were no differences between the two groups at any time point.

(Mean visual analogue scale pain score at different time intervals after separator placement in Ibuprofen and Belladonna group)

The authors concluded that Ibuprofen and Belladonna 6C are effective and provide adequate analgesia with no statistically significant difference. Lack of adverse effects with Belladonna 6C makes it an effective and viable alternative.

FINALLY, THE PROOF HOMEOPATHS HAVE BEEN WAITING FOR: HOMEOPATHY DOES WORK AFTER ALL!

Not so fast – before we draw any conclusions, let’s have a closer look at this study. Here are a few of its limitations (apart from the fact that it was published in a journal that does not exactly belong to the ‘crème de la crème’ of medical publications):

  • Patients obviously knew which group they were assigned to; thus their expectations would have influenced the outcome.
  • The same applies to the researchers (the study could have been ‘blind’ using a ‘double dummy’ method, but the researchers did not use it).
  • The study was an equivalence trial (it did not test whether homeopathy is superior to placebo, but whether its effects are equivalent to Ibuprofen); such studies need sample sizes that are about one dimension larger than was the case here.

Therefore, all this trial does demonstrate that the sample was too small for an existing group difference in favour of Ibuprofen to show.

So sorry, my homeopathic friends!

Acupressure is the stimulation of acu-points by using pressure instead of needles, as in acupuncture. The evidence for or against acupressure mirrors that of acupuncture, except there is far less of it. This is why this new trial might be important.

The aim of this RCT was to determine the effect of self-acupressure on fasting blood sugar (FBS) and insulin level in type 2 diabetes patients. A total of 60 diabetic patients were selected from diabetes clinic in Rafsanjan in Iran, and  assigned to 2 groups, 30 in the acupressure and 30 in the control-group. The intervention group received acupressure at ST-36, LIV-3, KD-3 and SP-6 points bilaterally for 5 minutes at each point in 10 seconds pressure and 2 seconds rest periods. Subjects in the control group received no intervention. The FBS and insulin levels were measured before and after the intervention for both groups.

There were no significant differences between the acupressure and control group regarding age, sex and level of education. The insulin level significantly increased after treatment in the acupressure group (p=0.001). There were no significant differences between the levels of insulin in study or control groups. Serum FBS level decreased significantly after intervention in the acupressure group compared to the control group (p=0.02).

The authors concluded that self-acupressure as a complementary alternative medicine can be a helpful complementary method in reducing FBS and increasing insulin levels in type 2 diabetic patients.

I do not want to go into the methodological details of this study; suffice to say that it was less than rigorous and that its findings are therefore not trustworthy (never mind the fact that the results are biologically implausible). Even if that had not been the case, a single study would certainly not be sufficient reason to reach the conclusion that acupressure is helpful to control diabetes. For that, I am sure, we would need at least half a dozen independent replications.

Like most people, I have several non-medical friends who suffer from diabetes. They would love nothing better than having a simple, safe and effective method applying pressure to their skin in order to manage their disease. If they read this paper, some of them might conclude that acupressure is the answer to their problems and use it to control their condition. One does not need all that much imagination to see that this could seriously harm them, or even cost several lives.

Acupressure might be virtually free of risks, but with a bit of ill advice, even seemingly harmless treatments can kill.

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.

Ginkgo biloba is a well-researched herbal medicine which has shown promise for a number of indications. But does this include coronary heart disease?

The aim of this systematic review was to provide information about the effectiveness and safety of Ginkgo Leaf Extract and Dipyridamole Injection (GD) as one adjuvant therapy for treating angina pectoris (AP) and to evaluate the relevant randomized controlled trials (RCTs) with meta-analysis. (Ginkgo Leaf Extract and Dipyridamole Injection is a Chinese compound preparation, which consists of ginkgo flavone glycosides (24%), terpene lactones (ginkgolide about 13%, ginkgolide about 2.9%) and dipyridamole.)

RCTs concerning AP treated by GD were searched and the Cochrane Risk Assessment Tool was adopted to assess the methodological quality of the RCTs. A total of 41 RCTs involving 4,462 patients were included in the meta-analysis. The results indicated that the combined use of GD and Western medicine (WM) against AP was associated with a higher total effective rate [risk ratio (RR)=1.25, 95% confidence interval (CI): 1.21–1.29, P<0.01], total effective rate of electrocardiogram (RR=1.29, 95% CI: 1.21–1.36, P<0.01). Additional, GD combined with WM could decrease the level of plasma viscosity [mean difference (MD)=–0.56, 95% CI:–0,81 to–0.30, P<0.01], fibrinogen [MD=–1.02, 95% CI:–1.50 to–0.54, P<0.01], whole blood low shear viscosity [MD=–2.27, 95% CI:–3.04 to–1.49, P<0.01], and whole blood high shear viscosity (MD=–0.90, 95% CI: 1.37 to–0.44, P<0.01).

The authors concluded that comparing with receiving WM only, the combine use of GD and WM was associated with a better curative effect for patients with AP. Nevertheless, limited by the methodological quality of included RCTs more large-sample, multi-center RCTs were needed to confirm our findings and provide further evidence for the clinical utility of GD.

If one reads this conclusion, one might be tempted to use GD to cure AP. I would, however, strongly warn everyone from doing so. There are many reasons for my caution:

  • All the 41 RCTs originate from China, and we have repeatedly discussed that Chinese TCM trials are highly unreliable.
  • The methodological quality of the primary RCTs was, according to the review authors ‘moderate’. This is not true; it was, in fact, lousy.
  • Dipyridamole is not indicated in angina pectoris.
  • To the best of my knowledge, there is no good evidence from outside China to suggest that Ginkgo biloba is effective for angina pectoris.
  • Angina pectoris is caused by coronary artery disease (a narrowing of one or more coronary arteries due to atherosclerosis), and it seems implausible that this condition can be ‘cured’ with any medication.

So, what we have here is yet another nonsensical paper, published in a dubious journal, employing evidently irresponsible reviewers, run by evidently irresponsible editors, hosted by a seemingly reputable publisher (Springer). This is reminiscent of my previous post (and many posts before). Alarmingly, it is also what I encounter on a daily basis when scanning the new publications in my field.

The effects of this incessant stream of nonsense can only have one of two effects:

  1. People take this ‘evidence’ seriously. In this case, many patients might pay with their lives for this collective incompetence.
  2. People conclude that alt med research cannot be taken seriously. In this case, we are unlikely to ever see anything useful emerging from it.

Either way, the result will be profoundly negative!

It is high time to stop this idiocy; but how?

I wish, I knew the answer.

Shiatsu has been mentioned here before (see for instance here, here and here). It is one of those alternative therapies for which a plethora of therapeutic claims are being made in the almost total absence of reliable evidence. This is why I am delighted each time a new study emerges.

This proof of concept study explored the feasibility of ‘hand self-shiatsu’ as an intervention to promote sleep onset and continuity for young adults with SRC. It employed a prospective case-series design, where participants, athletes who have suffered from concussion, act as their own controls. Baseline and follow-up data included standardized self-reported assessment tools and sleep actigraphy. Seven athletes, aged between 18 and 25 years, participated. Although statistically significant improvement in actigraphy sleep scores between baseline and follow-up was not achieved, metrics for sleep quality and daytime fatigue showed significant improvement.

The authors concluded from these data that these findings support the hypothesis that ‘hand self-shiatsu has the potential to improve sleep and reduce daytime fatigue in young postconcussion athletes. This pilot study provides guidance to refine research protocols and lays a foundation for further, large-sample, controlled studies.

How very disappointing! If this was truly meant to be a pilot study, it should not mention findings of clinical improvement at all. I suspect that the authors labelled it ‘a pilot study’ only when they realised that it was wholly inadequate. I also suspect that the study did not yield the result they had hoped for (a significant improvement in actigraphy sleep scores), and thus they included the metrics for sleep quality and daytime fatigue in the abstract.

In any case, even a pilot study of just 7 patients is hardly worth writing home about. And the remark that participants acted as their own controls is a new level of obfuscation: there were no controls, and the results are based on before/after comparisons. Thus none of the outcomes can be attributed to shiatsu; more likely, they are due to the natural history of the condition, placebo effects, concomitant treatments, social desirability etc.

What sort of journal publishes such drivel that can only have the effect of giving a bad name to clinical research? The Journal of Integrative Medicine (JIM) is a peer-reviewed journal sponsored by Shanghai Association of Integrative Medicine and Shanghai Changhai Hospital, China. It is a continuation of the Journal of Chinese Integrative Medicine (JCIM), which was established in 2003 and published in Chinese language. Since 2013, JIM has been published in English language. They state that the editorial board is committed to publishing high-quality papers on integrative medicine... I consider this as a bad joke! More likely, this journal is little more than an organ for popularising TCM propaganda in the West.

And which publisher hosts such a journal?

Elsevier

What a disgrace!

 

The over-use of X-ray diagnostics by chiropractors has long been a concern (see for instance here,and here). As there is a paucity of reliable research on this issue, this new review is more than welcome.

It aimed to summarise the current evidence for the use of spinal X-ray in chiropractic practice, with consideration of the related risks and benefits. The authors, chiropractors from Australia and Canada who did a remarkable job in avoiding the term SUBLUXATION throughout the paper, showed that the proportion of patients receiving X-ray as a result of chiropractic consultation ranges from 8 to 84%. I find this range quite staggering and in need of an explanation.

The authors also stated that current evidence supports the use of spinal X-rays only in the diagnosis of trauma and spondyloarthropathy, and in the assessment of progressive spinal structural deformities such as adolescent idiopathic scoliosis. MRI is indicated to diagnose serious pathology such as cancer or infection, and to assess the need for surgical management in radiculopathy and spinal stenosis. Strong evidence demonstrates risks of imaging such as excessive radiation exposure, over-diagnosis, subsequent low-value investigation and treatment procedures, and increased costs. In most cases the potential benefits from routine imaging, including spinal X-rays, do not outweigh the potential harms. The authors state that the use of spinal X-rays should not be routinely performed in chiropractic practice, and should be guided by clinical guidelines and clinician judgement.

The problem, however, is that many chiropractors do not abide by those guidelines. The most recent data I am aware of suggests that  only about half of them are even aware of radiographic guidelines for low back pain. The reasons given for obtaining spinal X-rays by chiropractors are varied and many are not supported by evidence of benefit. These include diagnosis of pathology or trauma; determination of treatment options; detection of contraindications to care; spinal biomechanical analysis; patient reassurance; and medicolegal reasons.

One may well ask why chiropractors over-use X-rays. The authors of the new paper provide the following explanations:

  • lack of education,
  • ownership of X-ray facilities,
  • and preferred chiropractic technique modalities (i. e. treatment techniques which advocate the use of routine spinal X-rays to perform biomechanical analysis, direct appropriate treatment, and perform patient reassessment).

Crucially, the authors state that, based on the evidence, the use of X-ray imaging to diagnose benign spinal findings will not improve patient outcomes or safety. For care of non-specific back or neck pain, studies show no difference in treatment outcome when routine spinal X-rays have been used, compared to management without X-rays.

A common reason suggested by chiropractors for spinal X-ray imaging is to screen for anomalies or serious pathology that may contraindicate treatment that were otherwise unsuspected by the clinical presentation. While some cases of serious pathology, such as cancer and infection, may not initially present with definitive symptoms, X-ray assessment at this early stage of the disease process is also likely to be negative, and is not recommended as a screening tool.

The authors concluded that the use of spinal X-rays in chiropractic has been controversial, with benefits for the use of routine spinal X-rays being proposed by some elements of the profession. However, evidence of these postulated benefits is limited or non-existent. There is strong evidence to demonstrate potential harms associated with spinal X-rays including increased ionising radiation exposure, over-diagnosis, subsequent low-value investigation and treatment procedures, and increased unnecessary costs. Therefore, in the vast majority of cases who present to chiropractors, the potential benefit from spinal X-rays does not outweigh the potential harms. Spinal X-rays should not be performed as a routine part of chiropractic practice, and the decision to perform diagnostic imaging should be informed by evidence based clinical practice guidelines and clinician judgement.

So, if you consult a chiropractor – and I don’t quite see why you should – my advice would be not to agree to an X-ray.

Alternative medicine is an odd term (but it is probably as good or bad as any other term for it). It describes a wide range of treatments (and diagnostic techniques which I exclude from this discussion) that have hardly anything in common.

Hardly anything!

And that means there are a few common denominators. Here are 7 of them:

  1. The treatments have a long history and have thus stood the ‘test of time’.
  2. The treatments enjoy a lot of support.
  3. The treatments are natural and therefore safe.
  4. The treatments are holistic.
  5. The treatments tackle the root causes of the problem.
  6. The treatments are being suppressed by the establishment.
  7. The treatments are inexpensive and therefore value for money.

One only has to scratch the surface to discover that these common denominators of alternative medicine turn out to be unmitigated nonsense.

Let me explain:

The treatments have a long history and have thus stood the ‘test of time’.

It is true that most alternative therapies have a long history; but what does that really mean? In my view, it signals but one thing: when these therapies were invented, people had no idea how our body functions; they mostly had speculations, superstitions and myths. It follows, I think, that the treatments in question are built on speculations, superstitions and myths.

This might be a bit too harsh, I admit. But one thing is absolutely sure: a long history of usage is no proof of efficacy.

The treatments enjoy a lot of support.

Again, this is true. Alternative treatments are supported by many patients who swear by them, by thousands of clinicians who employ them as well as by royalty and other celebrities who make the headlines with them.

Such support is usually based on experience or belief. Neither are evidence; quite the opposite, remember: the three most dangerous words in medicine are ‘IN MY EXPERIENCE’. To be clear, experience and belief can fool us profoundly, and science is a tool to prevent us being misled by them.

The treatments are natural and therefore safe.

Here we have two fallacies moulded into one. Firstly, not all alternative therapies are natural; secondly, none is entirely safe.

There is nothing natural about diluting the Berlin Wall and selling it as a homeopathic remedy. There is nothing natural about forcing a spinal joint beyond its physiological range of motion and calling it spinal manipulation. There is nothing natural about sticking needles into the skin and claiming this re-balances our vital energies.

Acupuncture, chiropractic, herbal medicine, etc. are burdened with their fair share of adverse effects. But the real danger of alternative medicine is the harm done by neglecting effective therapies. Anyone who decides to forfeit conventional treatments for a serious condition, and uses alternative therapies instead, runs the risk of shortening their lives.

The treatments are holistic.

Alternative therapists try very hard to sell their treatments as holistic. This sounds good and must be an excellent marketing gimmick. Alas, it is not true.

There is nothing less holistic than seeing subluxations, yin/yang imbalances, auto-intoxications, energy blockages, etc. as the cause of all illness. Holism is at the heart of all good healthcare; the attempt by alternative practitioners to hijack it is merely a transparent attempt to boost their business.

The treatments tackle the root causes of the problem.

Alternative therapists claim that they can identify the root causes of all conditions and thus treat them more effectively than conventional clinicians who merely treat their symptoms. Nothing could be further from the truth. Conventional medicine has been so spectacularly successful not least because we always aim at identifying the cause that underlie a symptom and, whenever possible, treat that cause (often in addition to treating symptoms). Alternative practitioners may well delude themselves that energy imbalances, subluxations, chi-blockages etc. are root causes, but there simply is no evidence to support their deluded claims.

The treatments are being suppressed by the establishment.

The feeling of paranoia seems endemic in alternative medicine. Many practitioners are so affected by it that they believe everyone who doubts their implausible notions and misconceptions is out to get them. Big Pharma’ or whoever else they feel prosecuted by are more likely to smile at such wild conspiracy theories than to fear for their profit margins. And whenever ‘Big Pharma’ does smell a fast buck, they do not hesitate to jump on the alternative band-waggon joining them in ripping off the public by flogging dubious supplements, homeopathics, essential oils, vitamins, flower remedies, detox-remedies, etc.

The treatments are inexpensive and therefore value for money.

It is probably true that the average cost of a homeopathic remedy, an acupuncture treatment or an aromatherapy session costs less than the average conventional treatment. However, to conclude from it that alternative therapies are value for money is wrong. To be of real value, a treatment needs to generate more good than harm; but very few alternative treatments fulfil this criterion. To use a blunt analogy, if someone offers you a used car, it may well be inexpensive – if, however, it does not run and is beyond repair, it cannot be value for money.

As I already stated: alternative medicine is so diverse that its various branches are almost entirely unrelated, and the few common denominators of alternative medicine that do exist are unmitigated nonsense.

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