MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

conflict of interest

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A comprehensive review of the evidence relating to acupuncture entitled “The Acupuncture Evidence Project: A Comparative Literature Review” has just been published. The document aims to provide “an updated review of the literature with greater rigour than was possible in the past.” That sounds great! Let’s see just how rigorous the assessment is.

The review was conducted by John McDonald who no stranger to this blog; we have mentioned him here, for instance. To call him an unbiased, experienced, or expert researcher would, in my view, be more than a little optimistic.

The review was financed by the ‘Australian Acupuncture and Chinese Medicine Association Ltd.’ – call me a pessimist, but I do wonder whether this bodes well for the objectivity of the findings.

The research seems to have been assisted by a range of experts: Professor Caroline Smith, National Institute of Complementary Medicine, Western Sydney University, provided advice regarding evidence levels for assisted reproduction trials; Associate Professor Zhen Zheng, RMIT University identified the evidence levels for postoperative nausea and vomiting and post-operative pain; Dr Suzanne Cochrane, Western Sydney University; Associate Professor Chris Zaslawski, University of Technology Sydney; and Associate Professor Zhen Zheng, RMIT University provided prepublication commentary and advice. I fail to see anyone in this list who is an expert in EBM or who is even mildly critical of acupuncture and the many claims that are being made for it.

The review has not been published in a journal. This means, it has not been peer-reviewed. As we will see shortly, there is reason to doubt that it could pass the peer-review process of any serious journal.

There is an intriguing declaration of conflicts of interest: “Dr John McDonald was a co-author of three of the research papers referenced in this review. Professor Caroline Smith was a co-author of six of the research papers referenced in this review, and Associate Professor Zhen Zheng was co-author of one of the research papers in this review. There were no other conflicts of interest.” Did they all forget to mention that they earn their livelihoods through acupuncture? Or is that not a conflict?

I do love the disclaimer: “The authors and the Australian Acupuncture and Chinese Medicine Association Ltd (AACMA) give no warranty that the information contained in this publication and within any online updates available on the AACMA website are correct or complete.” I think they have a point here.

But let’s not be petty, let’s look at the actual review and how well it was done!

Systematic reviews must first formulate a precise research question, then disclose the exact methodology, reveal the results and finally discuss them critically. I am afraid, I miss almost all of these essential elements in the document in question.

The methods section includes statements which puzzle me (my comments are in bold):

  • A total of 136 systematic reviews, including 27 Cochrane systematic reviews were included in this review, along with three network meta-analyses, nine reviews of reviews and 20 other reviews. Does that indicate that non-systematic reviews were included too? Yes, it does – but only, if they reported a positive result, I presume.
  • Some of the included systematic reviews included studies which were not randomised controlled trials. In this case, they should have not been included at all, in my view.
  • … evidence from individual randomised controlled trials has been included occasionally where new high quality randomised trials may have changed the conclusions from the most recent systematic review. ‘Occasionally’ is the antithesis of systematic. This discloses the present review as being non-systematic and therefore worthless.
  • Some systematic reviews have not reported an assessment of quality of evidence of included trials, and due to time constraints, this review has not attempted to make such an assessment. Say no more!

It is almost needless to mention that the findings (presented in a host of hardly understandable tables) suggest that acupuncture is of proven or possible effectiveness/efficacy for a very wide array of conditions. It also goes without saying that there is no critical discussion, for instance, of the fact that most of the included evidence originated from China, and that it has been shown over and over again that Chinese acupuncture research never seems to produce negative results.

So, what might we conclude from all this?

I don’t know about you, but for me this new review is nothing but an orgy in deceit and wishful thinking!

When I started this blog, I promised to discuss all major alternative modalities. This is a big task, and I am not nearly there yet. For instance, I have so far written hardly anything about ‘Schuessler Salts’, a derivative of homeopathy that is hugely popular in Germany and is slowly spreading also to other countries. According to ‘Homeopathy Plus’, Schuessler’s Tissue Salts are ‘a medicine chest for the whole family’. Specifically, his is what they say:

… Tissue Salts were first developed by the German doctor, Wilhelm Schuessler, who said ill-health was caused by an imbalance in the bodies twelve vital cell salts. Schuessler believed that these imbalances could be corrected by easily absorbed and homeopathically-prepared, micro-doses of each salt.

Schuessler’s Tissue Salts (also known as biochemic or cell salts) are potentised micro-doses of the 12 essential minerals your body needs to repair and maintain itself.  They are prepared in homeopathic 6X potencies that are gentle enough to be used by the youngest to the eldest member of your family. They can even be used with pets.

Schuessler introduced his homeopathically-Wilhelm Schüßlerprepared Tissue Salts more than 100 years ago but today, they have spread to most parts of the world where families and individuals rely on them as simple home treatments for a wide range of problems.

Tissue Salts, as either individual remedies or in combination, are an ideal addition to the home medicine cabinet for simple health complaints. They are:

  • Gentle
  • Absorbed rapidly
  • Natural
  • Pleasant tasting
  • Lactose free
  • Convenient to carry
  • Non-toxic and non-addictive
  • Safe to use with prescription medicines
  • Suitable for broad, general health complaints (unlike standard homeopathy that requires more precise symptom matching).

END OF QUOTE

Other websites offer much more concrete recommendations for the 12 specific remedies; for instance this one:

1.  KALI  PHOS (Kali Phosphoricum; Potassium Phosphate)
a. mental/emotional symptoms predominate
b. Feel as if “I’m too tired to rest.”
c. Anxiety, brain fatigue, irritability, temper-tantrums, sleeplessness, dizziness,
nervous asthma
d. easily bleeding gums

2.  KALI MUR (Kali Muriaticum; Potassium Chloride)
a. white mucus, swollen glands
b. white or gray coated tongue, glandular swellings, discharge of white, thick
mucus from nose or eyes
c. indigestion from rich food

3.  KALI SULPH (Kali Sulphuricum; Potassium Sulphate)
a. yellow mucus, later stages of illness, congestion and cough worse in evening
b. dandruff, yellow coated tongue, yellow crusts on eyelids
c. gas, poor digestion

4.  CALC PHOS (Calcarea Phosphorica; Calcium Phosphate)
a. teething remedy
b. upset stomach, post-nasal drip, chronic cold feet, poor dentition

5.  CALC SULPH (Calcarea Sulphurica; Calcium Sulphate)
a. sores that heal poorly, herpes blisters
b. pain in forehead, vertigo, pimples on the face

6.  CALC FLUOR (Calcarea Fluorica; Calcium Fluoride)
a. poor tooth enamel, cracks in palms of hands, lips
b. hemorrhoids

7.  NAT MUR (Natrum Muriate; Sodium Chloride)
a.  dryness of body openings, clear thin mucus
b. effects of excess overheating; itching of hair at nape of neck
c. early stage of common colds with clear, running discharge
d. insect bites (applied locally)

8.  NAT SULPH (Natrum Sulphuricum; Sodium Sulphate)
a. rarely needed
b. green stools and other excess bile symptoms
c. Sensitive scalp, greenish-gray or greenish-brown coating on tongue, influenza

9.  NAT PHOS (Natrum Phosphoricum; Sodium Phosphate)
a. simple morning sickness; acid rising in throat
b. Headache on crown of head, eyelids glued together in morning,
c. grinding of teeth in sleep; pain and sour risings from stomach after eating

10. MAG PHOS (Magnesia Phosphorica; Magnesium Phosphate)
a. Muscle spasms, cramps and menstrual cramps, if always better with heat
b. hiccups; trembling of hands
c. teeth sensitive to cold

11. FERRUM PHOS ( Ferrum Phosphate; Ferrum Phosphate)
a. first stages of inflammation, redness, swelling, early fever
b. congestive headache, earache, sore throat
c. loss of voice from overuse

12. SILICEA (Silica)
a. white pus forming conditions, boils (“homeopathic lancet”), stony-hard glands
b. Sty in eye area, tonsillitis, brittle nails

END OF QUOTE

All these promotional websites are guilty of two remarkable omissions:

  1. these remedies are biologically implausible,
  2. there is not a jot of evidence to suggest they are more than pure placebos.

Even if the ingredients named on the bottles were effective, the salts are far too dilute (6X signifies a dilution of 1: 1000000) to have any meaningful health effects. Unsurprisingly, there is no evidence whatsoever that these remedies work. I could not find a single study on Schuessler Salts – but if anyone knows of one, I would be ready to change my view. However, I did find this quote from the ‘Government Gazette of Western Australia’ 1946:

THE following report is issued under section 210 of the Health Act, 1911-1944:- It is claimed that the above “remedy” [Dr. Schuessler’s Cell Salts, Kali Phos. 3X] is “indicated in loss of mental power, brain fog, paralysis of any part, nervous headaches, neuralgic pains, general disability and exhaustion and sleeplessness from nervous disorders.” The “remedy” has been analysed and been found to contain potassium dihydrogen phosphate and lactose. The actual quantity of potassium dihydrogen phosphate in the “adult dose” is so minute that over 9,000 tablets would be necessary to give the minimum medicinal dose of this drug. Lactose is a sugar which is of no value in the treatment of any of the above-mentioned maladies. Dr. Schuessler’s Cell Salts can therefore have no curative value. They will bring about no improvement in any of the illnesses for which they are said to be indicated. Any expenditure on the purchase of these salts will be money wasted.

— C. E. COOK, Commissioner of Public Health
END OF QUOTE
The conclusion is depressingly simple: Schuessler Salts may be popular, but they are both implausible and unproven; hence they do not belong in anyone’s medicine chest.

Chiropractic is hugely popular, we are often told. The fallacious implication is, of course, that popularity can serve as a surrogate measure for effectiveness. In the United States, chiropractors provided 18.6 million clinical services under Medicare in 2015, and overall spending for chiropractic services was estimated at USD $12.5 billion. Elsewhere, chiropractic seems to be less commonly used, and the global situation has not recently been outlined. The authors of this ‘global overview‘ might fill this gap by summarizing the current literature on the utilization of chiropractic services, reasons for seeking care, patient profiles, and assessment and treatment provided.

Systematic searches were conducted in MEDLINE, CINAHL, and Index to Chiropractic Literature from database inception to January 2016. Eligible articles

1) were published in English or French (not all that global then!);

2) were case series, descriptive, cross-sectional, or cohort studies;

3) described patients receiving chiropractic services;

4) reported on the following theme(s): utilization rates of chiropractic services; reasons for attending chiropractic care; profiles of chiropractic patients; or, types of chiropractic services provided.

The literature searches retrieved 328 studies (reported in 337 articles) that reported on chiropractic utilization (245 studies), reason for attending chiropractic care (85 studies), patient demographics (130 studies), and assessment and treatment provided (34 studies).

Globally, the median 12-month utilization of chiropractic services was 9.1% (interquartile range (IQR): 6.7%-13.1%) and remained stable between 1980 and 2015. Most patients consulting chiropractors were female (57.0%, IQR: 53.2%-60.0%) with a median age of 43.4 years (IQR: 39.6-48.0), and were employed.

The most common reported reasons for people attending chiropractic care were (median) low back pain (49.7%, IQR: 43.0%-60.2%), neck pain (22.5%, IQR: 16.3%-24.5%), and extremity problems (10.0%, IQR: 4.3%-22.0%). The most common treatment provided by chiropractors included (median) spinal manipulation (79.3%, IQR: 55.4%-91.3%), soft-tissue therapy (35.1%, IQR: 16.5%-52.0%), and formal patient education (31.3%, IQR: 22.6%-65.0%).

The authors concluded that this comprehensive overview on the world-wide state of the chiropractic profession documented trends in the literature over the last four decades. The findings support the diverse nature of chiropractic practice, although common trends emerged.

My interpretation of the data presented is somewhat different from that of the authors. For instance, I fail to share the notion that utilization remained stable over time.

The figure might not be totally conclusive, but I seem to detect a peak in 2005, followed by a decline. Also, as the vast majority of studies originate from the US, I find it difficult to conclude anything about global trends in utilization.

Some of the more remarkable findings of this paper include the fact that 3.1% (IQR: 1.6%-6.1%) of the general population sought chiropractic care for visceral/non-musculoskeletal conditions. Some of the reasons for attending chiropractic care reported by the paediatric population are equally noteworthy: 7% for infections, 5% for asthma, and 5% for stomach problems. Globally, 5% of all consultations were for wellness/maintenance. None of these indications is even remotely evidence-based, of course.

Remarkably, 35% of chiropractors used X-ray diagnostics, and only 31% did a full history of their patients. Spinal manipulation was used by 79%, 31% sold nutritional supplements to their patients, and 10% used applied kinesiology.

In general, this is an informative paper. However, it suffers from a distinct lack of critical input. It seems to skip over almost all areas that might be less than favourable for chiropractors. The reason for this becomes clear, I think, when we read the source of funding for the research: PJHB, AEB, SAM and SDF have received research funding from the Canadian national and provincial chiropractic organizations, either as salary support or for research project funding. JJW received research project funding from the Ontario Chiropractic Association, outside the submitted work. SDF is Deputy Editor-in-Chief for Chiropractic and Manual Therapies; however, he did not have any involvement in the editorial process for this manuscript and was blinded from the editorial system for this paper from submission to decision.

 

Malaria is an infection caused by protozoa usually transmitted via mosquito bites. Malaria is an important disease for homeopaths because of Hahnemann’s quinine experiment: it made him postulate his ‘like cures like’ theory. Today, many experts assume that Hahnemann misinterpreted the results of this experience. Yet most homeopaths are still convinced that potentised cinchona bark is an effective prophylaxis against malaria. Some homeopathic pharmacies still offer homeopathic immunisations against the infection. In several cases, this has caused people who believed to be protected fall ill with the infection.

Perhaps because of this long tradition, homeopaths seem to have difficulties giving up the idea that they hold the key to effective malaria prevention. An article published in THE INDIAN EXPRESS entitled ‘Research suggests hope for homoeopathic vaccine to treat malaria’ reminds us of this bizarre phenomenon:

…In a laboratory test set-up, an ultra-dilute homoeopathic preparation was prepared by extracting samples from Plasmodium falciparum, the parasite that causes malaria. The homoeopathic preparation was used in-vitro to check if it had anti-malarial activity… “Homoeopathy has been criticised for lack of scientific evidence. This lab-model test established that a medicine developed from an organism that causes malaria can be used to treat the infection,” said Dr Rajesh Shah, principal investigator in the research.

Following the tests, Shah is approaching the government in order to conduct a full-fledged clinical trial for the homoeopathic medicine. “We found that the homoeopathic medicine exhibited 65 per cent inhibition against malaria while chloroquine treatment has 54 per cent efficacy,” Shah claimed. The research was published in the International Journal of Medical and Health Research in July. It observed that the homoeopathic solution inhibited enzyme called hemozoin is known to have an anti-malarial effect…

END OF QUOTE

I thought this story was both remarkable and odd. So I looked up the original paper. Here is the abstract:

The inventor has developed malaria nosode and has subjected it for evaluation of antimalarial activity in vitro assay along with few other homeopathy preparations. The potential antimalarial activity of the Malaria nosode, Malaria officinalis and China officinalis was evaluated by β-Hematin Formation Assay. The hemozoin content was determined by measuring the absorbance at 400 nm. The results were recorded as % inhibition of heme crystallization compared to negative control (DMSO) Malaria nosode, Malaria officinalis and China officinalis exhibited inhibition of hemozoin and the inhibition was greater than the positive control Chloroquine diphosphate used in the study. The study has shown anti-disease activity of an ultra-dilute (potentized) homeopathic preparation. The Malaria nosode prepared by potentizing Plasmodium falciparum organisms has demonstrated antimalarial activity, which supports the basic principle behind homeopathy, the law of similar.

Now I am just as puzzled!

Why would any responsible scientist advocate running a ‘full-fledged clinical trial’ on the basis of such flimsy and implausible findings?

Would that not be highly unethical?

Would one not do further in-vitro tests?

Then perhaps some animal studies?

Followed by first studies in humans?

Followed perhaps by a small pilot study?

And, if all these have generated positive results, eventually a proper clinical trial?

The answers to all these questions is YES.

But not in homeopathy, it seems!

This article is worth reading, I think.

It again begs the question whether the GCC is fit for purpose.

START OF QUOTE

AN ILKLEY chiropractor has been found guilty of unacceptable professional conduct by the General Chiropractic Council (GCC).

Dr John Rees, who works at Ilkley Chiropractic Clinic, Wilmot House, Railway Road, appeared before the Professional Conduct Committee of the Council at a hearing in London from November 6 to 8. Dr Rees faced allegations in relation to a female patient, known as patient A, who was registered under the care of Mr Rees on various dates between May 20, 2016 and June 10, 2016 and June 11, 2016 and June 15, 2016.

The committee found the admitted particulars proved, however, other, more serious allegations he had been facing, but had always denied, were dropped as there was no reliable evidence to support them. Ms Harris for the GCC told the hearing that notwithstanding the concessions made by the GCC the registrant’s behaviour, even if well received by the patient, was inappropriate, an abuse of the patient-practitioner relationship and the sort of behaviour that brings the profession into disrepute.

Dr Rees was represented at the hearing by Mr Kitching who described the events of 2016 as “a professional disaster for the registrant, an embarrassment which he regretted on a personal and professional level.” Mr Kitching submitted that physical contact with patient A had gone no further than drinks, a kiss, a hug and that the matters were at the lower end of the scale of breaches. He invited the committee to consider patient A had been a willing participant and was both intelligent and mature and could not be considered as vulnerable.

However, the committee determined that Dr Rees’s behaviour “embraced both a risk to the reputation of the profession and also the protection of patients. The committee added: “Whilst much of the behaviour had been consensual the registrant had been in a position of power, he had planned the progression of the relationship and this amounted to serious acts on his behalf.”

The hearing concluded that Dr Rees’s conduct “fell seriously below the standards expected of a chiropractor and that, consequently, Dr Rees is guilty of unacceptable professional conduct.” In making a sanction against Dr Rees the committee noted a wide range of supportive testimonials and references and his previous good character. The committee was satisfied that the misconduct was not “fundamentally incompatible with continued registration”. It imposed the sanction of an admonishment – a formal warning – upon Dr Rees.

Following the hearing Dr Rees told the Gazette: “My professional body has considered all the pertinent facts and come to its decision. The matter is now closed. I would like to thank my patients for their generous support during this difficult period.”

END OF QUOTE

ADDITIONAL INFO COPIED FROM THE GCC ‘NOTICE OF DECISION’:

  • The kiss or attempted kiss was ‘on the lips’.
  • Rees gave the patient presents, including a bikini.
  • Rees attended patient’s home address.
  • Rees seems to have falsified the patient’s case notes and thus ‘acted dishonestly’.
  • Rees called the patient ‘an evil loose woman’, ‘a bunny boiler’ and ‘a slapper’.

Do I understand this right? The GCC concluded that “much of the behaviour had been consensual”. To me, this indicates that some of the behaviour was not consensual. How then could the GCC find that Rees’s behaviour was compatible with continued registration?  And how could they imposed merely a formal warning upon Dr Rees?

I fail to comprehend this verdict.

Also I fail to understand why Rees allows himself to be called a ‘doctor’.

And I again ask: IS THE GCC FIT FOR PURPOSE?

This randomized controlled trial was aimed to investigate the effect of aromatherapy massage on anxiety, depression, and physiologic parameters in older patients with acute coronary syndrome. It was conducted on 90 older women with acute coronary syndrome. The participants were randomly assigned into the intervention and control groups. The intervention group received reflexology with lavender essential oil plus routine care and the control group only received routine care. Physiologic parameters, the levels of anxiety and depression in the hospital were evaluated using a checklist and the Hospital’s Anxiety and Depression Scale, respectively, before and immediately after the intervention.

Significant differences in the levels of anxiety and depression were reported between the groups after the intervention. The analysis of physiological parameters revealed a statistically significant reduction in systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate. However, no significant difference was observed in the respiratory rate.

The authors concluded that aromatherapy massage can be considered by clinical nurses an efficient therapy for alleviating psychological and physiological responses among older women suffering from acute coronary syndrome.

WRONG!

This trial does not show remotely what the authors think. It demonstrates that A+B is always more than B. We have discussed this phenomenon so often that I hesitate to mention it again. Any study with the ‘A+B versus B’ design can only produce a positive result. The danger that this result is false-positive is so high that it is best to forget about such investigations altogether.

Ethics committees should not accept such protocols.

Researchers should stop running such studies.

Reviewers should not pass them for publication.

Editors should not publish such trials.

THEY MISLEAD ALL OF US AND GIVE CLINICAL RESEARCH A BAD NAME.

George Vithoulkas * (GV) is one of today’s most influential lay-homeopaths, a real ‘super guru’. He has many bizarre ideas; one of the most peculiar one was recently outlined in his article entitled ‘An innovative proposal for scientific alternative medical journals’. Here are a few excerpts from it:

…the only evidence that homeopathy can present to the scientific world at this moment are these thousands of cured cases. It is a waste of time, money, and energy to attempt to demonstrate the effectiveness of homeopathy through double blind trials.

… the international “scientific” community, which has neither direct perception nor personal experience of the beneficial effects of homeopathy, is forced to repeat the same old mantra: “Where is the evidence? Show us the evidence!” … the successes of homeopathy have remained hidden in the offices of hardworking homeopaths – and thus go largely ignored by the world’s medical authorities, governments, and the whole international scientific community…

… simple questions that are usually asked by the “gnorant”, for example, “Can homeopathy cure cancer, multiple sclerosis, ulcerative colitis, etc.?” are invalid and cannot elicit a direct answer because the reality is that many such cases can be ameliorated significantly, and a number can be cured…

A journal could invite a selected number of good prescribers from all over the world as a start to this project and let them contribute to their honest experience and results, as well as their failures. The possibilities and limitations would soon be revealed…

I admit that an argument against accepting cases is that it is possible that false or unreliable information could be provided. This risk could be minimized by preselecting a well-known group of good prescribers, who could be asked to submit their cases, at least in the first phase of such a radical change in the policy of the journals…

This way, instead of rejecting important homeopathic case studies, in the name of a dry intellectualism and conservatism, homeopathy journals (including alternative and complementary journals) could become lively and interesting: initiating debates and discussions on real issues of therapeutics in medicine…

Our own “Evidence Based Medicine” lies in the multitude of chronic cases treated with homeopathy that we can present to the world and on the better quality of life that such cures offer.

END OF QUOTES

So, GV wants homeopathy to thrive by means of publishing lots of case reports of patients who benefitted from homeopathy. And he believes that this suggestion is ‘innovative’? It is not! Case reports were all the rage 150 years ago before medicine started to become a little more scientific. And today, there are several journals specialising in the publication of case-reports, hundreds of journals that like accepting them, as well as dozens of websites that do little else but publishing case reports of homeopathy.

But case reports essentially are anecdotes. Medicine finally managed to progress from its dark ages when we realised how unreliable case reports truly are. To state it yet again (especially for GV who seems to be a bit slow on the uptake): THE PLURAL OF ANECDOTE IS ANECDOTES, NOT EVIDENCE!

In the above article, GV claims that ‘it is a waste of time, money, and energy to attempt to demonstrate the effectiveness of homeopathy through double blind trials.’ That is most puzzling because, only a few years ago, he did publish this:

Alternative therapies in general, and homeopathy in particular, lack clear scientific evaluation of efficacy. Controlled clinical trials are urgently needed, especially for conditions that are not helped by conventional methods. The objective of this work was to assess the efficacy of homeopathic treatment in relieving symptoms associated with premenstrual syndrome (PMS). It was a randomised controlled double-blind clinical trial. Two months baseline assessment with post-intervention follow-up for 3 months was conducted at Hadassah Hospital outpatient gynaecology clinic in Jerusalem in Israel 1992-1994. The subjects were 20 women, aged 20-48, suffering from PMS. Homeopathic intervention was chosen individually for each patient, according to a model of symptom clusters. Recruited volunteers with PMS were treated randomly with one oral dose of a homeopathic medication or placebo. The main outcome measure was scores of a daily menstrual distress questionnaire (MDQ) before and after treatment. Psychological tests for suggestibility were used to examine the possible effects of suggestion. Mean MDQ scores fell from 0.44 to 0.13 (P<0.05) with active treatment, and from 0.38 to 0.34 with placebo (NS). (Between group P=0.057). Improvement >30% was observed in 90% of patients receiving active treatment and 37.5% receiving placebo (P=0.048). Homeopathic treatment was found to be effective in alleviating the symptoms of PMS in comparison to placebo. The use of symptom clusters in this trial may offer a novel approach that will facilitate clinical trials in homeopathy. Further research is in progress.

I find this intriguing, particularly because the ‘further research’ mentioned prominently in the conclusions never did surface! Perhaps its results turned out to be unfavourable to homeopathy? Perhaps this is why GV dislikes RCTs these days? Perhaps this is why he prefers case reports such as this one which he recently published:

START OF QUOTE

An 81-year-old female patient was admitted in July 2015 to the Cardiovascular Surgery Department of a hospital in Bucharest for an aortic valve replacement surgery.

The patient had a history of mild hypertension, insulin-dependent type 2 diabetes, coronary artery disease, congestive heart failure NYHA 2, severe aortic stenosis, moderate mitral regurgitation, mild pulmonary hypertension, bilateral carotid atheromatosis with a 50% stenosis of the left internal carotid artery, complete right mastectomy for breast cancer (at that moment in remission).

After a preoperative evaluation and preparation, the surgery was completed with the replacement of the aortic valve with a bioprosthesis (Medtronic Hancock II Ultra no. 23) and myocardial revascularization by using a double aortic-coronary bypass.

The post-operatory evolution was a good one in terms of the heart disease. However, the patient did not regain consciousness after the anaesthesia, maintaining a deep comatose state (GCS 7 points – E1V2M4).

A brain CT was performed the third day postoperatively, showing no recent ischemic or haemorrhagic cerebral lesions, moderate diffuse cerebral atrophy and carotid atheromatosis.

After the surgery, the patient was admitted to the Intensive Care Unit and was treated by using a multidisciplinary approach. The patient was treated with inotropic, antiarrhythmic, and diuretic drugs, insulin and antidiabetic drugs were used in order to keep the blood sugar levels under control. The patient was kept hydrated and the electrolytes balanced by using an i.v. line, prophylaxis for deep vein thrombosis, and pulmonary thromboembolism was performed by using low molecular weight heparin. Prophylaxis for bedsores was also performed by using a pressure relieve air mattress.

The patient went into acute respiratory distress, needing mechanical ventilation in order to maintain oxygenation.

Despite these complex and correctly performed therapeutic efforts, the patient did not regain consciousness and was still in a deep coma in the fourteenth day post-operatory (GCS 7 points – E1V2M4), without having a confirmed medical explanation.

At that point, the patient’s family requested a consult from a homeopathic specialist.

The homeopathic examination, which was performed in the fourteenth day postoperatively, revealed the following: old, comatose, tranquil patient, with pale and cold skin, with the need to uncover herself (the few movements that she made with her hands were to remove her blanket and clothes, as if she wanted more air – “thirst for air”), abdominal distension, and bloating.

The thorough evaluation of the patient and the analysis of her symptoms led us to the remedy most appropriate for this critical situation – Carbo Vegetabilis.

Homeopathic treatment was initiated the same day, by using Carbo Vegetabilis 200CH 7 granules twice a day, administered diluted in 20ml of water by using a nasogastric tube.

The patient’s evolution was spectacular. The next day after the initiation of the treatment (fifteenth day postoperatively) the patient was in a superficial coma (GCS 11 points – E2V4M5), and the following day she regained consciousness. Carbo Vegetabilis was administered in the same dose for a total of five days (including the nineteenth day postoperatively).

After these five days, the case was reassessed from a homeopathically point of view and the second evaluation revealed the following: severely dyspnoeic patient (even talking caused exhaustion) with pale skin, severe fatigue aggravated by the slightest movements, a weakness sensation located in the chest area, extreme lack of energy, the wish “to be left alone”.

Considering the state of general exhaustion the patient was in at that moment and her lack of energy, the homeopathic treatment was changed to a new remedy: Stanum metallicum 30CH 7 granules administered sublingually twice a day for a week.

After the administration of the second remedy, the patient’s general condition improved dramatically: she started eating, she was able to get up in a sitting position with only little help, her fatigue diminished significantly.

The patient was then transferred to a recovery clinic in Cluj-Napoca in order to continue the cardiovascular recovery treatment. During her three-week admission in the clinic, she followed an individualized cardiovascular recovery program, which led to her ability to walk short distances with minimal support and has was released from the hospital in September 2015.

The following weeks after release, the patient recovered almost entirely, both physically and mentally. She was able to retake her place in her family and in society in general.

END OF QUOTE

One has to be a homeopath (one who is ignorant of the ‘post hoc propter hoc fallacy’) to believe in a causal link between the intake of the homeopathic remedy and the recovery of this patient. Thankfully, comatose patients do re-gain consciousness all the time! Even without homeopathy! But GV seems to not know that. In the discussion of this paper, he even states this: “ even after a well-conducted therapy, this condition leads to the death of the patient.” Is it ethical to publish such falsehoods, I wonder?

As far as the case report goes, the homeopathic remedy might even have delayed the process – perhaps the patient would have re-gained consciousness quicker and more completely without it! My hypothesis (homeopathy cased harm) is exactly as strong and silly as the one (homeopathy cased benefit) of GV. Anecdotes will never be able to answer the question as to who is correct.

One has to be a homeopath (and a daft one at that) to believe that this sort of evidence will lead to the acceptance of homeopathy by the scientific community. No journal will take GV seriously. No editor can be that stupid!

Oooops! Hold on, I might be wrong here.

Dr Peter Fisher, editor of the journal ‘Homeopathy’ just published an editorial ( Fisher P, Homeopathy and intellectual honesty, Homeopathy (2017), see also my previous post) stating that, in future, ‘we will increase publication of well-documented case-reports’.

Did I just claim that no editor can be that stupid?

 

 

 

  • I should declare a conflict of interest: when he got his ‘Right Livelihood Award’, GV sent me (and other prominent homeopathy-researchers) some of the prize money (I think it was around £ 1000) to support my research in homeopathy. I used it for exactly that purpose.

 

Dr Peter Fisher (I have mentioned him several times before, see for instance here, here and here) claimed in his recent editorial (Fisher P, Homeopathy and intellectual honesty, Homeopathy (2017) – not yet available on Medline) that 43 systematic reviews of homeopathy have so far been published, and stated that “of these 21 were clearly or tentatively positive and 9 inconclusive”. In my book, this would mean that the majority of systematic reviews fail to be clearly positive. But Fisher seems to view this mini-statistic as a proof of homeopathy’s efficacy.

As evidence for his statement, Fisher cites this article from his own journal (‘Homeopathy’). However, the paper actually says this: “A total of 36 condition-specific systematic reviews have been identified in the peer-reviewed literature: 16 of them reported positive, or tentatively positive, conclusions about homeopathy’s clinical effectiveness; the other 20 were negative or non-conclusive.”

Odd?

Confused by this contradiction, I try to dig deeper. Medline provides currently 66 hits when searching systematic reviews of homeopathy. But this figure includes papers that are not really systematic reviews and excludes some relevant articles that are not Medline-listed.

The NHMRC report which Fisher also cites (see below) considered 57 systematic reviews of homeopathy. In his editorial, Fisher stated that the NHMRC report “seems to have missed some systematic reviews of homeopathy”. This can only mean that Fisher knows of more than 57 reviews. Why then does he claim that there are just 43?

Odd?

Yes, but Fisher’s editorial seems odd in several other ways as well.

  • He accuses the NHMRC-authors of ‘malpractice’.
  • He finds ‘shocking evidence of bias’.
  • He alleges that the EASAC-report ‘cherry-picks evidence’.
  • He accuses the EASAC-authors of ‘abuse of authority’.

Definitely odd!

Why does Dr Peter Fisher go this far, why is he so very aggressive?

I know Peter quite well. He is usually a fairly calm and collected sort of person who is not prone to irrational outbursts. This behaviour is therefore out of character.

So, why?

The only explanation that I have for his strange behaviour is that he feels cornered, has run out of rational arguments, and senses that homeopathy is now on its last leg.

What do you think?

The German Heilpraktiker (a phenomenon vaguely equivalent to the ‘naturopath’ in English speaking countries) has become a fairly regular feature on this blog – see, for instance here, here, and here. The nationally influential German Medical Journal, a weekly publication of the German Medical Association, recently published an article about the education of this profession.

In it, we are told that the German Ministry of Health has drafted a 9-page document to unify the examination of the Heilpraktiker throughout Germany. The German Medical Association, however, are critical about the planned reform. The draft document suggest that, in future, all Heilpraktiker should pass an exam consisting of 60 multiple choice questions, in addition to an oral examination in which 4 candidates are being interviewed simultaneously for one hour. The draft also stipulates that Heilpraktiker may only practice such that they present no danger for public health and only use methods they muster.

The German Medical Association feel that these reforms do not go far enough. They claim that the authors of the draft have ‘totally misunderstood the complexity of the medical context, particularly the amount of necessary knowledge necessary for risk-minimisation in clinical practice’. They furthermore feel that the document is ‘an effort that is in every respect insufficient for protecting the public or individuals from the practice of the Heilpraktiker’. They also state that it is unclear how the document might provide a means to test Heilpraktiker in respect of risk-minimisation. The Medical Association demands that ‘the practice of certain therapies by Heilpraktiker must be forbidden. Finally, they say that ‘the practice of invasive methods and the treatment of caner by Heilpraktiker must be urgently prohibited’.

The German Heilpraktiker has been a subject of much public debate recently, not least after the ‘Muenster Group’ suggested a comprehensive reform. (I reported about this at the time.)

For those who can read German, the original article from the German Medical Journal is copied below:

Das Bundesministerium für Gesundheit (BMG) will gemeinsam mit den Ländern die Heilpraktikerüberprüfung bundesweit vereinheitlichen und Patienten besser schützen. Dafür haben Bund und Länder einen neunseitigen Entwurf erarbeitet. Die Bundes­ärzte­kammer (BÄK) zeigt sich angesichts der Pläne besorgt und übt deutliche Kritik.

Der Entwurf sieht vor, dass zur Überprüfung der Kenntnisse von Heilpraktikern künftig eine Prüfung verpflichtend sein soll. Diese soll aus 60 Multiple-Choice-Fragen bestehen, von denen der Anwärter innerhalb von zwei Stunden 45 korrekt ankreuzen muss. Darüber hinaus ist ein mündlicher Prüfungsteil von einer Stunde vorgesehen – bei vier Prüflingen gleichzeitig.

Zusätzlich stellt der Entwurf klar, dass Heilpraktiker nur in dem Umfang Heilkunde ausüben dürfen, in dem von ihrer Tätigkeit keine Gefahr für die Gesundheit der Bevölkerung oder für Patientinnen und Patienten ausgeht. Sie müssten zudem „eventuelle Arztvorbehalte beachten und sich auf die Tätigkeiten beschränken, die sie sicher beherrschen“, heißt es in der Präambel des Bund-Länder-Entwurfes, der dem Deutschen Ärzteblatt vorliegt.

Der Bundes­ärzte­kammer geht der Text nicht weit genug. Die Autoren der Leitlinie für die Prüfung haben laut BÄK „die Komplexität des medizinischen Kontextes“ völlig verkannt, „insbesondere das Ausmaß des notwendigen medizinischen Wissens, das für eine gefahrenminimierte Ausübung der Heilkunde notwendig ist“, so die Kammer weiter. Die jetzt vorgelegten Leitlinien für die Überprüfung stelle „eine in jeder Hinsicht unzureichende Maßnahme zum Schutz der Bevölkerung oder gar einzelner Patienten vor möglichen Gesundheitsgefahren durch die Tätigkeit von Heilpraktikern dar.

Es sei nicht nachvollziehbar, „wie auf der Grundlage dieser Leitlinien eine Überprüfung von Heilpaktikeranwärtern unter dem Aspekt einer funktionierenden Gefahrenabwehr erfolgen soll“, so die Kammer weiter. Sie fordert, dass Heilpraktikern bestimmte Tätigkeiten verboten werden. „Konkret sieht die Bundes­ärzte­kammer insbesondere den Ausschluss aller invasiven Maßnahmen sowie der Behandlung von Krebserkrankungen als zwingend notwendig an“, heißt es in der Stellungnahme.

Der Bund-Länder-Entwurf ist Ergebnis einer Debatte darüber, was Heilpraktiker dürfen oder künftig nicht (mehr) dürfen sollten und wie die Regeln für den Gesundheitsberuf aussehen. Eine Expertengruppe, der „Münsteraner Kreis“, hatte unlängst Vorschläge für eine umfassende Reform erarbeitet. Das Thema war zuletzt in der Öffentlichkeit und auch der Ärzteschaft heftig diskutiert worden.

END OF QUOTE

So, how well should alt med practitioners be educated and trained?

The answer depends, I think, on what precisely they are allowed to do. Medical responsibility must always be matched to medical competence. If a massage therapist merely acts on the instructions of a doctor, she does not need to know the differential diagnosis of a headache, for instance.

If, however, practitioners independently diagnose diseases (and alt med practitioners often do exactly that!), they must have a knowledge-base similar to that of a GP. If they use potentially harmful treatments (and which therapy does not have the potential to do harm?), they must be aware of the evidence for or against these interventions, as well as the evidence for all other therapeutic options for the conditions in question. Again, this would mean having a knowledge close to GP-level. If there is a mismatch between responsibility and competence (as very often is the case), patients are exposed to avoidable risks.

It is clear from these considerations that an exam with 60 multiple-choice questions followed by an hour-long interview is woefully inadequate for testing whether a practitioner has sufficient medical competence to independently care for patients. It is also clear, I think, that practitioners who regularly diagnose and treat patients – usually without any supervision – ought to have an education that covers much of what doctors learn while in medical school. Finally, it is clear that even after an adequate education, practitioners need to gather experience and work under supervision for some time before they can responsibly practice independently.

In any case, uncritically teaching obsolete notions of vitalism, yin and yang, subluxation, detox, potentisation, millennia of experience etc. is certainly not good enough. Education has to be based on sound evidence; if not, it is not education but brain-washing. And the result would be that students do not become responsible healthcare professionals but irresponsible charlatans.

Of course, alt med practitioners will argue that these arguments are merely the expression of medics defending their lucrative patch. But even if this were true (which, in my view, it is not), it would not absolve them from the moral, ethical and legal duty to demonstrate that their educational standards are sufficiently rigorous to avoid harm to their patients.

In a nutshell: an education in nonsense must result in nonsense.

 

Gastro-oesophageal reflux disease (GORD) is a common, benign condition. It can be treated by changing eating habits or drugs. Many alternative therapies are also on offer, for instance, acupuncture. But does it work? Let’s find out.

The objective of this meta-analysis was to explore the effectiveness of acupuncture for the treatment of gastro-oesophageal reflux disease (GORD). Four English and four Chinese databases were searched through June 2016. Randomised controlled trials investigating the effectiveness of manual acupuncture or electroacupuncture (MA/EA) for GORD versus or as an adjunct to Western medicine (WM) were selected.

A total of 12 trials involving 1235 patients were included. The results demonstrated that patients receiving MA/EA combined with WM had a superior global symptom improvement compared with those receiving WM alone  with no significant heterogeneity. Recurrence rates of those receiving MA/EA alone were lower than those receiving WM  with low heterogeneity, while global symptom improvement (six studies) and symptom scores (three studies) were similar. Descriptive analyses suggested that acupuncture also improves quality of life in patients with GORD.

The authors concluded that this meta-analysis suggests that acupuncture is an effective and safe treatment for GORD. However, due to the small sample size and poor methodological quality of the included trials, further studies are required to validate our conclusions.

I am glad the authors used the verb ‘suggest’ in their conclusions. In fact, even this cautious terminology is too strong, in my view. Here are 9 reasons why:

  1. The hypothesis that acupuncture is effective for GORD lacks plausibility.
  2. All the studies were of poor or very poor methodological quality.
  3. All but one were from China, and we know that all acupuncture trials from this country are positive, thus casting serious doubt on their validity.
  4. Six trials had the infamous ‘A+B versus B’ design which never generates a negative result.
  5. There was evidence of publication bias, i. e. negative trials had disappeared and were thus not included in the meta-analysis.
  6. None of the trials made an attempt to control for placebo effects by using a sham-control procedure.
  7. None used patient-blinding.
  8. The safety of a therapy cannot be assessed on the basis of 12 trials
  9. Seven studies failed to report adverse effects, thus violating research ethics.

Considering these facts, I think that a different conclusion would have been more appropriate:  this meta-analysis provides no good evidence for the assumption that acupuncture is an effective and safe treatment for GORD.

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